User Manual
Dexcom G5x System User Guide
Glossary
2
Table of Contents
!"#$$%&'())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(*"
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2/3455453(6#7&(8/9:#; G5®x +#5.457#7$(!"7:#$/(<#54.#&453(='$./;(
>!?9@(A#7&5/'())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(01"
1.1"Introduction"...................................................................................."14"
1.2"Self-Paced"Resources"......................................................................"15"
1.3"Your"Dexcom"Account"....................................................................."18"
+,%-./&(B())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BC"
D5E4:%.4#5$(F#&(G$/(%5E(=%F/.'(=.%./;/5.()))))))))))))))))))))))))))))))))))))))))))))(BC"
2.1"Introduction"...................................................................................."20"
2.2"Important"User"Information"............................................................"20"
2.3"Safety"Statements"..........................................................................."21"
2.4"Overview"of"Safety"Statements"......................................................."23"
2.5"General"CGM"System"Warnings"......................................................"25"
2.6"Calibration"Warning"and"Precautions"............................................."27"
2.7"System/Hardware/Software"Warnings"and"Precautions"................"28"
+,%-./&(H())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(HI"
J4$K$(%5E(2/5/F4.$()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(HI"
3.1"Risks"................................................................................................"37"
3.2"Benefits"..........................................................................................."39"
+,%-./&(1())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(1B"
L,%.(D$(.,/(!?9M())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(1B"
4.1"System"Description"........................................................................."42"
4.2"Safety"Statement"............................................................................."42"
4.3"The"G5x"..........................................................................................."44"
4.4"What’s"New"to"the"G5x?"................................................................."46"
4.5"System"Information"........................................................................."47"
4.6"System"Components"......................................................................."47"
4.7"Smart"Device"Overview"..................................................................."57"
+,%-./&(?())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(?N"
=/.(G-(6#7&(84$-"%'(8/O4:/$())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(?N"
5.1"Introduction"...................................................................................."59"
5.2"Safety"Statement"............................................................................."59"
5.3"Why"Different"Monitoring"Methods?"............................................."60"
5.4"App".................................................................................................."61"
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3
5.5"Dexcom"Receiver"............................................................................."74"
+,%-./&(P())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(*0"
=.%&.453(%(=/5$#&(=/$$4#5Q(D5$/&.453(=/5$#&R(S..%:,453(T&%5$;4../&R(%5E(
=.%&.453(6#7&(=/$$4#5())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(*0"
6.1"Overview"........................................................................................."81"
6.2"Safety"Statements"..........................................................................."82"
6.3"Prepping"for"Sensor"Insertion"........................................................."85"
6.4"Choosing"Your"Insertion"Site"..........................................................."88"
6.5"Inserting"Your"Sensor"......................................................................"90"
6.6"Attaching"Your"Transmitter"............................................................."94"
6.7"Loose"Transmitter"Holder"..............................................................."97"
6.8"Starting"Your"Sensor"Session"..........................................................."97"
6.9"Receiver"Bluetooth"Tips"................................................................."102"
6.10"Sensor"Session"Warmup".............................................................."106"
+,%-./&(I())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0C*"
+%"4U&%.4#5())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0C*"
7.1"Introduction".................................................................................."108"
7.2"Safety"Statements"........................................................................."109"
7.3"Calibration"Overview"....................................................................."111"
7.4"When"to"Calibrate"........................................................................."113"
7.5"Calibration"Notifications"..............................................................."114"
7.6"Preparing"for"Calibration"..............................................................."118"
7.7"Ready?"Set?"Calibrate!".................................................................."119"
7.8"Calibration"Errors".........................................................................."126"
+,%-./&(*())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0BN"
V5E453(6#7&(=/5$#&(=/$$4#5(%5E(T&%5$;4../&(=/$$4#5())))))))))))))))))))))))))(0BN"
8.1"Introduction".................................................................................."129"
8.2"Safety"Statements"........................................................................."129"
8.3"Ending"Your"Sensor"Session".........................................................."130"
8.4"Remove"Sensor,"Transmitter,"and"Transmitter"Holder"................."145"
8.5"End"of"Transmitter"Battery"............................................................"148"
8.6"Pair"New"Transmitter"...................................................................."151"
+,%-./&(N())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0P0"
W#;/(=:&//5R(J%./(#F(+,%53/(S&&#X$R(%5E(V&&#&$()))))))))))))))))))))))))))))))(0P0"
9.1"Introduction"to"Home"Screens"......................................................"161"
9.2"Safety"Statements"........................................................................."161"
9.3"Overview"of"Home"Screen"............................................................."163"
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Glossary
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Apple"Today"View"Widget"..................................................................."171"
9.4"Rate"of"Change"Arrows"................................................................."181"
9.5"Error"Messages".............................................................................."182"
+,%-./&(0C())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0*N"
8%4"'(VO/5.$(SFF/:.(6#7&(!"7:#$/(T&/5E$(%5E(Y%../&5$())))))))))))))))))))))))(0*N"
10.1"Introduction"................................................................................"189"
10.2"What"Is"an"Event?"......................................................................."189"
10.3"Entering"Events"..........................................................................."198"
10.4"Viewing"Events"............................................................................"207"
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=/5$#&(!"7:#$/(S"%&;(%5E(S"/&.$())))))))))))))))))))))))))))))))))))))))))))))))))))))))(BCN"
11.1"Introduction"................................................................................"209"
11.2"Safety"Statements"......................................................................."210"
11.3"Alarm"and"Alerts"........................................................................."213"
11.4"Alarm"and"Alerts"Screens"............................................................"215"
11.5"App:"Alarm/Alert"Recommended"Settings".................................."221"
11.6"Receiver:"Default"Beeps"and"Vibrations"......................................"222"
11.7"Clearing"Alarm/Alerts".................................................................."226"
+,%-./&(0B())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BBN"
Next%StepsQ()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BBN"
Z5(.,/(!#(L4.,(!?9Q(+7$.#;4[453(6#7&(S"%&;(%5E(S"/&.$())))))))))))))))))))(BBN"
12.1"Introduction"................................................................................"229"
12.2"Safety"Statement"........................................................................."229"
12.3"Changing"app"Alarm"and"Alerts"..................................................."230"
12.4"Changing"Receiver"Alarm"and"Alerts"..........................................."243"
V\VJ6TWD]!(V^=V(!?9()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B?B"
+,%-./&(0H())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B?H"
L%&&%5.'Q(T,/(_45/(Y&45.()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B?H"
13.1"Introduction"................................................................................"253"
13.2"Receiver"Warranty"Information".................................................."253"
13.3"Transmitter"Warranty"Information"............................................."256"
13.4"Dexcom’s"Obligations"Under"the"Limited"Warranty"..................."257"
+,%-./&(01())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BPC"
W#X(.#(T%K/(+%&/(#F(6#7&(!?9())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BPC"
14.1"Introduction"................................................................................"260"
14.2"Basic"Maintenance"......................................................................"260"
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14.3"Storage"........................................................................................"268"
14.4"Checking"app"and"Receiver"Information"....................................."269"
14.5"System"Disposal".........................................................................."270"
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Z5(.,/(!#(L4.,(!?9Q(!/..453(T,I,(=/:7&4.'()))))))))))))))))))))))))))))))))))(BIB"
15.1"Introduction"................................................................................"272"
15.2"Safety"Statement"........................................................................."272"
15.3"Going"Through"Security"..............................................................."273"
+,%-./&(0P())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BIP"
]//E(W/"-M(6#7`&/(]#.(S"#5/a())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BIP"
16.1"Dexcom"Technical"Support"Team"................................................"276"
16.2"Dexcom"Patient"Care"Team"........................................................."277"
16.3"Dexcom"Sales"Support"Team"......................................................."278"
16.4"Corporate"...................................................................................."279"
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T/:,54:%"(D5F#&;%.4#5()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B*C"
17.1"Device"Performance"Characteristics"..........................................."280"
17.2"Product"Specifications"................................................................."325"
17.3"FCC"Requirements"......................................................................."334"
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TU"/$,##.453()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(HHP"
18.1"Introduction"................................................................................"336"
18.2"Safety"Statements"......................................................................."336"
18.3"Troubleshooting".........................................................................."337"
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=';U#"$(#5(Y%:K%3/(^%U/"$()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?H"
=WSJD]!(D=(+SJD]!())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?P"
+,%-./&(BC())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?I"
8/9:#;(Shareb()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?I"
20.1"Learning"About"Dexcom"Share"...................................................."357"
20.2"Dexcom"Share"Overview"............................................................."363"
20.3"Risks"and"Benefits"......................................................................."366"
20.4"Safety"Statement"........................................................................."367"
20.5"Setting"Up"Dexcom"Share"............................................................"371"
20.6"Using"Dexcom"Share"..................................................................."380"
20.7"Dexcom"Follow"App"...................................................................."386"
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Glossary
8
Glossary
A1C
Blood test used to diagnose type 1 or 2 diabetes
and to gauge how well you’re managing your
diabetes. The A1C test result reflects your
average blood sugar level for the past two to
three months.
Accessory Device
Hardware, connected to your smart device by
Bluetooth
, you use to get easy access to some of
its features. For example,
Bluetooth
headset,
Apple watch, or smart watch.
Also called wearables.
Alternative Site
Testing
Using a blood sample from non-fingertip
(alternative) sites such as the palm, forearm, or
upper arm for meter readings.
Do not use alternative site testing to calibrate the
Dexcom G5®x CGM System (G5x), only use
fingerstick measurement.
App
A self-contained program or piece of software
designed to fulfill a particular purpose; an
application, especially as downloaded by a user
to a smart or mobile device.
The Dexcom G5® Mobile app (app) was
developed as a display for continuous glucose
monitoring.
Apple Watch®
Accessory device for iPhone®.
Blood Glucose (BG)
An abbreviation of blood glucose. Blood glucose
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Glossary
9
(BG) value is the amount of glucose in the blood
measured by a BG meter.
Blood Glucose
Meter/Meter/BG
Meter
A medical device used to measure how much
glucose is in the blood.
Calibration
A comparison or measurement between your
meter’s fingerstick BG values and the sensor’s
interstitial fluid glucose readings. Although blood
and interstitial fluids are similar, glucose
concentration is higher in your blood. Calibration
allows alignment between your sensor and meter
readings.
When you calibrate, you take a fingerstick
measurement from your meter then enter the
value into your receiver or smart device. The
system uses that value to verify that the sensor
glucose reading is on track.
Continuous Glucose
Monitoring (CGM)
A system that uses a sensor inserted under the
skin to check glucose levels in interstitial fluid. A
transmitter sends sensor glucose readings to a
display device.
Users must confirm glucose levels with a BG
meter before making a change in treatment.
Contraindication
A safety statement outlining specific situations
where the system should not be used because it
may be harmful to you. The risk of use clearly
outweighs any possible benefit.
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Hyperglycemia
High BG. Same as “high” or high blood sugar.
Hyperglycemia is characterized by an excess of
glucose in the bloodstream.
It’s important to treat hyperglycemia. If left
untreated, hyperglycemia can lead to serious
complications.
The default High Glucose Alert in the G5x is set
to 200 mg/dL. Consult your healthcare
professional to determine the appropriate
hyperglycemic setting for you.
Hypoglycemia
Low BG. Same as “low” or low blood sugar.
Hypoglycemia is characterized by a low level of
glucose in the bloodstream.
It’s important to treat hypoglycemia. If left
untreated, hypoglycemia can lead to serious
complications.
The default Low Glucose Alert in the G5x is set to
80 mg/dL. Consult your healthcare professional
to determine the appropriate hypoglycemic
setting for you.
Indications
A condition making a particular treatment or
procedure advisable. How, for what purposes,
and under what circumstances you should use
the G5x. Indications let you know who should use
the G5x and when.
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IP
The International Electrotechnical Commission
(IEC) is a nonprofit, non-governmental,
international organization created to produce
safety standards for electronics. One of the
safety standards it designed is the Ingress
Protection (IP) Marking, which classifies and
rates how protected an electronic device is
against dust, water, accidental contact, etc.
IP ratings are numerical, with the number based
on the conditions the electronic device comes
across.
An IP22 rating lets you know your electronic
device won’t allow you to stick your fingers in it
and won’t get damaged or be unsafe during
specific testing with water dripping down.
An IP28 rating tells you your electronic device
won’t let you stick your fingers in it and is safe for
long-term immersion in liquid up to a specified
pressure.
Jailbroken
The removal of limitations and security measures
set by the manufacturer on a smart device. The
removal poses a security risk, and data may
become vulnerable.
Do not use, install, or run the Dexcom G5 Mobile
app on a jailbroken smart device. The app may
not work correctly on a jailbroken smart device.
Landscape
When your smart device is oriented sideways.
mg/dL
Milligrams per deciliter. The standard unit of
measure for glucose readings in the United
States.
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Portrait
When your smart device is oriented vertically.
Precaution
A safety statement regarding any special care to
be exercised by you or your healthcare
professional for the safe and effective use of the
G5x.
RF
Radio-frequency (RF) transmission used to send
glucose information from the transmitter to the
receiver or smart device. Also used to send
calibration data from the receiver or smart device
to the transmitter.
Safety Statement
A statement of the intended uses of G5x and
relevant warnings, precautions, and
contraindications.
Sensor Session
The seven-day monitoring period after inserting a
new sensor.
During this time frame, your glucose is being
monitored and reported every five minutes, with
data being sent to your display device(s).
Smart/Mobile Device
Electronic device that can be wirelessly
connected to networks over Wi-Fi,
Bluetooth
, or a
cellular data connection (3G, 4G, etc.
Examples are smartphones, tablets, and smart
watches.
Today View
Swipe down to access information and
notifications on your iPhone, iPad®, and iPod®.
Warning
A safety statement letting you know the following
feature has important hazard information.
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Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey
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Chapter 1
Getting Started:
Beginning Your Dexcom G5®x Continuous Glucose
Monitoring System (G5x) Journey
1.1 Introduction
Welcome to the G5x family!
We are excited you chose us to partner with you in your journey to manage
your diabetes. As a continuous glucose monitoring (CGM) device, the G5x
allows you to break free from constant fingersticks. But how do you use the
G5x? What are its features? Do you need to avoid anything?
Where do you even begin?
This chapter is the first step to answering these and many other questions.
After this chapter, you will be able to:
• Describe different training resources
• Locate tutorials about using the G5x in your diabetes management
• Find G5x’s step-by-step instructions
• Recall how to use the user guide
• Explain why you need a Dexcom® account
We have numerous resources available to help you get the most out of your
G5x. Between our self-paced training resources and our friendly and
knowledgeable Dexcom customer support teams, help is always available.
First Things First - Learning How to Learn
Knowing about the G5x is your first step in creating a successful CGM
experience. Before using it, learn about it.
You have numerous self-paced resources, helping you get to know the G5x:
1. Tutorials
2. Getting Started Guide
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3. User Guide
No matter which resource(s) you select, make sure you review them prior to
using your new CGM system.
1.2 Self-Paced Resources
Tutorials
Along with step-by-step instructions, our tutorials illustrate how real-time CGM
can assist in your daily diabetes management. The following is a list of
tutorials and how to access them.
Online Tutorials
First Steps With Your Dexcom CGM
Designed for those who have never used a Dexcom CGM. This tutorial
covers what to expect in your first week and includes links to step-by-step
videos on how to insert your sensor, calibrations, ending a sensor session,
etc.
Next Steps With Your Dexcom CGM
Just finished First Steps or already familiar with how a CGM can benefit
you? This tutorial covers looking at trends and introduces some advanced
features including our reporting tools.
Accessing Online Tutorials:
From dexcom.com homepage, click
Support
.
Once you have viewed the online tutorials, you should be pretty comfortable
with what CGMs do and how the G5x can help you.
Offline Tutorials
You don’t need to be tied to the Internet to view our instructional tutorials,
they’re also available offline.
Accessing Offline Tutorials:
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USB Card in the receiver package.
Guides
Getting Started Guide (GSG)
The G5x GSG complements the tutorials by providing the same step-by-step
instructions in a booklet form or within the app.
One of the great things about the GSG is you can use it in conjunction with the
videos, taking notes as you go!
Accessing the GSG:
Booklet in the receiver package.
Both the tutorial and the GSG give you a brief look at the G5x. But what if you
want more detailed information?
User Guide
Your G5x reference book!
This user guide gives you the most extensive overview of the system,
detailing features, important safety information, and so much more.
To download an eBook of the user guide or request a printed user guide, visit
dexcom.com/guides.
The G5x user guide is grouped into six separate parts:
Part 1:
Getting Started
• Glossary
• Getting Started
o Learning how to learn about the G5x
o Registering at dexcom.com
• Indications for Use and Safety Statement
• Risks and Benefits
Part 2:
Let’s G5x! The Basics
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• Introduction to the G5x
• Initial Setup
• Starting a Sensor Session: Inserting the Sensor and Attaching
Transmitter
• Calibration
• Ending a Sensor Session and Transmitter Session
Part 3:
Next Steps - Getting the Most out of Your G5x
Once you are up and running, how you can maximize the G5x features:
• Reading Trend Graph Screens and Recognizing Trends
• Events
• Alarm and Alerts
• Sounds for Alarm, Alerts, and System Messages
Part 4:
Everything Else G5x
• Warranty
• G5x Maintenance
• Travel Tips
• Customer Service Contacts
• Technical Information
• Troubleshooting
• Symbols on Package Labels
At the end of your G5x user guide, Part 5, is the user guide for Dexcom
Share
®™.
Part 5:
Sharing Is Caring
• Dexcom
Share
o What Is Dexcom
Share
?
o Setting Up Dexcom
Share
o How to Use Dexcom
Share
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o Your Followers
o Troubleshooting
Part 6
• Index for G5x System and Dexcom
Share
How to Use Your User Guide
All chapters in the G5x user guide are laid out the same way:
The beginning of each chapter lists what you’ll be able to do after you have
finished, after that, any applicable safety statements you need to know,
followed by the chapter’s content. At the end, there’s a recap of what was
covered and what’s in the next chapter.
1.3 Your Dexcom Account
You’ll need a username and password to set up the G5 Mobile app (app) and
for reordering.
If you haven’t already done so, go to dexcom.com and set up your own
account.
Or, if you prefer, the app walks you through creating your log-in credentials as
part of your initial app setup.
Summary
Now You Can:
• Describe different training resources
• Locate tutorials about using the G5x
• Find step-by-step instructions for the G5x
• Recall how to use the user guide
• Explain why you need a Dexcom® account
What’s Next?
Now you are familiar with how to use this user guide and where to go for help.
Throughout the user guide you’ll see color-coded boxes containing Safety
Statements. The next chapter, Indications for Use and Safety Statement, lists
all Safety Statements along with how to read and interpret them.
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Chapter 2
Getting Started:
Indications for Use and Safety Statement
2.1 Introduction
We want the G5x to be a valuable tool in your diabetes management. Like any
system, there are steps to take to get the most out of it. As excited as you are
about getting started, did you know if you just took Tylenol®, maybe you
should wait? Did you know taking Tylenol is contraindicated?
In this chapter, you’ll learn about some key areas that might prevent you from
having the best CGM experience, or, if you’re not careful, might even harm
you or the system. You’ll even learn what a contraindication is!
2.2 Important User Information
Each part of your system has instructions including indications,
contraindications, warnings, precautions, and other important user
information. Please review the instructions for each part of the system in this
user guide before using the G5x.
This chapter is important to read. It helps you use the G5x safely and covers:
• What is a Safety Statement?
o Telling the difference between an indication and a
contraindication
o Explaining why warnings are so important
o Defining precautions
• How to read a chapter’s Safety Statement
• Overview of Safety Statements
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Let’s start with definitions, look at a Safety Statement example used
throughout the User Guide, and then review the Safety Statements broken
down into the system’s components.
Safety Statement
A Safety Statement is a brief statement of the G5x’s indications, relevant
warnings, precautions, or its contraindications (when to avoid using it). The
Safety Statements are meant to keep you and the system safe while using the
G5x:
1) Indications
How, for what purposes, and under what circumstances you should use
the G5x. Indications let you know who should use the G5x and when.
Indications are the who, what, and why of the G5x.
2) Contraindications
Contraindications let you know when
not
to use the G5x. If used during
these situations, you may hurt yourself or the system; the risk of use
clearly outweighs the benefit.
3) Warning
Important hazard information: Describes serious or life-threatening
circumstances to stay away from while using the G5x, their
consequences, and how to avoid danger.
4) Precaution
Special steps you need to take while using the G5x, preventing minor or
moderate injury to either you or the system.
2.3 Safety Statements
This user guide presents Safety Statement two ways:
1. In this chapter’s Overview of Safety Statements
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o Lists all Safety Statements
o Includes a section reviewing how the statements are formatted
2. Within each chapter
o Lists only those statements applicable to that specific chapter
Chapter’s Safety Statements
Each chapter will list all applicable indications, contraindications, warnings,
and precautions.
Some chapters will have multiple Safety Statements; others have none.
Safety Statements are located toward the front so you can keep them in mind
as you learn about that chapter’s topic. The same statement may be repeated
throughout the user guide. It’s important to recognize which factors could
prevent the system from working correctly, or even harm you.
Within chapters, each color-coded Safety Statement is in a box, broken down
into four sections:
1. Type of statement
a. Bold and color-coded
• WARNING-Red
• PRECAUTION-Blue
• INDICATION-Green
• CONTRAINDICATION-Purple
2. Do’s/Don’ts
a. An action you should or should not take
b.
Italicized
3. Why
a. A statement of the potential harm
4. Consequences
a. What could happen if you don’t follow the instructions
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The following is an example of a chapter’s Safety Statement and how to read
it.
Warning
Do:
Calibrate at least once every 12 hours
Why: Calibrating less often than every 12 hours might cause inaccurate
sensor glucose readings
Consequences: Missing severe low (hypoglycemia ) or high
(hyperglycemia) Alarm or Alerts
Since this is a Warning, you know it covers important safety information.
Italics are the Do/Don’t steps to follow:
Calibrate at least once every 12
hours
. Below the italics is a statement explaining Why you need to follow the
steps: Calibrating less often than every 12 hours might cause inaccurate
sensor glucose readings. And finally what happens, or the Consequences, if
you don’t: Missing a severe low (hypoglycemia) or high (hyperglycemia)
glucose event.
2.4 Overview of Safety Statements
This section provides a review of Safety Statements containing the same
elements described above (type of Safety Statement, an action, a statement
of potential harm, and consequences) but listed in a narrative, not boxed,
format. Here you’ll learn what indications and contraindications are and what
to do to keep you safe and the system in proper working order.
Safety Statements are broken down into two major categories. First, general
CGM system Warnings which review warnings and precautions you take with
most CGM systems—and second, Hardware/Software Warnings and
Precautions which list warnings and precautions specific to the G5x
components.
Indications and Contraindications
Indications
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What are the G5x indications? Well, in technical terms, the indications are:
The Dexcom G5x Continuous Glucose Monitoring (CGM) System (G5x) is a
glucose monitoring system indicated for detecting trends and tracking patterns
in persons (age 2 years and older) with diabetes. The system is intended for
single patient use and requires a prescription.
The system is indicated for use as an adjunctive device to complement, not
replace, information obtained from standard home glucose monitoring
devices.
The system aids in the detection of episodes of hyperglycemia and
hypoglycemia, facilitating both acute and long-term therapy adjustments,
which may minimize these excursions. Interpretation of the system results
should be based on the trends and patterns seen with several sequential
readings over time.
In Layman’s Terms
But what does that mean? Indications are the who, what, and why of the G5x.
Who
The G5x is a single patient use device (meaning you can’t share the
components with others) for people age 2 years and older with diabetes.
What
The G5x is a prescription-only glucose-monitoring device. G5x tracks your
glucose patterns and detects trends. Working with your home blood glucose
(BG) meter, the system is meant to complement, not replace, your BG meter.
Why
The CGM system’s trend and pattern information, its glucose Alarm/Alerts,
combined with your meter’s actual BG value, can help you manage your
diabetes.
By identifying low and high glucose level periods, the G5x allows you to take
action when needed and create long-term management strategies with your
healthcare professional. Using trend information to see your highs and lows
helps you stay inside your target range.
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The G5x’s trend and pattern information is based on a series of sensor
glucose readings taken over a period of time.
Work with your healthcare professional and create a game plan on how to
best use your trend and pattern information in managing your diabetes.
Contraindications
Contraindications let you know when
not
to use the G5x; you may hurt
yourself or damage the system. Remember, if used during certain situations,
the risk of use may clearly outweigh any potential benefit. Within the chapters,
contraindications are in purple boxes.
MRI/CT/Diathermy
Don’t wear the system (sensor, transmitter, and receiver) before Magnetic
Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-
frequency electrical heat (diathermy) treatment.
The system hasn’t been tested during MRI, CT scans, or with diathermy
treatment. Magnetic fields and heat could damage the components, stopping
sensor glucose readings or Alarm/Alert notifications. Without sensor glucose
readings or Alarm/Alert notifications, you might miss a severe low or high
glucose event.
Medications
Taking medications with acetaminophen (such as Tylenol or Excedrin® Extra
Strength) while wearing the sensor may falsely raise your sensor glucose
readings. The level of inaccuracy depends on the amount of acetaminophen
active in your body and is different for each person.
2.5 General CGM System Warnings
Warnings
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Warnings outline important hazard information, describing any serious and/or
life-threatening situations, their consequences, how to avoid danger while
using the system and how to protect the G5x from harm.
Review Training Materials
Thoroughly review the training materials included with your system before
using.
Incorrect use could lead you to misunderstand system information or might
affect its performance and you might miss a severe low or high glucose event.
Treatment Decisions
The system does not replace your BG meter.
When making treatment decisions, such as the amount of insulin you need,
only use your BG value. Don’t use the G5x sensor glucose readings because
they can be different from your BG value. If sensor glucose readings are used
in determining treatments, it could result in you missing a severe low or high
glucose event.
Don’t Ignore Low/High Symptoms
If your sensor glucose readings don’t match your symptoms, measure your
BG with a fingerstick. You may miss a severe low or high glucose event.
Who Shouldn’t Use
The system was not evaluated for the following persons:
• Pregnant women
• Persons on dialysis
Do not use the Dexcom G5x System in critically ill patients. It is not known
how different conditions or medications common to the critically ill population
may affect the performance of the system. Sensor glucose readings may be
inaccurate in critically ill patients.
The system’s accuracy hasn’t been tested in people falling into these groups
and sensor glucose readings may be inaccurate, resulting in missing a severe
low or high event.
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2.6 Calibration Warning and Precautions
Calibration is the process of making sure your sensor continues to be
accurate. Your sensor doesn’t automatically know what your glucose levels
are—you have to teach your system what a given BG value is by entering in a
KNOWN glucose value from your BG meter.
Warning
Calibrate on Schedule
Calibrate at least once every 12 hours. Calibrating less often than every 12
hours might cause sensor glucose readings to be inaccurate, resulting in you
missing a severe low or high glucose event.
Precautions
Be Accurate, Be Quick
Enter the exact BG value displayed on your BG meter within five minutes of a
fingerstick.
Entering the wrong BG values, or waiting more than five minutes before entry,
might affect sensor performance, resulting in you missing a severe low or high
event.
Significant Glucose Rate Changes
Don’t calibrate when your BG is changing at a significant rate: more than 2
mg/dL per minute.
Look for rate of change arrows on your display device screen and don’t
calibrate when you see:
• A single arrow, pointing up
o Rising 2-3 mg/dL each minute
• Two arrows pointing up
o Rising more than 3 mg/dL each minute
• Single arrow pointing down
o Falling 2-3 mg/dL each minute
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• Two arrows pointing down
o Falling more than 3 mg/dL each minute
Calibrating during a significant rise/fall of your BG may affect accuracy of
sensor glucose readings, resulting in you missing a severe low or high
glucose event.
Fingerstick Only
Only use fingerstick measurements from your BG meter for calibration.
Alternative site BG values from your arms, palm of your hand, etc., may be
different and less accurate than your fingerstick BG values. Using alternative
sites for calibration might affect sensor performance, resulting in you missing
a severe low or high glucose event.
Prior to Startup Calibration: Data/Alarm/Alert
After starting a new sensor session, until completing your startup calibrations
you won’t receive any sensor information such as readings, Alarm or Alerts.
Without these, you may miss a severe low or high glucose event.
Continue to take fingerstick measurements during a new sensor warmup
period.
Now that we have reviewed common CGM Safety Statements, let’s focus on
the G5x components.
2.7 System/Hardware/Software Warnings and
Precautions
In this section, you will learn how to safely use the G5x’s hardware and
software. Some sections have either Precautions or Warnings, others will
have both.
Sensor/Transmitter Holder Warnings and Precautions
Warnings
Sensor Breaking Off
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On rare occasions, the sensor wire may break or detach from the transmitter
holder.
Within 24 hours of experiencing a broken sensor wire, please call our 24/7
Technical Support department, toll free at 1.888.738.3646
If a sensor wire breaks under the skin with no portion of it visible, don’t remove
it. Contact your healthcare professional if you have redness, swelling, or pain
at the insertion site.
Placement
Do not insert the sensor component of the system in a site other than the
belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17
years). The placement and insertion of the sensor component of the system is
not approved for other sites.
The system has not been tested in other areas and may not work properly if
inserted in other areas.
Storage
During a sensor’s shelf life, store it between 36° F-86° F. While you don’t need
to keep your sensor in a refrigerator, you can as long as the refrigerator is
between 36° F-86° F.
Never store sensors and/or sensor packages in a freezer.
Storing the sensor incorrectly might cause the sensor glucose readings to be
incorrect, resulting in you missing a severe low or high glucose event.
Precautions
Expiration Date
Don’t use expired sensors. Before inserting, always check the package label
for the expiration date using the YYYY-MM-DD format.
If past the expiration date, don’t use because the sensor glucose readings
might not be accurate, resulting in you missing a severe low or high glucose
event.
Sensor Package
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Don’t use sensor if its sterile package has been damaged or opened. Using a
non-sterile sensor might cause infection.
Clean and Dry Before Using
Before opening the sensor package, wash your hands with soap and water,
then dry. If your hands are dirty while inserting the sensor, you may
contaminate the insertion site and get an infection.
Before sensor insertion, clean the skin with alcohol wipes to prevent
infections. Don’t insert the sensor until the cleaned insertion site is dry, and
free from any lotions or perfumes.
If your insertion site is not clean and completely dry, you run the risk of
infection or the transmitter holder not sticking and falling off.
Sensor Placement
Don’t insert the sensor where bones are close to the skin’s surface (for
example, over your ribs or hip bones). If you insert the sensor in these areas,
you may feel excessive pain or damage your sensor.
Don’t remove the safety guard before placing the applicator on the skin. If you
remove the safety guard first, you may accidentally deploy the needle and
hurt yourself. Change the site where you place the sensor with each new
insertion. Using the same site too often might not allow the skin to heal,
causing scarring or skin irritation.
Sensor placement is important. Choose a site:
• At least 3 inches from insulin pump infusion set or injection site
• Away from waistband, scarring, tattoos, irritation
• Unlikely to be bumped or pushed
Insertion in these areas might affect sensor performance, resulting in you
missing a severe low or high glucose event.
Transmitter Warnings and Precautions
Warnings
Inspect Transmitter
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If your transmitter is damaged or cracked in any way, don’t use it. Damaged
components could create an electrical safety hazard or malfunction, which
might cause electrical shocks.
Choking
The transmitter is small and may pose a choking hazard. Don’t put it in your
mouth or allow children to play with it.
Precautions
Reusable: Don’t Throw Away
When ending a session, don’t throw away the transmitter.
The transmitter is reusable and can be used in multiple sensor sessions. Keep
using it until the system notifies you the transmitter battery is about to expire.
Don’t Share Your Transmitter
Never share your transmitter with another person. The system is a
prescription-only medical device and is meant, or indicated, for your use only.
Your transmitter is tied to
your
readings. If used by someone else, your
reports, Alarm and Alerts, etc., would be wrong, resulting in you missing a
severe low or high glucose event.
System Precautions
Next are precautions for the receiver, transmitter, sensor, and the system.
Precautions
Use Correct Transmitter, Receiver, and Sensor
The G5x transmitter must be used with the G5x Sensor and is not
interchangeable with the Dexcom G5®Mobile/G4® PLATINUM Sensor. The
G5x transmitter is compatible with the G5 Mobile receiver.
The G5x transmitter and receiver are not compatible with the Dexcom G4
PLATINUM CGM System’s transmitter and receiver.
System Accuracy
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System accuracy may be affected when your glucose is changing at a
significant rate such as during exercise or after a meal.
Significant glucose rise/fall rates:
• Rising 2-3 mg/dL each minute
• Rising more than 3 mg/dL each minute
• Falling 2-3 mg/dL each minute
• Falling more than 3 mg/dL each minute
Airport Scanners
Be aware of airport body scanners and baggage x-rays when you travel. Do
not place any part of the G5x system in the baggage x-ray machine or body
scanner. Ask for visual inspection instead:
• Baggage x-ray machine: Instead of putting any part of your G5x
through the baggage x-ray, ask the TSA officers to visually inspect it.
• Body scanner: When you are wearing your G5x, request hand-
wanding or full-body pat-down and visual inspection instead of going
through the Advanced Imaging Technology (AIT) body scanner. AIT is
also called millimeter wave scanner.
The system has not been tested in x-rays or AIT body scanners, and it is
unknown if exposure to x-rays or AIT body scanners can affect the system
performance and result in you missing a severe low or high glucose event.
It is safe to wear the system through the walk-through metal detector or hand-
wanding. If you are unsure of whether the airport scanner is a metal detector,
an AIT body scanner or an x-ray, ask the TSA officer or request hand-wanding
or full-body pat-down.
Receiver and Smart Device Precautions
The Dexcom receiver and your smart device share some warnings and
precautions.
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Precautions
Communication Range
Do not separate the transmitter from the receiver or smart device by more
than 20 feet. The transmission range from the transmitter to receiver or smart
device is up to 20 feet without obstruction.
Types of obstruction differ and not all have been tested. Obstructions can
include water, walls, metal, etc. If your transmitter and display device(s) are
more than 20 feet from each other or are separated by an obstruction, they
might not communicate, resulting in you missing a severe low or high glucose
event.
As with any wireless device, water in reducing the communication distance.
This applies to the transmitter and display devices. Take special care when
swimming, taking a bath, or getting into a hot tub.
Setting Alarm/Alert Notifications
When using both a receiver and a smart device, you must set your settings
separately in each. If you set up one device and then use another, you might
not get an Alarm or Alerts, causing you to miss a severe low or high glucose
event.
Using an accessory device (like a smart watch) might override your smart
device sounds. Alarms or Alerts might vibrate or be heard on the accessory
instead of your smart device. After connecting any accessories, make sure
that the smart device settings allow you to continue receiving Alarms or Alerts
on the smart device.
Is It On?
If the receiver or smart device is turned off (Shut Down), it will not display
sensor data, information, Alarm or Alerts. Make sure they are turned on;
otherwise you won’t get sensor glucose readings or Alarm or Alerts, causing
you to miss a severe low or high glucose event.
Smart Device Warnings
Next are warnings for just your smart device.
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Warnings
Smart Device Settings
The app can’t override your smart device’s internal settings. Also, accessory
devices (like a smart watch or other wearable smart devices) might override
your smart device’s Alerts and Alarm.
To receive Alarm or Alerts you must:
1. Make sure app Notifications are turned on in the
Setting’s
menu.
2. Verify app hasn’t been shut down.
3. Turn
Bluetooth
®
on.
4. Turn off
Do Not Disturb
(if available on your smart device).
5. Restart app after device is restarted.
6. Set
Volume
at a level you can hear.
7. Do not close app, always run app in the background.
8. Make sure accessory devices do not override your smart device
settings.
If your settings are incorrect, you might miss a severe low or high glucose
event.
App Alarm/Alert vibrations aren’t any different from other vibrating apps on
your smart device. Medical device apps, like this app, don’t have any special
priorities over your smart device’s features. G5 Mobile app notifications or
Alerts may sound or feel the same as notifications from another app. The only
way to know is to look at the screen.
Did You Miss an Alarm or Alert?
