Dexcom G5 User Manual

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User Guide
for Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System
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IMPORTANT CONTACTS AND NUMBERS
Emergency Phone Number: ______________________________________________
Your Healthcare Professional: _____________________________________________
Your Receiver Serial Number: _____________________________________________
Your Transmitter Serial Number: ___________________________________________ ___________________________________________________________________
Dexcom® Technical Support/Patient Care Team: _______________________________
Dexcom Website: ______________________________________________________
Nearest Hospital: ______________________________________________________ ___________________________________________________________________
1.888.738.3646
dexcom.com
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Dexcom G5 Mobile System User Guide
1Table of Contents
Table of Contents
Part 1: Getting Started
Glossary ........................................................ 5
Chapter 1 - Beginning Your Dexcom G5 Mobile® Continuous Glucose Monitoring
(CGM) System Journey ................................ 9
1.1 Introduction .............................................. 9
1.2 Self-Paced Resources ............................ 10
1.3 Your Dexcom Account ............................. 13
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 .............. 18
Chapter 3 - Risks and Benefits ................. 29
3.1 Risks ...................................................... 29
3.2 Benefits .................................................. 31
Part 2: Let’s G5®! The Basics
Chapter 4 - What’s the Dexcom G5 Mobile? ... 37
4.1 Introduction ............................................ 37
4.2 Safety Statement ................................... 37
4.3 The Dexcom G5 Mobile ........................... 39
4.4 What’s New to the Dexcom G5 Mobile? .. 41
4.5 System Information ................................ 42
4.6 System Components .............................. 42
4.7 Smart Device Overview .......................... 49
Chapter 5 - Set Up Your Display Devices .. 51
5.1 Introduction ............................................ 51
5.2 Safety Statement ................................... 51
5.3 Why Different Monitoring Methods? ....... 52
5.4 Dexcom G5 Mobile App .......................... 52
5.5 Receiver ................................................. 66
Chapter 6 - Starting a Sensor Session: Inserting Sensor, Attaching Transmitter,
and Starting Your Session ......................... 71
6.1 Introduction ............................................ 71
6.2 Safety Statements .................................. 72
6.3 Prepping for Sensor Insertion ................. 74
6.4 Choosing Your Insertion Site ................... 77
6.5 Inserting Your Sensor ............................. 79
6.6 Attaching Your Transmitter ..................... 83
6.7 Loose Sensor Pod ...................................86
6.8 Starting Your Sensor Session ................. 86
6.9 Receiver Bluetooth Tips .......................... 91
6.10 Sensor Session Warmup ....................... 92
Chapter 7 - Calibration .............................. 95
7.1 Introduction ............................................ 95
7.2 Safety Statements .................................. 96
7.3 Calibration Overview ............................... 98
7.4 When to Calibrate ................................... 99
7.5 Calibration Prompts .............................. 101
7.6 Preparing for Calibration ....................... 105
7.7 Ready? Set? Calibrate! ......................... 106
7.8 Calibration Errors ...................................114
Chapter 8 - Ending Your Sensor Session
and Transmitter Session...........................117
8.1 Introduction ...........................................117
8.2 Safety Statements .................................118
8.3 Ending Your Sensor Session ..................119
8.4 Remove Sensor Pod and Transmitter .... 133
8.5 End of Transmitter Battery ................... 135
8.6 Pair New Transmitter ............................ 139
Part 3: Next Steps - Getting the Most out of Your Dexcom® CGM
Chapter 9 - Home Screen, Rate of Change
Arrows, and Errors ................................... 153
9.1 Introduction to Home Screens ............... 153
9.2 Safety Statements ................................ 154
9.3 Home Screen Overview ........................ 155
9.4 Rate of Change Arrows ......................... 170
9.5 Error Messages .................................... 172
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Dexcom G5 Mobile System User Guide
2Table of Contents
Chapter 10 - Daily Events Affect Your
Glucose Trends and Patterns .................. 177
10.1 Introduction ........................................ 177
10.2 What Is an Event? ............................... 177
10.3 Entering Events .................................. 186
10.4 Viewing Events ................................... 196
Chapter 11 - Sensor Glucose Alarm and
Alerts ........................................................ 199
11.1 Introduction ......................................... 199
11.2 Safety Statements .............................. 200
11.3 Alarm and Alerts ................................. 202
11.4 Alarm and Alerts Screens ...................204
11.5 App: Alert Sound and Vibration ........... 211
11.6 Receiver: Alert Sound and Vibration .... 215
11.7 Confirming Alarm/Alerts ..................... 219
11.8 Receiver: Test Speaker and Vibrations .... 221
Chapter 12 - On the Go With G5: Customizing
Your Alarm and Alerts .............................. 225
12.1 Introduction ........................................226
12.2 Safety Statement ................................226
12.3 Changing App Alarm and Alerts .......... 226
12.4 Changing Receiver Alarm and Alerts ... 242
Chapter 13 - Using the Dexcom G5 Mobile
System for Treatment Decisions ............. 253
13.1 Introduction ........................................253
13.2 Safety Statement ................................ 254
13.3 Treatment Decisions: The Basics ........ 254
13.4 Treatment Decisions: Beyond the Basics ...258
13.5 You Decide! ........................................ 265
13.6 General Guidlines................................268
Part 4: Everything Else G5
Chapter 14 - Warranty: The Fine Print .... 273
14.1 Introduction ........................................ 273
14.2 Receiver Warranty Information .......... 273
14.3 Transmitter Warranty Information ...... 276
14.4 Dexcom’s Obligations Under the
Limited Warranty ........................................ 277
Chapter 15 - How to Take Care of Your
Dexcom G5 Mobile ...................................279
15.1 Introduction ........................................ 279
15.2 Safety Statements .............................. 280
15.3 Basic Maintenance ............................. 281
15.4 Storage ............................................... 286
15.5 Checking App and Receiver Information ... 287
15.6 System Disposal .................................288
Chapter 16 - On the Go With Dexcom G5
Mobile: Getting Through Security ........... 291
16.1 Introduction ........................................291
16.2 Safety Statements ..............................292
16.3 Going Through Security ...................... 292
Chapter 17 - Need Help? You’re Not Alone! ....295
17.1 Dexcom Technical Support Team ........295
17.2 Dexcom Patient Care Team ................. 296
17.3 Dexcom Sales Support Team ..............297
17.4 Corporate ........................................... 298
Chapter 18 - Technical Information ........ 299
18.1 Device Performance Characteristics ... 299
18.2 Product Specifications ........................ 337
18.3 FCC Requirements ..............................345
Chapter 19 - Troubleshooting .................. 347
19.1 Introduction ........................................ 347
19.2 Safety Statements .............................. 348
19.3 Troubleshooting .................................. 349
Chapter 20 - Symbols on Package Labels ... 365
Part 5: Sharing Is Caring
Chapter 21 - Dexcom Share ..................... 371
21.1 Learning About Dexcom Share ............ 371
21.2 Dexcom Share Overview ..................... 375
21.3 Risks and Benefits ..............................377
21.4 Safety Statement ................................ 379
21.5 Setting Up Dexcom Share ................... 382
21.6 Using Dexcom Share...........................392
21.7 Dexcom Follow App ............................ 398
21.8 Troubleshooting .................................. 401
Part 6: Index
Index .........................................................405
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• Glossary
• Getting Started
• Indications for Use and Safety Statement
• Risks and Benefits
GETTING STARTED
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Glossary
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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 (Accessory)
A device meant to connect to a smart device, to add or extend features. For example, a smart watch or headphones.
Alternative Site Testing
Using a blood sample from non-fingertip (alternative) sites such as the palm, forearm or upper arm for meter readings.
Do not use alternative site testing to calibrate the Dexcom G5
®
Mobile CGM System (G5 Mobile). Only use fingerstick
measurement.
App A software application on a smart device.
The G5 Mobile app was developed as a display for continuous glucose monitoring.
Blood Glucose (BG) Value
An abbreviation of blood glucose. Blood glucose (BG) value is the amount of glucose in the blood measured by a BG meter.
Blood Glucose Meter/Meter/BG Meter
A medical device used to measure how much glucose is in the blood.
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Glossary
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Glossary
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Calibration A comparison or measurement between your meter’s fingerstick BG
values and the sensor’s interstitial fluid glucose readings. Although blood and interstitial fluids are similar, glucose concentration is higher in your blood. Calibration allows alignment between your sensor and meter readings.
When you calibrate, you take a fingerstick measurement from your meter then enter the value into your receiver or smart device. The system uses that value to verify that the sensor glucose reading is on track.
Continuous Glucose Monitor (CGM)
A system that uses a sensor inserted under the skin to check glucose levels in interstitial fluid. A transmitter sends sensor glucose readings to a display device.
Contraindication A safety statement outlining specific situations where the G5 Mobile
should not be used because it may be harmful to you. The risk of use clearly outweighs any possible benefit.
Hyperglycemia High BG. Same as “high” or high blood sugar. Hyperglycemia is
characterized by an excess of glucose in the bloodstream. It’s important to treat hyperglycemia. If left untreated, hyperglycemia
can lead to serious complications. The default High Glucose Alert in the G5 Mobile is set to 200 mg/dL.
Consult your healthcare professional to determine the appropriate hyperglycemia setting for you.
Hypoglycemia
Low BG. Same as “low” or low blood sugar. Hypoglycemia is characterized by a low level of glucose in the bloodstream.
It’s important to treat hypoglycemia. If left untreated, hypoglycemia can lead to serious complications.
The default Low Glucose Alert in the G5 Mobile is set to 80 mg/dL. Consult your healthcare professional to determine the appropriate hypoglycemia setting for you.
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Glossary
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(Continued from previous page)
Indication
A condition making a particular treatment or procedure advisable. Indications let you know who should use the G5 Mobile 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.
An IP28 rating tells you your electronic device won’t let you stick your fingers in it and is safe for long-term immersion in liquid up to a specified pressure.
