User Manual
G5 Mobile System User Guide
Glossary
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G5 Mobile System User Guide
Glossary
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Table of Contents
Chapter 1 ........................................................................................... 14
Beginning Your Dexcom G5® Mobile Continuous Glucose Monitoring
(CGM) System Journey ........................................................................ 14
1.1 Introduction...................................................................................... 14
1.2 Self-Paced Resources ....................................................................... 15
1.3 Your Dexcom Account ...................................................................... 18
Chapter 2 ........................................................................................... 20
Indications for Use and Safety Statement ............................................ 20
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 .............................................. 26
2.7 System/Hardware/Software Warnings and Precautions ................. 28
Chapter 3 ........................................................................................... 37
Risks and Benefits ............................................................................... 37
3.1 Risks .................................................................................................. 37
3.2 Benefits ............................................................................................ 38
Chapter 4 ........................................................................................... 42
What’s the G5 Mobile? ....................................................................... 42
4.1 Introduction...................................................................................... 42
4.2 Safety Statement .............................................................................. 42
4.3 The G5 Mobile .................................................................................. 44
4.4 What’s New to the G5 Mobile? ........................................................ 46
4.5 System Information .......................................................................... 47
4.6 System Components ........................................................................ 47
4.7 Smart Device Overview .................................................................... 55
Chapter 5 ........................................................................................... 57
Set Up Your Display Devices ................................................................ 57
5.1 Introduction...................................................................................... 57
5.2 Safety Statement .............................................................................. 57
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5.3 Why Different Monitoring Methods? .............................................. 58
5.4 G5 Mobile App.................................................................................. 58
5.5 Receiver ............................................................................................ 71
Chapter 6 ........................................................................................... 78
Starting a Sensor Session: Inserting Sensor, AttachingTransmitter, and
Starting Your Session .......................................................................... 78
6.1 Introduction...................................................................................... 78
6.2 Safety Statements ............................................................................ 79
6.3 Prepping for Sensor Insertion .......................................................... 81
6.4 Choosing Your Insertion Site ............................................................ 84
6.5 Inserting Your Sensor ....................................................................... 86
6.6 Attaching Your Transmitter .............................................................. 91
6.7 Loose Sensor Pod ............................................................................. 93
6.8 Starting Your Sensor Session ............................................................ 94
6.9 Receiver Bluetooth Tips .................................................................... 99
6.10 Sensor Session Warmup ............................................................... 100
Chapter 7 ......................................................................................... 101
Calibration ....................................................................................... 101
7.1 Introduction.................................................................................... 101
7.2 Safety Statements .......................................................................... 102
7.3 Calibration Overview ...................................................................... 104
7.4 When to Calibrate .......................................................................... 106
7.5 Calibration Prompts ....................................................................... 107
7.6 Preparing for Calibration ................................................................ 111
7.7 Ready? Set? Calibrate! ................................................................... 112
7.8 Calibration Errors ........................................................................... 117
Chapter 8 ......................................................................................... 121
Ending Your Sensor Session and Transmitter Session ......................... 121
8.1 Introduction.................................................................................... 121
8.2 Safety Statements .......................................................................... 121
8.3 Ending Your Sensor Session............................................................ 122
8.4 Remove Sensor Pod and Transmitter ............................................. 129
8.5 End of Transmitter Battery ............................................................. 131
8.6 Pair New Transmitter ..................................................................... 133
Chapter 9 ......................................................................................... 140
Home Screen, Rate of Change Arrows, and Errors .............................. 140
9.1 Introduction to Home Screens ....................................................... 140
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9.2 Safety Statements .......................................................................... 140
9.3 Overview of Home Screen .............................................................. 142
9.4 Rate of Change Arrows ................................................................... 163
9.5 Error Messages ............................................................................... 164
Chapter 10 ....................................................................................... 171
Daily Events Affect Your Glucose Trends and Patterns ....................... 171
10.1 Introduction ................................................................................. 171
10.2 What Is an Event? ......................................................................... 171
10.3 Entering Events ............................................................................ 180
10.4 Viewing Events ............................................................................. 190
Chapter 11 ....................................................................................... 192
Sensor Glucose Alarm and Alerts....................................................... 192
11.1 Introduction ................................................................................. 192
11.2 Safety Statements ........................................................................ 193
11.3 Alarm and Alerts ........................................................................... 195
11.4 Alarm and Alerts Screens ............................................................. 197
11.5 App: Alarm/Alert Recommended Settings ................................... 205
11.6 Receiver: Default Beeps and Vibrations ....................................... 205
11.7 Clearing Alarm/Alerts ................................................................... 210
Chapter 12 ....................................................................................... 213
On the Go With G5: Customizing Your Alarm and Alerts .................... 213
12.1 Introduction ................................................................................. 213
12.2 Safety Statement .......................................................................... 213
12.3 Changing App Alarm and Alerts ................................................... 214
12.4 Changing Receiver Alarm and Alerts ............................................ 226
EVERYTHING ELSE G5 ................................................................... 235
Chapter 13 ....................................................................................... 236
Warranty: The Fine Print ................................................................... 236
13.1 Introduction ................................................................................. 236
13.2 Receiver Warranty Information ................................................... 236
13.3 Transmitter Warranty Information .............................................. 239
13.4 Dexcom’s Obligations Under the Limited Warranty .................... 240
Chapter 14 ....................................................................................... 243
How to Take Care of Your G5 Mobile ................................................. 243
14.1 Introduction ................................................................................. 243
14.2 Safety Statements ........................................................................ 244
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14.3 Basic Maintenance ....................................................................... 246
14.4 Storage ......................................................................................... 251
14.5 Checking App and Receiver Information ...................................... 252
14.6 System Disposal ............................................................................ 253
Chapter 15 ....................................................................................... 255
On the Go With G5 Mobile: Getting Through Security ........................ 255
15.1 Introduction ................................................................................. 255
15.2 Safety Statements ........................................................................ 255
15.3 Going Through Security ................................................................ 256
Chapter 16 ....................................................................................... 259
Need Help? You’re Not Alone! .......................................................... 259
16.1 Dexcom Technical Support ........................................................... 259
16.2 Dexcom Patient Care Team .......................................................... 260
16.3 Dexcom Sales Support Team ........................................................ 261
16.4 Corporate ..................................................................................... 262
Chapter 17 ....................................................................................... 263
Technical Information ....................................................................... 263
17.1 Device Performance Characteristics ............................................ 263
17.2 Product Specifications .................................................................. 304
17.3 FCC Requirements ........................................................................ 314
Chapter 18 ....................................................................................... 317
Troubleshooting ............................................................................... 317
18.1 Introduction ................................................................................. 317
18.2 Safety Statements ........................................................................ 317
18.3 Troubleshooting ........................................................................... 318
Chapter 19 ....................................................................................... 333
Symbols on Package Labels ............................................................... 333
SHARING IS CARING ..................................................................... 335
Chapter 20 ....................................................................................... 336
Dexcom Share® ................................................................................. 336
20.1 Learning About Dexcom Share ..................................................... 336
20.2 Dexcom Share Overview .............................................................. 342
20.3 Risks and Benefits ......................................................................... 344
20.4 Safety Statement .......................................................................... 345
20.5 Setting Up Dexcom Share ............................................................. 349
20.6 Using Dexcom Share ..................................................................... 357
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20.7 Dexcom Follow App ...................................................................... 364
20.8 Troubleshooting ........................................................................... 367
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1
GETTING STARTED
• Glossary
• Getting Started
• Indications for Use and Safety Statement
• Risks and Benefits
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Glossary
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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® Mobile CGM System (G5 Mobile).
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 G5 Mobile app was developed as a display
for continuous glucose monitoring.
Apple Watch
®
Accessory device for iPhones®.
Blood Glucose (BG)
Value
An abbreviation of blood glucose. Blood glucose
(BG) value is the amount of glucose in the blood
measured by a BG meter.
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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 G5 Mobile 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 G5 Mobile
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 G5 Mobile 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. Indications let you know
who should use the G5 Mobile 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 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
G5 Mobile.
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 G5 Mobile
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.
Describes serious and life threatening
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circumstances of using the G5 Mobile, their
consequences, and how to avoid the hazard.
(Continued on next page)
(Continued on next page)
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Chapter 1
Getting Started:
Beginning Your Dexcom G5® Mobile Continuous
Glucose Monitoring (CGM) System Journey
1.1 Introduction
Welcome to the Dexcom G5 Mobile CGM System (G5 Mobile) 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 G5
Mobile System allows you to break free from constant fingersticks. But how do
you use the G5 Mobile? 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 G5 Mobile in your diabetes
management
• Find G5 Mobile System’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
G5 Mobile. 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
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Knowing about the G5 Mobile 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 G5
Mobile:
1. Tutorials
2. Getting Started Guide
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 (see Chapter 10.4).
Accessing Online Tutorials:
From dexcom.com homepage,
click
Support
.
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Once you have viewed the online tutorials you should be pretty comfortable
with what CGMs do and how the G5 Mobile 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:
• USB card in the receiver package
Written Mobile Resources
Getting Started Guide (GSG)
The G5 Mobile 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 G5 Mobile. But what
if you want more detailed information?
User Guide
Your G5 Mobile encyclopedia!
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 G5 Mobile user guide is grouped into six separate parts:
Part 1:
Getting Started
• Glossary
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• Getting Started
o Getting more information about the G5 Mobile
o Registering at dexcom.com
• Indications for Use and Safety Statement
• Risks and Benefits
Part 2:
Let’s G5! The Basics
• Introduction to the G5 Mobile
• Initial Setup
• Starting a Sensor Session: Inserting the Sensor & Attaching the
Transmitter
• Calibration
• Ending a Sensor Session & Transmission Session
Part 3:
Next Steps - Getting the Most out of Your G5 Mobile
Once you are up and running, how you can maximize the G5 Mobile features:
• Reading Trend Graph Screens and Recognizing Trends
• Events
• Alarm and Alerts
• Sounds for Alarm, Alerts and System Messages
Part 4:
Everything Else G5
• Warranty
• Maintenance
• Travel Tips
• Customer Service Contacts
• Technical Information
• Troubleshooting
• Symbols on Package Labels
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At the end of your G5 Mobile user guide is the Dexcom
Share
® user guide.
Part 5:
Sharing Is Caring
• Dexcom
Share
o What Is Dexcom
Share
?
o Setting Up Dexcom
Share
o How to Use Dexcom
Share
o Your Followers
o Troubleshooting
Part 6
• Index for G5 Mobile and Dexcom
Share
How to Use Your User Guide
All chapters in the G5 Mobile 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, it shows 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 and for
reordering supplies.
If you haven’t already done so, go to dexcom.com and set up your own
account.
Or, if you prefer, the G5 Mobile app walks you through creating your login
credentials as part of your initial app setup.
Summary
Now You Can:
• Describe different training resources
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• Locate tutorials about using a real-time CGM in your diabetes
management
• Find G5 Mobile step-by-step instructions
• 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.
Next you’ll learn about when and how to use the G5 Mobile safely.
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Chapter 2
Getting Started:
Indications for Use and Safety Statement
2.1 Introduction
We want the G5 Mobile System 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 that 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 system.
This chapter is important to read. It helps you use the system 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. Then we’ll 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 system’s indications,
contraindications (when to avoid using it), relevant warnings, and precautions.
The Safety Statements are meant to keep you and the system safe while
using the system:
1)
Indications
How, for what purposes, and under what circumstances you should use
the system. Indications let you know who should use the system and
when. Indications are the who, what, and why of the system.
2)
Contraindications
Contraindications let you know when
not
to use the system. 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 system, their
consequences, and how to avoid danger.
4)
Precaution
Special steps you need to take while using the system preventing minor or
moderate injury to either you or the system.
2.3 Safety Statements
This user guide presents Safety Statements two ways:
1. In this chapter’s Overview of Safety Statements
o Lists all Safety Statements
o Includes a section reviewing how the statements are formatted
2. Within each chapter
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o Lists only those statements applicable to that specific chapter
Chapter’s Safety Statements
Each chapter will list all applicable indications, contraindications, precautions,
and warnings.
Some chapters will have multiple Safety Statements; others have none.
Safety Statements are located toward the beginning 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
•
INDICATION-Green
•
CONTRAINDICATION-Purple
•
WARNING-Red
•
PRECAUTION-Blue
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) Alarm or
Alerts.
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 system
components.
