Dexcom 9688 User Manual

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Continuous Glucose Monitoring System

User Guide

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WARNING:

Failure to use the Dexcom G6® Continuous Glucose Monitoring System (G6) 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 G6 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 G6. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the G6. Discuss with your healthcare professional how you should use the information displayed on the G6 to help manage your diabetes. The product instructions contain important information on troubleshooting the G6 and on the performance characteristics of the system.

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Dexcom G6 System User Guide

Table of Contents

Part 1: Get Started

Chapter 1 | Begin Your Dexcom G6® Continuous Glucose Monitoring System (G6) Journey

1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . 9

1.2 Resources . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.3 Your Dexcom Account . . . . . . . . . . . . . 12

1.4 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.5 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . . . . . .17

Chapter 2 | Indications for Use and Safety Statements

2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . 19

2.2 Important User Information . . . . . . . . 19

2.3 Dexcom G6 Safety Statements . . . . . 20

2.4 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . . . . . 34

Chapter 3 | Risks and Benefits

3.1 Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

3.2 Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.3 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . . . . . 40

Part 2: Let's G6

Chapter 4 | What is the Dexcom G6® Continuous Glucose Monitoring System (G6)?

4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . 43

4.2 G6 CGM System . . . . . . . . . . . . . . . . . . 43

4.3 What’s New for G6? . . . . . . . . . . . . . . . 44

4.4 G6 Components . . . . . . . . . . . . . . . . . . 47

4.5 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . . . . . 49

Chapter 5 | Set Up Your Display Devices

5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . .51

5.2 Choose the App, the Receiver,

or Both . . . . . . . . . . . . . . . . . . . . . . . . . . .51

5.3 App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

5.4 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . 63

5.5 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . . . . . 69

Chapter 6 | Start Your Sensor

6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . .71

6.2 Prepare to Insert Sensor . . . . . . . . . . . .71

6.3 Choose Sensor Site . . . . . . . . . . . . . . . 73

6.4 Insert Sensor . . . . . . . . . . . . . . . . . . . . . 75

6.5 Attach Transmitter . . . . . . . . . . . . . . . . 81

6.6 Pair and Start Your Sensor. . . . . . . . . . 85

6.7 Pairing Tips. . . . . . . . . . . . . . . . . . . . . . . 91

6.8 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . . . . . 92

Chapter 7 | Calibrate

7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . 93

7.2 Calibration Overview . . . . . . . . . . . . . . 93

7.3 Prepare to Calibrate . . . . . . . . . . . . . . . 95

7.4 Calibrating . . . . . . . . . . . . . . . . . . . . . . . 96

7.5 Calibrate Without Prompts . . . . . . . . 106

7.6 Check In With Jake and Kelly . . . . . . 106

7.7 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . . . . 108

Part 3: Next Steps

Chapter 8 | Home Screen

8.1 Introduction . . . . . . . . . . . . . . . . . . . . . .111

8.2 Home Screen Overview . . . . . . . . . . .111

8.3 Glucose Information . . . . . . . . . . . . . .113

8.4 Navigation and Status Bar . . . . . . . . . .116

8.5 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . . . . .121

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Dexcom G6 System User Guide

Chapter 9 | Events

9.1 Introduction . . . . . . . . . . . . . . . . . . .123

9.2 Events Overview . . . . . . . . . . . . . . .123

9.3 Enter Insulin Event . . . . . . . . . . . . .124

9.4 Other Events . . . . . . . . . . . . . . . . . .128

9.5 App: Edit or Delete an Event . . . . .129

9.6 App: View Events. . . . . . . . . . . . . . . 131

9.7 What Was Covered and

What’s Coming . . . . . . . . . . . . . . . .132

Chapter 10 | Alarm and Alerts

10.1 Introduction . . . . . . . . . . . . . . . . . . 133

10.2 Alarm and Alerts Overview . . . . .133

10.3 Check In With Kelly . . . . . . . . . . . . 147

10.4 Confirming Alarm/Alerts . . . . . . .148

10.5 Customizing Your Alerts . . . . . . .150

10.6 Why Customize Alerts? . . . . . . . . 162

10.7 Check In With Jake and Kelly . . . 163

10.8 App: Control When

Alarm/Alerts Sound . . . . . . . . . . .165

10.9 App: Alert Schedule . . . . . . . . . . .166

10.10 What Was Covered and

What’s Coming . . . . . . . . . . . . . . 171

Chapter 11 | Treatment Decisions

11.1 Introduction . . . . . . . . . . . . . . . . . .173

11.2 How Do You Know

You’re Ready? . . . . . . . . . . . . . . . . . 173

11.3 Your HCP Is Your Partner . . . . . . . 174

11.4 When to Use Your Meter . . . . . . . 175

11.5 Watch and Wait . . . . . . . . . . . . . . . 177

11.6 Using Your G6

for Treatment Decisions . . . . . . . 177

11.7 Check In With Jake and Kelly . . .179

11.8 You Decide! . . . . . . . . . . . . . . . . . . 181

11.9 What Was Covered and

What’s Coming . . . . . . . . . . . . . . .183

Chapter 12 | App: Sharing Information With Your Support Team

12.1 Introduction . . . . . . . . . . . . . . . . . .185

12.2 Share and Follow . . . . . . . . . . . . .185

12.3 Check In With Jake and Kelly . . 203

12.4 What Was Covered and

What’s Coming . . . . . . . . . . . . . . 205

Chapter 13 | End Sensor and Transmitter Sessions

13.1 Introduction . . . . . . . . . . . . . . . . . .207

13.2 End Your Sensor Session . . . . . . .207

13.3 Remove Sensor and Transmitter 210

13.4 End of Transmitter Battery . . . . .214

13.5 Pair New Transmitter . . . . . . . . . .214

13.6 What Was Covered and

What’s Coming . . . . . . . . . . . . . . .224

Chapter 14 | Troubleshooting

14.1 Introduction . . . . . . . . . . . . . . . . . .225

14.2 Alarm/Alerts and G6 Readings . .225

14.3 Applicator . . . . . . . . . . . . . . . . . . . .235

14.4 App . . . . . . . . . . . . . . . . . . . . . . . . 240

14.5 Receiver . . . . . . . . . . . . . . . . . . . . 240

14.6 Recalibration Alert . . . . . . . . . . . 250

14.7 Transmitter . . . . . . . . . . . . . . . . . . .252

14.8 Sensor . . . . . . . . . . . . . . . . . . . . . . 254

14.9 Share . . . . . . . . . . . . . . . . . . . . . . . .255

14.10 Accuracy . . . . . . . . . . . . . . . . . . . .257

14.11 Calibration Prompts . . . . . . . . . 258

14.12 What Was Covered and

What’s Coming . . . . . . . . . . . . . .259

Part 4: Everything Else G6

Appendix A | Need Help?

You’re Not Alone! . . . . . . . . . . . . . . . . 263

Appendix B | Security and

Air Travel . . . . . . . . . . . . . . . . . . . . . . . . .267

Appendix C | Extend Your App . . . 269 Appendix D | Take Care of

Your G6 . . . . . . . . . . . . . . . . . . . . . . . . . .275

Appendix E | Warranty . . . . . . . . . . . 283

Appendix F | Technical

Information . . . . . . . . . . . . . . . . . . . . . 289

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Dexcom G6 System User Guide

Appendix G | Label Symbols . . . . . .327

Appendix H | Alarm/Alerts

Vibrations and Sounds . . . . . . . . . . . . 331

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . .347

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Get Started

• Get Started

• Indications for Use and Safety Statement

• Risks and Benefits

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

Chapter 1 | Begin Your Dexcom G6

Continuous Glucose Monitoring System (G6) Journey

1.1 Introduction

Welcome to the G6 continuous glucose monitoring (CGM) family!

