No G6 Readings: Signal Loss Alert Problem • Not getting G6 readings • Display device and transmitter not connecting Solution • Use meter. No glucose alarm/alerts or G6 readings until fixed. • For more information see Chapter 10. • Tap alert to get more information. • Keep your transmitter and display device within 20 feet of each other. Wait 30 minutes. • App: • If that doesn't work, turn Bluetooth off and on. Wait 10 minutes. • If that doesn't work, restart the smart device and reopen the Dexcom app.
App Notification App Receiver PRECAUTION 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. Follow G6 instructions.
No G6 Reading: Low or High Instead of G6 Reading Problem • System shows Low or High instead of G6 reading Solution • System is working as it should. Use your meter and treat your high or low. When your G6 reading is between 40 and 400 mg/dL your G6 will display your G6 reading instead of Low or High. Below 40 mg/dL Above 400 mg/dL Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Receiver Only: Can’t See Screen Because of Lock Screen Problem • Information is blocked by lock screen Solution • It's working the way it is supposed to. Your receiver screen locks so you don’t accidentally change something without noticing it. • Tap 1 then 2 to unlock the lock screen. • If you don’t tap quickly, or you tap several times outside the buttons, the screen goes to sleep. Receiver Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
14.3 Applicator Orange Button Stuck Problem • Can’t push the applicator orange button in Solution • Fold and break off safety guard before pushing orange button • See Chapter 6 Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Adhesive Backing Won’t Come Off Problem • Backing won’t come off the patch Solution • Lift the backing by the tab Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Adhesive Patch Won’t Stick Problem • The adhesive patch won’t stay on your skin for the entire sensor session Solution • Before applying sensor: Use an optional skin adhesive (such as Mastisol or SkinTac) • After applying sensor: Put overpatch or tape over patch • Order overpatches at dexcom.
Applicator Sticks to You Problem • The applicator won’t come off your skin after you push the button to insert the sensor Solution • Don’t panic! • Remove applicator and adhesive patch: 1. Gently pull applicator up until you see adhesive patch 2. Using your finger or thumb, hold front edge of patch and peel from skin Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
3. While holding the front edge of the adhesive patch, gently rock back applicator, away from your body 4. Check insertion site to make sure the sensor isn’t left on the skin 5. Don’t try to reuse applicator 6. Contact Sales Support: • Email: CustomerService@dexcom.com • Toll free: 1.888.738.3646 • Toll: 1.858.200.0200 Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
14.4 App Can’t Download App Problem • You got a new smart device and can’t download the Dexcom app Solution • Check dexcom.com/compatibility for a list of smart devices that work with the G6 app. • If it's a compatible device, and you’re not using your receiver, stop your sensor session on your current smart device. See Chapter 13. • Install the app on your new smart device. See Chapter 5. • Follow the app screens to get the app set up on your new smart device.
Won’t Turn On – Battery Charged Problem • The receiver won’t turn on but battery is fully charged Solution • See Chapter 5 • Reset receiver: • Press and hold power button for 10 seconds • Release power button • Press and hold power button for 2 seconds to turn back on • Connect receiver to charger – this turns it on Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Can’t See Screen – Change Brightness Problem • The receiver screen is too dim or bright Solution • Go to Menu > Brightness and change it. No Beep or Vibration – Speaker Test Problem • Don’t hear or feel alarm/alerts or notifications Solution • Test your speaker and vibrations using steps below. • If receiver speaker/vibrations don’t work, you won’t hear alarm/alerts. Use app until issue is fixed. • Contact Technical Support (available 24/7) at: • Web: dexcom.com/tech-support • Toll free: 1.888.738.
1. Plug receiver into wall to charge. The light shows the receiver is charging. 2. Tap Test Now quickly before screen disappears. If screen disappears too quickly, go to first step. 3. Receiver will beep and vibrate. Listen for the beeps and feel for the vibrations. Is your receiver Sound set to Vibrate or Soft? If your speaker and vibrations work, this test makes your receiver beep and vibrate anyway.