An Alarm or Alert can’t be heard through your smart device’s speakers if
headphones are plugged in.
Make sure you unplug your headphones when you are done using them,
otherwise you might not hear an Alarm or Alert, causing you to miss a severe
low or high glucose event.
Receiver Warning and Precaution
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Warning
Don’t Use Damaged Goods
If your receiver is damaged or cracked, don’t use it. This could create an
electrical safety hazard or malfunction, causing possible electrical shocks.
Avoid Strangulation
Use USB cable only as directed and store safely. Misuse of the USB cable
can present a strangulation risk.
Precaution
Test Receiver
If your receiver gets wet or dropped, make sure the speaker and vibrations
still work. To check, either plug it in, turn it on, or go to the
Profiles
menu and
select
Try It
. If it doesn’t vibrate and beep, contact Technical Support.
If the vibration motor and/or speaker on your receiver aren’t functioning
properly you may miss a severe low or high Alarm/Alert. Use the app on your
smart device until this issue is resolved
Keep Receiver Clean and Dry
Keep the USB port cover on the receiver closed whenever the USB cable is
not attached and do not submerge in water.
If dirt or water gets into the USB port, the receiver could become damaged
and stop displaying readings or providing Alerts; you might miss a severe low
or high glucose event.
Caution
U.S. law restricts the sale of the G5x to sale by or on order of a physician.
Summary
Now You Can:
• Define a Safety Statement
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• Explain the difference between an indication and a contraindication
• Describe the importance of warnings
• Describe what a precaution is
• Correctly read a chapter’s Safety Statement
• Provide an overview of Safety Statements by category
What’s Next?
In our next chapter, you will learn about the risks and benefits of using the
G5x.
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Chapter 3
Getting Started:
Risks and Benefits
When using any medical device, there are risks and benefits. In this chapter,
you’ll learn what they are so you can better understand the pros and cons of
CGM and the G5x.
First, let’s review some possible risks.
3.1 Risks
There are some risks with using real-time CGM.
Not Receiving Alarm/Alerts
If you aren’t getting your CGM Alarm/Alerts, you run the risk of not knowing
you are having a severe glucose low or high.
Some hardware issues preventing Alarm/Alerts:
• Alert function is turned off
• Transmitter or display device is out of range
• Display device isn’t showing sensor glucose readings
• Display device battery is dead
• Unable to hear Alarm/Alerts or feel vibration
• Speaker or vibration motor not working
• App not running in the background
• Smart device is on
Do Not Disturb
or Silent Mode
See Troubleshooting in Chapter 18 or recommended settings in Chapter 11
for more information.
Different Devices May Give Different Numbers
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The sensor glucose reading can be different from your meter’s BG value.
If the sensor’s glucose reading is higher than your meter’s BG value, you may
miss a Low Alert. As an example, your last sensor glucose reading was 82
mg/dL, whereas your meter BG value shows 78 mg/dL. If your Low Alert is set
at 80 mg/dL, you won’t receive an alert because the sensor glucose reading is
82 mg/dL.
If you’re not receiving an Alarm/Alert, and not taking fingerstick
measurements, you may be unaware of low or high glucose levels.
Sensor Insertion Risks
Inserting the sensor and wearing the adhesive patch might cause infection,
bleeding, pain, or skin irritations (for example, redness, swelling, bruising,
itching, scarring, or skin discoloration). The chance of this happening is low.
The G5x uses a different applicator than older systems. The G5x clinical
studies showed slight redness and swelling occurring only in a few patients.
Different people may have different skin sensitivity to the sensor adhesive. If
skin irritation is seen, follow up with your healthcare professional on ways or
tips to reduce or avoid sensor site irritation.
With any sensor, if you don’t follow the instructions for sensor insertion, there
is a chance you may mistakenly insert the sensor before you are ready. Be
careful to ensure you place the sensor on your sensor insertion site
before
taking off the safety guard.
After
placing the applicator on the body, fold and
break the safety guard.
The safety guard can be a choking hazard. Carefully throw it away, especially
if around children.
During Dexcom’s G5x clinical studies, no sensor wires broke; however, there
is a remote chance a sensor wire could break or detach and remain under
your skin. Sterile broken sensor wires usually don’t pose a significant medical
risk.
If a sensor wire breaks off or detaches and remains under your skin, contact
your healthcare professional and call Dexcom’s Technical Support toll free,
24/7, at 1.888.738.3646 or toll at 1.858.200.0200 within 24 hours.
Those are the risks, let’s now review the benefits!
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3.2 Benefits
Daily habits impact your BG levels. With the G5x, you can track how your
exercise, carbs, stress levels, medication, or illness influences your glucose
levels.
Knowing Your Trends
Providing sensor glucose readings every five minutes, for up to seven days,
the G5x helps you detect trends and patterns. Trend information reveals
where your glucose is now, where it’s been, where it’s heading, and how fast
it’s changing.
Understanding your trends allows you to take proactive action, helping you
avoid dangerously low or high glucose values.
Using Dexcom
Share
(see Part 5) allows friends and family, your Followers, to
monitor your glucose activity, adding another layer of support and peace of
mind.
Simplified Sensor Insertion
The redesigned G5x sensor applicator allows you to insert a sensor with fewer
steps while using just one hand. Fewer steps simplify the insertion process.
Helping Your Diabetes Management
Wearing the G5x on a consistent and ongoing basis helps you manage your
diabetes. The Alarm/Alerts features (see Chapter 11) keep you aware of your
glucose levels. Alerts notify you when your glucose goes outside your target
range or is rapidly falling or rising, letting you take action before you get too
low or too high. The Urgent Low Glucose Alarm lets you know when you are
dangerously or urgently low, going below 55 mg/dL. By taking corrective
measures, you reduce the time spent in your low/high range, while increasing
time in your target range (Garg, S. Z., 2006) (Battelino, T., 2011).
Real-time CGM can help improve your A1C as well as improve the quality of
your glucose control. If you are at or below 7%, using a CGM such as the G5x
helps reduce hypoglycemia (Tamborlane, W. V., 2008).
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Lowering your A1C, increasing your time in your target range while
decreasing time in low/high BG range is believed to reduce your risk of
diabetes-related complications (Ohkubo, Y., 1995).
In some cases, patients perceived an increase in their quality of life and peace
of mind when using real-time CGM (Juvenile Diabetes Research Foundation
Continuous Glucose Monitoring Study Group, 2010).
What’s Next?
You’ve read the Safety Statements, reviewed the risks and benefits; now let’s
take a look at Dexcom’s G5x!
References:
Battelino, T., Phillip, M., Bratina, N., Nimri, R., Oskarsson, P., & Bolinder, J.
(2011). Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1
Diabetes.
Diabetes Care
, 34(4), 795-800.
Garg, S., Zisser, H., Schwartz, S., Bailey, T., Kaplan, R., Ellis, S., &
Jovanovic, L. (2006). Improvement in Glycemic Excursions With a
Transcutaneous, Real-Time Continuous Glucose Sensor: A Randomized
Controlled Trial.
Diabetes Care
, 29(1), 44-50.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring
Study Group (2010). Quality-of-Life Measures in Children and Adults With
Type 1 Diabetes.
Diabetes Care
, 33(10), 2175-2177.
Ohkubo, Y., Kishikawa, H., Araki, E., Miyata, T., Isami, S., Motoyoshi, S., &
Shichiri, M. (1995). Intensive Insulin Therapy Prevents the Progression of
Diabetic Microvascular Complications in Japanese Patients With Non-insulin-
dependent Diabetes Mellitus: A Randomized Prospective 6-year Study.
Diabetes Research and Clinical Practice
, 28(2), 103-117.
Tamborlane, W. V., Beck, R. W., Bode, B. W., Buckingham, B., Chase, H. P.,
Clemons, R., ... & Xing, D. (2008). Continuous Glucose Monitoring and
Intensive Treatment of Type 1 Diabetes.
The New England Journal of
Medicine,
359(14), 1464-1476.
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2
LET’S G5x! THE BASICS
• Introduction to the G5x
• Initial Setup
• Starting a Sensor Session: Inserting the Sensor and Transmitter
• Calibration
• Ending a Sensor Session and Transmitter Session
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Chapter 4
Let’s G5x! The Basics:
What Is the G5x?
4.1 System Description
Now it’s time to get an overview of the the Dexcom G5x.
After this chapter, you’ll be able to:
• Explain the G5x
• Describe options to view trends
• Locate your historical readings
• Recognize system components
• Explain each part’s function
4.2 Safety Statement
While you can use the G5 Mobile receiver with the G5x, you can’t use the
sensor or transmitter from previous generations. If the transmitter or sensor
box says “G5 Mobile” or “G4 PLATINUM,” don’t use them with the G5x.
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Warning
Don’t:
The system was not evaluated for the following persons:
•
Pregnant women
•
Persons on dialysis
Don’t use the system in critically ill patients. It is not known how different
conditions or medications common to the critically ill population may affect
the performance of the system. Sensor glucose readings may be
inaccurate in critically ill patients.
Consequences: The system’s accuracy hasn’t been tested in people
falling into these groups, and sensor glucose readings may be inaccurate,
resulting in missing a severe low or high event.
Precaution
Do
: The G5x transmitter must be used with the G5x Sensor and is not
interchangeable with Dexcom the G5®Mobile/G4
® PLATINUM Sensor.
The G5x transmitter is compatible with the G5 Mobile receiver.
Why: The G5x transmitter and G5 receiver are not compatible with the
Dexcom G4 PLATINUM CGM System’s transmitter and receiver.
Consequences: Missing a severe low (hypoglycemia) or high
(hyperglycemia) glucose event.
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G5x-Compatible Components
G5x System Components
Components Not Compatible with
G5x
G5x Sensor
G5x Transmitter
G5 Mobile Receiver
G5 Mobile App
G5 Mobile/G4 PLATINUM Sensor
G5 Mobile Transmitter
G4 PLATINUM Transmitter
G4 PLATINUM Receiver with Share
G4 PLATINUM Receiver
4.3 The G5x
The G5x is a medical device you use on yourself. It allows you to continually
see your sensor glucose readings, updated every five minutes for up to 7
days, without the bother of taking constant fingerstick measurements. A
single-use sensor inserted under your skin measures your sensor glucose
readings. A reusable transmitter sends your data to your display device.
The G5x provides personalized trend Alerts, notifying you to proactively react
when your glucose levels are getting too low or too high. Dexcom provides
web-based reports reflecting your glucose trends and patterns. Share the
reports with your healthcare professional when developing your diabetes
management treatment plans.
Some users of the G5x System may need a caregiver involved in their care.
Please consult your physician for guidance.
Options to View Your Trends
The G5x transmitter works with a number of display devices, giving you
flexibility to use what’s best for you, your situation, or your lifestyle.
1. Receiver
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2. G5 Mobile app (app) on your smart device
While the system works with different smart devices, they’re not
interchangeable during a sensor session, so before starting one, select which
smart device you want to use and stick with it throughout your session. You
can’t use multiple smart devices at the same time, but you can combine the
receiver with a smart device during a session.
The G5x is the first CGM system where a smart device acts as a receiver. For
a list of current devices and operating systems, go to:
dexcom.com/compatibility.
Chapter 5 covers how to set up your smart device with the app.
The primary difference between the receiver and app is not the information
they give you, but how that information is presented. The following are some
of the shared CGM data and system information features.
Tracking Real-Time CGM Data
The receiver and app give you the ability to track your glucose trends in a
number of different ways. Each device’s home screen opens to your glucose
trend screen.
Viewing Glucose Levels
The receiver and app share many of the same glucose-monitoring features.
Your glucose values are color-coded to highlight what zone you are in,
allowing you, at a glance, to see what your levels are.
Color-coded glucose levels:
• Red - Low
• Gray - Within your target range
• Yellow – High
Trend Arrows
Glucose levels are not just about the numbers. The G5x includes trend arrows
so you know the speed and direction of your glucose, allowing you to
proactively react before your glucose gets too high or too low.
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Alarm/Alerts
Being warned when your glucose value is too high or too low, falling or rising
too quickly, or trending toward a severe low or high is very important.
Warnings in the form of Alerts or an Alarm help you avoid getting too low or
too high. Alarm and Alert notifications help keep you aware of your glucose
trends and are made up of a combination of sounds, vibrations, and screens.
There are a number of Alerts, but only one Alarm: when your glucose level
dips below 55 mg/dL. Some customization options are available and are part
of the setup process for the receiver and smart device.
In Chapter 11, you can learn more about the Alarm and Alerts feature.
Viewing Your Glucose Values
The G5x allows you to see your last 1-3-6-12-24 hours of your sensor
glucose readings. On the receiver, from the home screen, press
Up/Down
Arrows
to view. On a smart device, hold upright in
portrait
mode to see the
most recent three hours; turn sideways to
landscape
mode to view your
glucose levels over the last 1-3-6-12-24 hours.
Go to Chapter 9 to learn more about viewing your glucose trends.
4.4 What’s New to the G5x?
Dexcom’s G5x has features not found in our previous generations. They
include:
• G5x sensor applicator
• Redesigned transmitter and transmitter holder
G5x Sensor Applicator
Inserting a sensor has never been easier! The redesigned G5x sensor
applicator allows you to insert a sensor with just one hand. Just peel away the
adhesive’s backing, place the applicator on your body, fold and break off the
safety guard, and push the applicator’s button. For detailed steps on sensor
insertion, see Chapter 6.
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Redesigned G5x Transmitter Holder and Transmitter
The redesigned transmitter and its holder enjoy a lower profile. The
transmitter snaps into the newly designed holder and, with its new breakaway
feature, snaps out for easy transmitter removal. For more information on how
to attach the transmitter, go to Chapter 6. After a sensor session has ended,
see Chapter 8 for its removal.
4.5 System Information
The receiver and app also keep you informed on the system’s status.
Technical notifications provide information about your sensor session and
about the system’s hardware. Each chapter provides a table of the
notifications, system, and error messages applicable to its subject. As an
example, the calibration chapter will review all calibration messages you may
see.
Now that you know what the G5x does and what’s new, let’s open your G5x
packages, see what’s inside, and review each item.
4.6 System Components
Package
The G5x comes to you in a number of boxes; after opening, keep the
packaging until you are no longer using its contents.
G5x System Component Packaging
Sensor
Sensor package
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Getting Started Guide
Training Checklist attached to Getting Started
Guide
Training Tutorial USB Card
Overview of System Components
This section is meant as a quick overview of each part; specifics for each are
found in following chapters. For detailed product specifications and technical
information, please go to Chapter 17.
The G5x is comprised of four key parts:
1. Applicator with single use sensor
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2. Reusable transmitter
3. Rechargeable receiver
4. G5 Mobile app
G5x optional:
Dexcom
Share
Sensor Applicator Overview
After removing the backing from the adhesive patch on the back of the sensor
applicator, place the applicator on your skin and remove the safety guard.
Push the orange button to insert the sensor wire and release the transmitter
holder.
The sensor wire is made of silver and platinum with polymer membranes.
Once inserted, the thin and flexible wire measures your glucose levels in the
fluid between your cells (interstitial fluid) for up to seven days.
This section is meant as a quick overview. More information on using and
inserting the applicator, sensor, and sensor wire can be found in Chapter 6.
Figure 1. G5x Sensor Applicator and Transmitter Holder
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Applicator and Transmitter Holder
What it’s called
What it does
Applicator
Applicator
Contains small insertion needle and sensor wire.
Inserts sensor wire under the skin.
Disposable, for single use only.
Removed after insertion.
Safety Guard
Keeps all moving parts in place before insertion.
Prevents accidental sensor insertion.
Fold and break to remove.
Button
Press to insert sensor wire and release transmitter
holder.
Transmitter Holder
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Transmitter Holder
Holds sensor wire and transmitter in place.
Water resistant when transmitter is properly
installed.
Discarded after sensor session.
Adhesive Patch
Keeps transmitter holder attached to your skin.
Sensor Wire
Measures glucose levels in the fluid between your
cells (interstitial fluid).
Attached to transmitter holder once inserted under
skin.
Discarded with holder after session.
Transmitter Overview
Figure 2. G5x Transmitter Front and Back
Please Note: Pictures above are representational only; your transmitter may look different.
Snapping into the transmitter holder, the gray plastic transmitter wirelessly
sends your glucose information to your display devices—receiver and/or smart
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device. If you have a new transmitter, open the package when you are ready
to use it.
Transmitter features:
• Reusable
o Do not discard after sensor session.
o Only for you, don’t share transmitter.
• Water resistant
• Can transmit data to your display devices for up to 20 feet
o Range is less if you are in or under water.
• Battery lasts approximately three months
o Receiver or smart device notifies you when battery is running
low.
• Transmitter’s serial number is on the back
More transmitter features and insertion information are in Chapter 6.
Now that you are familiar with the sensor applicator and transmitter, let’s
review the receiver.
Receiver
The receiver is a small hand-held device. Your receiver, along with your smart
device, shows your sensor glucose readings, trend graphs, and trend arrows,
and notifies you when your glucose is too high or too low or if there is
something you should be aware of or need to do.
The receiver is neither water resistant nor waterproof
and can get damaged if
moisture gets inside, so keep it away from any liquids and very high humidity
as well as dirt and dust. Keeping the micro USB port closed helps prevent
damaging fluids and dust from getting inside the receiver. If your receiver
does get wet or dirty, test it to make sure the speaker and vibrations still work
(see Chapter 12).
If your receiver isn’t charged, see Chapter 14 for charging your receiver’s
battery.
If you want to use the receiver along with a smart device, you need to set
them up separately.
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Remember, you can’t use a combination of smart devices during a sensor
session; select just one.
Receiver Overview
What you see
What it’s called
What it does
Receiver
Provides data about your
glucose trends via screen
display, sounds, and
vibration.
Micro USB Port
Plug
USB cable
into
port
for
recharging.
USB Port Door
Close
USB port door
after
removing
USB cable
to keep
receiver clean and dry.
Micro USB
Cable
Plug into
receiver
to charge
battery.
Don’t plug into a computer
port to charge.
Battery can only be charged
using the adapter/wall
charger.
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What you see
What it’s called
What it does
Wall Charger
Plug
USB cable
into
adapter/wall
charger.
Plug
wall charger
into an
electrical outlet to charge
receiver’s battery.
Don’t block access to the
charger.
Display Screen
Shows sensor glucose
readings, trend graphs and
arrows, Alarm/Alerts, sensor
session status.
Change settings on Menu
screen.
Speaker
Allows you to hear your
Alarm/Alerts sounds.
Navigation
Wheel
Arrows and button to help
you navigate through the
receiver’s menu options and
choose features.
Select Button
Press to select menu
option.
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What you see
What it’s called
What it does
Left Arrow
Press to go back to last
item/screen or home
screen.
Right Arrow
Press to highlight next
item.
Up/Down
Arrows
Press to scroll up or down
to select menu items or set
values.
Press to scroll back and
forth from the 3-hour trend
graph to the 1-6-12-24
views.
4.7 Smart Device Overview
The app was created to work with your smart device, giving you even more
options in monitoring your glucose trends and patterns. The app is similar to
all other apps.
This user guide is not meant to show you how to use your smart device.
Please contact your smart device support or read your smart device’s user
guide for assistance.
Summary
Now You Can:
• Explain the G5x
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• Describe options to view trends
• Locate your historical readings
• Recognize system components
• Explain each part’s function
Next Steps
Your next step in getting started with the G5x is selecting how to continuously
receive your sensor glucose readings: using the app, the receiver, or a
combination.
Our next chapter helps you set up both!
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Chapter 5
Let’s G5x! The Basics:
Set Up Your Display Devices
5.1 Introduction
In the previous chapter, you received a high level overview of the G5x and
learned you can monitor your glucose levels with different display devices.
Now it’s time to set up your app and your receiver.
After this chapter, you will be able to:
• Create a Dexcom username and password
• Download the app
• Set up the app with the recommended settings
• Successfully set up your receiver
5.2 Safety Statement
While you can use the G5 Mobile receiver with the G5x, you can’t use the
sensor or transmitter from previous generations. If the transmitter or sensor
box says “G5 Mobile” or “G4 PLATINUM,” don’t use them with the G5x.
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Precaution
Do
: The G5x transmitter must be used with the G5x Sensor and is not
interchangeable with the Dexcom G5® Mobile/G4
® PLATINUM Sensor.
The G5x transmitter is compatible with the G5 Mobile receiver.
Why: The G5x transmitter and G5 receiver are not compatible with the
Dexcom G4 PLATINUM CGM System’s transmitter and receiver.
Consequences: Missing a severe low (hypoglycemia) or high
(hyperglycemia) glucose event.
G5x-Compatible Components
G5x System Components
Components Not Compatible with
G5x
G5x Sensor
G5x Transmitter
G5 Mobile Receiver
G5 Mobile App
G5 Mobile/G4 PLATINUM Sensor
G5 Mobile Transmitter
G4 PLATINUM Transmitter
G4 PLATINUM Receiver with Share
G4 PLATINUM Receiver
5.3 Why Different Monitoring Methods?
Your convenience!
By offering two separate monitoring systems, the app or receiver, you can
choose to monitor your glucose levels in the handiest method at that moment.
Forgot your receiver at home? Use your smart device! Battery died on your
smart device? Smart device memory full? Your receiver has you covered!
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With the exception of Dexcom
Share
, the primary difference between the two
monitoring systems is not the data itself, but how it’s presented.
The next section walks you through the initial setup for the app. To set up the
receiver, go to Section 5.5. If you want to use both the app and the receiver,
you need to setup each individually.
Once you have completed the initial setup, you’re one step closer to beginning
your sensor session!
5.4 App
Before starting your first sensor session, pick the smart device you want to
use. As mentioned in the previous chapter, you can use the receiver with one
smart device during a session; however, you can’t use multiple smart devices
during the same session.
While your smart device can have the app installed, part of your initial setup is
entering the transmitter’s serial number (SN). If by accident you enter the SN
into more than one smart device, the system warns you and you won’t be able
to complete the setup process.
Suggested Smart Device Settings
Bluetooth
is designed for wireless communication between devices (unlike
Wi-Fi®, which wirelessly connects devices to the Internet). Your transmitter
communicates to your app via
Bluetooth
® Smart! Before beginning, make
sure your smart device’s
Bluetooth
is available and turned on.
Refer to your smart device’s user guide if you have questions on how to
change your smart device settings.
• While checking your
Bluetooth
settings, check to see
Silent
and
Do
Not Disturb
are off. Your app does not override these settings; if you
have them on, you will miss Alarm/Alerts
• After verifying all your settings are correct, there is one more thing to
check. Make sure your smart device’s
Volume
is loud enough for you
to hear any Alarm/Alerts
• Make sure your smart device settings allow your Alarm/Alerts to
always show on your lock screen
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• For information on how to set the above settings, see your smart
device’s user guide. Once you have verified your smart device’s
settings are right, the next step is installing the app
• The app needs to be open and running in the background. This may
drain your smart device’s battery; make sure you check its battery is
charged
• Don’t change your smart device’s time because it can make the time
on the trend screen wrong and the app may stop displaying data
If your smart device is broken or lost, use your receiver until it’s fixed or
replaced.
App Installation
Installing the app is easy! Simply download the Dexcom G5 Mobile app from
your smart device’s store. However, if your smart device has been jailbroken,
do not install the app.
For information on how to install an app, see your smart device’s user guide.
Initial App Setup
Setting up your app is easy! You’ll need your Dexcom account
username
and
password
, along with your
transmitter
box
. Once inside, simply follow the
setup wizard instructions. The setup wizard walks you through safety
information, recommended settings, entering transmitter SN, setting your
high/low glucose levels, and receiving CGM notifications.
Your initial setup will require a Dexcom username and password. You can
create them by tapping
Sign Up
within the app, or by going to dexcom.com.
From Your Web Browser:
1. Go to dexcom.com.
2. Click
My Account
at top right of page
• If no
My Account
, click green menu bars at top left
• Click
My Account
3. Click
Create a Dexcom Account
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But what if you are unclear about a step?
The app has notifications allowing you to get more information. If you are
unsure of something during your initial setup process, look at the screen for
additional information notifications. Informational notifications include, but
aren’t limited to:
I don’t understand, Learn More,
or
Question Mark
. Tap your
informational notification
to get more information.
To close out of the information notification, tap the
X
in the upper right-hand
corner.
Initial App Setup
Step
What you see
What you do
Introductory Screens
1
Tap
app
icon to open app.
Introductory Screens
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2
Swipe through introductory screens or
tap
Log In
.
3
Enter existing
username
and
password
OR
Need a Dexcom username and
password?
Tap
Sign Up.
Complete
Username/Password
fields
.
Tap
Login
once.
Introductory Screens
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4
Tap
Let’s Get Started.
5
The next screens are the Terms of Use,
safety warnings, contraindications, and
the recommended settings.
Once each screen is read, tap the
appropriate answer
to move forward.
Tap
Full Safety Statement
or, when
applicable,
I don’t understand
to get more
information.
Setting Up Your App Alarm/Alerts and Basic Settings
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6
Set your Low Glucose Alert.
Default is 80 mg/dL.
Scroll to select another amount.
Tap
Save
to move forward.
Once your Low Glucose Alert is set, you’ll
receive an Alert notification if your
glucose dips below your set amount.
7
Set your High Glucose Alert.
Default is 200 mg/dL.
Scroll to select another amount.
Tap
Save
to move forward.
Once your High Glucose Alert is set, you’ll
receive an Alert notification if your
glucose rises above your set amount.
Setting Up Your App Alarm/Alerts and Basic Settings
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8a
Make sure you get your Alarm/Alerts
notifications.
Tap the
appropriate response
to move
forward and set your notifications.
8b
Tap
OK
to receive Alarm/Alerts
notifications.
Setting Up Your App Alarm/Alerts and Basic Settings
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9
The next screens provide suggestions for
device volume,
Do Not Disturb
, and other
basic settings.
Tap
appropriate answer
to move forward.
Connecting/Pairing Transmitter With App
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12a
Turn transmitter box upside down on
a flat surface with barcodes facing up.
Center longest barcode within green
brackets.
For information on how to pair
transmitter after initial setup, see
Chapter 8.
12b
Center longest barcode within green
brackets.
Tap
Take Photo
Connecting/Pairing Transmitter With App
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12c
Check mark confirms successful
transmitter SN scan.
13a
If unable to use app’s scanning device:
Tap
Enter transmitter SN by hand
.
Connecting/Pairing Transmitter With App
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13b
Use keyboard to enter transmitter SN.
Confirm correct SN .
Tap
Save
.
14
Insert sensor and attach transmitter
following video’s instructions.
See Chapter 6 for more information.
Connecting/Pairing Transmitter With App
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15
Wait up to 30 minutes for smart device
and transmitter to connect.
16
At notification, Tap
Pair
to pair app with
smart device.
Connecting/Pairing Transmitter With App
17
Make sure your transmitter and smart
device have paired before starting your
sensor session
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18
Tap the
Sensor warmup
circle to start
your two-hour sensor warmup.
When you see the sensor warmup timer,
your initial setup is complete.
Congratulations!
If you have any issues setting up the G5 Mobile app, always contact Technical
Support (available 24/7) at:
• TechSupport@dexcom.com
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
If you are having problems with your smart device, contact your smart
device’s support line.
After completing your initial app setup, set up the receiver or go to Chapter 6
to start your initial sensor session.
5.5 Dexcom Receiver
In the previous chapter, you learned about the receiver’s components. The
following is a refresher to help in your initial setup.
Display Screen:
• Trend screen
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• Menu selection screen
Navigation Wheel:
• Select
o Button in the middle of the navigation wheel
! Center button does not say “Select”
o Press to:
! Turn on receiver
! Select options/features
! Accept changes
! Move forward through menus/features
• Up/Down
o Scroll through trend screens
o Highlight menu items
o Change values
• Left
o Go back to last item or screen
• Right
o Go to next item or screen
Initial Setup of the Dexcom Receiver
Press
Select
to turn receiver on.
The first screen you see is the startup screen with ascending green bars.
Once complete, a setup wizard guides you through the initial setup steps.
Don’t be worry if your receiver buzzes or makes other sounds during this
process.
After your initial setup is complete, you won’t see the setup wizard again. Your
settings can always be adjusted using menu options.
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How you complete your initial setup differs between the receiver and your
smart device; however, the data is the same.
Setup Wizard Notifications:
• Time/Date
• Transmitter Serial Number
o Back of transmitter
o Back of transmitter’s box
• Setting Low Glucose Alert
• Setting High Glucose Alert
Before starting a session, you may want to check the receiver’s battery level.
If it is less than half, go to Chapter 4 for charging instructions.
Initial Receiver Setup
Step
What you see
What you do
Initial Screens
1
Press
Select
to turn receiver on.
2
Wait.
Time/Date
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3
Press
Up/Down
Arrow
to change year.
Press
Right Arrow
to move forward.
Press
Up/Down Arrow
to change month.
Press
Right Arrow
.
Press
Up/Down Arrow
to change day.
Press
Right Arrow
to move to time.
Time/Date
3b
Press
Up/Down Arrow
to change hour.
Press
Right Arrow
.
Press
Up/Down Arrow
to change
minutes.
Press
Right Arrow
.
Press
Up/Down Arrow
to select AM/PM.
Press
Select
to save and close.
NOTE: After initial setup, if battery is
drained, receiver will vibrate once and
you will need to reset date and time.
Transmitter
4a
Turn
transmitter box
upside down to
locate SN number.
For information on how to pair transmitter
after initial setup, see Chapter 8.
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4b
If transmitter package isn’t available:
• SN is on transmitter’s back
4c
Press
Up/Down Arrows
to select and
enter transmitter SN.
Press
Right Arrow
to move to next digit.
Press
Select
to save and close.
Setting Low Alert
5a
System default is at 80 mg/dL.
Press
Select
to save at present levels
and close.
5b
To change value:
Press
Up/Down Arrows
to change value
at 5 mg/dL increments.
Press
Select
to save and close.
Setting High Alert
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6a
System default is at 200 mg/dL.
Press
Select
to save at present levels
and close.
6b
To change value:
Press
Up/Down Arrows
to change value
at 10 mg/dL increments.
Press
Select
to save and close.
These steps are enough to get you going; now you can start your sensor
session!
Summary
Now You Can:
• Create a Dexcom username and password
• Download the Dexcom G5 Mobile app
• Set up app with the recommended settings
• Successfully set up your receiver
What’s Next?
Now that you have completed setting up your app and/or the receiver, your
next step is starting a sensor session.
No matter what monitoring method you choose, starting a sensor session is
the same:
1. Inserting the sensor.
2. Attaching the transmitter.
3. Pairing the transmitter to your device.
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Chapter 6
Let’s G5x! The Basics:
Starting a Sensor Session: Inserting Sensor, Attaching
Transmitter, and Starting Your Session
6.1 Introduction
Now that your display devices are set up, you’re ready to begin a sensor
session. If this is your first time inserting a sensor, you may want to watch the
G5x sensor insertion video to get a better understanding of the process.
There are three ways to get the sensor insertion video:
1. Through the app
2. On the USB card in your receiver package
3. Online at dexcom.com:
a. Top of page, click
Support
After inserting the sensor, start the sensor warmup on your smart device and
receiver. The sensor warmup takes approximately two hours; during this time
your body is getting used to the new sensor, allowing for more accurate
sensor glucose readings. Once the two-hour sensor warmup has passed, you
enter two back-to-back fingerstick measurements to calibrate the sensor’s
glucose readings with your fingerstick measurements (Calibration is covered
in the next chapter).
Make sure you give yourself enough time to finish the startup session.
Remember your smart device’s
Bluetooth
needs to pair with the transmitter,
adding up to 30 minutes to your wait time. Good news is you don’t need to sit
around waiting: as long as you have your display device near, you can go
about your day running errands, gardening, personalizing the G5x settings,
whatever you choose during that time frame.
Keep your display device(s) handy during the warmup period—it shows how
much time has passed, notifying you with beeps and an icon when your
sensor session is ready for its startup calibrations.
After this chapter you will be able to:
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• Identify sensor applicator features
• Properly prepare for sensor insertion
• Choose the best location to insert your sensor
• Correctly insert your sensor
• Prepare transmitter for placement
• Correctly attach transmitter to transmitter holder
• Outline what happens during the sensor warmup
• Identify countdown icon
6.2 Safety Statements
Following are some important Precautions and Warnings to review; we want
to make sure you and the system are safe before starting a sensor session.
Warning
Don’t:
If a sensor breaks under the skin with no portion visible above the
skin, don’t remove it.
Do:
Contact your healthcare professional if you have redness, swelling, or
pain at the insertion site.
Within 24 hours of experiencing a broken sensor wire, please call our 24/7
Technical Support department:
Email: TechSupport@dexcom.com
Toll free: 1.888.738.3646
Toll call: 1.858.200.0200
Why: Sensors may fracture on rare occasions.
MRI with broken wire
For patients undergoing an MRI with a retained wire broken off from a G5x
sensor, in-vitro MRI testing did not detect any safety hazards. There was
no significant migration or heating of the wire and imaging artifacts were
limited to the area around the wire.
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Warning
Do:
During a sensor’s shelf life, store it between 36° F-86° F.
Why: Storing the sensor incorrectly might cause the sensor glucose
readings to be incorrect.
Never store sensors and/or sensor packages in the freezer.
Consequences: Missing a severe low or high glucose event.
Warning
Don’t:
Insert the sensor component of the system in a site other than
the belly/abdomen (ages 2 years and older) or the upper buttocks (ages
2 to 17 years).
Why: The placement and insertion of the sensor component of the
system is not approved for other sites.
Consequences: The system has not been tested in other areas and
may not work properly if inserted in other areas.
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Warning
Don’t:
Use the system sensor glucose readings for treatment decisions.
Do:
When making treatment decisions, such as the amount of insulin you
need, only use your BG value from your BG meter.
Why: Since they measure your glucose from different body fluids, sensor
glucose readings can be different from your meter’s BG values.
Consequences: If sensor glucose readings are used in determining
treatments, it could result in you missing a severe low or high glucose
event.
Precaution
Don’t:
Insert the sensor where bones are close to the skin’s surface (for
example, over your ribs or hip bones).
Why: If you insert the sensor in these areas, you may feel excessive pain
or damage your sensor.
Precaution
Do:
Change the site where you place the sensor with each new insertion.
Sensor placement is important. Choose a site:
• At least 3 inches from insulin pump infusion set or injection site
• Away from waistband, scarring, tattoos, irritation
• Unlikely to be bumped or pushed
Why: Using the same site too often might not allow the skin to heal. Also,
insertion in these areas might affect sensor performance.
Consequences: Missing a severe low or high glucose event.
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Precaution
Don’t:
Use sensor if its sterile package has been damaged or opened.
Why: Make sure the sterile sensor pack has not been damaged or
previously opened. If opened or damaged, sensor may be unsterile.
Consequences: Using a non-sterile sensor might cause an infection.
Precaution
Don’t:
Don’t remove the safety guard before placing the applicator on the
skin.
Why: If you remove the safety guard first, you may accidentally deploy the
needle and hurt yourself.
Precaution
Don’t:
Get dirt or water in the receiver’s USB port or submerge in water.
Why: If dirt or water gets into the USB port, the receiver could become
damaged and stop displaying readings or providing Alerts.
Consequences: You might miss a severe low or high glucose event.
6.3 Prepping for Sensor Insertion
Before inserting a sensor, make sure you have everything you need. Some
items are included in your G5x packages, others are not.
Included in Your G5x Packages
For sensor insertion, you need the sensor and transmitter.
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Sensor Applicator
Inside Sensor Box
What you see
What it is
Sterilized applicator and sensor tray with
important label information.
Check
expiration
date.
Do not use if it is past the expiration date.
Open when ready to use.
Single use sensor applicator.
Knowing what each applicator piece does helps you successfully insert your
sensor. Chapter 4, Section 4.6 gave you an overview of the sensor applicator.
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Figure 3. G5x Sensor Applicator and Transmitter Holder
The following table reviews the sensor applicator components in order of use.
Sensor Applicator Components
Order of Use
Name
What it does
1
Adhesive Patch
Keeps transmitter holder securely on
your skin.
2
Safety Guard
Prevents applicator from inserting
sensor wire before you are ready.
