Dexcom 9496 Spread Spectrum Device User Manual Part 1

Dexcom, Inc. Spread Spectrum Device Part 1

1. User Manual Part 1
2. User Manual Part 2

User Manual Part 1

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CONTINUOUS GLUCOSE
MONITORING SYSTEM
User Guide
IMPORTANT CONTACTS AND NUMBERS
Emergency Phone Number:_______________________________________________
Your Healthcare Professional:______________________________________________
Your Receiver Serial Number:______________________________________________
Your Transmitter Serial Number:____________________________________________
___________________________________________________________________
1.877.339.2664
Dexcom® Technical Support/Patient Care Team:________________________________
dexcom.com
Dexcom Website:_______________________________________________________
Nearest Hospital:_______________________________________________________
___________________________________________________________________
Table of Contents
Part 1: Getting Started
Glossary
Chapter 1 - Beginning Your Dexcom G5®
Mobile Continuous Glucose Monitoring
(CGM) System Journey
1.1 Introduction. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . 9
1.2 Self-Paced Resources. . . .. . . . . . . . . . . . . . . . 10
1.3 Your Dexcom Account.. . . .. . . . . . . . . . . . . . . . 12
Chapter 2 - Indications for Use and Safety
Statement
15
2.1 Introduction. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . 15
2.2 Important User Information. . . . . . . . . . . . . . . 15
2.3 Safety Statements. . . . . . . .. . . . . . . . . . . . . . . . 16
2.4 Overview of Safety Statements.. . . . . . . . . . 17
2.5 General CGM System Warnings. . . . . . . . . . 20
2.6 Calibration Warning and Precautions.. . . . 20
2.7 System/Hardware/Software Warnings and
Precautions.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Chapter 3 - Risks and Benefits
29
3.1 Risks... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.2 Benefits.. . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . 30
Part 2: Let’s G5®! The Basics
Chapter 4 - What Is the Dexcom G5 Mobile
CGM System?
35
4.1 System Description. . . . . . . . . . . . . . . . . . . . . . . 35
4.2 Safety Statement.. . . . . . . . . . . . . . . . . . . . . . . . . 35
4.3 The Dexcom G5 Mobile CGM System. . . . 36
4.4 What’s New to the Dexcom G5 Mobile
CGM System?. . . . . . . . . . . . .. . . . . . . . . . . . . . . .38
4.5 System Information. . . . . . .. . . . . . . . . . . . . . . . 39
4.6 System Components. . . . . .. . . . . . . . . . . . . . . . 39
4.7 Smart Device Overview. . . . . . . . . . . . . . . . . . .48
Chapter 5 - Set up Your Display Devices.... 49
5.1 Introduction. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . 49
5.2 Safety Statement.. . . . . . . . . . . . . . . . . . . . . . . . . 49
5.3 Why Different Monitoring Methods?. . .... 50
5.4 Dexcom G5 Mobile App. .................. 50
5.5 Dexcom G5 Mobile Receiver..............63
Chapter 6 - Starting a Sensor Session:
Inserting Sensor, Transmitter, and Starting
Your Session
69
6.1 Overview.................................. 69
6.2 Safety Statements. ....................... 70
6.3 Prepping for Sensor Insertion............. 72
6.4 Choosing Your Insertion Site. . ............ 75
6.5 Inserting Your Sensor. .................... 76
6.6 Attaching Your Transmitter............... 80
6.7 Loose Sensor Pod. ........................ 81
6.8 Starting Your Sensor Session............. 82
6.9 Receiver Bluetooth® Tips. ................86
6.10 Sensor Session Warmup..................90
Chapter 7 - Calibration
91
7.1 Introduction............................... 91
7.2 Calibration Overview...................... 92
7.3 Safety Statements. ....................... 93
7.4 When to Calibrate. ........................ 95
7.5 Calibration Prompts.......................96
7.6 Preparing for Calibration................ 100
7.7 Ready? Set? Calibrate!.................. 100
7.8 Calibration Errors....................... 106
Chapter 8 - Ending Your Sensor Session and
Transmitter Session
109
8.1 Introduction............................. 109
8.2 Safety Statements. ..................... 110
8.3 Ending Your Sensor Session............ 110
8.4 Remove Sensor Pod and Transmitter.. . 124
8.5 End of Transmitter Battery.............. 126
Part 3: Next Steps - Getting the Most
out of Your Dexcom® CGM
Chapter 9 - Home Screen, Rate of Change
Arrows, and Errors
133
Dexcom G5 Mobile System User Guide
Table of Contents
9.1
9.2
9.3
9.4
9.5
Introduction to Home Screens. . . . . . . . . .
Safety Statements. . . . . . . .. . . . . . . . . . . . . .
Overview of Home Screen.. . . . . . . . . . . . .
Rate of Change Arrows.. . . . . . . . . . . . . . . .
Error Messages. . . . . . . . . . .. . . . . . . . . . . . . .
133
133
134
146
147
Chapter 10 - Daily Events Affect Your
Glucose Trends and Patterns
10.1 Introduction. . . . . . . . . . . . . . .. . . . . . . . . . . . . .
10.2 What Is an Event?.. . . . . . . . . . . . . . . . . . . . . .
10.3 Entering Events.. . . . . . . . . . . . . . . . . . . . . . . . .
10.4 Viewing Events. . . . . . . . . . . . . . . . . . . . . . . . . .
153
153
153
162
170
Chapter 11 - Sensor Glucose Alarm and
Alerts
11.1 Introduction. . . . . . . . . . . . . . .. . . . . . . . . . . . . .
11.2 Safety Statements. . . . . . . .. . . . . . . . . . . . . .
11.3 Alarm and Alerts. . . . . . . . . .. . . . . . . . . . . . . .
11.4 Alarm and Alerts Screens.. . . . . . . . . . . . . .
11.5 App: Alarm/Alert Recommended
Settings.. . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . .
11.6 Receiver: Default Beeps and
Vibrations.. . . . . . . . . . . . . . . . .. . . . . . . . . . . . . .
11.7 Clearing Alarm/Alerts.. . . .. . . . . . . . . . . . . .
173
173
174
175
177
183
184
188
Chapter 12 - On the Go With G5: Customizing
Your Alarm and Alerts
191
12.1 Introduction. . . . . . . . . . . . . . .. . . . . . . . . . . . . . 191
12.2 Safety Statement.. . . . . . . . . . . . . . . . . . . . . . . 192
12.3 Changing App Alarm and Alerts. . . . . . . . 192
12.4 Changing Receiver Alarm and Alerts. . . 204
Part 4: Everything Else G5
Chapter 13 - Warranty: The Fine Print
215
13.1 Introduction. . . . . . . . . . . . . . .. . . . . . . . . . . . . . 215
13.2 Receiver Warranty Information. . . . . . . . . 215
13.3 Transmitter Warranty Information.. . . . . 217
13.4 Dexcom’s Obligations Under the Limited
Warranty.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
Chapter 14 - How to Take Care of Your
Dexcom G5 Mobile CGM System
221
14.1 Introduction. . . . . . . . . . . . . . .. . . . . . . . . . . . . . 221
14.2 Basic Maintenance. . . . . . . . . . . . . . . . . . . . . . 222
14.3 Storage. ................................. 226
14.4 Checking App and Receiver
Information.............................. 227
14.5 System Disposal........................ 228
Chapter 15 - On the Go With Dexcom G5
Mobile CGM System: Getting Through
Security
229
15.1 Introduction............................. 229
15.2 Going Through Security................. 229
Chapter 16 - Need Help? You’re Not
Alone!
233
16.1 Dexcom Technical Support. ............ 233
16.2 Patient Care Team...................... 234
16.3 Sales Support Team..................... 235
16.4 Corporate................................ 235
Chapter 17 - Technical Information
237
17.1 Device Performance Characteristics... 237
17.2 Product Specifications. ................. 275
17.3 FCC Requirements. ..................... 283
Chapter 18 - Troubleshooting
285
18.1 Introduction............................. 285
18.2 Safety Statements. ..................... 285
18.3 Troubleshooting. ........................ 287
Chapter 19 - Symbols on Package Labels 299
Part 5: Sharing Is Caring
Chapter 20 - Dexcom Share™
303
20.1 Learning About Dexcom Share......... 303
20.2 Dexcom Share Overview................ 307
20.3 Risks and Benefits...................... 309
20.4 Safety Statement........................ 310
20.5 Setting up Dexcom Share. . ............. 313
20.6 Using Dexcom Share. ................... 323
20.7 Dexcom Follow™ App. .................. 328
20.8 Troubleshooting. ........................ 330
Index
333
Dexcom G5 Mobile System User Guide
Table of Contents
GETTING STARTED
•
Glossary
•
Getting Started
•
Indications for Use and Safety Statement
•
Risks and Benefits
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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
A device that connects with and extends a smart device. Such a
device requires the smart device connection for full functionality.
Examples are a smart watch or a Bluetooth headset.
Also see the Apple Watch and Smart Watch entries in this
glossary.
Alternative Site
Testing
Using a blood sample from non-fingertip (alternate) 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, only use fingerstick measurement.
App
A self-contained program or piece of software designed to fulfill a
particular purpose; an application, especially as downloaded by a
user to a smart or mobile device.
The Dexcom G5 Mobile App was developed as a display for
continuous glucose monitoring.
Apple Watch
A specific smart watch that is compatible with iPhones only.
The Apple Watch is considered an accessory device as it
requires an active connection with the iPhone to have full
functionality.
Also see the Accessory Device and Smart Watch entries in this
glossary.
Blood Glucose (BG)
Value
BG is an abbreviation of blood glucose. Blood glucose value is the
amount of glucose in the blood measured by a BG meter.
Blood Glucose
Meter/Meter/BG
Meter
A blood glucose meter is a medical device used to measure how
much glucose is in the blood.
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Dexcom G5 Mobile System User Guide
Glossary
(Continued on next page)
Calibration
Calibration is 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 the sensor glucose reading is on
track.
Continuous
Glucose
Monitoring (CGM)
Continuous glucose monitoring (CGM) systems use 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 Dexcom
G5 Mobile should not be used because it may be harmful to you. The
risk of use clearly outweighs any possible benefit.
Hyperglycemia
High blood glucose. Same as “high” or high blood sugar.
Hyperglycemia is a 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 alert in the Dexcom G5 Mobile CGM System is set
to 200 mg/dL. Consult your healthcare professional to determine the
appropriate hyperglycemic setting for you.
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Dexcom G5 Mobile System User Guide
Glossary
(Continued from previous page)
Hypoglycemia
Low blood glucose. 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 alert in the Dexcom G5 Mobile CGM System is set
to 80 mg/dL. Consult your healthcare professional to determine the
appropriate hypoglycemic setting for you.
Indication
A condition making a particular treatment or procedure advisable.
How, for what purposes, and under what circumstances you should
use the Dexcom G5 Mobile CGM System. Indications let you know
who should use the Dexcom G5 Mobile CGM System and when.
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.
Jailbroken
The removal of limitations and security measures set by the
manufacturer on a smart device. The removal poses a security risk
and data may become vulnerable.
Do not use, install or run the Dexcom G5 Mobile App on a jailbroken
smart device. The app may not work correctly on a jailbroken smart
device.
Landscape
If your smart device is oriented sideways.
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Dexcom G5 Mobile System User Guide
Glossary
(Continued from previous page)
mg/dL
Milligrams per deciliter. The standard unit of measure for glucose
readings in the United States.
Portrait
If 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 Dexcom G5 Mobile CGM System.
RF
Radio-frequency transmission used to send glucose information
from the transmitter to the receiver or smart device.