Jailbreak, Root
The removal of limitations and security measures set by the manufacturer on a smart device. The removal poses a security risk and data may become vulnerable.
Do not use, install or run the G5 Mobile app on a jailbroken or rooted smart device. The app may not work correctly on such a device.
Landscape
When your smart device is oriented sideways.
mg/dL Milligrams per deciliter. The standard unit of measure for glucose
readings in the United States.
Portrait When your smart device is oriented vertically.
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Glossary
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(Continued from previous page)
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.
RF Radio-frequency (RF) transmission used to send glucose
information from the transmitter to the receiver or smart device. Also used to send calibration data from the receiver or smart device to the transmitter.
Safety Statement A statement of the intended uses of G5 Mobile and relevant
warnings, precautions, and contraindications.
Sensor Session The seven-day monitoring period after inserting a new sensor.
During this time frame, your glucose is being monitored and reported every five minutes, with data being sent to your display device(s).
Smart Device A mobile device that can wirelessly connect to networks over Wi-
Fi or a cellular data connection (3G, 4G, etc). Examples are smartphones and tablets.
Smart Watch A watch with wireless connectivity, typically designed to pair with
a smart device. An example is the Apple Watch.
Stacking Insulin Taking a dose of insulin soon after your most recent dose. This
can result in low blood sugar. Doesn’t apply to taking insulin doses to cover what you just ate.
Today View Swipe down, then right, to access information and notifications on
your iPhone, iPad
®
, and iPod®.
Warning A safety statement letting you know the following feature
has important hazard information. Describes serious and life-threatening circumstances of using the G5 Mobile, their consequences, and how to avoid the hazard.
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Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
1.1 Introduction
Welcome to the Dexcom G5 Mobile CGM System (G5 Mobile) family! We are excited you chose us to partner with you in your journey to manage your diabetes. As
a continuous glucose-monitoring (CGM) device, the G5 Mobile System allows you to break free from constant fingersticks. But how do you use the G5 Mobile? What are its features? Do you need to avoid anything?
Where do you even begin? This chapter is the first step to answering these and many other questions. After this chapter, you will be able to:
• Describe different training resources
• Locate tutorials about using the Dexcom G5 Mobile in your diabetes management
• Find step-by-step instructions for the Dexcom G5 Mobile
• Recall how to use the User Guide
• Explain why you need a Dexcom® account
We have numerous resources available to help you get the most out of your Dexcom G5 Mobile. Between our self-paced training resources and our friendly and knowledgeable Dexcom customer support teams, help is always available.
First Things First—Learning How to Learn
Knowing about the Dexcom G5 Mobile is your first step in creating a successful CGM experience. Before using it, learn about it.
You have numerous self-paced resources, helping you get to know the Dexcom G5 Mobile:
Chapter 1
Getting Started:
Beginning Your Dexcom G5 Mobile® Continuous Glucose Monitoring (CGM) System Journey
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Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
1. Tutorials
2. Getting Started Guide
3. User Guide
No matter which resource(s) you select, make sure you review them prior to using your new CGM system.
1.2 Self-Paced Resources
Tutorials
Along with step-by-step instructions, our tutorials illustrate how real-time CGM can assist in your daily diabetes management. The following is a list of tutorials and how to access them.
Online Tutorials
First Steps With Your Dexcom CGM
Designed for those who have never used a Dexcom CGM, this tutorial covers what to expect in your first week and includes links to step-by-step videos on how to insert your sensor, calibrations, ending a sensor session, etc.
Next Steps With Your Dexcom CGM
Just finished First Steps or already familiar with how a CGM can benefit you? This tutorial covers looking at trends and introduces some advanced features including our reporting tools (see Chapter 10).
Accessing Online Tutorials:
Go to dexcom.com, click the menu, then Support. Once you have viewed the online tutorials you should be pretty comfortable with what CGMs
do and how the Dexcom G5 Mobile can help you.
Offline Tutorials
You don’t need to be tied to the Internet to view our instructional tutorials, they’re also available offline.
Accessing Offline Tutorials:
Use the USB card in the receiver package.
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Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
Written Mobile Resources
Getting Started Guide (GSG)
The Dexcom G5 Mobile GSG complements the tutorials by providing in booklet form the same step-by-step instructions seen in the app.
One of the great things about the GSG is you can use it in conjunction with the videos, taking notes as you go!
Accessing the GSG:
Use the GSG booklet in the receiver package Both the tutorial and the GSG give you a brief look at the Dexcom G5 Mobile. But what if you
want more detailed information?
User Guide
Your Dexcom G5 Mobile encyclopedia! This user guide gives you the most extensive overview of the system detailing features,
important safety information, and so much more. To download an eBook of the user guide or request a printed user guide, visit
dexcom.com/guides. The Dexcom G5 Mobile user guide is grouped into six separate parts: Part 1:
Getting Started
• Glossary
• Getting Started – Getting more information about the Dexcom G5 Mobile – Registering at dexcom.com
• Indications for Use and Safety Statement
• Risks and Benefits
Part 2:
Let’s G5! The Basics
• Introduction to the Dexcom G5 Mobile
• Initial Setup
• Starting a Sensor Session: Inserting the Sensor and Attaching the Transmitter
• Calibration
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Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
• Ending a Sensor Session and Transmission Session
Part 3:
Next Steps - Getting the Most Out of Your G5 Mobile
Once you are up and running, how you can maximize the Dexcom G5 Mobile features:
• Reading Trend Graph Screens and Recognizing Trends
• Events
• Alarm and Alerts
• Sounds for Alarm, Alerts, and System Messages
• Using Dexcom G5 Mobile for Treatment Decisions
Part 4:
Everything Else G5
• Warranty
• Maintenance
• Travel Tips
• Customer Service Contacts
• Technical Information
• Troubleshooting
• Symbols on Package Labels
At the end of your Dexcom G5 Mobile user guide is the Dexcom
Share
®
user guide.
Part 5:
Sharing Is Caring
• Dexcom Share – What Is Dexcom Share? – Setting Up Dexcom Share – How to Use Dexcom Share – Your Followers
– Troubleshooting
Part 6:
• Index for Dexcom G5 Mobile and Dexcom Share
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Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey
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, it shows any applicable safety statements you need to know, followed by the chapter’s content. At the end, there’s a recap of what was covered and what’s in the next chapter.
1.3 Your Dexcom Account
You’ll need a username and password to set up the Dexcom G5 Mobile app and for reordering supplies.
If you haven’t already done so, go to dexcom.com and set up your own account. Or, if you prefer, the Dexcom G5 Mobile app walks you through creating your login credentials
as part of your initial app setup.
Summary
Now You Can:
• Describe different training resources
• Locate tutorials about using real-time CGM in your diabetes management
• Find step-by-step instructions for the Dexcom G5 Mobile
• 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 safely.
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Dexcom G5 Mobile System User Guide
15Indications for Use and Safety Statement
2.1 Introduction
We want the Dexcom G5 Mobile System to be a valuable tool in your diabetes management. Like any system, there are steps to take to get the most out of it. As excited as you are about getting started, did you know that if you just took Tylenol®, maybe you should wait? Did you know taking Tylenol is contraindicated?
In this chapter, you’ll learn about some key areas that might prevent you from having the best CGM experience or if you’re not careful might even harm you or the system. You’ll even learn what a contraindication is!
2.2 Important User Information
Each part of your system has instructions including indications, contraindications, warnings, precautions, and other important user information. Please review the instructions for each part of the system in this user guide before using the system.
This chapter is important to read. It helps you use the system safely and covers:
• What is a Safety Statement? – 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, then look at a Safety Statement example used throughout the user guide, and then review the Safety Statements.
Chapter 2
Getting Started:
Indications for Use and Safety Statement
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16Indications for Use and Safety Statement
Safety Statement
A Safety Statement is a brief statement of the system’s indications, contraindications (when to avoid using it), relevant warnings, and precautions. The Safety Statements are meant to keep you and the system safe while using the system:
1) Indications How, for what purposes, and under what circumstances you should use the system.
Indications let you know who should use the system and when. Indications are the who, what, and why of the system.
2) Contraindications Contraindications let you know when
not
to use the system. If used during these situations,
you may hurt yourself or the system, the risk of use clearly outweighs the benefit.
3) Warning Important hazard information: Describes serious or life-threatening circumstances to stay
away from while using the system, their consequences, and how to avoid danger.
4) Precaution
Special steps you need to take while using the system preventing minor or moderate injury
to either you or the system.
2.3 Safety Statements
This user guide presents Safety Statements two ways:
1. In this chapter’s Overview of Safety Statements – Lists all Safety Statements – Includes a section reviewing how the statements are formatted
2. Within each chapter – Lists only those statements applicable to that specific chapter
Chapter’s Safety Statements
Each chapter will list all applicable indications, contraindications, precautions, and warnings. Some chapters will have multiple Safety Statements; others have none. Safety Statements
are located toward the beginning so you can keep them in mind as you learn about that chapter’s topic. The same statement may be repeated throughout the user guide. It’s important to recognize which factors could prevent the system from working correctly, or even harm you.
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Dexcom G5 Mobile System User Guide
17Indications for Use and Safety Statement
Within chapters, each color-coded Safety Statement is in a box, broken down into four sections:
1. Type of statement
a. Bold and color-coded
▪ INDICATION-Green
▪ CONTRAINDICATION-Purple
▪ WARNING-Red
▪ PRECAUTION-Blue
2. Do’s/Don’ts
a. An action you should or should not take b.
Italicized
3. Why
a. A statement of the potential harm
4. Consequences
a. What could happen if you don’t follow the instructions
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 a severe low or high glucose event or making a treatment decision that results in injury.
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 or making a treatment decision that results in injury.