3
Applicator
Inserts sensor under your skin.
4
Transmitter
Holder
Holds sensor wire in place under skin.
Holds transmitter.
Transmitter
Transmitter Box
What you see
What it is
Bottom of box with important label
information.
Keep box until transmitter battery dies.
Please Note: Picture is representative
only; your transmitter box may look
different.
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Reusable transmitter.
Please Note: Picture is representative
only; your transmitter may look different.
In the previous chapter, you entered your transmitter SN into your display
devices and made sure your smart device and/or receiver connected with the
transmitter. You won’t be able to start a sensor session if your transmitter isn’t
paired with your receiver and/or smart device.
Not included in packages:
1. Alcohol wipes
2. Your BG meter
3. Your test strips
Before starting, check your BG meter; make sure it’s in good working order
following manufacturer’s directions and the meter’s date and time match your
display device’s date and time.
Make sure test strips haven’t expired and work with your meter.
Before removing the sensor applicator from its sterile pack, determine the best
place to insert your sensor.
6.4 Choosing Your Insertion Site
Choose a place on your belly (or if user is between the ages of 2 and 17,
upper buttocks) to insert the sensor; the site should be either above or below
your belt line. The best areas are usually flat, “pinchable,” and free from where
rubbing can occur (along the waistband, seat belt strap, or where you lie when
sleeping).
For more help on ideal sensor insertion sites, contact your healthcare
professional.
Insertion Sites
Location
Where it is
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Front of body (belly area) for ages 2 years
and older.
If user is between the ages of 2 years and
17:
Back of body (upper buttocks)
Do:
• Remove the sensor applicator and attached transmitter holder from its
sterile pack only at time of use
• Place at least 3 inches from your insulin pump infusion set or injection
site
• If needed, shave the area so adhesive patch sticks securely
• Make sure area is clean and free of lotions, perfumes, medications
Don’t:
• Never use same site repeatedly for sensor insertion
• Never use same site for 2 sensor sessions in a row
If you have concerns about the transmitter holder not sticking, before inserting
your sensor, you can make the sensor site stickier to help ensure the
transmitter holder does not peel up.
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Optional Site Preparation
Use optional skin adhesives (Mastisol™, SkinTac™) as part of your insertion
site preparation to help keep your transmitter holder attached. Apply the skin
adhesive after you selected and cleaned your insertion site. Create an empty
sideways oval, making sure you don't get any skin adhesive inside the oval. .
Let the oval dry based on skin adhesive manufacture’s instructions. Once dry,
your skin may feel slightly sticky.
See Step 3 in the next table for directions.
NOTE: Contact your healthcare professional for specific questions regarding
the use of medical tape, barrier wipes, and/or other adhesives as it relates to
your use of Dexcom CGM.
6.5 Inserting Your Sensor
You’ve collected all of the needed items to begin a sensor session, viewed the
tutorials, reviewed the sensor applicator, and prepped the transmitter holder
site. You’re now ready to insert your sensor!
Inserting Sensor
Step
Picture
What you do
Preparation
1
Wash and dry your hands.
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2
Clean
insertion site
with alcohol wipe.
Let dry.
3
Optional Step: Skin Adhesive
Create a empty sideways
oval
on the
skin
• Do not get any skin adhesive inside
the oval
• Let skin adhesive dry (see
manufacturer’s instructions)
• Insert sensor on clean skin at the
center of the oval
Preparation
4
Check
pack
. Is it damaged or already
opened?
• If yes, do not use
Peel
lid
off of sensor pack
Keep
sensor packaging
until sensor
session is complete.
Attaching Transmitter Holder
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5
Place hand over
pack’s
opening
6
Gently roll
pack
so applicator falls out
and rests in the palm of your hand.
Closely inspect
sensor applicator
, to
check it has not been damaged.
Remove Adhesive Backing
7
2-step process:
1. Remove
large tab
covering
adhesive patch.
2. Remove
small tab.
Don’t touch adhesive after removing
backing.
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Inserting Sensor Wire and Transmitter Holder
8
Place
applicator
horizontally, not
vertically, on skin.
Firmly press down, sticking
adhesive
patch
to your skin.
9
Fold and break
safety guard.
Throw
safety guard
away.
10
Push
button
to insert sensor.
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11
Release
button
and remove
applicator.
Throw out
applicator
following local
guidelines for disposal of blood-
contacting components.
What’s left on your skin?
• Sensor wire
• Transmitter holder
You have successfully inserted the sensor! Now the transmitter holder and
sensor wire are attached to your body.
Having problems?
If it’s the first time inserting a sensor, you may have questions or need help. If
you do, please contact Technical Support (available 24/7) at:
• TechSupport@dexcom.com
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
The next step is attaching your transmitter to the transmitter holder.
6.6 Attaching Your Transmitter
Now that you have inserted your sensor, you need to attach your transmitter.
Since the transmitter is reusable, you don’t need a new one every time you
start a sensor session. Keep your current session’s transmitter box. The
bottom label has important information you may need after you’ve attached
the transmitter. Once the transmitter has been attached, you can’t remove it
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until your session is over. Chapter 8 reviews when and how to remove your
transmitter.
Before attaching your transmitter, check you’ve entered the correct transmitter
SN into your display device. Chapter 5 covers entering transmitter’s SN
number during initial setup. See Chapter 8 for pairing your transmitter after the
startup wizard
Attaching Transmitter
Step
Picture
What you do
1
Remove
transmitter
from box only when
you are ready to insert it.
Keep box.
Get alcohol wipe.
2
Wipe back of
transmitter
with alcohol
wipe.
Let dry for 2-3 minutes.
Do not let the back of transmitter touch
your skin.
Do not scratch transmitter’s back; this
can harm the waterproof seal.
Do not touch metal dots on transmitter’s
bottom.
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3
Hold
transmitter’s round end
.
Slide
transmitter’s narrow tip
into slot at
the narrow end of transmitter holder.
Step
Picture
What you do
4
Press down firmly on
round end
of the
transmitter until it clicks into place.
5
Move fingers around top of
adhesive
patch
three times to secure tape.
You’re almost done starting your sensor session!
Inserting the sensor, attaching the transmitter, and the two-hour sensor
warmup are the same, regardless of whether you use the receiver or app.
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The remaining steps vary from app to receiver:
1. Letting your device know you need to start the sensor warmup.
2. Following your warmup countdown.
6.7 Loose Transmitter Holder
The transmitter holder should be able to stay on your skin using its own
adhesive.
If the patch peels up, use medical tape (such as Blenderm™, Tegaderm™,
Smith & Nephew IV3000®, 3M™ tape) for extra support.
• Tape over white adhesive patch on all sides for even support
• Don’t tape over the transmitter or any plastic parts of the transmitter
holder
• Don’t tape under transmitter holder
• Don’t leave any substance on the skin where you insert the sensor
Figure 4. The Right Way to Use Tape for Extra Support
Image is representational only. Your transmitter may look different.
6.8 Starting Your Sensor Session
If you choose to use both the receiver and the app, each system requires
individual setups (see Chapter 5).
After pairing the transmitter to your display device(s), inserting your sensor,
and attaching the transmitter to the transmitter holder, your next step is telling
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your device(s) you want to start a sensor session. Transmitters are reusable;
pairing is required only when using a new transmitter.
During the warmup period, neither device will provide any sensor glucose
readings. Your sensor glucose readings begin after the two-hour sensor
warmup has passed and you entered the two startup calibration BG values
into either the smart device or the receiver.
We’ll first review starting the sensor session for the app.
Dexcom App: Starting a Session
Step
What you see
What you do
1
Wait for
Pair
Successful
notification.
Tap
green checkmark
in black square.
2
Tap
sensor warmup
circle to start your
two-hour sensor warmup.
NOTE: You will NOT get any sensor
glucose readings, Alarm/Alerts during
your two-hour sensor warmup period.
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3
Wait.
Screen provides countdown to sensor
warmup. The orange dashes darken as
the countdown moves forward.
Keep
smart device
within 20 feet of
transmitter during the sensor warmup
period.
Step
What you see
What you do
4
Locked screen.
Startup calibration
notification tells you
when warmup is complete.
Chapter 7 covers calibrating.
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5
Startup calibration
notification tells you
when warmup is complete.
Sensor warmup is complete.
You’re ready to calibrate!
Receiver: Starting a Session
Step
What you see
What you do
1
Press
Select
to turn on receiver.
Step
What you see
What you do
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2
Make sure
receiver
and
transmitter
are
connected/paired before starting sensor
session.
Check
receiver
10 minutes after starting
for
Bluetooth
icon.
• Solid: Connected/paired
• Blinking: Searching/not paired
Don’t start a sensor session until they are
paired.
Once connected/paired:
Press
Select
to go to the
Main Menu
3
Press
Down Arrow
to highlight
Start
Sensor.
Press
Select
to start new sensor
session.
NOTE: After sensor starts,
Start Sensor
option disappears.
4
“Start Sensor”
progress bar confirms two-
hour sensor warmup.
Keep your receiver within 20 feet during
the warmup period.
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5
Receiver returns to the trend graph
screen.
Step
What you see
What you do
6
Wait.
Screen provides countdown of the two-
hour sensor warmup.
7
Sensor warmup is complete.
You’re ready to calibrate!
6.9 Receiver
Bluetooth
Tips
Your transmitter and receiver begin communicating once you start a sensor
session. After approximately 30 minutes, if the
Bluetooth
symbol is solid, and
not blinking, your transmitter and receiver are talking to each other.
• If blinking,
Bluetooth
is looking for your transmitter
o Make sure your transmitter and receiver are within 20 feet of
each other
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o Don’t start a sensor session until they are paired.
If the
Bluetooth
icon isn’t on the receiver and the Signal Loss icon appears in
the receiver’s upper right corner of the status bar, they’re not communicating.
No Communication Between Transmitter and Receiver
Step
What you see
What you do
1
Check correct transmitter SN is in
receiver.
• SN is on the label on bottom of
transmitter box
Press
Select
to go to
Main Menu
.
2
Press
Down Arrow
to
Settings.
Press
Select
.
3
Press
Down Arrow
to
Transmitter
.
Press
Select
.
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Step
What you see
What you do
4
Press
Select
.
5
Check correct transmitter SN is in
receiver.
• SN is on the label on bottom of
transmitter box
Compare SN in receiver to SN on
transmitter box.
If correct, call our 24/7 Technical Support
department, toll free at 1.888.738.3646
or toll at 1.858.200.0200 for help.
Press
Select
to exit screen.
Press
Left Arrow
twice to go to
Main
Menu.
If Wrong SN Entered
6
Press
Left Arrow
twice to go to
Main
Menu.
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Step
What you see
What you do
7
If sensor session has started, to correct
the transmitter SN, you must stop the
sensor session.
Press
Down Arrow
to
Stop Sensor
.
Press
Select
.
8
Press
Select
to stop session.
If Wrong SN Entered
9
Wait for sensor session to end.
10
From
Main Menu
:
Press
Down Arrow
to
Settings
.
Press
Select
.
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Step
What you see
What you do
11
Press
Down Arrow
to
Transmitter
.
Press
Select
.
12
Highlight
Transmitter SN
.
Press
Select
.
13
Enter correct SN using
Up/Down Arrow
.
Press
Up/Down Arrow
to select and
enter transmitter SN.
Press
Right Arrow
to move to next digit.
Press
Select
to save and close.
Press
Left Arrow
twice to return to
Main
Menu.
14
Start Sensor Session.
Press
Up/Down Arrow
to highlight
Start
Sensor.
Press
Select
.
6.10 Sensor Session Warmup
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The sensor takes about two hours to adjust to your body. While you are in the
sensor warmup period, you can customize your settings. Chapter 12 steps
you through how to personalize your G5x display devices.
Once the sensor warmup is complete, you’re ready to enter your startup
calibrations! The next chapter shows you how.
Summary
Now You Can:
• Identify sensor applicator features
• Properly prepare for sensor insertion
• Choose the best location to insert your sensor
• Correctly insert your sensor
• Prepare transmitter for placement
• Properly attach transmitter to transmitter holder
• Outline sensor warmup
• Identify countdown icon
What’s Next?
The next chapter guides you through the calibration steps.
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Chapter 7
Let’s G5x! The Basics:
Calibration
7.1 Introduction
In the previous chapter, you learned how to insert your sensor, transmitter,
and start a new sensor session. You’re now ready to begin your last step
before getting your sensor glucose readings: Calibration.
This chapter reviews not just your startup calibration, but also update
calibrations required throughout your sensor session.
After this chapter, you will be able to:
• Calibration overview
o Define calibration
o Explain the importance of calibration
o Identify steps to ensure a successful calibration
• Recognize steps in taking accurate BG measurement
o Identify the correct BG site for calibrations
o Prepare finger for fingerstick measurement
• Determine if you should/should not calibrate
o Recognize when you can enter a fingerstick measurement for
calibration
o Recognize when you shouldn’t enter a fingerstick
measurement for calibration
o Determine if you need to calibrate outside of the normal
calibration requirements
• Initiate startup calibration
• Perform update calibrations
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• Correctly enter your fingerstick measurement
o In the app
o In the receiver
• Identify calibration errors
7.2 Safety Statements
Contraindication
Don’t:
Take medications containing acetaminophen while wearing the
sensor.
Why: Taking medications with acetaminophen (such as Tylenol or
Excedrin Extra Strength) while wearing the sensor may falsely raise your
sensor glucose readings. The level of sensor inaccuracy:
1. Depends on amount of acetaminophen active in your body.
2. May be different for each person.
Consequences: Without correct readings you might miss a severe low or
high glucose event.
Warning
Don’t:
Use the system sensor glucose readings for treatment decisions.
Do:
When making treatment decisions, such as the amount of insulin you
need, only use your BG value from your BG meter..
Why: Since they measure your glucose from different body fluids, sensor
glucose readings can be different from your meter’s BG values.
Consequences: If sensor glucose readings are used in determining
treatments, it could result in you missing a severe low or high glucose
event.
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Warning
Do:
Calibrate at least once every 12 hours.
Why: Calibrating less often than every 12 hours might cause sensor
glucose readings to be inaccurate.
Consequences: Missing severe low (hypoglycemia ) or high
(hyperglycemia) glucose event.
Precaution
Do:
Look for rate of change arrows on your display device screen. Trend
arrows help you determine if you can calibrate now or should wait.
Don’t:
Calibrate when your BG is changing at a significant rate: more than
2 mg/dL per minute.
Don’t calibrate when you see
:
•
A single arrow, pointing up
o
Rising 2-3 mg/dL each minute
•
Two arrows pointing up
o
Rising more than 3 mg/dL each minute
•
Single arrow pointing down
o
Falling 2-3 mg/dL each minute
•
Two arrows pointing down
o
Falling more than 3 mg/dL each minute
Why: Calibrating during a significant rise/fall of your BG may affect
accuracy of sensor glucose readings.
Consequences: You may miss a severe low or high glucose event.
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Precaution
Do:
Enter the exact BG value displayed on your BG meter within five
minutes of a fingerstick.
Why: Entering the wrong BG values, or waiting more than five minutes
before entry, might affect sensor performance.
Consequences: You may miss a severe low or high glucose event.
Precaution
Do:
Only use fingerstick measurements from your BG meter for
calibration.
Don’t:
Use alternative site BG values from your arms, palm of your hand,
etc.
Why: Alternative site BG values may be different and less accurate than
your fingerstick BG values.
Consequences: You may miss a severe low or high glucose event.
7.3 Calibration Overview
What Is a Calibration?
As you learned earlier, the sensor glucose readings come from measuring the
glucose fluids found between your cells (interstitial fluids). Although blood and
interstitial fluids are similar, sensor glucose readings can be different between
your fingerstick and your CGM. Calibration provides a comparison, or
measurement, between your meter’s fingerstick measurement and the
sensor’s glucose readings, allowing alignment between the sensor and meter.
Your BG meter “teaches” the sensor your glucose values through calibration.
Just like a clock can need adjusting—calibrations allow your CGM to adjust to
your body.
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Why Is Calibrating Important?
Calibrations are a must to make sure the CGM system is performing at its
best.
By calibrating when the system notifies you that a calibration is due, the G5x
uses your meter’s BG value to make sure the sensor glucose readings remain
accurate throughout your session.
How Do I Calibrate?
Take a fingerstick measurement from your meter, and simply enter the
meter’s BG value into one of your display devices. This chapter lets you know
what precautions you need to take before taking your BG meter value, then
entering your data. Up to now, you needed to enter information such as Alerts,
transmitter SN, etc., separately for the receiver and smart device. Calibration
is different. You only need to enter calibrations into one device.
Don’t enter your BG values into both devices: enter into either your app or the
receiver. If you enter your meter’s BG value into your receiver, it takes about
five minutes for your sensor glucose readings to begin. In approximately ten
minutes, you can view the readings in the other display device.
How Often Do I Calibrate?
There are three primary “must do” calibration events, each with its own
notifications:
1. Two startup calibrations once your warmup session is complete.
2. Update calibrations done twice daily, once every 12 hours.
3. When you’re notified.
If you receive a calibration notification outside of your scheduled calibration
schedule, either the system doesn’t accept your most recent calibration or
your meter’s BG value is very different from the sensor’s glucose reading.
Don’t worry about keeping track of the time between calibrations; the system
will notify you when you are ready for another.
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Now that you have an overview of calibration, let’s review some
contraindications, warnings, and precautions you need to know and follow
before you calibrate.
7.4 When to Calibrate
Calibrating on a regular schedule aligns your sensor glucose readings with
your meter’s BG values. Without calibrations, your sensor may be inaccurate,
and as a result, so will your display device’s sensor glucose readings, Alerts,
and notifications, etc.
There are important times when you
must
calibrate:
1. Startup Calibration: two hours after you insert your sensor.
2. 12 Hour Update Calibration: every 12 hours after two-hour startup
calibration.
3. When system notifies you.
With calibration notifications, your sensor and display device help you keep
your calibration schedule on track. If your BG values are not between 40-400
mg/dL, the system won’t accept your calibration. Wait until you are within the
40-400 mg/dL range before entering your BG values.
Startup Calibration: Sensor Startup Completed
1. At notifications (see next table) enter two back-to-back fingerstick
measurements into just one device.
2. No need to do startup calibrations twice.
a. Calibration data flows between the receiver and your app.
b. Five minute reporting delay between devices.
3. First update calibration is 12 hours after your startup calibration.
Update Calibration
Enter an update calibration every 12 hours after your initial calibration. Below
is a sample calibration schedule. As you can see from the calendar’s BG
meters, you:
1. Inserted your sensor and entered initial two calibrations on Monday at
10 AM.
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2. Entered update calibrations at 10 PM that night.
3. For the rest of the seven-day sensor period, you enter update
calibrations at 10 AM and 10 PM.
Figure 5. Example Minimum Calibration Schedule During Seven-Day Sensor Session
Update calibrations are typically 12 hours since your last calibration; however,
they can be sooner. As an example, if you know your next calibration is due at
10 PM, but you want to go to bed at 9 PM, you can do the calibration before
bedtime, resetting the 12-hour count down.
1. Enter one fingerstick measurement at least every 12 hours.
2. Display devices provide calibration prompts.
3. You may be prompted to enter additional fingerstick measurements
as needed.
7.5 Calibration Notifications
Sensor Session Startup Calibration Notifications
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Once your two-hour sensor warmup is complete, your display device tells you
it’s time to enter the first of your two back-to-back startup calibrations. Once
the system has accepted your BG values, your glucose readings begin. If you
don’t enter your BG values right away, the system reminds you every 15
minutes. Remember, use only your BG meter for calibrations, and never enter
values from your CGM.
Startup Calibration Notifications
Device
What you see
What it
means
What you
do
First Calibration
Smart
Device: Lock
Screen
Sensor
warmup is
complete.
Ready for first
of two startup
calibrations.
Follow steps
in Section 7.6
and 7.7.
Immediately
prepare for
next
calibration.
Smart
Device: In
App
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Receiver
Device
What you see
What it
means
What you
do
Second Calibration
Smart
Device: Lock
Screen
Sensor
accepted first
calibration.
Ready for
second BG
meter value.
Follow steps
in Section 7.6
and 7.7.
Next
calibration in
12 hours.
Smart
Device: In
App
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Receiver
Your sensor glucose readings begin in approximately five minutes once the
device(s) accepts your calibrations.
Update Calibration Notifications
Once your startup calibration is done, your update calibration schedule
begins.
The steps to enter your update calibrations are the same as your startup
calibration, including only entering values in one display device. The only
difference is, with update calibrations, enter your BG meter value just once.
The default BG value is your current reading if available or 120 mg/dL.
Like the reminders you received with your startup calibration, if you don’t enter
your BG meter values right away, the system notifies you every 15 minutes.
Update Calibration Notifications
Device
What you see
What it means
What you do
Smart
Device: Lock
Screen
Enter update
calibration.
If message
doesn’t go
away:
• System didn’t
accept
calibration
Follow steps
in Section 7.6
and 7.7 to
calibrate.
Immediately
prepare for
next
calibration.
Smart
Device:
In App
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Receiver
• BG values
are very
different from
sensor
glucose
readings
Tap
Message
to clear notification on your smart device. To clear a notification
on your receiver, press
Select
.
Sound/Vibration Notifications
In case you can’t look at your screen, both the smart device and receiver
provide, with the exception of your regular 12-hour update calibration,
beep/vibration notifications to let you know it’s time to calibrate or if there was
a system calibration error.
For more information on setting your sound/vibration notifications and how to
clear them, please see Chapter 9.
Smart Device
Calibration notifications will Alert you with a triple beep if your smart device is
not on
Silent
or
Do Not Disturb
.
Receiver
The receiver Alerts you with an initial vibration for calibration notifications. If
not cleared, you receive a vibrate/beep every five minutes until confirmed.
7.6 Preparing for Calibration
Your sensor depends on you to help make its sensor glucose readings
accurate. If you don’t prepare properly for the calibration, your sensor may not
provide you with the most accurate sensor glucose readings.
Nine Steps to Successful Calibration:
Do:
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1. Wash and dry your hands before staking a fingerstick measurement.
2. Always use the same meter you routinely use to measure your BG.
a. BG meter and strip accuracy vary between meter brands.
b. Switching within a session might cause sensor glucose
readings to be less accurate.
3. Follow meter’s instructions exactly when taking your fingerstick
measurement.
4. Verify test strips are current and, if required, coded correctly with
meter.
5. Check: Is
Bluetooth
on?
a. If off, can’t calibrate
6. Use fingerstick BG values only.
a. Other sites are not as accurate.
b. Must enter within five minutes of taking BG meter value.
c. Enter exact BG value from your meter for each calibration.
Don’t:
7. Don’t take acetaminophen-containing medication during your session
(for example, Tylenol).
a. See your healthcare professional to better understand how
long acetaminophen is active in your body.
8. Don’t calibrate if your BG values are under 40 mg/dL or over 400
mg/dL.
a. If BG value is outside of this range, receiver doesn’t
understand these values and won’t calibrate.
i. You must wait until your BG is in the range to
calibrate.
9. Don’t calibrate if trend arrows are going straight up or down
a. Glucose is changing too quickly for an accurate calibration.
Be safe—if BG is low, first treat low blood sugar, and then calibrate.
7.7 Ready? Set? Calibrate!
You’ve followed the nine steps above, have a valid BG value from your meter,
and your display device keeps alerting you: Calibrate! Calibrate! Calibrate!
Remember:
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You don’t have to take a fingerstick measurement for each display device
when calibrating. Once you enter the reading into one, data is pushed to the
other within ten minutes.
Next are steps to enter your calibrations using the app, followed by the steps
for entering your calibrations into the receiver.
Startup Calibration in the App
Step
What you see
What you do
Additional Info
1
Tap
circle
.
Startup
calibration: Enter
two back-to-back
meter BG values.
Update
calibration: Enter
one meter BG value.
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Step
What you see
What you do
Additional Info
2
Enter meter’s
BG
value
using number
pad.
Tap
Save
.
Double-check your
numbers.
Entering wrong
values, or values
taken more than five
minutes ago, can
affect the sensor’s
accuracy.
3
Verify value is
correct.
Tap
Save
.
If not correct:
Tap
Cancel
.
Reenter correct
value.
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Step
What you see
What you do
Additional Info
4
Tap
circle
to enter
your second BG
value.
Follow steps 2-3
and enter second
reading.
5
Meter icon has no
calibration
notification.
Calibration
accepted.
Your calibration was
successful.
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Step
What you see
What you do
Additional Info
6
Wait for next
calibration
notification in 12
hours.
Default Home trend
screen.
Calibration
accepted.
Startup Calibration With Your Receiver
Step
What you see
What you do
Additional Info
1
Press
Select
to turn
on receiver.
Press
Select
again
for Main Menu.
You won’t see
calibration
notifications when
receiver screen is
black.
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Step
What you see
What you do
Additional Info
2
Press
Up/Down
Arrow.
Highlight
Enter
BG.
Press
Select
.
3
Press
Up/Down
Arrow
to change
numbers.
Stop at meter’s BG
value.
Press
Select
.
Sensor default
reading is 120
mg/dL.
If sensor glucose
reading is within the
last 15 minutes,
screen will show
sensor’s actual
reading.
4a
Verify BG value is
correct.
If correct:
Press
Select
.
If Select is not
pressed:
• Receiver
times out
• BG level isn’t
recorded
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Step
What you see
What you do
Additional Info
4b
Verify BG value is
correct.
If incorrect:
Press
Right Arrow
to
Cancel.
Press
Select
.
Reenter BG value.
Cancel and reenter
BG value.
Fingerstick
measurement must
be within the last
five minutes.
5
Wait.
“Thinking” screen.
BG value is
accepted.
6
Immediately take
another meter
reading.
Enter meter’s BG
value.
First calibration
accepted.
Time for second
calibration.
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Step
What you see
What you do
Additional Info
7
Wait for next
calibration
notification in 12
hours.
Default trend
screen.
Calibration(s)
accepted.
7.8 Calibration Errors
Before or during your calibration process, your display device may show error
notifications. If the notifications don’t go away after 15 minutes, refer to
Chapter 18, Troubleshooting.
Calibration Error Notifications
Device
What you see
What it means
What you do
Smart
Device:
In App
Sensor can’t
calibrate now.
Wait 10-15
minutes.
Retake fingerstick
measurement at
notification.
Enter BG value.
Receive
r
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Device
What you see
What it means
What you do
Smart
Device:
In App
System didn’t
accept recent
calibration.
Additional
calibration needed
immediately.
Calibrate.
No sensor glucose
readings.
Receive
r
Approximately five minutes after entering your second BG meter value, your
display device(s) will start providing sensor glucose readings and glucose
level trends. While each display device may have different ways of presenting
sensor glucose readings and trends, the meanings are the same.
Fingerstick measurements entered into one device will be available in the
other approximately ten minutes after entering data.
Summary
Now You Can:
• Calibration overview
o Define calibration
o Explain the importance of calibration
o Identify steps to ensure a successful calibration
• Recognize steps required to take accurate BG measurements
o Identify the best BG site for calibrations
o Prepare finger for fingerstick measurement
• Determine if you should/should not calibrate
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o Recognize when you can enter BG meter values
o Recognize when you should not enter BG meter values
o Determine if you need to calibrate outside of the normal
calibration guidelines
• Initiate startup calibration
• Perform update calibrations
• Correctly enter your fingerstick measurement
o App
o Receiver
• Identify calibration errors
What’s Next?
In the next chapter, you’ll learn how to end a typical seven-day sensor
session, what to do if you need to end your sensor session early, along with
how to remove the transmitter and determining if you need to replace it.
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Chapter 8
Let’s G5x! The Basics:
Ending Your Sensor Session and Transmitter Session
8.1 Introduction
G5x sensor sessions last seven days. This chapter reviews what you should
expect when your session is about to expire, and removing the sensor and
transmitter. It also covers how to determine if you need to end your session
early.
After this chapter, you will be able to:
• Identify replace sensor notifications at the end of a seven-day sensor
session
• Recognize when you have to end a sensor session early
• Successfully end a sensor session early
o Identify how you can prevent sensor session failures
• Remove your transmitter holder with transmitter attached
• Separate transmitter from its holder
• Determine if transmitter can be used for another sensor session
• Pair a new transmitter
To keep up with your glucose trends, it’s important to begin a new sensor
session as quickly as possible. After a sensor session ends, the sensor stops
taking your sensor glucose readings. You won’t get your trends, nor will you
get any Alarm or Alerts.
Before stopping a session and removing the transmitter and its holder, review
the following safety statements to make sure you don’t harm yourself.
8.2 Safety Statements
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Warning
Don’t:
If a sensor breaks under the skin with no portion visible above the
skin, don’t remove it.
Do:
Contact your healthcare professional if you have redness, swelling, or
pain at the insertion site.
Within 24 hours of experiencing a broken sensor wire, please call our 24/7
Technical Support department:
:
Email: TechSupport@dexcom.com
Toll free: 1.888.738.3646
Toll call: 1.858.200.0200
Why: Sensors may fracture on rare occasions.
MRI with broken wire
For patients undergoing an MRI with a retained wire broken off from a G5x
sensor, in-vitro MRI testing did not detect any safety hazards. There was
no significant migration or heating of the wire and imaging artifacts were
limited to the area around the wire.
Precaution
Don’t:
When ending a session, don’t throw away the transmitter.
Do:
Keep using it until the system notifies you the transmitter battery is
about to expire.
Why: The transmitter is reusable and can be used in multiple sensor
sessions.
8.3 Ending Your Sensor Session
There are different ways your session might end.
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The most common is your sensor’s typical seven-day time frame ended. The
second is ending the sensor session early. You may end a session early
based on a personal decision, or, on rare occasions, the receiver or app
detects sensor issues and notifies you to end the session.
Let’s review ending a normal session first; later in this chapter we’ll review the
notifications for ending the session early.
Ending Your Seven-Day Sensor Session
Just like other notifications, your sensor session ending notifications need
clearing:
• App
o Tap
screen
• Receiver
o Press
Select
End of Seven-Day Sensor Session Notifications
Ending Sensor Session Notifications
Device
What you see
What it means
At Six Hours
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Device
What you see
What it means
Smart
Device: Lock
Screen
Notifications begin when sensor
session has only six hours left.
Clock will count down until
session has ended.
Continue to get sensor glucose
readings.
Smart
Device:
In App
Receiver
Device
What you see
What it means
At Two Hours
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Device
What you see
What it means
Smart
Device: Lock
Screen
Two hours remain on your
current sensor session.
Continue to get sensor glucose
readings.
Smart
Device:
In App
Receiver
Device
What you see
What it means
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Device
What you see
What it means
At Thirty Minutes
Smart
Device: Lock
Screen
Thirty minutes remain.
Continue to get sensor glucose
readings.
Smart
Device: In
App
Receiver
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Device
What you see
What it means
Session Ended
Smart
Device: Lock
Screen
What
see
Session has ended.
App
Tap screen’s “?” for steps to:
• Remove sensor
• Insert new sensor
Receiver
Press
Select
to clear.
Smart
Device: In
App
Receiver
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Device
What you see
What it means
Session Stopped
Smart
Device: Lock
Screen
N/A
Sensor session has stopped.
App
• No sensor glucose
readings
• Notifications for new
session
Receiver
No sensor glucose readings
• Straight line on trend
graph
• Dashed lines on status
bar
Smart
Device:
In App
Receiver
Sound/Vibration Notifications
In case you can’t look at your screen, both the smart device and receiver
provide beep/vibration notifications to remind you your sensor session will end
in 30 minutes, it has just ended, or your sensor failed and you need to start a
new session. Remember, if your smart device is on
Silent
or
Do Not Disturb
,
you won’t get any sound notifications.
For more information on setting your sound/vibration notifications, please see
Chapter 9.
Smart Device
Your smart device notifications you with a triple beep. If not cleared, you
receive the triple beep twice, five minutes apart.
Receiver
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The receiver alerts you with an initial vibration notification. If not cleared, you
receive a vibrate/beep twice, five minutes apart.
Once a sensor session has expired, you are ready to start your new session!
If you’re not sure what to do, the app will provide instructions, or you can refer
to the Getting Started Guide, online tutorials, or Chapter 6 in this user guide.
Ending Your Sensor Session Early
For personal reasons, you may want to force quit a sensor session early (for
example, you’re getting an MRI and need to remove all parts of the system).
Or, occasionally, the app or receiver may detect something is wrong with your
sensor and let you know it’s stopping the current session.
This may be caused by a number of reasons:
1. Unresolved calibration issues.
2. Error symbol does not go away.
3. Wait symbol does not go away.
4. Sensor is coming out of the body (for example, the adhesive is
peeling off).
You’ll receive error notifications leading to a new sensor session. If you see
error notifications, before stopping a sensor session early, always contact
Technical Support (available 24/7) at:
• Email: TechSupport@dexcom.com
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
When your display device has system errors, you may not receive any sensor
glucose readings and you should not calibrate.
Notifications to End Sensor Session Early
System Notifications
Device
What you see
What it means
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Device
What you see
What it means
Smart
Device: Lock
Screen
Sensor issues detected.
Session ends automatically.
No:
• Sensor Glucose
Readings
• Alarm/Alerts
Replace sensor.
Smart
Device:
In App
Receiver
Device
What you see
What it means
Smart
Device: Lock
Screen
Wait up to three hours while the
system autocorrects.
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Device
What you see
What it means
Smart
Device:
In App
Check transmitter—is it properly
inserted into transmitter holder?
Make sure you haven’t taken
acetaminophen.
If not corrected after 3 hours:
• Contact Dexcom
Technical Support
Receiver
Smart
Device: Lock
Screen
Wait up to three hours while the
system autocorrects.
Check transmitter—is it properly
inserted into transmitter holder?
Make sure you haven’t taken
acetaminophen.
If not corrected after 3 hours:
• Contact Dexcom
Technical Support
Smart
Device:
In App
Receiver
The G5x knows when a typical seven-day sensor session is over,
automatically ending the session in each display device. However, if you need
to end the session early, you need to let the system know by manually
stopping the sensor session.
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While the end result is the same (ending a sensor session), the steps differ
between the app and receiver. If you’re using both, no need to stop the sensor
session in each: the other display will see the session has stopped.
Let’s first look at how to end a sensor session in the app, then the receiver.
App: Ending a Sensor Session Early
Step
What you see
What it means
What you do
1
Access Main Menu.
Tap
Main Menu
icon.
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Step
What you see
What it means
What you do
2
Ends sensor
session.
During session:
•
Stop Sensor
option
appears
Not in active
session:
•
Start Sensor
option
appears
Tap
Stop Sensor
.
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Step
What you see
What it means
What you do
3
Blue ? icons provide
additional
information.
Tap
Stop Sensor
.
4
Confirms sensor
session has ended.
Ready for new
session.
Remove sensor.
Insert new sensor.
Tap
green circle
when ready for new
session.
Receiver: Ending a Sensor Session Early
Step
What you see
What it means
What you do
1
Go to Main Menu.
Press
Select
.
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Step
What you see
What it means
What you do
2
Ends sensor
session.
During session,
Stop Sensor
option
appears.
Press
Down Arrow
to
Stop Sensor
.
Press
Select
.
3
Thinking screen.
Wait
4
Confirms you want
to stop sensor.
Return to Main
Menu.
Press
Select
.
5
Ready to start a new
session.
Not in active
session,
Start
Sensor
option
appears.
Remove sensor.
Insert new sensor.
Press
Selec
t to
Start Sensor
when
ready for new
session.
Temporarily Shut Down Receiver
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To save on its battery, you can temporarily shut down the receiver. When shut
down, your receiver and transmitter no longer communicate and you will not
get any Alarm or Alerts although your sensor session remains active.
Shutting down the receiver does not extend your sensor session past the
seven days; it only stops the receiver from communicating with the
transmitter. Your sensor session will stop seven days after you started the
session.
Receiver: Temporary Shutdown
Step
What you see
What it means
What you do
1
Go to Main Menu.
Press
Select
.
2
Ends sensor
session.
During session,
Stop Sensor
option
appears.
Press
Down Arrow
to
Stop Sensor
.
Press
Select
.
3
Confirms you want
to shut down.
Shuts down
receiver.