Indications and Contraindications
Indications
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What are the system indications? Well, in technical terms, the indications are:
The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System 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 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
system.
Who
The system 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 system is a prescription-only glucose monitoring device. system tracks
your glucose patterns and detects trends. Working with your home 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 system 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 system’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 system; 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
Do not wear the system (sensor, transmitter, and receiver) during 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
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 system from harm.
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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 system 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 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.
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
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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
• Two arrows pointing down
o Falling more than 3 mg/dL each minute
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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 Initial Calibration: Data/Alarm/Alert
After starting a new sensor session, until completing your initial 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 system components.
2.7 System/Hardware/Software Warnings and
Precautions
In this section, you will learn how to safely use the system’s hardware and
software. Some sections will have either Precautions or Warnings, others will
have both.
Sensor/Sensor Pod Warnings and Precautions
Warnings
Sensor Breaking Off
On rare occasions, the sensor wire may break or detach from the sensor pod.
Within 24 hours of experiencing a broken sensor wire, please call our 24/7
Technical Support department, toll free at
1.888.738.3646
or toll at
1.858.200.0200
.
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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 system sensor 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-77° F. While you don’t need
to keep your sensor in a refrigerator, you can as long as the refrigerator is
between 36° F-77° 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
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
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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 sensor pod not sticking and falling off.
Sensor Placement
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
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.
Precaution
Reusable: Don’t Throw Away
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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
Different generations’ transmitters and receivers aren’t interchangeable with
each other.
The Dexcom G5 Mobile CGM System transmitter and receiver are not
compatible with the Dexcom G4® PLATINUM CGM System’s transmitter and
receiver. The Dexcom G5 Mobile CGM System won’t work if you mix receiver
and transmitter components from different generations, resulting in you
missing a severe low or high glucose event.
You can use a Dexcom G4® PLATINUM Sensor with the Dexcom G5 Mobile
CGM System. Before using the sensor, make sure the sensor label says
“Dexcom G5 Mobile/G4 PLATINUM Sensor”, or “Dexcom G4 PLATINUM
Sensor”.
System Accuracy
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
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• 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 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 system
through the baggage x-ray, ask the TSA officer to visually inspect it.
• Body scanner: When you are wearing your system, request hand-
wanding or full-body pat-down and visual inspection instead of going
through the Advanced Imaging Technology (AIT) body scanner (also
called a 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 for 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 receiver and your smart device share some precautions.
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
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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 is often the biggest culprit in reducing
communication distance. This applies to the transmitter and display devices.
Take special care when swimming, getting into a pool, bathtub, shower, etc.
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. Alarm 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 Alarm 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.
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
Settings
menu.
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2.
Verify
app hasn’t been shut down.
3.
Turn
on
Bluetooth
.
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. 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 connected.
Make sure you disconnect 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 Precautions
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
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Use USB cable only as directed and store safely. Misuse of the USB cable
can present a strangulation risk.
Precautions
Test Receiver
Shortly after the receiver is powered on or plugged in to charge, it should
briefly vibrate and beep. If this doesn’t happen, it may mean the vibration
motor and/or speaker are not functioning properly. Please retry. If it still
doesn’t vibrate and beep, contact Technical Support.
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
Sounds
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 is not 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
Do not get dirt or water in the USB port 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 system to sale by or on order of a physician.
Summary
Now You Can:
• Define a Safety Statement
• Explain the difference between an indication and a contraindication
Describe what a precaution is
• Describe the importance of warnings Correctly read a chapter’s
Safety Statement
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• 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
system.
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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 G5 Mobile System.
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 and display device are 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 (Chapter 18.3) or recommended settings in Chapter 11
for more information.
Different Devices May Give Different Numbers
The sensor glucose reading can be different from your meter’s BG value.
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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 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 G5 Mobile uses the same sensor as the previous CGM system—the
Dexcom G4 PLATINUM. The Dexcom G4 PLATINUM System clinical studies
and compliance data showed slight redness and swelling occurring only in a
few patients.
During Dexcom’s G4 PLATINUM System’s clinical study, 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 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!
3.2 Benefits
Daily habits impact your BG levels. With the G5 Mobile, you can track how
your exercise, carbs, stress levels, medication, or illness influence your
glucose levels.
Knowing Your Trends
Providing sensor glucose readings every five minutes, for up to seven days,
the G5 Mobile helps you detect trends and patterns. Trend information reveals
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where your glucose is now, where it has 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.
Helping Your Diabetes Management
Wearing the G5 Mobile 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 G5
Mobile System helps reduce hypoglycemia (Juvenile Diabetes Research
Foundation Continuous Glucose Monitoring Study Group et al, 2008).
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 the G5 Mobile!
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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: Juvenile Diabetes Research Foundation Continuous Glucose
Monitoring Study Group randomized trial.
Diabetes Care, 33
(10), 2175-2177.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring
Study Group , 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.
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.
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2
LET’S G5! THE BASICS
• Introduction to the G5 Mobile
• Initial Setup
• Starting a Sensor Session: Inserting the Sensor & Attaching the
Transmitter
• Calibration
• Ending a Sensor Session & Transmitter Session
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Chapter 4
Let’s G5! The Basics:
What’s the G5 Mobile?
4.1 Introduction
Now it’s time to get an overview of the G5 Mobile.
After this chapter, you’ll be able to:
• Explain the G5 Mobile
• Describe options to view trends
• Locate your historical readings
• Recognize system components
• Explain each part’s function
4.2 Safety Statement
If you’ve used the Dexcom G4 PLATINUM CGM System, you might still have
its transmitter or receiver. While you can use the sensors across the different
generations (look for “G5 Mobile,” “G4 PLATINUM,” or “Dexcom G5
Mobile/G4 PLATINUM” on the sensor’s package), you can’t mix the
transmitter or receiver between the two systems.
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Warning
Don’t:
The G5 Mobile was not evaluated for the following persons:
•
Pregnant women
•
Persons on dialysis
Do not use the Dexcom G5 Mobile 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
Don’t:
Never mix Dexcom G5 Mobile’s transmitter or receiver with Dexcom
G4 PLATINUM’s transmitter or receiver.
Why:
The G5 Mobile’s transmitter and receiver are not compatible with the
Dexcom G4 PLATINUM CGM System’s transmitter and receiver. The G5
Mobile won’t work if you mix receiver and transmitter components from
different generations.
Consequences:
Missing a severe low (hypoglycemia) or high
(hyperglycemia) event.
Only the components in the table below are compatible with each other within
the G5 Mobile System.
G5 Mobile
System
Components
Sensor
Transmitter
Display Device
Receiver
App
Brand Name
G5 Mobile/G4
G5 Mobile
Dexcom
G5
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PLATINUM
Sensor
Transmitter
Receiver
Mobile
App
Part
Number(s)
9500-27 9438-06 MT22949 SW10611
4.3 The G5 Mobile
The G5 Mobile 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.
Your sensor glucose readings are measured by a single use sensor inserted
under your skin. A reusable transmitter sends your data to your display
device.
The G5 Mobile provides personalized trend Alerts, prompting 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 G5 Mobile System may need a caregiver involved in their
care. Please consult your physician for guidance.
Options to View Your Trends
The G5 Mobile 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
2. G5 Mobile 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.
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The G5 Mobile 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 G5 Mobile 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.
View 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 G5 Mobile 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.
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
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.
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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 G5 Mobile allows you to see your last 1-3-6-12-24 hours of your sensor
glucose readings. On the receiver, from the home screen,
tap
graph
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 G5 Mobile?
Dexcom’s G5 Mobile has features not found in our previous generations. They
include:
• G5 Mobile app for your smart device and Apple® Watch
• Touchscreen receiver
• Software updates
o Dexcom
Share
in the G5 Mobile app
G5 Mobile App
You now have an option for how you view your information and enter data.
After downloading the app, you can monitor your glucose and enter
information from your smart device.
Check your CGM information on your wrist! The G5 Mobile app supports
Apple Watch. Use it to discreetly see your glucose information.
Touchscreen Receiver
With the new touchscreen receiver, your sensor glucose readings,
calibrations, events, menu options, etc. are accessible by just a tap or two.
Share Your Data
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Through secure wireless connections, Dexcom
Share
allows your loved ones
to view your sensor glucose readings, trends, and data by your loved ones
from a smart device. Activate Dexcom
Share
by tapping on the app’s
Share
icon, follow a few simple steps, then invite up to five people to connect with
you.
After downloading the Dexcom Follow® app, the invited person becomes your
Follower. As a Follower, he or she can watch your sensor glucose readings,
trends, and receive Alarm/Alerts when your glucose is low or high.
You determine what your Follower can see. Based on what you allow, your
Followers can receive your Alarm or Alerts and view your trends. Followers
can pick and choose, or turn off, the data they receive, including the
Alarm/Alerts, trends, and messages. The
Share
feature in the G5 Mobile app
is different from the Dexcom
Share
app used with other systems.
For more information about Dexcom
Share
and instructions for use, go to Part
5.
NOTE:
Review all Dexcom
Share
System warnings, precautions,
contraindications, indications, and detailed procedures in Part 5.
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 prompts,
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 G5 Mobile does and what’s new, let’s open your
G5 Mobile packages, see what’s inside, and review each item.
4.6 System Components
Package
The G5 Mobile comes to you in a number of boxes; after opening, keep each
box until you are no longer using its contents.
Dexcom G5 Mobile System User Guide
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Throughout this guide, all images are representational. Your product may look
slightly different.
Sensor Box
Single use sensor(s)
Transmitter Box
Reusable transmitter
Receiver Box
Receiver
Two extra colored cases
Receiver’s USB charging and download cable
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AC power adapter
Welcome card
Getting Started Guide
Training Tutorial USB card
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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 G5 Mobile is comprised of four key parts:
1. Single use sensor
2. Reusable transmitter
3. Rechargeable receiver
4. G5 Mobile app
a. Downloaded to your smart device
G5 Mobile optional:
Dexcom
Share
Sensor Overview
For your safety, the sensor is packaged in a sterile sealed pack. When you
first open the pack, your sensor looks like one item; however, it’s actually
three: sensor applicator, sensor pod, and sensor wire.
The applicator helps you insert the sensor wire inside the sensor pod under
your skin. After inserting the sensor wire, remove the applicator. The sensor
wire stays in the sensor pod with the pod attached to your skin by adhesive.
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.
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Figure 1. G5 Mobile Sensor Applicator and Pod
Applicator and Sensor Pod
What it’s called
What it does
Applicator
Applicator Barrel
Contains small insertion needle and sensor wire.
Inserts sensor wire under the skin.
Disposable, for single use only.
Removed after insertion.
Safety Lock
Keeps all moving parts in place before insertion.
Prevents accidental sensor insertion.
Tool to remove transmitter after sensor session.
Put in transmitter box after removal to use later.
Collar
Collar removes insertion needle.
Plunger
Inserts sensor wire into your body.
Transmitter Latch Securely snaps transmitter into sensor pod.
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Sensor Pod
Sensor Pod
Holds transmitter and sensor wire.
Water resistant when transmitter is properly
installed.
Discarded after sensor session.
Adhesive Patch
Keeps sensor pod attached to your skin.
Transmitter Cradle Holds transmitter in place during sensor session.
Sensor Wire
Wire measures glucose levels in fluid in between
your cells.
Attached to sensor pod.
Discarded with pod after session.
Transmitter Overview
Figure 2. G5 Mobile Transmitter Front and Back
Image is representational only. Your transmitter may look different.
Snapping into the sensor pod, the gray plastic transmitter wirelessly sends
your glucose information to your display devices—receiver and/or smart
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.
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• Battery lasts approximately three months
o Receiver or smart device prompts 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 and transmitter, let’s review the
receiver.
Receiver
The receiver is a small hand-held device. Your receiver, as well as your smart
device, shows your sensor glucose readings, trend graphs, and trend arrows
and alerts 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. If your receiver does get wet or dirty, test it to make
sure the speaker and vibrations still work (see Chapter 12).
The small hole on the back of the receiver is not to be used to reset the
receiver. Do not push anything through the hole.
If your receiver isn’t charged, see Chapter 14 for charging your receiver’s
battery.
You can change the protective case. Just take off the black one and put on
one of the colored ones. Be sure to line up the cover’s speaker holes with the
receiver speaker.
If you want to use the receiver along with a smart device, you need to set
them up separately.
Remember, you can’t use a combination of smart devices during a sensor
session; select just one.