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18Indications for Use and Safety Statement
2.4 Overview of Safety Statements
This section provides a review of Safety Statements containing the same elements described above (type of Safety Statement, an action, a statement of potential harm, and consequences) but listed in a narrative, not boxed, format. Here you’ll learn what indications and contraindications are and what to do to keep you safe and the system in proper working order.
Indications for Use
The Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5 Mobile) is a glucose monitoring system indicated for the management of diabetes in persons age 2 years and older. The Dexcom G5 Mobile is designed to replace fingerstick blood glucose testing for diabetes treatment decisions.
Interpretation of the Dexcom G5 Mobile results should be based on the glucose trends and several sequential readings over time. The Dexcom G5 Mobile also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G5 Mobile is intended for single patient use and requires a prescription.
Important User Information
Failure to use the Dexcom G5 Mobile and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from your Dexcom G5 Mobile do not match your symptoms or expectations, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.
Please review the product instructions before using the Dexcom G5 Mobile. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the Dexcom G5 Mobile. Discuss with your healthcare professional how you should use the information displayed on the Dexcom G5 Mobile to help manage your diabetes. The product instructions contain important information on troubleshooting the Dexcom G5 Mobile and on the performance characteristics of the system.
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19Indications for Use and Safety Statement
Contraindications
So what are contraindications? They let you know when not to use the system; you may hurt yourself or damage the system. Remember, if used during certain situations, the risk of use may clearly outweigh any potential benefit. Within the chapters, contraindications are in purple boxes.
MRI/CT/Diathermy
Do not wear the Dexcom G5 Mobile (sensor, transmitter, and receiver) during Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
The Dexcom G5 Mobile has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the components of the Dexcom G5 Mobile, which may cause it to display inaccurate blood glucose readings or may prevent alerts.
Medications
Taking medications with acetaminophen (such as Tylenol or Excedrin® Extra Strength) while wearing the Dexcom G5 Mobile may inaccurately raise the glucose readings generated by the Dexcom G5 Mobile. The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person. Do not rely on continuous glucose monitoring (CGM) data produced by the Dexcom G5 Mobile if you have recently taken acetaminophen.
Warnings
What are warnings for? They outline important hazard information, describing any serious and/or life-threatening situations, their consequences, how to avoid danger while using the system and how to protect the system from harm.
Sensor Fractures
Do not ignore sensor fractures. Sensors may fracture or detach from the sensor pod on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling, or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.888.738.3646 (toll free) or 1.858.200.0200.
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20Indications for Use and Safety Statement
Do Not Use Damaged Goods If the Dexcom G5 Mobile receiver or Dexcom G5 Mobile transmitter is damaged or cracked,
do not use it. This could create an electrical safety hazard or malfunction, causing possible electrical shocks resulting in injury. In addition, a damaged or cracked Dexcom G5 Mobile receiver or Dexcom G5 Mobile transmitter may cause the Dexcom G5 Mobile System not to function properly.
Choking
Do not allow young children to hold the sensor or transmitter without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard.
Avoid Strangulation
Use USB cable only as directed and store safely. Misuse of the USB cable can present a strangulation risk.
The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Review Training Materials
Thoroughly review the training materials included with your Dexcom G5 Mobile before use. Incorrect use of the Dexcom G5 Mobile could lead you to misunderstand information produced by the system or might affect the system’s performance.
Diabetes Treatment Decisions
If your Dexcom G5 Mobile does not display a sensor glucose reading and an arrow or if you are getting inaccurate or inconsistent readings, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions.
Do Not Ignore Low/High Symptoms
Do not ignore symptoms of low or high glucose. If your glucose alerts and readings do not match your symptoms or expectations, you should obtain a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions or seek immediate medical attention.
Who Should Not Use
The Dexcom G5 Mobile was not evaluated or approved for the following persons:
• Pregnant women
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21Indications for Use and Safety Statement
• Persons on dialysis
Warnings (continued)
The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Do not use the Dexcom G5 Mobile CGM System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the system. Sensor glucose readings may be inaccurate in critically ill patients.
The Dexcom G5 Mobile’s accuracy has not been tested in people within these groups and the system’s glucose readings may be inaccurate.
Calibrate on Schedule
What is calibrating and why it is important? 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.
Calibrate the Dexcom G5 Mobile at least once every 12 hours. The Dexcom G5 Mobile needs to be calibrated in order to provide accurate readings. Do not use the Dexcom G5 Mobile for diabetes treatment decisions unless you have followed the prompts from the device and calibrated every 12 hours after the initial calibration.
Placement
Do not insert the sensor component of the Dexcom G5 Mobile 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 is not approved for other sites. If placed in other areas, the Dexcom G5 Mobile may not function properly.
Prior to Initial Calibration: Data/Alarm/Alert
Do not expect sensor glucose readings or Alarms/Alerts from the Dexcom G5 Mobile until after the 2-hour startup. The Dexcom G5 Mobile will NOT provide any sensor glucose readings or Alarms/Alerts until after the 2-hour startup ends AND you complete the startup calibration. Use fingerstick glucose values from your blood glucose meter during the 2-hour startup.
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Warnings (continued)
The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Sensor Storage
Store the sensor at temperatures between 36°F-77°F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in the freezer.
Storing the sensor improperly might cause the sensor glucose readings to be inaccurate.
Smart Device Settings
Your smart device’s internal settings override any Dexcom G5 Mobile app setting. In addition, accessory devices (like a smart watch or other wearable smart devices) might override your smart device’s Alarm, Alert, and notification settings.
To receive Alarm or Alerts you must:
• Make sure the notifications for the Dexcom G5 Mobile app are turned on in the setting’s menu of your smart device
• Check that the Dexcom G5 Mobile app hasn’t been shut down by your smart device
• Turn on Bluetooth on your smart device
• Turn off the Do Not Disturb feature on your smart device (if available)
• Restart the Dexcom G5 Mobile app after your smart device is restarted
• Set the volume on your smart device at a level you can hear
• Do not close app; always run the app in the background
• Make sure accessory devices do not override your smart device settings
If the settings on your smart device are incorrect, your Dexcom G5 Mobile may not function properly.
The Dexcom G5 Mobile Alarm/Alert vibrations are not any different from other vibrating apps on your smart device. Medical device apps, like the Dexcom G5 Mobile app, may not always have special priorities over your smart device’s features.
App notifications or Alerts may sound or feel the same as notifications from another app. The only way to know is to look at the screen.
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Warnings (continued)
The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Missed an Alarm or Alert?
An Alarm or Alert from the G5 Mobile app cannot 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 from the Dexcom G5 Mobile.
Precautions
Sensor Package
Do not use the Dexcom G5 Mobile sensor if its sterile package has been damaged or opened. Using a non-sterile sensor might cause infection.
Clean and Dry Before Using
Do not open the sensor package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.
Do not insert the sensor until you have cleaned the skin near the insertion site with a topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.
Reusable: Don’t Throw Away
Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter’s battery life.
The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Be Accurate, Be Quick
To calibrate the system, enter the exact blood glucose value displayed on your blood glucose meter within five minutes of a carefully performed fingerstick.
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Precautions (continued)
The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Do not enter Dexcom G5 Mobile sensor glucose readings for calibration. Entering incorrect blood glucose values, blood glucose values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor performance.
Treatment Decisions
Make diabetes treatment decisions based on the combination of the sensor glucose reading, trend arrow, and/or alerts generated by the Dexcom G5 Mobile.
Expiration Date
Do not use Dexcom G5 Mobile sensors beyond their expiration date. Before inserting a sensor, confirm the expiration date that is listed on the package label in the following format: YYYY-MM-DD.
Do not use sensors that are beyond their expiration date, because the sensor glucose readings might not be accurate.
Sensor Placement
Avoid using the same spot repeatedly for sensor insertion. Rotate your sensor placement sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation.
Avoid inserting the sensor in areas that are likely to be bumped, pushed, or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in these areas might affect sensor accuracy.
Avoid injecting insulin or placing an insulin pump infusion set within three inches of the sensor. The insulin might affect sensor performance.
Use Correct Transmitter, Receiver, and Sensor
Different generations of Dexcom CGM System transmitters and receivers are not interchangeable with each other.
The Dexcom G5 Mobile transmitter and receiver are not compatible with the Dexcom G4® PLATINUM CGM System transmitter and receiver.
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Precautions (continued)
The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
The Dexcom G5 Mobile will not work if you mix the transmitter and receiver from different generations.
You can use a Dexcom G4 PLATINUM sensor with the Dexcom G5 Mobile System. Before using the sensor, make sure the sensor label says “Dexcom G5 Mobile/G4 PLATINUM Sensor” or “Dexcom G4 PLATINUM Sensor.”
Communication Range
Do not separate the transmitter and receiver by more than 20 feet. The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, shower, etc.
Types of obstruction differ and have not been tested. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter.
Setting Alarm/Alert Notifications
When using both a receiver and a smart device with your Dexcom G5 Mobile, 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 Alert.
Using an accessory device (like a smart watch) might override your smart device sounds. Alarm or Alerts might vibrate or be heard on the accessory instead of your smart device. After connecting any accessories, make sure that the smart device settings allow you to continue receiving Alarm or Alerts on the smart device.
Is It On?
If the receiver or smart device is turned off (Shut Down), it will not display sensor data, information, Alarm or Alerts generated by the Dexcom G5 Mobile. Make sure the display devices are turned on; otherwise you won’t get sensor glucose readings or Alarm or Alerts.
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Precautions (continued)
The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Test Receiver
Test your receiver speaker and vibration often. To test the speaker and vibration use the Speaker Test or go through the Try It menu option. Always test if your receiver gets wet or dropped.
To use the Speaker Test, plug the receiver in to charge to see the Speaker Test screen. Proceed through the speaker test. To use the Try It menu option, go to the Sounds menu and select Try It. Either way, if it doesn’t vibrate and beep, contact Technical Support.
If the vibration motor and/or speaker on your receiver is not functioning properly you may miss a severe low or high Alarm/Alert. Use the app on your smart device until this issue is resolved.