Press
Select
.
Press
Select
to turn the receiver back on. It may take up to 20 seconds for
the receiver to turn on.
Preventing Sensor Failures
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Sensor failures can happen when your display device doesn’t receive your
sensor’s glucose readings. While it is rare to have a sensor failure, there are
preventative steps you can take.
Help prevent sensor failures by checking:
1. Sensor hasn’t expired.
2. Transmitter is snapped securely into its holder.
3. Transmitter holder isn’t dislodged or adhesive isn’t peeling.
4. Nothing is rubbing against transmitter holder (for example, seat belts).
5. You selected a good insertion site (see Chapter 6).
6. Insertion site is clean and dry before sensor insertion.
8.4 Remove Sensor, Transmitter, and Transmitter
Holder
The app and receiver are ready for a new session! However, before you can
start a new sensor session, you need to end the current sensor session, and
remove the old sensor and transmitter.
Removing Transmitter Holder and Sensor
Think of the transmitter as being part of the transmitter holder. Do not remove
the transmitter before removing the transmitter holder from your body.
To remove the transmitter holder:
1. Gently peel transmitter holder adhesive patch from skin.
a. Sensor wire comes out with transmitter holder.
2. Separate the transmitter from the transmitter holder.
3. Discard the transmitter holder following your local waste management
regulations for disposing of blood-contacting parts (sensor and
transmitter holder).
Removing Transmitter From Its Holder
Remember, your transmitter is reusable, don’t throw it away until its battery
has died. With a battery life of 90 days, use the same transmitter over a
number of sensor sessions. You’ll receive notifications as it nears the end of
its battery life.
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Before reusing the transmitter in your new sensor session, remove it from the
old transmitter holder.
Removing Sensor, Transmitter, and Transmitter Holder
Step
Picture
What you do
1
Grasp end of
adhesive patch.
Peel
adhesive patch
up and away from
your body like a bandage, removing
sensor,
transmitter,
and its
holder
.
NOTE: Do not remove the transmitter while
the adhesive patch is on your skin.
2
Hold
transmitter holder
in your hand.
Bend and break
latch
, releasing the
transmitter.
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Step
Picture
What you do
3
Hold
ridged side
Pull
transmitter
straight out
4
Keep
transmitter
to use with next sensor.
5
Throw away
adhesive patch, transmitter
holder,
and
sensor
following your local
guidelines for disposal of blood-contacting
components.
After removing your sensor and taking the transmitter out of the transmitter
holder, you’re ready to begin a new sensor session. The transmitter’s battery
is good for up to three months. If you haven’t received your final seven-day
transmitter battery life warning, you can reuse the transmitter for your next
session.
Remember:
1. Never use same spot repeatedly for sensor insertion.
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2. Never use same site for 2 sensor sessions in a row.
8.5 End of Transmitter Battery
How do you know if your transmitter’s battery will last through your next
session?
System messages help you determine if your transmitter’s battery will last
through your next seven-day session. Starting at three weeks prior to the end
of its battery life, the messages count down the transmitter’s battery until it
has only seven days. If the transmitter battery has seven days or less
remaining, you won’t be able to start a new session.
Transmitter Battery Messages
Device
What you see
What it means
Smart
Device: Lock
Screen
Transmitter battery will expire in
three weeks.
Smart
Device: In
App
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Device
What you see
What it means
Receiver
Device
What you see
What it means
Smart
Device: Lock
Screen
Transmitter battery will expire in
two weeks.
Order a new transmitter.
Smart
Device: In
App
Receiver
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Device
What you see
What it means
Smart
Device: Lock
Screen
Transmitter battery will expire in
one week.
Order a new transmitter.
Smart
Device: In
App
Receiver
To make sure you have a transmitter that’s ready for a new sensor session,
you may want to reorder a new one at.dexcom.com/order, by calling
Customer Service (see Section 16.1), or through the channels you used
before, at your first low battery notification.
Sound/Vibration Notifications
In case you can’t look at your screen, both the smart device and receiver
provide beep/vibration notifications to tell you your transmitter’s battery is low
or the transmitter failed. Remember, if your smart device is turned on to
Silent
or
Do Not Disturb
, you won’t get any sound notifications.
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For more information on setting your sound/vibration notifications and how to
clear them, please see Chapter 9.
Smart Device
Your smart device notifies you with a triple beep. If not cleared, you receive
the triple beep twice, five minutes apart.
Receiver
The receiver alerts you with an initial vibration notification. If not cleared, you
receive a vibrate/beep twice, five minutes apart.
8.6 Pair New Transmitter
Once the transmitter battery has died, before starting a new sensor session,
you need to pair your new transmitter with your display device(s). In Chapter 5
you learned how to pair your transmitter using the set up wizard. But how do
you pair a new transmitter once your display device is setup?
Pair the transmitter before inserting the sensor, putting the transmitter in the
transmitter holder, and starting a new sensor session.
App
Step
Picture
What you do
1
Tap
Menu
icon
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Step
Picture
What you do
4
Tap
Pair New
5a
If you still have transmitter package:
Turn transmitter box upside down on a
flat surface with barcodes facing up.
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Step
Picture
What you do
5b
Center longest barcode within green
brackets.
Tap
Take Photo
5c
Check mark confirms successful transmitter
SN scan.
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Step
Picture
What you do
6a
If unable to use app’s scanning device:
Tap
Enter transmitter SN by hand
.
6b
Use keyboard to enter transmitter SN.
Confirm correct SN .
Tap
Save
.
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Step
Picture
What you do
7
Wait up to 30 minutes for smart device and
transmitter to connect.
8
At notification, Tap
Pair
to pair app with
smart device.
9
Before inserting the transmitter into its
holder and starting a new sensor session,
make sure your smart device and
transmitter are paired
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Receiver
Step
Picture
What you do
1
Press
Left Arrow
twice to go to
Main Menu.
2
Press
Down Arrow
to
Settings.
Press
Select
.
3
Press
Down Arrow
to
Transmitter
.
Press
Select
.
4
Highlight
Transmitter SN
.
Press
Select
.
5a
Turn
transmitter box
upside down to
locate SN number.
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Step
Picture
What you do
5b
If transmitter package isn’t available:
• SN is on transmitter’s back
6
Enter correct SN using
Up/Down Arrow
.
Press
Up/Down Arrow
to select and enter
transmitter SN.
Press
Right Arrow
to move to next digit.
Press
Select
to save and close.
Press
Left Arrow
twice to return to
Main
Menu.
7
Make sure
receiver
and
transmitter
are
connected/paired.
Check
receiver
10 minutes after starting for
Bluetooth
icon.
• Solid: Connected/paired
• Blinking: Searching,/not paired
Don’t insert the transmitter into its holder or
start a new sensor session until they are
paired.
Summary
Now You Can:
• Identify replace sensor notification at the end of a seven-day sensor
session
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• Recognize when you have to end a sensor session early
• Successfully end a sensor session early
• Identify how you can prevent sensor session failures
• Remove your transmitter holder with transmitter attached
• Separate transmitter from transmitter holder
• Determine if transmitter can be used for another sensor session
• Pair new transmitter
What’s Next?
Congratulations, you have the basics down!
You can set up your app and receiver, start a sensor session, calibrate, as
well as end your sensor session and know when to replace your transmitter.
But the G5x can do much more!
In the next part, Part 3: Next Steps, you will learn how to get the most out of
your G5x.
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3
NEXT STEPS - GETTING THE MOST
OUT OF YOUR G5x
• Reading Trend Graph Screens and Recognizing Trends
• Events
• Alarm and Alerts
• Sounds for Alarm, Alerts, and System Messages
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Chapter 9
Next Steps:
Home Screen, Rate of Change Arrows, and Errors
9.1 Introduction to Home Screens
In the previous chapter, you learned about calibrations: why they are
important and how to do them. Within five minutes of your final startup
calibration your sensor glucose readings begin!
In this chapter, you’ll learn three things. First, reading the home screen,
second, identifying your sensor glucose readings and trends: What do they
mean? What’s the best way to use trend information? And third, what you do if
you aren’t getting your sensor glucose readings.
The purpose of this chapter isn’t to tell you how to react to your trends but to
help you recognize where your glucose was and where it’s going. Your
healthcare professional can help you with your questions on what actions to
take based on your glucose trends.
After this chapter, you’ll be able to:
• Recognize home screen icons
• Locate sensor glucose reading
• Explain sensor glucose target range
• Recognize the importance of gray, yellow, and red colors
• Identify Low/High Glucose Alert levels on your trend graph
• Describe when you receive a High or Low sensor glucose reading
• Change trend graph views
• Cite differences between rate of change arrows
• Recognize error messages
9.2 Safety Statements
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Take a moment and read the safety statements. If not followed, your sensor
glucose readings and trends may be less accurate, and you may miss
important High or Low Glucose Alerts.
Contraindication
Don’t:
Take medications with acetaminophen while wearing the sensor.
Why: Taking medications with acetaminophen (such as Tylenol or
Excedrin Extra Strength) while wearing the sensor may falsely raise your
sensor glucose readings. The level of sensor inaccuracy:
• Depends on amount of acetaminophen active in your body.
• May be different for each person.
Consequences: Without correct readings you might miss a severe low or
high glucose event.
Warning
Don’t:
Use the system sensor glucose readings for treatment decisions.
Do:
When making treatment decisions, such as the amount of insulin you
need, only use your BG value from your BG meter..
Why: Since they measure your glucose from different body fluids, sensor
glucose readings can be different from your meter’s BG values.
Consequences: If sensor glucose readings are used in determining
treatments, it could result in you missing a severe low or high glucose
event.
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Warning
Don’t:
Ignore symptoms of high and low glucose.
Do:
If your sensor glucose readings don’t match your symptoms, measure
your BG with a fingerstick.
Why: Your sensor glucose readings may not be accurately reading your
glucose.
Consequences: You may miss a severe low (hypoglycemia) or high
(hyperglycemia) glucose event.
Precaution
Do: When using both a receiver and a smart device, you must set your
settings separately in each.
Why: If you set up one device and then use another device with different
settings, you might not get an Alarm or Alerts.
Consequences: You may miss a severe low or high glucose event.
Precaution
Do: After connecting any accessories, make sure that the smart device
settings allow you to continue receiving Alarm or Alerts on the smart device.
Why: Using an accessory device (like a smart watch) might override your
smart device sounds.
Consequences: Alarm or Alerts might vibrate or be heard on the accessory
instead of your smart device causing you to miss severe low or high glucose
event.
9.3 Overview of Home Screen
Regardless of your display device, the home screen shows your current
sensor glucose value, glucose trend, rate of change arrow, and CGM system
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status. While the screen does look different between the receiver, smart
devices, along with the Apple Today View, and Apple Watch the information
and color-coding are the same.
No matter how you hold it, the receiver’s view does not change. The app,
however, has two ways to view data based on how you hold your smart
device:
1. Vertically in portrait: 3-hour trend information with task bar.
2. Horizontally in landscape: 1, 3, 6, 12, or 24-hour trend information
without task bar.
This section first familiarizes you with the app’s home screen, the Apple
Today View, then the receiver’s home screen, and last with the Apple Watch
home screen. In other chapters, you’ll see how to use the icons or use the
navigation wheel to enter data or make system changes.
App Home Screen
The app’s home screen has two main sections:
1. Status/Task Bar
a. Status Bar reflects status of smart device’s system.
i. Battery,
Bluetooth
, etc.
b. Task Bar allows you to change settings, enter data, etc.
2. Glucose Information
a. Reflects sensor glucose readings and trends.
Status and Task Bar
Glucose Information
Task Bar
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Figure 6. Example App Home Screen on Smart Device
App Task Bar
App
Name
What it means
What you do
Status Bar: Information Only
Status Bar
Displays signal
strength, time,
Bluetooth,
and
battery level.
Changes are
made using
smart device
settings, not in
the app.
May look
different
depending on
your smart
device/carrier.
Time:
Check smart
device and
receiver show
same time.
Bluetooth:
Check
Bluetooth
is on.
Battery:
App can use up
battery—Check
you are
charged.
Task Bar: Complete Tasks
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App
Name
What it means
What you do
Main Menu
Goes to other
options.
Tap
Main Menu
icon to access:
• Alerts
• Settings
• Help
• Start/Stop
Sensor
BG Meter
with red
circle and
number
Calibration
Notification.
Tap
icon
and
enter fingerstick
BG value (see
Chapter 7).
BG Meter
without red
circle
No need to
calibrate.
Do nothing.
Event
Enter different
events capturing
activities
affecting your
glucose.
Tap
icon
to
enter data for:
• Carbs
• Insulin
• Exercise
• Health
(See Chapter
10).
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App
Name
What it means
What you do
Dexcom
Share
Dexcom
Share
is available only
on the app.
Gray icon
means
Share
is
not active.
Tap
icon
to
activate (see
Part 5).
Dexcom
Share
Once activated,
Dexcom
Share
icon is colored.
Do nothing.
Tap
icon
to
access Dexcom
Share.
Glucose Information
App: Portrait
App: Landscape
What it means
Home Screen
In Landscape mode,
Tap the
trend view
you want to see at
the top of the screen:
1, 3, 6, 12, or 24-hour
historical trend views.
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App: Portrait
App: Landscape
What it means
Number: Most
recent sensor
glucose reading.
Shown in milligrams
per deciliter (mg/dL).
• Yellow: At or
above target
• Gray: Within
range
• Red: At or below
target
N/A
Historical
Readings
Turn smart device to
Landscape
mode.
Tap
time
shows time
frame’s sensor
glucose reading.
Slide finger across
screen to view rest of
day’s sensor glucose
readings.
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App: Portrait
App: Landscape
What it means
N/A
Rate of Change
Arrow
Direction and number
of arrows show
sensor glucose
change rate.
Sensor Glucose
Reading Range
Shows between 40-
400 mg/dL.
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App: Portrait
App: Landscape
What it means
Within Glucose
Range and Alert
Levels
• Yellow: High
Alert level
• Gray: Within
range
• Red: Low Alert
level
Trend Graph Time
Frame
Default is most recent
3 hours.
Turn smart device to
Landscape
mode for
most recent 1, 3, 6,
12, and 24-hour
readings.
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Apple Today View Widget
Check your CGM on your smart device without opening the app, even when
the smart device is locked. Swipe down from the top edge of your smart
device to find the Dexcom widget in your Today view; the widget installs when
you install the app. (See your smart device instructions for customizing your
Today view.)
Apple Today View
Apple Today View
Name
What it does
What you do
Glucose Information
Glucose
Information
Displays your
glucose
information:
• Current
glucose
number
• Direction
your
glucose is
heading
• Graph of
glucose
trend
Review and take
appropriate
action.
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Apple Today View
Name
What it does
What you do
Sensor
Glucose
Reading
Shows most
recent sensor
glucose reading.
Color of circle
changes:
• Yellow: At
or above
target
• Gray: Within
target range
• Red: At or
below target
Take
appropriate
action.
Trend Arrow
Shows direction
and speed your
glucose is
changing.
Review and take
appropriate
action based on
fingerstick BG
value.
(See Chapter 9)
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Apple Today View
Name
What it does
What you do
Historical
Readings
Graph of your
recent glucose
readings
between 40 and
400 mg/dL.
Glucose target
range Alert
settings:
• Yellow Line:
High Alert
setting
• Gray: Target
range
• Red Line:
Low Alert
setting or, if
that’s
disabled, 55
mg/dL
(Urgent Low
Glucose
Alarm)
Review and take
appropriate
action based on
fingerstick BG
value.
(See Chapter 9)
Receiver Home Screen
This section gets you familiar with the receiver’s home screen. In other
chapters, you’ll see how to enter data or make system changes.
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Receiver Home Screen
Unlike your smart device screens, the receiver’s screen is not interactive; all
notifications are for information only. To make changes or enter data in the
receiver, press
Select
and go to the Main Menu.
The receiver’s home screen has two main sections:
1. Status Bar
a. Reflects glucose trends, readings, status of receiver’s system
(e.g., battery level).
2. Glucose Information Trend Graph
a. Reflects sensor glucose readings and trends.
This section will get you familiar with the receiver’s home screen. In other
chapters, you’ll see how to use the navigation wheel to enter data or make
system changes.
Figure 7. Home Screen on Receiver
Status Bar
Glucose
Information
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Status Bar
Receiver
Name
What it does
What you do
Status Bar
Provides at-a-
glance
information
about the
receiver,
system, or you.
Icons will
change based
on current data.
Review and take
appropriate
action.
Battery
Shows battery
level.
When low, plug
micro USB
cable
into
receiver.
Plug
USB
into
the adapter and
then into
electrical outlet.
Bluetooth
Shows
Bluetooth
connection is
working.
Do nothing.
Receiver’s
Bluetooth
is
always on.
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Receiver
Name
What it does
What you do
Sensor
Glucose
Reading
Shows most
recent sensor
glucose reading.
Color of status
bar changes:
• Yellow: At
or above
target
• Gray: Within
target range
• Red: At or
below target
Take
appropriate
action.
Trend Arrow
Shows direction
and speed your
glucose is
changing.
Review and take
appropriate
action based on
fingerstick BG
value.
Status Area
Far right.
Error icons and
calibration
notifications.
Take
appropriate
action.
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Glucose Information
Receiver
What it does
Home screen.
Number: Most recent sensor glucose reading.
Shown in milligrams per deciliter (mg/dL). Color of
status bar changes:
• Yellow: At or above target
• Gray: Within target range
• Red: At or below target
Historical Readings
Default is most recent 3 hours.
Press
Up/Down Arrows
to access 1, 3, 6, 12, or 24-
hour trend views.
Rate of Change Arrow
Direction and speed of your glucose changes.
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Receiver
What it does
Sensor Glucose Reading Range
Shows between 40-400 mg/dL.
Glucose target range Alert settings.
• Yellow: High Alert setting
• Gray: Target range
• Red: Low Alert setting
Now that you’re familiar with the basic layout of the trend graph screen, can
locate readings, identify color-coding, and view time frames, let’s take a closer
look at the rate of change arrows.
Apple Watch Home Screen
This section gets you familiar with the Apple Watch home screen.
Like your smart device, your Apple Watch has a touchscreen.
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Apple Watch
Receiver
Name
What it does
What you do
Apple Watch
Home
Screen
Displays your
glucose
information:
• Current
glucose
number
• Direction
your
glucose is
heading
• Graph of
glucose
trend
Review and take
appropriate
action.
Sensor
Glucose
Reading
Shows most
recent sensor
glucose reading.
Take
appropriate
action.
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Receiver
Name
What it does
What you do
Trend Arrow
Shows direction
and speed your
glucose is
changing.
Review and take
appropriate
action based on
fingerstick BG
value.
(See Chapter 9)
Historical
Readings
Graph of your
recent glucose
readings
between 40 and
400 mg/dL.
Glucose target
range Alert
settings:
• Yellow: High
Alert setting
• Gray: Target
range
• Red: Low
Alert setting
or, if that’s
disabled, 55
mg/dL
(Urgent Low
Glucose
Alarm)
Review 3-hour
trend graph; no
other views are
available. Take
appropriate
action based on
fingerstick BG
value.
(See Chapter 9)
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9.4 Rate of Change Arrows
Not sure of how your sensor glucose readings are trending?
Rate of change arrows show the speed and direction of your glucose trends
based on the last several sensor glucose readings. Arrows and the trend
graph help you know when to take action before you are too high or too low.
However, before doing anything, think about your most recent insulin dosing,
food intake, overall trend graph, and current BG value. Don’t overreact to
the arrows. Remember the arrows don’t reflect your latest reading: they
reflect a combination of recent readings.
Rate of Change Arrows
App
Receiver
What your glucose is doing
Steady
Changing:
• Less than 1 mg/dL each minute
Up to 15 mg/dL in 15 minutes
Slowly Rising or Falling
Changing:
• 1-2 mg/dL each minute
Up to 30 mg/dL in 15 minutes
Rising or Falling
Changing:
• 2-3 mg/dL each minute
Up to 45 mg/dL in 15 minutes
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Rapidly Rising or Falling
Changing:
• More than 3 mg/dL each minute
More than 45 mg/dL in 15 minutes
System can’t calculate the speed and
direction of your glucose change.
There are a number of reasons why you may not get rate of change arrows:
• You just started your sensor session
• No sensor glucose readings over the last few minutes
9.5 Error Messages
Sometimes the transmitter or sensor isn’t communicating with the display
device, causing you not to get your sensor glucose readings or rate of change
arrows. Each device notifies you when there is an issue; however, the
notifications look different.
Before the system can move forward, you need to address the error.
App
1. If screen is locked:
a. Swipe message to go to app.
2. Within app:
a. Read message.
i. Tap Question Marks for more information and follow
steps as appropriate.
Receiver
1. Press
Select
to clear message.
You will not get any sensor glucose readings or rate of change arrows on
either display device until the error is resolved. Check with your BG meter to
monitor your glucose during these error periods.
Error Messages
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What you see
What you do
Bluetooth
Is Out of Range
Smart
Device:
Lock Screen
Make sure there are no
obstructions, such as a wall or
water between your transmitter and
your display device.
Move within 20 feet of display
device.
Wait up to 30 minutes while
transmitter restores communication.
Smart
Device:
In App
Receiver
Bluetooth
Off
Smart
Device:
Lock Screen
Smart device:
1.
Exit app.
2.
Tap
Settings
.
3.
Tap
Bluetooth
.
4. Turn
Bluetooth
on.
Smart
Device:
In App
Receiver
N/A;
Bluetooth
is
always on.
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What you see
What you do
Not Getting Sensor Glucose Reading
Smart
Device:
Lock Screen
N/A
Check—Are you:
• Within 20 feet of your
display device?
• In your two-hour warmup
period?
• Outside of your calibration
schedule?
• In a sensor session?
Smart
Device:
In App
N/A
Receiver
System Found Temporary Sensor Issue
Smart
Device:
Lock Screen
N/A
Don’t calibrate.
System may correct problem on its
own and display sensor glucose
readings again.
If notification stays for three hours:
• Contact Technical Support
(see Section 16.1).
Smart
Device:
In App
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What you see
What you do
Receiver
Transmitter and Sensor Not Communicating
Smart
Device:
Lock Screen
N/A
Wait three hours while the
transmitter tries to fix the error.
Do not enter calibrations during this
time.
Make sure your transmitter is
properly inserted into the
transmitter holder.
If not corrected:
• Contact Technical Support
(see Section 16.1)
• Remove sensor
• Insert new sensor
Smart
Device:
In App
Receiver
Calibration Required
Smart
Device:
Lock Screen
Error in calibrating.
Verify you did not enter a BG
reading outside the range of 40-400
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What you see
What you do
Smart
Device:
In App
mg/dL.
Enter another BG meter value.
Receiver
Calibration Error
Smart
Device:
Lock Screen
N/A
Wait 15 minutes.
Enter a BG meter value.
If error screen still appears, enter
one more BG meter value.
Wait 15 minutes.
If no sensor glucose readings
appear on the display, the sensor
needs to be replaced.
Contact Technical Support
(available 24/7) at:
• TechSupport@dexcom.co
m
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
Smart
Device:
In App
Receiver
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What you see
What you do
Display Devices and Transmitter Not Communicating
Smart
Device:
Lock Screen
App/Receiver
Wait 10 minutes.
Move display device and transmitter
within 20 feet of each other without
obstruction (walls or water).
Wait up to 30 minutes.
In app (if not resolved):
• Tap
Settings
.
• Tap
Bluetooth
.
• Turn
Bluetooth
Off and On.
Smart
Device:
In App
Receiver
If error messages don’t go away after you followed necessary steps, and you
aren’t getting sensor glucose readings, contact Technical Support (see
Section 16.1).
Now You Can:
• Recognize home screen icons
• Locate sensor glucose reading
• Explain glucose target range
• Recognize the importance of gray, yellow, and red colors
• Identify Low/High Glucose Alert setting lines
• Describe when you receive a high or low sensor glucose reading
• Change trend graph hours view
• Cite differences between rate of change arrows
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• Recognize error messages
What’s Next?
By now you have a pretty good understanding of how your trends look on the
different display devices, but did you know what you do can affect your trends
and patterns? It’s important to track actions or well-being to better understand
that what you do or how you feel can change your trends.
In the next chapter, you will learn how to enter Events into your G5x.
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Chapter 10
Next Steps:
Daily Events Affect Your Glucose Trends and Patterns
10.1 Introduction
Your daily activities can impact your glucose trends and patterns. In the
previous chapter, you learned how to read your glucose trend screens; in this
chapter, you learn how to enter situations, or “Events.” By tracking Events,
you can determine how certain actions or circumstances affect your glucose
levels.
After this chapter, you’ll be able to:
• Define Event
• Describe each Event
• Create Events
o App
o Receiver
• Recognize Event markers on app
o Describe how Event markers are different in portrait and
landscape view
• Describe how to view Events entered via your receiver
• View Event markers on your smart device
10.2 What Is an Event?
Did you take a walk after lunch today? Did you go to happy hour with your co-
workers and have a beer? Are you feeling stressed? Did you catch your kid’s
sniffles? How much insulin did you take for your dinner meal? These are all
Events that can raise or lower your blood sugar.
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An Event is an action or situation affecting your glucose levels. With the G5x,
you have the ability to enter your daily Events, helping you track their effect on
your glucose trends. Once entered into the smart device or receiver, Events
can be viewed in Dexcom reports. The reports help you review how each
Event influenced your glucose trends. You can use the reports with your
healthcare professional to create a game plan in managing your diabetes.
Even though they differ on how to enter an Event and time, the app and
receiver have the same Event categories and subcategories. Later in this
chapter, you’ll learn how to enter Events in each device.
Event Categories
There are four main Event categories:
1. Carbs
2. Insulin
3. Exercise
4. Health
The fourth category, Health, has more options:
• Illness
• Stress
• Feel High
• Feel Low
• Cycle
• Alcohol
The following table provides more detail on each type of Event.
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Events Menu
Device
What you see
What it means
What you do
Carbs
Smart
Device:
In App
How many grams
did you just eat?
Receiver’s screen
reflects last
number entered.
Enter Carb
grams per snack
or meal, up to
250 grams.
Receiver
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Device
What you see
What it means
What you do
Insulin
Smart
Device:
In App
Receiver’s screen
reflects last
number entered.
Enter insulin
units for each
dose, up to 250
units.
Can’t enter type
of insulin, only
dosage.
Receiver
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Device
What you see
What it means
What you do
Exercise
Smart
Device:
In App
Default is 30
minutes.
Select each
exercise’s
intensity level
and duration.
Enter intensity
and duration.
Type of exercise
isn’t an option.
Receiver
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Device
What you see
What it means
What you do
Health
Smart
Device:
In App
General well-
being.
Enter different
health Events
(see following
Health Events
Menu table).
Receiver
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Device
What you see
What it means
What you do
Event Time
Smart
Device:
In App ice
Event time.
For each
separate Event,
enter date/time
Event began.
Receiver
As mentioned in the last table, Health has a series of Events. Tell the system
how you are feeling, if you had a drink, if you’re having low or high BG
symptoms, etc. You select the Event: no amounts are entered, just date and
time.
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Health Events Menu
Device
What you see
What it means
Health Main Menu
Smart
Device:
In App
Use Health Main Menu to access
selections.
Receiver
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Device
What you see
What it means
Health Main Menu
Smart
Device:
In App
Illness
Have a cold, flu, or any other
temporary illness affecting your well-
being?
Stress
Are you under stress? Feeling
anxious?
High Symptoms
Feel high BG symptoms?
Low Symptoms
Feel low BG symptoms?
Cycle
Have you started your menstrual
cycle?
Alcohol
Had a glass of wine, beer, or cocktail?
Receiver
You can have multiple Events in a single day, or even during the same time
frame and enter them all in at the same time. As an example, you’re running
late because of traffic (Stress) and quickly swing by a drive-thru to get lunch
(Carbs of 85 grams).
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For your convenience (and safety!), no need to stop everything and enter your
Events as they are happening. When you have a moment, you can enter your
Events retroactively in your app or receiver.
Events are entered as individual occurrences: don’t enter daily totals, enter
each Event separately.
In the next section, you will learn how to enter Events, first in your smart
device, then in your receiver.
10.3 Entering Events
You probably will enter Events in the display device you use most often;
however, you should know how to enter Events into each.
First, let’s look at how to enter Events in a smart device, then in the receiver.
When using Dexcom Share, you can allow your Followers to see your Event
entries. For more Dexcom Share information, please see Part 5.
Entering Events: Smart Device
In the app, Events are just a tap away! The Event icon, a running man, is on
the app’s home screen task bar in portrait mode (remember, you don’t have
the task bar in landscape).
Entering Events for the Carbs, Insulin, Exercise, and Health categories follows
the same steps. If you can enter a Carbs Event, you can enter an Insulin
Event. To enter Events, we’ll use the above scenario. The following table
shows how to enter Carbs (drive-thru lunch) and Stress (traffic jam) Events.
Entering Events: App
Step
What you see
What you do
Enter Carbs Event
1
Tap
Running Man.
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Step
What you see
What you do
2
Tap
Carbs
.
Enter Carbs Event
3
Using the above example, add up all
carb grams from lunch.
Enter “85” using keypad.
Tap
Done
.
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11
Scroll
and
select
date and time
.
Tap
Done.
12
Tap
Save
or
Cancel.
View Events
13
Trend graph shows events.
Turn to landscape to see more
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The receiver and app don’t talk to one another. If you enter an Event only into
the receiver, while the information will appear on Dexcom reports, you won’t
get an Event marker on your app’s trend screen.
The app has Event markers on its screen, but the receiver doesn’t.
However, there may be times when you want or need to enter Events on the
receiver.
Entering Events: Receiver
While the Event data is the same between display devices, the flow is not the
same, including how to enter the Event’s date and time. The following table
reviews how to enter the same Carbs/Stress Event data from the previous
scenario: Carbs at 85, and a Stress Event.
Entering Events: Receiver
Step
What you see
What you do
Enter Carbs Event
1
Default screen
Press
Select
to go to Main Menu.
2
Press
Down Arrow
until
Events
is
highlighted.
Press
Select
.
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3
Highlight
Carbs
.
Press
Select
.
4
Add up all carb grams from lunch.
Arrow up to “85.”
Press
Select
.
Enter Carbs Event
5
Press
Left/Right Arrows
to change time
and date.
• Left: Backwards
• Right: Forward
Press
Select
.
6
Confirmation screen.
Press
Select
.
Enter Health Event - Stress
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7
Press
Down Arrow
until
Health
is
highlighted.
Press
Select
.
8
Press
Down Arrow
to
Stress
.
Press
Select
.
Enter Health Event - Stress
9
Press
Left/Right Arrows
to change time
and date.
• Left: Backward
• Right: Forward
Press
Select
.
10
Verify information is correct.
Press
Left/Right Arrows
to highlight
field.
Press
Up/Down Arrows
to change
numbers.
Press
Select
to save.
10.4 Viewing Events
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Events entered into your receiver can only be viewed on a Dexcom report;
there are no markers on your receiver’s screen.
On your smart device, turn to landscape to view your Event markers. A single
small square marks all Events entered on your smart device. Slide your finger
across the screen or tap the square to get your Event’s information.
App: Viewing Events
Landscape
What it does
What you do
Landscape Only
Show Event details.
Landscape Only
Slide finger across
screen.
Once your Share Follower’s access your trend screen, they too will be able to
view your Events. See Part 5 for more information.
Summary
Now You Can:
• Define Event
• Describe each Event
• Create an Event
o App
o Receiver
• Recognize Event markers on the app
o Describe how Event markers are different in portrait and
landscape view
What’s Next?
In the next chapter, you will learn about how your Alarm and Alerts help you
monitor your glucose levels. You’ll also learn how you know when your
system loses its signal and stops communicating.
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Chapter 11
Next Steps:
Sensor Glucose Alarm and Alerts
11.1 Introduction
Monitoring your glucose trends is critical in managing your diabetes. But what
happens if you’re driving, in a meeting, at the movies, and can’t, or don’t want
to, keep looking at your display device?
The G5x understands there are times when you can’t look at your receiver or
smart device; however, you still need to know critical glucose trends or if
you’re not getting your sensor glucose readings.
This chapter reviews the sensor glucose Alarm and Alerts based on your
sensor glucose readings, allowing you to proactively manage your glucose
trend levels and make sure your transmitter is communicating with your
display device.
In the next chapter, you’ll learn how to customize the Alarm and Alerts.
After this chapter you will be able to:
• Define an Alarm
• Define an Alert
• Identify the different types of Alerts
• Describe the difference between an Alarm and an Alert
• Recognize different Alarm/Alert notifications and sounds
• Determine if signal loss is preventing you from getting an Alarm or
Alert
• Describe recommended app settings
• Successfully clear an Alert
o App
o Receiver
Your trending information is one of the greatest benefits of the G5x. It’s
important to focus on your trends and rate of change arrows, rather than the
exact number of your glucose reading.
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11.2 Safety Statements
The Alarm and Alerts were designed to keep you safe, helping you avoid
severe lows and highs or missing your readings. The following safety
statements help ensure you get your Alerts and Alarm.
Warning
Do:
Verify that your smart device’s internal settings let you receive Alarm
and Alerts.
To receive Alarm/Alerts you must:
1. Make sure Dexcom G5 Mobile app Notifications are turned
on in your smart device settings
2. Verify app hasn’t been shut down
3. Turn
Bluetooth
on
4. Turn off
Do Not Disturb
(if available on your smart device)
5. Restart app after device is restarted
6. Set Volume at a level you can hear
7. Do not close app, always run app in the background
8. Make sure accessory devices do not override your smart device
settings
Why: The app cannot override your smart device’s internal settings. Also,
accessory devices (like a smart watch or other wearable smart devices)
might override your smart device’s Alarm, Alerts, and notification settings.
Consequences: If your settings are incorrect, you might miss a severe
low or high glucose Alarm or Alerts.
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Warning
Don’t:
Assume the app Alarm/Alert vibrations are different from other
vibrating apps on your smart device.
Do:
Look at the screen of your smart device and check to see if the sound
or vibration is from the G5 Mobile app.
Why: Medical device apps, like this app, don’t have any special priorities
over your smart device’s features. App notifications or alerts may sound or
feel the same as notifications from another app.
Consequences: You might miss a severe low or high glucose event.
Warning
Do:
Make sure you unplug your headphones from your smart device when
you are done using them.
Why: An Alarm or Alert can’t be heard through your smart device’s
speakers if headphones are plugged in.
Consequences: You might not hear an Alarm or Alert, causing you to
miss a severe low or high glucose event.
Precaution
Don’t:
Separate the transmitter from the receiver or smart device by more
than 20 feet.
Why: The transmission range from the transmitter to receiver or smart
device is up to 20 feet without obstruction. If your transmitter and display
device(s) are more than 20 feet apart or are separated by an obstruction,
they might not communicate.
Types of obstruction differ and not all have been tested. Obstructions can
include water, walls, metal, etc.
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As with any wireless device, water is often the biggest culprit in reducing
communication distance. This applies to the transmitter and display
devices. Take special care when swimming, taking a bath, or getting into a
hot tub.
Consequences: Missing a severe low or high glucose event.
Precaution
Do: When using both a receiver and a smart device, you must set your
settings separately in each
.
Why: Settings are specific to each display device and don’t carry over to
other devices. If you set up one device and then use another device with
different settings, you might not get an Alarm or Alerts.
Consequences: You may miss a severe low or high glucose event.
Precaution
Do: After connecting any accessories, make sure that the smart device
settings allow you to continue receiving Alarm or Alerts on the smart device.
Why: Using an accessory device (like a smart watch) might override your
smart device sounds.
Consequences: Alarm or Alerts might vibrate or be heard on the accessory
instead of your smart device, causing you to miss severe low or high glucose
event.
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Precaution
Do:
Make sure the receiver and smart device are turned on.
Why: If the receiver or smart device is turned off (Shut Down), it will not
display sensor information, Alarm or Alerts.
Consequences: You may miss a severe low or high glucose event.
11.3 Alarm and Alerts
As part of managing your diabetes, you learned how to read your trend screen
and how to enter Events. In this chapter, you’ll learn how Alarm and Alerts can
keep you safe from severe lows or highs.