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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
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
Wall Charger
Plug
USB cable
into
adapter/wall
charger
Plug
wall charger
into an
electrical outlet to charge
receiver’s battery
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What you see
What it’s called
What it does
Display Screen
Shows sensor glucose
readings, trend graphs and
arrows, Alarm/Alerts, sensor
session status.
Change settings on Menu
screen.
Charging
Indicator
Turns on when receiver is
being charged.
Speaker
Allows you to hear your
Alarm/Alerts sounds.
Power and
Wake-up Button
Press and hold button for
two seconds to turn it on.
Press briefly to wake it up.
4.7 Smart Device Overview
The G5 Mobile 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.
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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 G5 Mobile
• 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 G5 Mobile is selecting how to
continuously receive your sensor glucose readings: the G5 Mobile app, the
receiver, or a combination.
Our next chapter helps you set up both!
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Chapter 5
Let’s G5! The Basics:
Set Up Your Display Devices
5.1 Introduction
In the previous chapter, you received a high level overview of the G5 Mobile
and learned you can monitor your glucose levels with different display
devices. Now it’s time to set up your G5 Mobile app and your receiver.
After this chapter, you will be able to:
• Determine which display device(s) you’ll use
• Create a Dexcom username and password
• Download the G5 Mobile app
• Set up the G5 Mobile app with the recommended settings
• Successfully set up your receiver
5.2 Safety Statement
If you’ve used the Dexcom G4 PLATINUM CGM System, you might still have
its transmitter or receiver. While you can use the sensors across the different
generations (look for the Dexcom G5 Mobile/G4 PLATINUM Sensor package),
you can’t mix the transmitter or receiver between the two systems.
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Precaution
Don’t:
Never mix G5 Mobile’s transmitter or receiver with Dexcom G4
PLATINUM’s transmitter or receiver.
Why:
The G5 Mobile’s transmitter and receiver are not compatible with the
Dexcom G4 PLATINUM CGM System’s transmitter and receiver. The G5
Mobile won’t work if you mix receiver and transmitter components from
different generations.
Consequences:
Missing a severe low (hypoglycemia) or high
(hyperglycemia) event.
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!
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 Chapter 5.5. If you want to use both the G5 Mobile app and the
receiver, you need to set up each individually.
Once you have completed the initial setup, you’re one step closer to beginning
your sensor session!
5.4 G5 Mobile 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
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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
• 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 G5 Mobile 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 receiver until it’s fixed or replaced.
G5 Mobile App Installation
Installing the app is easy! Simply download the G5 Mobile app from your
smart device’s store. However, if your smart device has been jailbroken, do
not install the app.
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For information on how to install an app, see your smart device’s user guide.
Initial G5 Mobile 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
green
Get Started
tab or the three green bars, then “Get
Started.”
3.
Click
green
Get Started
button on the page.
4.
Fill out
User account
screen.
5.
Click
the green
Create New Account
button towards the bottom of the
screen.
But what if you are unclear about a step?
The G5 Mobile app has prompts allowing you to get more information. If you
are unsure of something during your initial setup process, look at the screen
for additional information prompts. Informational prompts include, but aren’t
limited to:
I don’t understand, Learn More,
or
Question Mark
.
Tap
your
informational prompt
to get more information.
To close out of the information prompt,
tap
the
X
in the upper right-hand
corner.
Initial App Setup
Step
What you see
What you do
Introductory Screens
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Step
What you see
What you do
1
Tap
G5 Mobile app
icon to open app.
Introductory Screens
2
Swipe
through introductory screens or
tap
Log In
.
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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
4
Tap
Let’s Get Started
.
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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
available,
I don’t understand
to get more
information.
Setting Up Your App Alarm/Alerts and Basic Settings
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 if your glucose dips below
your set amount.
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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 if your glucose rises
above your set amount.
Setting Up Your App Alarm/Alerts and Basic Settings
8a
Make sure you get your Alarm/Alerts
notifications.
Tap
the
appropriate response
to move
forward and set your notifications.
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8b
Tap
OK
to receive Alarm/Alerts
notifications.
Setting Up Your App Alarm/Alerts and Basic Settings
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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10
Tap
Next
.
11
Verify
Bluetooth
is on.
The app will check to see if
Bluetooth
is
turned “on.”
Connecting/Pairing Transmitter With App
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12a
Get
your transmitter box.
Turn
transmitter box
upside down
on a flat
surface with barcodes facing up.
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. (This screen is
skipped for smart devices.)
16 At prompt,
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 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 bar, meter, and events icons
Initial Setup of the Receiver
Press and hold
power button
for two seconds 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.
Your receiver has a touchscreen. Be sure your fingers are dry when you touch
it. Don’t be alarmed 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.
How you complete your initial setup differs between the receiver and your
smart device; however, the data are the same.
Setup Wizard Prompts:
• Date/Time
• Transmitter Serial Number
o Back of transmitter
o Back of transmitter’s box
• Setting Low Alert
• Setting High 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
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1
Press
and hold
power button
for two
seconds to turn receiver on.
Wait
for the Dexcom screen to appear.
2
Wait.
Within 20 seconds, receiver will beep and
vibrate briefly to show the speaker and
vibration motor are working.
3
Tap
OK
.
Date/Time
4a
The green box shows what is selected.
Tap
up/down
arrow
to change year.
Tap
month
to select it.
Tap
up/down arrow
to change month.
Tap
day
to select it.
Tap
up/down arrow
to change day.
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4b
Tap
hour
to select it.
Tap
up/down arrow
to change hour.
Tap
minutes
to select them.
Tap
up/down arrow
to change minutes.
Tap
AM/PM
to select it.
Tap
up/down arrow
to change between
AM and PM.
Tap
Save
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
5a
Turn
transmitter box
upside
down
to locate SN number.
For information on how to pair
transmitter after initial setup,
see Chapter 8.
5b
If transmitter package isn’t
available:
• SN is on transmitter’s
back
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5c
Tap
up/down arrows
to select
and enter transmitter SN.
Tap
number
to select it. To
choose a letter, tap up from 9 or
down from 0.
Tap
Save
to save and close.
Setting Low Alert
6a System default is set at 80 mg/dL.
Tap
Save
to save at present levels and
close.
6b
To change value:
Tap
up/down arrows
to change value at 5
mg/dL increments.
Tap
Save
to save and close.
Setting High Alert
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7a System default is set at 200 mg/dL.
Tap
Save
to save at present levels and
close.
7b
To change value:
Tap
up/down arrows
to change value at
10 mg/dL increments.
Tap
Save
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 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:
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1. Inserting the sensor.
2. Attaching the transmitter.
3. Pairing the transmitter to your device.
4. Two-hour sensor warmup.
5. Initial calibrations.
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Chapter 6
Let’s G5! The Basics:
Starting a Sensor Session: Inserting Sensor,
AttachingTransmitter, 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
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:
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 G5 Mobile
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 initial calibrations.
After this chapter you will be able to:
• Identify sensor applicator features
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• 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 sensor
• Outline what happens during the sensor warmup
• Identify countdown icon
6.2 Safety Statements
Following are some important Warnings and Precautions 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:
Seek professional medical help if you have symptoms of infection or
inflammation (for example,, redness, swelling or pain) at the insertion site.
If your sensor breaks under your skin, report it to Technical Support
(available 24/7) as soon as possible:
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 G5
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
Don’t
:
Insert the sensor component of the G5 Mobile 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 G5 Mobile sensor 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
.
Warning
Do:
Store sensor between 36° F-77° F during its shelf life.
Why:
Storing the sensor incorrectly might cause the sensor glucose
readings to be inaccurate.
Never store sensors in the freezer.
Consequences:
If stored outside of 36° F-77° F, your sensor glucose
readings may not be accurate, resulting in you missing a severe low or
high glucose event.
Warning
Don’t:
Never use the G5 Mobile sensor glucose readings for treatment
decisions.
Do:
Only use BG values from your BG meter for treatment decisions (for
example, how much insulin to take).
Why:
Since they measure your glucose from different body fluids, sensor
glucose readings can be different from your meter’s BG values.
Consequences:
Using sensor glucose readings for treatment decisions
could result in you missing a severe low or high event.
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Precaution
Do:
Select sensor insertion site with care.
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:
Insertion in these areas might affect sensor performance.
Consequences:
Inaccurate sensor glucose readings may result in you
missing a severe low or high event.
Precaution
Do
:
Check sensor package before opening.
Why:
Make sure the sterile sensor pack has not been damaged or
previously opened. If opened or damaged, sensor may be unsterile.
Consequences: Using an unsterile sensor may cause an infection.
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.
6.3 Prepping for Sensor Insertion
Before inserting a sensor, make sure you have everything you need. Some
items are included in the G5 Mobile’s packages, others are not.
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Included in Your G5 Mobile Packages
For sensor insertion, you need the sensor and transmitter.
Sensor Applicator
Inside Sensor Box
What you see
What it is
Sterilized sensor pack with important label
information.
Check
expiration date.
Single use sensor applicator.
Knowing what each applicator piece does helps you successfully insert your
sensor. Chapter 4.6 gave you an overview of the sensor applicator.
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Figure 3. G5 Mobile Sensor Applicator and Pod
The following table reviews the sensor applicator components in order of use.
Order of
Use
Name What it does
1 Sensor Pack Sterilized for your protection.
Open to remove applicator and sensor.
2 Adhesive Patch Holds the sensor/transmitter in place
on your skin.
3 Safety Lock Prevents plunger from inserting sensor
until you are ready.
4 Plunger Inserts sensor wire into your body.
5 Applicator Barrel
Contains small insertion needle and
sensor wire.
Disposable, for single use only.
6 Collar
Collar removes insertion needle.
Helps remove applicator barrel once
sensor wire is inserted.
Order of
Use
Name What it does
7 Sensor Pod Holds sensor wire in place under skin.
Holds transmitter.
8 Transmitter
Latch
Locks transmitter into sensor pod.
9 Release Tab Allows you to remove applicator barrel
from sensor pod.
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Transmitter
Transmitter Box
What you see
What it is
Bottom of box with important label
information.
Keep box until transmitter battery dies.
Reusable transmitter.
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 out of its sterile pack, determine the
best place to insert your sensor.
6.4 Choosing Your Insertion Site
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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 waist band, 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
Front of body (belly area) for ages 2 years
and above.
If user is between the ages of 2 years and
17:
Back of body (Upper buttocks)
Do:
• Remove the sensor and applicator from its sterile pack only at time of
use
• Place at least 3 inches from your insulin pump infusion set or injection
site
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• 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 sensor pod not sticking, before inserting your
sensor, you can make the sensor site stickier to help ensure the sensor pod
does not peel.
Optional Site Preparation
Use optional skin adhesives (Mastisol™, SkinTac™) as part of your insertion
site preparation to help keep your sensor pod 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 manufacturer’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 sensor pod site.
You’re now ready to insert your sensor!
Step
Picture
What you do
Preparation
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1
Wash
and
dry
your hands.
2
Clean
insertion site
with alcohol wipe.
Let dry.
3
Optional Step: Skin Adhesive
Create
an
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
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4
Check
pack
: Is it damaged or already
opened?
Remove
sensor applicator
from sterile
pack.
Closely inspect
sensor
, check it hasn’t
been damaged.
Keep
sensor packaging
until sensor
session is complete.
Attaching Sensor Pod
5
Pull
adhesive backing tabs.
Don’t touch
sticky adhesive patch.
Inserting Sensor Wire
6
Place
sensor
horizontally, not vertically,
on skin.
Move
fingers around
the adhesive patch
several times to secure tape.
Preparation
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7
Hold
applicator barrel.
Pull
safety lock
out.
8
Place
fingers of one hand on edges of
adhesive patch
.
Pinch
up your skin at the tips of the
white
adhesive.
9
Place
two fingers directly
above
collar to
steady applicator barrel.
Place
thumb on the
white plunger
.
Push
plunger
completely down the
applicator barrel.
You should hear 2 clicks.
NOTE:
Finger placement is important for
correct insertion.
Removing Applicator and Collar
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10
Move
two fingers from
above
collar to
below
collar.
Keeping your thumb as a base on the
white plunger.
Pull
collar
all the way back towards your
thumb.
You should hear 2 clicks.
NOTE:
Finger placement is important for
correct removal.
11
Hold
transmitter latch
down against your
body.
Squeeze
ribbed release
tabs
on the sides
of sensor pod.