This User Guide supports you in getting to know your G6. We also have numerous other resources available to help you to get the most out of your G6.

After this chapter, you’ll be able to:

• Locate different training resources

• Explain why you need a Dexcom account

Images and screens in this User Guide are representational and may differ from your G6.

1.2 Resources

Tutorial

Our tutorial walks you through your first sensor session, including picking a display device, inserting the sensor, and using alarm/alerts, and making treatment decisions.

Your First Sensor Session tutorial is at dexcom.com/support

In-App Videos

Watch the videos in your app to find out more:

• Overview: See how your CGM shows where your sensor glucose is now, where it’s going, and where it’s been

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

• Sensor Insertion and Attaching Transmitter Attachment: Walks through inserting your sensor and attaching your transmitter

• Treatment Decisions: Learn how to use your G6 to make treatment decisions, like dosing for highs and treating for lows

You can watch these videos when you set up your app or anytime at Settings > Help > Videos.

Guides

Getting Started Guides

Two guides are included with your boxes:

• Start Here guides you through setting up your display devices, inserting your sensor, and starting your first sensor session

• Using Your G6 helps you during your first week (for example, how to read the home screen) and beyond

User Guide

This User Guide is your encyclopedia. It gives you the most extensive overview of the G6, detailing features, important safety information, and so much more.

Download the User Guide or ask for a printed version:

Download a PDF at dexcom.com/guides

Complete an online form at dexcom.com/guides to receive a free printed copy

Ask for a free copy by mail by filling out and returning the business card found in the back of this guide

Ask for a free copy by phone:

Toll free: 1.888.738.3646

Toll: 1.858.200.0200

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

The G6 User Guide is grouped into four parts:

Part 1: Get Started

• Chapter 1: Begin Your Dexcom G6® Continuous Glucose Monitoring System (G6) Journey

• Chapter 2: Indications for Use and Safety Statements

• Chapter 3: Risks and Benefits

Part 2: Let’s G6! The Basics

• Chapter 4: What is the G6?

• Chapter 5: Set Up Your Display Devices

• Chapter 6: Start Your Sensor

• Chapter 7: Calibrate

Part 3: Next Steps

• Chapter 8: Home Screen

• Chapter 9: Events

• Chapter 10: Alarm and Alerts

• Chapter 11: Treatment Decisions

• Chapter 12: Sharing Information With Your Support Team

• Chapter 13: End Sensor and Transmitter Sessions

• Chapter 14: Troubleshooting

Part 4: Appendices

• Appendix A: Need Help? You're Not Alone

• Appendix B: Security and Air Travel

• Appendix C: Extend Your App

• Appendix D: Take Care of Your G6

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

• Appendix E: Warranty

• Appendix F: Technical Information

• Appendix G: Label Symbols

• Appendix H: Alarm/Alert Vibrations and Sounds

How to Use Your User Guide

Start with the table of contents. Each chapter includes information to guide you through your sensor session, from setting it up, to taking it off, and everything in between.

All chapters in the G6 User Guide are structured the same way: The beginning of each chapter lists what you’ll be able to do after you’ve finished, followed by the chapter’s content. At the end, there’s a recap of what was covered and what’s in the next chapter.

The appendices have additional information you may want to reference. For example, about the warranty, and taking care of your device.

This User Guide isn’t meant to show you how to use your smart device. Contact your smart device support or read your smart device’s user guide for assistance.

Label Symbols

Symbols may be found on the sensor, transmitter, and receiver package labels. These symbols tell you about the proper and safe use of the G6. For a listing of what they mean, see the Symbols Glossary in Appendix G and at dexcom.com/symbols.

1.3 Your Dexcom Account

You’ll need a Dexcom username and password to set up the Dexcom G6 App (app) and for reordering. If you don't have a Dexcom user name and password, go to dexcom. com and set up an account. Or, if you prefer, create your account in the app during setup.

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

1.4 Glossary

A1C

Blood test used to diagnose type 1 or 2 diabetes and to gauge how well you’re managing your diabetes. A1C reflects your average blood sugar level for the past 2 to 3 months.

Airplane Mode

A setting on a smart device where certain features are disabled to comply with airline regulations.

Alternative Site Testing

Using a blood sample from non-fingertip (alternate) sites such as the palm, forearm, or upper arm for meter values.

Don’t use alternative site testing to calibrate the G6. Only use fingerstick measurements.

Android Operating system used for smart devices.

Android Wear A type of smart watch.

App or Application

Software installed on a smart or mobile device.

The G6 app is a display for continuous glucose monitoring.

App Store or Play Store

Internet store for downloading applications to a smart device.

Apple Watch A smart watch for iPhone.

Blood Glucose (BG) Meter

A medical device used to measure how much glucose is in the blood.

Blood Glucose (BG) Value

Blood glucose value is the amount of glucose in the blood measured by a meter.

Bluetooth

A technology that allows devices to wirelessly communicate with each other.

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

Calibration

Calibration is a comparison or measurement between your meter fingerstick BG values, and the sensor interstitial fluid glucose readings. Although blood and interstitial fluids are similar, glucose concentrations may differ. Calibration allows alignment between your G6 readings and meter values.

When you calibrate, you take a fingerstick measurement from your meter then enter the value into your receiver or smart device

Calibrating your G6 is optional.

Continuous Glucose Monitoring

A sensor inserted under the skin checks glucose levels in interstitial fluid. A transmitter sends readings to a display device.

Contraindication

A safety statement outlining specific situations where the G6 shouldn't be used because it may be harmful to you. The risk of use clearly outweighs any possible benefit.

Default A manufacturer’s preset option for a device setting.

Follow or Dexcom Follow App

A Dexcom app used for monitoring another user’s glucose information and alerts.

Follower A person who receives a Sharer’s information in Follow.

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 Alert in the G6 is set to 200 mg/dL. Consult your HCP (healthcare professional) to determine the appropriate hyperglycemia setting for you.

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

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 Alert in the G6 is set to 80 mg/dL. Consult your HCP to determine the appropriate hypoglycemia setting for you.

Indications

How, for what purposes, and under what circumstances you should use the G6.

iOS Operating system used for Apple smart devices.

The International Electrotechnical Commission (IEC) is a nonprofit, non-governmental, international organization created to produce safety standards for electronics. One of the safety standards 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 encounters.

An IP22 rating lets you know your electronic device won’t allow you to stick your fingers in it and won’t get damaged or be unsafe during specific testing with water dripping down.

Jailbroken or Rooted

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.

Don't install the G6 app on a jailbroken or rooted smart device. It may not work correctly.

mg/dL

Milligrams per deciliter. The standard unit of measure for BG readings in the United States.

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

Notification

An app message that appears on the screen of a smart device. Notification may also include a sound or vibration, depending on the smart device settings.

Peripheral Device

Hardware connected to your smart device. For example, a

Bluetooth

headset, Apple watch, or other smart watch.

Precaution

A safety statement regarding any special care to be exercised by you or your HCP for the safe and effective use of the G6.

Safety Statement

A statement of the intended uses of G6 and relevant warnings, precautions, and contraindications.

Sensor Glucose Reading

A BG measurement taken by the G6. Typically referred to as “G6 readings” in these instructions.

Sensor Session

The 10-day monitoring period after inserting a new sensor. During this time frame, your glucose is being monitored and reported every 5 minutes, with data being sent to your display device(s).

Share or Dexcom Share App

A feature of the Dexcom G6 app that lets you securely send your G6 information to Followers.

Sharer The G6 user who shares their G6 information with Followers.

Simultaneous Voice and Data

The ability to make a phone call and access the Internet on the same cellular connection at the same time.

Smart or Mobile Device

An electronic device that is cordless, mobile, and connected to the Internet, such as a smartphone or tablet.