Safety Statement
A statement of the intended uses of Dexcom G5 Mobile
CGM System 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
A smart/mobile device is an electronic, mobile device that can
wirelessly connect to networks over Wi-Fi or a cellular data
connection (3G, 4G, etc.).
Examples of smart/mobile devices are smartphones and tablets.
Smart Watch
A watch that communicates with and extends a smart device.
These devices typically require a smart device connection for full
functionality. An example is the Apple Watch.
Also see the Apple Watch and Accessory Device entries in this
glossary.
Today View
A feature found on iOS smart devices used to quickly access
information from any activity or from the lock screen. Access by
swiping down from the top edge of your device.
Warning
A safety statement letting you know the following feature
has important hazard information. Describes serious and life
threatening circumstances of using the Dexcom G5 Mobile CGM
System, their consequences, and how to avoid the hazard.
Dexcom G5 Mobile System User Guide
Glossary
Chapter 1
Getting Started:
Beginning Your Dexcom G5 Mobile Continuous
Glucose Monitoring (CGM) System Journey
1.1 Introduction
Welcome to the Dexcom 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 Dexcom G5 Mobile CGM System allows
you to break free from constant fingersticks. But how do you use the Dexcom G5 Mobile
CGM System? 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 Dexcom G5 Mobile CGM System in your diabetes
management
• Find Dexcom 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 to get the most out of your Dexcom
G5 Mobile CGM System. Between our self-paced training resources and our friendly and
knowledgeable Dexcom customer support teams, help is always available.
First Things First - Learning How to Learn
Knowing about the Dexcom G5 Mobile CGM System 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 Dexcom G5 Mobile
CGM System:
Dexcom G5 Mobile System User Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
1. Tutorials
2. Quick Start Guide
3. User Guide
No matter which resource you select, make sure you review them prior to using your new
CGM system.
1.2 Self-Paced Resources
Tutorials
Along with step-by-step instructions, our tutorials illustrate how real-time CGM can assist in
your daily diabetes management. The following is a list of tutorials and how to access them.
Online Tutorials
First Steps With Your Dexcom CGM
Designed for those who have never used a Dexcom CGM. This tutorial covers what to expect
in your first week and includes links to step-by-step videos on how to insert your sensor,
calibrations, ending a sensor session, etc.
Next Steps With Your Dexcom CGM
Just finished First Steps or already familiar with how a CGM can benefit you? This
tutorial covers looking at trends and introduces some advanced features including our
reporting tools.
Accessing Online Tutorials:
From dexcom.com homepage, click Support, click Training.
Once you have viewed the online tutorials you should be pretty comfortable with what CGMs
do and how the Dexcom G5 Mobile CGM System 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.
Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
10
Written Mobile Resources
Quick Start Guide (QSG)
The Dexcom G5 Mobile Quick Start Guide compliments the tutorials by proving the same
step-by-step instructions in a booklet form or within the app.
One of the great things about the QSG is you can use it in conjunction with the videos, taking
notes as you go!
Accessing the QSG:
Booklet in the receiver package.
Both the tutorial and the QSG give you brief look at the Dexcom G5 Mobile CGM System. But
what if you want more detailed information?
User Guide
Your Dexcom G5 Mobile CGM System reference book!
This user guide gives you the most extensive overview of the system detailing features,
important safety information and so much more.
To download an ebook of the user guide or request a printed user guide, visit
dexcom.com/guides.
The Dexcom G5 Mobile User Guide is grouped into six separate parts:
Part 1: Getting Started
1. Glossary
2. Getting Started
a. Learning how to learn about the Dexcom G5 Mobile CGM System
b. Registering at dexcom.com
3. Indications for Use and Safety Statement
4. Risks and Benefits
Part 2: Let’s G5®! The Basics
1. Introduction to the Dexcom G5 Mobile CGM System
2. Choose and Set up Your Display Device(s)
3. Initiating a Sensor Session: Inserting the Sensor & Transmitter
4. Calibration
5. End a Sensor Session
Dexcom G5 Mobile System User Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
11
Part 3: Next Steps - Getting the Most out of Your Dexcom CGM
Once you are up and running, how you can maximize the Dexcom G5 Mobile features:
1. Reading Trend Graph Screens and Recognizing Trends
2. Events
3. Alarm and Alerts
4. Sounds for Alarm, Alerts and System Messages
Part 4: Everything Else G5
1. Warranty
2. Dexcom G5 Mobile CGM System Maintenance
3. Travel Tips
4. Customer Service Contacts
5. Technical Information
6. Troubleshooting
7. Package Label and Product Symbols
At the end of your Dexcom G5 Mobile System User Guide, Part 5, is the user guide of a new
Dexcom G5 Mobile System feature: Dexcom Share™.
Part 5: Sharing is Caring
1. Dexcom Share
a. What Is Dexcom Share?
b. Setting Up Dexcom Share
c. How to Use Dexcom Share
d. Your Followers
e. Troubleshooting
Part 6
1. Index for Dexcom G5 Mobile System and Dexcom Share
How to Use Your User Guide
All chapters in the Dexcom 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, 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 Dexcom G5 Mobile App and
for reordering.
Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
12
If you haven’t already done so, go to dexcom.com and set up your own account.
Or, if you prefer, the Dexcom G5 Mobile App walks you through creating your log in
credentials as part of your initial app set up.
Summary
Now You Can:
•
•
•
•
•
Describe different training resources
Locate tutorials about using a real-time CGM in your diabetes management
Find Dexcom G5 Mobile System’s 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 Dexcom G5 Mobile CGM System safely.
Dexcom G5 Mobile System User Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
13
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Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
14
Chapter 2
Getting Started:
Indications for Use and Safety Statement
2.1 Introduction
We want the Dexcom G5 Mobile CGM 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 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 any of the Dexcom G5 Mobile CGM System.
This chapter is important to read. It helps you use the Dexcom G5 Mobile CGM System safely
and covers:
• What is a Safety Statement?
○○ Telling the difference between an indication and a contraindication
○○ Explaining why warnings are so important
○○ Defining precautions
• How to read a chapter’s Safety Statement
• Overview of Safety Statements
Let’s start with definitions, look at a Safety Statement example used throughout the User
Guide, and then review the Safety Statements broken down into the system’s components.
Safety Statement
A Safety Statement is a brief statement of the Dexcom G5 Mobile CGM System’s indications,
relevant warnings, precautions, or its contraindications (when to avoid using it). The Safety
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
15
Statements are meant to keep you and the system safe while using the Dexcom G5 Mobile
CGM System:
1) Indications
How, for what purposes, and under what circumstances you should use the Dexcom G5
Mobile CGM System. Indications let you know who should use the Dexcom G5 Mobile
CGM System and when. Indications are the who, what, and why of the Dexcom G5 Mobile
CGM System.
2) Contraindications
Contraindications let you know when not to use the Dexcom G5 Mobile CGM 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 Dexcom G5 Mobile CGM System, their consequences, and how
to avoid danger.
4) Precaution
Special steps you need to take while using the Dexcom G5 Mobile CGM System, preventing
minor or moderate injury to either you or the system.
2.3 Safety Statements
This user guide presents Safety Statement two ways:
1. In this chapter’s Overview of Safety Statements
○○ Lists all Safety Statements
○○ Includes a section reviewing how the statements are formatted
2. Within a chapter
○○ Lists only those statements applicable to the chapter
Chapter’s Safety Statements
Each chapter will list all applicable indications, contraindications, warnings, and precautions.
Some chapters will have multiple Safety Statements; others have none. Safety Statements
are located towards the front so you can keep them in mind as you learn about that chapter’s
topic. The same statement may be repeated throughout the user guide. It’s important
to recognize which factors could prevent the system from working correctly, or even
harming you.
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
16
Within chapters, each color coded Safety Statement is in a box, broken down into
four sections:
1. Type of statement
a. Bold and color-coded
▪▪ WARNING-Red
▪▪ PRECAUTION-Blue
▪▪ INDICATION-Green
▪▪ CONTRAINDICATION-Purple
2. Do’s/Don’ts
a. An action you should or should not take
b. Italicized
3. Why
a. A statement of the potential harm
4. Consequences
a. What could happen if you don’t follow the instructions
The following is an example of a chapter’s Safety Statement and how to read it.
WARNING
Do: Calibrate at least once every 12 hours.
Why: Calibrating less often than every 12 hours might cause inaccurate sensor
glucose readings.
Consequences: Missing severe low (hypoglycemia ) or high (hyperglycemia) Alarm
or Alerts.
Since this is a WARNING, you know it covers important safety information. Italics are the
Do/Don’t steps to follow: Calibrate at least once every 12 hours. Below the italics is a
statement explaining Why you need to follow the steps: Calibrating less often than every
12 hours might cause inaccurate sensor glucose readings. And finally what happens, or the
Consequences, if you don’t: missing a severe low (hypoglycemia) or high (hyperglycemia)
glucose event.
2.4 Overview of Safety Statements
This section provides a review of Safety Statements containing the same elements
described above (type of Safety Statement, an action, a statement of potential harm, and
consequences) listed in a narrative, not boxed, format. Here you’ll learn what indications
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
17
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—reviews warnings and precautions you take with most CGM systems—and
second, Hardware/Software Warnings and Precautions list warnings and precautions specific
to the Dexcom G5 Mobile CGM System components.
Indications and Contraindications
Indications
What are the Dexcom G5 Mobile CGM 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 Dexcom G5 Mobile CGM System is indicated for use as an adjunctive device
to complement, not replace, information obtained from standard home glucose
monitoring devices.
The Dexcom G5 Mobile CGM System aids in the detection of episodes of hyperglycemia
and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may
minimize these excursions. Interpretation of the Dexcom G5 Mobile CGM 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 Dexcom G5 Mobile
CGM System.
Who
The Dexcom G5 Mobile CGM System is a single patient use device (meaning you can’t share
the components with others) for people 2 years or older with diabetes.
What
The Dexcom G5 Mobile CGM System is a prescription-only glucose monitoring device.
Dexcom G5 Mobile CGM System tracks your glucose patterns and detects trends. Working
with your home blood glucose (BG) meter, the system is meant to complement, not replace,
your BG meter.
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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 Dexcom G5 Mobile CGM 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.
The Dexcom G5 Mobile CGM 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 Dexcom G5 Mobile CGM 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
Remove the Dexcom G5 Mobile CGM System (sensor, transmitter, and receiver)
before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or
high-frequency electrical heat (diathermy) treatment.
The system hasn’t been tested during MRI, CT scans, or with diathermy treatment. Magnetic
fields and heat could damage the components, stopping sensor glucose readings or
Alarm/Alert notifications. Without sensor glucose readings or Alarm/Alert notifications, you
might miss a severe low or high glucose event.
Medications
Taking medications with acetaminophen (such as Tylenol or Excedrin® Extra Strength)
while wearing the sensor may falsely raise your sensor glucose readings. The level of
inaccuracy depends on the amount of acetaminophen active in your body and is different for
each person.
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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 Dexcom G5 Mobile CGM System from harm.
Review Training Materials
Thoroughly review the training materials included with your Dexcom G5 Mobile CGM 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 Dexcom G5 Mobile CGM 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 Dexcom G5 Mobile CGM System sensor glucose readings because
readings 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 Dexcom G5 Mobile CGM System 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.
The system’s accuracy hasn’t been tested in people falling into these groups and sensor
glucose readings may be inaccurate, resulting in missing a severe low or high event.
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2.6 Calibration Warning and Precautions
Calibration is the process of making sure your sensor continues to be accurate. Your sensor
doesn’t automatically know what your glucose levels are—you have to teach your system
what a given BG value is by entering in a KNOWN glucose value from your BG meter.
Warning
Calibrate on Schedule
Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might
cause sensor glucose readings to be inaccurate, resulting in you missing a severe low or high
glucose event.