Depending on your display device, you can customize how you receive your
Alarm or Alerts.
What Is an Alarm?
While there are a variety of Alerts, there is just one Alarm
: the Urgent Low
Glucose Alarm (Alarm), is set at 55 mg/dL. The Alarm will repeat every 5
minutes until you clear the Alarm (see Chapter 12 on how to customize the
sounds). If you clear the Alarm and your sensor glucose readings don’t go
over 55 mg/dL in the next 30 minutes, you get another Alarm.
Unlike Alerts, the Urgent Low Glucose Alarm setting can’t be changed or
turned off.
Think of it as a safety net: your glucose level is dangerously low—
pay attention now!
What Are Alerts?
An Alert is a message telling you your glucose trend levels need attention.
Low/High Glucose Alerts tell you when your sensor glucose readings are
outside your target glucose ranges. Think of them as an FYI: You need to
know what’s happening. Rising/Falling Alerts tell you your glucose levels are
changing quickly. Their default settings are Off (see Chapter 12 on how to turn
them on).
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Alerts message you with vibrations (vibrations not available on all smart
devices), visual notifications, sounds, or a combination of all three.
Unlike the Alarm, you can customize your different Alert’s target range (see
Chapter 12).
During your initial setup, you establish your Low/High Glucose Alert levels. As
mentioned before, this chapter is a review of the Alarm and Alerts,
recommended smart device settings, and the receiver’s default Alert settings.
Chapter 12 will show you how to change their settings: customize glucose
levels notifications, how you are notified, and in some cases, how often you
get notified. The following are the defaults.
Default Alerts
Low/High Glucose Alerts
Your Low/High Glucose Alerts have the same color-coding as your trend
graph screen:
1. Red: Glucose levels are below your low threshold.
a. Default setting of 80 mg/dL.
2. Gray: Glucose levels are within your Low/High Glucose Alert levels.
a. No Alerts.
3. Yellow: Glucose levels are above your high threshold.
a. Default setting of 200 mg/dL.
Rise Rate/Fall Rate/Repeat Alerts
Rise Rate and Fall Rate Alerts warn you when your glucose levels are
changing rapidly, either down or up, and look similar to the rate of change
arrows. Repeat Alerts let you know if your sensor glucose readings continue
to be above or below your Alert levels.
Glucose Level Alerts
1. Rise Rate
a. Default setting is Off—No Alert.
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b. Need to change settings to receive Rising Alert.
2. Fall Rate
a. Default setting is Off—No Alert.
b. Need to change settings to receive Falling Alert.
3. Repeat
a. Default setting is Off—No Alert.
b. Need to change settings to receive Repeat Alert.
Signal Loss Alert
Signal Loss tells you when you and the transmitter are too far from your
display device or something is blocking your transmitter signal, causing you
not to get sensor glucose readings. The default setting for Signal Loss is On.
Now you have the basics for the G5x Alarm/Alerts features. Next, you will
learn about each Alarm/Alert in more detail.
11.4 Alarm and Alerts Screens
When you fall within an Alarm or Alert target range, your display device will tell
you. As mentioned in previous chapters, you won’t get any Alarm or Alerts
within five minutes of calibration.
Let’s first review how the information is presented visually across the devices.
While the Alarm/Alerts notifications look different on the display devices, they
reflect the same information.
After notifications, we’ll separately review the vibration and audible
Alarm/Alerts for app and receiver.
Urgent Low Glucose Alarm
Device
What you see
What it means
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Smart
Device:
Lock Screen
Sensor glucose reading at or
below 55 mg/dL.
Shows last glucose value.
Arrows reflect rate of change.
Check BG meter to make
treatment decisions.
Smart
Device:
In App
Receiver
Low/High Glucose Alerts
Device
What you see
What it means
Smart
Device:
Lock Screen
Sensor glucose reading at or
below your Low Glucose Alert
level.
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Smart
Device:
In App
Shows most current sensor
glucose reading.
Arrows reflect rate of change.
Can be set to repeat between
15 minutes to 4 hours.
Check your BG meter to make
any treatment decisions.
Receiver
Device
What you see
What it means
Smart
Device:
Lock Screen
Sensor glucose reading at or
above your High Glucose Alert
level.
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Smart
Device:
In App
Shows most current sensor
glucose reading.
Arrows reflect rate of change.
Can be set to repeat between
15 minutes to 4 hours.
Check BG meter to make
treatment decisions.
Receiver
Rise Rate/Fall Rate Alerts
Device
What you see
What it means
Smart
Device:
Lock Screen
Sensor glucose readings
rising quickly.
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Smart
Device:
In App
Number of arrows
shows how fast
(2 mg/dL/min;
3+ mg/dL/min) glucose
is rising.
Check BG meter to
make any treatment
decisions.
Receiver
Device
What you see
What it means
Smart
Device:
Lock Screen
Sensor glucose readings
falling quickly.
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Smart
Device:
In App
Number of arrows
shows how fast
(2 mg/dL/min;
3+ mg/dL/min) glucose
is falling.
Check BG meter to
make any treatment
decisions.
Receiver
Signal Loss Alert
Device
What you see
What it means
Smart
Device:
Lock Screen
Your display device and
transmitter are not
communicating.
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Smart
Device:
In App
You will not receive
glucose readings or
Alarm/Alerts.
Check BG meter to
check your glucose and
make any treatment
decisions.
Receiver
11.5 App: Alarm/Alert Recommended Settings
The receiver is a standalone medical device and used solely to monitor your
glucose trends.
The app can’t override your smart device’s general settings:
• When your smart device is on Silent, you’ll still receive Alarm/Alerts
visual notifications and messages, but not vibrations if you haven’t
adjusted your smart device settings
• Some smart devices don’t have a Vibration feature, so you won’t get
any vibration notifications
• When your ringer’s volume is low, you may not hear an Alarm or Alert
• When your smart device is in Do Not Disturb mode, you won’t receive
any Alarm/Alerts. The app can’t override the Do Not Disturb setting
• If you don’t enable your G5 push Notifications settings during setup,
you won’t get any Alarm/Alerts
• Check in Settings under Notifications on how your Alarm/Alerts are
prioritized
For information on smart device settings, see your smart device’s instructions.
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If you are concerned about missing an Alarm or Alert (for example, due to
smart device settings, app shutting off due to lack of storage, low smart device
battery, etc.), bring your receiver with you.
11.6 Receiver: Default Beeps and Vibrations
The receiver’s Alarm/Alerts are vibrations and a beep, or a series of beeps,
based on the Alarm or Alert. Beeps and vibrations are preprogrammed into
the receiver, and unlike the smart device, the volume can’t be changed.
In Chapter 12 you’ll learn how to adjust the volume and intensity of your
Alarm/Alerts.
The following is a table of the receiver’s default beep and vibration patterns. If
you clear the Alert’s initial vibration, you won’t get any beeps or sounds unless
you’ve turned on the Repeat Alert.
In the next section, you’ll learn how to clear the Alarm/Alerts.
Urgent Low Glucose Alarm
What you see
Beeps and vibration
Initial Default Alert:
Vibrates 4 times.
After 5 Minutes:
Vibrates/beeps 4 times every 5 minutes until cleared
or sensor glucose readings go above Alarm level.
After 30 Minutes:
After clearing Alarm, continues to notify if sensor
glucose readings remain at or below Alarm level.
Low/High Glucose Alerts
What you see
Beeps and vibration
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Initial Default Alert:
Vibrates 3 times.
After 5 Minutes:
Vibrates/beeps 3 times every 5 minutes until
cleared.
Trend screen will continue to reflect Alert until
sensor glucose readings go above Alert level.
Initial Default Alert:
Vibrates 2 times.
After 5 Minutes:
Vibrates/beeps 2 times every 5 minutes until
cleared.
Trend screen will continue to reflect Alert until
sensor glucose readings go below Alert level.
Rise Rate/Fall Rate Alerts
What you see
Beeps and vibration
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Initial Default Alert:
None/Off.
After Setting Change:
Vibrates 2 times, 2 sounds.
After 5 Minutes:
Vibrates/beeps 2 times every 5 minutes until cleared
or sensor glucose reading drops below Alert level.
Initial Default Alert:
None/Off.
After Setting Change:
Vibrates 3 times.
After 5 Minutes:
Vibrates/beeps 3 times every 5 minutes until cleared
or sensor glucose reading rises above Alert level.
Low Repeat/High Repeat
What you see
Beeps and vibration
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Initial Default Alert:
None/Off.
After Setting Change:
Vibrates 3 times.
After 5 Minutes:
Vibrates/beeps 3 times every 5 minutes until cleared.
Will re-Alert if sensor glucose readings drop at or
below 55 mg/dL.
Initial Default Alert:
None/Off.
After Setting Change:
Vibrates 2 times.
After 5 Minutes:
Vibrates/beeps 2 times every 5 minutes until cleared.
Signal Loss Alert
What you see
Beeps and vibration
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Initial Default Alert:
On.
After Setting Change:
Vibrates 1 time.
After 5 Minutes:
Vibrates/beeps 1 time every 5 minutes for a total of 6
times if not cleared.
After 6 times it will not Alert again.
11.7 Clearing Alarm/Alerts
Alerts require you to acknowledge and clear them. How this is done depends
on your display device. If using both display devices, you’ll need to clear each
separately.
Due to its medical importance, the Alarm is more persistent than an Alert.
Even after acknowledging and clearing an Alarm, if your sensor’s glucose
readings remain at or below 55 mg/dL, the Alarm will sound every 30 minutes
until readings are above 55 mg/dL.
Clearing Your Smart Device
Device
What you see
What it means
Smart
Device:
Lock Screen
Slide
Alarm
or
Alert
to
access app.
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Smart
Device: In
App
Tap
OK
to accept Alarm
or Alert.
Clearing Your Receiver
What you see
What you do
Press
Select
.
Once an Alert is cleared, you won’t receive the same Alert unless you hit the
Alert’s target range again. Your Alarm will repeat even after clearing if your
glucose levels do not return to your target range.
Summary
Now You Can:
• Define an Alarm
• Define an Alert
• Identify the different types of Alerts
• Describe the difference between an Alarm and an Alert
• Recognize different Alarm/Alert notifications and sounds
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• Determine if signal loss is preventing you from getting an Alarm/Alert
• Describe recommended app settings
• Successfully clear an Alert on
o App
o Receiver
What’s Next?
Up to now, you have learned about the Alarm or Alert default settings. But
what do you do if you want to decrease the High Glucose Alert setting, or you
want to continue getting a Low Glucose Alert if your glucose levels don’t
improve, even though you cleared the message?
How do you make your Alarm/Alerts fit your needs?
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Chapter 12
Next Steps
:
On the Go With G5x: Customizing Your Alarm and
Alerts
12.1 Introduction
The receiver and app come with default glucose Alert level settings, but
perhaps they don’t reflect the glucose level that works best for you.
Perhaps you’re in a meeting and can only clear an Alert, yet want to make
sure your Alert repeats, or continues, until you’re able to take corrective
measures. Maybe you’d like to get a Rising/Falling glucose Alert, but their
settings are off by default. How do you turn them on?
In this chapter, you’ll learn how to personalize your Alarm and Alerts tones
and glucose levels.
After this chapter you will be able to:
• Customize your glucose trend Low/High Glucose Alert notifications
o App
o Receiver
• Adjust Alarm sound notification
• Use receiver’s Advanced Alerts
o Low/High Repeat
o Rise/Fall Alerts
o Signal Loss
Each display device has customization options; however, the setup flow is
different. Before making any changes to your Alert levels, talk with your
healthcare professional.
First, let’s take a look at personalizing your app Alarm and Alerts, and then
we’ll review the same process for the receiver.
12.2 Safety Statement
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Precaution
Do: When using both a receiver and a smart device, you must set your
settings separately in each
.
Why: Settings are specific to each display device and don’t carry over to
other devices. If you set up one device and then use another device with
different settings, you might not get an Alarm or Alerts.
Consequences: You may miss a severe low or high glucose event.
Precaution
Do: After connecting any accessories, make sure that the smart device
settings allow you to continue receiving Alarm or Alerts on the smart device.
Why: Using an accessory device (like a smart watch) might override your
smart device sounds.
Consequences: Alarm or Alerts might vibrate or be heard on the accessory
instead of your smart device, causing you to miss severe low or high glucose
event.
12.3 Changing Alarm and Alerts
App Screen Overview
The Alerts Main Menu lists all customizable Alarm and Alerts and their current
settings. Part of your initial setup included setting your Low/High Glucose
Alerts. In this chapter, you’ll learn how to change them.
Before learning how to change your settings, let’s review the app’s Alerts Main
Menu screen.
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Customizing Alerts: App Alarm/Alerts Screen Overview
Step
What you see
What it means
What you do
1
Access Main Menu.
Tap
Main Menu
icon.
Step
What you see
What it means
What you do
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Step
What you see
What it means
What you do
2
Access Alerts Main
Menu.
Tap
Alerts
.
3
All customizable
Alarm and Alerts.
Current Alert
settings.
All Alerts have:
•
On/Off
switch
•
Notify me
options
•
Sound
options
Tap
Alarm/Alert
you
want to change.
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Step
What you see
What it means
What you do
4
“?” explains:
• Each
Alarm/Alert
• Message
options
• Recommended
settings
Tap “?” for
Alarm/Alert
information.
5
Urgent Low Glucose
Alarm:
• Preset at
55 mg/dL and
cannot be
changed
•
Repeat
preset
at 30 minutes
and can’t be
changed
•
Sound
is the
only change
option
Tap
Sound
to
change sound.
Steps to Customize App Alarm/Alerts
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Although the results will vary depending on the Alarm or Alert you are
customizing, the steps to change your Alerts are the same:
From app’s Main Menu:
1. Tap
Alerts
.
2. Tap the
Alert
you want.
a. Tap
On
or
Off
switch to turn on desired Alerts.
3. Tap
Notify me
.
a. Change the Alert glucose level (mg/dL).
i. Scroll selection wheel, find your desired Alert level.
ii. Tap to highlight.
iii. Tap
Save
.
4. Tap
Repeat
.
a. Change the amount of time you want between your High/Low
Glucose Alerts if your sensor glucose readings continue to be low
or high.
i. Scroll selection wheel, find your desired Alert level.
ii. Tap to highlight.
iii. Tap
Save
.
5. Tap
Sound
.
a. Assign a different sound to each Alarm or Alert.
i. Scroll selection wheel, find your desired sound.
ii. Tap to highlight.
iii. Tap
back arrow
.
In this following example, we’ll change the High Alert level from 200 mg/dL to
190 mg/dL, repeating every hour if you continue to stay high, with a Door Bell
sound.
Customizing Alerts: App
Step
What you see
What it means
What you do
Access Alerts Main Menu
1
Access Main Menu.
Tap
Main Menu
icon.
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3
Access High Alert
settings (mg/dL).
Tap
High mg/dL.
4
Shows High Alert
options and current
settings.
Check
High Alert
is
On.
• On - Orange
• Off - Gray
Changing an Alert
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5
Won’t get Alerts if
Off.
If Off:
Slide to
On
.
• On - Orange
• Off - Gray
6
Change High Alert
(mg/dL).
Tap
Notify Me
Above
.
Changing an Alert
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7
Change glucose level
from current level
(mg/dL).
Scroll selection
wheel.
Stop at 190 mg/dL.
8
Saves new High Alert
glucose level
(mg/dL).
Returns to
High
Glucose Alert
screen
options.
Notify Me Above
set
at 190 mg/dL.
Tap
Save
.
Changing an Alert
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9
Changes how often
your High Alert
repeats after initial
Alert and
confirmation.
Repeats only if you
are above your high
glucose level.
Tap
Repeat.
10
Change the current
repeat setting.
Can select in 5-
minute steps (range
15 minutes-4 hours).
Scroll selection
wheel.
Stop at 1 hour.
Changing an Alert
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11
Saves your new
repeat timing.
Returns to
High
Glucose Alert
screen
options.
Repeat
shows how
often you’ll get
notified.
Tap
Save.
12
Customize Alert
sound.
Tap
Sound.
Changing an Alert
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13
Change current
sound setting.
Tap
Door Bell.
Tap
Sound
again to
hear sound sample.
14
Saves your new Alert
sound.
Returns to
High
Glucose Alert
Menu.
Tap
back arrow.
Changing an Alert
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15
Return to Main Menu.
Tap
“X”.
16
Return to trend
screen.
Tap
Menu
icon
Or
Swipe right.
Any changes to the app will not carry over to the receiver. If using both, make
the same changes in the receiver you made in your smart device. If you don’t,
you may miss an Alarm or Alert.
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12.4 Changing Receiver Alarm and Alerts
You’ll notice a flow difference between the app and the receiver when
personalizing your Alarm/Alerts. With the app, all Alert adjustments are made
from one screen, whereas in the receiver, you make changes in different
screens.
Unlike the app, you change your receiver’s tones (known as Profiles) through
a number of different screens in the Profiles menu.
Profiles
Profiles determine the sound and volume of your Alarm and Alerts.
As mentioned in the previous chapter, the receiver uses a series of
beeps/vibrations for an Alarm or Alert. The receiver doesn’t have the same
variety of tones as the app; however, you
can
adjust their volume. While the
receiver doesn’t have a silent mode, selecting
Vibrate
will replace audible
beeps with quiet vibrations. The only exception is the Alarm: the Urgent Low
Glucose Alarm can’t be turned off.
Changes made in
Profiles
are applied to all of the receiver’s Alarm/Alerts. If
you choose
Soft
(see next table), all Alerts are in Soft mode. In Chapter 11,
you learned how many beeps each Alarm/Alert has.
Normal
is the default setting for your receiver sound Profiles.
Attentive
uses a rising or falling melody instead of beeps.
The receiver first vibrates when sending you an Alarm or Alert. If you clear the
Alarm/Alert at the first vibration by pressing the
Select
button on your
navigation wheel, you won’t get any Alarm/Alert tones. If you would like to
continue to get your Alarm or Alert after clearing, later in this chapter you’ll
learn about setting up Repeat Alerts.
HypoRepeat
is very similar to the
Normal
Profile, but keeps repeating the
Urgent Low Glucose Alarm every 5 seconds until your sensor glucose value
rises above 55 mg/dL or you confirm by pressing the
Select
button.
The next table lists the different sound Profiles, starting with the quietest,
working its way up to the loudest.
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Alarm/Alert Sound Profiles: Receiver
Icon
Profile name
Notification description
Vibrate
Vibration only.
Only sound is your receiver vibrating.
Vibrate is not available for the Urgent Low
Glucose Alarm.
Soft
Lower volume beeps.
Normal
Medium volume beeps.
Default Profile.
Attentive
No beeps.
Rising melody for High and Rising Alerts
Dropping melody for Low and Falling Alerts
HypoRepeat
Medium volume beeps.
Urgent Low Glucose Alarm only.
Repeats Urgent Low Alarm every 5 seconds
until sensor glucose reading rises above
55 mg/dL or is confirmed.
Try It
Sample
Profile
setting before selecting.
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After choosing your sound Profile, changing it is just a few steps away!
Change your Profile throughout the day depending on what lies ahead: In a
meeting? Select
Vibrate
. Going to a ball game after work? Select
Attentive
.
The next table shows how to change a sound Profile, then sample how it
sounds.
Customizing Sound Profile: Receiver
Step
What you see
What it means
What you do
1
Go to Main Menu.
Press
Select
.
2
Access second Main
Menu screen.
Press
Down Arrow
.
Profiles
on second
screen.
3
Profiles adjusts
volume of
Alarm/Alerts.
Press
Up/Down
Arrow.
Stop at
Profiles
.
Press
Select
.
4
Choose sound
Profile.
Check mark shows
current Profile.
Press
Up/Down
Arrow
.
Stop at desired
Profile
.
Press
Select
.
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Step
What you see
What it means
What you do
5
Hear selected Profile
.
To sample sound:
Press
Down Arrow
.
Stop at
Try It
.
Press
Select
to
play the sound.
To exit Profiles:
Press
Left Arrow
to
Main Menu
.
6
N/A
Repeat as needed.
Repeat steps 2-5 to
change Profile.
To exit Profiles:
Press
Left Arrow
to
Main Menu
.
Profiles allow you to change your Alarm and Alerts tones. The Alerts menu
gives you options for personalizing your glucose level Alerts, repeating Alerts,
turning on your Rise/Fall Alerts, and turning on your Signal Loss Alert.
Alerts Main Menu
Low/High
Alert option lets you adjust your low/high glucose Alert level
(mg/dL).
Advanced
gives you options to turn on Low/High Repeat, Rise/Fall Alerts, and
Signal Loss Alert.
Low/High Repeat
In the previous chapter, you learned clearing an Alert stops it from repeating.
If you want to continue to be re-Alerted until your glucose levels are back in
your target range, turn on the
Repeat
option.
Rise/Fall Rate
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Your trend screen provides visual cues letting you know your sensor glucose
readings are falling or rising rapidly.
Constantly looking at your screen may not be practical. You can customize
your Rise/Fall Alert with vibrations or beeps letting you know when your
glucose is rising or falling (2 mg/dL/min or 30 mg/dL up or down in 15 minutes)
or rising or falling rapidly (3 or more mg/dL/min or 45 mg/dL or more up or
down in 15 minutes).
The default setting for Repeat and Rise/Fall Rate is
Off
.
It’s important you discuss your Alert settings with your healthcare
professional.
Signal Loss
Signal Loss Alert tells you when your transmitter and receiver aren’t
communicating. Set the Signal Loss Alert and get notified if your sensor
glucose readings have stopped due to a signal loss anywhere from 20 to 200
minutes.
The default setting for Signal Loss is
On
.
Steps to Customize Receiver Alarm/Alerts
Using the same example from changing your app Alerts, let’s change the
receiver’s High Alert notification level from 200 mg/dL to 190 mg/dL, repeating
every 60 minutes.
Follow the same steps turning on the Rise/Fall Alerts, and adjusting your Low
Alerts.
Customizing Alerts: Receiver
Step
What you see
What it means
What you do
Change High Alert Level
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Step
What you see
What it means
What you do
1
Go to Main Menu.
Press
Select
.
2
Alerts option from the
Main Menu.
Enter Alerts menu
option.
Press
Down Arrow
.
Stop at
Alerts
.
Press
Select
.
3
Alerts option menu.
Lists different Alerts:
High/Low/Advanced
(Repeat, Rise/Fall,
Signal Loss) Alerts.
Press
Up/Down
Arrow.
Stop at
High Alert
.
Press
Select
.
Change High Alert Level
4
Alert’s current
settings.
Change your current
High Alert level.
Press
Down Arrow
.
Stop at
Level
.
Press
Select
.
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5
Current setting.
Use
Up/Down
arrows to change
your High Alert level
(mg/dL).
Press
Down Arrow
.
Stop at 190 mg/dL.
6
Saves new High Alert
level.
Return to Alerts
Menu.
Press
Select
.
To exit:
Press
Left Arrow
.
Turn On Repeat
7
Alerts Menu.
Choose
Advanced
to
get to Repeat Alert.
Press
Down Arrow
.
Stop at
Advanced
.
Turn On Repeat
8
Enter Advanced Alert
options.
Press
Select
on
Advanced
.
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9
Main Advanced
screen.
Set Repeat Alerts.
Turn on Rise/Fall
Rate Alerts.
Arrow to
High
Repeat.
Press
Select
.
10
Initial screen shows
current repeat
minutes.
Change time frame in
5-minute increments.
Press
Up/Down
Arrow.
Stop at 60 minutes.
11
Changed
Repeat
time for High Alert.
Press
Select
.
12
Change completed.
Return to
Alerts
Menu.
To exit:
Press
Left Arrow
.
It doesn’t matter which device you first use to customize your Alarm/Alert
settings; the key is to make sure you make the same changes in both or you
may miss an Alarm or Alert.
Summary
Now You Can:
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• Customize your glucose trend Low/High Alerts in
o App
o Receiver
• Adjust Alarm Profiles
• Set up receiver’s Advanced Alerts
o Low/High Repeat
o Rise/Fall Rate
o Signal Loss
What’s Next?
Believe it or not, you are becoming a pro at using your G5x! You’ve set up the
app and receiver, started a session, calibrated, followed your glucose trends,
paid attention to your Alarm/Alerts notifications, and ended a session!
The next chapters begin our fourth part of the user guide: information you
need to know, but unlike the previous chapters, typically not part of your day-
to-day G5x experience.
The next part, Part 4: Everything Else G5x, reviews the technical
specifications, the warranty, how to take care of the G5x components, going
through security when traveling, contacting the Help Desk, Troubleshooting
information, and symbols on system components and packages.
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4
EVERYTHING ELSE G5x
• Warranty
• G5x Maintenance
• Travel Tips
• Customer Service Contacts
• Technical Information
• Troubleshooting
• Symbols on Package Labels
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Chapter 13
Everything Else G5x:
Warranty: The Fine Print
13.1 Introduction
Sometimes stuff happens. Dexcom has you covered!
The following is our warranty information outlining what we do cover, what we
don’t, and for how long. First the receiver’s limited warranty information, then
the transmitter’s limited warranty information.
13.2 Receiver Warranty Information
G5x’s Limited Warranty
What’s Covered and for How Long?
Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser
(“you” or “Purchaser”) that the Dexcom receiver (the “receiver”) is free from
defects in material and workmanship under normal use (“Limited Warranty”)
for the period starting from the shipment date and continuing for a year
following the shipment date (“Warranty Period”):
Dexcom receiver: 1 year from shipment date
NOTE: If you received this receiver as a replacement for an in-warranty
receiver, the Limited Warranty for the original receiver shall continue for the
Warranty Period on the original receiver, but the replacement is not subject to
any other warranty.
What’s Not Covered?
This Limited Warranty is based on the Purchaser properly using the CGM
system in accordance with the documentation provided by Dexcom. You are
not permitted to use the CGM system otherwise. You understand that
misusing the CGM system, improperly accessing it or the information it
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processes and transmits, “jailbreaking” your CGM system or cell phone, and
taking other unauthorized actions may put you at risk, cause the CGM system
to malfunction, is not permitted and voids your Limited Warranty.
This Limited Warranty does not cover:
1. Defects or damage resulting from accident, misuse, abuse, neglect,
unusual physical, electrical or electromechanical stress, modification
of any part of the product, or cosmetic damage.
2. Equipment with the ID number removed or made illegible.
3. All surfaces and other externally exposed parts that are scratched or
damaged due to normal use.
4. Malfunctions resulting from the use of the receiver in conjunction with
accessories, ancillary products, and peripheral equipment, whether
hardware or software, not furnished or approved by Dexcom.
5. Defects or damage from improper testing, operation, maintenance,
installation, or adjustment.
6. Installation, maintenance, and service of products or services other
than the CGM system (which may be subject to a separate limited
warranty), whether provided by Dexcom or any other party; this
includes your cell phone or smart device and your connection to the
Internet.
7. Equipment which has been taken apart physically or which has had
any of its software accessed in any unauthorized manner.
8. Water damage to the receiver.
a. Receiver is not water resistant.
b. Do not get the receiver wet at any time.
Dexcom’s Obligations Under the Limited Warranty
During the Warranty Period, Dexcom will replace, without charge to
purchaser, any defective G5 Mobile receiver.
To return, you must send the receiver to an authorized Dexcom Technical
Support Department. Make sure you package the receiver adequately for
shipping.
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The return package needs to include:
1. Receiver
2. Sales receipt or comparable substitute proof of sale showing the date
of purchase
3. Receiver’s serial number
4. Seller’s name and address
Call Dexcom Technical Support Department for delivery
information help:
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
Upon receipt, Dexcom will replace the defective receiver.
If Dexcom determines the receiver isn’t covered by this Limited Warranty,
Purchaser must pay all shipping charges for the receiver’s return by Dexcom.
Limits on Dexcom’s Warranty and Liability Obligations
The Limited Warranty described above is the exclusive warranty for the
receiver, and in lieu of all other warranties, expressed or implied, either in fact
or by operation of law, statutory or otherwise.
Dexcom expressly excludes and disclaims all other warranties, including
without limitation any warranty of merchantability, fitness for a particular
purpose, or non-infringement, except to the extent prohibited by applicable
law.
Dexcom shall not be liable for any special, incidental, consequential, or
indirect damages, however caused, and on any theory of liability, arising in
any way out of the sale, use, misuse, or inability to use, any G5x or any
feature or service provided by Dexcom for use with the G5x.
These limits on Dexcom’s warranty and liability obligations apply even if
Dexcom, or its agent, has been advised of such damages and notwithstanding
any failure of essential purpose of this Limited Warranty and the limited
remedy provided by Dexcom.
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This Limited Warranty is only provided to the original Purchaser and can’t be
transferred to anyone else, and states Purchaser’s exclusive remedy.
If any portion of this Limited Warranty is illegal or unenforceable by reason of
any law, such partial illegality or enforceability shall not affect the
enforceability of the remainder of this Limited Warranty. This Limited Warranty
will be enforced to the maximum extent permitted by law.
13.3 Transmitter Warranty Information
G5x Transmitter Limited Warranty
What’s Covered and for How Long?
Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser
that the G5x transmitter is free from defects in material and workmanship
under normal use for the period commencing on the date of first use by the
original purchaser (the “Date of First Use”) and expiring three (3) months
thereafter; provided, that, the Date of First use occurs within five (5) months of
the date of shipment (or disbursement) of the transmitter to the original
purchaser.
NOTE: If you received this transmitter as a replacement for an in-warranty
transmitter, the Limited Warranty for the original transmitter shall continue for
the Warranty Period on the original transmitter, but the replacement is not
subject to any other warranty.
What’s Not Covered?
This Limited Warranty is based on the Purchaser properly using the CGM
system in a timely manner and in accordance with the documentation
provided by Dexcom. You are not permitted to use the CGM system
otherwise. You understand that misusing the CGM system, improperly
accessing it or the information it processes and transmits, “jailbreaking” your
CGM system or cell phone, and taking other unauthorized actions may put
you at risk, cause the CGM system to malfunction, is not permitted and voids
your Limited Warranty.
This Limited Warranty does not cover:
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1. Defects or damage resulting from accident, misuse, abuse, neglect,
unusual physical, electrical or electromechanical stress, modification
of any part of the product, or cosmetic damage.
2. Equipment with the ID number removed or made illegible.
3. All surfaces and other externally exposed parts that are scratched or
damaged due to normal use.
4. Malfunctions resulting from the use of the transmitter in conjunction
with accessories, ancillary products, and peripheral equipment,
whether hardware or software, not furnished or approved by Dexcom.
5. Defects or damage from improper testing, operation, maintenance,
installation, or adjustment.
6. Installation, maintenance, and service of products or services other
than the CGM system (which may be subject to a separate limited
warranty), whether provided by Dexcom or any other party; this
includes your cell phone or smart device and your connection to the
Internet.
7. Equipment which has been taken apart physically or which has had
any of its software accessed in any unauthorized manner.
8. Water damage to transmitter.
a. Beyond specifications listed in G5 Mobile’s user guide.
b. Your options to get the user guide:
i. Download or view: dexcom.com/guides
ii. Online request form to receive free printed copy:
dexcom.com/guides
iii. Request a free copy by mail
iv. Request a free copy by phone:
Toll free: 1.888.738.3646
Toll call: 1.858.200.0200
v. Located on dexcom.com.
13.4 Dexcom’s Obligations Under the Limited Warranty
During the Warranty Period, Dexcom will replace, without charge to
purchaser, any defective G5x transmitter.
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To return, you must send the transmitter to an authorized Dexcom Technical
Support Department. Make sure you package the transmitter adequately for
shipping.
The return package needs to include:
1. Transmitter
2. Sales receipt or comparable substitute proof of sale showing the date
of purchase
3. Transmitter’s serial number
4. Seller’s name and address
Call Dexcom Technical Support Department for delivery information or help:
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
Upon receipt, Dexcom will replace the defective transmitter.
If Dexcom determines this Limited Warranty doesn’t cover the transmitter,
Purchaser must pay all shipping charges for the transmitter’s return by
Dexcom.
Limits on Dexcom’s Warranty and Liability Obligations
The Limited Warranty described above is the exclusive warranty for the
transmitter, and in lieu of all other warranties, expressed or implied, either in
fact or by operations of law, statutory or otherwise.
Dexcom expressly excludes and disclaims all other warranties, including
without limitation any warranty merchantability, fitness for a particular
purpose, or non-infringement, except to the extent prohibited by applicable
law.
Dexcom shall not be liable for any special, incidental, consequential, or
indirect damages, however caused, and on any theory of liability, arising in
any way out of the sale, use, misuse, or inability to use, any G5x or any
feature or service provided by Dexcom for use with the G5x.
These limits on Dexcom’s warranty and liability obligations apply even if
Dexcom, or its agent, has been advised of such damages and notwithstanding
any failure of essential purpose of this Limited Warranty and the limited
remedy provided by Dexcom.
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This Limited Warranty is only provided to the original Purchaser and can’t be
transferred to anyone else, and states Purchaser’s exclusive remedy.
If any portion of this Limited Warranty is illegal or unenforceable by reason of
any law, such partial illegality or enforceability shall not affect the
enforceability of the remainder of this Limited Warranty.
This Limited Warranty will be enforced to the maximum extent permitted by
law.
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Chapter 14
Everything Else G5x:
How to Take Care of Your G5x
14.1 Introduction
There are not a lot of moving parts in the G5x, so maintenance is relatively
simple:
• Keep it clean
• Keep display device(s) dry and protected
• Use accessory parts, like the USB cable, etc., included with the
system
• Store according to each piece’s instructions
This chapter covers only Dexcom parts (sensor, transmitter, and receiver).
Follow the manufacturer’s instructions when caring for your smart device.
After this chapter, you will be able to:
1. Demonstrate proper maintenance
a. Sensor applicator
b. Transmitter
c. Receiver
d. Receiver battery
e. Accessories
2. Identify the best storage methods
a. Sensor applicator
b. Transmitter
c. Receiver
3. Check app and receiver information
4. Safely dispose of system components
a. Sensor
b. Transmitter
c. ReceiverX
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14.2 Safety Statements
Following are some important Warnings and Precautions to review. This
information helps you take care of your system so it can take care of you.
Warning
Do:
Inspect your transmitter.
Don’t:
Use your transmitter if it is damaged or cracked in any way.
Why: Damaged components could create an electrical safety hazard or
malfunction.
Consequences: Electrical safety hazard or malfunction could cause
electrical shocks.
Warning
.
Don’t:
Use your receiver if it is damaged or cracked in any way.
Why: Damaged components could create an electrical safety hazard or
malfunction.
Consequences: Electrical safety hazards or malfunctions could cause
electrical shocks.
Precaution
Don’t:
Never get dirt or water in the receiver’s USB port or submerge in
water.
Why: If dirt or water gets into the USB port, the receiver could become
damaged and stop displaying readings or providing Alerts.
Consequences: You might miss a severe low or high glucose event.
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Precaution
Don’t:
Use expired sensors. Before inserting, always check the package
label for the expiration date using the YYYY-MM-DD format.
Why; If past the expiration date, the sensor glucose readings might not be
accurate.
Consequences: Missing severe low or high glucose event.
Precaution
Don’t:
Share your transmitter with another person.
Why: The system is a prescription-only medical device and is meant, or
indicated, for your use only.
Consequences: Your transmitter is tied to
your
readings. If used by
someone else, your reports, Alarm and Alerts, etc., would be wrong,
resulting in you missing a severe low or high glucose event.
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Precaution
Do:
If your receiver gets wet or dropped, make sure the speaker and
vibrations still work.
To check, either plug it in, turn it on, or go to the Profiles menu and select
Try It. If it doesn’t vibrate and beep, contact Technical Support.
Why: If your receiver gets wet or dropped, the speaker and vibrations may
not work.
Consequences: If the vibration motor and/or speaker on your receiver
aren’t functioning properly you may miss a severe low or high Alarm/Alert.
Use the app on your smart device until this issue is resolved
.
14.3 Basic Maintenance
14.2 Basic Maintenance
Sensor Applicator
1. Keep in sterile package until ready for use.
2. Check package label for expiration date.
a. Expiration date format is YYYY-MM-DD (year-month-day)
format.
b. Don’t use if past expiration date.
i. May provide inaccurate sensor glucose readings.
ii. May be unsterile.