4. Did your receiver beep and vibrate? • Yes? Tap Yes and go to next step. • No? Tap No and go to Step 6. 5. Congratulations! You tested your speaker and vibrations and determined they work! You’ll hear your alarm/alerts. You’re done. Don’t go on to the next step. Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
6. Uh-oh. You tested your speaker and vibrations and determined that they don’t work. You won’t hear alarm/alerts. Contact Technical Support (available 24/7) at: • Web: dexcom.com/tech-support • Toll free: 1.888.738.3646 • Toll: 1.858.200.0200 Use app until issue is fixed. Tap Try Again to retry and go to Step 3. Or, tap Cancel to return to your Home screen. PRECAUTION Test Speaker and Vibrations You have to hear or feel alarm/alerts to react to them, so test your receiver speaker and vibrations regularly.
Low Battery Problem • Receiver displays low battery notification and icon. Appears when 20% remains (shown below) and when 10% remains. Solution • Charge receiver Prevention: • To conserve battery power, you can power off the receiver by tapping Menu > Shutdown. You won’t get alarm/alerts or G6 readings, but your sensor session remains active. • When the receiver and transmitter reconnect after a temporary shutdown, Signal Loss, or similar issue, up to 3 hours of missed G6 readings can fill in on the graph.
Unexpected Dexcom Stripe Screen – System Check Problem • Dexcom stripe screen displays for no reason Solution • Wait a few seconds • If Dexcom stripe screen (see below) displays for more than 3 minutes, contact Technical Support (available 24/7) at: • Web: dexcom.com/tech-support • Toll free: 1.888.738.3646 • Toll: 1.858.200.0200 Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
System Check Passed Screen Problem • System check results Solution • Do nothing. Receiver recovered from an error and continues to work. Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Call Tech Support Screen Problem • Screen is locked Solution • Use your meter. No alarm/alerts or G6 readings until fixed. • If same code displays again, write it down and contact Technical Support (available 24/7) at: • Web: dexcom.com/tech-support • Toll free: 1.888.738.3646 • Toll: 1.858.200.0200 Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
14.6 Recalibration Alert Problem • System didn’t accept calibration Solution • Use your meter. No alarm/alerts or G6 readings until fixed. • Follow instructions on screen. It asks you to recalibrate in 15 minutes. • For more information: • See Chapter 7. • App: Tap Help. • Receiver: • If you calibrate again and still get this error, enter one more meter value. • Wait 15 minutes. • If no G6 readings appear on the display, the sensor needs to be replaced.
App Receiver Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
14.7 Transmitter Transmitter Not Found Alert Problem • Transmitter didn’t pair with display device Solution • Use your meter. No alarm/alerts or G6 readings until fixed. • Make sure Transmitter SN in Settings matches the Transmitter SN on the transmitter box. • Make sure transmitter is snapped into holder. • App: For more information, tap Help. • If these solutions don’t fix the issue, sensor may not be inserted correctly. Contact Technical Support (available 24/7) at: • Web: dexcom.
App Receiver Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
14.8 Sensor Problem • You need to end your sensor session early because of: • Personal reasons • Error notifications telling you to end sensor session • Unresolved calibration issues • Error or wait screens that won’t go away • Sensor coming out of body 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.
Stopping sensor problems Make sure: • Sensor hasn’t expired • You selected a good insertion site (see Chapter 6) • Nothing is rubbing against transmitter holder, like a seatbelt or waistband • Insertion site is clean and dry before sensor insertion • Transmitter is snapped securely in transmitter holder • Transmitter holder isn’t dislodged and patch isn’t peeling App Receiver 14.9 Share Troubleshooting Share Status Issues The Share status bar is a useful tool.
No Active Followers Status Problem • No Followers accepted your invitation or you haven’t invited anyone Solution • If you invited a Follower, ask them to look for your invitation email Share App If the invitation expired, re-invite them by tapping Add Follower (see Chapter 12). If they stopped following you, their status shows Removed. If you turn off sharing for a Follower, their status shows Paused.
Server Unavailable Status Problem • Share isn’t sharing because Dexcom server is offline Solution • Wait. Dexcom will fix the issue as soon as possible. For more information, contact your local Dexcom representative. Share App 14.10 Accuracy G6 Reading ≠ Meter Value Problem • G6 reading and meter value don’t match Solution • Different body fluids give different numbers: • Meter measures glucose from blood. • Sensor measures glucose from interstitial fluid.