Precautions
Be Accurate, Be Quick
Enter the exact BG value displayed on your BG meter within five minutes of a fingerstick.
Entering the wrong BG values, or waiting more than five minutes before entry, might affect
sensor performance, resulting in you missing a severe low or high event.
Significant Glucose Rate Changes
Don’t calibrate when your BG is changing at a significant rate: more than 2 mg/dL
per minute.
Look for rate of change arrows on your display device screen and don’t calibrate when
you see:
• A single arrow, pointing up
○○ Rising 2-3 mg/dL each minute
• Two arrows pointing up
○○ Rising more than 3 mg/dL each minute
• Single arrow pointing down
○○ Falling 2-3 mg/dL each minute
• Two arrows pointing down
○○ Falling more than 3 mg/dL each minute
Calibrating during a significant rise/fall of your BG may affect accuracy of sensor glucose
readings, resulting in you missing a severe low or high glucose event.
Fingerstick Only
Only use fingerstick measurements from your BG meter for calibration.
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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 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 the Dexcom G5
Mobile CGM System components.
2.7 System/Hardware/Software Warnings and
Precautions
In this section, you will learn how to safely use the Dexcom G5 Mobile CGM System’s
hardware and software. Some sections 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 1.877.339.2664 or toll at 1.858.200.0200.
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 Dexcom G5 Mobile System in a site other than
the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The
placement and insertion of the sensor component of the Dexcom G5 Mobile System is not
approved for other sites.
If placed in other areas, the Dexcom G5 Mobile System may not function properly.
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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
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. Make sure the area you place your sensor won’t:
• Be bumped, pushed, or squeezed
• Have scars, tattoos, or irritation
Insertion in these areas might affect sensor performance, resulting in you missing a severe
low or high glucose event.
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Avoid injecting insulin or placing an insulin pump infusion set within three inches of the
sensor. The insulin 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.
Precautions
Reusable: Don’t Throw Away
When ending a session, don’t throw away the transmitter.
The transmitter is reusable and can be used in multiple sensor sessions. Keep using it until
the system notifies you the transmitter battery is about to expire.
Don’t Share Your Transmitter
Never share your transmitter with another person. The Dexcom G5 Mobile CGM 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’s 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.
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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
Rising more than 3 mg/dL each minute
Falling 2-3 mg/dL each minute
Falling more than 3 mg/dL each minute
Receiver and Smart Device Precautions
The Dexcom G5 Mobile Receiver and your smart device share some warnings and
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 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.
Water is often the biggest culprit in reducing the communication distance between 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.
Alarms or Alerts might vibrate or be heard on the accessory instead of your smart device.
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After connecting any accessories, make sure that the smart device settings allow you to
continue receiving Alarms or Alerts on the smart device.
Is It On?
If the receiver or smart device is turned off (Shut Down), it will not display sensor data,
information, Alarm or Alerts. Make sure they are turned on; otherwise you won’t get sensor
glucose readings or Alarm or Alerts, causing you to miss a severe low or high glucose event.
Smart Device Warnings
Next are warnings for just your smart device.
Warnings
Smart Device Settings
The Dexcom G5 Mobile 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 Dexcom G5 Mobile App Notifications are turned on in the Setting’s menu.
2. Verify app hasn’t been shut down.
3. Turn Bluetooth on.
4. Turn off Do Not Disturb (if available on your smart device).
5. Restart app after device is restarted.
6. Set Volume at a level you can hear.
7. Do not close app, always run app in the background.
8. Make sure accessory devices do not override your smart device settings.
If your settings are incorrect, you might miss a severe low or high glucose event.
Dexcom G5 Mobile CGM System Alarm/Alert vibrations aren’t any different from other
vibrating apps on your smart device. Medical device apps, like the Dexcom G5 Mobile App,
don’t have any special priorities over your smart device’s features. Dexcom G5 Mobile App
notifications or alerts may sound or feel the same as notifications from another app. The only
way to know is look at the screen.
Can’t Hear Your Alarm or Alert?
An Alarm or Alert can’t be heard through your smart device’s speakers if headphones are
plugged in.
Make sure you unplug your headphones when you are done using them, otherwise you might
not hear an Alarm or Alert, causing you to miss a severe low or high glucose event.
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Receiver Warning and Precaution
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.
Precaution
Keep Receiver Dry
Keep the USB port cover on the receiver closed whenever the USB cable is not attached and
do not submerge in water.
If 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 Dexcom G5 Mobile CGM 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 the importance of warnings
○○ Describe what a precaution is
• Correctly read a chapter’s Safety Statement
• Provide an overview of Safety Statements by category
What’s Next?
In our next chapter, you will learn about the risks and benefits of using Dexcom’s G5 Mobile
CGM 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, helping you decide if Dexcom’s G5 Mobile CGM System is right for you.
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 is out of range
Receiver or smart device isn’t showing sensor glucose readings
Receiver or smart device battery is dead
Unable to hear Alarm/Alerts or feel vibration
App not running in the background
Smart device is in Do Not Disturb
See Troubleshooting or recommended settings in Chapter 11 for more information.
Sensor Glucose Reading Different From Meter’s
The sensor glucose reading can be different than your meter’s BG value.
If the sensor’s glucose reading is higher than your meter’s BG value, you may miss a Low
Alert. As an example, your last sensor’s 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.
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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 (e.g., redness, swelling, bruising, itching, scarring or skin discoloration). The
chance of this happening is low. The Dexcom G5 Mobile CGM System uses the same sensor
as the previous CGM system—the Dexcom G4 PLATINUM. The Dexcom G4 PLATINUM
System clinical studies and compliant 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 sensor fragments could remain under your skin if the sensor breaks
during normal wear. 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 1.877.339.2664 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 Dexcom G5 Mobile CGM System, you can track
how your exercise, carbs, stress levels, medication, or illness, influences your glucose levels.
Knowing Your Trends
Wearing the Dexcom G5 Mobile CGM System on a consistent and ongoing basis helps you
manage your diabetes. Providing sensor glucose readings every five minutes, for up to seven
days, the Dexcom G5 Mobile CGM System helps you detect trends and patterns. Trend
information reveals where your glucose is now, where your glucose is 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.
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Helps in Your Diabetes Management
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 to take action before you get too low or too high. The Urgent Low Alarm lets you
know when you are dangerously or urgently low, going below 55 mg/dL. By taking corrective
measures, you lessen the time spent in your low/high range, while increasing time in your
targeted 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 Dexcom’s G5 Mobile CGM System,
helps reduce hypoglycemia (Tamborlane, W. V.,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
Dexcom’s G5 Mobile CGM System!
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.
The Diabetes Control and Complications Trial Research Group. The Effect of Intensive
Treatment of Diabetes on the Development and Progression of Long-Term Complications in
Insulin-Dependent Diabetes Mellitus. The New England Journal of Medicine, Vol. 329, No. 14.
(September 1993), pp. 977-986.
Garg, S., Zisser, H., Schwartz, S., Bailey, T., Kaplan, R., Ellis, S., & Jovanovic, L. (2005).
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. (2009).
The Effect of Continuous Glucose Monitoring in Well-Controlled Type 1 Diabetes, Diabetes
Care, 32(8), 1378-1383.
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Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group.
(2009). Sustained Benefit of Continuous Glucose Monitoring on A1C, Glucose Profiles, and
Hypoglycemia in Adults With Type 1 Diabetes. Diabetes Care, 32(11), 2047-2049.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2010).
Quality-of-Life Measures in Children and Adults with Type 1 Diabetes. Diabetes Care, 33(10),
2175-2177.
Ohkubo, Y., Kishikawa, H., Araki, E., Miyata, T., Isami, S., Motoyoshi, S., & Shichiri, M. (1995).
Intensive Insulin Therapy Prevents the Progression of Diabetic Microvascular Complications in
Japanese Patients with Non-insulin-dependent Diabetes Mellitus: A Randomized Prospective
6-year Study. Diabetes Research and Clinical Practice, 28(2), 103-117.
Tamborlane, W. V., Beck, R. W., Bode, B. W., Buckingham, B., Chase, H. P., Clemons, R., ... &
Xing, D. (2008). Continuous Glucose Monitoring and Intensive Treatment Of Type 1 Diabetes.
The New England Journal of Medicine, 359(14), 1464-1476.
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LET’S G5! THE BASICS
•
Introduction to the Dexcom G5 Mobile CGM System
•
Initial Set-Up
•
Starting a Sensor Session: Inserting the Sensor & Transmitter
•
Calibration
•
Ending a Sensor Session
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Chapter 4
Let’s G5! The Basics:
What Is the Dexcom G5 Mobile CGM System?
4.1 System Description
Now it’s time to get an overview of the Dexcom’s G5 Mobile CGM System.
After this chapter, you’ll be able to:
•
•
•
•
•
Explain the Dexcom G5 Mobile CGM System
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” or “G4 PLATINUM” on the sensor’s package), you can’t mix the transmitter or
receiver between the two systems.
WARNING
Don’t: The Dexcom G5 Mobile CGM System 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.
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PRECAUTION
Don’t: Never mix Dexcom G5 Mobile’s Transmitter or Receiver with Dexcom G4
PLATINUM’s Transmitter or Receiver.
Why: The Dexcom G5 Mobile CGM System’s 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.
Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) event.
4.3 The Dexcom G5 Mobile CGM System
CGM
The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System 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
measurement. 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 Dexcom G5 Mobile CGM System 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.
Options to View Your Trends
The Dexcom G5 Mobile CGM System transmitter works with a number of display devices
giving you flexibility to use what’s best for you, your situation, or your lifestyle.
1. Dexcom G5 Mobile Receiver
2. Dexcom G5 Mobile App on your smart device
While the system works with different smart devices, they’re not interchangeable during a
sensor session. Before starting one, select which smart device you want to use and stick
with it throughout your session. You can’t use multiple smart devices at the same time, but
you can combine the receiver with a smart device during a session.
The Dexcom G5 Mobile CGM System 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
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Chapter 5 covers how to set up your smart device with the Dexcom 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
• Grey - Within your normal range
• Yellow - High
Trend Arrows
Glucose levels are not just about the numbers. The Dexcom G5 Mobile CGM System
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
if it’s trending towards 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.
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 set up process for the
receiver and smart device.
In Chapter 11, you can learn more about the Alarm and Alerts feature.
Viewing Your Glucose Values
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The Dexcom G5 Mobile CGM System allows you to see your last 1-3-6-12-24 hours of your
sensor glucose readings. On the receiver, from the home screen, press Up/Down Arrows to
view. On a smart device, hold upright in portrait mode, and see the most recent three hours,
turn sideways to landscape 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 Dexcom G5 Mobile CGM
System?
Dexcom’s G5 Mobile CGM System has features not found in our previous generations.
These items are new to the Dexcom G5 Mobile App:
• The Dexcom G5 Mobile widget in the Apple Today view
• Dexcom G5 Mobile on Apple Watch
• Share as a feature of the app
The Dexcom G5 Mobile Widget in the Apple Today View
Check your CGM information on your smart device without needing to open the app, even
when the device is locked. Swipe down from the top of your screen to access the Dexcom G5
Mobile widget in the Apple Today view. This is where you might check the weather or stocks
if using the default settings.
For more information about the Dexcom G5 Mobile for Apple Watch, go to Chapter 9.3 under
Additional Ways to View Your App’s CGM Information.
Dexcom G5 Mobile for Apple Watch
Check your CGM information on your wrist! The Dexcom G5 Mobile App supports Apple
Watch* and can be used to discreetly view your glucose reading, trend arrow, and trend
graph.