Transmitter
1. Keep in box until ready for use.
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a. Check transmitter and don’t use if damaged.
2. Transmitter is reusable, but only by the same person.
a. Never share transmitter with anyone.
3. Between uses, clean outside of the transmitter with damp cloth or
alcohol wipes. Let dry before use or storage.
4. When not in use:
a. Protect transmitter by returning it to its packaging or another
safe place.
b. Store between 32° F-113° F.
Receiver
1. Check receiver casing; if it’s cracked or damaged, don’t use. Do not
open it. There are no serviceable parts inside.
a. May get an electric shock.
2. Keep receiver dry—it is only splash resistant.
a. Don’t submerge in liquid.
b. Don’t spill fluids on receiver.
3. Keep battery charged.
a. Only use Dexcom USB charging/download cable.
4. Keep the micro USB port cover closed if not using USB cable.
a. Prevents fluid from getting inside receiver.
Charging Receiver’s Battery
The receiver’s status bar lets you see its battery level and notifications you
when the battery is getting low. While the receiver is being charged, you will
continue to get your sensor glucose readings if the transmitter and receiver
are within 20 feet of each other.
Each charge lasts approximately three days. If your receiver’s battery was
drained, after charging, you may need to reset its time and date. If this is
required, the system tells you to reset and takes you to the time/date setting
screens.
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Charging Receiver Battery
Step
What you see
What it means
What you do
1
Low Battery
Charge your battery.
2
Micro USB Port
Open
USB port
door.
Plug
USB cable
into port for
recharging.
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Step
What you see
What it means
What you do
3
Micro USB Cable
Plug into
receiver
to
charge battery.
Don’t plug into a
computer port to
charge.
Don’t use an
external USB hub; it
doesn’t provide
enough power to
charge battery.
Battery can only be
charged using the
adapter/wall
charger.
Charge battery
before each new
sensor session.
4
Wall Charger
Plug
USB cable
into
adapter/wall
charger
.
Plug wall charger
into an electrical
outlet to charge
receiver’s battery.
Don’t block access
to the charger.
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Step
What you see
What it means
What you do
5
Battery Charging
Keep charging until
battery icon is solid.
6
Battery Charged
Disconnect
wall
charger
from outlet
when fully charged.
7
USB Port Door
Remove
USB
cable
from receiver.
Close
USB port
door
after removing
USB cable to keep
receiver clean and
dry.
Accessories
1. Only use Dexcom-supplied parts (including cable and charger).
a. Use of non-Dexcom supplied parts may affect safety and
performance.
2. Insert cable only as directed.
a. Do not force cable in place.
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3. Look at cable for signs of wear and tear. Do not use if worn or
damaged.
There is no repair service available for any G5x parts.
If you experience problems, report the issue to Technical Support (available
24/7) at:
• TechSupport@dexcom.com
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
14.4 Storage
Storing your G5x correctly helps prevent system failures.
Sensor Applicator
1. Keep the sensor applicator in its sterile packaging until you are ready
to use it.
2. Store at temperatures between 36° F-86° F.
a. Storing outside of this range may cause inaccurate sensor
glucose readings.
b. May store in refrigerator if it’s within this temperature range.
c. Sensors should not be stored in freezer.
3. Store at humidity levels between 10%-90% relative humidity.
Transmitter
1. Keep transmitter protected when not in use.
2. Store at temperatures between 32° F-113° F.
3. Store at humidity levels between 10%-95% relative humidity.
Receiver
1. Keep receiver protected when not in use.
2. Fully charge the battery before storing for over 3 months.
3. Store at temperatures between 32° F-104° F.
4. Store at humidity levels between 10%-95% relative humidity.
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14.5 Checking app and Receiver Information
You can check your app or receiver for information about your CGM system at
any time.
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CHECKING YOUR APP & RECEIVER SOFTWARE
VERSION
You can check your app or receiver for information about your CGM
system at any time.
Receiver
1. From the Settings menu, press
Up
or
Down
arrows
to scroll to
“Device Info.”
2. Press
Select
. Information about your sensor session and system
will show
App
1. From Main Menu, tap
Settings
.
2. Tap
Device Info
.
Available Information
• Insertion Time
• Last Calibration
• Transmitter Battery
• Transmitter Serial Number
• Part Number
• Part Revision
• Software Number
14.5 System Disposal
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Different municipalities have different requirements when throwing away
electronics (receiver and transmitter) and parts that have come in contact with
blood or other bodily fluids (sensor).
Consult your area’s local waste management authorities for proper disposal
instructions.
Taking care of your G5x is pretty easy. In the next chapter, “On the Go With
G5x: Getting Through Security” you’ll learn how simple it is to travel the world
with your G5x!
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Chapter 15
Everything Else G5x:
On the Go With G5x: Getting Through Security
15.1 Introduction
G5x can be a great travel companion; you can go through metal detectors, be
handwanded, and even keep your receiver on during your flight.
This chapter covers only the G5x. It doesn’t cover steps you need to take
when traveling with your smart device. See your smart device’s instructions
for use to learn how to travel with it.
After this chapter, you will be able to:
• Explain proper procedure if you prefer a full-body pat-down
• Describe steps needed for a TSA officer to inspect G5x components
• Identify when your display device(s) can be on during a flight
• Contact TSA directly with your security questions
15.2 Safety Statement
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Precaution
Don’t:
Place any part of the G5x in the baggage x-ray machine or body
scanner.
Do:
Ask for visual inspection instead:
• Baggage x-ray machine: Instead of putting any part of your G5 Mobile
through the baggage x-ray, ask the TSA officer to visually inspect it.
• Body scanner: When you are wearing your G5 Mobile, request hand-
wanding or full-body pat-down and visual inspection instead of going
through the Advanced Imaging Technology (AIT) body scanner. (AIT
is also called millimeter wave scanner.)
Why: The system has not been tested in x-rays or AIT body scanners, and it
is unknown if exposure to x-rays or AIT body scanners can affect the system
performance.
It is safe to wear the system through the walk-through metal detector or hand-
wanding. If you are unsure of whether the airport scanner is a metal detector,
an AIT body scanner or an x-ray, ask the TSA officer or request hand-wanding
or full body pat-down.
Consequences: Missing a severe low (hypoglycemia) or high
(hyperglycemia) glucose event.
15.3 Going Through Security
Walk-Through Metal Detectors
Transmitter and Sensor
No worries about wearing your transmitter and sensor when going through
security.
Go through walk-in metal detectors or, if you prefer, be handwanded without
worrying about damaging your transmitter or sensor.
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If you’re concerned or uncomfortable about walking through the metal
detector, the Transportation Security Administration (TSA) requests you tell
the Security Officer that you’re wearing a continuous glucose monitor and
want a full-body pat-down with a visual inspection of your sensor and
transmitter.
Let the Security Officer know the sensor can’t be removed because it’s
inserted under the skin.
X-Ray Machines
Receiver, Extra Sensors
Don’t put your components through x-ray machines.
Before your screening process begins, ask the TSA Officer to perform a visual
inspection of the receiver and your extra sensors. Place all components in a
separate bag before handing over to the Security Officer.
For other medical supplies, such as medications, meters, and strips, check
manufacturer’s instructions or the TSA website.
Body Scanners
Use of advanced imaging technology (AIT) body scanners, like millimeter
wave scanners, has not been studied, and we therefore recommend hand-
wanding or full-body pat-down and visual inspection in those situations.
In the Plane
To use your smart device, receiver, or both to get sensor glucose information
while in the plane:
• Smart device: When you switch to airplane mode, keep
Bluetooth
on
• Receiver: Keep receiver on
Contact your airline for their policies.
Technical Information
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The G5x System is an M-PED (Medical-Portable Electronic Device) which
meets the FAA RTCA/DO-160 edition G section 21, Category M. It can be
used on aircraft according to the directions provided by the operator of the
aircraft..
Any M-PED that meets this standard in all modes may be used onboard the
aircraft without any further testing by the operator.
This device can withstand exposure to common electrostatic discharge (ESD)
and electromagnetic interference (EMI).
Still Have Questions?
Visit the TSA’s website if you have any questions or concerns at tsa.gov.
Email: TSA-ContactCenter@tsa.dhs.gov
Phone: 1.866.289.9673
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Chapter 16
Everything Else G5x:
Need Help? You’re Not Alone!
Dexcom has three support teams to help you, each with their own specialty:
• Dexcom Technical Support Team
• Dexcom Patient Care Team
• Dexcom Sales Support Team
16.1 Dexcom Technical Support Team
The Dexcom Technical Support Team helps you with all CGM system-related
issues as well as software-related issues. They provide replacement units,
resolve technical issues and take product complaints.
Dexcom Technical Support does not offer medical advice.
By Email
Email: TechSupport@dexcom.com
If you prefer to email, to help us help you best, include the following
information in your email:
• Name of patient
• Patient’s date of birth
• Description of technical problem
• When the problem happened (date and time)
• Patient’s address
• Patient’s phone number
• Item SKU number and description (for example, name of the device)
• Lot number and/or serial number(s) of affected device(s) (for
example, sensor)
• Your preferred contact method and information so Dexcom can reach
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you if needed. For example: by phone 555-555-5555 after 5 PM
Pacific Time
By Phone
Available 24 hours a day, 7 days a week
Dexcom Technical Support phone numbers:
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
16.2 Dexcom Patient Care Team
The Dexcom Patient Care Team is a group of Certified
Diabetes Educators (CDE®) and Registered Nurses
(RNs) offering you customer care and individualized
education services around Dexcom CGM.
Your Dexcom Patient Care Team provides education and support throughout
your CGM experience, such as:
• Initial CGM product training
• Ongoing Dexcom product education (for example, how to use a
specific feature)
• How to maximize Dexcom CGM use
• Dexcom CGM reporting software and features
• How to review and understand Dexcom CGM reports
By Email
Email: patientcare@dexcom.com
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If you prefer to email, to help us help you best, include the following
information in your email:
• Name of patient
• Patient’s date of birth
• Contact phone number
• Reason for inquiry or education needed
For additional Dexcom CGM education, check the Dexcom website:
dexcom.com/web-based-education
By Phone
Available Monday-Friday 5:30 AM-8:00 PM PST (subject to change)
Toll Free: 1.888.738.3646
Toll Call: 1.858.200.0200
16.3 Dexcom Sales Support Team
Inside Sales Support Team
For help with:
• First-time orders
• Re-orders
• Tracking shipments
• Locating a local Dexcom representative
By Internet
Dexcom online store: dexcom.com/order
By Email
Email: CustomerService@dexcom.com
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By Phone
Dexcom Inside Sales Support phone numbers:
Toll Free: 1.888.738.3646
Toll Call: 1.858.200.0200
By Fax
1.877.633.9266
16.4 Corporate
Dexcom Website:
dexcom.com
Dexcom Address:
6340 Sequence Drive
San Diego, CA 92121
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Chapter 17
Everything Else G5x:
Technical Information
17.1 Device Performance Characteristics
NOTE: We recommend that you review the information in this chapter with
your healthcare professional to understand how well the G5 Mobile performs.
The G5 Mobile (the System) uses a glucose sensor to continuously measure
and monitor your glucose levels. The sensor is “calibrated” using a
commercially available BG meter. Once calibrated, the System reports
glucose readings up to every 5 minutes. The System was evaluated in clinical
studies in which System readings were compared to BG values to assess its
performance and how well the System readings compared to a laboratory test
method that measures BG values. Additionally, subjects performed self-
monitoring BG meter tests at home to assess the System performance in a
real use environment.
Although the performance characteristics of the System are presented in the
following, there is no commonly accepted statistical approach for capturing
performance of continuous glucose monitors (CGMs), such as the G5 Mobile.
Clinical Study Overview
The System performance was evaluated in four separate prospective clinical
studies. Two studies included adults, and two studies included pediatrics. In
the following sections and tables, the studies will be identified as follows:
Adult Studies (18 years and older)
Original Adult Study: the receiver included software version SW10050
Software 505 Adult Study: the receiver included software version
SW10505
Pediatric Studies (2 to 17 years)
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Original Pediatric Study: the receiver included software version
SW10050
Software 505 Pediatric Study: the receiver included software version
SW10505
The G5 Mobile incorporates the algorithm from software version SW10505
and has a new software number.
Overview of Adult Studies
The System performance for adults was evaluated in two separate
prospective clinical studies: Original Adult Study (software SW10050) and
the Software 505 Adult Study (software SW10505). Differences between
the studies include the number of subjects enrolled, the number of Systems
worn by each participant, the SMBG meter used, and the number of clinic
days each subject participated in during the study. An overview of each study
is provided here.
The Original Adult Study enrolled 72 subjects, and the Software 505
Adult Study enrolled 51 subjects. All subjects had Type 1 or Type 2 diabetes
mellitus, and required insulin or oral medication to manage their diabetes. In
the Original Adult Study, 83% of subjects had Type 1 diabetes, and 17% of
subjects had Type 2 diabetes. In the Software 505 Adult Study, 86% of
subjects had Type 1 diabetes, and 14% of subjects had Type 2 diabetes. Both
studies included subjects greater than 18 years of age.
Subjects in both studies used the System for seven days. In the Original
Adult Study, thirty-six subjects each wore 2 sensors; in the Software 505
Adult Study, all subjects wore 1 sensor only. Throughout the 7-day wear
period, the sensor was calibrated with an average of 2 fingersticks per day
(approximately once every 12 hours). In the Original Adult Study, subjects
used the LifeScan® OneTouch® Ultra®2 meter and in the Software 505
Adult Study, subjects used Bayer’s CONTOUR® NEXT USB meter.
In the Original Adult Study, all subjects were evaluated in a controlled clinic
environment on all three clinic days: Day 1, Day 4, and Day 7 of the 7-day
wear period. In the Software 505 Adult Study, subjects were evaluated in
one of the three clinic days so there are fewer data samples than in the
Original Adult Study. While using the System in the clinic, subjects had their
BG measured every 15 minutes with a reliable laboratory method, the Yellow
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Springs Instrument 2300 STAT Plus™ Glucose Analyzer. This instrument is
referred to as the “YSI.” Readings from the System were reported every 5
minutes and paired with YSI values in order to characterize how well the
System readings agreed with laboratory standard BG results. The remainder
of the study took place at home, and the System performance was also paired
with the comparative meter results, referred to as the “SMBG.”
Overview of Pediatric Studies
The System performance for children and adolescents was evaluated in two
separate prospective clinical studies: the Original Pediatric Study
(SW10050) and the Software 505 Pediatric Study (SW10505).
Differences between the studies include the number of subjects enrolled, the
number of Systems worn by each participant, the SMBG meter used, the
length of time subjects were evaluated in a controlled clinic environment and
whether or not subjects ages 13-17 had their glucose levels intentionally
manipulated during the study. An overview of each study is provided here.
The Original Pediatric Study enrolled 176 subjects, with 16% of subjects
younger than 6-years old, and the Software 505 Pediatric Study enrolled
79 subjects, with 20% of subjects younger than 6-years old. All subjects had
Type 1 or Type 2 diabetes mellitus and required insulin or oral medication to
manage their diabetes. In the Original Pediatric Study, about 99% of
subjects had Type 1 diabetes and 1% had Type 2 diabetes. In the Software
505 Pediatric Study, all subjects had Type 1 diabetes. Sensors were
inserted in either the abdomen or upper buttocks.
Subjects in all studies used the System for seven days. In the Original
Pediatric Study, all subjects wore 2 sensors; in the Software 505
Pediatric Study, all subjects wore 1 sensor only. Throughout the 7-day wear
period, the sensors were calibrated with an average of 2 fingersticks per day
(approximately once every 12 hours), using self-monitoring BG (SMBG) meter
values. The Original Pediatric Study used the LifeScan® OneTouch®
Verio® IQ meter; the Software 505 Pediatric Study used Bayer’s
CONTOUR® NEXT USB meter.
All subjects were evaluated in a controlled clinic environment on Day 1, Day 4,
or Day 7 of the 7-day wear period. While using the System in the clinic,
subjects provided at least two fingerstick measurements per hour, and
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subjects ages 6-17 also provided venous blood for comparison to a laboratory
method, the Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer.
This instrument is referred to as the “YSI.” In the Original Pediatric Study,
subjects’ glucose levels were not intentionally manipulated during this study;
in the Software 505 Pediatric Study, subjects ages 13-17 had their
glucose levels intentionally manipulated during the clinic session. Readings
from the System were reported every 5 minutes and paired with YSI values
collected every 15 minutes in order to characterize how well the System
readings agreed with laboratory standard BG results. The remainder of the
study took place at home, and the System performance was also paired with
the comparative meter results, referred to as the “SMBG.”
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Table 1-A. System Agreement to YSI Within CGM Glucose
Ranges (Adult)
CGM
Glucose
Range1
(mg/dL)
Study2
Number
of Paired
CGM-YSI
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
Greater
than
40/40%
YSI
Overall
Original
9152
71%
82%
92%
3%
Software 505
2263
86%
93%
98%
1%
40-60
Original
512
67%
78%
88%
6%
Software 505
120
89%
94%
98%
0%
61-80
Original
781
73%
85%
94%
2%
Software 505
226
91%
96%
99%
0%
81-180
Original
3853
67%
78%
91%
3%
Software 505
738
84%
92%
98%
1%
181-300
Original
2784
72%
84%
93%
4%
Software 505
798
86%
93%
98%
1%
301-350
Original
775
82%
91%
97%
2%
Software 505
229
86%
94%
98%
1%
351-400
Original
447
74%
84%
91%
5%
Software 505
152
80%
92%
97%
0%
1
CGM readings are within 40-400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 1-B. System Agreement to YSI Within CGM Glucose
Ranges (Pediatric)
CGM
Glucose
Range1
(mg/dL)
Study2
Number
of Paired
CGM-YSI
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
Greater
than
40/40%
YSI
Overall
Original
2922
55%
68%
85%
7%
Software 505
2262
81%
91%
96%
2%
40-60
Original
19
63%
74%
79%
21%
Software 505
86
54%
74%
91%
3%
61-80
Original
76
61%
82%
92%
4%
Software 505
142
77%
82%
90%
3%
81-180
Original
1155
56%
69%
84%
6%
Software 505
805
78%
88%
97%
1%
181-300
Original
1380
55%
68%
85%
7%
Software 505
957
89%
96%
99%
1%
301-350
Original
206
48%
62%
80%
11%
Software 505
209
81%
91%
94%
5%
351-400
Original
86
48%
61%
79%
12%
Software 505
63
64%
81%
83%
8%
1
CGM readings are within 40-400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Agreement Relative to YSI
Agreement between the System and BG values is characterized using paired
System and YSI values. The System and YSI results were compared by
pairing the YSI BG value to a System glucose reading that occurred
immediately after the YSI was collected.
The agreement of the System to BG value was assessed by calculating the
percentage of System readings that were within 15%, 20%, 30% and greater
than 40% of the YSI values. For readings less than or equal to 80 mg/dL the
absolute difference in mg/dL between the two glucose results was calculated.
For values greater than 80 mg/dL the absolute percent difference (%) from the
YSI values was calculated. The percentages of total readings within 15 mg/dL
or 15%, 20 mg/dL or 20%, 30 mg/dL or 30% or greater than 40 mg/dL or 40%
are provided in Table 1-A and 1-B. The tables are categorized within CGM
glucose ranges. When you see a CGM reading on your receiver, this table
shows you how likely that reading matches your BG level (measured by YSI in
the study).
For example, in the SW10505 Adult Study (Table 1-A), the total number of
data pairs considered in the analysis was 2263. Of these, 93% of the System
readings fall within ± 20 mg/dL of the YSI BG values ≤ 80 mg/dL and within ±
20% of YSI BG values > 80 mg/dL.
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Table 2-A. Number and Percentage of YSI Values When CGM
Readings Are “LOW” or “HIGH” (Adult)
YSI mg/dL
Total
CGM
Readings
Study1
CGM-YSI
Pairs
< 55
< 60
< 70
< 80
≥ 80
“LOW”
Original
n
66
84
123
142
13
155
Cumulative
Percent
42%
54%
79%
92%
8%
Software
505
n
11
16
17
18
0
18
Cumulative
Percent
61%
89%
94%
100%
0%
YSI mg/dL
Total
CGM
Readings
Study1
CGM-YSI
Pairs
> 340
> 320
> 280
> 240
≤ 240
“HIGH”
Original
n
189
220
238
246
2
248
Cumulative
Percent
76%
89%
96%
99%
1%
Software
505
n
40
43
45
45
0
45
Cumulative
Percent
89%
96%
100%
100%
0%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 2-B. Number and Percentage of YSI Values When CGM
Readings Are “LOW” or “HIGH” (Pediatric)
YSI mg/dL
Total
CGM
Readings
Study1
CGM-YSI
Pairs
< 55
< 60
< 70
< 80
≥ 80
“LOW”
Original
n
0
0
0
0
13
13
Cumulative
Percent
0%
0%
0%
0%
100%
Software
505
n
3
5
10
15
1
16
Cumulative
Percent
19%
31%
63%
94%
6%
YSI mg/dL
Total
CGM
Readings
Study1
CGM-YSI
Pairs
> 340
> 320
> 280
> 240
≤ 240
“HIGH”
Original
n
38
51
68
69
1
70
Cumulative
Percent
54%
73%
97%
99%
1%
Software
505
n
14
19
22
23
1
24
Cumulative
Percent
58%
79%
92%
96%
4%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Agreement When CGM Reads “LOW” or “HIGH”
The System reports glucose readings between 40 and 400 mg/dL. When the
System determines the glucose reading is below 40 mg/dL, it displays “LOW”
in the Receiver Status Box. When the System determines that the glucose
level is above 400 mg/dL, it displays “HIGH” in the Receiver Status Box.
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Because the System does not display glucose values below 40 mg/dL or
above 400 mg/dL, the comparisons to the actual BG levels (as determined by
the YSI analyzer) when CGM is classified as “LOW” or “HIGH” are included
separately in Table 2-A and 2-B. The tables include the numbers and the
cumulative percentages when YSI values were less than certain glucose
levels (for “LOW”), and when YSI values were greater than certain glucose
levels (for “HIGH”).
For example, in the Software 505 Adult Study (Table 2-A), when the
System displayed “LOW” (18 occasions), 100% (18 out of 18) of the YSI
values were less than 80 mg/dL, and 94% (17 out of 18) of the YSI values
were less than 70 mg/dL. When the System displayed “HIGH” (45 occasions),
100% (45 out of 45) of the YSI values were greater than 240 mg/dL, and
100% (45 out of 45) of the YSI values were greater than 280 mg/dL.
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Table 3-A. Concurrence of CGM Readings and YSI Values
(Original Adult Study)
CGM
(mg/dL)
YSI (mg/dL)
Row Percentage of Matched Pairs in Each CGM Glucose Range
< 40
40-
60
61-
80
81-
120
121-
160
161-
200
201-
250
251-
300
301-
350
351-
400
>
400
Number
of Paired
CGM-YSI
< 40
6%
48%
37%
7%
1%
0%
0%
0%
0%
0%
0%
155
40-60
4%
49%
36%
11%
1%
0%
0%
0%
0%
0%
0%
512
61-80
0%
22%
51%
24%
1%
0%
0%
0%
0%
0%
0%
781
81-120
0%
2%
17%
66%
13%
1%
0%
0%
0%
0%
0%
1706
121-160
0%
0%
1%
25%
60%
13%
2%
0%
0%
0%
0%
1492
161-200
0%
0%
0%
2%
28%
53%
16%
2%
0%
0%
0%
1240
201-250
0%
0%
0%
0%
3%
21%
51%
21%
3%
1%
0%
1181
251-300
0%
0%
0%
0%
0%
4%
19%
49%
24%
3%
0%
1018
301-350
0%
0%
0%
0%
0%
0%
3%
28%
51%
16%
1%
775
351-400
0%
0%
0%
0%
0%
0%
3%
10%
43%
38%
7%
447
> 400
0%
0%
0%
0%
0%
0%
1%
6%
21%
57%
15%
248
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Table 3-B. Concurrence of CGM Readings and YSI Values
(Software 505 Adult Study)
CGM
(mg/dL)
YSI (mg/dL)
Row Percentage of Matched Pairs in Each CGM Glucose Range
< 40
40-
60
61-
80
81-
120
121-
160
161-
200
201-
250
251-
300
301-
350
351-
400
>
400
Number
of Paired
CGM-YSI
< 40
6%
83%
11%
0%
0%
0%
0%
0%
0%
0%
0%
18
40-60
2%
74%
22%
3%
0%
0%
0%
0%
0%
0%
0%
120
61-80
0%
19%
68%
13%
0%
0%
0%
0%
0%
0%
0%
226
81-120
0%
0%
19%
72%
8%
1%
0%
0%
0%
0%
0%
347
121-160
0%
0%
0%
17%
72%
11%
0%
0%
0%
0%
0%
246
161-200
0%
0%
0%
0%
25%
59%
16%
0%
0%
0%
0%
286
201-250
0%
0%
0%
0%
0%
16%
70%
13%
1%
0%
0%
376
251-300
0%
0%
0%
0%
0%
2%
16%
61%
14%
7%
0%
281
301-350
0%
0%
0%
0%
0%
0%
2%
28%
59%
10%
1%
229
351-400
0%
0%
0%
0%
0%
0%
0%
4%
47%
45%
5%
152
> 400
0%
0%
0%
0%
0%
0%
0%
0%
20%
38%
42%
45
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Table 3-C. Concurrence of CGM Readings and YSI Values
(Original Pediatric Study)
CGM
(mg/dL)
YSI (mg/dL)
Row Percentage of Matched Pairs in Each CGM Glucose Range
< 40
40-
60
61-
80
81-
120
121-
160
161-
200
201-
250
251-
300
301-
350
351-
400
> 400
Number
of Paired
CGM-YSI
< 40
0%
0%
0%
54%
31%
15%
0%
0%
0%
0%
0%
13
40-60
0%
21%
58%
16%
5%
0%
0%
0%
0%
0%
0%
19
61-80
0%
21%
45%
30%
4%
0%
0%
0%
0%
0%
0%
76
81-120
0%
1%
20%
66%
12%
1%
0%
0%
0%
0%
0%
338
121-160
0%
0%
1%
36%
54%
7%
1%
0%
0%
0%
0%
511
161-200
0%
0%
0%
4%
40%
48%
6%
1%
0%
0%
0%
596
201-250
0%
0%
0%
1%
9%
44%
41%
5%
0%
0%
0%
658
251-300
0%
0%
0%
0%
2%
7%
50%
36%
3%
0%
2%
432
301-350
0%
0%
0%
0%
0%
2%
18%
59%
21%
0%
0%
206
351-400
0%
0%
0%
0%
0%
0%
3%
28%
50%
16%
2%
86
> 400
0%
0%
0%
0%
0%
0%
1%
14%
41%
36%
7%
70
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Table 3-D. Concurrence of CGM Readings and YSI Values
(Software 505 Pediatric Study)
CGM
(mg/dL)
YSI (mg/dL)
Row Percentage of Matched Pairs in Each CGM Glucose Range
< 40
40-
60
61-
80
81-
120
121-
160
161-
200
201-
250
251-
300
301-
350
351-
400
> 400
Number
of Paired
CGM-YSI
< 40
6%
25%
63%
6%
0%
0%
0%
0%
0%
0%
0%
16
40-60
0%
33%
60%
6%
1%
0%
0%
0%
0%
0%
0%
86
61-80
0%
8%
64%
26%
2%
0%
0%
0%
0%
0%
0%
142
81-120
0%
1%
15%
69%
13%
1%
1%
0%
0%
0%
0%
314
121-160
0%
0%
0%
15%
66%
18%
1%
0%
0%
0%
0%
313
161-200
0%
0%
0%
1%
18%
66%
15%
0%
0%
0%
0%
355
201-250
0%
0%
0%
0%
1%
17%
68%
14%
0%
0%
0%
444
251-300
0%
0%
0%
0%
0%
0%
26%
58%
16%
0%
0%
336
301-350
0%
0%
0%
0%
0%
0%
4%
40%
46%
9%
0%
209
351-400
0%
0%
0%
0%
0%
0%
3%
14%
62%
21%
0%
63
> 400
0%
0%
0%
0%
0%
0%
4%
13%
29%
38%
17%
24
Concurrence of System and Laboratory Reference
Table 3-A (Original Adult Study), 3-B (Software 505 Adult Study), 3-C
(Original Pediatric Study) and 3-D (Software 505 Pediatric Study) are
categorized by ranges of CGM glucose readings. These tables describe, for
each range of CGM glucose readings, what percentage of paired YSI values
were in the same glucose range (shaded) or in glucose ranges above and
below the paired CGM readings. For example, based on the Software 505
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Adult Study, when CGM readings are within 81 to 120 mg/dL, you can expect
your BG levels are within 81 to 120 mg/dL 72% of time.
Table 4-A. System Difference to YSI Within CGM Glucose Ranges
(Adult)
CGM
Glucose
Range1
(mg/dL)
Study2
Number of
Paired
CGM-YSI
Mean
Percent
Difference
Median
Percent
Difference
Mean
Absolute
Percent
Difference
Median
Absolute
Percent
Difference
Overall
Original
9152
2.9%
1.7%
13.3%
9.8%
Software 505
2263
2.5%
2.4%
9.0%
7.0%
*40-60
Original
512
-10.0
-8.2
13.5
9.7
Software 505
120
-3.3
-2.1
6.9
4.8
*61-80
Original
781
-2.4
-0.4
11.4
8.6
Software 505
226
0.8
1.4
6.7
5.4
81-180
Original
3853
4.8%
3.0%
13.8%
9.8%
Software 505
738
3.9%
4.1%
9.6%
8.2%
181-300
Original
2784
2.1%
0.0%
11.9%
9.2%
Software 505
798
0.6%
0.4%
8.0%
6.1%
301-350
Original
775
3.8%
2.8%
9.8%
7.9%
Software 505
229
4.1%
3.4%
8.0%
5.8%
351-400
Original
447
10.4%
7.7%
12.8%
9.1%
Software 505
152
7.2%
6.3%
9.2%
7.2%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 4-B. System Difference to YSI Within CGM Glucose Ranges
(Pediatric)
CGM
Glucose
Range1
(mg/dL)
Study2
Number of
Paired
CGM-YSI
Mean
Percent
Difference
Median
Percent
Difference
Mean
Absolute
Percent
Difference
Median
Absolute
Percent
Difference
Overall
Original
2922
13.5%
11.6%
17.4%
13.5%
Software 505
2262
1.8%
1.2%
10.4%
7.9%
*40-60
Original
19
-18.1
-9.1
19.2
9.1
Software 505
86
-15.3
-13.2
16.1
13.2
*61-80
Original
76
-3.7
-2.3
13.4
10.6
Software 505
142
-4.8
-1.0
11.8
7.7
81-180
Original
1155
11.9%
9.7%
17.0%
13.0%
Software 505
805
1.9%
0.7%
10.6%
8.1%
181-300
Original
1380
14.8%
12.4%
17.4%
13.3%
Software 505
957
2.2%
1.0%
8.1%
6.5%
301-350
Original
206
19.2%
15.9%
19.4%
15.9%
Software 505
209
7.8%
6.5%
11.0%
7.9%
351-400
Original
86
18.5%
15.5%
19.1%
15.5%
Software 505
63
14.9%
11.6%
15.2%
11.6%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
*
For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included
instead of percent differences (%).
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Accuracy Relative to YSI
Accuracy between matched pairs was also estimated by calculating the
percent difference between the System reading and the YSI value. For
example, if the YSI value is 100 mg/dL and the System reading is 90 mg/dL, a
10% difference between the System and the YSI is reported. The System and
YSI values were compared by pairing the System reading that fell immediately
after the YSI value was collected.
In the example above, the System reading is less than the YSI value, so the
percent difference reading is negative. The mean percent difference is the
average of all positive and negative percent differences between the two
devices; it tells you if the System reads higher or lower on average than the
YSI within each glucose range.
Another estimate used to show the accuracy of the System is the absolute
percent difference. The absolute percent difference tells you the percent
difference or “distance” between the System and YSI values, but does not tell
you whether the System is reading, on average, higher or lower than the YSI
laboratory standard. The mean absolute percent difference is the average
“distance” (regardless if positive or negative) between System readings and
YSI values.
Accuracy measures in differences for both the Original Adult and Software
505 Adult Studies are summarized in Table 4-A. Accuracy measures in
differences for both the Original Pediatric and Software 505 Pediatric
Studies are summarized in Table 4-B. Table 4-A and 4-B are categorized
within CGM glucose ranges.
For example, in the Software 505 Adult Study (Table 4-A), overall, on
average, the System reads 2.5% different (Mean Percent Difference) than the
reference and 9.0% absolute different (Mean Absolute Difference) than the
reference values. The Median Percent Difference shows that half of the time
the System reads 2.4% or less than the YSI BG values and the Median
Absolute Percent Difference shows that half of the time the System reads
about 7.0% or less than the YSI BG values.
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Table 5-A. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Adult)
Hypoglycemia
Alert Level
(mg/dL)
Study1
True
Alert
Rate
False
Alert
Rate
Hypoglycemia
Detection Rate
Hypoglycemia
Missed
Detection Rate
55
Original
50%
50%
71%
29%
Software
505
71%
29%
68%
32%
60
Original
64%
36%
75%
25%
Software
505
85%
15%
83%
17%
70
Original
79%
21%
83%
17%
Software
505
92%
8%
91%
9%
80
Original
87%
13%
86%
14%
Software
505
95%
5%
90%
10%
90
Original
90%
10%
89%
11%
Software
505
96%
4%
94%
6%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 5-B. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-
17 Years)
Hypoglycemia
Alert Level
(mg/dL)
Study1
True
Alert
Rate
False
Alert
Rate
Hypoglycemia
Detection Rate
Hypoglycemia
Missed
Detection Rate
55
Original
0%
100%
0%
100%
Software
505
22%
78%
75%
25%
60
Original
11%
89%
25%
75%
Software
505
42%
58%
78%
23%
70
Original
47%
53%
50%
50%
Software
505
68%
32%
75%
25%
80
Original
55%
45%
55%
45%
Software
505
86%
14%
91%
9%
90
Original
69%
31%
62%
38%
Software
505
90%
10%
93%
7%
100
Original
75%
25%
62%
38%
Software
505
91%
9%
93%
7%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 5-C. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to SMBG 30 Minutes Before and After (Pediatric, Ages
2-5 Years)
Hypoglycemia
Alert Level
(mg/dL)
Study1
True
Alert
Rate
False
Alert
Rate
Hypoglycemia
Detection Rate
Hypoglycemia
Missed
Detection Rate
55
Original
3%
97%
57%
43%
Software
505
25%
75%
100%
0%
60
Original
11%
89%
62%
38%
Software
505
20%
80%
100%
0%
70
Original
29%
71%
77%
23%
Software
505
20%
80%
100%
0%
80
Original
35%
65%
85%
15%
Software
505
61%
39%
100%
0%
90
Original
51%
49%
89%
11%
Software
505
78%
22%
100%
0%
100
Original
64%
36%
91%
9%
Software
505
82%
18%
100%
0%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Low and High Glucose Alerts
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The ability of the System to detect high and low glucose levels is assessed by
comparing System results to YSI results at low and high BG levels and
determining if the Alert may have sounded. The System and YSI values were
compared by pairing the System reading that occurred immediately after the
YSI value was collected. We suggest that you ask your doctor what Alert
settings would be best for you.
The Low Glucose Alert
Estimates of how well the adjustable Low Glucose Alert performs are
presented in Table 5-A, 5-B and 5-C. Table 5-A represents the hypoglycemic
Alert evaluation within 15 minutes of the YSI value in the adult studies. Table
5-B represents the Alert evaluation within 15 minutes of the YSI value for a
subset of the pediatric population—subjects age 6 to 17 years who had YSI
measurements every 15 minutes. Table 5-C represents the Alert evaluation
within 30 minutes of an SMBG reading for 2- to 5-year-old subjects in the
pediatric studies.
Hypoglycemia Alert Rate
The Alert Rate shows how often the Alert is right or wrong. The True Alert
Rate is the % of time the device alarmed when the BG level was at or below
the Alert setting within 15 or 30 minutes before or after the device alarmed.