G6 Readings Do Not Match Symptoms Problem • G6 readings don't match how you feel Solution • Wash your hands with soap and water. Dry them. Then take a fingerstick with your meter. If your meter value matches your symptoms, use it to take treatment decisions. • Calibrating may help align your G6 readings to your meter values. See Chapter 7. 14.11 Calibration Prompts Calibration Error/Recalibration Alert Problem • Displays when you enter a calibration outside the expected range.
Receiver 14.12 What Was Covered and What’s Coming Now You Can: • Troubleshoot a variety of issues. What’s Next? Congratulations! Great job working your way through this guide! Make sure to check out the appendices for additional information that may be useful to you. And remember, you can always refer back to this guide as you get used to your G6 or if you have any questions in the future. Dexcom G6 System User Guide Chapter 14: Troubleshooting LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Page intentionally left blank LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
4 Everything Else G6 • Need Help? You're Not Alone • Security and Air Travel • Peripherals • Care of G6 • Warranty • Technical Information • Label Symbols • Alarm/Alert Sounds and Vibrations • Index LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Page intentionally left blank LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Appendix A | Need Help? You’re Not Alone! Dexcom has three support teams to help you, each with their own specialty: • Dexcom Technical Support Team • Dexcom Patient Care Team • Dexcom Sales Support Team A.1 Dexcom Technical Support Team This team helps you with all CGM system-related issues as well as software-related issues. They provide replacement units, resolve technical issues, and take product complaints. They don’t offer medical advice. Contact Information • Web: dexcom.
A.2 Dexcom Patient Care Team The Dexcom Patient Care Team is a group of Certified Diabetes Educators (CDE) and Registered Nurses (RNs) offering you customer care and individualized education services around Dexcom CGM, including: • Product training – both initial and ongoing (for example, how to use a specific feature) • Regularly scheduled webinars at dexcom.
A.3 Dexcom Sales Support Team The Dexcom Inside Sales Support Team helps with: • First-time orders and re-orders • Tracking shipments • Locating a local Dexcom representative Contact Information • Internet: dexcom.com/order • Email: CustomerService@dexcom.com • Phone: • Toll Free: 1.888.738.3646 • Toll: 1.858.200.0200 • Fax: 1.877.633.9266 A.4 Corporate • Internet: dexcom.
Page intentionally left blank LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Appendix B | Security and Air Travel The Dexcom G6® Continuous Glucose Monitoring System (G6) can be a great travel companion – you can go through metal detectors and hand-wanding and even keep your receiver on during your flight. B.1 Security Going through security often means you and your belongings go through a metal detector, x-ray machine, or even a body scanner. In this section, you’ll find out which are OK for your G6 components and which haven’t been tested and should be avoided.
PRECAUTION 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.
Appendix C | Extend Your App With your Dexcom G6® Continuous Glucose Monitoring System (G6) app, you see notifications from your lock screen or smart watch. Not seeing any data? Open your app. C.1 Today View (Apple) Check your CGM information in the Today view, even when your smart device is locked. From the left edge of your Home or Lock screen, swipe right. To add G6 1. Scroll to the bottom 2. Tap Edit See your smart device instructions for details.
Tap Show More to show your graph. Sensor Reading Trend Arrow Shows Past 3 hours High Alert Level Current Reading Low Alert Level Trend Graph Dexcom G6 System User Guide Appendix C: Extend Your App LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
C.2 Quick Glance (Android) Check your G6 on your lock screen or swipe down from the top. Quick Glance Drag down on the lower edge of Quick Glance to show your graph. Sensor Reading Trend Arrow Trend Graph High Alert Level Current Reading Low Alert Level Shown Past 3 hours Quick Glance is on by default. Turn it off in the app: Settings > Quick Glance. Dexcom G6 System User Guide Appendix C: Extend Your App LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
C.3 Smart Watches Check your G6 on your Apple or Android smart watch. Suggested Use Using a smart watch with your system may change how you get alarm/alerts. • Your smart watch only communicates with your smart device, not the transmitter. • You won’t get alarm/alerts or G6 readings on your watch unless it’s connected to your smart device. Make sure you understand how you get notifications when a watch is connected. • You must wear the watch to see alerts and feel their vibrations.