For more information about Dexcom G5 Mobile for Apple Watch or the Dexcom G5 Mobile
widget in the Apple Today View, go to Chapter 9.3 under Additional Ways to View Your App’s
CGM Information.
*For compatibility information see dexcom.com/compatibility.
Share Your Data
Through secure wireless connections, Dexcom Share allows remote viewing of your sensor
glucose readings, trends, and data by your loved ones from a smart device. Activate Dexcom
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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, they become your Follower. As a Follower, they
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 Dexcom G5 Mobile App is different than the Dexcom Share App used with other
systems.
More information about Dexcom Share and instructions for use, go to Part 5.
NOTE: Review all Dexcom Share System indications, contraindications, warnings,
precautions 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 you know what the Dexcom G5 Mobile CGM System does and what’s new, let’s open
your Dexcom G5 Mobile packages, see what’s inside, and review each item.
4.6 System Components
Package
The Dexcom G5 Mobile CGM System comes to you in a number of boxes; after opening keep
the packaging until you are no longer using its contents.
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Sensor
Sensor package
Single use sensor(s)
Insert
Transmitter
Transmitter package
Reusable transmitter
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(Continued from previous page)
Receiver
Receiver package
Receiver
Receiver’s USB charging and download cable
AC power adapter
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Receiver
Getting Started with
Your Dexcom CGM
Dexcom CARE is committed to making your CGM experience a positive one.
We are here to ensure that you experience CGM the way it was designed to
help you manage your diabetes.
Refer to your enclosed Quick Start Guide or Tutorial.
Get Started*
Call us at 877-339-2664 Ext. 4900 and speak with a Certified
Diabetes Educator.
Register for a live, no-charge training webinar at www.dexcom.com or
open an online account to begin “sharing” at www.dexcom.com/register.
Welcome Card
*Learn at your own pace with our Self-Guided Training Tutorial at www.dexcom.com/tutorial or review the disc and Quick Start materials inside your Dexcom G5 Mobile Receiver box; or
receive remote training with Dexcom’s Patient Care Specialist; or schedule an appointment for the Dexcom G5 Mobile device training in your physician’s office or diabetes center.
Expert Advice | Personalized Training | Customized Support | Guidance | Encouragement
LBL013034 Rev 002 MT23142
Quick Start Guide
Training Checklist attached to Quick Start Guide
Training Tutorial USB Card
Overview of System Components
This section is meant as a quick overview of each part, specifics for each are found in
following chapters. For detailed product specifications and technical information, please go
to Chapter 17.
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The Dexcom G5 Mobile CGM System is comprised of four key parts:
1. Single use sensor
2. Reusable transmitter
3. Rechargeable receiver
4. Dexcom G5 Mobile App
a. Downloaded to your smart device
Dexcom G5 Mobile CGM System optional:
Dexcom Share
Sensor Overview
For your safety, the sensor is packaged in a sterile sealed pouch, containing an applicator,
sensor pod, and sensor wire. When you first open the package, your sensor looks like one
item, however it’s actually three: sensor applicator barrel, sensor pod, and sensor wire.
The applicator barrel helps you insert the sensor wire inside the sensor pod under your skin.
After inserting the sensor wire, remove the applicator barrel. 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.
Plunger
Applicator Barrel
(contains small
introducer needle
and sensor)
Transmitter Latch
Release Tab
Safety Lock
Collar
Sensor Pod
Adhesive Patch
Figure 1. Dexcom G5 Mobile Sensor Applicator and Pod
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Applicator and Sensor Pod
What it’s called
What it does
Applicator
Contains small insertion needle and sensor wire.
Applicator Barrel
Inserts sensor wire under the skin.
Disposable, for single use only.
Removed after insertion.
Keeps all moving parts in place before insertion.
Safety Lock
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.
Sensor Pod
Holds transmitter and sensor wire.
Sensor Pod
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.
Wire measures glucose levels in fluid in between your cells.
Sensor Wire
Attached to sensor pod.
Discarded with pod after session.
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Transmitter Overview
Figure 2. Dexcom G5 Mobile Transmitter Front and Back
Snapping into the sensor pod, the gray plastic transmitter wirelessly sends your glucose
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.
The transmitter is:
1. Reusable
a. Do not discard after sensor session.
b. Only for you, don’t share transmitter.
2. Water resistant
3. Can transmit data to your display devices for up to 20 feet
a. Range is less if you are in or under water.
4. Battery lasts approximately three months
a. Receiver or smart devices prompts you when battery is running low.
5. Transmitter’s serial number is on the back
More transmitter features and insertion information is in Chapter 6.
Now you are familiar with sensor and transmitter, let’s review the Dexcom G5
Mobile Receiver.
Dexcom G5 Mobile Receiver
The receiver is a small hand-held device. Your receiver, along with your smart device, shows
your sensor glucose readings, trend graphs, 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. Keeping the micro
USB port closed helps prevent damaging fluids and dust from getting inside the receiver. If
your receiver does get wet, test it to make sure the speaker and vibrations still work (see
Chapter 12).
If your receiver isn’t charged, see Chapter 14 for charging your receiver’s battery.
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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.
Receiver Overview
What you see
What it’s called
What it does
Receiver
Provides data about your glucose
trends via screen display, sounds
and vibration.
Micro USB Port
Plug USB cable into port for
recharging.
USB Port Door
Close USB port door after removing
USB cable to keep receiver clean
and dry.
Plug into receiver to charge battery.
Micro USB Cable
Don’t plug into a computer port to
charge.
Battery can only be charged using
the adapter/wall charger.
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What you see
What it’s called
What it does
Plug USB cable into adapter/wall
charger.
Wall Charger
Plug wall charger into an electrical
outlet to charge receiver’s battery.
Don’t block access to the charger.
Display Screen
Shows sensor glucose readings,
trend graphs and arrows,
Alarm/Alerts, sensor session status.
Change settings on Menu screen.
Speaker
Allows you to hear your Alarm/Alerts
sounds.
Navigation Wheel
Arrows and button to help you
navigate through the receiver’s menu
options and choose features.
Select Button
Press to select menu option.
Left Arrow
Press to go back to last item/screen
or home screen.
Right Arrow
Press to highlight next item.
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What you see
What it’s called
What it does
Press to scroll up or down to select
menu items or set values.
Up/Down Arrows
Press to scroll back and forth
beyond from the 3 hour trend graph
to the 1-6-12-24 views.
4.7 Smart Device Overview
The Dexcom 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.
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 Dexcom G5 Mobile CGM System
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 Dexcom G5 Mobile CGM System is selecting how to
continuously receive your sensor glucose readings: Dexcom G5 Mobile App, the Dexcom G5
Mobile 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 Dexcom G5 Mobile CGM
System and learned you can monitor your glucose levels with different display devices. Now
it’s time to set up your Dexcom G5 Mobile App and your receiver.
After this chapter, you will be able to:
•
•
•
•
Create a Dexcom username and password
Download the Dexcom G5 Mobile App
Set up the Dexcom G5 Mobile App with the recommended settings
Successfully set up your Dexcom G5 Mobile 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.
PRECAUTION
Don’t: Never mix Dexcom G5 Mobile’s Transmitter or Receiver with Dexcom G4
PLATINUM’s Transmitter or Receiver.
Why: The Dexcom G5 Mobile CGM System’s 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.
Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) event.
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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. Smart device ran out of memory.
If you 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 set up for the app. To set up the receiver, go
to Section 5.5. If you want to use both the mobile app and the receiver, you need to set each
up individually.
Once you have completed the initial set up, you’re one step closer to beginning your
sensor session!
5.4 Dexcom 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 set up is entering the
transmitter’s serial number (SN). If by accident you enter the SN into more than one smart
device, the system warns you and you won’t be able to complete the set up process.
Suggested Smart Device Settings
Bluetooth is designed 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
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• Make sure your smart device settings allow your Dexcom 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 Dexcom 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.
Dexcom G5 Mobile App Installation
Installing the app is easy! Simply download the Dexcom G5 Mobile App from your smart
device’s store. However, if your smart device has been jailbroken, do not install the app.
For information on how to install an app, see your smart device’s user guide.
Initial Dexcom 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 set up wizard instructions.
The set up wizard walks you through safety information, recommended settings, entering
transmitter SN, setting your high/low glucose levels, and receiving CGM notifications.
Your initial set up 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 Dexcom App has prompts allowing you to get more information. If you are unsure of
something during your initial set up process, look at the screen for additional information
prompt. 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.
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Initial App Setup
Step
What you see
What you do
Introductory Screens
Tap Dexcom G5 Mobile App icon to open app.
Swipe through introductory screens or tap Log In.
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Introductory Screens
Enter existing username and password
OR
Need a Dexcom username and password?
Tap Sign Up.
Complete Username/Password fields.
Tap Login once.
Tap Let’s Get Started.
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Introductory Screens
The next screens are the Terms of Use, safety
warnings, contraindications, and the recommended
settings.
Once each screen is read, tap the appropriate
answer to move forward.
Tap Full Safety Statement or, when applicable, I
don’t understand to get more information.
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Setting up Your App Alarm/Alerts and Basic Settings
Set your Low Glucose Alert.
Default is 80 mg/dL.
Scroll to select another amount.
Tap Save to move forward.
Once set, you’ll receive an Alert notification if your
glucose dips below your set amount.
Set your High Glucose Alert.
Default is 200 mg/dL.
Scroll to select another amount.
Tap Save to move forward.
Once set, you’ll receive an Alert notification if your
glucose rises above your set amount.
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Setting up Your App Alarm/Alerts and Basic Settings
Make sure you get your Alarm/Alerts notifications.
8a
Tap the appropriate response to move forward and
set your notifications.
8b
Tap OK to receive Alarm/Alerts notifications.
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Setting up Your App Alarm/Alerts and Basic Settings
The next screens provide suggestions for device
volume, Do Not Disturb, and other basic settings.
Tap appropriate answer to move forward.
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Connecting/Pairing Transmitter With App
10
Tap Next.
Verify Bluetooth is on.
11
The app will check to see if Bluetooth is turned
“on.”
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Connecting/Pairing Transmitter With App
12a
12b
Get your Transmitter box.
Tap Take Photo.
Turn transmitter box upside down on a flat surface
with barcodes facing up.
Center longest barcode within green brackets.
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Connecting/Pairing Transmitter With App
12c
13a
Check mark confirms successful transmitter SN
scan.
If unable to use app’s scanning device:
Tap Enter transmitter SN by hand.
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Connecting/Pairing Transmitter With App
Use keyboard to enter transmitter SN.
13b
Confirm correct SN .
Tap Save.
14
Insert sensor and attach transmitter following
video’s instructions.
See Chapter 6 for more information.
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Connecting/Pairing Transmitter with App
15
Wait up to 30 minutes for smart device and
transmitter to connect.
16
At prompt, Tap Pair to pair app with smart device.
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Connecting/Pairing Transmitter with App
Tap the Sensor warmup circle to start your two
hour sensor warmup.
17
When you see the sensor warmup timer, your initial
set up is complete.
Congratulations!
If you have any issues setting up the Dexcom G5 Mobile App, call Technical Support toll free
at 1.877.339.2664 or toll at 1.858.200.0200. We are here 24/7 to assist you.
If you are having problems with your smart device, contact your smart device’s support line.
After completing your initial app setup, set up the receiver or go to Chapter 6 to start your
initial sensor session.
5.5 Dexcom G5 Mobile Receiver
In the previous chapter, you learned about the receiver’s components. The following is a
refresher to help in your initial set up.