Smart Watch

A watch that communicates with and extends a smart device. For example, an 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.

Warning

Describes serious and life-threatening circumstances, the consequences, and how to avoid the hazard while using the G6.

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Dexcom G6 System User Guide

Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey

1.5 What Was Covered and What’s Coming

Now You Can:

• Locate different training resources

• Explain why you need a Dexcom account

What’s Next?

Next you’ll learn when and how to use the G6 safely.

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Dexcom G6 System User Guide

Chapter 2: Indications for Use and Safety Statements

Chapter 2 | Indications for Use and

Safety Statements

2.1 Introduction

We want the Dexcom G6® Continuous Glucose Monitoring System (G6) to be a valuable tool in your diabetes management. Like any system, there are steps to take to get the most out of it.

In this chapter, you will learn about some key areas that might prevent you from having the best CGM experience or if you are not careful might even harm you or the G6.

2.2 Important User Information

What is a Safety Statement

A Safety Statement is a brief statement of the G6 indications, contraindications (when to avoid using it), relevant warnings, and precautions. The Safety Statements are meant to keep you and the G6 safe while using it:

1) Indications

How, for what purposes, and under what circumstances you should use the G6. Indications let you know who should use the G6 and when.

2) Contraindications

Contraindications let you know when not to use the G6. If used during these situations, you may hurt yourself or the G6 and 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.

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Dexcom G6 System User Guide

Chapter 2: Indications for Use and Safety Statements

Safety Statements in Chapters

Each chapter shows applicable indications, contraindications, precautions, and warnings. Some chapters have multiple Safety Statements; others have none. The same statement may be repeated in several chapters.

2.3 Dexcom G6 Safety Statements

Indications for Use

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.

The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

Contraindication

• No MRI/CT/Diathermy – MR Unsafe

Don’t wear your CGM (sensor, transmitter, receiver, or smart device) for magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.

The G6 hasn’t been tested in those situations. The magnetic fields and heat could damage the components of the G6, which may cause it to display inaccurate G6 sensor glucose readings (G6 readings) or may prevent alerts. Without G6 readings or alarm/alert notifications, you might miss a severe low or high glucose event.

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Dexcom G6 System User Guide

Chapter 2: Indications for Use and Safety Statements

Warnings

• Read User Materials

Before you use your G6, carefully read the materials included with it. If you don’t, you might:

• Not use the G6 correctly

• Not understand G6 information

• Affect how well it works

• Don’t Ignore Low/High Symptoms

Don’t ignore how you feel. If your glucose alerts and G6 readings don’t match what you’re feeling, use your blood glucose meter (meter) to make diabetes treatment decisions or, if needed, seek immediate medical attention.

When in doubt, get your meter out.

• No Number, No Arrow, No CGM Treatment Decision

If your G6 doesn’t show a number or arrow, or your readings don’t match your symptoms, use your meter to make diabetes treatment decisions.

No number, no arrow, no treatment decision. When in doubt, get your meter out.

• Don’t Use If…

Do not use the G6 if you are pregnant, on dialysis, or critically ill. It is not known how different conditions or medications common to theses populations may affect performance of the system. G6 readings may be inaccurate in these populations.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Precaution

• Avoid Sunscreen and Insect Repellent

Some skin care products, such as sunscreens and insect repellents, can make the plastic used in your G6 crack. Before using your G6, make sure there are no cracks in your receiver, transmitter, and transmitter holder. If you find a crack, please contact Technical Support. Do not allow these skin care products to contact your G6. After using skin care products, wash your hands before touching your G6. If any skin care products get on your G6, immediately wipe with a clean cloth.

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Dexcom G6 System User Guide

Chapter 2: Indications for Use and Safety Statements

Start Up Safety Statements

Warnings

• Use Meter During Startup

When you start a new sensor, you won’t get any G6 readings or alarm/alerts until you enter your sensor code or two calibrations. Use your meter to make treatment decisions during the 2-hour sensor warmup period.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Precautions

• Use Correct Sensor Code

When you start a new sensor, you must enter a code into your display device to use the G6 without fingerstick calibrations. Each sensor has its own code printed on the back of the adhesive patch. Do not use a code from a different sensor or make up a code. If you do not enter the correct code, your sensor will not work as well and could be inaccurate. If you lost the sensor code, you may calibrate the G6 using fingersticks.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Calibration Safety Statements

Calibration is not required if users enter a sensor code. If users do not enter a sensor code, the following warnings and precautions apply.

Warnings

• Don’t Wait – Calibrate!

If you have not used the calibration code, you must manually calibrate your G6 using values obtained from a blood glucose meter and fingersticks daily. You must calibrate immediately when the G6 notifies you. If you haven’t calibrated when notified, your G6 may not be accurate, so use your glucose meter to make treatment decisions until you calibrate your G6.

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• Use Fingersticks

Use fingertips to calibrate from your BG meter. Blood from other places may be less accurate and not as timely.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Precautions

• Be Accurate, Be Quick.

Enter the exact BG value displayed on your meter within five minutes of using your meter. Don’t enter the G6 reading as a calibration.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

System/Hardware/Software Safety Statements

Warnings

• Wire Breaks Off

Don’t ignore broken or detached sensor wires. A sensor wire could remain under your skin. If this happens, please contact our 24/7 Technical Support.

If a sensor wire breaks off under your skin and you can’t see it, don’t try to remove it. Contact your HCP. Also seek professional medical help if you have symptoms of infection or inflammation – redness, swelling, or pain – at the insertion site.

• Where to Insert: Belly or Buttocks?

All patients can use their bellies (abdomen). Patients 2 to 17 years old can also choose their upper buttocks. Look for a place on your belly or upper buttocks where you have some padding.

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The sensor is not tested or approved for other sites. Talk to your HCP about the best site for you.

Where to Store

You can store your sensors at room temperature or in your refrigerator – as long as it’s between 36°F and 86°F. Don’t store sensors in the freezer.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Precautions

• Don’t Use if Expired

Don’t use expired sensors, because they may give incorrect results. Check the package label for the expiration date. It’s in YYYY-MM-DD (Year-Month-Day) format.

• Check Package

Don’t use sensor if its sterile package has been damaged or opened, because it might cause an infection.

18 years and older

2-17 years

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• Clean and Dry Skin

Clean and dry your hands and your insertion site before inserting your sensor.

Wash your hands with soap and water, not gel cleaners, and then dry them before opening the sensor package. If your hands are dirty when you insert the sensor, you may get germs on the insertion site and get an infection.

Clean your insertion site with alcohol wipes to prevent infections. Don’t insert the sensor until your skin is dry. If your insertion site is not clean and completely dry, you run the risk of infection or the transmitter holder not sticking well.

Make sure you don’t have insect repellent, sunscreen, perfume, or lotion on your skin.

• Where to Insert: Things to Check

Keep the safety guard on until you put the G6 applicator against your skin. If you remove the safety guard first, you may hurt yourself by accidentally pushing the button that inserts the sensor before you mean to.

Change your insertion site with each sensor. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation.

Sensor placement is important. Choose a site:

• At least 3 inches from insulin pump infusion set or injection site

• Away from waistband, scarring, tattoos, irritation, and bones

• Unlikely to be bumped, pushed, or laid on while sleeping

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Transmitter Safety Statements

Warnings

• Inspect

Don’t use a damaged or cracked transmitter. A damaged transmitter could cause injuries from electrical shocks and may make the G6 not work correctly.

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• Use as Directed

The transmitter is small and may pose a choking hazard. Don’t put it in your mouth or let children hold it without adult supervision.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Precautions

• Reuse – Don’t Throw Away

When ending a session, don’t throw away the transmitter. The transmitter is reusable until the G6 notifies you that the transmitter battery is about to expire.