Android Wear Setup Using the Dexcom G6 watch face, check your G6 information. See your watch instructions for details. Android Wear Trend Arrow Sensor Reading Current Time Shown Past 3 hours High Alert Level Trend Graph Current Reading Low Alert Level Dexcom G6 System User Guide Appendix C: Extend Your App LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Page intentionally left blank LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Appendix D | Take Care of Your G6 D.1 G6 Maintenance Applicator/Sensor • Keep in sterile package until ready for use • Don’t use if sensor has expired • May provide inaccurate Dexcom G6® Continuous Glucose Monitoring System (G6) readings • May be unsterile • Expiration date is on package in year-month-day format • Don’t use lotions, sunscreen, insect repellent, or similar items on the sensor Transmitter • Keep in box until ready for use. Check transmitter and don’t use if damaged.
Receiver • Check receiver casing. If cracked or damaged, don’t use or you may get an electric shock. • Don’t open casing. • Don’t put anything in the casing’s openings. • Keep receiver dry – it is only splash resistant. • Don’t submerge in liquid. • Don’t spill fluids on receiver. • Don’t use lotions, sunscreen, insect repellent, or similar items on the receiver. • Use the supplied case to protect receiver from bumps and falls. When putting case on, make sure the speaker holes align with receiver speaker.
Each charge lasts approximately 2 days. If your receiver battery was drained prior to charging, then after charging you may need to reset its time and date. If this is required, the system tells you to reset and takes you to the applicable screens. STEP 1 of 4 Receiver: Charging Battery Tap OK. STEP 2 of 4 Receiver: Charging Battery Plug Micro USB cable into Micro USB port and wall charger. Plug wall charger into electrical outlet.
STEP 3 of 4 Receiver: Charging Battery Light in upper right corner goes on when charging. When you plug in the receiver to charge, the Speaker Test screen displays. See Chapter 14 for more information. Tap Skip Test to return to the Home screen. Keep charging until home screen displays battery icon filled in. STEP 4 of 4 Receiver: Charging Battery Unplug wall charger from outlet when fully charged. Home screen displays battery icon filled in when battery is charged.
Peripherals • Parts: Use only Dexcom-supplied parts (including cables and chargers). Use of nonDexcom-supplied parts may affect safety and performance. • Charging: Charge battery before each new sensor session. • Battery can only be charged using the Dexcom adapter/wall charger – don’t use a computer port or an external USB hub. • Only use the Dexcom cable and charger to charge the Dexcom receiver. • Don’t block access to the charger. • Cable: Insert cable only as directed. • Don’t force cable into place.
Transmitter • Keep protected when not in use • Store at temperatures between 32°F and 113°F • Store between 10% and 95% relative humidity Receiver • Keep protected when not in use • Fully charge the battery before storing for over 3 months • Store at temperatures between 32°F and 104°F • Store between 10% and 95% relative humidity D.3 Checking System Information You can check your app or receiver for information about your CGM system any time.
STEP 2 of 2 App: Check CGM Settings You can update and/or check: • CGM information: Insertion date and time, last calibration, transmitter SN, when sensor expires • Software versions: Transmitter and receiver • Support: Online help, account, and contact information Finished! Dexcom G6 System User Guide Appendix D: Take Care of Your G6 LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Receiver: Check CGM Settings STEP 1 of 3 Receiver: Check CGM Settings Tap Menu. STEP 2 of 3 Receiver: Check CGM Settings Tap Settings. STEP 3 of 3 Receiver: Check CGM Settings You can update and/or check: • Alerts and sounds: Customize how and when you get alerts • Transmitter information: Transmitter SN and battery life • Sensor information: Insertion date and time; last calibration date, time, and value; when sensor expires • Receiver information: Receiver SN and battery life D.
Appendix E | Warranty Sometimes stuff happens. Dexcom has you covered! This appendix covers our warranty information outlining what we cover and for how long. E.1 Dexcom Receiver Limited Warranty What’s Covered and for How Long? Dexcom, Inc.
• Malfunctions resulting from the use of the receiver in conjunction with accessories, ancillary products, and peripheral equipment, whether hardware or software, not furnished or approved by Dexcom. • Defects or damage from improper testing, operation, maintenance, installation, or adjustment.
