Dexcom G6 Pro Continuous Glucose Monitoring System Using Your G6 Pro For Unblinded Patient Only • Welcome • Safety Statements • Risks and Benefits • Home Screen Overview • Alarm and Alerts • Treatment Decisions • Ending Your Sensor Session • Appendices Dexcom G6 Pro CGM System and pictured smart devices are sold separately. Instructions available in Spanish at dexcom.com/ayuda Las instrucciones están disponibles en español en dexcom.
Table of Contents Chapter 1: Welcome � � � � � � � � � � � � � � � � � � � � � � � � � 2 1.1 Get Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Chapter 2: Safety Statements � � � � � � � � � � � � � � � � � 3 2.1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 2.2 Important User Information . . . . . . . . . . . . . . . . . . . 4 2.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2.4 Warnings . . . . . . . . . . . . .
Chapter 1: Welcome Congratulations! Your healthcare professional (HCP) thinks you are a great candidate to experience the Dexcom G6 Pro Continuous Glucose Monitoring System (G6 Pro) for a full sensor session. During this time, you can watch how what you do affects your glucose readings, see your glucose trends and much more. 1.1 Get Started After Your Visit During your office visit, your HCP inserted the sensor, attached the transmitter and reviewed the Unblinded Patient Handout with you.
Chapter 2: Safety Statements 2.1 Indications for Use The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions.
2.2 Important User Information Failure to use the G6 Pro and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury.
2.4 Warnings 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. The sensor is not tested or approved for other sites. Talk to your healthcare professional about the best site for you. Inspect Don’t use a damaged or cracked transmitter.
No Number, No Arrow, No CGM Treatment Decision If G6 Pro doesn’t show a number or arrow, or readings don’t match symptoms, use meter to make diabetes treatment decisions. No number, no arrow, no treatment decision. When in doubt, get meter out. Don’t use G6 Pro if 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 Pro readings may be inaccurate in these populations.
If the smart device is on mute, only these notifications make a sound: Glucose Alarm: • Urgent Low System Alerts: • Sensor Failed • Transmitter Failed • App Stopped Android users must allow Do Not Disturb Permission to use the app. Bluetooth® The transmitter talks to the app with Bluetooth. Make sure the smart device Bluetooth is on. If not, you won’t get alarm/alerts or CGM information. Notifications Make sure smart device settings allow Dexcom app notifications to show on Lock screen.
Time Let the date and time on smart device automatically update when traveling across time zones or switch between standard and daylight-saving times. Don’t manually change smart device time. It can make the time on the trend screen wrong and the app may stop displaying data. Follow G6 Pro instructions. If not, you could have a severe low or high glucose event. Use as Directed The transmitter is a small part and poses a choking hazard, particularly for children.
2.5 Precautions Don’t Start Past "Use By Date" Don’t start using a sensor past its Use By Date because it may give incorrect results. The Use By Date is in YYYY-MM-DD (Year-Month-Day) format on the sensor package label beside the hourglass symbol. Check Package Don’t use sensor if its sterile package has been damaged or opened, because it might cause an infection. Clean and Dry Skin Clean and dry your hands, then put on your gloves before inserting your sensor.
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 Pro instructions. If not, patient could have a severe low or high glucose event. Use Correct Transmitter, and Sensor G6 Pro components are not compatible with any previous G6 products. Do not mix transmitters and sensors from different generations.
Not sure what kind of machine it is? Be safe – either ask the TSA officer, request handwanding, or request full-body pat-down. Interfering Substance Risks Acetaminophen In previous generations of Dexcom CGM systems (G4/G5), acetaminophen could affect sensor readings, making them look higher than they really were. However, with the G6 Pro, you can take a standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours and still use the G6 Pro readings to make treatment decisions.
Keep Transmitter Close to Display Device Keep 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 the transmitter and the display device – for example, while you're showering or swimming – keep them closer to each other. The range is reduced because Bluetooth doesn’t work as well through water.
Chapter 3: Risks and Benefits 3.1 Risks The risks with using G6 Pro are: • Sensor insertion issues • Local skin irritation from adhesive patch Additional risks if using the G6 Pro app are: • Not getting your alarm/alerts • Using G6 Pro to make treatment decisions when you shouldn’t This section covers each of those risks in detail. Follow system instructions. If not, you could have a severe low or high glucose event.