12a
Move
applicator barrel
forward and out,
away from your body.
Follow local ordinances when disposing
the applicator.
12b
What’s left?
1.
Sensor pod
2.
Transmitter latch
You have successfully inserted the sensor!
At this point, you should have two items attached:
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1. The sensor pod
2. The transmitter latch
Having problems?
If it’s the first time inserting a sensor, you may have questions or need help. If
you do, please contact your 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 sensor pod.
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
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
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1
Remove
transmitter
from box.
Keep
box.
Save
safety latch
from sensor applicator
(helps remove transmitter once sensor
session is over).
Get alcohol wipe.
2
Wipe
back of transmitter
with alcohol
wipe.
Let dry
for 2-3 minutes.
Don’t
let the back of transmitter touch
your skin.
Don’t
scratch transmitter’s back, this can
harm the waterproof seal.
3
Flat side down.
Slide
transmitter’s
small end
under the
sensor pod lip located in front of pod’s
ribbed tabs, away from
transmitter latch
.
Step
Picture
What you do
4
Keep
finger on
transmitter
holding it in
place.
Push
transmitter latch
up and forward
over the transmitter’s wide end with your
other hand.
You should hear 2 clicks.
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5
Is transmitter secure?
Before removing transmitter latch, verify
transmitter is securely in place.
Make sure none of the transmitter’s sides
popped out of the sensor pod.
If not completely snapped in, you may
have a bad connection and it won’t be
water tight.
6
Hold
sensor pod sides
with one hand.
Twist
latch
away
from your body with
other hand.
Remove
latch
.
Don’t
remove
transmitter
while sensor
pod is attached to skin.
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.
No matter which display device you use, you’ll insert the sensor and attach
the transmitter only once during your seven-day sensor session.
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 Sensor Pod
The sensor pod should 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
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• Don’t tape over the transmitter or any plastic parts of the sensor pod
• Don’t tape under sensor pod
• Don’t leave any substance on the skin where you insert the sensor
Figure 4. The Right Way to Use Tape for Extra Support
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 sensor pod, your next step is telling 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 initial two 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
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1
Wait
for
Pair
Successful
.
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.
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
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4
Locked screen.
Initial calibration
prompt tells you when
warmup is complete.
Chapter 7 covers calibrating.
5
Initial calibration
prompt 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
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1
Turn on receiver:
•
Press
and hold
power button
for two seconds to turn
receiver on
• Within 20 seconds, receiver
will beep and vibrate briefly
to show the speaker and
vibration motor are working
Wake up receiver:
•
Press
power button
briefly to
wake up receiver
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.
3
Tap
Start Sensor
.
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4
Thinking screen
5
Receiver returns to the trend graph
screen.
Sensor Warmup
confirms two-hour
sensor warmup.
Keep your receiver within 20 feet
during the warmup period
NOTE:
After sensor starts,
Start
Sensor
option disappears from Main
Menu and
Stop Sensor
appears.
6
Wait
.
In the upper right corner, icon shows
countdown of the two-hour sensor
warmup.
7 Sensor warmup is complete.
You’re ready to calibrate!
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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
o Don’t start a sensor session until they are paired.
If the
Bluetooth
icon is blinking and
Signal Loss
displays, your transmitter and
receiver are not communicating.
No Communication Between Transmitter and Receiver
Step
What you see
What you do
1
Tap OK.
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.
No sensor glucose readings display until
error is fixed.
More than 30 minutes? Contact Technical
Support (available 24/7) at:
• TechSupport@dexcom.com
• Toll free:
1.888.738.3646
• Toll call:
1.858.200.0200
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6.10 Sensor Session Warmup
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 G5 Mobile’s display devices.
Once the sensor warmup is complete, you’re ready to enter your initial
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 sensor
• 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 G5! The Basics:
Calibration
7.1 Introduction
In the previous chapter, you learned how to insert your sensor, attach your
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 initial 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 the 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 App
o Receiver
• Identify calibration errors
7.2 Safety Statements
Contraindication
Don’t:
Never take any medications containing acetaminophen during your
sensor session.
Why:
Taking medications with acetaminophen (such as Tylenol or
Excedrin Extra Strength) while wearing your sensor may falsely raise
sensor glucose readings. 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
glucose event.
Warning
Don’t:
Never use the G5 Mobile sensor glucose readings for treatment
decisions.
Do:
Only use BG values from your BG meter for treatment decisions (for
example, how much insulin to take).
Why:
Since they measure your glucose from different body fluids, sensor
glucose readings can be different from your meter’s BG values.
Consequences:
Using sensor glucose readings for treatment decisions
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 inaccurate
sensor glucose readings.
Consequences:
Missing severe low (hypoglycemia) or high
(hyperglycemia) Alarm or Alerts.
Precaution
Do:
Look at trend arrows before calibrating. Trend arrows help you
determine if you can calibrate now or should wait.
Don’t:
Never calibrate if your BG is changing at a significant rate, typically
more than 2 mg/dL per minute.
Never 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 significant rise/fall of 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 carefully performed fingerstick measurement.
Why:
Entering the wrong BG values, or waiting more than five minutes
before entry, might affect sensor accuracy.
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:
Never use alternative site BG values such as blood from palms,
forearms, etc.
Why:
Alternative site BG values are different from a fingerstick BG value
and may not reflect most recent BG value.
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.
Why Is Calibrating Important?
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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 G5
Mobile 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 display device. 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 display 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
prompts:
1. Two initial calibrations once your warmup session is complete.
2. Update calibrations done twice daily, once every 12 hours.
3. When you’re prompted.
If you receive a calibration prompt 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 prompt you when you are ready for another.
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.
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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 prompts, etc.
There are important times when you
must
calibrate:
1. Initial or Startup Calibration: two hours after you insert your sensor.
2. 12 Hour Update: every 12 hours after two-hour startup calibration.
3. When system prompts you.
With calibration prompts, 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.
Initial Calibration: Sensor Startup Completed
1. At prompts (see next table) enter two back-to-back fingerstick
measurements into just one device.
2. No need to do initial calibrations twice.
a. Calibration data flows between the receiver and your app.
b. Ten minute reporting delay between devices.
3. First update calibration is 12 hours after your initial 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.
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.
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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 Prompts
Sensor Session Startup Calibration Prompts
Once your two-hour sensor startup 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, only use your BG meter for calibrations, and never enter
values from your CGM.
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Startup Calibration Prompts
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 initial
calibrations.
Follow steps
in Chapters
7.6 and 7.7.
Immediately
prepare for
next
calibration.
Smart Device:
In App
Receiver
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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 Chapters
7.6 and 7.7.
Next
calibration in
12 hours.
Smart Device:
In App
Receiver
Your sensor glucose readings begin in approximately five minutes once the
device(s) accepts your calibrations.
Update Calibration Prompts
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Once your startup calibration is done, your update calibration schedule
begins.
The steps to enter your update calibrations are the same as your initial
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 initial calibration, if you don’t enter
your BG meter values right away, the system prompts you every 15 minutes.
Update Calibration Prompts
Device What you see What it means What you do
Smart Device:
Lock Screen
Enter update
calibration.
If prompt
doesn’t go
away:
• System didn’t
accept
calibration
• BG values
are very
different from
sensor
glucose
readings
Follow steps
in Chapters
7.6 and 7.7.
Immediately
prepare for
next
calibration.
Smart Device:
In App
Receiver
Tap
Message
to clear prompt on your smart device; to clear a prompt on your
receiver,
Tap
OK
.
Sound/Vibration Prompts
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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 prompts 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 prompts and how to
clear them, please see Chapter 9.
Smart Device
Calibration prompts 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 prompts. 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:
1. Wash and dry your hands before taking 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?
6. Use fingerstick BG values only.
a. Other sites are not as accurate.
b. Must enter within five minutes of taking BG meter value.
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c. Enter exact BG value from your meter for each calibration.
Don’t:
1. 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.
2. 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.
3. 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 eight steps above, have a valid BG value from your
meter, and your display device keeps alerting you: Calibrate! Calibrate!
Calibrate!
Remember:
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.
Initial Calibration With Your G5 Mobile app
Step
What you see
What you do
Additional Info
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Step
What you see
What you do
Additional Info
1
Tap
circle
.
Initial calibration:
Enter two back-to-
back meter BG
values.
Update calibration:
Enter single meter
BG value.
2
Enter
meter’s
BG
value
using number
pad.
Tap
Save
.
Double-check your
numbers.
Entering wrong
values, or values
taken more than 5
minutes ago, can
affect the sensor’s
accuracy.
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Step
What you see
What you do
Additional Info
3
Verify
value is
correct.
Tap
Save
.
If not correct:
Tap
Cancel
.
Reenter
correct
value.
4
Tap
circle
to enter
your second BG
value.
Follow steps 2-3
and enter second
reading.
5
Meter icon has no
calibration prompt.
Calibration
accepted.
Your calibration was
successful.
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Step
What you see
What you do
Additional Info
6
Wait
for next
calibration prompt in
12 hours.
Default Home Trend
screen.
Calibration
accepted.
Initial Calibration With Your Receiver
Step
What you see
What you do
Additional Info
1
Press
power button
briefly to wake up
receiver.
Tap
OK
.
You won’t see
calibration prompts
when receiver
screen is black.
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Step
What you see
What you do Additional Info
2
Tap
up/down arrows
to change numbers.
Stop
at meter’s BG
value.
Tap
Done
.
Sensor default
reading for initial
calibration is 120
mg/dL.
3a
Verify BG value is
correct.
If correct:
Tap
Save
.
If
Save
is not
tapped:
• Receiver
times out
• BG level isn’t
recorded
3b
Verify BG value is
correct.
If incorrect:
Tap
Cancel
.
Reenter
BG value.
Cancel and reenter
BG value.
Fingerstick
measurement must
be within the last
five minutes.
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Step
What you see
What you do Additional Info
4
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.
7
Wait
for next
calibration prompt 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
prompts. If the prompts don’t go away after 15 minutes, refer to Chapter 18,
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Troubleshooting.
Device
What you see
What it means
What you do
Smart
Device:
In App
Sensor can’t
calibrate now.
Wait
5 minutes.
Retake
fingerstick
measurement at
prompt.
Enter
BG value.
Receiver
Smart
Device:
In App
System didn’t
accept recent
calibration.
Additional
calibration needed
immediately.
Calibrate
.
No sensor glucose
readings.
Receiver
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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
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?
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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
removing the transmitter and determining if you need to replace it.
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Chapter 8
Let’s G5! The Basics:
Ending Your Sensor Session and Transmitter Session
8.1 Introduction
G5 Mobile 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 prompts 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 sensor pod with transmitter attached
• Separate transmitter from sensor pod
• 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 sensor pod and transmitter, review the following safety statements to make sure
you don’t harm yourself.
8.2 Safety Statements
Warning
Don’t:
If a sensor breaks under the skin with no portion visible above the
skin, don’t remove it. Don’t ignore sensor fractures.
Do:
Seek professional medical help if you have symptoms of infection or
inflammation (for example, redness, swelling or pain) at the insertion site.
If your sensor breaks under your skin, report it to Technical Support
(available 24/7) as soon as possible:
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 G5
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
Do:
Keep Transmitter until it’s battery life has ended.
Why:
Transmitter is reusable.
• Use for multiple sessions
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8.3 Ending Your Sensor Session
There are different ways your session might end.
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
prompts you to end the session.
Let’s review ending a normal session first; later in this chapter we’ll review the prompts for ending the session early.
Ending Your Seven-Day Sensor Session
Just like other prompts, your sensor session ending prompts need clearing:
• App
o
Tap
screen
• Receiver
o
Tap
OK
End Seven-Day Sensor Session Prompts
Ending Sensor Session Prompts
Device
What you see
What it means
At Six Hours
Smart Device:
Lock Screen
Prompts begin when sensor
session has only six hours left.
Clock will countdown 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
At Thirty Minutes
Smart Device:
Lock Screen
Thirty minutes remain.
Continue to get sensor glucose
readings.
Smart Device:
In App
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Device
What you see
What it means
Receiver
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
Tap
OK
to clear.
Smart Device:
In App
Receiver
Device
What you see
What it means
Session Stopped
Smart Device:
Lock Screen
N/A Sensor session has stopped.