• Don’t Share

Never share your transmitter. The G6 is a prescription-only medical device and is meant for your use only. The transmitter is tied to the G6 readings. If used by more than one person, the G6 readings, reports, alarm/alerts, etc., may be wrong.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

System Safety Statements

Precautions

• Treatment Decisions

Use your G6 reading and trend arrow to make treatment decisions.

• Use Correct Transmitter, Receiver, and Sensor

G6 components are not compatible with any previous Dexcom products. Do not mix transmitters, receivers, and sensors from different generations.

• Going Through Security Check Point

When wearing your G6, ask for hand-wanding or full-body pat-down and visual inspection instead of going through theAdvanced Imaging Technology (AIT) body scanner (also called a millimeter wave scanner) or putting any part of the G6 in the baggage x-ray machine.

You can wear the G6 for the walk-through metal detector. If you do, use your meter for treatment decisions until you leave the security area.

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Because we haven’t tested every x-ray and scanner, we don’t know if they damage the G6.

Not sure what kind of machine it is? Be safe – either ask the TSA officer, request hand-wanding, or request full-body pat-down.

• Interfering Substance Risks

In previous generations of Dexcom CGM systems (G4/G5), acetaminophen could affect your sensor readings, making them look higher than they really were. However, with the G6, you can take a standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours and still use the G6 readings to make treatment decisions. Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the G6 readings and make them look higher than they really are.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Receiver and Smart Device Safety Statements

Precautions

• Keep Transmitter Close to Display Device

Keep your transmitter and display device within 20 feet with no obstacles (like walls or metal) between them. Otherwise, they might not be able to communicate. If water is between your transmitter and the display device – for example, if you’re showering or swimming – keep them closer to each other. The range is reduced because Bluetooth® doesn’t work as well through water.

• Get Alarm/Alerts on Display Device You Use

To get your alarm/alerts, set them on the display device you use. Your receiver won’t get the alarm/alerts you set on your app. Likewise, your app won’t get the alarm/alerts you set on your receiver.

• Is It On?

If the receiver or smart device is turned off (shut down), it will not show G6 readings or alarm/alerts. Make sure your display device is turned on.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

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Smart Device Safety Statements

Warning

• Check Settings

Your alarm and important alerts sound and display information even when your volume is low or muted. Specifically, if your smart device is on mute and you have the Always Sound setting turned on (the default setting), only these notifications make a sound:

• Glucose Alarm/Alerts:

• Urgent Low

• Urgent Low Soon

• Low Glucose

• High Glucose

• Rise Rate

• Fall Rate

• No Readings Alert

• System Alerts:

• Calibration Required (after 2-hour sensor warmup, only appears when a sensor code is not active)

• Calibration Error (only appears when a user enters a calibration; calibration is not required)

• Sensor Expired

• Replace Sensor

• Transmitter (not working)

• No Storage Error

• App Stopped

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• Exceptions: On Apple devices, Signal Loss does not sound when your volume is low or muted. No alarm/alerts sound on your phone when your Android phone is in the most restrictive Do Not Disturb setting.

• Repeating: Some notifications are silent during the first visual and vibrate notification and then make a sound on the second notification. If you do not clear the alert, it repeats at half volume after 5 minutes and at full volume after 10 minutes.

• Accessories: When using Bluetooth headphones, speakers, etc., your alarm/ alerts may sound on your primary smart device or on the accessory. Each accessory is different. Test yours so you know where you’ll hear your alarm/ alerts.

• Bluetooth: Your transmitter talks to your app with Bluetooth. Make sure your smart device Bluetooth is on. If not, you will not get alarm/alerts or CGM information.

• Notifications:

• Make sure your smart device settings allow Dexcom app notifications to

show on your Lock screen. This will allow you to see notifications without unlocking your phone.

• Apple: During G6 setup, enable Dexcom app notifications or you won’t get

alarm/alerts.

• Battery: The app must always be running in the background and may drain your smart device battery. Keep the battery charged.

• Compatibility: Before upgrading your smart device or its operating system, check dexcom.com/compatibility. Automatic updates of the app or your device operating system can change settings or shut down the app. Always update manually and verify correct device settings afterward.

• Time: Let the date and time on your smart device automatically update when you travel across time zones or switch between standard and daylight saving times. Don’t manually change your smart device time, because it can make the time on the trend screen wrong and the app may stop displaying data.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

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Precautions

• Test Speaker and Vibrations

You have to hear or feel alarm/alerts to react to them, so test your smart device speaker and vibrations regularly (see your smart device product instructions). If they don’t work, contact your smart device’s product support.

• Check Peripheral Devices

Do you use headphones with your smart device? What about Bluetooth speakers or a smart watch? When using peripherals, keep in mind you may get your alarm/ alerts on only one device or peripheral, not all. After connecting any peripheral devices, make sure that your smart device settings allow you to continue receiving alarms or alerts.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Receiver Safety Statements

Warnings

• Don’t Use if Damaged

Don’t use a receiver that is damaged or cracked. A damaged receiver could cause injuries from electrical shocks and may make the G6 not work correctly.

• Use Cable as Directed

Use USB cable only as directed, and store safely. Misuse of the USB cable can be a strangulation risk.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Precautions

• Test Speaker and Vibrations

You have to hear or feel alarm/alerts to react to them, so test your receiver speaker and vibrations regularly.

To make sure the speaker and vibrations work, plug in the receiver to charge. The Speaker Test screen appears for a few seconds. Follow the directions on the screen to test the speaker and vibrations. If you hear and feel them, great! But if it doesn’t beep and vibrate – perhaps it got wet or was dropped – contact Technical Support and use your app until the receiver is fixed.

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• Keep Clean and Dry

Don’t submerge your receiver in water and don’t get dirt or water in the USB port. That could damage it.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Caution

• Requires Prescription

U.S. law restricts the sale of the G6 Mobile to sale by, or on the order of, a physician.

Dexcom Share Safety Statements

Important User Information

Dexcom Share (Share) lets you send your sensor information from your app to your Followers’ smart devices! Read the indications, warnings, and precautions below to find out how you can safely use this app feature.

Share and Managing Your Diabetes Safety Statements

Indications

• Keep Followers Informed

Use Share to send your sensor information from your smart device to your Followers’ smart devices.

• Use as Secondary Notice

The information on your smart device is sent directly from your G6 transmitter. After it is on your device, Share sends it to your Followers. So your Followers’ information is always older than yours. Use your current information to manage your diabetes, not your Followers’ possibly outdated information.

Your Followers can use the information they get to reach out to you and support you in managing your diabetes. The information they get is not meant to be used for treatment decisions, analysis, or teaching. Followers can’t change your information.

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Warnings

• Use Your G6 to Make Treatment Decisions

Don’t use Share information for treatment decisions, like treating for a low or dosing for a high. Use the sensor information on your G6 instead.

• Take HCP Advice

Has your HCP given you self-monitoring tasks? Keep doing them. Having Followers doesn’t replace them.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Share Setup and Settings Safety Statements

Warning

• Followers Must Follow and You Must Share

You have to turn Share on to make it send your sensor information to your Followers. Followers have to download the Dexcom Follow app to see what you send.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Precautions

• Followers Don’t Manage Your Diabetes, You Do

Don’t rely on your Followers to let you know you need to make a treatment decision. Stay on top of your diabetes management. Look at your G6 often. Respond to alarm/alerts. Don’t wait for a Follower to reach out – they may not be getting your sensor information because of a technical issue.

• Check Your Smart Device and Your Followers’ Smart Devices

• Internet access required: Both smart devices need to be connected to the Internet to use Share. Try sending your Follower an email from your device. If your Follower gets it on their device, both smart devices are connected.

• Batteries charged: Make sure the smart device batteries are charged. If either your or your Followers’ smart device batteries aren’t charged, Share won’t work.