Display Screen:
• Trend screen
• Menu selection screen
Navigation Wheel:
• Select
○○ Button in the middle of the navigation wheel
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▪▪ Center button does not say “Select”
○○ Press to
▪▪ Turn on receiver
▪▪ Select options/features
▪▪ Accept changes
▪▪ Move forward through menus/features
• Up/Down
○○ Scroll through trend screens
○○ Highlight menu items
○○ Change values
• Left
○○ Go back to last item or screen
• Right
○○ Go to next item or screen
Initial Setup of the Dexcom G5 Mobile Receiver
Press Select to turn receiver on.
The first screen you see is the startup screen with ascending green bars. Once complete, a
set up wizard guides you through the initial set ups steps. 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 set up differs between the receiver and your smart device;
however, the data is the same.
Setup Wizard Prompts:
• Time/Date
• Transmitter Serial Number
○○ Back of transmitter
○○ 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.
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Initial Receiver Set up
Step
What you see
What you do
Initial Screens
Press Select to turn receiver on.
Wait.
Time/Date
Press Up/Down Arrow to change year.
Press Right Arrow to move forward.
3a
Press Up/Down Arrow to change month.
Press Right Arrow.
Press Up/Down Arrow to change day.
Press Right Arrow to move to time.
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(Continued from previous page)
Time/Date
Press Up/Down Arrow to change hour.
Press Right Arrow.
Press Up/Down Arrow to change minutes.
3b
Press Right Arrow.
Press Up/Down Arrow to select AM/PM.
Press Select to save and close.
NOTE: After initial set up, if battery is drained,
receiver will vibrate once and you will need to reset
date and time.
Transmitter
4a
4b
4c
Turn transmitter box upside down to locate SN
number.
If transmitter package isn’t available:
• SN is on transmitter’s back
Press Up/Down Arrows to select and enter
transmitter SN.
Press Right Arrow to move to next digit.
Press Select to save and close.
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Setting Low Alert
5a
System default is at 80 mg/dL.
Press Select to save at present levels and close.
To change value:
5b
Press Up/Down Arrows to change value at 5 mg/dL
increments.
Press Select to save and close.
Setting High Alert
6a
System default is at 200 mg/dL.
Press Select to save at present levels and close.
To change value:
6b
Press Up/Down Arrows to change value at 10
mg/dL increments.
Press Select to save and close.
These steps are enough to get you going; now you can start your sensor session!
Summary
Now You Can:
• Create a Dexcom username and password
• Download the Dexcom G5 Mobile App
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• Set app up with the recommended settings
• Successfully set up your Dexcom G5 Mobile Receiver
What’s Next?
Now you have completed setting up your app and/or the receiver, your next step is starting a
sensor session.
No matter what monitoring method you choose, starting a sensor session is the same:
1. Inserting the sensor.
2. Inserting 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,
Transmitter, and Starting Your Session
6.1 Overview
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 Dexcom G5 Mobile sensor
insertion video to get a better understanding of the process.
The Dexcom G5 Mobile sensor insertion video is available by three ways:
1. Through the App
2. USB card in your Dexcom G5 Mobile Receiver package
3. Online at dexcom.com:
a. Top of page, click Support Tab.
b. Click Education.
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
Dexcom 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:
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•
•
•
•
•
•
•
•
Identify sensor applicator features
Properly prepare for sensor insertion
Choose the best location to insert your sensor
Correctly insert your sensor
Prepare transmitter for placement
Correctly attach transmitter to sensor
Outline what happens during the sensor warmup
Identify countdown icon
6.2 Safety Statements
Following are some important Precautions and Warnings to review; we want to make sure
you and the system are safe before starting a sensor session.
WARNING
Don’t: If a sensor breaks under the skin with no portion visible above the skin, don’t
remove it.
Do: Seek professional medical help if you have symptoms of infection or inflammation
(e.g., redness, swelling or pain) at the insertion site.
Always report a broken sensor to our Technical Support, 24/7, team at as soon
as possible:
Toll free: 1.877.339.2664
Toll call: 1.858.200.0200
Why: Sensors may fracture on rare occasions.
Testing done in a controlled environment (in-vitro) didn’t find any safety hazards during
an MRI with a broken off sensor under the skin. The wire didn’t heat up nor have any
significant movement during the MRI, images were affected only in the area around the
sensor’s wire.
MRI with broken wire
If you have experienced a broken sensor and are planning to take an MRI, please discuss
the following with your doctor or technician.
Laboratory (in vitro) MRI tests did not detect any safety hazards for a broken sensor that
remains in the body.
There was no significant movement or heating of the wire. Imaging artifacts were limited
to the area around the wire.
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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 Dexcom G5 Mobile CGM System sensor glucose readings for
treatment decisions.
Do: Only use BG values from your BG meter for treatment decisions (e.g., 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 blood glucose values.
Consequences: Using sensor glucose readings for treatment decisions could result in you
missing a severe low or high event.
PRECAUTION
Do: Select sensor insertion site with care.
Avoid:
•
•
•
•
Areas likely to be bumped, pushed or squeezed
Areas of skin with scarring, tattoos, or irritation
Injecting insulin within 3 inches of sensor
Placing an insulin pump infusion set within 3 inches of sensor
Why: Inserting sensor in these areas may affect sensor glucose readings.
Consequences: Inaccurate sensor glucose readings may result in you missing a severe
low or high event.
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PRECAUTION
Do: Check sensor package before opening.
Why: Make sure the sterilized package has not been damaged or previously opened. If
opened or damaged, sensor may be unsterile.
Consequences: Using an unsterile sensor may cause an infection.
6.3 Prepping for Sensor Insertion
Before inserting a sensor, make sure you have everything you need. Some items are included
in the Dexcom G5 Mobile CGM System’s packages, others are not.
Items Included in Your Dexcom 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 pouch 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, Section 4.6 gave you overview of the sensor applicator.
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4. Plunger
3. Safety Lock
5. Applicator Barrel
(contains small
introducer needle
and sensor)
6. Collar
8. Transmitter Latch
7. Sensor Pod
9. Release Tab
2. Adhesive Patch
Figure 3. Dexcom 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
Sterilized for your protection.
Sensor Pouch
Adhesive Patch
Holds the sensor/transmitter in place on your
skin.
Safety Lock
Prevents plunger from inserting sensor until
you are ready.
Plunger
Inserts sensor wire into your body.
Applicator Barrel
Contains small insertion needle and sensor
wire.
Open to remove applicator and sensor.
Disposable, for single use only.
Collar removes insertion needle.
Collar
Helps remove applicator barrel once sensor
wire is inserted.
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(Continued from previous page)
Order of Use Name
What it does
Holds sensor wire in place under skin.
Sensor Pod
Transmitter Latch
Locks transmitter into sensor pod.
Release Tab
Allows you to remove applicator barrel from
sensor pod.
Holds transmitter.
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 blood glucose meter
3. Your test strips
Before starting, check your blood glucose 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.
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Before removing the sensor applicator out of its sterile pouch, determine the best place to
insert your sensor.
6.4 Choosing Your Insertion Site
Choose a place on your belly (or if user is between the ages of 2 and 17, upper buttocks) to
insert the sensor; the site should be either above or below your belt line. The best areas are
usually flat, “pinchable,” and free from where rubbing can occur (along the waist band, seat
belt strap or where you lay 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 package 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. Use circular motions and create an “O” outline, making sure you don’t get
any skin adhesive inside the outline. Let the “O” 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
Wash and dry your hands.
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Preparation
Clean insertion site with alcohol wipe.
Let dry.
Optional Step: Skin Adhesive
Create an oval on the skin
• Do not get any skin adhesive inside the circle
• Let skin adhesive dry
• Insert sensor on clean skin at the center of the
circle
Check pouch: Is it damaged or already opened?
Remove sensor applicator from sterile pouch.
Closely inspect sensor, check it hasn’t been
damaged.
Keep sensor packaging until sensor session is
complete.
Attaching Sensor Pod
Pull adhesive backing tabs.
Don’t touch sticky adhesive patch.
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(Continued from previous page)
Inserting Sensor Wire
Place sensor horizontally, not vertically, on skin.
Move fingers around adhesive patch’s top several
times to secure tape.
Hold applicator barrel.
Pull safety lock out.
Place fingers of one hand on edges of adhesive patch.
Pinch up your skin at the tips of the white adhesive.
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.
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Removing Applicator Barrel and Collar
Move two fingers from above collar to below collar.
Keeping your thumb as a base on the white plunger.
10
Pull collar all the way back towards your thumb.
You should hear 2 clicks.
NOTE: Finger placement is important for correct
needle removal.
Hold transmitter latch down against your body.
11
12a
Squeeze ribbed release tabs on the sides of sensor
pod.
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:
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 Dexcom G5 Mobile CGM System Technical Support team, 24/7, at:
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• Toll free: 1.877.339.2664
• 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 inserted 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 inserting your transmitter, check you entered the correct transmitter SN into your
display device. Chapter 5 covers entering transmitter’s SN number.
Step
Picture
What you do
Remove transmitter from box.
Keep box.
Save safety latch from sensor applicator (helps
remove transmitter once sensor session is over).
Get alcohol wipe.
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.
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.
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(Continued from previous page)
Step
Picture
What you do
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.
Is transmitter secure?
Before removing transmitter latch, verify transmitter is
securely in place.
Make sure none of the transmitters 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.
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 whether you use the receiver or app.
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.
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If the patch peels up, use medical tape (such as Blenderm™, Tegaderm™, Smith & Nephew
IV3000®, 3M™ tape) for extra support.
•
•
•
•
Tape over white adhesive patch on all sides for even support
Don’t tape over the transmitter or any plastic parts of the 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 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.
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Dexcom App: Starting a Session
Step
What you see
What you do
Wait for Successful Pairing notification.
Tap green checkmark in black square.
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.
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.
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(Continued from previous page)
Step
What you see
What you do
Locked screen.
Initial calibration prompt tells you when warmup is
complete.
Chapter 7 covers calibrating.
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
Press Select to turn on receiver.
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(Continued from previous page)
Step
What you see
What you do
From Trend Graph.
Press Select to go to Main Menu.
Press Down Arrow to highlight Start Sensor.
Press Select to start new sensor session.
NOTE: After sensor starts, Start Sensor option
disappears.
“Start Sensor” progress bar confirms two hour
sensor warmup.
Keep your receiver within 20 feet during the
warmup period.
Receiver returns to the trend graph screen.
Make sure receiver and transmitter are
communicating.
Check receiver 10 minutes after starting for
Bluetooth icon.
• Solid: Connected
• Blinking: Searching for connection
• No Bluetooth Icon: No connection
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(Continued from previous page)
Step
What you see
What you do
Wait.
Screen provides countdown of the two hour sensor
warmup.
Sensor warmup is complete.
You’re ready to calibrate!
6.9 Receiver Bluetooth Tips
Your transmitter and receiver begin communicating once you start a sensor session. After
approximately 30 minutes, if the Bluetooth symbol is solid, and not blinking, your transmitter
and receiver are talking to each other.
• If blinking, Bluetooth is looking for your transmitter
○○ Make sure your transmitter and receiver are within 20 feet of each other
If the Bluetooth icon isn’t on the receiver and the Signal Loss icon appears in the receiver’s
upper right corner of the status bar, they’re not communicating.
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No Communication Between Transmitter and
Receiver
Step
What you see
What you do
Check correct transmitter SN is in receiver.
• SN is on the label on bottom of transmitter box
Press Select to go to Main Menu.
Press Down Arrow to Settings.
Press Select.
Press Down Arrow to Transmitter.
Press Select.
Press Select.
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(Continued from previous page)
Step
What you see
What you do
Check correct transmitter SN is in receiver.
• SN is on the label on bottom of transmitter box
Compare SN in receiver to SN on transmitter box.
If correct, call our 24/7 Technical Support
department, toll free at 1.877.339.2664 or toll at
1.858.200.0200 for help.