App
• No sensor glucose
readings
• Prompts for new
session
Receiver
Smart Device:
In App
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Device
What you see
What it means
Receiver
• Straight line
o No sensor glucose
readings
Sound/Vibration Prompts
In case you can’t look at your screen, both the smart device and receiver provide beep/vibration prompts 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 prompts.
For more information on setting your sound/vibration prompts, please see Chapter 9.
Smart Device
Your smart device prompts 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 prompt. 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 go to Chapter 6 in the 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 sensor pod).
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 prompts leading to a new sensor session. If you see error prompts, before stopping a sensor session early,
always contact Technical Support (available 24/7) at:
• 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.
Prompts to End Sensor Session Early
System Prompts
Device
What you see
What it means
Smart Device:
Lock Screen
Sensor issues detected.
Session ends automatically.
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Device
What you see
What it means
Smart Device:
In App
No:
• Sensor Glucose
Readings
• Alarm/Alerts
Replace sensor.
Receiver
Device
What you see
What it means
Smart Device:
Lock Screen
Wait up to three hours while the
system autocorrects.
Check transmitter—is it properly
inserted into sensor pod?
Make sure you haven’t taken
acetaminophen.
If not corrected after 3 hours:
• Contact Dexcom
Technical Support
Smart Device:
In App
Receiver
Smart Device:
Lock Screen
Wait up to three hours while the
system autocorrects.
Check transmitter—is it properly
inserted into sensor pod?
Make sure you haven’t taken
acetaminophen.
If not corrected after 3 hours:
• Contact Dexcom
Technical Support
Smart Device:
In App
Receiver
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The G5 Mobile 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.
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.
2
Ends sensor
session.
During session:
•
Stop Sensor
option
appears
Not in active
session:
•
Start Sensor
option
appears
Tap
Stop Sensor
.
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
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Step
What you see
What it means What you do
1 Go to Main Menu.
Tap
Menu
.
2
Ends sensor
session.
During session,
Stop Sensor
option
appears.
Tap
Stop Sensor
.
3 Do you want to stop
the sensor?
Tap
OK
.
4 Thinking screen.
Wait.
5
Ready to start a new
session.
Not in active
session,
Start
Sensor
option
appears.
Remove
sensor.
Insert
new sensor.
Tap
Start Sensor
when ready for new
session.
Temporarily Shut Down Receiver
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
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Step
What you see
What it means
What you do
1 Go to Main Menu.
Tap
Menu
.
2 Turns off receiver.
Tap
Shutdown
.
3
Confirms you want
to shut down.
Shuts down
receiver.
Tap
OK
.
Press
power button
for two seconds to turn the receiver back on. It may take up to 20 seconds for the receiver to turn on.
Preventing Sensor Failures
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 in sensor pod.
3. Sensor pod isn’t dislodged or adhesive isn’t peeling.
4. Nothing is rubbing against sensor pod (for example, seat belts, etc.).
5. You selected a good insertion site (see Chapter 6).
6. Insertion site is clean and dry before sensor insertion.
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.
8.4 Remove Sensor Pod and Transmitter
Remove Sensor Pod
Think of the transmitter as being part of the sensor pod. Do not remove the transmitter before removing the sensor pod from
your body.
To remove the sensor pod:
1. Gently peel sensor pod adhesive patch from skin.
a. Sensor wire comes out with sensor pod.
2. Separate the transmitter from the sensor pod.
3. Discard the sensor pod following your local waste management regulations for disposing of blood-contacting parts
(sensor and applicator).
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Remove Transmitter From Sensor Pod
Remember that the transmitter is reusable—do not throw away. It lasts 90 days and can be used in multiple sensor sessions.
Keep using it until the system notifies you the transmitter battery is about to expire.
Before reusing the transmitter in your new sensor session, remove it from the old sensor pod.
You can detach transmitter two ways:
1. Use safety lock (see With Safety Lock table). You removed this from the applicator barrel at the beginning of the
session.
2. Manually spread out tabs holding transmitter in sensor pod (see Without Safety Lock table).
With Safety Lock
Step
Picture
What you do
1
Grasp
end of
adhesive patch
.
Peel
adhesive patch
up and away from your
body to remove
sensor pod
and
transmitter
.
2
Put
sensor pod
on flat surface.
3
Place
safety latch’s
jagged edge:
Over transmitter’s wide edge
In between open slots on sensor pod’s
sides
4
Lift up
safety latch
.
After removing your sensor, and taking the transmitter out of the sensor pod, you’re ready to begin a new sensor session. The
transmitter’s battery is good 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.
2. Never use same site for 2 sensor sessions in a row.
Without Safety Lock
Step
Picture
What you do
1
Grasp
end of
adhesive patch
.
Peel
adhesive patch
up and away from your
body to remove
sensor pod
and
transmitter
.
2
Put
sensor pod
on flat surface.
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Step
Picture
What you do
3
Grasp
sensor pod’s
wide end with two
hands and place fingers in sides’ open
slots.
4
Pull
tabs
away from transmitter.
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 countdown 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. Order a new
transmitter.
Smart Device:
In App
Receiver
Device
What you see
What it means
Smart Device:
Lock Screen
Transmitter battery will expire in
two weeks.
Order a new transmitter.
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Device
What you see
What it means
Smart Device:
In App
Receiver
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 Chapter 16.1), or through the channels you used before, at your first low
battery prompt.
Sound/Vibration Prompts
In case you can’t look at your screen, both the smart device and receiver provide beep/vibration prompts 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 prompts.
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For more information on setting your sound/vibration prompts and how to clear them, please see Chapter 9.
Smart Device
Your smart device prompts 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 prompt. If not cleared, you receive a vibrate/beep twice, five minutes apart.
8.6 Pair New Transmitter
After the transmitter battery has died and 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 set up?
Part of pairing the transmitter is entering it’s SN into your display device, inserting the sensor, and attaching the transmitter.
After the transmitter and display device are paired,start a new sensor session.
App
Step
What you see
What you do
1
Tap
Menu
2
Tap
Settings
3
Tap
Transmitter
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Step
What you see
What you do
4
Tap
Pair New
5a
Turn
transmitter box
upside down
on a flat
surface with barcodes facing up. (If you
don’t have the box, go to step 6a.)
5b
Center
longest barcode within green
brackets.
Tap
Take Photo
5c
Check mark confirms successful transmitter
SN scan.
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Step
What you see
What you do
6a
Or, if you don’t have the box, find the SN on
the back of the transmitter and type it in.
Tap
Enter transmitter SN by hand
.
6b
Use
keyboard to enter transmitter SN.
Confirm
correct SN .
Tap
Save
.
7
Insert
sensor and
attach
transmitter.
See Chapter 6 for more information.
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Step
What you see
What you do
8
Wait
up to 30 minutes for smart device and
transmitter to connect.
9 At notification,
Tap
Pair
to pair app with
smart device.
10
Before starting a new sensor session, make
sure your smart device and transmitter are
paired
Receiver
Step
What you see
What you do
1
Press
and hold the
power button
for 2
seconds to turn receiver on.
2
Tap
Menu
icon
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Step
What you see
What you do
3
Tap
Settings
4
Tap
Transmitter
5
Tap
Transmitter SN
.
6a
8
Turn
transmitter box
upside down
to locate
SN number.
6b
If transmitter package isn’t available,
SN is also on back of transmitter
6c
Tap
up/down arrows
to select and enter
transmitter SN.
Tap
number
to select it. To choose a letter,
tap up from 9 or down from 0.
Tap
Save
to save and close.
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Step
What you see
What you do
7
Insert sensor and attach transmitter.
See Chapter 6 for more information.
8
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 start a new sensor session until they
are paired.
Summary
Now You Can!
• Identify replace sensor prompts 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 sensor pod with transmitter attached
• Separate transmitter from sensor pod
• Determine if transmitter can be used for another sensor session
• Pair a 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 G5 Mobile can do much more.
In the next part, Part 3: Next Steps, you will learn how to get the most out of your G5 Mobile.
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3
NEXT STEPS - GETTING THE MOST
OUT OF YOUR G5 MOBILE
• 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 - Getting the Most out of Your G5 Mobile:
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 entering your two initial
calibrations 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:
Never take any medications containing acetaminophen during your
sensor session.
Why:
Taking medications with acetaminophen (such as Tylenol or
Excedrin Extra Strength) while wearing sensor may falsely raise sensor
glucose readings. Level of 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
event.
Warning
Don’t:
Never use the G5 Mobile sensor glucose readings for treatment
decisions.
Do:
Only use BG values from your BG meter for treatment decisions (for
example, how much insulin to take).
Why:
Since they measure your glucose from different body fluids, sensor
glucose readings can be different from your meter’s BG values.
Consequences:
Using sensor glucose readings for treatment decisions
could result in you missing a severe low or high glucose event.
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Warning
Don’t:
Never ignore symptoms of high and low glucose.
Do:
Measure your BG with a fingerstick measurement if sensor glucose
readings don’t match your symptoms.
Why:
Your sensor glucose readings may not be accurately reading your
glucose.
Consequences:
Using sensor glucose readings for treatment decisions
could result in having severe low (hypoglycemia) or high (hyperglycemia)
events.
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 Alarm or Alerts.
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
status. While the screen does look different between the receiver, smart
device, Apple Today View, and Apple Watch, the information is the same.
The G5 Mobile app has two ways to view data based on how you hold your
smart device:
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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.
To change between the 1, 3, 6, 12, or 24-hour trend information in the
receiver, tap the graph.
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 to enter data
or make system changes.
App Home Screen
The app’s home screen has two main sections:
1. Task Bar
a. Allows you to change settings, enter data, etc.
2. Glucose Information
a. Reflects sensor glucose readings and trends.
Task Bar
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Figure 6. Example App Home Screen on Smart Device
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App Task Bar
App
Name
What it means
What you do
Task Bar: Complete Tasks
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
Prompt.
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
.
App Glucose Information
App: Portrait
App: Landscape
What it means
Glucose Information: Review
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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.
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
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App: Portrait
App: Landscape
What it means
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.
N/A
Rate of Change
Arrow
Direction and
number of arrows
show sensor
glucose change
rate.
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App: Portrait
App: Landscape
What it means
Sensor Glucose
Reading Range
Shows between
40-400 mg/dL.
Within Glucose
Range and Alert
Levels
• Yellow: High
Alert level
• Gray: Within
range
• Red: Low Alert
level or, if
that’s disabled,
55 mg/dL
(Urgent Low
Glucose
Alarm)
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App: Portrait
App: Landscape
What it means
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.
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 Apple
mobile 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
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Apple Today View
Name
What it does
What you do
Glucose
Information
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.
Color of circle
changes:
• Yellow: At
or above
target
• Gray: Within
target range
• Red: At or
below target
Take
appropriate
action.
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Apple Today View
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)
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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.
Like your smart device, your receiver has a touchscreen..
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The receiver’s home screen has three sections:
Figure 7. Home Screen on Receiver
• Status Bar: Shows Bluetooth status, system time, and battery level.
• Task Bar: Tap icons to go to the Main Menu, enter your BG numbers,
or record Events.
• Glucose Information: Shows your sensor glucose readings and
trends.
Receiver Status Bar
Receiver
Name
What it does
What you do
Status Bar: System Information
Task Bar
Glucose Information
Status Bar
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Receiver
Name
What it does
What you do
Status Bar
At-a-glance
receiver
information.
Icons change
based on what’s
happening.
Review and take
appropriate
action.
Bluetooth
Shows
Bluetooth
is
connected.
Do nothing.
Receiver’s
Bluetooth
is
always on.
If blinking, move
receiver closer
to transmitter.
Time
Shows system
time.
Do nothing.
To change, go
to Settings.
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Receiver
Name
What it does
What you do
Battery Shows battery
level.
When low,
plug
micro USB
cable
into
receiver.
Plug
USB
into
the adapter and
then into
electrical outlet
(see Chapter
14).
Receiver Task Bar
Receiver Name What it does What you do
Task Bar: Complete Tasks
Task Bar
Goes to the
Main Menu,
enter BG meter
values, and
record Events.
Tap
applicable
icon
.
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Receiver
Name
What it does
What you do
Main Menu Goes to other
options.
Tap
Main Menu
icon to access:
• Alerts
• Settings
• Sounds
• Shutdown
• Start/Stop
Sensor
BG Meter
with red
circle and
number
Calibration
Prompt.
Tap
icon
and
enter fingerstick
BG value (see
Chapter 7).
BG Meter
without red
circle
No need to
calibrate. Do nothing.