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• Check Your Smart Device

App on: Whenever you power on your smart device, tap the G6 app to open it. If the app isn’t open, Share won’t work.

• Check Followers’ Smart Devices

• Sounds on: Followers must keep their smart device volume on, or at least the keep vibration on, so they can hear and/or feel alarm/alerts. Smart device settings trump Follow app settings

• Sharing gaps: Followers won’t get your sensor information when their smart device is off, not connected to the Internet, or in Do Not Disturb or Airplane mode. When the Followers fix those issues, they’ll start getting the current information but they won’t get the information they missed

• Cell carrier supports simultaneous voice and data: Most cell service carriers support using voice and data at the same time. Check yours and have Followers check theirs. If it’s not supported, Share won’t work during phone calls. Share will restart when the call is over and send any waiting notifications

• Customize Share So Followers Can Support You

• Customize Share to make sure your Followers have the information they need to help you manage your diabetes

• Delay feature: Your Follower won’t get notified until after the delay time you set

• Not Share feature: You can stop sharing with a Follower any time by choosing Not Share. That Follower will stop getting any of your sensor information until you choose to Share again

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

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2.4 What Was Covered and What’s Coming

Now You:

• Can explain how safety statements keep you safe

• Can explain how to interpret safety statements

• Have an overview of safety statements

What’s Next?

In the next chapter, you’ll learn the risks and benefits of using the G6.

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Chapter 3 | Risks and Benefits

When using any medical device, there are risks and benefits. In this chapter, you’ll learn what they are.

3.1 Risks

The risks with using Dexcom G6® Continuous Glucose Monitoring System (G6) are:

• Not getting your alarm/alerts

• Using G6 to make treatment decisions when you shouldn’t

• Sensor insertion issues

This section covers each of those risks in detail.

Follow system instructions. If you don’t, you could have a severe low or high glucose event.

Not Getting Alarm/Alerts

If you aren’t getting your alarm/alerts, you could have severe low or high glucose without knowing it. Check your display device:

• Battery charged: If the display device battery is dead, you won’t get G6 readings or alarm/alerts.

• App on: Keep the app on so you get G6 readings or alarm/alerts.

• Alerts on: Leave the alert function on to get alarm/alerts.

• Volume up: Keep the volume loud enough to hear your alarm/alerts.

• Speaker and vibrations work: If the speaker or vibrations aren’t working, you won’t hear or feel your alarm/alerts.

• In range: Keep your display device no more than 20 feet from your transmitter, with no obstacles between them. They have to be that close to communicate. If they aren’t in range, you won’t get G6 readings or alarm/alerts.

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• No System errors: If you get a system error – such as No Readings, Sensor Error, or Signal Loss – you won’t get G6 readings or alarm/alerts.

• During warmup and after session ends: You won’t get alarm/alerts or G6 readings during the 2-hour warmup or after a sensor session ends.

See Troubleshooting (Chapter 14), recommended settings (Chapter 5), and notifications that sound while smart device is silenced/muted (Appendix H) for more information.

Using G6 for Treatment Decisions

You can use your G6 to treat for a low or dose for a high in all but these few situations . See table below for details.

Situation Treatment Descision Tool

How you feel is consistent with our G6 reading

Use your CGM to make a treatment decision

How you feel is inconsistent with your CGM G6 reading

Take a fingerstick with your blood glucose meter to make a treatment decision

Your CGM displays a sensor glucose number and arrow(s)

Use your CGM to make a treatment decision

Your CGM display is missing G6 reading (number) or arrow(s), or both

Take a fingerstick with your meter to make a treatment decision

Use your G6 for treatment decisions, not your Followers: Dexcom Share allows you to share your sensor glucose information from your smart device to your Followers’. The main risk with Share is misunderstanding its purpose. The information on your display device is the most current – it comes straight from your transmitter – so only use yours for treatment decisions. There can be technical issues and delays in sharing information. Followers can reach out and support you, but don’t rely on them or their information to manage your diabetes for you.

Some users found accuracy between different sensors varied significantly. When you insert each sensor, pay attention to its accuracy before deciding to use it for treatment decisions.

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For more information on how to make treatment decisions using your G6, see Chapter

11. For more information on Share, see Chapter 12.

Interfering Substance Risks

Sensor Insertion Risks

It’s uncommon, but inserting the sensor can cause infection, bleeding, or pain, and wearing the adhesive patch can irritate your skin. Only a few patients in the G6 clinical studies got slight redness and swelling.

No sensor wires broke in the clinical studies; however, there is a remote chance a sensor wire could break or detach and remain under your skin. Sterile broken sensor wires usually don’t pose a significant medical risk. If a sensor wire breaks off or detaches and remains under your skin, contact your HCP and Technical Support (24/7):

• Web: dexcom.com/tech-support

• Toll free: 1.888.738.3646

• Toll call: 1.858.200.0200

3.2 Benefits

Some benefits of using your G6 are:

• Knowing your trends

• Making treatment decisions using your G6

• Managing your diabetes

• Getting alerted for low and high G6 readings

This section covers each of those benefits in detail.

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Knowing Your Trends

The G6 sends you a reading every 5 minutes. It also provides reports and views of your information so you can detect and reflect on trends, patterns, and how your body responds to different things, like exercise or pizza. This provides you with a more complete picture of your glucose and lets you see how your daily habits impact your glucose trends.

Making Treatment Decisions Using G6

You can use your G6 reading and trend arrow to make treatment decisions – like treating for a low or dosing for a high. See Chapter 11 for more information on treatment decisions. With G6, there’s no need to take fingersticks to calibrate the system or for treatment decisions (as long as your symptoms match your G6 readings). This can reduce the pain and burden of excessive fingersticks (Aleppo 2017) and reduce potential errors due to inaccurate calibration.

Helping Your Diabetes Management

The alarm/alerts features (Chapter 10) keep you aware of your glucose levels. Alarm/ alerts notify you when your glucose goes outside your target range, goes too low, or too high, or is rapidly falling or rising. This lets you take action to prevent glucose from going too low or high (Pettus 2015).

Some people perceive an increase in their quality of life and peace of mind when using real-time CGM (Polonsky 2017). Share may improve the quality of life and peace of mind for patients, their caregivers, and their support team because it sends Followers G6 readings and alarm/alerts remotely. Followers can then reach out when G6 readings go too low or high.

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References

Aleppo, Grazia,KatrinaRuedy,TonyaRiddlesworth,DavidaKruger,Anne Peters,IrlHirsch,Richard Bergenstal,ElenaToschi,AndrewAhmann,Viral Shah,MichaelRickels,BruceBode,AthenaPhilis-Tsimikas,RodicaPopBusui,HenryRodriguez,EmilyEyth,AnujBhargava,CraigKollman,and Roy Beck.

2017. “Replace-BG: a randomized trial comparing continuous glucose monitoring with

and without routine blood glucose monitoring in well-controlled adults with type 1 diabetes.” DiabetesCare.40(4):538-545. doi: 10.2337/dc16-2482.

Beck, Roy, Tonya Riddlesworth, Katrina Ruedy, Andrew Ahmann, Richard Bergenstal, Stacie Haller, Craig Kollman, Davida Kruger, Janet McGill, William Polonsky, Elena Roschi, Howard Wolpert, and David Price for the DIAMOND Study Group. 2017. “Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the DIAMOND randomized clinical trial.” JAMA.317(4):371-

378. doi:10.1001/jama.2016.19975.

The Diabetes Control and Complications Trial Research Group. September 30, 1993. “The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.” N Engl J Med. 329:977-986.