Contact Dexcom Technical Support Department for delivery information help: • Web: dexcom.com/tech-support • Toll free: 1.888.738.3646 • Toll: 1.858.200.0200 Upon receipt by Dexcom of a defective receiver covered by this Limited Warranty, Dexcom will promptly replace the defective receiver. If Dexcom determines the receiver isn’t covered by this Limited Warranty, Purchaser must pay all shipping charges for the receiver’s return by Dexcom.
E.2 Dexcom Transmitter Limited Warranty What’s Covered and for How Long? Dexcom, Inc.
• Defects or damage from improper testing, operation, maintenance, installation, or adjustment. • Installation, maintenance, and service of products or services other than the CGM system (which may be subject to a separate limited warranty), whether provided by Dexcom or any other party; this includes your cell phone or smart device and your connection to the Internet. • A transmitter which has been taken apart physically or which has had any of its software accessed in any unauthorized manner.
Call Dexcom Technical Support Department for delivery information or help: • Web: dexcom.com/tech-support • Toll free: 1.888.738.3646 • Toll: 1.858.200.0200 Upon receipt by Dexcom of a defective transmitter covered by this Limited Warranty, Dexcom will promptly replace the defective transmitter. If Dexcom determines the transmitter isn’t covered by this Limited Warranty, Purchaser must pay all shipping charges for the transmitter’s return by Dexcom.
Appendix F | Technical Information F.1 Device Performance Characteristics NOTE: We recommend that you review the information in this chapter with your healthcare professional to understand how well the Dexcom G6® Continuous Glucose Monitoring System (G6) performs. The Dexcom G6 (G6) uses a glucose sensor to continuously measure and monitor your glucose levels. Once the sensor code is entered, the G6 reports glucose readings up to every 5 minutes.
Depending on the participant’s age, they participated in either 1, 2 or 3 clinic sessions of varying duration. • Adult subjects: two (2) or three (3) 12-hour clinic sessions • Pediatric subjects 13-17 years of age: one (1) 12-hour clinic session • Pediatric subjects 6-12 years of age: one (1) 6-hour clinic session • Pediatric subjects 2-5 years of age: one (1) 4-hour clinic session (compared to fingerstick blood glucose meter measurements only).
wear locations (Tables 1-B to 1-E) and categorized within YSI glucose ranges (Tables 1-F to 1-I). When you see a CGM reading on your receiver or mobile application, these tables show you how likely that reading matches your blood glucose level (measured by YSI in the study). These tables include overall pooled data from both G6 studies. For example, the total number of data pairs considered in the analysis was 25,101. Of these, 91.
1 CGM readings are within 40-400 mg/dL, inclusive. Table 1-B. G6 Accuracy to YSI within CGM Glucose Ranges (Adults; n=159) CGM Glucose Range1 (mg/dL) <54 Percent Number within of paired 15 mg/dL CGM-YSI YSI Percent within 20 mg/dL YSI Percent within 40 mg/dL YSI Percent within 15% YSI Percent within 20% YSI Percent within 40% YSI Mean bias (mg/dL) MARD (%) 383 84.3 90.6 98.4 -6.9 13.8 54-69 1,537 89.6 95.1 99.5 -0.5 11.5 70-180 9,453 73.9 86.6 99.3 -2.8 10.
Table 1-D. G6 Accuracy to YSI within CGM Glucose Ranges (Pediatrics*, Abdomen; n=99) CGM Glucose Range1 (mg/dL) Percent Number within of paired 15 mg/dL CGM-YSI YSI Percent within 20 mg/dL YSI Percent within 40 mg/dL YSI Percent within 15% YSI Percent within 20% YSI Percent within 40% YSI Mean bias (mg/dL) MARD (%) <54 60 40.0 51.7 80.0 -24.1 28.9 54-69 177 87.0 88.1 96.0 -6.3 13.4 70-180 1,910 80.5 91.0 99.5 -1.1 9.7 181-250 775 81.9 95.0 100.0 -2.3 9.1 >250 574 89.
Table 1-F. G6 Accuracy to YSI within YSI Glucose Ranges (Adults; n=159) YSI Glucose Range (mg/dL) <54 Percent Number within of paired 15 mg/dL CGM-YSI YSI Percent within 20 mg/dL YSI Percent within 40 mg/dL YSI Percent within 15% YSI Percent within 20% YSI Percent within 40% YSI Mean bias (mg/dL) MARD (%) 483 88.2 95.9 99.8 6.0 15.8 54-69 1,783 88.8 96.1 99.9 4.0 12.4 70-180 8,713 76.8 89.0 99.6 -0.8 10.3 181-250 3,940 83.0 92.7 99.8 -7.2 8.8 >250 4,410 83.4 93.3 99.