The False Alert Rate is the % of time the device alarmed when the BG level
was above the Alert setting within 15 or 30 minutes before or after the device
alarmed.
For example, if you set the Low Glucose Alert to 70 mg/dL and your Alarm
sounds, how often can you expect your blood sugar to actually be low? In the
Software 505 Adult Study (Table 5-A), when your Alarm sounds, you can
expect your blood sugar to be below 70 mg/dL approximately 92% of the time
and above 70 mg/dL approximately 8% of the time within the 15 minute period
before or after your Alarm sounds.
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Hypoglycemia Detection Rate
The Detection Rate shows how often the device recognizes and Alerts you to
an episode of hypoglycemia or how often it misses such an event. The
Hypoglycemia Detection Rate is the % of time the BG level was at or below
the Alert setting and device alarmed within 15 or 30 minutes before or after
the BG was at or below the Alert settings. The Hypoglycemia Missed
Detection Rate is the % of time the BG was at or below the Alert setting, but
the device did not alarm within 15 or 30 minutes before or after the BG was at
or below the Alert setting.
For example, if you set the Low Glucose Alert to 70 mg/dL, how often will your
Alarm Alert you if your BG goes below 70 mg/dL? In the Software 505
Adult Study (Table 5-A), when your blood sugar goes below 70 mg/dL, you
can expect your alarm to sound 91% of the time and not to sound
approximately 9% of time within the 15 minute period before or after your
blood sugar goes below 70 mg/dL.
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Table 6-A. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Adult)
Hyperglycemia
Alert Level
(mg/dL)
Study1
True
Alert
Rate
False
Alert
Rate
Hyperglycemia
Detection Rate
Hyperglycemia
Missed
Detection Rate
120
Original
95%
5%
98%
2%
Software
505
98%
2%
100%
0%
140
Original
94%
6%
97%
3%
Software
505
97%
3%
99%
1%
180
Original
92%
8%
97%
3%
Software
505
97%
3%
99%
1%
200
Original
92%
8%
97%
3%
Software
505
96%
4%
98%
2%
220
Original
91%
9%
95%
5%
Software
505
94%
6%
98%
2%
240
Original
91%
9%
94%
6%
Software
505
93%
7%
95%
5%
300
Original
82%
18%
86%
14%
Software
505
86%
14%
90%
10%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 6-B. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-
17 Years)
Hyperglycemia
Alert Level
(mg/dL)
Study1
True
Alert
Rate
False
Alert
Rate
Hyperglycemia
Detection
Rate
Hyperglycemia
Missed
Detection
Rate
120
Original
91%
9%
98%
2%
Software
505
98%
2%
99%
1%
140
Original
87%
13%
99%
1%
Software
505
97%
3%
98%
2%
180
Original
75%
25%
99%
1%
Software
505
94%
6%
98%
2%
200
Original
71%
29%
98%
2%
Software
505
94%
6%
97%
3%
220
Original
67%
33%
97%
3%
Software
505
93%
7%
96%
4%
240
Original
62%
38%
96%
4%
Software
505
88%
12%
94%
6%
300
Original
43%
57%
93%
7%
Software
505
69%
31%
84%
16%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 6-C. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to SMBG 30 Minutes Before and After (Pediatric, Ages
2-5 Years)
Hyperglycemia
Alert Level
(mg/dL)
Study1
True
Alert
Rate
False
Alert
Rate
Hyperglycemia
Detection Rate
Hyperglycemia
Missed
Detection Rate
120
Original
92%
8%
98%
2%
Software
505
97%
3%
99%
1%
140
Original
90%
10%
98%
2%
Software
505
98%
2%
100%
0%
180
Original
87%
13%
96%
4%
Software
505
99%
1%
93%
7%
200
Original
85%
15%
96%
4%
Software
505
98%
2%
93%
7%
220
Original
81%
19%
95%
5%
Software
505
100%
0%
97%
3%
240
Original
80%
20%
95%
5%
Software
505
99%
1%
98%
2%
300
Original
71%
29%
90%
10%
Software
505
95%
5%
96%
4%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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The High Glucose Alert
Estimates of how well the adjustable High Glucose Alert performs are
presented in Table 6-A, 6-B and 6-C. Table 6-A represents the hyperglycemia
Alert evaluation within 15 minutes of the YSI value in the adult studies. Table
6-B represents the Alert evaluation within 15 minutes of the YSI value for a
subset of the pediatric population—subjects age 6 to 17 years who had YSI
measurements every 15 minutes. Table 6-C represents the Alert evaluation
within 30 minutes of an SMBG reading for 2- to 5-year-old subjects in the
pediatric studies.
Hyperglycemia Alert Rate
The Alert Rate shows how often the Alert is right or wrong. The True Alert
Rate is the % of time the device alarmed when the BG level was at or above
the Alert setting within 15 or 30 minutes before or after the device alarmed.
The False Alert Rate is the % of time the device alarmed when the BG level
was below the Alert setting within 15 or 30 minutes before or after the device
alarmed.
For example, if you set the High Glucose Alert to 200 mg/dL and your Alarm
sounds, how often can you expect your blood sugar to actually be high? In the
Software 505 Adult Study (Table 6-A), when your Alarm sounds, you can
expect your blood sugar to be at or above 200 mg/dL approximately 96% of
the time and not be above 200 mg/dL approximately 4% of the time within the
15 minute period before or after your Alarm sounds.
Hyperglycemia Detection Rate
The Detection Rate shows how often the device recognizes and Alerts you to
an episode of hyperglycemia or how often it misses such an event. The
Hyperglycemia Detection Rate is the % of time the BG level was at or above
the Alert setting and the device alarmed within 15 or 30 minutes before or
after the BG was at or above the Alert settings. The Hyperglycemia Missed
Detection Rate is the % of time the BG was at or above the Alert setting, but
the device did not alarm within 15 or 30 minutes before or after the BG was at
or above the Alert setting.
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For example, if you set your High Glucose Alert to 200 mg/dL, how often will
your Alarm Alert you if your BG goes at or above 200 mg/dL? In the
Software 505 Adult Study (Table 6-A), when your blood sugar goes above
200 mg/dL, you can expect your Alarm to sound 98% of the time and not to
sound approximately 2% of time within the 15 minute period before or after
your blood sugar goes above 200 mg/dL.
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Table 7-A. Percentage of System Readings1 Within YSI Values
With Data Stratified in 2-Hour Increments After Calibration (Adult)
Time from
Calibration
Study2
Number
of Paired
CGM-YSI
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
Greater
than
40/40%
YSI
0-2 hours
Original
1929
78%
88%
96%
2%
Software 505
469
93%
97%
99%
0%
2-4 hours
Original
1516
69%
81%
91%
4%
Software 505
389
90%
97%
99%
0%
4-6 hours
Original
1547
69%
79%
91%
5%
Software 505
383
85%
91%
97%
2%
6-8 hours
Original
1520
68%
79%
92%
3%
Software 505
380
79%
90%
97%
2%
8-10 hours
Original
1555
71%
82%
92%
4%
Software 505
347
83%
92%
98%
0%
10-12 hours
Original
1068
65%
77%
91%
4%
Software 505
295
80%
90%
98%
0%
12-14 hours
Original
17
65%
76%
82%
12%
Software 505
0
--
--
--
--
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 7-B. Percentage of System Readings1 Within YSI Values
With Data Stratified in 2-Hour Increments After Calibration
(Pediatric)
Time from
Calibration
Study2
Number of
paired
CGM-YSI
Percent
within
15/15%
YSI
Percent
within
20/20% YSI
Percent
within
30/30% YSI
Percent
greater
than
40/40% YSI
0-2 hours
Original
648
65%
75%
87%
7%
Software 505
545
83%
91%
97%
1%
2-4 hours
Original
649
51%
67%
86%
7%
Software 505
460
72%
89%
96%
2%
4-6 hours
Original
630
51%
61%
80%
10%
Software 505
428
77%
88%
95%
2%
6-8 hours
Original
409
52%
68%
85%
5%
Software 505
325
88%
92%
94%
3%
8-10 hours
Original
296
53%
69%
84%
7%
Software 505
305
86%
93%
97%
1%
10-12 hours
Original
253
58%
74%
89%
5%
Software 505
198
89%
94%
98%
0%
12-14 hours
Original
37
32%
38%
65%
22%
Software 505
1
100%
100%
100%
0%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Calibration Stability
The System must be calibrated every 12 hours. To demonstrate performance
of the System over a 12-hour calibration period, Systems were evaluated to
verify that performance remains consistent over the 12-hour calibration period.
Systems were evaluated in 2-hour increments after calibration. Performance
was estimated at each 2-hour interval and stratified by glucose values by
calculating the percentage of System readings within 15 mg/dL or 15%, 20
mg/dL or 20%, 30 mg/dL or 30%, 40 mg/dL or 40% and greater than 40 mg/dL
or 40% of the YSI values in Table 7-A and 7-B.
Table 8-A. Sensor Stability Relative to YSI (Accuracy Over Time1)
- (Adult)
Day
of
Wear
Study2
Number
of
Paired
CGM-
YSI
Mean
Absolute
Percent
Differenc
es
Median
Absolute
Percent
Differenc
es
Percen
t
Within
15/15%
YSI
Percen
t
Within
20/20%
YSI
Percen
t
Within
30/30%
YSI
Percen
t
Greater
than
40/40%
YSI
Day
1
Original
3023
16.7%
13.2%
59%
71%
86%
6%
Software
505
680
10.7%
7.9%
77%
84%
96%
2%
Day
4
Original
3108
11.4%
8.2%
77%
87%
95%
2%
Software
505
777
8.0%
6.4%
89%
96%
99%
0%
Day
7
Original
3021
11.9%
8.9%
76%
87%
95%
2%
Software
505
806
8.5%
7.2%
90%
97%
99%
0%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 8-B. Sensor Stability Relative to YSI (Accuracy Over Time1)
- (Pediatric, Ages 6-17 Years)
Day
of
Wear
Study2
Number
of
Paired
CGM-
YSI
Mean
Absolute
Percent
Differenc
es
Median
Absolute
Percent
Differenc
es
Percen
t
Within
15/15%
YSI
Percen
t
Within
20/20%
YSI
Percen
t
Within
30/30%
YSI
Percen
t
Greater
than
40/40%
YSI
Day
1
Original
1016
21.2%
15.8%
48%
61%
78%
15%
Software
505
740
12.7%
8.5%
75%
83%
91%
4%
Day
4
Original
810
16.0%
13.9%
52%
66%
87%
3%
Software
505
795
8.1%
6.7%
89%
97%
100%
0%
Day
7
Original
1096
15.1%
11.3%
63%
76%
89%
4%
Software
505
727
10.4%
8.4%
80%
91%
98%
1%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 8-C. Sensor Stability Relative to SMBG (Accuracy Over
Time1) - (Pediatric, Ages 2-17 Years)
Day
of
Wear
Study2
Number
of
Paired
CGM-
SMBG
Mean
Absolute
Percent
Differenc
es
Median
Absolute
Percent
Differenc
es
Percen
t
Within
15/15%
SMBG
Percen
t
Within
20/20%
SMBG
Percen
t
Within
30/30%
SMBG
Percen
t
Greater
than
40/40%
SMBG
Day
1
Original
3216
18.8%
14.2%
53%
65%
81%
10%
Software
505
893
14.8%
10.7%
64%
79%
91%
5%
Day
2
Original
2148
16.2%
12.4%
60%
74%
87%
6%
Software
505
436
13.2%
10.4%
69%
81%
95%
3%
Day
3
Original
1977
15.2%
11.0%
63%
76%
89%
5%
Software
505
441
13.8%
11.3%
66%
77%
91%
2%
Day
4
Original
2830
14.0%
10.9%
66%
79%
91%
4%
Software
505
850
10.7%
8.5%
79%
91%
97%
1%
Day
5
Original
1768
15.4%
10.7%
67%
78%
90%
5%
Software
505
374
11.4%
8.7%
74%
86%
96%
1%
Day
6
Original
1704
14.3%
9.8%
68%
79%
90%
4%
Software
505
410
12.3%
9.2%
72%
80%
93%
2%
Day
7
Original
2675
12.4%
9.2%
72%
83%
94%
3%
Software
505
860
11.3%
8.6%
79%
90%
96%
2%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
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Sensor Stability
Relative to YSI
Sensors can be worn for up to 7 days. Performance was estimated by
calculating the percentage of System readings within 15 mg/dL or 15%, 20
mg/dL or 20%, 30 mg/dL or 30% , 40 mg/dL or 40% and greater than 40
mg/dL or 40% of the YSI values at the beginning (Day 1), middle (Day 4) and
end (Day 7) of the System lifecycle. The average and median of the absolute
percent differences are included in Table 8-A and 8-B showing consistent
accuracy and sensor stability over the 7-day life of the sensor.
Relative to SMBG (Pediatric Study)
Performance was also estimated by calculating the percentage of system
readings within various percentages of the SMBG values at each day of the
sensor wear period (Table 8-C). The average and median of the absolute
percent differences are included in the table.
Precision of System Readings
A subset of subjects wore two Systems at the same time. This was to look at
how similarly two Systems function on the same subject (sensor precision).
Precision was evaluated by comparing the glucose readings from the two
Systems worn on the same subject at the same time.
In the Original Adult Study, 36 subjects wore two Systems. Results showed
that System readings from the two sensors generally agreed with each other
within 9% (absolute percent difference) with a 7% coefficient of variation. In
the Original Pediatric Study, all subjects wore two Systems. Results
showed that System readings from the two sensors generally agreed with
each other within 10% (absolute percent difference) with a 7% coefficient of
variation. Only one System was worn in the Software 505 Adult and
Software 505 Pediatric Studies, so precision data was not collected.
Sensor Life
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Sensors may be worn for up to 7 days (168 hours). To estimate how long a
sensor will work over 7 days, all sensors worn were evaluated to determine
how many days/hours of readings each sensor provided.
In the Original Adult Study, 108 sensors were evaluated. Ninety-four
percent (94%) of the sensors lasted until Day 7 (145-168 hours). There were 6
(6%) sensors that ended early, four of which lasted more than 3 days.
In the Software 505 Adult Study, 51 sensors were evaluated. Ninety-eight
percent (98%) of the sensors lasted until Day 7 (145-168 hours). There was 1
(2%) sensor that ended early, which lasted until day 5 of the sensor wear.
In the Original Pediatric Study, 351 sensors were evaluated. Eighty-five
percent (85%) of the sensors lasted until Day 7 (145-168 hours).
In the Software 505 Pediatric Study, 77 sensors were evaluated. Ninety-
four percent (94%) of the sensors lasted until Day 7 (145-168 hours).
Table 9-A. Number of Readings Provided by Each Sensor Over 7
Days (Adult)
% of Total Possible
Readings Provided
Study1
Total Readings
Provided
(Min-Max)
% of Systems Providing
That Number of
Readings
0-25%
Original
167-491
2%
Software 505
0
0%
26-50%
Original
719-914
4%
Software 505
856-856
2%
51-75%
Original
1267-1267
1%
Software 505
1253-1253
2%
76-100%
Original
1811-1992
94%
Software 505
1497-1992
96%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 9-B. Number of Readings Provided by Each Sensor Over 7
Days (Pediatric)
% of Total Possible
Readings Provided
Study1
Total Readings
Provided
(Min-Max)
% of Systems Providing
That Number of
Readings
0-25%
Original
103-427
3%
Software 505
60-223
4%
26-50%
Original
569-954
3%
Software 505
877-891
3%
51-75%
Original
1006-1484
9%
Software 505
1131-1342
3%
76-100%
Original
1518-1992
86%
Software 505
1623-1990
91%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 10-A. System Readings Within Wear Days (Adult)
Statistic
Study1
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
All
Days2
Mean
Original
98%
98%
98%
98%
97%
99%
95%
97%
Software
505
98%
99%
98%
98%
96%
99%
97%
98%
Median
Original
100%
100%
100%
100%
100%
100%
100%
100%
Software
505
99%
100%
100%
100%
100%
100%
100%
100%
Standard
Deviation
Original
5%
3%
9%
8%
10%
3%
11%
8%
Software
505
3%
2%
8%
11%
15%
2%
13%
9%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
2
A total of 108 sensors were included with the Original Study and 51 sensors were
included with the Software 505 Study.
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Table 10-B. System Readings Within Wear Days (Pediatric)
Statistic
Study1
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
All
Days2
Mean
Original
97%
96%
96%
95%
94%
94%
92%
95%
Software
505
96%
96%
95%
96%
93%
95%
93%
95%
Median
Original
99%
99%
99%
99%
99%
99%
98%
99%
Software
505
99%
98%
99%
99%
97%
97%
98%
98%
Standard
Deviation
Original
6%
10%
9%
12%
14%
14%
17%
12%
Software
505
9%
6%
12%
10%
15%
7%
12%
11%
1
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
2
A total of 108 sensors were included with the Original Study and 77 sensors were
included with the Software 505 Study.
Number of Readings Provided
The System is capable of providing a reading up to every 5 minutes, or up to
288 readings per day. For a variety of reasons, the System may not display a
glucose reading and readings are “skipped.” Table 9-A and 9-B estimate the
number of readings you can expect to receive from the System over the entire
7-day period after calibration. Table 10-A and 10-B show the number of
readings you can expect to receive from the System within each system wear
day.
For the Software 505 Adult Study (SW10505), 96% of Systems provided
between 1497 and 1992 valid glucose readings (or more than 75% of the
expected number of readings) as seen in Table 9-A. Adjusted within each
system wear-day, the System in the Software 505 Adult Study provided an
average of 98% of all expected glucose readings (288) as seen in Table 10-A.
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Table 11-A. System Agreement to SMBG Within CGM Glucose
Ranges (Adult)
CGM
Glucose
Range1
(mg/dL)
Study2
Number
of Paired
CGM-
SMBG
Percent
Within
15/15%
SMBG
Percent
Within
20/20%
SMBG
Percent
Within
30/30%
SMBG
Percent
Greater
than
40/40%
SMBG
Overall
Original
7508
69%
81%
94%
2%
Software
505
2992
77%
87%
96%
1%
40-60
Original
731
75%
84%
92%
4%
Software
505
221
73%
80%
87%
7%
61-80
Original
968
78%
86%
95%
1%
Software
505
336
77%
85%
95%
1%
81-180
Original
3141
65%
78%
93%
2%
Software
505
1362
74%
85%
96%
1%
181-300
Original
1960
68%
81%
94%
3%
Software
505
826
80%
90%
97%
1%
301-350
Original
450
77%
88%
98%
1%
Software
505
161
83%
93%
99%
0%
351-400
Original
258
75%
85%
95%
2%
Software
505
86
90%
93%
98%
1%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 11-B. System Agreement to SMBG Within CGM Glucose
Ranges (Pediatric)
CGM
Glucose
Range1
(mg/dL)
Study2
Number
of Paired
CGM-
SMBG
Percent
Within
15/15%
SMBG
Percent
Within
20/20%
SMBG
Percent
Within
30/30%
SMBG
Percent
Greater
than
40/40%
SMBG
Overall
Original
16,318
64%
76%
89%
5%
Software 505
4264
73%
84%
94%
2%
40-60
Original
487
44%
55%
68%
19%
Software 505
240
54%
71%
86%
7%
61-80
Original
1340
59%
70%
85%
7%
Software 505
399
64%
76%
92%
2%
81-180
Original
7084
62%
74%
90%
5%
Software 505
1650
72%
84%
95%
2%
181-300
Original
5627
69%
80%
90%
5%
Software 505
1526
79%
89%
97%
2%
301-350
Original
1176
65%
77%
90%
4%
Software 505
319
72%
83%
94%
2%
351-400
Original
604
58%
72%
86%
6%
Software 505
130
69%
79%
86%
8%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
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Table 12-A. System Difference to SMBG Within CGM Glucose
Ranges (Adult)
CGM
Glucose
Range1
(mg/dL)
Study2
Number
of Paired
CGM-
SMBG
Mean
Percent
Difference
Median
Percent
Difference
Mean
Absolute
Percent
Difference
Median
Absolute
Percent
Difference
Overall
Original
7508
-0.4%
-1.4%
14.0%
11.0%
Software
505
2992
-2.6%
-2.7%
11.3%
8.6%
*40-60
Original
731
-9.3
-8.0
11.7
8.0
Software
505
221
-10.3
-6.0
13.0
8.0
*61-80
Original
968
-1.0
1.0
10.7
8.0
Software
505
336
-4.0
-2.0
10.1
7.0
81-180
Original
3141
1.4%
0.0%
14.2%
11.0%
Software
505
1362
-2.6%
-3.1%
11.4%
8.9%
181-300
Original
1960
-0.7%
-2.8%
13.0%
10.3%
Software
505
826
-1.4%
-2.0%
9.5%
7.4%
301-350
Original
450
-0.7%
-2.6%
10.5%
8.6%
Software
505
161
-0.0%
0.0%
8.3%
6.0%
351-400
Original
258
5.0%
3.0%
11.9%
8.6%
Software
505
86
3.9%
3.2%
8.1%
6.7%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
*
For CGM ≤ 80 mg/dL, the differences in mg/dL are included instead of percent
differences (%).
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Table 12-B. System Difference to SMBG Within CGM Glucose
Ranges (Pediatric)
CGM
Glucose
Range1
(mg/dL)
Study2
Number
of Paired
CGM-
SMBG
Mean
Percent
Difference
Median
Percent
Difference
Mean
Absolute
Percent
Difference
Median
Absolute
Percent
Difference
Overall
Original
16,318
2.2%
0.9%
15.3%
11.1%
Software
505
4264
-0.7%
-1.1%
12.5%
9.5%
*40-60
Original
487
-22.1
-17.0
23.9
18.0
Software
505
240
-15.9
-14.0
16.9
14.0
*61-80
Original
1340
-11.8
-8.0
17.0
11.0
Software
505
399
-7.8
-6.0
13.7
10.0
81-180
Original
7084
1.1%
-1.0%
15.4%
11.4%
Software
505
1650
-1.2%
-2.6%
12.1%
9.5%
181-300
Original
5627
5.7%
3.4%
13.5%
9.5%
Software
505
1526
1.7%
0.9%
10.1%
7.7%
301-350
Original
1176
9.6%
7.2%
14.2%
10.4%
Software
505
319
6.7%
5.9%
11.8%
8.9%
351-400
Original
604
12.7%
10.2%
16.1%
11.9%
Software
505
130
12.0%
8.9%
15.7%
10.6%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
*
For CGM ≤ 80 mg/dL, the differences in mg/dL are included instead of percent
differences (%).
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Agreement and Accuracy Relative to SMBG
Agreement between the System and BG values is also characterized using
paired System and SMBG results (Table 11 to 12). The System and SMBG
values were compared by pairing the comparative SMBG value to a System
glucose reading that occurred immediately after the SMBG was collected.
These results characterize the performance that subjects expect during real-
time use of the System in their daily diabetes management when comparing
the System readings to their home BG meter results. For readings less than or
equal to 80 mg/dL, the absolute difference in mg/dL between the two glucose
results was calculated. For values greater than 80 mg/dL, the absolute
percent difference (%) from the SMBG values was calculated. The
percentages of total readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30
mg/dL or 30%, 40 mg/dL or 40% or greater than 40 mg/dL or 40% were then
calculated.
For example, if the System reads 100 mg/dL, it is between 81-180 mg/dL
range and you can expect the System readings to be within 20% of the SMBG
values 85% of the time for the Software 505 Adult Study, as seen in Table
11-A.
Overall, the System in the Software 505 Adult Study reads, on average,
2.6% lower (Mean Percent Difference) than SMBG values and 11.3%
absolute different (Mean Absolute Percent Difference) than the SMBG values.
The Median Percent Difference shows that half of the time the System reads
lower in 2.7% or less than the SMBG values and the Median Absolute Percent
Difference shows that half of the time the System reads about 8.6% or less
different than SMBG values, as seen in Table 12-A.
Adverse Events
No serious adverse events or device-related serious adverse events occurred
during the studies. Mild to moderate skin irritation, such as erythema or
edema, occurred at the sensor needle insertion area or around the adhesive
area. No infection, bruising, or bleeding occurred at the sensor needle
insertion area or the adhesive area.
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17.2 Product Specifications
The G5x is intended for single patient use in the home environment and
requires a prescription.
Use of accessories, transducers, and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Do not touch the metal connectors on the bottom of the transmitter and other
open connectors on the receiver, charging cable, and charger.
Sensor Product Specifications
Glucose Range
40-400 mg/dL
Sensor Life
Up to 7 days
Calibration
Commercially available BG meter
Calibration Range
40-400 mg/dL
Storage
/Operational/Transport
Conditions
Temperature: 36° F-86° F
Humidity: 10%-90% RH
Sterilization
Sterile by radiation
Transmitter Product Specifications
Part Number
9445-01
Dimensions
(Including Transmitter
Holder)
Length: 1.5 inches
Width: 0.9 inches
Thickness: 0.5 inches
Weight (Including
Transmitter Holder)
0.3 ounces
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Part Number
9445-01
Power Supply
Lithium manganese dioxide/Organic electrolyte battery (not
replaceable)
Operational
Conditions
Ambient temperature is 10° C-42° C (50° F-107.6° F)
Equilibrium temperature of less than 0.5° C (0.9° F) above ambient
Humidity: 10%-95% RH
Storage /Transport
Conditions
Temperature: 32° F-113° F
Humidity: 10%-95% RH
Operating Altitude
-1300 feet to 13,800 feet
Limited Warranty
3 months
Moisture Protection
IP28: Protection against insertion of large objects and immersion in
water for up to 8 feet for 24 hours
Protection against submersion in water
Protection Against
Electrical Shock
Type BF applied part
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Transmitter Performance Characteristics
Parameter
Performance Characteristic
TX/RX Frequencies
2.402-2.480 GHz
Bandwidth
1.02 MHz
Maximum Output Power
1.0 mW EIRP
Modulation
Gaussian Frequency-Shift Keying
Data Rate
1 Mbps
Data Communication Range
20 feet
The Dexcom G5x CGM System is safe for use on U.S. commercial airlines.
The G5x System is an M-PED (Medical-Portable Electronic Device), which
meets the FAA RTCA /DO-160 edition G section 21, Category M. It can be
used on aircraft according to the directions provided by the operator of the
aircraft.
This device can withstand exposure to common electrostatic discharge (ESD)
and electromagnetic interference (EMI).
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The transmitter (P/N 9445-01) is intended for use in the electromagnetic
environment specified in the next table. The customer or the user of the
transmitter should ensure that it is used in such an environment.
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Transmitter Electromagnetic Immunity Specifications
Immunity Test
IEC 60601 Test
Level
Transmitter
Compliance Level
Electromagnetic
Environment
Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
± 8 kV Contact
± 15 kV Air
± 8 kV Contact
± 15 kV Air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Power Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency
magnetic fields should be
at levels characteristic of
a typical location in a
typical commercial or
hospital environment.
Receiver Product Specifications
Part Number
MT22719
Reading Frequency
Every 5 minutes
Dimensions
Length: 4.0 inches
Width: 1.8 inches
Thickness: 0.5 inches
TX/RX Frequencies
2.402-2.480 GHz
Bandwidth
1.22 MHz
Maximum Output Power
2.5 mW EIRP
Modulation
Gaussian Frequency-Shift Keying
Data Rate
1 Mbps
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Weight
2.4 ounces
Receiver Input
5V DC, 1A
Power Supply
MT21255
Communication Range
20 feet
Memory Storage
30 days of glucose data
7 days of tech support data
Re-Chargeable Battery
Use
3 days
Charging Time
3 hours wall outlet
The device behaves normally while being charged
Do not hold the receiver while charging for over a minute
There are no risks to connecting any part of the system to an MSO
(Multiple Socket Outlet)
Storage/Operational/Tra
nsport Conditions
Temperature: 32° F-104° F
Humidity: 15%-95% RH, (Storage 10%-95% RH)
Operating Altitude
-1300 feet to 13,800 feet
Medium Priority Alarm
Audible Output
50 dBa at 1 meter
Moisture Protection
IP22: Vertically falling drops
Protection against insertion of large objects and dripping water
Limited Warranty
1 year
Control Classification
Class II equipment
No cleaning methods are recommended or tested for the receiver. The
warranty life of the receiver is 1 year. The service life for the accessories is
noted to be up to 1 year. If you have difficulty reading your receiver in bright
sunlight, you may need to seek a shady location. Do not connect the receiver
to any equipment not specified in IFU.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
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The receiver (MT22719) is intended for use in the electromagnetic
environment specified in the next table. The customer or the user of the
receiver should ensure that it is used in such an environment.
Receiver Electromagnetic Immunity Specifications
Immunity Test
IEC 60601 Test
Level
Transmitter
Compliance
Level
Electromagnetic
Environment Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
± 8 kV Contact
± 15 kV Air
± 8 kV Contact
± 15 kV Air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 2 kV for power supply
lines
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage Dips,
Short
Interruptions and
Voltage
Variations on
Power Supply
Input Lines
IEC 61000-4-11
IEC 60601-1-11
0%
U
T for 1 cycle
0%
U
T for 0.5 cycle at
8 phase angles
70%
U
T (30% dip in Ut)
for 25 cycles
0%
U
T for 250 cycles
0%
U
T for 1 cycle
0%
U
T for 0.5 cycle at
8 phase angles
70%
U
T (30% dip in
U
T)
for 25 cycles
0%
U
T for 250 cycles
Mains power quality should be that
of a typical commercial or hospital
environment.
Power Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Dexcom G5 Mobile System is intended for use in the electromagnetic
environment specified in the next table. The customer or the user of the
Dexcom G5 Mobile System should ensure that it is used in such an
environment.
System Electromagnetic Immunity Specifications
Immunity Test
IEC 60601 Test
Level
Transmitter
Compliance
Level
Electromagnetic
Environment Guidance
Conducted RF
IEC 61000-4-6
(Receiver only)
3 Vrms
150 kHz to 80 MHz
6 Vrms
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Recommended Separation
Distance
d = 1.2 √P 150 kHz to 80 MHz
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site surveya
should be less than the
compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Radiated RF
IEC 61000-4-3
10 V/m at 80 MHz to
2700 MHz (AM
Modulation)
10 V/m
NOTE 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
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NOTE 2:
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the
location in which the G5 Mobile System is used exceeds the applicable RF compliance
level above, the G5 Mobile System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the G5 Mobile System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
10 V/m.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The G5 Mobile System is intended for use in the electromagnetic environment
specified in the next table. The customer or the user of the G5 Mobile System
should ensure that it is used in such an environment.
Electromagnetic Emissions Specifications
Immunity Test
Compliance
Electromagnetic Environment Guidance
RF Emissions
CISPR 11
Group 1
The G5 Mobile System uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
RF Emissions
CISPR 11
Class B
The G5 Mobile System is suitable for use in all
establishments including domestic and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
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Recommended Separation Distances Between Portable and Mobile
RF Communications Equipment and the Receiver
The receiver is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
receiver can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the receiver as recommended in the next table,
according to the maximum output power of the communications equipment.
Portable and mobile RF equipment include: baby monitors,
Bluetooth
wireless
headsets, wireless routers, microwave ovens, laptops with internal Wi-Fi
adapters, GSM cell phones, RFID scanners and hand-held security metal
detector often used by security screeners.
Minimum Recommended Distance Between Other RF Transmitters
and the Dexcom Transmitter/Receiver
Rated Maximum
Output Power of
Transmitter (W)
Separation Distance According to Frequency of Transmitter
(m)
150 kHz to 80 MHz
d = 1.2 P½
80 MHz to 800 MHz
d = 1.2 P½
800 MHz to 2.5
GHz
d = 2.3 P½
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance (d) in feet can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
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propagation is affected by absorption and reflection from structures, objects and
people.
USB Charging/Download Cable* Specifications
Part Number
MT20655
Input/Output
5V DC, 1A
Type
USB A to USB micro B
Length
3 feet
*
The power supply/charger can be connected to the USB charging/download cable for
charging using an AC power outlet. Misuse of the USB cable can present a
strangulation risk. Isolation of system is by disconnecting charger from wall.
Power Supply/Charger Specifications
Part Number
MT21255
Class
II
Input
AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100 Vac
DC Output
5V DC, 1A (5.0 Watts)
17.3 FCC Requirements
The transmitter and receiver covered by this user guide have been certified
under FCC ID:
• G5x Transmitter: PH29588
• G5 Mobile receiver: PH29496
Although the transmitter and receiver have been approved by the Federal
Communications Commission, there is no guarantee that they will not receive
interference or that any particular transmission from either device will be free
from interference.
Compliance Statement (Part 15.19)
This device complies with Part 15 of the FCC Rules.
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Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including
interference that may cause undesired operation.
Warning (Part 15.21)
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment. No
modification of the equipment is allowed as it could create an unsafe
condition.
FCC Interference Statement (Part 15.105 (b))
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
This portable transmitter with its antenna complies with FCC/IC RF exposure
limits for general population/uncontrolled exposure.
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Chapter 18
Everything Else G5x:
Troubleshooting
18.1 Introduction
Transmitter holder not sticking? Notification won’t go away? Not getting your
sensor glucose readings? Don’t know when to replace your transmitter? This
chapter will help you figure it out!
Troubleshooting sections are categorized by function or system component.
The solutions here are meant to be brief and not all-inclusive; some have
audible notifications, and others don’t. When more detailed answers or
preventative measures are in a chapter, you’ll get a brief explanation here,
and then get directed to the applicable chapter and section.
After looking at the troubleshooting chapter, are you still not sure what to do?
Or maybe your problem is hardware (for example, receiver or transmitter
failure).
If your problem is not found here, follow the steps listed on your app screen,
or call Technical Support.
If any of these errors continue and the instructions don’t resolve the issue,
please contact Technical Support (available 24/7) at:
• TechSupport@dexcom.com
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
18.2 Safety Statements
Following are the Safety Statements for the Troubleshooting chapter.
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Warning
Do:
Calibrate at least once every 12 hours
.
Why: Calibrating less often than every 12 hours might cause sensor
glucose readings to be inaccurate.
Consequences: Missing severe low (hypoglycemia) or high
(hyperglycemia) glucose event.
Precaution
Do:
Enter the exact BG value displayed on your BG meter within five
minutes of a carefully performed fingerstick
.
Why: Entering the wrong BG values, or waiting more than five minutes
before entry, might affect sensor performance.
Consequences: Missing a severe low or high glucose event.
Precaution
Don’t:
Separate the transmitter from the receiver or smart device by more
than 20 feet.
Why: The transmission range from the transmitter to receiver or smart
device is up to 20 feet without obstruction. If your transmitter and display
device(s) are more than 20 feet apart or are separated by an obstruction,
they might not communicate.
Types of obstruction differ and not all have been tested. Obstructions can
include water, walls, metal, etc.
As with any wireless device, water is often the biggest culprit in reducing
communication distance. This applies to the transmitter and display
devices. Take special care when swimming, taking a bath, or getting into a
hot tub.
Consequences: Missing a severe low or high glucose event.
18.3 Troubleshooting
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No Alarm/Alerts
Device
What you see
Problem
What you do
Smart
Device:
In app
Not receiving
Alarm/Alerts
See Chapter 11.
Check
Alarm/Alerts
, sound
and/or vibrations
notifications are
turned on.
Check your smart
device is not on
Silent or Do Not
Disturb (if
applicable).
Receiver
Sensor Glucose Readings
Device
What you see
Problem
What you do
BG
Meter
Sensor
readings and
BG meter
glucose values
often don’t
show the same
numbers.
See Chapter 7.
Differences are not
uncommon.
Readings from different
body fluids reflect
different numbers:
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Device
What you see
Problem
What you do
Smart
Device:
In app
Meter - from blood
Sensor - from
interstitial fluid
20/20 Rule:
If the meter shows 80
or less, CGM should
read within ± 20 points.
If the meter shows 80
or above, the CGM
should read ± 20%.
Example: a 202 mg/dL
sensor reading and a
188 mg/dL glucose
meter value = a 7%
difference (this is still
considered accurate).
Outside of 20/20
rule:
Calibrate again.