Press Select to exit screen.
Press Left Arrow twice to go to Main Menu.
If Wrong SN Entered
Press Left Arrow twice to go to Main Menu.
If sensor session has started, to correct transmitter
SN, you must stop the sensor session.
Press Down Arrow to Stop Sensor.
Press Select.
Press Select to stop session.
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(Continued from previous page)
If Wrong SN Entered
Wait for sensor session to end.
From Main Menu:
10
Press Down Arrow to Settings.
Press Select.
11
12
Press Down Arrow to Transmitter.
Press Select.
Highlight Transmitter SN.
Press Select.
Enter correct SN using Up/Down Arrow.
13
Press Up/Down Arrow to select and enter transmitter
SN.
Press Right Arrow to move to next digit.
Press Select to save and close.
Press Left Arrow twice to return to Main Menu.
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If Wrong SN Entered
Start Sensor Session.
14
Press Up/Down Arrow to highlight Start Sensor.
Press Select on Start Sensor.
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 Dexcom G5 Mobile CGM System’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, 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
○○ Define calibration
○○ Explain the importance of calibration
○○ Identify steps to ensure a successful calibration
• Recognize steps in taking accurate blood glucose measurement
○○ Identify the correct blood glucose site for calibrations
○○ Prepare finger for fingerstick measurement
• Determine if you should/should not calibrate
○○ Recognize when you can enter fingerstick measurement for calibration
○○ Recognize when you shouldn’t enter the fingerstick measurement for calibration
○○ Determine if you need to calibrate outside of the normal calibration requirements
• Initiate startup calibration
• Perform update calibrations
• Correctly enter your fingerstick measurement
○○ Dexcom G5 Mobile App
○○ Dexcom G5 Mobile Receiver
• Identify calibration errors
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7.2 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?
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 Dexcom G5 Mobile
CGM System 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 your 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.
Don’t enter your BG values in 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.
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If you receive a calibration prompt outside of your scheduled calibration schedule, 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 you have an overview of calibration, let’s review some contraindications, warnings, and
precautions you need to know and follow before you calibrate.
7.3 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 sensor may falsely raise sensor glucose readings. Level of inaccuracy
depends on:
1. Amount of acetaminophen active in your body.
2. May be different for each person.
Consequences: Without correct readings you might miss a severe low event.
WARNING
Don’t: Never use the Dexcom G5 Mobile CGM System sensor glucose readings for
treatment decisions.
Do: Only use BG values from your BG meter for treatment decisions (e.g., 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 blood glucose values.
Consequences: Using sensor glucose readings for treatment decisions could result in you
missing a severe low or high 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 blood glucose is changing at a significant rate, typically more
than 2 mg/dL per minute.
Never calibrate when you see:
• A single arrow, pointing up
○○ Rising 2-3 mg/dL each minute
• Two Arrows pointing up
○○ Rising more than 3 mg/dL each minute
• Single arrow pointing down
○○ Falling 2-3 mg/dL each minute
• Two arrows pointing down
○○ Falling more than 3 mg/dL each minute
Why: Calibrating during significant rise/fall of blood glucose may affect accuracy of sensor
glucose readings.
Consequences: You may miss a severe low or high glucose event.
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 blood glucose values, or waiting more than five minutes before
entry, might affect sensor accuracy.
Consequences: You may miss a severe low or high glucose events.
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PRECAUTION
Do: Only use fingerstick measurements from your BG meter for calibration.
Don’t: Never use alternative site blood glucose values such as blood from palms,
forearms, etc.
Why: Alternative site BG values are different from a fingerstick blood glucose value and
may not reflect most recent blood glucose value.
Consequences: You may miss a severe low or high glucose event.
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 Start-Up 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 helps 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 Start-Up 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. Five minute reporting delay between devices.
3. First update calibration is 12 hours after your initial calibration.
Update Calibration
Update calibrations are typically 12 hours since your last calibration, however it can be
sooner. As an example, if you know your next calibration is due at 4 AM, you can do the
calibration before bedtime, resetting the 12hour count down.
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1. Enter one fingerstick measurement at least every 12 hours.
2. Display devices provides calibration prompts.
3. You may be prompted to enter additional fingerstick measurements as needed.
Figure 5. Example Minimum Calibration Schedule During
Seven-Day Sensor Session
7.5 Calibration Prompts
Sensor Session Start-Up Calibration Prompts
Once your two hour sensor start-up is complete, your display device tells you it’s time to
enter the first of your two back-to-back start-up 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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Start-Up Calibration Prompts
Device
What you see
What it means
What you do
First Calibration
Smart Device:
Lock Screen
Smart Device:
In App
Sensor warmup is
complete.
Ready for first
of two initial
calibrations.
Follow steps in
Section 7.6 and 7.7.
Immediately prepare
for next calibration.
Receiver
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(Continued from previous page)
Device
What you see
What it means
What you do
Sensor accepted
first calibration.
Follow steps in
Section 7.6 and 7.7.
Ready for second
BG meter value.
Next calibration in
12 hours.
Second Calibration
Smart Device:
Lock Screen
Smart Device:
In App
Receiver
Your sensor glucose readings begin in approximately five minutes once the device(s) accepts
your calibrations.
Update Calibration Prompts
Once your start-up calibration is done, your update calibration schedule begins.
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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.
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
Smart Device:
Lock Screen
Smart Device:
In App
Receiver
What it means
What you do
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
Section 7.6 and 7.7.
Immediately prepare
for next calibration.
Tap message to clear prompt on your smart device and to clear a prompt on your receiver,
press Select.
Sound/Vibration Prompts
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.
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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.
Eight Steps to Successful Calibration:
Do:
1. Wash and dry your hands before staking a fingerstick measurement.
2. Always use the same meter you routinely use to measure your blood glucose.
a. Blood glucose 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 is active?
6. Use fingerstick BG values only.
a. Other sites are not as accurate.
b. Must enter within five minutes of taking BG meter value.
c. Enter exact BG value from your meter for each calibration.
Don’t:
7. Don’t take acetaminophen containing medication during your session (e.g., Tylenol).
a. See your healthcare professional to better understand how long acetaminophen
is active in your body.
8. Don’t calibrate if your BG values are under 40 mg/dL or over 400 mg/dL.
a. If BG value is outside of this range, receiver doesn’t understand these values and
won’t calibrate.
i. You must wait until your blood glucose is in the range to calibrate.
Be safe—if blood glucose 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!
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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 five minutes.
Next are steps to enter your calibrations using the app, followed by the steps for entering
your calibrations into the receiver.
Calibrate With Your Dexcom G5 Mobile App
Step
What you see
What you do
Tap circle.
Additional info
Initial calibration: Enter
two back-to-back meter
BG value.
Update calibration:
Enter one meter BG
value.
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(Continued from previous page)
Step
What you see
What you do
Enter meter’s BG value
using number pad.
Tap Save.
Additional Info
Double check your
numbers.
Entering wrong values
can affect the sensor’s
accuracy.
Verify value is correct.
Tap Save.
If not correct:
Tap Cancel.
Reenter correct value.
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(Continued from previous page)
Step
What you see
What you do
Additional Info
Tap circle to enter your
second BG value.
Follow steps 2-3 and
enter second reading.
Meter icon has no
calibration prompt.
Calibration accepted.
Your calibration was
successful.
(Continued on next page)
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(Continued from previous page)
Step
What you see
What you do
Wait for next calibration
prompt in 12 hours.
Additional Info
Default Home Trend
screen.
Calibration accepted.
Calibrate With Your Dexcom G5 Mobile Receiver
Step
What you see
What you do
Press Select to turn on
receiver.
Press Select again for
Main Menu.
Additional Info
You won’t see calibration
prompts when receiver
screen is black.
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(Continued from previous page)
Step
What you see
What you do
Additional Info
Press Up/Down Arrow.
Highlight Enter BG.
Press Select.
Press Up/Down Arrow
to change numbers.
Stop at meter’s BG
value.
Press Select.
4a
Verify BG value is
correct.
If correct:
Press Select.
Verify BG value is
correct.
4b
If incorrect:
Press Right Arrow to
Cancel.
Press Select.
Reenter BG value.
Sensor default reading is
120 mg/dL.
If sensor glucose
reading is within the last
15 minutes, screen will
show sensor’s actual
reading.
If Select is not pressed:
• Receiver times out
• BG level isn’t
recorded
Cancel and re-enter BG
value.
Fingerstick
measurement must
be within five minute
window.
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(Continued from previous page)
Step
What you see
What you do
Wait.
Immediately take
another meter reading.
Enter meter’s BG Value.
Wait for next calibration
prompt in 12 hours.
Additional Info
“Thinking” screen.
BG value is accepted.
First calibration
accepted.
Time for second
calibration.
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, Troubleshooting.
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Device
What you see
What it means
Smart Device:
In App
Wait 10-15 minutes.
Sensor can’t
calibrate now.
Retake fingerstick
measurement at
prompt.
Enter BG value.
Receiver
Smart Device:
In App
System didn’t
accept recent
calibration.
Receiver
What you do
Additional
calibration needed
immediately.
Calibrate.
No sensor glucose
readings.
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.
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Summary
Now You Can:
• Calibration Overview
○○ Define calibration
○○ Explain the importance of calibration
○○ Identify steps to ensure a successful calibration
• Recognize the steps required to take an accurate blood glucose levels
○○ Identify the best blood glucose site for calibrations
○○ Prepare finger for fingerstick measurement
• Determine if you should/should not calibrate
○○ Recognize when you can enter BG meter values
○○ Recognize when should not enter the BG meter values
○○ Determine if you need to calibrate outside of the normal calibration guides
• Initiate startup calibration
• Perform maintenance calibrations
• Correctly enter your fingerstick measurement
○○ Dexcom G5 Mobile App
○○ Dexcom G5 Mobile Receiver
• Identify calibration errors
What’s Next?
In the next chapter, you’ll learn how to end a typical seven day sensor session, what to
do if you need to end your sensor session early, along with 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
Dexcom G5 Mobile Sensor Sessions last seven days. This chapter reviews what you should
expect when your session is about to expire, 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
○○ 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
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.
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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
(e.g., redness, swelling or pain) at the insertion site.
Always report a broken sensor to our Technical Support, 24/7, team as soon as possible:
Toll free: 1.877.339.2664
Toll call: 1.858.200.0200
Why: Sensors may fracture on rare occasions.
Testing done in a controlled environment (in-vitro) didn’t find any safety hazards during
an MRI with a broken off sensor under the skin. The wire didn’t heat up nor have any
significant movement during the MRI, images were affected only in the area around the
sensor’s wire.
MRI with broken wire
If you have experienced a broken sensor and are planning to take an MRI, please discuss
the following with your doctor or technician.
Laboratory (in vitro) MRI tests did not detect any safety hazards for a broken sensor that
remains in the body.
There was no significant movement or heating of the wire. 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
8.3 Ending Your Sensor Session
There are different ways your session might end.
The most common is your sensor’s typical seven day timeframe ended. The second is
ending the sensor session early. You may end a session early based on a personal decision,
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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
○○ Tap screen
• Receiver
○○ Press Select
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End of 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.
Smart Device:
In App
Clock will countdown until session has
ended.
Continue to get sensor glucose readings.
Receiver
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(Continued from previous page)
Device
What you see
What it means
At Two Hours
Smart Device:
Lock Screen
Two hours remain on your current sensor
session.
Smart Device:
In App
Continue to get sensor glucose readings.
Receiver
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(Continued from previous page)
Device
What you see
What it means
At Thirty Minutes
Smart Device:
Lock Screen
Thirty minutes remain.
Smart Device:
In App
Continue to get sensor glucose readings.