Not Getting Alarm/Alerts If you're using the G6 Pro system in real-time and you aren’t getting your alarm/ alerts, you could have severe low or high glucose without knowing it. Check smart device: • Battery charged: If the smart device battery is dead, you won’t get readings or alarm/alerts. • App on: Keep the app on to get readings or alarm/alerts. • Alerts on: Leave the alert function on to get alarm/alerts. • Volume up: Keep the volume loud enough to hear alarm/alerts.
Using G6 Pro for Treatment Decisions You can use your G6 Pro to treat for a low or dose for a high in all but these few situations.
Knowing Your Trends The G6 Pro sends 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, stress, or food you have eaten. This provides you with a more complete picture of your glucose and lets you see how your daily habits impact your glucose control.
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 Pop- Busui, 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.
Chapter 4: Home Screen Overview You spend most of your time on the home screen. It gives you your G6 Pro sensor glucose readings (G6 Pro readings) and trend information and gets you to other G6 Pro functions. The next section shows you all the home screen features. Later we review how to interpret your G6 Pro readings, trend arrows, and graph, followed by how to navigate to other functions. 4.
Where You Are Going To know where you’re going, look at your trend arrows.
Home Screen Issues Sometimes you don’t get G6 Pro readings or you won’t see a number, just a message. Those are times you won’t get alarm/alerts. What You See What It Means Low Your G6 reading is 40 mg/dL or below High Your G6 reading is 400 mg/dL or above. mg/dL mg/dL App Signal Loss Alert You will not receive alerts, alarms, or sensor glucose readings. OK An error message means your G6 Pro isn’t working and you won’t get alarm/ alerts or G6 Pro readings. 4.
Chapter 5: Alarm and Alerts Your alarm and alerts help you stay in your target range. They tell you when you: • Are out of your target range • Are at or below 55 mg/dL Keep your alerts on: They are an important part of making G6 treatment decisions. Talk to your healthcare professional about the best Low and High Alert settings for you. 5.1 Low Alarm and Low Alerts What You See What It Means App Urgent Low Alarm Urgent Low Glucose Alarm Your sensor glucose reading is urgently low.
5.2 High Alert What You See What It Means App High Glucose Alert (High Alert) High Glucose Alert Lets you know when your G6 sensor reading is above your target range. Your sensor glucose reading is high. OK You can change your High Alert: • On by default; can be turned off • Choose the alert level and sound 5.3 Changing Alerts Talk to your healthcare professional before changing your alert settings. They can help you find the best settings to manage your diabetes without getting too many alerts.
Chapter 6: Treatment Decisions 207 mg/dL With Dexcom G6 CGM (G6), you can make treatment decisions without using your blood glucose (BG) meter (meter). But sometimes you must use your meter instead of the G6 Pro. And other times it’s best not to treat, just watch and wait. Work with your healthcare professional to review what works best for you when making treatment decisions. 6.1 How to Use the Trend Arrows The trend arrows help you decide how much to dose.
Situation Solution Early morning: Think about: Your Low Alert wakes you up. • Number and Arrow: You have both. You see: 80 mg/dL • Number: Your glucose is low–80 mg/dL. • Slowly Falling Arrow: Glucose is falling 1–2 mg/dL each minute. What you should do: • Use your G6 Pro to treat as you normally would. Breakfast time: Think about: Ninety minutes later you’re sitting down for breakfast. • Number and Arrow: You have both. You see: 132 mg/dL • Up Arrow: Glucose is rising 2 mg/dL each minute.
Situation Solution An hour later: Think about: You watched and waited. • Insulin: The insulin you took with breakfast has you back in your target range. You see: 179 mg/dL What you should do: • Nothing. No treatment needed. Mid-morning: Think about: You are about to have a midmorning snack. • No Number and No Arrow: You have neither. Notice the gap in G6 Pro readings. You see: • Error Message: You are not getting G6 Pro readings. What you should do: • Use your meter for treatment decisions.
Situation Solution Mid-afternoon: Think about: It is 3 hours after lunch. • Number and No Arrow: You don’t have an arrow. You see: What you should do: 202 mg/dL Early Evening: • Use your meter for treatment decisions. Think about: Just before dinner, • Symptoms and you feel a little Reading: Your shaky and sweaty. symptoms don’t match your sensor You see: G6 Pro readings. 123 mg/dL 26 What you should do: • Thoroughly wash your hands and take a fingerstick.