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Receiver
Name
What it does
What you do
Events
Enter different
events,
capturing
activities
affecting your
glucose.
Tap
icon
to
enter data for:
• Carbs
• Insulin
• Exercise
• Health
(See Chapter
10).
Receiver Glucose Information
Receiver
Name
What it does
What you do
Glucose Information: Review
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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Receiver
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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Receiver
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: High
Alert setting
• Gray: Target
range
• Red: Low
Alert setting
or, if that’s
disabled, 55
mg/dL
(Urgent Low
Glucose
Alarm)
Tap
graph
for 1,
3, 6, 12, or 24-
hour trend
views.
Now that you’re familiar with the basic layout of the trend graph screen and
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.
Apple Watch
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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
Change Arrows 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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Change Arrows
What your glucose is doing
Rapidly Rising or Falling
Changing:
• More than 3 mg/dL each minute
• More than 45 mg/dL in 15 minutes
N/A 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(s), causing you to not 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.
Tap
OK
to clear message.
You will not get any sensor glucose readings or rate of change arrows on
either display device until the error is fixed. Check with your BG meter to
monitor your glucose during these error periods.
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Error Messages
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
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Receiver
N/A;
Bluetooth
is
always on.
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
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Smart Device:
In App
own and display sensor glucose
readings again.
If prompt stays for three hours:
Contact Technical Support (see
Chapter 16.1).
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 sensor
pod.
If not corrected:
• Contact Technical Support
(see Chapter 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
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Smart Device:
In App
reading outside the range of 40-400
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.
Smart Device:
In App
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If error messages don’t go away after you followed necessary steps, and you
Receiver
Contact Technical Support
(available 24/7) at:
• TechSupport@dexcom.co
m
• Toll free:
1.888.738.3646
• Toll call:
1.858.200.0200
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 fixed):
•
Tap
Settings
.
•
Tap
Bluetooth
.
•
Turn
Bluetooth
Off and
On.
Tap
OK
Tap
Settings
.
Turn
Bluetooth
Off
and On.
Smart Device:
In App
Receiver
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aren’t getting sensor glucose readings, contact Technical Support (see
Chapter 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
• Recognize error messages
What’s Next?
By now you have a pretty good understanding 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 G5 Mobile.
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Chapter 10
Next Steps - Getting the Most out of Your G5 Mobile:
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 the 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 G5
Mobile, 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.
Events Menu
Device
What you see
What it means
What you do
Carbs
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Device
What you see
What it means
What you do
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
Device
What you see
What it means
What you do
Insulin
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Device
What you see
What it means
What you do
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
Device
What you see
What it means
What you do
Exercise
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Device
What you see
What it means
What you do
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
Device What you see What it means What you do
Health
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Device What you see What it means What you do
Smart
Device:
In App
General well-
being.
Enter different
health Events
(see following
Health Events
Menu table).
Receiver
Device
What you see
What it means
What you do
Event Time
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Device
What you see
What it means
What you do
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.
Health Events Menu
Device What you see What it means
Health Main Menu
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Device What you see What it means
Smart
Device:
In App
Use Health Main Menu to access
selections.
Receiver
Device What you see What it means
Health Main Menu
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Device What you see What it means
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 meant to be 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.
Enter Events: Smart Device
In the G5 Mobile app, Events are just a tap away! The Event icon, a running
man, is on the app’s home screen’s 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: G5 Mobile App
Step What you see What you do
Enter Carbs Event
1
Tap
Events
icon
.
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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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4
Tap
Event Time
.
Enter Carbs Event
5
Scroll
and
select
date and time.
Tap
Done
.
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6
Tap
Save
or
Cancel
.
Enter Stress Event
7
Tap
Events
icon.
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8
Tap
Health
.
Enter Stress Event
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9
Tap
Stress
.
Tap
Done
.
10
Tap
Event Time
.
Enter Stress Event
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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.
Enter 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
Tap
Events
icon.
2
Tap
Carbs.
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3
Add up all carb grams from lunch. For
example, 85.
Tap
arrow
to “85.”
Tap
Done
.
Enter Carbs Event
4
Tap
Edit Date/Time
5
Tap
year/month/day
box
to select date.
Tap
up/down arrow
to change hour.
Tap
Minutes
to select them.
Tap
up/down arrow
to change minutes.
Tap
AM/PM
to select it.
Tap
up/down arrow
to change between
AM and PM.
Tap
Done
to save and close.
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6 Confirmation screen.
Tap
Save
.
Enter Health Event
7
Tap
Health.
8
Tap
Stress
Enter Health Event
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9
Tap
year/month/day
box
to select date.
Tap
up/down arrow
to change hour.
Tap
minutes
to select them.
Tap
up/down arrow
to change minutes.
Tap
AM/PM
to select it.
Tap
up/down arrow
to change between
AM and PM.
Tap
Done
to save and close.
10
Tap
Save.
10.4 Viewing Events
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.
Landscape What it does What you do
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Landscape Only
Shows Event
details.
Landscape Only
Tap
square.
Slide finger across
screen.
Once you have allowed your
Share
Follower’s access to 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
• Describe how to view Events entered via your receiver
What’s Next?
In the next chapter, you will learn about your trend’s Alarm and Alerts helping
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 - Getting the Most out of Your G5 Mobile:
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 or at the movies and can’t, or don’t want to, keep
looking at your display device?
The G5 Mobile 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 prompts 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 G5 Mobile. 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 your smart device settings let you get Alarm and Alerts.
To receive Alarm/Alerts you must:
1.
Make sure
G5 Mobile app Notifications are
turned
on
in Settings
menu.
2.
Verify
app hasn’t been shut down.
3.
Adjust
volume so you can hear sounds.
4.
Turn
Bluetooth
on.
5.
Turn off
Do Not Disturb
.
6.
Keep
G5 Mobile app running in the background.
7.
Restart
app after device is restarted.
Why:
Your app’s settings do not override phone settings.
Consequences: Missing severe low or high glucose Alarm or Alerts.
Warning
Don’t:
Never assume the G5 Mobile’s Alarm/Alert vibrations are different
from other vibrating apps.
Do:
Look at your smart device and check if vibration is a G5 Mobile Alarm
or Alert.
Why:
Medical device apps don’t have special priority over your smart
device’s features. You can’t determine if the vibration is coming from your
G5 Mobile app or another app.
Consequences:
Missing severe low or high glucose Alarm or Alerts.
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Warning
Do:
Disconnect headphones from your smart device when not in use.
Why:
If headphones are connected while not being used, you won’t hear
an Alarm or Alert.
Consequences:
Missing severe low or high glucose Alarm or Alerts.
Precaution
Don’t:
Never prevent communication between transmitter and display
devices.
Do:
Keep smart device and receiver within 20 feet of transmitter and away
from obstructions.
Why:
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 types have been tested. Obstructions
can include water, walls, metal, etc.
Water (for example, when swimming, surfing, bathing, etc.) can severely
limit communication range.
Consequences: Missing severe low or high glucose Alarm or Alerts.
Precaution
Do:
Set smart device and receiver settings separately.
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, you won’t get
an Alarm or Alert.
Consequences: Missing severe low or high glucose Alarm or Alerts.
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Precaution
Do:
Verify smart device and receiver are turned on.
Why:
Neither the receiver nor smart device will generate sensor glucose
readings, Alarm or Alerts if turned off.
Consequences:
Missing severe low or high glucose Alarm or Alerts.
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), which 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 do not 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 prompts, 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 prompts, 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/Signal Loss 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 G5 Mobile’s 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 tells
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 prompts look different on the display devices, they
reflect the same information.
After prompts, 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 Alert level.
Shows most current sensor
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Smart Device:
In App
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 Alert level.
Shows most current sensor
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Smart Device:
In App
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.
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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.
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Receiver
Signal Loss Alert
Device What you see What it means
Smart Device:
Lock Screen
Your receiver and
transmitter are not
communicating.
You will not receive
glucose readings or
Alarm/Alerts.
Check BG meter to
Smart Device:
In App
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Receiver
check your glucose and
make any treatment
decisions.
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 settings:
• When your smart device is on Silent, you’ll still receive Alarm/Alerts
visual prompts 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 G5 Mobile app can’t override the Do Not
Disturb setting
• If you don’t enable your G5 Mobile 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.
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
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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
or sensor glucose readings rises above Alert level.
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.or sensor glucose readings go below Alert
level.
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 rises rate 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 fall rate rises above Alert
level.
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Low Repeat/High Repeat
What you see
Beeps and vibration
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.
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
or sensor glucose reading drops below Alert level.
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, an 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
Tap
OK.
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
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• Describe the difference between an Alarm and an Alert
• Recognize different Alarm/Alert prompts and sounds
• Determine if signal loss is preventing you from getting an Alarm/Alert
• Describe recommended app settings
• Successfully clear an Alert
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 - Getting the Most out of Your G5 Mobile:
On the Go With G5: 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 Alerts prompts
o App
o Receiver
• Adjust Alarm sound prompts
• Set up other 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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Warning
Do:
If using both receiver and app to get an Alarm or Alert, change settings
in each display device.
Why:
Any changes to the G5 Mobile app will not carry over to the receiver.
Consequences:
Missing severe low or high Alarm or Alerts.
12.3 Changing App Alarm and Alerts
App Screen Overview
The Alerts Main Menu lists all customizable 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.
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 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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Step What you see What it means What you do
2
Access Alerts Main
Menu.
Tap
Alerts.
Changing an Alert
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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
Changing 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
Changes current
sound setting.
Tap
Door Bell.
Tap
Sound
again to
hear sound sample.
14
Saves your new Alert
sound.
Return 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 sounds) in the
Sounds menu.
Sounds
Sounds 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 sounds 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 10,
you learned how many beeps each Alarm/Alert has.
Normal
is the default setting for your receiver sounds.
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, 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
sound, 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 tapping
OK
on your screen.
The next table lists the different Sounds, starting with the quietest, working its
way up to the loudest.
Alarm/Alert Sounds
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Icon Sound Name Sound 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 Sound.
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 Glucose Alarm every 5
seconds until sensor glucose reading rises
above 55 mg/dL or is confirmed.
Try It
Sample sound setting before selecting.
This does not select your sound. To select
your sound, use the
Sounds
menu.
After choosing your sound, changing it is just a few steps away! Change your
sound throughout the day depending on what lies ahead: In a meeting? Select
Vibrate
. Going to a ball game after work? Select
Attentive
.
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The next table shows how to change your Sound, then hear a sample of it.
Customizing Alert Sounds: Receiver
Step What you see What it means What you do
1
Go to Main Menu.
Tap
Menu
icon.
2 Change your Sounds.
Tap
Sounds.
3 Choose one
.
Selected Sound
is
check marked.
Tap
your choice.
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Step What you see What it means What you do
4 Hear your Sound.
Sample Sound:
Tap
Try It
to
hear
selected Sound.
Exit Sound:
Tap
left arrow
.
5 Hear Sound for each
Alarm/Alert.
Tap
the
Alarm/Alert
to hear.
To Exit:
Tap
left arrow.
6 N/A Repeat as needed.
Repeat
steps 2-5 to
change Sound.
In the previous chapter, you learned clearing an Alert stops it from repeating.
If you want the Urgent Low Glucose Alarm to repeat until your glucose levels
are back above 55 mg/dL, turn on the
Hypo
Repeat
option.
Alerts Menu
The Alerts menu gives you options for personalizing your glucose level Alerts
and turning on your Rising/Falling and Signal Loss Alerts.
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Low and High
Adjust your Low and High Glucose Alert levels (mg/dL) along with turning on
and setting the time for the Repeat prompt.
Rise and Fall Rates
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 and Fall Rate Alerts 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 is
Off
for Repeat, Rise Rate, and Fall Rate.
It’s important that 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 alerted if your sensor
glucose readings have stopped due to a signal loss lasting 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 level from 200 mg/dL to 190 mg/dL, repeating every 60
minutes.
Follow these same steps for turning on the Rise/Fall Rate Alerts and adjusting
your Low Alerts.
Customizing Alerts: Receiver
Step What you see What it means What you do
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Step What you see What it means What you do
Change Low Alert Level
1
Go to Main Menu.
Tap
Menu
icon.
2 Alerts option from the
Main Menu.
Tap
Alerts.
3
Alert’s current
settings.
Change your current
Low Alert level.
Tap
Low.
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4 Current setting.
Tap
Level.
5
Saves new Low Alert
level.