Receiver
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(Continued from previous page)
Device
What you see
What it means
Session Ended
Smart Device:
Lock Screen
Session has ended.
App
Tap screen’s “?” for steps to:
Smart Device:
In App
• Remove sensor
• Insert new sensor
Receiver
Press Select to clear.
Receiver
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(Continued from previous page)
Device
What you see
What it means
Session Stopped
Smart Device:
Lock Screen
N/A
Sensor session has stopped.
Smart Device:
In App
App
• No sensor glucose readings
• Prompts for new session
Receiver
Receiver
• Straight line
○○ 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 if 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 prompts. 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 Quick Start Guide,
online tutorials, or go to Chapter 6 in the User Guide.
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Ending Your Sensor Session Early
For personal reasons, you may want to force quit a sensor session early (e.g., 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,
always contact Technical Support before stopping a sensor session early.
Technical Support, 24/7, at:
Toll free: 1.877.339.2664
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.
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Prompts to End Sensor Session Early
System Prompts
Device
What you see
What it means
Smart Device:
Lock Screen
Sensor issues detected.
Smart Device:
In App
Session ends automatically.
No:
• Sensor Glucose Readings
• Alarm/Alerts
Replace sensor.
Receiver
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(Continued from previous page)
Device
What you see
What it means
Smart Device:
Lock Screen
Wait up to three hours while the system
autocorrects.
Smart Device:
In App
Check transmitter—is it properly inserted
into sensor pod?
Make sure you haven’t taken
acetaminophen.
If not corrected after 3 hours:
Receiver
• Contact Dexcom Technical Support
Smart Device:
Lock Screen
Wait up to three hours while the system
autocorrects.
Smart Device:
In App
Check transmitter—is it properly inserted
into sensor pod?
Make sure you haven’t taken
acetaminophen.
If not corrected after 3 hours:
Receiver
• Contact Dexcom Technical Support
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The Dexcom G5 Mobile CGM System 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
Access Main Menu.
Tap Main Menu icon.
Ends sensor session.
During session:
• Stop Sensor option
appears
Tap Stop Sensor.
Not in active session:
• Start Sensor option
appears
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(Continued from previous page)
Step
What you see
What it means
What you do
Blue “?” icons provide
additional information.
Tap Stop Sensor.
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
Go to Main Menu.
Press Select.
(Continued on next page)
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(Continued from previous page)
Step
What you see
What it means
What you do
Ends sensor session.
Press Down Arrow to
Stop Sensor.
During session, Stop
Sensor option appears.
Press Select.
Thinking screen.
Wait.
Confirms you want to
stop sensor.
Press Select.
Return to Main Menu.
Ready to start a new
session.
Remove sensor.
Not in active session,
Start Sensor option
appears.
Press Start Sensor
when ready for new
session.
Insert new sensor.
Temporary Shutdown 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.
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Step
What you see
What it means
What you do
Go to Main Menu.
Press Select.
Shutdown confirmation
screen appears.
Confirms you want to
shut down.
Press Down Arrow to
Shutdown.
Press Select.
Press Select.
Shuts down receiver.
Press Select 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 (e.g., seat belts, etc.).
5. You selected a good insertion site (see Chapter 6).
6. Insertion site is clean and dry before sensor insertion.
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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 blood contacting parts (sensor and applicator).
Remove Transmitter from Sensor Pod
Remember your transmitter is reusable. With a battery life of 90 days, use the same
transmitter over a number of sensor sessions. You’ll receive prompts as you near the end of
its battery life.
Before reusing the transmitter in your new sensor session, separate 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).
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With Safety Lock
Step
Picture
What you do
Grasp end of adhesive patch.
Peel adhesive patch up and away from your body to
remove sensor pod and transmitter.
Put sensor pod on flat surface.
Place safety latch’s jagged edge:
• Over transmitters wide edge
• In between open slots on sensor pods sides
Lift up safety latch.
If you no longer have the safety lock, don’t worry! You can use your fingers to remove the
transmitter from the old sensor pod.
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.
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Without Safety Lock
Step
Picture
What you do
Grasp end of adhesive patch.
Peel adhesive patch up and away from your body to
remove sensor pod and transmitter.
Put sensor pod on flat surface.
Grasp sensor pod’s wide end with two hands and
place fingers in side’s open slots.
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 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.
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Transmitter Battery Messages
Device
What you see
What it means
Smart Device:
Lock Screen
Smart Device:
In App
Battery will expire in three weeks.
Order a new transmitter.
Receiver
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(Continued from previous page)
Device
What you see
What it means
Smart Device:
Lock Screen
Smart Device:
In App
Battery will expire in two weeks.
Order a new transmitter.
Receiver
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(Continued from previous page)
Device
What you see
What it means
Smart Device:
Lock Screen
Smart Device:
In App
Battery will expire in one week.
Order a new transmitter.
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 store.dexcom.com, by calling Customer Service (see Section 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 transmitters 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.
For more information on setting your sound/vibration prompts and how to clear them, please
see Chapter 9.
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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 prompts. If not cleared, you receive a
vibrate/beep twice, five minutes apart.
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
○○ 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
What’s Next?
Congratulations, you have the basics down!
You can set up your app and receiver, start a sensor session, calibrate, along with ending
your sensor session and when to replace your transmitter. But the Dexcom G5 Mobile CGM
System can do much more.
In the next part, Part 3: Next Steps, you will learn how to get the most out of your Dexcom G5
Mobile CGM System.
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NEXT STEPS - GETTING THE MOST
OUT OF YOUR DEXCOM CGM
•
Reading Trend Graph Screens and Recognizing Trends
•
Events
•
Alarm and Alerts
•
Sounds for Alarm, Alerts and System Messages
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Chapter 9
Next Steps:
Home Screen, Rate of Change Arrows, and
Errors
9.1 Introduction to Home Screens
In the previous chapter, you learned about calibrations: why they are important and how
to do complete them. Within five minutes of your final calibration your sensor glucose
readings begin!
In this chapter, you’ll learn three things. First, reading the home screen, second, identifying
your sensor glucose readings and trends: What do they mean? What’s the best way to use
trend information? And third, what you do if you aren’t getting your sensor glucose readings.
The purpose of this chapter isn’t to tell you how to react to your trends, but to help you
recognize where your glucose was and where it’s going. Your healthcare professional can
help you with your questions on what actions to take based on your glucose trends.
After this chapter, you’ll be able to:
•
•
•
•
•
•
•
•
•
Recognize home screen icons
Locate sensor glucose reading
Explain sensor glucose target range
Recognize the importance of gray, yellow, and red colors
Identify low/high glucose alert levels on your trend graph
Describe when you receive a High or Low sensor glucose reading
Change trend graph views
Cite differences between rate of change arrows
Recognize error messages
9.2 Safety Statements
Take a moment and read the safety statements. If not followed, your sensor glucose
readings and trends may be less accurate, plus and you may miss important high or low
glucose alerts.
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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:
1. Amount of acetaminophen active in your body.
2. May be different for each person.
Consequences: Without correct readings you might miss a severe low event.
WARNING
Don’t: Never use the Dexcom G5 Mobile CGM System sensor glucose readings for
treatment decisions.
Do: Only use BG values from your BG meter for treatment decisions (e.g., 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 blood glucose values.
Consequences: Using sensor glucose readings for treatment decisions could result in you
missing a severe low or high event.
WARNING
Don’t: Never ignore symptoms of high and low glucose.
Do: Measure your blood glucose with 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
having severe low (hypoglycemia) or high (hyperglycemia) events.
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 and smart devices, their information and color coding are
the same.
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No matter how you hold it the receiver’s view does not change; the Dexcom G5 Mobile App
has two ways to view data based on how you hold your smart device:
1. Vertically in portrait: 3-hour trend information with task bar.
2. Horizontally in landscape: 1, 3, 6, 12 or 24 hour trend information without task bar.
This section first familiarizes you with the app’s home screen, then with the receiver’s home
screen.
The app also supports two additional, and optional, ways that you can see your app’s CGM
information: the Today view widget and the Apple Watch. See Additional Ways to View Your
App’s CGM Information in this chapter for more detail.
In other chapters, you’ll see how to use the icons or use the navigation wheel to enter data or
make system changes.
App Home Screen
The app’s home screen has two main sections:
1. The Task Bar. This is where you go to do tasks such as changing settings and entering
data.
2. The Glucose Information area. This area displays your sensor glucose readings and
trends.
Task Bar
Glucose Information
Figure 6. App Home Screen on Mobile Device
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Task Bar
App
Name
What it means
What you do
Task Bar: Complete Tasks
Tap Main Menu
icon to access:
Main Menu
Goes to other options.
•
•
•
•
Alerts
Settings
Help
Start/Stop
Sensor
BG Meter
with red circle Calibration Prompt.
and number
Tap icon and
enter fingerstick
BG value (see
Chapter 7).
BG Meter
without red
circle
Do nothing.
Event
No need to calibrate.
Enter different events
capturing activities
affecting your
glucose.
Tap icon to enter
data for:
•
•
•
•
Carbs
Insulin
Exercise
Health
(See Chapter 10).
Dexcom
Share
Dexcom
Share
Dexcom Share is only
available on the app.
Gray icon means
Share is not active.
Once activated,
Dexcom Share icon is
colored.
Tap icon to activate
(see Part 5).
Do nothing.
Tap icon to access
Dexcom Share.
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Glucose Information
App: Portrait
App: Landscape
What it means
Home Screen
In Landscape mode,
tap on the trend view
you want to see at the
top of the screen: 1, 3,
6, 12, or 24 historical
trend views.
Number: Most recent
sensor glucose
reading.
Shown in milligrams
per deciliter(mg/dL).
1. Yellow: At or
above target
2. Gray: Within
range
3. Red: At or below
target
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(Continued from previous page)
App: Portrait
App: Landscape
What it means
Historical Readings
Turn smart device to
Landscape mode.
Tap time, shows
timeframe’s sensor
glucose reading.
N/A
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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(Continued from previous page)
App: Portrait
App: Landscape
What it means
Sensor Glucose
Reading Range
Shows between
40-400 mg/dL.
Within Glucose
Range and Alert
Levels
1. Yellow Bar: High
Alert level
2. Gray
Background:
Within range
3. Red Bar: Low
Alert level
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(Continued from previous page)
App: Portrait
App: Landscape
What it means
Trend Graph
Timeframe
Default is most recent
3 hours.
Turn smart device
to Landscape mode
for most recent 1, 3,
6, 12, and 24 hour
readings.
Additional Ways to View Your App’s CGM Information
The Dexcom G5 Mobile App offers more ways to check on your CGM information apart from
opening the app. If you choose, you can expand the flexibility of your app by using either of
the following features:
• Dexcom G5 Mobile widget in the Apple Today view
• Dexcom G5 Mobile for Apple Watch
Safety Statements
PRECAUTION
Using an accessory device (like a smart watch) might override your smart device sounds.
Alarms or Alerts might vibrate or be heard on the accessory instead of your smart device.
After connecting any accessories, make sure that the smart device settings allow you to
continue receiving Alarms or Alerts on the smart device.
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The Dexcom G5 Mobile Widget in the Apple Today View
Check your CGM information on your smart device without needing to open the app, even
when the device is locked. Your Dexcom G5 Mobile App provides a widget for your Today
view that’s accessed by swiping down from the top edge of the screen.
Sensor Glucose
Reading
Trend Arrow
Trend Graph
Figure 7. The Dexcom G5 Mobile App widget in the Today view.
You can edit your widgets by clicking on the Edit button at the bottom of the Today view. See
your smart device instructions for the latest information on customizing your Today view.