Lind, Marcus, William Polonsky, Irl Hirsch, Tim Heise, Jan Bolinder, Sofia Dahlqvist, Erik Schwarz, Arndis Finna Olafsdottir, Anders Frid, Hand Wedel, Elsa Ahlen, Thomas Nystom, and Jarl Hellman. 2017. “Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: the gold randomized clinical trial.” JAMA. 317(4):379-387. doi:10.1001/jama.2016.19976.

Pettus, Jeremy, David Price, and Steven Edelman. 2015. ‘How patients with type 1 diabetes translate continuous glucose monitoring data into diabetes management decisions.” Endocr Pract. 21(6):613-620. doi: 10.4158/EP14520.OR.

Polonsky, William, Danielle Hessler, Katrina Ruedy, Roy Beck, for the DIAMOND Study Group. 2017. “The impact of continuous glucose monitoring on markers of quality of life in adults with type 1 diabetes: further findings from the DIAMOND randomized clinical trial.” Diabetes Care. 40(6):736-741. doi:10.2337/dc17-0133.

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3.3 What Was Covered and What’s Coming

Now You Can:

• List the risks and benefits of using the G6

What’s Next:

Now let’s take a look at the G6!

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Let’s G6–The Basics

• What is the G6?

• Set up Display Devices

• Start Your Sensor

• Calibrate

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Chapter 4: What is the G6?

Chapter 4 | What is the Dexcom G6

Continuous Glucose Monitoring System (G6)?

4.1 Introduction

This chapter is an overview of the G6.

After this chapter, you’ll be able to:

• Explain what the G6 does

• List what’s new in the G6

• Explain each component’s function

4.2 G6 CGM System

The G6 allows you to continually see your G6 readings, updated every 5 minutes for up to 10 days, without the bother of taking constant fingerstick measurements or calibrations. You’ll see:

• G6 readings are updated every 5 minutes.

• Trend arrows show where your BG is heading.

• Alarm/alerts warn you when you need to take action; for example, when your BG is too high or too low.

• Trend graphs show the last 1, 3, 6, 12, and 24 hours of your G6 readings.

• Share/Follow App allows you to share your G6 readings and trends with your support team.

• CLARITY Reports lets you see different reports reflecting your glucose trends. With CLARITY, you and your HCP can review, analyze, and evaluate your historical G6 data. Go to clarity.dexcom.com for more information, and download the app from the app store.

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4.3 What’s New for G6?

Dexcom’s G6 features include:

• No fingerstick calibrations are required! You still have the option to enter calibration if you want to.

• Wear sensor for 10 days

• Sensor overpatch

• Urgent Low Soon Alert

• Acetaminophen blocking

• New sensor applicator

• Streamlined transmitter and transmitter holder

No Fingerstick Calibrations

With the G6, there’s no need to calibrate! The G6 was designed as a no calibration system. After entering the sensor code (See Chapter 5), you won’t receive any calibration prompts.

One of the great things about the G6 is that, although calibrations are not required, you have the option to calibrate if you want to (See Chapter 7).

Sensor Overpatch

If you have problems with your sensor coming off, use the overpatch. It’s designed to cover the sensor’s adhesive patch and help keep your sensor in place for all of your 10-day sensor session.

Urgent Low Soon Alert

Get an alert when your glucose is quickly heading toward 55 mg/dL.

Sometimes glucose levels fall fast. The Urgent Low Soon Alert notifies you when your G6 reading is predicted to reach 55 mg/dL within 20 minutes. This helps you to determine what the appropriate treatment action will be before your glucose levels drop too low. For additional information on alerts, please see Chapter 9.

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Chapter 4: What is the G6?

Acetaminophen Blocking

Additional notes for health care professionals:

A clinical study was conducted to demonstrate that a maximum dose of acetaminophen (1000 mg) does not interfere with the G6 readings. 65 adult subjects wore both a G6 and a G4 PLATINUM with SW505 CGM system. The G4/G5 sensor was used as a comparator for establishing the time to reach a peak acetaminophen concentration (~1 hour), in the interstitial fluid, from the time the acetaminophen was administered. The observed peak plasma acetaminophen concentration ranged from 0.2 to 2.6 mg/dL. To assess whether this peak acetaminophen concentration had an interference effect on the G6 readings, the G6 readings were compared to reference plasma glucose measurements with YSI. Venous blood was sampled every 10-15 minutes from 1 hour before and up to 6 hours after the acetaminophen was administered. The observed mean maximum bias of the G6 readings to the reference YSI measurements at the time of peak acetaminophen concentration across all subjects was +5.2 mg/dL and was statistically significantly lower than the performance goal of <10 mg/dL (one-sided upper 95% CI of 6.4 mg/dL, p < 0.001).

While no interference effect was observed in the clinical study with a maximum dose, bench studies were conducted to test higher concentrations of acetaminophen. According to the bench testing, acetaminophen concentrations of > 6.5 mg/dL (~2-3 times maximum therapeutic levels) showed significant bias. Supratherapeutic (high levels of acetaminophen beyond the maximum dose) levels may cause an overestimation of G6 readings.

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Chapter 4: What is the G6?

Sensor Applicator

The redesigned sensor applicator allows you to insert a sensor with just one hand. Peel away the adhesive’s backing, place the applicator on your body, fold and break off the safety guard, and push the applicator’s button. For detailed steps on sensor insertion, see Chapter 6.

Streamlined Transmitter Holder and Transmitter

The redesigned transmitter and its holder have a lower profile. With the transmitter holder’s new breakaway feature, when your sensor session is done, the transmitter snaps out for easy removal. For more information on how to attach the transmitter, go to Chapter 6. After a sensor session has ended, see Chapter 13 about transmitter removal.

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Chapter 4: What is the G6?

4.4 G6 Components

The G6 has three key parts. See the table below for details.

What you see What it's called What it does

Applicator

Sensor (inside)

Applicator with built-in sensor

Applicator helps you insert the sensor wire under your skin.

Sensor gets your glucose information.

Transmitter

Transmitter sends your glucose information from the sensor to the display device.

Display Device(s):

• Receiver

• Your smart device

Display device(s) shows your glucose information.

Receiver is required for Medicare. It’s not required for some plans.

See dexcom.com/compatibility for a list of compatible smart devices and operating systems.

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Chapter 4: What is the G6?

Once you’ve set up your G6, it sends G6 readings to your display device every five minutes for up to 10 days.

G6 and Previous Dexcom System Components

The G6 isn't compatible with previous generations such as the Dexcom G4 PLATINUM CGM System or the Dexcom G5 Mobile system. You can’t switch the transmitter or sensor between the two systems. If you have an older receiver, it might need an upgrade to use it with the G6.

PRECAUTION

Use Correct Transmitter, Receiver, and Sensor

G6 components are not compatible with any previous Dexcom products. Do not mix transmitters, receivers, and sensors from different generations.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

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Chapter 4: What is the G6?

4.5 What Was Covered and What’s Coming

Now You Can:

• Explain what G6 does

• List what’s new in G6

• Explain each component’s function

What's Next

Your next step is setting up your display device(s).

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Chapter 5: Set Up Your Display Devices

Chapter 5 | Set Up Your Display Devices

5.1 Introduction

This chapter helps you choose and set up your display device(s).

After this chapter, you’ll be able to:

• Determine which display device(s) you’ll use

• Create a Dexcom username and password

• Use the recommended smart device settings

• Download and set up the Dexcom G6® CGM System (G6) app

• Set up your receiver

5.2 Choose the App, the Receiver, or Both

Use the receiver, the app, or both. You can choose to use the display device that’s best for you. The receiver is required for Medicare. It’s not required for some plans.

Both devices give you the information you need to make treatment decisions – your G6 reading and arrow(s) – as well as alarm/alerts.

The app has more features than the receiver. The app includes these additional features and functions:

• Dexcom SHARE (Share): Lets you send your glucose information to others.