Keep Receiver Clean and Dry
Do not get dirt or water in the USB port and do not submerge in water. If dirt or water gets into the USB port, the receiver could become damaged and
stop displaying readings or providing Alerts; you might miss a severe low or high glucose event.
No Alternative Site Testing–Fingerstick Only
Do not use alternative site blood glucose testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different from those taken from a fingerstick blood glucose test and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Using alternative site blood glucose values for calibration might affect Dexcom G5 Mobile accuracy.
When Not to Calibrate
Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your
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Precautions (continued)
The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
blood glucose is rapidly rising or falling. Calibrating during rapid rise or fall of blood glucose may affect sensor accuracy.
Don’t Share Your Transmitter
Do not share your transmitter with another person or use a transmitter from another person. The Dexcom G5 Mobile is a prescription-only medical device and is meant, or indicated, for individual use only.
The transmitter is tied to the sensor glucose readings. If the transmitter is used by more than one person, the glucose readings, alerts, and reports may be wrong.
Airport Scanners
Be aware of airport body scanners and baggage x-rays when you travel. Do not place any part of the Dexcom G5 Mobile system in the baggage x-ray machine or body scanner. Ask for visual inspection instead:
• Baggage x-ray machine: Instead of putting any part of your Dexcom G5 Mobile through the baggage x-ray, ask the TSA officers to visually inspect it
• Body scanner: When you are wearing your Dexcom G5 Mobile, request hand- wanding or full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner. AIT is also called millimeter wave scanner
Do not rely on CGM readings while being checked by an x-ray or hand-wand metal detector. Once you have cleared the security checkpoint area, you can resume using CGM data. Although the system has been tested with several metal detectors and hand-wands, it is unknown if exposure to certain x-ray, hand-wands, and/or AIT body scanners can affect the system performance and results in you missing a severe low or high glucose event.
If you are unsure of whether the airport scanner is a metal detector, an AIT body scanner or an x-ray, ask the TSA officer or request hand-wanding or full-body pat­down.
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Caution
U.S. law restricts the sale of the Dexcom G5 Mobile to sale by or on order of a physician.
Summary
Now You Can:
• Define a Safety Statement
• Explain the difference between an indication and a contraindication
• Describe what a precaution is
• Describe the importance of warnings Correctly read a chapter’s Safety Statement
• Provide an overview of Safety Statements by category
What’s Next?
In our next chapter, you will learn about the risks and benefits of using the system.
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When using any medical device, there are risks and benefits. In this chapter, you’ll learn what they are, helping you decide if Dexcom G5 Mobile 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 low or high glucose event.
Some hardware issues preventing Alarm/Alerts:
• Alert function is turned off
• Transmitter and display device are out of range
• Receiver or smart device isn’t showing sensor glucose readings. For example, when there are data gaps due to being out of range or a system error
• Receiver or smart device battery is dead
• Unable to hear Alarm/Alerts or feel vibration
• Speaker or vibration motor not working
• App not running in the background
• On Apple devices, Signal Loss Alert won’t be heard if smart device is silenced or in Do Not Disturb
See Troubleshooting (Chapter 19) and, for the app, Suggested Device Settings (Chapter 5).
Chapter 3
Getting Started:
Risks and Benefits
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Using CGM for Treatment Decisions
If you are taking acetaminophen, your sensor glucose readings may be falsely high, causing you to potentially miss a low glucose event or treat a high glucose event with insulin. Do not make any treatment decision based on your CGM when acetaminophen is active in your body.
In order to use CGM for your treatment decisions, you must calibrate a minimum of once every 12 hours to help keep your CGM system accurate. If you do not calibrate at this minimum frequency and make treatment decisions based on your CGM, you may not be getting the most accurate information and could miss a high or low glucose event.
In order to use CGM for your treatment decisions, you must have:
1. Sensor glucose reading
2. Trend arrow
For more information on how to make treatment decisions using your Dexcom G5 Mobile, see Chapter 13.
If you have symptoms of low or high glucose, but your CGM is not showing low or high glucose sensor readings, take a fingerstick blood glucose measurement with your BG meter. If you are a caregiver of someone using the Dexcom G5 Mobile, watch how they act. If their symptoms don’t match the CGM, take a fingerstick BG measurement.
Your BG meter is your backup when/if your CGM is not showing a sensor glucose reading or your symptoms do not match your sensor readings. Remember to wash your hands before taking a fingerstick.
Sensor Glucose Reading Different From Your Expectations or Symptoms
The sensor glucose reading can be different from your expectations and symptoms. In this case, wash your hands and take a fingerstick blood glucose measurement with your BG meter to confirm your expectations and symptoms. If your sensor readings and BG meter values are different, you can calibrate your CGM system. Wash and dry your hands, repeat the BG measurement, and, if still different, recalibrate.
If you’re not receiving an Alarm/Alert, and not taking fingerstick BG measurements, you may be unaware of low or high glucose levels.
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Sensor Insertion Risks
Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain, or skin irritations (for example, redness, swelling, bruising, itching, scarring, or skin discoloration). The chance of this happening is low.
The Dexcom G5 Mobile 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 the Dexcom G4 PLATINUM System's clinical study, no sensor wires broke; however, there is a remote chance a sensor wire could break or detach and remain under your skin. Sterile broken sensor wires don’t pose a significant medical risk.
If a sensor wire breaks off or detaches and remains under your skin, contact your healthcare professional and call Dexcom’s Technical Support toll free, 24/7, at 1.888.738.3646 or toll at
1.858.200.0200 within 24 hours. Those are the risks, let’s now review the benefits!
3.2 Benefits
Daily habits impact your BG levels. With the Dexcom G5 Mobile, you can track how your exercise, carbs, stress levels, medication, or illness influence your glucose levels.
Knowing Your Trends
Providing sensor glucose readings every five minutes, for up to seven days, the Dexcom G5 Mobile helps you detect trends and patterns. Trend information as well as the trend arrow reveals where your glucose is now, where it has been, where it’s heading, and how fast it’s changing. This provides you with a more complete picture of your glucose.
Making Treatment Decisions Based on Your CGM
With Dexcom G5 Mobile, you can now use the sensor glucose readings to make your diabetes treatment decisions (like how much insulin to take, when to treat a low glucose, etc.) when you have the key pieces of CGM information: your trend arrow and sensor glucose reading. If you are using the Dexcom G5 Mobile to make treatment decisions, make sure your Alerts are on. Talk to your healthcare professional to determine your best Alert levels.
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Helping 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 take action before you get too low or too high. The Urgent Low Glucose Alarm lets you know when you are dangerously or urgently low, going below 55 mg/dL. By taking corrective measures, you lessen the time spent in your low/high range, while increasing time in your targeted range (Battelino, 2011; Garg, 2006). If you are using the Dexcom G5 Mobile to make treatment decisions, make sure your Alerts are on. See Chapter 13 for Treatment Decisions.
Real-time CGM can help improve your A1C as well as improve the quality of your glucose control. If your A1C is at or below 7%, using a CGM such as the Dexcom G5 Mobile helps reduce hypoglycemia (Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group et al, 2008).
Lowering your A1C, increasing your time in your target range while decreasing time in low/high BG range is believed to reduce your risk of diabetes-related complications (Ohkubo, Y., 1995).
Some people perceive an increase in their quality of life and peace of mind when using real-time CGM (Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, 2010).
What’s Next?
You’ve read the Safety Statements, reviewed the risks and benefits; now let’s take a look at the Dexcom G5 Mobile!
References:
Battelino, T., Phillip, M., Bratina, N., Nimri, R., Oskarsson, P., & Bolinder, J. (2011). Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care, 34(4), 795-800.
Garg, S., Zisser, H., Schwartz, S., Bailey, T., Kaplan, R., Ellis, S., & Jovanovic, L. (2006). Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: A randomized controlled trial. Diabetes Care, 29(1), 44-50.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. (2010). Quality-of-life measures in children and adults with type 1 diabetes: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group randomized trial. Diabetes Care, 33(10), 2175-2177.
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Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group , Tamborlane, W. V., Beck, R. W., Bode, B. W., Buckingham, B., Chase, H. P., Clemons, R., ... & Xing, D. (2008). Continuous glucose monitoring and intensive treatment of type 1 diabetes. The New England Journal of Medicine, 359(14), 1464-1476.
Ohkubo, Y., Kishikawa, H., Araki, E., Miyata, T., Isami, S., Motoyoshi, S., ... & Shichiri, M. (1995). Intensive insulin therapy prevents the progression of diabetic microvascular complications in japanese patients with non-insulin-dependent diabetes mellitus: A randomized prospective 6-year study. Diabetes Research and Clinical Practice, 28(2), 103-117
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• Introduction to the Dexcom G5 Mobile
• Initial Setup
• Starting a Sensor Session: Inserting the Sensor and Attaching
the Transmitter
• Calibration
• Ending a Sensor Session and Transmitter Session
LET’S G5! THE BASICS
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4.1 Introduction
Now it’s time to get an overview of the Dexcom G5 Mobile. After this chapter, you’ll be able to:
• Explain the Dexcom G5 Mobile
• Describe options to view trends
• Locate your historical readings
• Recognize system components
• Explain each part’s function
4.2 Safety Statement
If you’ve used the Dexcom G4 PLATINUM CGM System, you might still have its transmitter or receiver. While you can use the sensors across the different generations (look for “G5 Mobile,” “G4 PLATINUM,” or “Dexcom G5 Mobile/G4 PLATINUM” on the sensor’s package), you can’t mix the transmitter or receiver between the two systems.
Chapter 4
Let’s G5! The Basics:
What’s the Dexcom G5 Mobile?
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WARNING
Don’t:
The Dexcom G5 Mobile was not evaluated for the following persons:
•
Pregnant women
•
Persons on dialysis
Do not use the Dexcom G5 Mobile System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor glucose readings may be inaccurate in critically ill patients.