Return to Alerts
Menu.
Tap
up/down
arrows
to change number.
To save and exit:
Tap
Save.
Turn On Repeat
6 Current setting is
updated.
Tap
Repeat
to have
the Alert keep
prompting you.
7
Initial screen shows
current repeat
minutes.
Change time frame in
15-minute
increments.
Tap
up/down
arrows.
Stop
at 60 minutes.
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8 Changed
Repeat
time for Low Repeat
Alert.
Tap
Save.
9 Change completed.
Return to
Alerts
Menu.
To exit:
Tap
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:
• Customize your glucose trend Low/High Glucose Alerts
o App
o Receiver
• Adjust Alarm sound
• Set up other Alerts
o Low/High Repeat
o Rise/Fall Rate
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o Signal Loss
What’s Next?
Believe it or not, you are becoming a pro at using your G5 Mobile! You’ve set
up the app and receiver, started a session, calibrated, followed your glucose
trends, paid attention to your Alarm/Alerts prompts, 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 G5 Mobile experience.
The next part, Part 4: Everything Else G5, reviews the technical specifications,
the warranty, how to take care of the G5 Mobile 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 G5
• Warranty
• Maintenance
• Travel Tips
• Customer Service Contacts
• Technical Information
• Troubleshooting
• Symbols on Package Labels
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Chapter 13
Everything Else G5:
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
G5 Mobile’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 G5 Mobile 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”):
G5 Mobile 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 Movile receiver.
To return, you must send the receiver to an authorized Dexcom Technical
Support Department. Make sure you package the receiver adequately for
shipping.
The return package needs to include:
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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
• Charges may apply:
1.858.200.0200
Upon receipt, Dexcom will promptly 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 G5 Mobile or any
feature or service provided by Dexcom for use with the G5 Mobile.
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.
This Limited Warranty is only provided to the original Purchaser and can’t be
transferred to anyone else, and states Purchaser’s exclusive remedy.
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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
G5 Mobile Transmitter Limited Warranty
What’s Covered and for How Long?
Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser
that the G5 Mobile 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:
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.
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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 G5 Mobile transmitter.
To return, you must send the transmitter to an authorized Dexcom Technical
Support Department. Make sure you package the transmitter adequately for
shipping.
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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
• Charges may apply:
1.858.200.0200
Upon receipt, Dexcom will promptly replace the defective transmitter.
If Dexcom determines the transmitter isn’t covered by this Limited Warranty,
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 G5 Mobile or any
feature or service provided by Dexcom for use with the G5 Mobile.
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 G5:
How to Take Care of Your G5 Mobile
14.1 Introduction
There are not a lot of moving parts in the G5 Mobile, 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
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. Receiver
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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:
Check for the receiver to briefly vibrate and beep shortly after you
power on or plug in to charge. If it doesn’t, please retry. If it still doesn’t
vibrate and beep, contact Technical Support.
To check, either plug it in, turn it on, or go to the Sounds menu and select
Try It. If it doesn’t vibrate and beep, contact Technical Support.
Use the app on your smart device until this issue is resolved.
Why:
If your receiver gets wet or dropped, make sure the speaker and
vibrations still work.
Consequences
: Missing severe low (hypoglycemia) or high
(hyperglycemia) Alarm or Alerts.
14.3 Basic Maintenance
Sensor
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 sensor has expired.
i. May provide inaccurate sensor glucose readings.
ii. May be unsterile.
Transmitter
1. Keep in box until ready for use.
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
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a. Protect transmitter by returning 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.
a. May get an electric shock.
b. Don’t open it. There are no serviceable parts inside.
2. Keep receiver dry—it is only splash resistant.
a. Don’t submerge in liquid.
b. Don’t spill fluids on receiver.
3. Use case to protect receiver from bumps and falls.
a. When putting case on, make sure the speaker holes align
with receiver’s speaker.
4. Keep battery charged.
a. Only use Dexcom USB charging/download cable.
5. Do not push anything into the small hole on the back of the receiver.
Charging Receiver’s Battery
The receiver’s status bar lets you see its battery level and prompts 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 two 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.
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
Low Battery Charge your battery.
2
Micro USB Port
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.
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Step What you see What it means What you do
5
Within 6 seconds,
receiver will beep
and vibrate briefly to
show the speaker
and vibration motor
are working.
Receiver vibrates
and beeps on plug-in
displays for 10
seconds, then home
screen.
Tap
Continue
or
wait 10 seconds.
If receiver doesn’t
vibrate and beep,
retry. If it still
doesn’t, call
Technical Support.
Use app until issue
is fixed.
Keep charging until
home screen
displays with battery
icon filled in.
The charge indicator
turns on while the
battery is charging.
6 Battery Charged
Unplug
wall charger
from outlet when
fully charged.
Accessories
1. Only use Dexcom-supplied parts (including cables and chargers).
a. Use of non–Dexcom-supplied parts may affect safety and
performance.
2. Insert cables only as directed.
a. Do not force cables in place.
3. Look at cables for signs of wear and tear. Do not use if worn or
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damaged.
There is no repair service available for any G5 Mobile 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 G5 Mobile correctly helps prevent system failures.
Sensor
1. Keep the sensor in its sterile packaging until you are ready to use it.
2. Store at temperatures between 36° F-77° 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 15%-85% 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.
Check CGM System Settings: App
Step What you see What it means What you do
1
Settings menu
Update:
• Insertion date
and time
• Last calibration
date, time, and
value
• Transmitter
battery life
• Transmitter SN
• Receiver SN
• Receiver battery
life
• Part number
• Part revision
• Software
number
2
Device information
menu
Check:
• Insertion time
• Last calibration
• Software
number and
revision
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Check CGM System Settings: Receiver
Step
What you see
What it means
What you do
1
Settings menu
Tap
Device Info
2 Device Information
menu
Check:
• Transmitter SN
• Part number
and revision
• Firmware and
Software
numbers
• Transmitter
battery life
14.6 System Disposal
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 G5 Mobile is pretty easy. In the next chapter, “On the Go
With G5 Mobile: Getting Through Security,” you’ll learn how simple it is to
travel the world with your G5 Mobile!
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Chapter 15
Everything Else G5:
On the Go With G5 Mobile: Getting Through Security
15.1 Introduction
G5 Mobile 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 G5 Mobile. It doesn’t cover steps you need to
take when traveling with your smart device. See your smart device’s
instructions 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 G5 Mobile
components
• Identify when your display device(s) can be on during a flight
• Contact TSA directly with your security questions
15.2 Safety Statements
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Precaution
Don’t:
Never bring the G5 (sensor applicator, transmitter, and receiver) into
an AIT body scanner (airport body scanner).
Never put any part of the G5 in the baggage x-ray machine.
Do:
Request hand-wanding or full-body pat-down and visual inspection
instead.
Why:
The system has not been tested in AIT scanners.
Consequences
: Missing severe low (hypoglycemia) or high
(hyperglycemia) Alarm or Alerts.
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 hand-wanded without
worrying about damaging your transmitter or sensor.
If you’re concerned or uncomfortable about walking through the metal
detector, the Transportation Security Administration (TSA) requests you tell
the Security Officer 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 G5 Mobile components through x-ray machines.
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Before your screening process begins, ask the TSA Officer to perform a visual
inspection of the receiver and your extra sensors. Place all G5 Mobile
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
The G5 Mobile System is an M-PED (Medical-Portable Electronic Device) that
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
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Phone: 1.866.289.9673
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Chapter 16
Everything Else G5:
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
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 it 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 devices (for example,
sensor)
• Your preferred contact method and information so Dexcom can reach
you if needed. For example: by phone 555-555-5555 after 5 PM
Pacific Time
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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
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:
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dexcom.com/web-based-education.
By Phone
Available Monday-Friday 5:30 AM-8:00 PM PST (subject to change)
Dexcom Patient Care Team phone numbers:
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
By Phone
Dexcom Inside Sales Support phone numbers:
Toll free:
1.888.738.3646
Toll call:
1.858.200.0200
By Fax
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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 G5:
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)
Original Pediatric Study: the receiver included software version SW10050
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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
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
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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
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,
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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. Because
the system does not display glucose values below 40 mg/dL or above 400
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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
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.
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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).
*
For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included
instead of percent differences (%).
Table 4-B. System Difference to YSI Within CGM Glucose Ranges (Pediatric)
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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
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
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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
Differences
Median
Absolute
Percent
Differences
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
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
Differences
Median
Absolute
Percent
Differences
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
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
Differences
Median
Absolute
Percent
Differences
Percent
Within
15/15%
SMBG
Percent
Within
20/20%
SMBG
Percent
Within
30/30%
SMBG
Percent
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.
2
Both sets of study data are presented and are labeled as
Original
(SW10050) or
Software 505
(SW10505).
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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
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.
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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.
17.2 Product Specifications
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User is the single use operator in the home environment.
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 and Transport
Conditions
Temperature: 36° F-77° F
Humidity: 15%-85% RH
Sterilization
Sterile by radiation
Transmitter Product Specifications
Part Number
9438-06
Dimensions (Including
Sensor Pod)
Length: 1.5 inches
Width: 0.9 inches
Thickness: 0.5 inches
Weight (Including Sensor
Pod)
0.4 ounces
Power Supply
Silver oxide batteries (not replaceable)
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Part Number
9438-06
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 and 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 G5 Mobile 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 9438-06) 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
MT22949
Reading Frequency
Every 5 minutes
Dimensions
Length: 4.0 inches
Width: 2.5 inches
Thickness: 0.55 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
4.0 ounces
Receiver Input
5V DC, 1A
Power Supply
MT23681
Communication Range
20 feet
Memory Storage
30 days of glucose data
7 days of tech support data
Re-Chargeable Battery Use
2 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 and
Transport/Operating
Conditions
Temperature: 32° F-104° F
Humidity: 15%-95% RH, (Storage/Transport 10%-95% RH)
Operating Altitude
-1,200 feet to 13,500 feet
Medium Priority Alarm
Audible Output
50 dBSPL at 1 meter
Moisture Protection
IP22: Vertically falling drops
Protection against insertion of large objects and dripping water
Limited Warranty
1 year
Safety 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.
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The receiver (MT22949) 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
U
T)
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.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
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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.
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.
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
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(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 propagation
is affected by absorption and reflection from structures, objects and people.
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USB Charging/Download Cable* Specifications
Part Number
MT20655
OEM Number
P-HJX-00110
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 unplugging charger from wall.
Power Supply/Charger Specifications
Part Number
MT23681
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:
• G5 Mobile transmitter: PH29715
• G5 Mobile receiver: PH29949
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 G5:
Troubleshooting
18.1 Introduction
Sensor pod adhesive not sticking? Prompt 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 prompts, 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.
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 inaccurate
sensor glucose readings.
Consequences:
Missing severe low (hypoglycemia) or high
(hyperglycemia) Alarm or Alerts.
Precaution
Do:
Enter the exact BG value displayed on your BG meter within five
minutes of a carefully performed fingerstick measurement
.
Why:
Entering the wrong BG values, or waiting more than five minutes
before entry, might affect sensor accuracy.
Consequences: You may miss a severe low or high glucose event.
Precaution
Don’t:
Never prevent communication between transmitter and display
devices.
Do:
Keep smart device and receiver within 20 feet of transmitter and away
from obstructions.
Why:
If your transmitter 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 types have been tested. Obstructions
can include water, walls, metal, etc.
Water (for example, swimming, surfing, bathing, etc.) can severely limit
communication range.
Consequences: Missing severe low or high Alarm or Alerts.
18.3 Troubleshooting
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No Alarm/Alerts or Glucose Readings
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
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Device
What you see
Problem What you do
BG Meter
Sensor
readings and
BG meter
glucose values
often don’t
show the
same.
See Chapter 7.
Differences are not
uncommon.
Readings from different
body fluids reflect
different numbers:
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.
Smart
Device:
In App
Receiver
Device
What you see
Problem What you do
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Device
What you see
Problem What you do
Smart
Device:
In App
Not getting
sensor glucose
readings.
See Chapter 9.
Don’t
calibrate.
Wait
for more prompts.
System may correct
problem itself and
continue to provide
sensor glucose
readings.
3 hours since last
sensor reading:
Contact
Technical
Support (see Chapter
16).
Receiver
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
the sensor pod?
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).
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
display 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 fixed):
1.
Go
to
Settings.
2.
Tap
Bluetooth
.
3.