Chapter 7: Ending Your Sensor Session Each sensor session lasts 10 days. Your G6 Pro alerts you when you have 24 hours left in your session, then 6 hours, then 2 hours, and finally, 30 minutes. You can end your session anytime during this period or wait for your final alert letting you know your session has ended. Remember, after your sensor session has ended, you won’t get any G6 Pro readings. Make sure you return the transmitter within 30 days of sensor insertion. 7.
Appendix A: Troubleshooting This appendix has brief instructions for the most common questions. They are listed in alphabetical order, as shown below: • A.1 Accuracy • A.2 Adhesive Patch • A.3 Alarm/Alerts – Hearing Them • A.4 Common Alerts • No Readings Alert • Signal Loss Alert • Transmitter Not Found • A.5 End Sensor Session Early • A.6 Gap in Graph For full troubleshooting information, see the user guide, the frequently asked questions section on the Dexcom website (dexcom.
A.2 Adhesive Patch Issue Solution Adhesive patch peeling off body After your sensor is inserted, you can correct peeling by: • Put Overpatch or medical tape (such as Blenderm) over adhesive patch. Don’t cover transmitter. • Ask your HCP about getting an overpatch.
A.3 Alarm/Alerts – Hearing Them Overview Your app beeps, vibrates, and displays a message when you get an alarm/alert. Can't Hear Alarm/Alerts If you can’t hear your alarm/alerts on your app: • Make sure: • App, Bluetooth, volume, and notifications are on • Battery is charged • Screens and speaker work • If your smart device restarts, always reopen the G6 app. • When using a peripheral (headphones, Bluetooth speakers, smart watch, etc.) you may not hear alarm/alerts on your primary display device.
A.4 Common Alerts Issue Solution No Readings Alert 1. Check transmitter; is it snapped into transmitter holder? Sensor is temporarily unable to measure glucose. No Readings Alert You will not receive alerts, alarms, or sensor glucose readings. OK Signal Loss Display device and transmitter are not communicating. Signal Loss Alert You will not receive alerts, alarms, or sensor glucose readings. OK 2. Wait up to 3 hours while the G6 Pro fixes itself. 3.
Issue Solution Transmitter Not Found 1. Make sure transmitter is snapped into transmitter holder. G6 did not pair. 2. Verify transmitter serial number (SN) entered is correct. Transmitter Not Found Help 3. If not fixed, sensor may not be inserted correctly. Insert a new sensor. For a replacement, contact your healthcare professional. No Alarm/Alerts or G6 Pro readings until fixed. Use your meter for treatment decisions.
A.5 End Sensor Session Early You might want to end your sensor session early. If you do, contact your healthcare professional. Once you stop your sensor session, you won’t be able to restart it. End Sensor Session Early Apple - 40 1PM 2PM 3PM Now Events Settings Always check with your HCP before stopping a sensor session. • Go to Settings 1 • Tap Transmitter Android • Tap Pair New • Tap Stop Sensor SETTINGS Remove the transmitter and sensor.
Appendix B: Going Through Security Concerned about the security equipment? TSA requests you tell the Security Officer you’re wearing a continuous glucose monitor and want to be hand-wanded or get a fullbody pat-down with a visual inspection of your sensor and transmitter. Let the Security Officer know you can’t remove the sensor because it’s inserted under your skin.
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Index Accuracy, 28 Adhesive Patch, 29 Alarm/Alerts Sound While Display Device Is Muted/Silenced, 33 Alarm or Alerts, 30, 31 Urgent Low Glucose Alarm, 21 Alerts, 30, 31 Changing, 22 End Sensor Session Early, 33 End Your Sensor Session, 27 Error Message, 19 Graph Missing Readings, 33 Reading, 18 High Alert, 22 High Reading, 19 Home Screen, 18 Low Reading, 19 Mute, 33 No Readings Alert, 31 Readings Don’t Match BG Meter Value, 28 Resources, 34 36
Screen Messages, 19 Security, 34 Sensor Error, 31 Sensor Session End Early, 33 Set Up, 2 Signal Loss Alert, 31 Transmitter Not Found Alert, 32 Travel, 34 Treatment Decisions, 23 Trend Arrow, 18, 19 Troubleshooting, 28 Urgent Low Glucose Alarm, 21 Use Meter Instead of G6, 23 37
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