Consequences: The system’s accuracy hasn’t been tested in people falling into these groups and sensor glucose readings may be inaccurate, resulting in missing a severe low or high event.
PRECAUTION
Don’t: Never mix the Dexcom G5 Mobile transmitter or receiver with the Dexcom G4 PLATINUM transmitter or receiver.
Why: The Dexcom G5 Mobile transmitter and receiver are not compatible with the Dexcom G4 PLATINUM CGM System transmitter and receiver. The Dexcom G5 Mobile won’t work if you mix receiver and transmitter components from different generations.
Consequences: Missing a severe low or high glucose event or making a treatment decision that results in injury.
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Only the components in the table below are compatible with each other within the Dexcom G5 Mobile System.
Dexcom G5 Mobile System Components
Sensor Transmitter
Display Device
Receiver App
Brand Name
Dexcom G5 Mobile/G4 PLATINUM Sensor
Dexcom G5 Mobile Transmitter
Dexcom Receiver
Dexcom G5 Mobile App
Part Number(s) 9500-27 9438-06 MT22949
SW10940 (Android)
SW10611 (iOS)
4.3 The Dexcom G5 Mobile
CGM
The Dexcom G5 Mobile is a medical device you use on yourself. It allows you to continually see your sensor glucose readings, updated every five minutes for up to seven days, without the bother of taking constant fingerstick measurements. Your sensor glucose readings are measured by a single use sensor inserted under your skin. A reusable transmitter sends your data to your display device.
The Dexcom G5 Mobile provides personalized trend Alerts, prompting you to proactively react when your glucose levels are getting too low or too high. Dexcom provides web-based reports reflecting your glucose trends and patterns. Share the reports with your healthcare professional (HCP) when developing your diabetes management treatment plans.
Some users of the Dexcom G5 Mobile System may need a caregiver involved in their care. Please consult your physician for guidance.
Options to View Your Trends
The Dexcom G5 Mobile transmitter works with a number of display devices, giving you flexibility to use what’s best for you, your situation, or your lifestyle.
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• Dexcom Receiver
• Dexcom G5 Mobile app on your smart device
While the system works with different smart devices, they’re not interchangeable during a sensor session, so before starting one, select which smart device you want to use and stick with it throughout your session. You can’t use multiple smart devices at the same time, but you can combine the receiver with a smart device during a session.
The Dexcom G5 Mobile is the first CGM system where a smart device acts as a receiver. For a list of current devices and operating systems go to: dexcom.com/compatibility.
Chapter 5 covers how to set up your smart device with the 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 target range
• Yellow - High
Trend Arrows
Glucose levels are not just about the numbers. The Dexcom G5 Mobile includes trend arrows so you know the speed and direction of your glucose, allowing you to proactively react before your glucose gets too high or too low. See Chapter 13 and learn how to make treatment decisions based on your Dexcom G5 Mobile.
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Alarm/Alerts
Being warned when your glucose value is too high or too low, falling or rising too quickly, or trending toward a severe low or high is very important. Warnings in the form of Alerts or an Alarm help you avoid getting too low or high. Alarm and Alert notifications help keep you aware of your glucose trends and are made up of a combination of sounds, vibrations, and screens.
There are a number of Alerts, but only one Alarm: when your glucose level dips below 55 mg/dL. Some customization options are available and are part of the setup process for the receiver and smart device.
In Chapter 11, you can learn more about the Alarm and Alerts feature.
Viewing Your Glucose Values
The Dexcom G5 Mobile allows you to see the last 1-, 3-, 6-, 12-, 24-hours of your sensor glucose readings. On the receiver, from the home screen, tap
graph
to view. On a smart
device, hold upright in
portrait
mode to see the most recent three hours; turn sideways to
landscape
mode to view your glucose levels over the last 1-, 3-, 6-, 12-, 24-hours.
Go to Chapter 9 to learn more about viewing your glucose trends.
4.4 What’s New to the Dexcom G5 Mobile?
With this system, you:
• Can make treatment decisions using your Dexcom G5 Mobile
• Get a new receiver
Treatment Decisions
The Dexcom G5 Mobile allows you to make treatment decisions, including help in determining your insulin doses.
Use the glucose readings and trend arrow to determine the speed and direction of your glucose changes. Based on your Dexcom G5 Mobile, you determine if you should dose, eat carbs, or do nothing without a fingerstick.
You still need your BG meter to calibrate the Dexcom G5 Mobile and as a backup when your CGM data does not reflect how you feel or if you don’t have enough information on your home screen.
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For more information on how to use your Dexcom G5 Mobile to make treatment decisions, go to Chapter 13.
New Receiver
With the new touchscreen receiver, your sensor glucose readings, calibrations, events, menu options, etc. are accessible by just a tap or two.
4.5 System Information
The receiver and app also keep you informed on the system’s status. Technical notifications provide information about your sensor session and about the system’s hardware. Each chapter provides a table of the prompts, system, and error messages applicable to its subject. As an example, the Calibration chapter will review all calibration messages you may see.
Now that you know what the Dexcom G5 Mobile 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 comes to you in a number of boxes; after opening, keep each box until you are no longer using its contents.
Throughout this guide, all images are representational. Your product may look slightly different.
Sensor Box
Single use sensor(s)
(Continued on next page)
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(Continued from previous page)
Transmitter Box
Reusable transmitter
Receiver Box
Receiver Two extra colored cases Welcome Card Getting Started Guide Tutorial USB Card
Receiver
Receiver’s USB charging and download cable
AC power adapter
Overview of System Components
This section is meant as a quick overview of each part; specifics for each are found in following chapters. For detailed product specifications and technical information, please go to Chapter 17.
The Dexcom G5 Mobile is comprised of four key parts:
1. Single-use sensor
2. Reusable transmitter
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3. Rechargeable receiver
4. Dexcom G5 Mobile app
a. Downloaded to your smart device b. Dexcom G5 Mobile optional: Dexcom Share
Sensor Overview
For your safety, the sensor is packaged in a sterile sealed pack. When you first open the pack, your sensor looks like one item; however, it’s actually three: sensor applicator, sensor pod, and sensor wire.
The applicator helps you insert the sensor wire inside the sensor pod under your skin. After inserting the sensor wire, remove the applicator. The sensor wire stays in the sensor pod with the pod attached to your skin by adhesive.
The sensor wire is made of silver and platinum with polymer membranes. Once inserted, the thin and flexible wire measures your glucose levels in the fluid between your cells (interstitial fluid) for up to seven days.
This section is meant as a quick overview. More information on using the applicator to insert the sensor wire can be found in Chapter 6.
Safety Lock
Collar
Sensor Pod
Adhesive
Release Tab
Transmitter Latch
Applicator Barrel
(Contains small
introducer needle
and sensor)
Plunger
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
Applicator Barrel
Contains small insertion needle and sensor wire. Inserts sensor wire under the skin. Disposable, for single use only. Removed after insertion.
Safety Lock
Keeps all moving parts in place before insertion. Prevents accidental sensor insertion. Tool to remove transmitter after sensor session. Put in transmitter box after removal to use later.
Collar Collar removes insertion needle.
Plunger Inserts sensor wire into your body.
Transmitter Latch Securely snaps transmitter into sensor pod.
Sensor Pod
Sensor Pod
Holds transmitter and sensor wire. Water resistant when transmitter is properly installed. Discarded after sensor session.
Adhesive Patch Keeps sensor pod attached to your skin.
Transmitter Cradle Holds transmitter in place during sensor session.
Sensor Wire
Wire measures glucose levels in fluid in between your cells. Attached to sensor pod. Discarded with pod after session.
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Transmitter Overview
Figure 2. Dexcom G5 Mobile Transmitter Front and Back
Image is representational only. Your transmitter may look different.
Snapping into the sensor pod, the gray plastic transmitter wirelessly sends your glucose information to your display devices—receiver and/or smart device. If you have a new transmitter, open the package when you are ready to use it.
Transmitter features:
• Reusable
– Do not discard after sensor session – Only for you, don’t share transmitter
• Water resistant
• Can transmit data to your display devices for up to 20 feet
– Range is less if you are in or under water
• Battery lasts approximately three months
– Receiver or smart device prompts you when battery is running low
• Transmitter’s serial number is on the back
More transmitter features and insertion information are in Chapter 6. Now that you are familiar with the sensor and transmitter, let’s review the receiver.
Receiver
Your receiver, as well as your smart device, shows your sensor glucose readings, trend graphs, and trend arrows and alerts you when your glucose is too high or too low or if there is something you should be aware of or need to do.
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The receiver is neither water resistant nor waterproof and can get damaged if moisture gets inside, so keep it away from any liquids and very high humidity as well as dirt and dust. If your receiver does get wet or dirty, test it to make sure the speaker and vibrations still work (see Chapter 11).
The small hole on the back of the receiver is not to be used to reset the receiver. Do not push anything through the hole.
If your receiver isn’t charged, see Chapter 14 for charging your receiver’s battery. You can change the protective case. Just take off the black one and put on one of the colored
ones. Be sure to line up the cover’s speaker holes with the receiver speaker. If you want to use the receiver along with a smart device, you need to set them up
separately. Remember, you can’t use a combination of smart devices during a sensor session; select just
one.
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.
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(Continued from previous page)
What you see What it’s called What it does
Wall Charger
Plug
USB cable
into
adapter/wall
charger
.
Plug
wall charger
into an electrical
outlet to charge receiver’s battery.
Display Screen
Shows sensor glucose readings, trend graphs and arrows, Alarm/Alerts, sensor session status.
Change settings on Menu screen.
Charging Indicator
Turns on when receiver is being charged.
Speaker
Allows you to hear your Alarm/Alerts sounds.
Power Button
Press and hold button for two seconds to turn it on.
Press briefly to turn the screen on or off.