Turn
Bluetooth
Off and On.
App/Receiver:
If this continues for
more than 3 hours,
contact Technical
Support (see Chapter
16).
Receiver
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Device
What you see
Problem What you do
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 initial calibration.
Receiver
Applicator
Picture
Problem
What you do
Safety lock
stuck.
See Chapter 6.
•
Pull
safety lock
straight out:Away
from your body
• Follow direction of safety lock
up
arrow
Collar
won’t pull
up.
See Chapter 6.
Use
force when pulling the collar up.
Check
white plunger
is completely
down—flush to the applicator barrel.
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Picture
Problem
What you do
Can’t
remove
transmitter
latch.
See Chapter 6.
Don’t pull it straight off.
Hold
sensor pod
with one hand.
Twist
transmitter latch
with other hand
to break transmitter latch off.
Sensor pod
won’t stick.
Put
medical tape over sensor pod’s
white adhesive patch (for example,
Blenderm).
Don’t
place tape over the transmitter.
Hardware Error
Device
What you see
Problem What you do
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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 three hours.
Receiver
After full
charge
session:
Won’t turn on.
See Chapter 4.
Reset
receiver
:
1.
Press and hold
power button
for
10 seconds
2.
Release
power
button
3.
Press and hold
for 2 seconds to
turn back on
Connect
receiver
to
charger
.
Receiver will turn on.
Processing screen
appears.
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Device
What you see
Problem What you do
Receiver
Power on or
plug in
receiver but
don’t get beep
or vibration.
Don’t hear or
feel
Alarm/Alerts
or prompts.
Retry.
If it doesn’t beep
and/or vibrate again,
contact Technical
Support (See Chapter
16.1).
You may not hear or feel
Alarm/Alerts or prompts.
Use app until issue is
fixed.
Receiver
Receiver low
battery prompt
and icon.
See Chapter 4.
Charge
receiver
.
Receiver
Loading
screen
displays
unexpectedly.
Wait
a few seconds for
System Check Passed
or Contact Technical
Support Error screen
(see next rows).
Device
What you see
Problem
What you do
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Device
What you see
Problem What you do
Receiver
System check
results (xxxxx
displays as a
code).
See Chapter 16.
Do nothing.
Receiver is able to
continue to work and
recover from an error.
Tap
OK
to clear Alert.
If the same code
displays repeatedly,
write down the error
code and contact
Technical Support. (see
Chapter 16.1) Use BG
meter for BG reading
until resolved.
Receiver
Repeated
hardware
error.
See Chapter 16.
This locks your screen.
Write
down
error code.
Contact Dexcom
Technical Support (see
Chapter 16.1)..
Check
BG value using
BG meter.
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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
display until
error is
resolved.
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.
Receiver
:
Wait
15 minutes.
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Device
What you see
Problem What you do
Receiver
for a possible
reason).
No sensor
readings,
Alarm/Alerts or
notifications
display until
error is fixed.
Enter
1 calibration.
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.
Contact Technical
Support to report error
(see Chapter 16.1).
Device
What you see
Problem
What you do
Smart
Device:
In App
System didn’t
accept recent
calibration.
No sensor
readings,
Alarm/Alerts or
notifications
display until
error is fixed.
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
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Device
What you see
Problem What you do
Receiver
display, the sensor
needs to be replaced.
Contact
Technical
Support (see Chapter
16.1) to report error.
Transmitter Error
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
display until
error is fixed.
Contact Technical
Support (See Chapter
16).
Use BG meter for BG
reading.
You won’t get
additional alerts after
clearing.
Receiver
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Device
What you see
Problem What you do
Smart
Device: In
App
Pairing failed.
No sensor
readings,
Alarm/Alerts or
notifications
display until
error is fixed.
See Chapter 6.
Sensor may not be
inserted correctly.
Insert a new sensor.
For a replacement,
contact Technical
Support (see Chapter
16.1).
Receiver
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 low
battery prompt.
Order a new
transmitter.
Receiver
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Chapter 19
Everything Else G5:
Symbols on Package Labels
The following symbols may be found on the sensor, transmitter, and receiver
packaging. These symbols tell you about the proper and safe use of the G5
Mobile 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
Humidity Limitation
Input
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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
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5
SHARING IS CARING
• Dexcom
Share
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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 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.
BG 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
Share
Cloud
A secure online storage server where Dexcom
Share
feature information is stored and then shared
with Followers.
Dexcom Follow App
A software program that gets the Sharer’s glucose
information and prompt data from the Dexcom
Share
Cloud.
Dexcom
Share
A secondary notification system using the following
parts:
• Dexcom G5 Mobile System
•
Bluetooth
wireless technology
• Sharer’s smart device
• G5 Mobile app
• Internet
• Follower’s smart device
• Dexcom Follow app
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 Sharers.
Follower’s Smart
Device
Runs the Dexcom Follow app.
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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.
Hyperglycemia
High BG. Same as “high.”
The Default High Glucose Alert in the G5 Mobile is
set to 200 mg/dL.
Consult your healthcare professional to determine
the appropriate hyperglycemia setting for you.
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Hypoglycemia
Low BG. Same as “low.”
The Default Low Glucose Alert in the G5 Mobile is
set to 80 mg/dL.
Consult your healthcare professional to determine
the appropriate hypoglycemia 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
Prompt
Prompts the Follower when the Sharer is unable to
share glucose information.
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.
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Profile
Located in Follow Dashboard and displays the
Sharer’s glucose information, trend arrow, and
profile picture.
Prompt
A visual message that appears on the screen of the
Follower’s smart device. Prompt may also include a
sound, depending on the smart device’s settings.
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 G5 Mobile app and the
Dexcom Follow app.
Repeat
Amount of time the Follower chooses before he/she
wishes to receive a repeated notification.
Sensor Glucose
Reading
A glucose measurement taken by the G5 Mobile.
Sharer
The person who uses the G5 Mobile.
Sharing
The act of electronically transmitting glucose
information from the Sharer’s smart device to the
Follower’s smart device.
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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
receiver.
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.
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20.2 Dexcom
Share
Overview
Dexcom
Share
is a feature within the G5 Mobile app. It allows for remote
monitoring from one person, the Sharer, to another person, the Follower, of
G5 Mobile data.
Dexcom
Share
includes:
• G5 Mobile System
• Sharer’s smart device
• G5 Mobile app
• Internet connection
• Follower’s smart device
• Dexcom Follow app
You cannot use the
Share
feature with the receiver.
Once the Sharer activates the G5 Mobile app
Share
feature, 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.
Figure 8. Sharing
The Sharer must be within 20 feet of the smart device in order to send data to
the Follower or it will not work.
Dexcom
Share
Parts
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Sharer’s smart device*1
Follower’s smart device*1
G5 Mobile app
Dexcom Follow app
G5 Mobile transmitter*
G5 Mobile/G4 PLATINUM 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.
Conditions Affecting Use
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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
• Sharer’s smart device has Internet connection
• Notifications turned on. If turned off, Follower won’t receive any
notifications
• Follower’s smart device has an Internet connection
Dexcom recommends charging the smart device while sharing.
20.3 Risks and Benefits
Risks
Dexcom
Share
is a feature of the G5 Mobile . The main risks involved with
using the Dexcom
Share
feature are based on misunderstanding its purpose.
Remember that the Dexcom
Share
feature in the G5 Mobile 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.
G5 Mobile:
Use the G5 Mobile 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 G5 Mobile 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 the patients 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 alert 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 G5 Mobile Alarm, Alerts, 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 (Dexcom G5 Mobile System) 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 G5 Mobile user guide. Dexcom
Share
is a feature of the G5 Mobile.
If you do not have the Dexcom G5 Mobile System User Guide, you can view it
on dexcom.com or call
1.888.738.3646
to request a copy. Availability hours:
Monday-Friday, 6am-6pm 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 the Dexcom G5 Mobile System 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 G5 Mobile receiver as the main device to track sensor
glucose information, notifications and Alarm.
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 alert 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 G5
Mobile app is reopened after the smart device is turned back on in order to
resume sharing. If the G5 Mobile 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 G5 Mobile 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.
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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.
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:
• Let you know when the Follower is not receiving your sensor glucose
readings and information
Tips
• Read the rest of the G5 Mobile 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 G5 Mobile 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 G5 Mobile app to use Dexcom
Share
.
2
Launch the G5 Mobile 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
3
Message about
Internet access.
Tap
Next
.
4 How to know you
are sharing your
data.
Tap
Next
.
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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 smart device.
Tap
Next
.
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Step What you see What you do
3
Tap
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 sensor glucose
Alarm/Alerts.
Choose
if you want your Follower to get
prompts if not receiving your sensor glucose
readings.
Select
what Alarm/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
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
tab on the
Share
status
screen.
Invite
up to a total of five (5) Followers.
20.6 Using Dexcom
Share
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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.
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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 grayed out
Share
icon
when it 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.
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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 G5 Mobile
display device for your sensor glucose readings and Alerts.
All treatment decisions must be based on your BG value from your BG meter.
Share
Status Troubleshooting Tips
What you see What it means What you do
Green Check:
All connections are
working
N/A.
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What you see What it means What you do
Issue with:
• Sharer’s CGM
data
• Your smart
device
The Sharer should make
sure:
• There is a
glucose value on
the smart device
• Transmitter is in
range of the
smart device
• To
tap
on blue
“?”
to learn more
about how to
troubleshoot this
issue
• To allow up to 10
minutes for
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 make
sure:
• Their Wi-Fi or
cellular
connection is On
• They are in an
area that has
cellular reception
• They are not on a
voice call
• They can access
the web via a
browser
• To check later or
follow up with
their Internet
connectivity
provider
• To
tap
on blue
“?”
to learn more
about how to
troubleshoot this
issue
Followers List
The Followers list allows the Sharer to manage 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 current Followers have
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Icon/Status
What you see What it means
Invite a new Follower.
Follower is set to get prompts 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 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 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, that Follower won’t get glucose information or
Alarm/Alerts.
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NOTE:
The Sharer cannot change any Follower settings after the Follow
Invitation email is sent.
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
saying the Sharer’s data has been 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. Followers
only need to download and install the Dexcom Follow app.
What the Dexcom Follow app does:
• Allows the Follower to view the Sharer’s glucose information
• Allows the Follower to get Alarm and Alerts
• Allows the Follower to view the Sharer’s trend graph
What the Follow 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 app
on smart device.
Glucose Alarm and Alerts
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A glucose prompt is a visual message saying “Glucose notification from
[Sharer’s name]” that appears on the screen of the Follower’s smart device.
The prompt may include sounds, depending on the smart device’s settings.
Types of prompts Followers get:
• Low Sensor Glucose Reading
• Urgent Low Glucose Alarm (< 55 mg/dL)
• High Sensor Glucose Reading
The Follower can change some of the initial settings to fit his/her needs. The
Follower cannot change the Sharer’s permission settings to see the trend
graph.
Sharer Status Changes That Notify the Follower
Some Sharer status changes will prompt the Followers.
•
Not Sharing
- Sharer decides to temporarily stop sharing
•
Removed by Sharer
- Sharer removes Follower
•
No More Data
- Prompt sent when active glucose sharing is stopped
for any reason, other than the Sharer turning
Share
“Off”
o The Follower should contact the Sharer for more information
about the data interruption
The Follower Dashboard
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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
If the Sharer chooses to have the Follower see the trend graph, he/she will
see:
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20.8 Troubleshooting
Dexcom
Share
Troubleshooting
Troubleshooting Status - See the “Troubleshooting Status Issues” portion of
Chapter 20.6.
Figure 14. Sharing Status Troubleshooting
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 G5 Mobile 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 prompts
• Smart device is sufficiently charged or charging
• Smart device is within 20 feet of the transmitter
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• Smart device has 35 MB of available memory
Refer to the smart device user manual for further instructions
Tips
• Read the G5 Mobile user guide before using the Dexcom
Share
feature
• Always confirm information with a BG meter before you make
treatment decisions
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6
INDEX for G5 MOBILE AND
DEXCOM
SHARE
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© 2016 Dexcom, Inc. All rights reserved.
Covered by patents www.dexcom.com/patents.
Dexcom, Dexcom Follow, Dexcom G4, Dexcom G4 PLATINUM, Dexcom G5,
Dexcom G5 Mobile, Dexcom
Share
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.
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Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
Phone:
1.858.200.0200
Technical Support:
1.888.738.3646
Web: dexcom.com
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