Receiver
Device
What you see
Problem
What you do
Smart
Device:
In app
Not getting
sensor glucose
readings.
See Chapter 9.
Wait.
System will often
resolve itself.
Check transmitter—is it
properly inserted into
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Device
What you see
Problem
What you do
Receiver
the transmitter holder?
Make sure you haven’t
taken acetaminophen.
Don’t calibrate. Use BG
meter for BG reading.
If this continues for
more than 3 hours,
contact Technical
Support (see Chapter
16.:
Smart
Device:
In app
Not getting
sensor glucose
readings.
See Chapter 9.
Wait
System will often
resolve itself.
Check transmitter—is it
properly inserted into
transmitter holder?
Make sure you haven’t
taken acetaminophen.
Don’t calibrate.
If this continues for
more than 3 hours, call
Technical Support (see
Chapter 16):
Receiver
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Device
What you see
Problem
What you do
Smart
Device:
In app
System display
device and
transmitter not
connecting.
No sensor
readings,
Alarm/Alerts or
notifications
until error is
fixed.
See Chapter 9.
Don’t
calibrate.
Verify display device
and transmitter are
within 20 feet of each
other without
obstruction.
Wait up to 30 minutes.
Don’t calibrate. Use BG
meter for BG reading.
More than 30 minutes?
App (if not
resolved):
• Go to
Settings
.
• Tap
Bluetooth
.
• Turn
Bluetooth
Off
and
On
.
App/Receiver:
If this continues for
more than 3 hours,
contact Technical
Support (see Chapter
16).
Receiver
Smart
Device:
In app
No sensor
glucose
readings
See Chapter 7.
Wait up to 2 hours.
System is counting
down to when you do
your startup calibration.
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Device
What you see
Problem
What you do
Receiver
Applicator
Picture
Problem
What you do
Can’t push
in orange
button.
After placing on body, make sure safety
guard is removed.
Fold and break away guard.
Hurts when
the needle
fires.
Make sure your application site is not
directly over a bone.
Use an area of your belly with less scar
tissue or irritation.
Smaller
adhesive
patch won’t
come off.
Lift up the tab of the label.
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Picture
Problem
What you do
Transmitter
holder
won’t stick.
See Chapter 6.
Put medical tape over transmitter
holder’s white adhesive patch (e.g.,
Blenderm).
Don’t place tape over the transmitter.
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Picture
Problem
What you do
Applicator
doesn’t
come off
after
pushing
button
Don’t panic!
Remove applicator and adhesive patch:
1. Gently pull applicator up until
you see adhesive patch
2. Using your finger or thumb, hold
front edge of patch and peel
from skin
3. While holding adhesive patch’s
front edge, gently rock back
applicator, away from your
body.
Check insertion site to make sure
the sensor isn’t left on the skin.
Don’t try to reuse applicator.
Call Customer Service.
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
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Hardware Error
Device
What you see
Problem
What you do
Receiver
Won’t turn on:
Battery dead.
See Chapter 4.
Charge
receiver
using
electrical outlet, not
computer/laptop.
Full charge may take up
to five hours.
Receiver
After full
charge
session:
Won’t turn on.
See Chapter 4.
Reset
receiver
.
Connect
receiver
to
charger
.
Insert end of paper clip
into small circular hole
on receiver’s back.
Push down on paper
clip.
Receiver will vibrate.
Processing screen
appears.
Charge
receiver
.
Receiver
Receiver low
battery.
See Chapter 4.
Charge
receiver
.
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Device
What you see
Problem
What you do
Receiver
Corrupted
database.
See Chapter 16.
Write down error code.
(Screen may show other
codes.)
Call Technical Support:
• Toll free:
1.888.738.36
46
• Toll call:
1.858.200.02
00
Notification: Vibrates
one time for four
seconds and four beeps.
Receiver
System
recovery.
See Chapter 16.
Do nothing.
Receiver is able to
continue to work and
recover from an error.
app: Tap
OK
to clear
Alert.
Receiver: Press
Select
to clear Alert.
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Device
What you see
Problem
What you do
Smart
Device:
In app
No
Bluetooth.
No sensor
readings,
Alarm/Alerts
or notifications
until error is
fixed.
See Chapter 5.
Go to smart device’s
Settings
.
Make sure
Bluetooth
is
On.
If problem persists,
please contact device’s
manufacturer.
Calibration Error
Device
What you see
Problem
What you do
BG
Meter
System will not
accept
calibration if
outside of the
40-400 mg/dL
range.
See Chapter 7.
Wait until your glucose
is between 40-400
mg/dL.
Calibrate only when
your BG meter values
are between 40-400
mg/dL.
Smart
Device:
In app
System didn’t
accept recent
calibration (see
Sensor
Glucose
Readings
troubleshooting
See Chapter 7.
app:
Tap
question mark
to
get more information.
OR
Follow instructions
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Device
What you see
Problem
What you do
Receiver
for a possible
reason).
No sensor
readings,
Alarm/Alerts or
notifications
until error is
fixed.
below.
app/Receiver:
Wait 15 minutes.
Enter 1 calibration.
If error screen still
appears enter 1 more
BG meter value.
Wait 15 minutes.
If no sensor glucose
readings display on the
smart device or
receiver, the sensor
needs to be replaced.
Contact Technical
Support (see Section
16.1) to report error:
Device
What you see
Problem
What you do
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Device
What you see
Problem
What you do
Smart
Device:
In app
System didn’t
accept recent
calibration.
See Chapter 7.
Wait 15 minutes.
Enter 1 BG meter
value.
Wait 15 more minutes.
If error screen still
appears enter 1 more
BG meter value.
Wait 15 minutes.
If no sensor glucose
readings appear on the
display, the sensor
needs to be replaced.
Call Technical Support
(see Section 16.1) to
report error:
• TechSupport@dex
com.com
• Toll free:
1.888.738.3646
• Toll call:
1.858.200.0200
Receiver
Transmitter Error
Device
What you see
Problem
What you do
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Device
What you see
Problem
What you do
Smart
Device:
In App
Transmitter not
working.
Sensor session
automatically
stopped.
No sensor
readings,
Alarm/Alerts or
notifications
until transmitter
is replaced
See Chapter 16.
Make sure transmitter
is snapped into sensor
pod
Contact Technical
Support:
• TechSupport@dex
com.com
• Toll free:
1.888.738.3646
• Toll call:
1.858.200.0200
Use BG meter for BG
reading.
You won’t get
additional Alerts after
clearing.
Receiver
Device
What you see
Problem
What you do
Smart
Device:
In App
Pairing failed
Transmitter
and sensor not
connected.
See Chapter 6.
Sensor may not be
inserted correctly.
Insert a new sensor.
For a replacement,
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Device
What you see
Problem
What you do
Receiver
No sensor
readings,
Alarm/Alerts or
notifications
until transmitter
is paired.
contact Tech Support
at:
• TechSupport@dex
com.com
• Toll free:
1.888.738.3646
• Toll call:
1.858.200.0200
Device
What you see
Problem
What you do
Smart
Device:
In App
Transmitter
Low Battery
See Chapter 16.
Contact Technical
Support:
• TechSupport@dex
com.com
• Toll free:
1.888.738.3646
• Toll call:
1.858.200.0200
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353
Chapter 19
Everything Else G5x:
Symbols on Package Labels
The following symbols may be found on the sensor, transmitter, and receiver
package labels. These symbols tell you about the proper and safe use of the
Dexcom G5x System.
Some of these symbols may not have meaning in your region, and are listed
for informational purposes only. This table shows what each symbol means.
Alternating Current
Authorized
Representative in the
European
Community
Batch/Lot Number
Bluetooth
Caution
Class II Equipment
Date of Manufacture
Direct Current
Do Not Reuse
Do Not Use If
Package Is
Damaged
Electrical Equipment
Designed Primarily
for Indoor Use
European Union
WEEE Directive
2012/19/EU
EC REP
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Symbols on Package Labels
354
Humidity Limitation
Input
IP22: Protection
Against Insertion of
Large Objects and
Dripping Water
IP28: Protection
Against Insertion of
Large Objects and
Immersion in Water
Keep Dry
Manufacturer
Marking Certifies
Device Meets
European Council
Directive 93/42/EEC
MR Unsafe
Non-Ionizing
Radiation
Prescription
Required
Refer to Instruction
Manual/Booklet
Serial Number
Ship By Date
Sterile by Radiation
Temperature
Limitation
Type BF Applied
Part
Use By Date
SN
STERILE R
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Chapter 20
Sharing is Caring:
Dexcom
Share
®
20.1 Learning About Dexcom
Share
Glossary
Airplane Mode
A setting on a smart device where wireless features
are disabled in order to comply with airline
regulations.
Application or
App
A software program, such as the Dexcom G5 Mobile
app and the Dexcom Follow app, designed to run on
a smart device.
App Store
Internet store for downloading applications to a
smart device.
Blood Glucose
Meter
A device used to measure how much glucose is in
the blood.
BG Value
The measurement of glucose in the blood.
Bluetooth
A wireless technology that allows devices to
wirelessly communicate with each other.
Default
A manufacturer’s preset option for a device setting.
Delay
Amount of set time that passes before a notification
is sent to a Follower.
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Dexcom Follow
App
Gets the Sharer’s glucose information and
notification data from the Dexcom
Share
Cloud.
Dexcom G5
Mobile App
Receives glucose information from the G5x
transmitter. Sends glucose information to the
Dexcom Cloud using an Internet connection.
Dexcom G5x
Sensor
The Dexcom G5x System part that includes an
applicator and sensor wire.
Dexcom G5x
System
CGM system made of a sensor, transmitter, and
smart device/receiver.
Dexcom G5x
Transmitter
The G5x System part that wirelessly sends glucose
information to the app.
Dexcom
Share
A secondary notification system using the following
parts:
• G5x
•
Bluetooth
wireless technology
• Sharer’s smart device
• App
• Internet
• Follower’s smart device
• Dexcom Follow app
Dexcom
Share
Cloud
A secure online storage server where Dexcom
Share
feature information is stored and then shared
with Followers.
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Do Not Disturb
A setting on a smart device where all incoming calls,
Alerts, and notifications are silenced.
Do Not Disturb can be set to specific times and can
be set to allow exceptions (people who can disturb
you).
Follower
A person that gets the Sharer’s shared information
in the Dexcom Follow app.
Follow
Dashboard®
On the Dexcom Follow app, the Follow Dashboard
shows the glucose information of up to five (5)
Sharers.
Follower’s Smart
Device
Runs the Dexcom Follow app.
G5 Mobile/G4
PLATINUM
Sensor
G5 Mobile part that includes an applicator and
sensor wire.
G5 Mobile
System
CGM system made of a sensor, transmitter, and
smart device/receiver.
G5 Mobile
Transmitter
G5 Mobile part that wirelessly sends glucose
information to the G5 Mobile app.
G5 Mobile App
Receives glucose information from the G5
transmitter. Sends glucose information to the
Dexcom
Share
Cloud using an Internet connection.
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Hyperglycemia
High BG. Same as “high.”
The default High Glucose Alert in the G5x is set to
200 mg/dL.
Consult your healthcare professional to determine
the appropriate hyperglycemia setting for you.
Hypoglycemia
Low BG. Same as “low.”
The default Low Glucose Alert in the G5x is set to
80 mg/dL.
Consult your healthcare professional to determine
the appropriate hypoglycemic setting for you.
Invite/Follow
Invitation Email
An email request for a person to download the
Dexcom Follow app and get the Sharer’s shared
information.
Jailbroken
The removal of limitations set by the manufacturer
on a smart device.
Do not use jailbroken smart devices with Dexcom
Share
.
mg/dL
Milligrams per deciliter. The standard unit of
measure for sensor glucose information in the
United States.
Mobile Data
Connections
Cellular networks, such as 3G, 4G, and LTE™, used
by a smart device to access the Internet.
No More Data
Notification
Notifies the Follower when the Sharer is unable to
share glucose information.
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Notification
A visual message that appears on the screen of the
Follower’s smart device. Notifications may also
include a sound, depending on the smart device’s
settings.
Not Sharing
When the Sharer chooses to temporarily not share
glucose data with the Follower.
Obstruction
An object that stops the wireless communication
between devices, such as wall thickness or radio
waves.
Profile
Located in Follow Dashboard and displays the
Sharer’s glucose information, trend arrow, and
profile picture.
Range
Maximum distance two devices can communicate
wirelessly without obstruction.
Real-Time CGM
Data the Sharer receives on the G5 Mobile app.
Although your Dexcom Follow app might be similar
to what you see on your G5 Mobile app, it cannot be
considered real-time because there are layers of
communication between the Dexcom G5 Mobile app
and the Dexcom Follow app.
Repeat
Amount of time the Follower chooses before he/she
wishes to receive a repeat notification.
Sensor Glucose
Reading
A glucose measurement taken by the G5x.
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Sharer
The person who uses the Dexcom
Share
app..
Sharing
The act of electronically transmitting glucose
information from the Sharer’s smart device to the
Follower’s smart device.
Simultaneous
Voice and Data
The ability to make a phone call and access the
Internet on the same cellular connection at the
same time.
Smart Device
A cordless (unless charging), mobile (easily
transportable), connected (via Wi-Fi, 3G, 4G, etc.)
electronic device that can operate the G5 Mobile
app or the Dexcom Follow app.
Examples of smart devices are smartphones or
tablets.
For a list of compatible smart devices, see
dexcom.com/compatibility.
Standard Home
Glucose
Monitoring
Self-monitoring of BG using blood taken from the
finger and a BG meter.
Trend Arrow
The arrow next to the Sharer’s glucose value,
located on the Sharer’s profile on the Dexcom
Follow app.
This is the same trend arrow that is found on the
Dexcom receiver.
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Trend Graph
Displays the pattern of the Sharer’s glucose
information.
Wi-Fi or Wireless
Internet
A technology that allows electronic devices to
wirelessly access the Internet. These networks can
include your home Internet or one found at a public
location.
20.2 Dexcom
Share
Overview
Dexcom
Share
is a feature within the G5 Mobile app. It allows for remote
monitoring of G5x data from one person, the Sharer, to another person, the
Follower.
Dexcom
Share
includes:
• G5x CGM System
• Sharer’s smart device
• App
• Internet connection
• Follower’s smart device
• Dexcom Follow app
You cannot use the
Share
feature with the receiver.
Once the Sharer activates the
Share
feature in their app, the smart device
transfers sensor glucose readings to the Dexcom
Share
Cloud using either
Wi-Fi or a cellular data plan. Then, the sensor glucose readings are sent from
the Dexcom
Share
Cloud to the Follower’s smart device using Wi-Fi or the
Follower’s cellular data plan.
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Dexcom
Share
Parts
Sharer’s smart device*1
Follower’s smart device*1
G5 Mobile app
Dexcom Follow app
G5x transmitter*
G5x sensor*
Internet/Wi-Fi or mobile data service/3G/4G/LTE*
Bluetooth
*
Must be purchased separately.
1
A list of compatible devices can be found at dexcom.com/compatibility.
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Conditions Affecting Use
Once sharing is active, make sure the Sharer’s and Follower’s smart device
settings are not altered.
Make sure the Sharer’s and Follower’s smart devices have:
• Enough battery power to maintain sharing
• An active Internet connection
• Notifications turned on. If turned off, Follower won’t receive any
notifications
Dexcom recommends charging the smart device while sharing.
20.3 Risks and Benefits
Risks
Dexcom
Share
is a feature of the G5x. The main risks involved with using the
Dexcom
Share
feature are based on misunderstanding its purpose.
Remember that the Dexcom
Share
feature in the G5x is a secondary
notification feature, not a real-time remote monitoring system.
With using the Dexcom
Share
feature, there are three distinct parts of glucose
monitoring:
1. BG meter—use this to make any treatment decisions.
2. G5x—Use the G5x to complement, but not replace, information
obtained from the BG meter. It detects glucose trends and tracks
glucose patterns.
3. Dexcom
Share
—This is an optional add-on to the G5x that can
share glucose information and notifications with up to five (5) other
people. Shared sensor glucose readings and information can add
another level of awareness.
Using the wrong glucose information for treatment decisions could lead to low
or high glucose. BG values from a BG meter may differ from the information
displayed on the Dexcom Follow app. All treatment decisions should be made
using a BG value from your meter, not the glucose information displayed on
the Dexcom Follow app.
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Followers who are concerned by notifications on the Dexcom Follow app
should contact Sharers and remind them to check their BG with a BG meter
before driving a car or making any treatment decisions, such as taking insulin
or eating fast-acting carbohydrates.
Sharers should not rely on Followers to notify them about low or high glucose.
Any problems with smart device(s),
Bluetooth
, wireless Internet connection,
mobile data connection, Dexcom
Share
Cloud, or not being in the
communication range could cause data to not be shared with the Follower. In
addition, if the Delay setting is too long, the Follower might not be aware of
glucose level changes in a reasonable time. Therefore, the Dexcom
Share
feature should be used only to give a secondary level of awareness and
should not be expected to always communicate and transfer sensor glucose
readings and information.
Benefits
Patients usually respond when their continuous glucose monitoring (CGM)
systems notify them.
However, experts advise that an additional CGM Alert to another person may
be helpful in increasing the detection of low glucose or high glucose values,
especially at night. The Dexcom
Share
feature enables this additional
awareness, even when the Sharer and Follower are not in the same place.
The Dexcom
Share
feature may provide improved quality of life and greater
peace of mind to patients, their caregivers, and their support team by allowing
the G5x Alerts, Alarms, and trend graphs to be checked remotely.
20.4 Safety Statement
Intended Use
The purpose of Dexcom
Share
Direct Secondary Displays is to notify another
person, the Follower, of the patient’s Dexcom Continuous Glucose Monitoring
(CGM) System sensor glucose information.
The Secondary Displays is intended for providing secondary notification of a
continuous glucose monitoring system and does not replace real time
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continuous glucose monitoring (G5x) or standard home BG monitoring. The
Dexcom
Share
Direct Secondary Displays is not intended to modify or analyze
data received from the continuous glucose monitoring system, nor is it
intended to instruct, or to transmit information to the continuous glucose
monitoring system.
The Dexcom
Share
Direct Secondary Displays is not intended to serve as a
replacement for a primary display device for a continuous glucose monitoring
system. The Dexcom
Share
Direct Secondary Displays is not intended to
receive information directly from the sensor or transmitter of a continuous
glucose monitoring system.
Important User Information
Please review the indications, contraindications, warnings, precautions,
cautions and other important information in the G5x user guide. Dexcom
Share
is a feature of the G5x.
If you do not have the G5x user guide, you can view it on dexcom.com or call
1.888.738.3646 to request a copy. Availability hours: Monday-Friday, 6 AM-
6 PM PST. Please contact your healthcare professional during hours the line is
unavailable.
Contraindications
Do not bring the smart device (e.g., mobile phone, tablet computer) into a
room containing medical equipment such as Magnetic Resonance Imaging
(MRI), Computed Tomography (CT), or diathermy.
These smart devices have not been tested with this equipment. Exposure to
these types of equipment could heat and damage the smart devices so that
they are unable to send or receive glucose information.
Warnings
Dosing decisions should not be made based on this device. The user should
follow instructions on the continuous glucose monitoring system.
This device is not intended to replace self-monitoring practices advised by a
physician. Dexcom
Share
does not work alone. Dexcom
Share
does not
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replace G5x and requires
Share
to be turned “On” to communicate glucose
information to the Follower.
You cannot use Dexcom
Share
to make treatment decisions, such as how
much insulin to take. Dexcom
Share
does not replace a BG meter. Always use
the values from a BG meter for treatment decisions.
BG values may differ from the sensor glucose information. Using the sensor
glucose information for treatment decisions could lead to low or high BG
values.
Precautions
Do not use Dexcom
Share
as the main source of CGM glucose trend
information. Use the Dexcom receiver as the main device to track sensor
glucose information, notifications and Alarms.
At times, the patient will be unable to share data using Dexcom
Share
, and
the Follower might miss helping the patient in the event of low or high BG
values. Do not rely solely on the Follower to notify the patient of low or high
glucose events or other important information. At times, the Follower may not
receive data, and the patient will not be notified of this fact.
When using Dexcom
Share
, make sure
Share
is turned “On.” If not, the
patient will be unable to share data, and the Follower might miss helping the
patient in the event of low or high BG values. If the patient’s smart device
does not have a connection or loses the connection, the patient will be unable
to share data, and the Follower might miss helping the patient in the event of
low or high BG values.
Do not use Dexcom
Share
unless both the patient’s and Follower’s smart
devices have active Internet connections in order to share data. If either the
patient or the Follower does not have a connection, loses their connection,
turns off the connection (“Airplane Mode”) or if the smart device is in Do Not
Disturb mode, the patient will be unable to share data and the Follower might
miss helping the patient in the event of low or high BG values. To check this,
make sure that the Follower’s smart device can receive text messages. Follow
notifications and text messages work by a similar process.
Make sure the patient’s and Follower’s smart devices have charged batteries
or are connected to electrical outlets. If the smart device shuts down due to
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low battery, the patient will be unable to share data, and the Follower might
miss helping the patient in the event of low or high BG values.
If the patient’s smart device is powered off or restarted, make sure the app is
reopened after the smart device is turned back on in order to resume sharing.
If the app is not reopened, the patient will be unable to share data, and the
Follower might miss helping the patient in the event of low or high BG values.
Do not turn off sounds in the Follower’s smart device at any time that he or
she wants Follow notifications to be heard. The smart device settings override
the Dexcom Follow app, and all notifications will be silent even if the Follower
has selected a Dexcom Follow app notification sound. If the smart device has
a vibrate feature and vibrate is On, the Dexcom Follow app notifications will
only vibrate.
Check the delay settings on the patient’s smart device to make sure they are
not too long. The Follower will not receive notifications until after the time
period in the delay has passed, and the Follower might miss helping the
patient in the event of low or high BG values if the delay is too long.
The patient should not choose to “Not Share” with the Follower at any time
when he or she wants the Follower to get notifications. During the time the
patient chooses to “Not Share,” the Follower will not receive notifications and
might miss helping the patient in the event of low or high BG values.
Check the Dexcom Follow app’s trend graph if the Follower’s smart device
has been off or if there is no data connection (for example, Internet/Wi-Fi or
mobile data service/3G/4G/LTE is lost, connection is turned off in Airplane
Mode, or smart device touch is placed in Do Not Disturb mode). When the
smart device is turned back on, the Follower will only receive the most recent
notification and might miss helping the patient in the event of prior low or high
BG values.
Sharers and Followers should check whether their cellular service carriers
support voice and data at the same time (simultaneous voice and data). If
their carriers do not support simultaneous voice and data, the app may not be
able to share glucose readings and the Dexcom Follow app may not be able
to receive notifications or glucose readings during phone calls. Dexcom
Share
will resume sharing after the phone call has ended, and the Follower will
receive any waiting notifications after the phone call has ended.
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20.5 Setting Up Dexcom
Share
Dexcom
Share
Description
What Dexcom
Share
does:
• Connects your smart device with your Follower’s smart device via
either a Wi-Fi or mobile data connection (connect to Wi-Fi through a
secured network to maintain data security)
• Invites and sends Followers your setting recommendations
• Displays the status of your smart device, and the Dexcom
Share
Cloud
o Confirms your sensor glucose readings are being shared with
your Follower(s)
What Dexcom
Share
does not do:
• Lets you know when the Follower is not receiving your sensor glucose
readings and information
Tips
• Read the rest of the G5x user guide before using Dexcom
Share
• Always confirm information with a BG meter before making treatment
decisions
• Check the status screen after turning Dexcom
Share
“On” on the
smart device to make sure it is working
Installing the App
Step
What you see
What you do
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Step
What you see
What you do
1
Download the G5 Mobile app from your app
store.
See your smart device’s user manual for
instructions.
Download the app to use Dexcom
Share
.
2
Launch the app.
Set up your smart device (see Chapter 5)
before sharing.
Once your app has been set up, activate
Dexcom
Share
.
A series of screens walk you through the Dexcom
Share
features, highlighting
important information.
Activating Your Share Feature
Step
What you see
What it means
What you do
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Step
What you see
What it means
What you do
1
Activates
Dexcom
Share
.
If Dexcom
Share
icon is gray, your
Share
feature
has not been
turned on.
Tap
Dexcom Share
icon
in the upper right
corner of your smart
device’s home screen.
2
Dexcom
Share
Welcome
Screen.
Read screen.
Tap
Next
when done.
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Step
What you see
What it means
What you do
5
How to know
your Follower is
not getting your
sensor data.
Tap
Let’s Get Started
to
move on and invite your
Followers.
Inviting Followers
Step
What you see
What you do
1
Tap
Invite Followers
to set up your
Followers.
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Step
What you see
What you do
2
Enter the Follower’s nickname and email
address.
Confirm Follower’s email address.
The Follower will get a Follow Invitation
email.
Make sure the Follower can access this
email account from their smart device.
Tap
Next
.
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Step
What you see
What you do
3
Slide
Allow Trend Graph View’s On/Off
switch
if you want Follower to see your trend
graph.
Tap
Next
.
Turned Off: Follower sees only your sensor
glucose reading and trend arrow.
Turned On: Follower sees your sensor
glucose reading, trend arrow, and trend
graph.
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Step
What you see
What you do
4
Choose if your Follower gets your Urgent
Low, Low, and High Glucose Alarm/Alerts.
Choose if you want your Follower to get
notifications if they are not receiving your
sensor glucose readings.
Select what Alarms/Alerts your follower gets
and how long you are low/high or not sharing
data (for example, if you want your Follower
to know when your glucose is above 200
mg/dL for more than 2 hours, you can set up
notifications in the Follower’s Settings
menu).
Tap
Save
for each Follower Setting “Save.”
Tap
Next
when done.
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Step
What you see
What you do
5
Before Follower invitation is sent, review the
Summary screen.
Tap
Send Invitation
.
After sending invitation, you cannot adjust
the Follower’s settings.
6
To add more Followers:
Tap
Followers
on the
Share
Status screen.
Invite up to a total of five (5) Followers.
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20.6 Using Dexcom
Share
Dexcom
Share
Status
You can look at the Dexcom
Share
icon on your home screen to see if
Dexcom
Share
is working. After turning Dexcom
Share
on, check its status.
Figure 9.
Share
Status
Dexcom
Share
Status Icons
Status tab
What it is
The
Share
icon is in color when Dexcom
Share
is
sending sensor glucose readings and information.
Share icon
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Status tab
What it is
The
Share
icon is dark gray with a red circle when
Dexcom
Share
is not working.
The Sharer should tap on the dark gray
Share
icon
when
Share
is not working to get further information
about the error.
The
Share
icon is light gray when Dexcom
Share
has
not been activated.
The Sharer should tap the light gray icon to get started
using Dexcom
Share
.
When a device or connection is not working, Dexcom
Share
will not work. The
Sharer will not be able to send sensor glucose readings and data to
Follower(s).
Troubleshooting Status Issues
The Dexcom
Share
status bar is a useful tool. It can help identify if there is a
problem and Dexcom
Share
is not working. The following table provides
troubleshooting tips for the
Share
status bar.
1
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Figure 10. Dexcom Share Screen
NOTE: Whether or not Dexcom
Share
is working and the Followers are
receiving glucose Alarm/Alerts, you must always refer to your G5x display
device for your sensor glucose readings and Alerts.
All treatment decisions must be based on your BG value from your BG meter.
Dexcom
Share
Status Issues
What you see
What it means
What you do
Green check mark:
All connections are
working.
N/A.
On/Off Switch -
Turns sharing on
or off
Sharing Status
Bar - Status of
sharing your
sensor glucose
readings with your
Followers
Follower List - Add
Followers and lists
status of Followers.
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What you see
What it means
What you do
Issue with:
• Sharer’s
CGM data
• Sharer’s
smart device
The Sharer should:
• Verify there is a
glucose value on the
smart device
• Be sure the
transmitter is in range
of the smart device
• Tap on blue
“?”
to
learn more about how
to troubleshoot this
issue
• Allow up to 10
minutes for their
status to turn green
and a green check
mark to appear
If the Sharer continues to see
this, the Sharer should turn
off
Share
and then turn it
back on.
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What you see
What it means
What you do
Issue with:
• Sharer’s
Internet
connection
• Dexcom
Share
Cloud
The Sharer should:
• Verify their Wi-Fi or
cellular connection is
ON
• Be sure they are in
an area that has
cellular reception
• Not be on a voice call
• Be sure they can
access the web via a
browser
• Check later or follow
up with their Internet
connectivity provider
• Tap on blue
“?”
to
learn more about how
to troubleshoot this
issue
Followers List
The Followers list allows the Sharer to manage his/her Followers.
In the Followers list the Sharer can:
• Invite a new Follower
• See the status of Followers that have been invited
• Glance at what options the current Followers have
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Icon/Status
What you see
What it means
Invite a new Follower.
Follower is set to get notifications from Sharer.
Follower is able to view Sharer’s trend graph.
Follower did not accept Sharer’s Follow Invitation
email within 7 days.
Sharer can invite Follower again by tapping on the +
icon in the top right corner of the screen.
Follower has been sent a Follow Invitation email but
has not accepted it yet.
Sharer stopped sharing with Follower.
Follower will not get any of the Sharer’s glucose
information, Alarm/Alerts, or trend graph updates.
Editing/Removing Followers
Tap on a Follower to edit the Follower’s profile (nickname or ability to view
trend graph) or remove a Follower. Remove a Follower by tapping “Remove
Follower.” Once removed, the Follower won’t get glucose information or
Alarm/Alerts.
NOTE: The Sharer cannot change any Follower settings after the Follow
Invitation email has been sent.
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Stop Sharing
The Sharer can swipe the On/Off switch to temporarily stop glucose
information and Alarm/Alerts from being sent to Followers. Sharing stops until
the Sharer turns the On/Off Switch back on.
For reasons of safety and intended use, the Follower will get a message
telling them the Sharer’s data was set to
Not Sharing
. The Follower’s
dashboard will show the Sharer has stopped sharing glucose information.
20.7 Dexcom Follow App
Dexcom Follow App Description
The Dexcom Follow app is a separate app from the G5 Mobile app. Your
Followers only need to download and install the Dexcom Follow app.
What the Dexcom Follow App does:
• Allows Follower to view Sharer’s glucose information
• Allows Follower to get Alarm and Alerts
• Allows Follower to view Sharer’s trend graph
What the Follower app does not do:
• Provide treatment advice
• Interact with the G5 Mobile app
Receiving Dexcom Follow Invitation Email
After getting the Sharer’s Follow invitation by email, the Follower sets up
his/her smart device.
Glucose Alarm and Alerts
A glucose notification is a visual message saying “Glucose notification from
[Sharer’s name]” that appears on the screen of the Follower’s smart device.
The notification may include sounds, depending on the smart device’s
settings.
Types of notifications the Follower gets:
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• Low Sensor Glucose Reading
• Urgent Low Glucose Alarm (< 55 mg/dL)
• High Sensor Glucose Reading
Followers can change some of the initial settings to fit their needs. Followers
cannot change the Sharer’s permission settings to see the trend graph.
Sharer Status Changes That Notify the Follower
Some Sharer status changes will notify the Follower:
• Not Sharing—Sharer decides to temporarily stop sharing
• Removed by Sharer—Sharer removes Follower
• No More Data—Active glucose sharing is stopped for any reason,
other than the Sharer turning Share “Off”
o Follower should contact Sharer for more information about
the data interruption
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The Follower Dashboard
If the Sharer doesn’t allow the Follower to see the trend graph, he/she will
only see the glucose reading and trend arrow.
Figure 12. Follower Information
Sharer’s glucose reading
and trend arrow
Sharer’s picture
How long ago
the Sharer’s
glucose reading
and trend arrow
were last updated
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If you choose to have your Followers see your trend graph, they see:
20.8 Troubleshooting
Dexcom
Share
Troubleshooting
Troubleshooting Status—See the Troubleshooting Status Issues portion of
Section 20.6.
Figure 14. Sharing Status Troubleshooting
Sharer’s name Notification settings
Home icon
Time
duration
setting of
3, 6, 12 or
24 hours
Trend graph
Trend arrow
Sharer’s
glucose
reading
Glucose range
(between high
and low alerts)
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Sharing Checklist
To share, make sure:
• Your smart device works with the G5 Mobile app
o To see a list of supported smart devices and operating
systems, go to: dexcom.com/compatibility
• The app is open or running in the background
• Your smart device has an active Internet connection (Wi-Fi, 3G, 4G,
LTE)
o Check to see if the Internet connection is working by trying to
open a web page on the smart device
• If on a phone call using your smart device, your CGM information may
not upload into the
Share
Cloud while on your call
• Airplane Mode is turned off
• Do Not Disturb is turned off
• Smart device sound is on in order to hear notifications
• Smart device is sufficiently charged or charging
• Smart device is within 20 feet of the transmitter
• Smart device has 35 MB of available memory
•
Refer to the smart device user manual for further instructions.
Tips
• Read the G5x user guide before using the Dexcom
Share
feature
• Always confirm information with a BG meter before you make
treatment decisions
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| Sample Index (note,
pagination is wrong)
A
A
Adhesive
Adhesive won’t stick 51
Optional use 30
Alarm or Alerts
Change Low/High Alerts 44
Rise Rate, Fall Rate, and Signal Loss Alerts
44
Urgent Low Glucose Alarm 44
App
Enter Initial BG Meter Values 22
Enter Update Calibration 23
Install App 21
View Home Screen 24
B
Benefits 15
C
Calibration
Entering initial BG in app 22
Enter update BG readings in app 12 Hours
23
Tips for Entering BG Meter Values 23
Warning and Precautions 6
Change Low/High Alerts 44
Choose Display Device 18
Components
Applicator and Sensor 17
Display Devices 17
Transmitter 17
Customer Service 60
E
Ending Sensor Session Early 42
End Sensor Session 40
Enter Initial BG Meter Values 36
F
Fall Rate 44
Fingerstick 7
H
Hourglass 46
I
Indications for Use 5
Install App 21
M
MRI/CT/Diathermy 5
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P
Precautions 7, 8, 10, 11, 13
Q
Question Marks 46
R
Receiver
Confirm Transmitter and Receiver
Communication 35
Ending Sensor Session Early 43
Enter BG Meter Values Every 12 Hours 37
Enter Initial BG Meter Values 36
Receiver Setup 27
Set Up Alert Sounds 34
Start Sensor 33
Trend Arrows 39
View Receiver Trend Screen 38
Rise Rate 44
Risks and Benefits
Benefits 15
Risks 14
S
Safety Statement
Calibration Warning and Precautions 6
Contraindications 5
Indications for Use 5
Receiver Warning and Precaution 11
System Precautions 10
Transmitter Warnings and Precautions 9
Sensor
Ending Sensor Session Early 43
End Sensor Session 40
Insert Sensor 29
Signal Loss 44
System Overview
Choose Display Device 18
Components 17
Applicator and Sensor 17
Display Device(s) 17
Transmitter 17
T
Training Options 4
Transmitter
Attach Transmitter 32
Errors 49
Remove 40
Travel 58
Trend Arrows
App 25
Receiver 39
Trend Graph
App 25
Receiver 39
Troubleshooting
Adhesive 51
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Applicator 52
Calibration Errors 48
Sensor Glucose Readings 45
Transmitter Errors 49
U
Urgent Low Glucose Alarm 44
W
Warnings 6, 8, 9, 12, 13
Warranty
Receiver Warranty Information 53
Transmitter Warranty Information 55
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© 2016 Dexcom, Inc. All rights reserved.
Covered by patents: dexcom.com/patents.
Dexcom, Dexcom G4 PLATINUM, G5, Dexcom G5, Dexcom G5 Mobile,
Dexcom G5x, G5x, Dexcom G5x CGM System, Dexcom Share, Dexcom Care
are either registered trademarks or trademarks of Dexcom, Inc. in the United
States and/or other countries. Bluetooth is a registered trademark owned by
Bluetooth SIG. All other product or company names that may be mentioned in
this publication are trade names, trademarks or registered trademarks of their
respective owners
Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
Web: dexcom.com
Phone: 1.858.200.0200
Tech Support: 1.888.738.3646
LBL013726"Rev"003"/"MT23637
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