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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 what Dexcom G5 Mobile does
• Describe options to view trends
• Locate your historical readings
• Recognize system components
• Explain each part’s function
What’s Next
Your next step in getting started with the Dexcom G5 Mobile is selecting how to continuously receive your sensor glucose readings: the Dexcom G5 Mobile app, the receiver, or a combination.
Our next chapter helps you set up both!
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5.1 Introduction
In the previous chapter, you received a high level overview of the Dexcom G5 Mobile 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:
• Determine which display device(s) you’ll use
• Create a Dexcom username and password
• Download the Dexcom G5 Mobile app
• Set up the Dexcom G5 Mobile app with the suggested settings
• Successfully set up your receiver
5.2 Safety Statement
If you’ve used the Dexcom G4 PLATINUM CGM System, you might still have its transmitter or receiver. While you can use the sensors across the different generations (look for the Dexcom G5 Mobile/G4 PLATINUM sensor package), you can’t mix the transmitter or receiver between the two systems.
PRECAUTION
Don’t: Never mix the Dexcom G5 Mobile transmitter or receiver with the Dexcom G4 PLATINUM transmitter or receiver.
Why: The Dexcom G5 Mobile transmitter and receiver are not compatible with the Dexcom G4 PLATINUM transmitter and receiver. The Dexcom G5 Mobile won’t work if you mix receiver and transmitter components from different generations.
Consequences: Missing a severe low or high glucose event or making a treatment decision that results in injury.
Chapter 5
Let’s G5! The Basics:
Set Up Your Display Devices
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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. Forgot your receiver at home? Use your smart device! Battery died on your smart device? Smart device memory full? Your receiver has you covered!
With the exception of Dexcom Share, the primary difference between the two monitoring systems is not the data itself, but how it’s presented.
The next section walks you through the initial setup for the app. To set up the receiver, go to Chapter 5.5. If you want to use both the Dexcom G5 Mobile app and the receiver, you need to set up each individually.
Once you have completed the initial setup, you’re one step closer to beginning your sensor session!
5.4 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 setup is entering the transmitter’s serial number (SN). If by accident you enter the SN into more than one smart device, the system warns you and you won’t be able to complete the setup process.
Suggested Device Settings
Get the best G5 app experience by using these tips. They help ensure you'll get your Alarm/ Alerts and readings.
See your smart device instructions to learn how to change its settings.
•
Bluetooth:
Your transmitter talks to your app with
Bluetooth
wireless technology. Bluetooth is designed for wireless communication between devices (unlike Wi-Fi, which wirelessly connects devices to the Internet). Make sure your smart device
Bluetooth
is
on. If not, you will not get Alarm, Alerts or CGM information.
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• Alarm/Alert notifications: – To get Alarm/Alerts, app notifications must be allowed. – Make sure your smart device settings allow Dexcom app notifications to show
on your lock screen.
– Android: All Alarm/Alerts are silent if you use the most restrictive Do Not Disturb
setting.
– Apple: Your Signal Loss Alert can't sound in Silent or Do Not Disturb.
• Battery: The app must always be running in the background and may drain your smart
device battery. Keep the battery charged. Avoid using power saving modes that could turn off Bluetooth or vibration.
• Update manually: Automatic updates of the app or your device operating system can
change settings or shutdown the app. Always update manually and verify correct device settings afterwards.
• Compatibility: Before upgrading your smart device or its operating system, check
dexcom.com/compatibility.
• Time: Don’t change your smart device time because it can make the time on the trend
screen wrong and the app may stop displaying data.
The receiver is a stand-alone medical device and used solely to monitor your glucose trends. If you are concerned about missing an Alarm/Alert (for example, due to smart device settings, app shutting off due to lack of storage, low smart device battery, etc.), bring your receiver with you. If your smart device is broken or lost, use the receiver.
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 or rooted, do not install the app.
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 setup wizard instructions. The setup wizard walks you through safety information, suggested settings, entering transmitter SN, setting your high/low glucose levels, and receiving CGM notifications.
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Your initial setup will require a Dexcom username and password. You can create them by tapping
Sign Up
within the app, or by going to dexcom.com. But what if you are unclear about a step? The Dexcom G5 Mobile app has prompts allowing you to get more information. If you are
unsure of something during your initial setup process, look at the screen for additional information prompts. Informational prompts include, but aren’t limited to:
I don’t understand
,
Learn More
, or
Question Mark
. Tap your
informational prompt
to get more information.
To close out of the information prompt, tap the X in the upper right-hand corner.
Initial App Setup
Step What you see What you do
Introductory Screens
1 Tap
Dexcom G5 Mobile app
icon to open app.
2
Tap
Log In
.
(Continued on next page)
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(Continued from previous page)
3
Need a Dexcom username and password? Tap Sign Up.
Enter username and password Tap Login.
4
Tap
Let’s Get Started
.
(Continued on next page)
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(Continued from previous page)
5
The next screens go over the safety warnings, treatment decisions information, and alerts.
Once each screen is read, tap the
appropriate
answer
to move forward.
Tap
Full Safety Statement
or, when available,
I don’t
understand
to get more information.
Setting Up Your App Alarm/Alerts and Basic Settings
6
Set your Low Glucose Alert. Default is 80 mg/dL. Scroll to select your level. Tap
Save
to continue.
Once your Low Glucose Alert is set, you’ll receive an Alert if your glucose dips below your set level.
(Continued on next page)
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(Continued from previous page)
Setting Up Your App Alarm/Alerts and Basic Settings
7
Set your High Glucose Alert. Scroll to select your level. Tap
Save
to continue.
Once your High Glucose Alert is set, you’ll receive an Alert if your glucose rises above your set level.
8a
Apple:
Make sure you get your Alarm/Alerts notifications. Tap the
appropriate response
to move forward and
set your notifications.
(Continued on next page)
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(Continued from previous page)
Setting Up Your App Alarm/Alerts and Basic Settings
8b
Apple:
Tap OK or
Allow
to get Alarms and Alerts.
9
The next screens provide suggestions for device volume,
Do Not Disturb
, and other basic settings.
Tap the
appropriate answer
to move forward.
(Continued on next page)
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59Set Up Your Display Devices
(Continued from previous page)
Connecting/Pairing Transmitter With App
10 Tap
Next
.
11a
Verify
Bluetooth
is on.
The app will check to see if
Bluetooth
is turned on.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter With App
11b
Android 6+:
To use Bluetooth, you must let the app use your location.
11c
Android 6+:
To use
Bluetooth
, tap Allow.
12a
Get your transmitter box. Turn transmitter box upside down on a flat surface
with barcodes facing up. For information on how to pair transmitter after
initial setup, see Chapter 8.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter With App
12b
Center longest barcode within green brackets. Tap
Take Photo
.
12c
Check mark confirms successful transmitter SN scan.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter With App
12d
If unable to use app’s scanning device: Tap
Enter transmitter SN by hand
.
12e
Use keyboard to enter transmitter SN. Confirm correct SN. Tap
Save
.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter With App
13
Insert sensor and attach transmitter following video’s instructions.
See Chapter 6 for more information.
14
Wait up to 30 minutes for smart device and transmitter to connect.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter With App
15
Apple:
Tap Pair to pair app with transmitter, when asked.
16
Tap the
Sensor warmup
circle to start your
two-hour sensor warmup. When you see the sensor warmup timer, your initial
setup is complete. Congratulations!
If you have any issues setting up the Dexcom G5 Mobile app, always contact Technical Support (available 24/7) at:
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200 If you are having problems with your smart device, contact your smart device’s support line. After completing your initial app setup, set up the receiver or go to Chapter 6 to start your
initial sensor session.
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5.5 Receiver
In the previous chapter, you learned about the receiver’s components. The following is a refresher to help in your initial setup.
Display Screen:
• Trend screen
• Menu bar, meter, and events icons
Initial Setup of the Receiver
Press and hold
power button
for two seconds to turn receiver on.
The first screen you see is the startup screen with ascending green bars. Once complete, a setup wizard guides you through the initial setup steps. Your receiver has a touchscreen. Be sure your fingers are dry when you touch it. Don’t be alarmed if your receiver buzzes or makes other sounds during this process.
After your initial setup is complete, you won’t see the setup wizard again. Your settings can always be adjusted using menu options.
How you complete your initial setup differs between the receiver and your smart device; however, the data are the same.
Setup Wizard Prompts:
• Date/Time
• Transmitter Serial Number
– 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 14 for charging instructions.
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Initial Receiver Setup
Step What you see What you do
Initial Screens
1
Press and hold
power button
for two seconds to
turn receiver on. Wait for the Dexcom screen to appear.
2
Wait.
3
Tap OK.
(Continued on next page)
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67Set Up Your Display Devices
(Continued from previous page)
Date/Time
4a
Green box shows what is selected.
4b
Tap
up/down arrow
to change year.
Tap
mm
to select it.
Tap
up/down arrow
to change month.
Tap dd to select it. Tap
up/down arrow
to change day.
Tap hh to select it. Tap
up/down arrow
to change hour.
Tap
mm
to select them.
Tap
up/down arrow
to change minutes.
Tap
AM/PM
to select it.
Tap
up/down arrow
to change between AM and PM.
Tap
Save
to save and close.
NOTE: After initial setup, if battery is drained, receiver will vibrate once and you will need to reset date and time.
(Continued on next page)
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(Continued from previous page)
Transmitter
5a
Turn
transmitter box
upside down to locate SN
number. For information on how to pair transmitter after
initial setup, see Chapter 8.
5b
If transmitter package isn’t available find the SN on the back of the transmitter.
5c
Green box shows what is selected.
5d
Tap
up/down arrows
to select and enter transmitter
SN. Tap
a grey box
to select it. To choose a letter, tap up from 9 or down from 0. Tap
Save
to save and close.
(Continued on next page)
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(Continued from previous page)
Setting Low Alert
6a Set your Low Alert level.