• Alert Schedule: You can have your alarm/alerts sound different during different times of the day.

• Always Sound: You can override your phone settings so your alarm/alerts will always sound, even when your phone is on mute/Do Not Disturb.

• Smart watch: Lets you see your G6 sensor information on your smart watch.

• Events: See the events you record on your app and how they impact your trend graph.

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The receiver is a dedicated medical device with a two-day battery life. Use the receiver or your BG meter if you are concerned about any problems with your smart device due to settings, lack of storage, low smart device battery, etc.

Whether you carry the app or the receiver, remember to keep your display device on.

PRECAUTION

Is It On?

If the receiver or smart device is turned off (shut down), it will not show G6 readings or alarm/alerts. Make sure your display device is turned on.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

The following section walks you through setting up the app. To set up the receiver, go to the next section. If you want to use both the receiver and the app, you need to set each up separately. Make sure you have started your sensor session first before setting up the other display device. See Appendix C for setting up peripheral devices.

5.3 App

Before starting your first sensor, pick the smart device. You can use the receiver with one smart device during a session; however, you can’t use multiple smart devices during the same session. Part of your setup is entering the transmitter 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.

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Recommended Smart Device Settings

See your smart device instructions to learn how to change its settings.

Use the following with your CGM system:

• Bluetooth on: Your transmitter and app communicate via Bluetooth. If it isn't on, you won’t get alarm/alerts or G6 readings.

• Notifications on:

• Enable Dexcom app notifications so you get alarm/alerts.

• Make sure you allow Dexcom app notifications to show on your locked screen.

• Battery charged: The app must always be running in the background and may drain your battery. Keep the battery charged.

• Device and app on: If you restart your smart device, reopen the Dexcom app.

• 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 afterward.

• Compatibility: For a list of smart devices and operating systems that work with the G6 app, check dexcom.com/compatibility. Before upgrading your smart device or its operating system, check the list.

• Time: Don’t change your smart device time, because it can make the time on the home screen wrong and the app may stop displaying data.

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WARNING

Check Settings

• Glucose Alarm/Alerts:

• Urgent Low

• Urgent Low Soon

• Low Glucose

• High Glucose

• Rise Rate

• Fall Rate

• No Readings Alert

• System Alerts:

• Calibration Required (after 2-hour sensor warmup, only appears when a sensor code is not used)

• Calibration Error (only appears when a user enters a calibration; calibration is not required)

• Sensor Expired

• Replace Sensor

• Transmitter (not working)

• No Storage Error

• App Stopped

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WARNING (CONTINUED)

• Bluetooth: Your transmitter talks to your app with Bluetooth. Make sure your smart device Bluetooth is on. If not, you will not get alarm/alerts or CGM information.

• Notifications:

• Make sure your smart device settings allow Dexcom app notifications to

show on your Lock screen. This will allow you to see notifications without unlocking your phone.

• Apple: During G6 setup, enable Dexcom app notifications or you won’t get

alarm/alerts.

• Battery: The app must always be running in the background and may drain your smart device battery. Keep the battery charged.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

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App Installation and Setup

Installing the app is easy! Simply download the Dexcom G6 App from your app store. For information on how to install an app, see your smart device instructions.

If your smart device has been jailbroken or rooted, do not install the app. The app may not work correctly or remain secure on a jailbroken/rooted smart device.

Is this your first Dexcom CGM app? If so, the app will walk you through setting it up. If you’ve used the app before, for your convenience, the G6 imports your existing settings. Either way, follow the instructions in the app: it knows if you’re new or an existing user based on your Dexcom login. If you want more information about a step, tap Help or Learn More. If you’d like, follow along with the steps below.

The following screens may look different than your app because of different operating systems or updates.

App: Setup

Tap Dexcom G6 to open app.



STEP

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App: Setup

Enter existing username and password. Or, if you need a Dexcom username and password, follow the onscreen instructions



App: Setup

Tap Let’s Get Started.



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App: Setup

The next screens go over legal and safety information, including videos on using your G6. To see videos later, go to Settings > Help > Videos.

Tap the appropriate answer to get more information or move forward.

App: Setup

Existing users only:

If you’ve used the Dexcom CGM app before, the system imports your settings and shows the new G6 features, including your Urgent Low Soon Alert.

After reading each screen, tap the appropriate answer to move forward.

App: Setup

New users:

If you’re new to the Dexcom app, review and set your alarm/alerts.

After reading each screen, tap Next to move forward.

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App: Setup

New users:

Set your Low Alert. You get an alert if your glucose dips below the number you set. Default is 80 mg/dL.

Scroll to select your level.

Tap Save.



App: Setup

New users:

Set your High Alert. You get an alert if your glucose rises above the number you set. Default is 200 mg/dL.

Scroll to select your level.

Tap Save.



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App: Setup

Apple:

Make sure you get your alarm/alerts.

When asked, tap Allow to receive alarm/alerts.



App: Setup

Next are recommendations for making sure you hear your alarms/alerts, going over the transmitter, and making sure Bluetooth is on.

Tap the appropriate answers to move forward or get more information.

App: Setup

Android: To use Bluetooth, the app may ask for access to your device location. Tap Allow.



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App: Setup

Enter sensor code.

If you don’t enter the sensor code, the G6 requires you to calibrate on a daily basis.

The sensor code is on the applicator’s adhesive label and is unique to that specific sensor. Enter the code from the applicator you’ll use to insert your sensor. If you enter the sensor code from another applicator, your G6 readings may be off. Enter the code by manually typing it into the app or take a picture of the 2D barcode.

Setting up both the app and the receiver? No need to enter the sensor code again; the receiver will join your current sensor session.

App: Setup

Enter transmitter SN.

To enter, either take a photo of the 2D barcode on the transmitter box or type in the SN.

Photo instructions:

a. Get your transmitter box. Tap Take Photo.



b. Turn transmitter box on a flat surface with 2D

barcode facing up



Checkmark confirms you entered the SN.

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Manual instructions:

a. Tap Manually Enter.



b. Find your transmitter SN on the transmitter box or

the back of the transmitter.

Confirm correct SN.

Tap Save.



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App: Setup

Insert sensor

Tap Start Video.

Insert sensor and attach transmitter following video’s

instructions.

If you want, after completing your app setup, set up your receiver. Before setting up your receiver, make sure you have started the sensor session (Chapter 6).

Problems setting up G6 app? Contact Technical Support (available 24/7) at:

• Web: dexcom.com/tech-support

• Toll free: 1.888.738.3646

• Toll: 1.858.200.0200

If you’re having problems with your smart device, contact your smart device support line.

Finished!

5.4 Receiver

Receiver Setup Overview

The receiver guides you through initial setup. If you’re using two display devices, make sure you started the sensor session in one before setting up the other.

Your receiver has a touchscreen. Be sure your fingers are dry when you touch it. Don’t worry if your receiver buzzes or makes other sounds during setup. After your initial setup is complete, you won’t see the setup screens again but your settings can always be adjusted using the menu.

Before putting your receiver in your pocket or purse, briefly press the power button to put the screen to sleep. This way, accidental movements and bumps don’t turn into screen selections. Just tap the power button again to wake the screen up.

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Receiver: Setup

Press and hold power button for 2 seconds to turn receiver on.

Wait for loading screen to appear.



Receiver: Setup

Wait.



Receiver: Setup

Welcome!

Tap Next.

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Receiver: Setup

Enter the date and time:

The blue outlined box shows what is selected.

Key for date boxes:

• mm = month

• dd = day

• yyyy = year

Key for time boxes:

• hh = hour

• mm = minute

• AM/PM = switch between the two

Tap each box.

Tap up/down arrows to change value in box.

Use this method throughout to enter information.

When done, tap Save.

If battery is ever completely drained, you’ll need to reset date and time.