Table 1-H. G6 Accuracy to YSI within YSI Glucose Ranges (Pediatrics*, Abdomen; n=99) YSI Glucose Range (mg/dL) Percent Number within of paired 15 mg/dL CGM-YSI YSI Percent within 20 mg/dL YSI Percent within 40 mg/dL YSI Percent within 15% YSI Percent within 20% YSI Percent within 40% YSI Mean bias (mg/dL) MARD (%) <54 28 100.0 100.0 100.0 4.2 11.3 54-69 201 90.0 96.0 100.0 3.0 12.8 70-180 1,904 79.3 89.5 98.5 0.4 10.2 181-250 761 84.9 94.9 99.6 -1.4 9.1 >250 602 85.
Agreement When CGM Reads “LOW” or “HIGH” The G6 reports glucose readings between 40 and 400 mg/dL. When the G6 determines the glucose reading is below 40 mg/dL, it displays “LOW” in the Receiver or Mobile Application Status Box. When the G6 determines that the glucose level is above 400 mg/dL, it displays “HIGH” in the Receiver or Mobile Application Status Box.
Concurrence of G6 and Laboratory Reference Tables 3-A to 3-D categorize concurrence by CGM reading and YSI values. Tables 3-A and 3-B describe, (row percent), for each range of CGM glucose readings, what percentage of paired YSI values was in the same glucose range (shaded) or in glucose ranges above and below the paired CGM readings. For example, Table 3-A shows that for adults, when CGM readings are within 81 to 120 mg/dL, you can expect your blood glucose levels are within 81 to 120 mg/dL 70 % of time.
Table 3-A. Concurrence of G6 CGM Readings and YSI Values by CGM Glucose Range (Adults; n=159) YSI (mg/dL) CGM Glucose Range 1 (mg/dL) < 40 <40 13.5% 56.7% 24.0% 3.8% 1.9% 40- 60 61- 80 4060 6180 81120 121- 161- 201- 251- 301- 351- > 160 200 250 300 350 400 400 . Total . . . . . 104 1.2% 67.8% 27.9% 2.7% 0.2% 0.1% . . . . . 917 0.1% 21.3% 61.4% 16.9% 0.3% 0.1% . . . . . 2,275 . . . . 3,782 . . 3,026 . 2,597 . 2,869 . 2,268 81- 120 . 0.4% 13.6% 70.3% 15.1% 0.
Table 3-B. Concurrence of G6 CGM Readings and YSI Values by CGM Glucose Range (Pediatrics*; n=165) YSI (mg/dL) CGM Glucose Range 1 (mg/dL) < 40 <40 2.9% 22.9% 28.6% 42.9% 2.9% 40- 60 0.6% 37.9% 43.5% 13.7% 3.7% 0.6% 4060 6180 81120 121- 161- 201- 251- 301- 351- > 160 200 250 300 350 400 400 . Total . . . . . 35 . . . . . 161 61- 80 . 11.5% 65.8% 20.4% 1.9% 0.4% . . . . . 485 81- 120 . 0.2% 12.5% 76.3% 10.5% 0.6% . . . . . 1,282 121- 160 . . . 13.6% 71.9% 13.
Table 3-C. Concurrence of G6 CGM Readings and YSI Values by YSI Glucose Range (Adults, n=159) YSI glucose range (mg/dL) CGM Glucose Range 1 (mg/dL) < 40 <40 51.9% 5.0% 40- 60 4060 6180 81120 121160 161200 201250 251300 301350 351400 > 400 1.1% 0.1% 0.1% . . . . . . 40.7% 52.7% 11.7% 0.7% 0.1% 0.0% . . . . . 41.0% 63.7% 11.0% 0.2% 0.1% . . . . . 23.4% 75.8% 19.7% 1.0% 0.0% . . . . 0.0% 12.2% 66.9% 24.8% 1.4% 0.0% 0.1% . . 13.0% 59.9% 25.3% 1.7% 0.