6b
To change value: Tap
up/down arrows
to change value at 5 mg/dL
increments, starting at 80. Tap
Save
to save and close.
Setting High Alert
7a Set your High Alert level.
(Continued on next page)
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(Continued from previous page)
Setting High Alert
7b
To change value: Tap
up/down arrows
to change value at 10 mg/dL
increments, starting at 200. Tap
Save
to save and close.
These steps are enough to get you going; now you can start your sensor session!
Summary
Now You Can:
• Create a Dexcom username and password
• Download the Dexcom G5 Mobile app
• Set up app with the suggested settings
• Successfully set up your receiver
What’s Next?
Now that you have completed setting up your app and/or the receiver, your next step is starting a sensor session.
No matter what monitoring method you choose, starting a sensor session is the same:
1. Inserting the sensor.
2. Attaching the transmitter.
3. Pairing the transmitter to your device.
4. Two-hour sensor warmup.
5. Initial calibrations.
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6.1 Introduction
Now that your display devices are set up, you’re ready to begin a sensor session. If this is your first time inserting a sensor, you may want to watch the sensor insertion video to get a better understanding of the process.
There are three ways to get the sensor insertion video:
1. Through the app
2. On the USB card in your receiver package
3. Online at dexcom.com. Click Menu, then click Support.
After inserting the sensor, start the sensor warmup on your smart device and receiver. The sensor warmup takes approximately two hours, during which 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 that 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:
• Identify sensor applicator features
Chapter 6
Let’s G5! The Basics:
Starting a Sensor Session: Inserting Sensor, Attaching Transmitter, and Starting Your Session
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• Properly prepare for sensor insertion
• Choose the best location to insert your sensor
• Correctly insert your sensor
• Prepare transmitter for placement
• Correctly attach transmitter to sensor
• Outline what happens during the sensor warmup
• Identify countdown icon
6.2 Safety Statements
Following are some important Warnings and Precautions to review; we want to make sure you and the system are safe before starting a sensor session.
WARNING
Don’t:
If a sensor breaks under the skin with no portion visible above the skin, don’t
remove it.
Do:
Seek professional medical help if you have symptoms of infection or inflammation (for example, redness, swelling or pain) at the insertion site. If your sensor breaks under your skin, report it to Technical Support (available 24/7) as soon as possible:
Email: [email protected] Toll free:
1.888.738.3646
Toll call:
1.858.200.0200
Why: Sensors may fracture on rare occasions.
MRI with broken wire
For patients undergoing an MRI with a retained wire broken off from a Dexcom G5 sensor, in vitro MRI testing did not detect any safety hazards. There was no significant migration or heating of the wire, and imaging artifacts were limited to the area around the wire.
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WARNING
Don’t:
Insert the sensor component of the Dexcom G5 Mobile in a site other than the belly/
abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).
Why: The placement and insertion of the sensor is not approved for other sites. Consequences: The system has not been tested in other areas and may not work
properly if inserted in other areas.
WARNING
Do:
Store sensor between 36° F-77° F during its shelf life.
Why: Storing the sensor incorrectly might cause the sensor glucose readings to be inaccurate.
Never store sensors in the freezer. Consequences: If stored outside of 36° F-77° F, your sensor glucose readings may not
be accurate, resulting in you missing a severe low or high glucose event or making a treatment decision that results in injury.
WARNING
Do: Use BG values from your BG meter for treatment decisions (e.g., how much insulin to take) if your Dexcom G5 Mobile does not display a sensor glucose reading or if you are getting inconsistent readings.
Why: Inconsistent readings may indicate that your sensor glucose readings are inaccurate. Consequences: Using inconsistent sensor glucose readings for treatment decisions could
result in you missing a severe low or high blood glucose event or making a treatment decision that results in injury.
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PRECAUTION
Do:
Select sensor insertion site with care. Choose a site:
•
At least 3 inches from insulin pump infusion set or injection site
•
Away from waistband, scarring, tattoos, irritation
•
Unlikely to be bumped or pushed
Why: Insertion in these areas might affect sensor performance. Consequences: Inaccurate sensor glucose readings may result in you missing a severe
low or high event or making a treatment decision that results in injury.
PRECAUTION
Do:
Check sensor package before opening.
Why: Make sure the sterile sensor pack has not been damaged or previously opened. If opened or damaged, sensor may be unsterile.
Consequences: Using an unsterile sensor may cause an infection.
PRECAUTION
Don’t:
Never get dirt or water in the receiver’s USB port or submerge in water.
Why: If dirt or water gets into the USB port, the receiver could become damaged and stop displaying readings or providing Alerts.
Consequences: You might miss a severe low or high glucose event.
6.3 Prepping for Sensor Insertion
Before inserting a sensor, make sure you have everything you need. Some items are included in the Dexcom G5 Mobile packages, others are not.
Included in Your Dexcom G5 Mobile Packages
For sensor insertion, you need the sensor and transmitter.
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Sensor Applicator
Inside Sensor Box
What you see What it is
Sterilized sensor pack with important label information. Check
expiration date
.
Single use sensor applicator.
Knowing what each applicator piece does helps you successfully insert your sensor. Chapter
4.6 gave you overview of the sensor applicator.
Figure 3. Dexcom G5 Mobile Sensor Applicator and Pod
3. Safety Lock
6. Collar
7. Sensor Pod
2. Adhesive Patch
9. Release Tab
8. Transmitter Latch
5. Applicator Barrel (Contains small
introducer needle
and sensor)
4. Plunger
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The following table reviews the sensor applicator components in order of use.
Applicator Components
Order of Use Name What it does
1 Sensor Pack
Sterilized for your protection. Open to remove applicator and sensor.
2 Adhesive Patch
Holds the sensor/transmitter in place on your skin.
3 Safety Lock
Prevents plunger from inserting sensor until you are ready.
4 Plunger Inserts sensor wire into your body.
5 Applicator Barrel
Contains small insertion needle and sensor wire.
Disposable, for single use only.
6 Collar
Collar removes insertion needle. Helps remove applicator barrel once sensor
wire is inserted.
7 Sensor Pod
Holds sensor wire in place under skin. Holds transmitter.
8 Transmitter Latch Locks transmitter into sensor pod.
9 Release Tab
Allows you to remove applicator barrel from sensor pod.
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Transmitter
Transmitter Box
What you see What it is
Bottom of box with important label information. Keep box until transmitter battery dies.
Reusable transmitter.
In the previous chapter, you entered your transmitter SN into your display devices and made sure your smart device and/or receiver connected with the transmitter. You won’t be able to start a sensor session if your transmitter isn’t paired with your receiver and/or smart device.
Not included in packages:
1. Alcohol wipes
2. Your BG meter
3. Your test strips
Before starting, check your BG meter; make sure it’s in good working order following manufacturer’s directions and the meter’s date and time match your display device’s date and time.
Make sure test strips haven’t expired and work with your meter. Before removing the sensor applicator out of its sterile pack, determine the best place to
insert your sensor.
6.4 Choosing Your Insertion Site
Choose a place on your belly (if the user is between 2 and 17 years old, you can also choose upper buttocks) to insert the sensor; the site should be either above or below your belt line. The best areas are usually flat, pinchable, and free from where rubbing can occur (along the waist band, seat belt strap, or where you lie when sleeping).
For more help on ideal sensor insertion sites, contact your HCP.
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Insertion Sites
Location Where it is
Front of body (belly area) for ages 2 years and older.
Back of body (upper buttocks) if user is between the ages of 2 and 17 years.
Do:
• Remove the sensor and applicator from its sterile pack only at time of use
• Place at least 3 inches from your insulin pump infusion set or injection site
• 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.
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Optional Site Preparation
Use optional skin adhesives (Mastisol™, SkinTac™) as part of your insertion site preparation to help keep your sensor pod attached. Apply the skin adhesive after you selected and cleaned your insertion site. Create an empty sideways oval, making sure you don’t get any skin adhesive inside the oval. Let the oval dry based on skin adhesive manufacturer’s instructions. Once dry, your skin may feel slightly sticky.
See Step 3 in the next table for directions. NOTE: Contact your HCP 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!
Sensor Insertion
Step What you see What you do
Preparation
1
Wash and dry your hands.
(Continued on next page)
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(Continued from previous page)
Preparation
2
Clean
insertion site
with alcohol wipe.
Let dry.
3
Optional Step: Skin Adhesive Create an
empty, sideways oval
on the skin
• Do not get any skin adhesive inside the oval
• Let skin adhesive dry (see manufacturer’s instructions)
• Insert sensor on clean skin at the center of the oval
4
Check
pack
: Is it damaged or already opened?
Remove
sensor applicator
from sterile pack.
Closely inspect
sensor
, check it hasn’t been
damaged. Keep
sensor packaging
until sensor session is
complete.
Attaching Sensor Pod
5
Pull off
adhesive backing tabs
.
Don’t touch
sticky adhesive patch
.
(Continued on next page)
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(Continued from previous page)
6
Place
sensor
horizontally, not vertically, on skin.
Move fingers around
top of adhesive patch
several
times to secure tape.
Inserting Sensor Wire
7
Hold
applicator barrel
.
Pull out
safety lock
.
8
Place fingers of one hand on edges of
adhesive patch
.
Pinch up your skin at the tips of the
white adhesive
.
9
Place two fingers directly
above
collar to steady
applicator barrel. Place thumb on the
white plunger
.
Push
plunger
completely down the applicator barrel. You should hear 2 clicks. NOTE: Finger placement is important for correct
insertion.
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Removing Applicator and Collar
10
Move two fingers from
above
collar to
below
collar. Keeping your thumb as a base on the white plunger. Pull back
collar
all the way towards your thumb. You should hear 2 clicks. NOTE: Finger placement is important for correct
needle removal.
11
Hold
transmitter latch
down against your body.
Squeeze
ribbed release tabs
on the sides of sensor
pod.