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Receiver: Setup

The next screens tell you about your alarm/alerts.

After reading each screen, tap Next.

Receiver: Setup

Set your Low and High alerts using levels you’ve discussed with your HCP. The Low Alert default is 80 mg/dL; High is 200 mg/dL.

Tap the up/down arrows to change the level. Tap Save.



Receiver: Setup

Enter your transmitter serial number.

Tap Next.

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Receiver: Setup

Enter sensor code.

If you don’t enter the sensor code, the G6 requires you to calibrate on a daily basis.

The sensor code is on the applicator’s adhesive

label and is unique to that specific sensor. Enter the code from the applicator you’ll use to insert your sensor. If you enter the sensor code from another applicator, your G6 readings may be off.

Setting up both the receiver and app? No need to enter the sensor code again, the app will join your current sensor session.

Receiver: Setup

Your transmitter serial number is on the bottom of the transmitter and its box. Look for SN.



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Receiver: Setup

Enter your transmitter SN by tapping the up/down arrows.

Tap Save.



Receiver: Setup

Go to Chapter 6, for step-by-step instructions on inserting your sensor and attaching, your transmitter, pairing your transmitter to your display device, and starting your sensor.

Finished!

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Chapter 5: Set Up Your Display Devices

5.5 What Was Covered and What’s Coming

Now You Can:

• Create a Dexcom username and password

• Download the Dexcom G6 app

• Set up the app with the recommended settings

• Set up your receiver

What’s Next?

• No matter which display device you use, next, you’ll insert your sensor.

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Chapter 6: Start Your Sensor

Chapter 6 | Start Your Sensor

6.1 Introduction

After this chapter, you’ll be able to:

• Prepare for sensor insertion

• Insert your sensor

• Attach transmitter to sensor

• Identify when the transmitter and display device pair

• Start sensor warmup

6.2 Prepare to Insert Sensor

Before inserting a sensor, make sure you have everything you need.

Dexcom Items:

• Sensor package

• Check expiration date on sensor tray. Don’t use if expired.

• Don’t open the sensor tray until you’re ready to insert the sensor.

• Transmitter box

• Check use by date on box. Start using the transmitter before that date.

Your Items:

• Alcohol wipes

• Your meter

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Chapter 6: Start Your Sensor

Optional Item:

If this is your first time inserting a sensor, watch the sensor insertion video to get a better understanding of the process. To see the sensor insertion video, go to:

• The app:

• In the setup screens

• In Settings > Help > Videos.

• The tutorial:

• Online at dexcom.com/support

PRECAUTION

Check Package

Don’t use sensor if its sterile package has been damaged or opened, because it might cause an infection.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

PRECAUTION

Don’t Use if Expired

Don’t use expired sensors, because they may give incorrect results. Check the package label for the expiration date. It’s in YYYY-MM-DD format.

Follow Dexcom G6® Continuous Glucose Monitoring System (G6) instructions. If you don’t, you could have a severe low or high glucose event.

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6.3 Choose Sensor Site

Choosing a comfortable, effective place for your sensor is important. Discuss ideal sensor insertion sites with your HCP.

People from 2 to 17 years old can use either their upper buttocks or bellies (abdomens).

Those 18 years and older can only use their belly.

Tips

Do:

• 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, and medications

• Contact your HCP if sensor adhesive irritates your skin

Don’t:

• Don't use same site for 2 sensors in a row

• Don't use bony sites, such as over your ribs

• Don't use sites where sensor can be rubbed – by your belt, waist band, seat belt

strap – or where you lay when you sleep

18 years and older

2-17 years

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Chapter 6: Start Your Sensor

PRECAUTION

Where to Insert: Things to Check

Change your insertion site with each sensor. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation.

Sensor placement is important. Choose a site:

• At least 3 inches from insulin pump infusion set or injection site

• Away from waistband, scarring, tattoos, irritation, and bones

• Unlikely to be bumped, pushed, or laid on while sleeping

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

Optional: Help Patch Stay On

Are you concerned about the patch not sticking? There are two ways to help keep it on:

• Before inserting your sensor, make the sensor site stickier

• After inserting your sensor, apply the overpatch or medical tape

Both are described in detail below.

Contact your HCP for specific questions regarding the use of medical tape, barrier wipes, or other adhesives.

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6.4 Insert Sensor

The sensor is inside the applicator. Before inserting the sensor, get familiar with its applicator.

Safety Guard

Protects button Remove when ready to insert sensor

Button

Inserts sensor under your skin

Sensor

Sensor inserts through this hole

Adhesive

Transmitter Holder

Transmitter snaps in

Keeps sensor and transmitter holder on skin

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Insert Sensor

Thoroughly wash and dry your hands.



Insert Sensor

Clean insertion site with alcohol.

Let dry.



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Insert Sensor

Optional Step: Skin Adhesive

• Create an empty oval on the skin with the skin adhesive, such as Mastisol or SkinTac.

• Let skin adhesive dry.

• Insert sensor on clean skin in center of oval.



Insert Sensor

Get the applicator you used when entering the sensor code. Check its packaging. Don’t use if it’s damaged or was already opened before you took it out of its box.

Make sure you use the same applicator Peel off cover. Keep sensor packaging until sensor session is complete.

Check sensor for damage.

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Insert Sensor

Pull off both adhesive labels.

Keep the tab with the sensor code.

Don’t touch adhesive.



Insert Sensor

Place applicator horizontally, not vertically, on skin.

Firmly press down, sticking adhesive to your skin.



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Insert Sensor

Fold and break safety guard and throw it away.



Insert Sensor

Push and release button to insert sensor.



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Insert Sensor

Remove applicator.

Throw out applicator following local guidelines for disposal of blood-contacting components.



Insert Sensor

What’s left on you?

• Sensor wire

• Transmitter holder



You've successfully inserted the sensor!

Finished!

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Having problems?

Do you have questions or need help? Contact Technical Support (available 24/7) at:

• Web: dexcom.com/tech-support

• Toll free: 1.888.738.3646

• Toll: 1.858.200.0200

6.5 Attach Transmitter

Now that you’ve inserted your sensor, attach your reusable transmitter.

Keep your current session’s transmitter box. It has important information you may need after you’ve attached the transmitter.

Before attaching your transmitter, check you’ve entered the correct transmitter SN into your display device. Chapter 5 covers entering transmitter SN during initial setup. Once you’ve snapped the transmitter into the holder, you can’t remove it until your session is over.

WARNING

Wire Breaks Off

Don’t ignore broken or detached sensor wires. A sensor wire could remain under your skin. If this happens, please contact our 24/7 Technical Support.

Follow G6 instructions. If you don’t, you could have a severe low or high glucose event.

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Attach Transmitter

Remove transmitter from box.



Attach Transmitter

Wipe bottom of transmitter with alcohol wipe. Let dry.

Be careful with the bottom of the transmitter. Don’t:

• Touch its metal dots

• Scratch it – that may harm the waterproof seal

Attach Transmitter

Slide transmitter tab into the slot at the narrow end of the holder.

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STEP 1

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STEP 2

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STEP 3

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Dexcom G6 System User Guide

Chapter 6: Start Your Sensor

Attach Transmitter

Press the wide end of the transmitter until it clicks into the holder.



Attach Transmitter

Secure by rubbing fingers around the patch three times.

You’re almost done starting your sensor!

Finished!

Loose Transmitter Holder

The transmitter holder should stay on your skin using its own adhesive, but the patch may start to peel up. If it peels up, or you want to prevent that, use either the overpatch or another adhesive, such as medical tape (brand names include Blenderm™, Tegaderm™, Smith & Nephew IV3000®, 3M™ tape) for extra support. Order overpatches at dexcom.com/order.

STEP 4

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STEP 5

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