The Dexcom G5 Mobile for Apple Watch
Check your CGM information on your wrist! The Dexcom G5 Mobile App supports Apple
Watch* and can be used to view your glucose reading, trend arrow, and trend graph.
Trend Arrow
Sensor Glucose
Reading
Trend Graph
Figure 8. The Dexcom G5 Mobile for Apple Watch
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To set up Dexcom G5 Mobile on your Apple Watch you’ll need to use the Watch app located
on your smart device. See your Apple Watch instructions for more detail on setting up an app
on the watch.
Your Apple Watch will only communicate with your smart device, not the Dexcom G5
Transmitter. You will not receive alerts, alarms, and other notifications on the watch unless it
is connected with your smart device. For example, if you have your watch on and you go out,
but leave your smart device at home, you will not receive any CGM updates.
When you wake your Apple Watch, it gets your current CGM data from your smart device.
There may be a brief delay before your watch app shows current information.
*For compatibility information see dexcom.com/compatibility.
Now that you’ve learned about the app’s home screen, let’s move our focus to the Dexcom
G5 Receiver.
Receiver Home Screen
Unlike your smart device screens, the receiver’s screen is not interactive; all prompts are for
information only. To make changes or enter data in the receiver, press Select and go to the
Main Menu.
The receiver’s home screen has two main sections:
1. Status Bar
a. Status Bar reflects glucose trends, readings, status of receiver’s system (e.g.,
battery level).
2. Glucose Information Trend Graph
a. Reflects sensor glucose readings and trends.
This section will get you familiar with the receiver’s home screen. In other chapters, you’ll
see how to use the navigation wheel to enter data or make system changes.
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Status Bar
Glucose
Information
Figure 9. Home Screen on Receiver
Status Bar
Receiver
Name
What it does
Status Bar
Provides at a
glance information
about the receiver,
system, or you.
Icons will change
based on current
data.
Battery
Shows battery
level.
Bluetooth
Shows Bluetooth
connection is
working.
What you do
Review and take
appropriate action.
When low, plug
micro USB cable
into receiver.
Plug USB into
the adapter and
then into electrical
outlet.
Do nothing.
Receiver’s
Bluetooth is always
on.
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(Continued from previous page)
Receiver
Name
What it does
What you do
Shows most recent
sensor glucose
reading. Color of
status bar changes:
Sensor Glucose
Reading
Trend Arrow
• Yellow: At or
above target
• Gray: Normal
range
• Red: At or
below target
Shows direction
and speed
your glucose is
changing.
Take appropriate
action.
Review and
take appropriate
action based on
fingerstick BG
value.
Far right.
Status Area
Error icons
and calibration
prompts.
Take appropriate
action.
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Glucose Information
Receiver
What it does
Home screen.
Number: Most recent sensor glucose reading.
Shown in milligrams per deciliter (mg/dL). Color of status bar
changes:
• Yellow: At or above target
• Gray: Normal Within range
• Red: At or below target
Historical Readings
Default is most recent 3 hours.
Press Up/Down Arrows to access 1, 3, 6, 12, or 24 hour
trend views.
Rate of Change Arrow
Direction and speed of your glucose changes.
Sensor Glucose Reading Range
Shows between 40-400 mg/dL.
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(Continued from previous page)
Receiver
What it does
Glucose target range Alert settings.
• Yellow Bar: High Alert setting
• Gray Fill: Normal range
• Red Bar: Low Alert setting
Now you’re familiar with the basic layout of the trend graph screen, can locate readings,
identify color coding, and view time frames. Let’s take a closer look at the rate of
change arrows.
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 your current BG value. Don’t overreact to the arrows. Remember
the arrows don’t reflect your latest reading: they reflect a combination of recent readings.
Rate of Change Arrows
App
Receiver
What your glucose is doing
Glucose is steady.
Not increasing/decreasing more than 1 mg/dL per
minute or up to 15 mg/dL in 15 minutes.
Glucose slowly rising 1-2 mg/dL each minute or up
to 30 mg/dL in 15 minutes.
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(Continued from previous page)
App
Receiver
What your glucose is doing
Glucose rising 2-3 mg/dL each minute or up to 45
mg/dL in 15 minutes.
Glucose rapidly rising more than 3 mg/dL each
minute or more than 45 mg/dL in 15 minutes.
Glucose is slowly falling 1-2 mg/dL each minute or
up to 30 mg/dL in 15 minutes.
Glucose is falling 2-3 mg/dL each minute or up to
45 mg/dL in 15 minutes.
Glucose is rapidly falling more than 3 mg/dL each
minute or more than 45 mg/dL in 15 minutes.
N/A
No arrow
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, or display devices aren’t communicating, causing you
not to get your sensor glucose readings or rate of change arrows. Each device notifies you
when there is an issue; however, the notifications look different.
Before the system can move forward, you need to address the error.
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App
1. If screen is locked:
a. Swipe message to go to app.
2. Within app:
a. Read message.
i. Tap Question Marks for more information and follow steps as appropriate.
Receiver
1. Press Select to clear message.
You will not get any sensor glucose readings or rate of change arrows on either display
device until the error is resolved. Check with your BG meter to monitor your glucose during
these error periods.
Error Messages
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.
Smart Device:
In App
Move within 20 feet of display device.
Wait up to 30 minutes while transmitter
restores communication.
Receiver
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(Continued from previous page)
Bluetooth Off
Smart Device:
Lock Screen
Smart device:
1. Exit app.
2. Tap Settings.
3. Tap Bluetooth.
4. Turn Bluetooth on.
Smart Device:
In App
Receiver
N/A; Bluetooth is always
on.
Not Getting Sensor Glucose Reading
Smart Device:
Lock Screen
N/A
Smart Device:
In App
N/A
Check—Are you:
•
•
•
•
Receiver
Within 20 feet of your display device?
In your two hour warmup period?
Outside of your calibration schedule?
In a sensor session?
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System Found Temporary Sensor Issue
Smart Device:
Lock Screen
N/A
Don’t calibrate.
Smart Device:
In App
System may correct problem on its own
and display sensor glucose readings again.
If prompt stays for three hours:
Contact Technical Support (see Section
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.
Smart Device:
In App
Make sure your transmitter is properly
inserted into the sensor pod.
If not corrected:
• Contact Technical Support (Section
16.1)
• Remove sensor
• Insert new sensor
Receiver
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(Continued from previous page)
Calibration Required
Smart Device:
Lock Screen
Smart Device:
In App
Error in calibrating.
Enter another BG meter value.
Receiver
Calibration Error
Smart Device:
Lock Screen
N/A
Smart Device:
In App
Wait 15 minutes.
Enter a BG meter value.
Receiver
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(Continued from previous page)
Display Devices and Transmitter not Communicating
Smart Device:
Lock Screen
Wait 10 minutes.
Smart Device:
In App
Move display device and transmitter within
20 feet of each other without obstruction
(walls or water).
Wait up to 30 minutes.
Receiver
In app (if not resolved):
1. Tap Settings.
2. Tap Bluetooth.
3. Turn Bluetooth Off and On.
If error messages don’t go away after you followed necessary steps, and you aren’t getting
sensor glucose readings, contact Technical Support (see Section 16.1).
Now You Can:
•
•
•
•
•
•
•
•
•
Recognize home screen icons
Locate sensor glucose reading
Explain glucose target range
Recognize the importance of gray, yellow, and red colors
Identify low/high alert glucose 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 what you do or how you feel can change
your trends.
In
the next chapter, you will learn how to enter Events in the Dexcom G5 Mobile System.
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Chapter 10
Next Steps:
Daily Events Affect Your Glucose Trends and
Patterns
10.1 Introduction
Your daily activities can impact your glucose trends and patterns. In the previous chapter,
you learned how to read your glucose trend screens; in this chapter, you learn how to
enter situations, or “Events”. By tracking Events, you can determine how certain actions or
circumstances affect your glucose levels.
After this chapter, you’ll be able to:
• Define Event
• Describe each Event
• Create Events
○○ Dexcom G5 Mobile App
○○ Dexcom G5 Mobile Receiver
• Recognize Event markers on the Dexcom G5 Mobile App
○○ 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 sugars.
An Event is an action or situation affecting your glucose levels. With the Dexcom G5 Mobile
CGM System, 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.
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153
You can use the reports with your healthcare professional to create a game plan in managing
your diabetes.
Even though they differ on how to enter an Event and time, the app and receiver have the
same Event categories and subcategories. Later in this chapter, you’ll learn how to enter
Events in each device.
Event Categories
There are four main Event categories:
1. Carbs
2. Insulin
3. Exercise
4. Health
The fourth category, Health, has more options:
•
•
•
•
•
•
Illness
Stress
Feel High
Feel Low
Cycle
Alcohol
The following table provides more detail on each type of Event.
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Events Menu
Device
What you see
What it means
What you do
Carbs
Smart Device:
In App
How many grams
did you just eat?
Receiver’s screen
reflects last number
entered.
Enter Carb grams
per snack or meal,
up to 250 grams.
Receiver
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(Continued from previous page)
Device
What you see
What it means
What you do
Insulin
Smart Device:
In App
Receiver’s screen
reflects last number
entered.
Enter insulin units
for each dose, up to
250 units.
Can’t enter type of
insulin, only dosage.
Receiver
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(Continued from previous page)
Device
What you see
What it means
What you do
Exercise
Smart Device:
In App
Defaulted at 30
minutes.
Select each
exercise’s intensity
level and duration.
Enter intensity and
duration.
Type of exercise
isn’t an option.
Receiver
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(Continued from previous page)
Device
What you see
What it means
What you do
General well being.
Enter different
health Events (see
following Health
Events Menu table).
Health
Smart Device:
In App
Receiver
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(Continued from previous page)
Device
What you see
What it means
What you do
Event time.
For each separate
Event, enter
date/time Event
began.
Event Time
Smart Device:
In App
Receiver
As mentioned in the last table, Health has a series of Events. Tell the system how you are
feeling, if you had a drink, if you’re having low or high BG symptoms, etc. You select the
Event: no amounts are entered, just date and time.
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Health Events Menu
Device
What you see
What it means
Health Main Menu
Smart Device:
In App
Use Health Main Menu to access
selections.
Receiver
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(Continued from previous page)
Device
What you see
What it means
Health Events
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 into
the receiver.
10.3 Entering Events
You probably will enter Events in your 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 see your Event entries. For more
Dexcom Share information, please see Part 5.
Enter Events: Smart Device
In the Dexcom 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 Carbs, Insulin, Exercise, and Health’s categories follow the same steps.
If you can enter a Carb Event, you can enter an Insulin Event. To enter Events, we’ll use the
above scenario. The following table shows how to enter Carb (drive-thru lunch) and Stress
(traffic jam) Events.
Entering Events: Dexcom G5 Mobile App
Step
What you see
What you do
Enter Carb Event
Tap Running Man.
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(Continued from previous page)
Enter Carb Event
Tap Carbs.
Add up all carb grams from lunch.
Enter “85” using keypad.
Tap Done.
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(Continued from previous page)
Enter Carb Event
Tap Event Time.
Scroll and select date and time.
Tap Done.
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(Continued from previous page)
Enter Carb Event
Tap Save or Cancel.
Enter Stress Event
Tap Running Man.
Tap Health.
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(Continued from previous page)
Enter Stress Event
Tap Stress.
Tap Done.
Tap Event Time.
10
(Continued on next page)
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(Continued from previous page)
Enter Stress Event
Scroll and select date and time.
11
Tap Done.
Tap Save or Cancel.
12
(Continued on next page)
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Dexcom 9496 Spread Spectrum Device User Manual Part 1

Dexcom, Inc. Spread Spectrum Device Part 1

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User Manual Part 1

FCC ID Filing: PH29496

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