12a
Move
applicator barrel
forward and out, away from
your body. Follow local ordinances when disposing of 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. Sensor pod
2. Transmitter latch
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Having problems?
If it’s the first time inserting a sensor, you may have questions or need help. If you do, please contact your Technical Support (available 24/7) at:
• Toll free: 1.888.738.3646
• Toll call: 1.858.200.0200
The next step is attaching your transmitter to the sensor pod.
6.6 Attaching Your Transmitter
Now that you have inserted your sensor, you need to attach your transmitter. Since the transmitter is reusable, you don’t need a new one every time you start a sensor
session. Keep your current session’s transmitter box. The bottom label has important information you may need after you’ve attached the transmitter. Once the transmitter has been attached, you can’t remove it until your session is over. Chapter 8 reviews when and how to remove your transmitter.
Before attaching your transmitter, check you’ve entered the correct transmitter SN into your display device. Chapter 5 covers entering the transmitter’s SN during initial setup. See Chapter 8 for pairing your transmitter after the startup wizard.
Attaching Transmitter
Step What you see What you do
1
Remove
transmitter
from box.
Keep box. Save
safety latch
from sensor applicator (helps
remove transmitter once sensor session is over). Get alcohol wipe.
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Step What you see What you do
2
Wipe
back of transmitter
with alcohol wipe.
Let dry for 2-3 minutes. Don’t let the back of transmitter touch your skin. Don’t scratch transmitter’s back, this can harm the
waterproof seal.
3
Flat side down. Slide
transmitter’s small end
under the sensor pod
lip located in front of pod’s ribbed tabs, away from
transmitter latch
.
4
Keep finger on
transmitter
holding it in place.
Push
transmitter latch
up and forward over the
transmitter’s wide end with your other hand. You should hear 2 clicks.
5
Is transmitter secure?
Before removing transmitter latch, verify transmitter is securely in place.
Make sure none of the transmitter’s sides popped out of the sensor pod.
If transmitter isn't completely snapped in, you may have a bad connection and it won’t be water tight.
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Step Picture What you do
6
Hold
sensor pod sides
with one hand.
Twist
latch
away from your body with other hand.
Remove
latch
.
Don’t remove
transmitter
while sensor pod is attached
to skin.
You’re almost done starting your sensor session! Inserting the sensor, attaching the transmitter, and the two-hour sensor warmup are the
same regardless of whether you use the receiver or app. No matter which display device you use, you’ll insert the sensor and attach the transmitter
only once during your seven-day sensor session. The remaining steps vary from app to receiver:
1. Letting your device know you need to start the sensor warmup.
2. Following your warmup countdown.
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6.7 Loose Sensor Pod
The sensor pod should stay on your skin using its own adhesive. If the patch peels up, use medical tape (such as Blenderm™, Tegaderm™, Smith & Nephew
IV3000®, 3M™ tape) for extra support.
• Tape over white adhesive patch on all sides for even support
• Don’t tape over the transmitter or any plastic parts of the sensor pod
• Don’t tape under sensor pod
• Don’t leave any substance on the skin where you insert the sensor
Figure 4. The Right Way to Use Tape for Extra Support
6.8 Starting Your Sensor Session
If you choose to use both the receiver and the app, each system requires individual setups (see Chapter 5).
After pairing the transmitter to your display device(s), inserting your sensor, and attaching the transmitter to the sensor pod, your next step is telling your device(s) you want to start a sensor session. Transmitters are reusable; pairing is required only when using a new transmitter.
During the warmup period, neither device will provide any sensor glucose readings. Your sensor glucose readings begin after the two-hour sensor warmup has passed and you entered the initial two calibration BG values into either the smart device or the receiver.
We’ll first review starting the sensor session for the app.
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Dexcom App: Starting a Session
Step What you see What you do
1
If starting a new transmitter, pair it first. See chapter 8.
2
Tap
sensor warmup
circle to start your two-hour
sensor warmup. NOTE: You will NOT get any sensor glucose
readings, Alarm/Alerts during your two-hour sensor warmup period. Use your BG meter during the warmup period, including when making a treatment decision.
3
Wait. Screen provides countdown to sensor warmup. The
orange dashes darken as the countdown moves forward.
Keep
smart device
within 20 feet of transmitter
during the sensor warmup period. You won’t get alarm, alerts, or readings during the
2-hour warmup.
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Step What you see What you do
4
Locked screen.
Initial calibration
notification tells you when warmup
is complete. Chapter 7 covers calibrating.
5
Initial calibration
prompt tells you when warmup is
complete. Sensor warmup is complete. You’re ready to calibrate!
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Receiver: Starting a Session
Step What you see What you do
1
Turn on receiver:
• Press and hold
power button
for two seconds
to turn receiver on
Wake up receiver:
• Press
power button
briefly to wake up receiver
2
Make sure
receiver
and
transmitter
are
connected/paired before starting sensor session. Check
receiver
10 minutes after starting for
Bluetooth
icon:
• Solid: connected/paired
• Blinking: searching/not paired
Don’t start a sensor session until they are paired.
3
Tap
Start Sensor
.
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Step What you see What you do
4 Thinking screen
5
Receiver returns to the trend graph screen.
Sensor Warmup
confirms two-hour sensor warmup.
Keep your receiver within 20 feet during the warmup period.
You won’t get alarm, alerts, or readings during the warmup.
NOTE: After sensor starts,
Start Sensor
option
disappears from Main Menu and
Stop Sensor
appears.
6
Wait.
In the upper right corner, icon shows countdown of the two-hour sensor warmup.
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Step What you see What you do
7
Sensor warmup is complete. You’re ready to calibrate!
6.9 Receiver
Bluetooth
Tips
Your transmitter and receiver begin communicating once you start a sensor session. After approximately 30 minutes, if the
Bluetooth
symbol is solid, and not blinking, your transmitter
and receiver are talking to each other.
• If blinking,
Bluetooth
is looking for your transmitter – Make sure your transmitter and receiver are within 20 feet of each other – Don’t start a sensor session until they are paired
If the
Bluetooth
icon is blinking and
Signal Loss
displays, your transmitter and receiver are
not communicating.
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No Communication Between Transmitter and Receiver
Step What you see What you do
1
Move display device and transmitter within 20 feet of each other without obstruction (walls or water).
Wait up to 30 minutes. App:
1. Restart
smart device
.
If error remains:
1. Open your device
Bluetooth settings
.
2. Delete all Dexcom
entries
.
3. Pair your
transmitter
.
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 display devices.
Once the sensor warmup is complete, you’re ready to enter your initial calibrations! The next chapter shows you how.
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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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7.1 Introduction
In the previous chapter, you learned how to insert your sensor, attach your transmitter, and start a new sensor session. You’re now ready to begin your last step before getting your sensor glucose readings: Calibration.
This chapter reviews not just your initial calibration, but also update calibrations required throughout your sensor session.
After this chapter, you will be able to:
• Provide an overview of calibration – Define calibration – Explain the importance of calibration – Identify steps to ensure a successful calibration
• Recognize steps in taking accurate BG measurement – Identify the correct BG site for calibrations – Prepare finger for fingerstick measurement
• Determine if you should/should not calibrate – Recognize when you can enter a fingerstick measurement for calibration – Recognize when you shouldn’t enter a 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 – App – Receiver
• Identify calibration errors
Chapter 7
Let’s G5! The Basics:
Calibration
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7.2 Safety Statements
CONTRAINDICATION
Don’t: Never take any medications containing acetaminophen during your sensor session. Why: Taking medications with acetaminophen (such as Tylenol®, Excedrin® Extra
Strength, Sudafed®, or Robitussin®) while wearing your sensor may falsely raise sensor glucose readings. Level of sensor inaccuracy:
1. Depends on amount of acetaminophen active in your body.
2. May be different for each person. Consequences: Without correct readings, you might miss a severe low or high blood
glucose event or make a treatment decision that results in injury.
WARNING
Do: Do take a BG measurement with your BG meter and use the BG value for treatment decisions (such as how much insulin to take) if your Dexcom G5 Mobile does not display both a number and a trend arrow.
Why: Not having both a number and the arrow means you may be getting inconsistent or inaccurate sensor glucose readings.
Consequences: Using inconsistent or inaccurate sensor glucose readings for treatment decisions could result in you missing a severe low or high blood glucose event or making a treatment decision that results in injury.
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 a severe low or high glucose event or making a treatment decision that results in injury.
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PRECAUTION
Do:
Look at trend arrows before calibrating. Trend arrows help you determine if you can
calibrate now or should wait.
Don’t:
Never calibrate if your BG is changing at a significant rate, typically more than 2
mg/dL per minute. Never calibrate when you see:
•
A single arrow, pointing up
– 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 BG may affect accuracy of sensor glucose readings.
Consequences: Missing a severe low or high glucose event or making a treatment decision that results in injury.
PRECAUTION
Do:
Enter the exact BG value displayed on your BG meter within five minutes of a carefully
performed fingerstick measurement.
Why: Entering the wrong BG values, or waiting more than five minutes before entry, might affect sensor accuracy.
Consequences: Missing a severe low or high glucose event or making a treatment decision that results in injury.
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PRECAUTION
Do:
Only use fingerstick measurements from your BG meter for calibration.
Don’t:
Never use alternative site BG values such as blood from palms, forearms, etc.
Why: Alternative site BG values are different from a fingerstick BG value and may not reflect most recent BG value.
Consequences: Missing a severe low or high glucose event or making a treatment decision that results in injury.
7.3 Calibration Overview
What Is a Calibration?
As you learned earlier, the sensor glucose readings come from measuring the glucose found in fluids 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
uses your meter’s BG value to make sure the sensor glucose readings remain accurate throughout your session.
How Do I Calibrate?
Take a fingerstick measurement from your meter, and simply enter the meter’s BG value into one display device.
When taking a fingerstick, it’s important to do it correctly. Make sure you wash and dry your hands right before. And remember: always use your finger, never another site.
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