Table 3-D. Concurrence of G6 CGM Readings and YSI Values by YSI Glucose Range (Pediatrics*; n=165) YSI glucose range (mg/dL) CGM Glucose Range 1 (mg/dL) < 40 <40 50.0% 6.3% 40- 60 4060 6180 81120 121160 161200 201250 251300 301350 351400 > 400 1.8% 1.2% 0.1% . . . . . . 50.0% 48.0% 12.5% 1.8% 0.6% 0.1% . . . . . 7.9% 61- 80 . 44.1% 57.1% 0.8% 0.2% . . . . . 81- 120 . 1.6% 28.6% 78.0% 12.4% 0.8% . . . . . 121- 160 . . . 11.0% 67.3% 14.5% 1.0% . .
Trend Accuracy Trend accuracy explains how well the G6 captures the time-dependent characteristics of glucose fluctuation. The following examples quantify G6’s Trend Accuracy: 3. When the G6 CGM rate of change is rapidly rising (≥ 2 mg/dL/min), how often is reference glucose also rising? The answer is 71.3% of the time for adults and 67.1% for pediatrics. 4. When the G6 CGM rate of change is rapidly falling (≤ 2 mg/dL/ min), how often is reference glucose also falling? The answer is 98.0% of the time. 5.
Table 4-B. Trend Accuracy Rate of Change (Pediatrics*; n=165) YSI glucose range (mg/dL) <-2 [-2,-1) [-1,-0) [0,1] (1,2] >2 CGM-YSI Pairs (n) <-2 47.9% 37.0% 12.8% 1.9% 0.0% 0.5% 211 [-2,-1) 6.6% 55.5% 33.8% 3.4% 0.6% 0.1% 686 [-1,0) 0.5% 8.9% 73.7% 15.8% 1.0% 0.0% 2,048 [0,1] 0.0% 0.8% 25.5% 62.9% 10.0% 0.8% 1,666 (1,2] 0.0% 0.4% 4.4% 35.9% 48.0% 11.4% 546 >2 0.0% 0.5% 1.7% 7.1% 23.6% 67.
Hypoglycemia and Hyperglycemia Alerts Low and High Glucose Alerts The ability of the G6 to detect high and low glucose levels is assessed by comparing G6 results to YSI results at low and high blood glucose levels and determining if the alert may have sounded. The G6 and YSI values were compared by pairing the G6 reading and the YSI value within before or after 15 minutes of each other. We suggest that you ask your doctor what alert settings would be best for you.
Hypoglycemic Detection Rate The Detection Rate is the % of time the device alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the hypoglycemic event. The Missed Detection Rate is the % of time the device did not alarm when the blood glucose level was at or below the alert setting within 15 minutes before and after the hypoglycemic event.
Table 5-B. Hypoglycemic Alert and Detection Rate Evaluations (Pediatrics*, n=1651) Hypoglycemic Alert Level (mg/dL) Alerts # of alerts (n) Detections True False # of Correct Alert Alert events Detection Rate (%) Rate (%) (n) Rate (%) Missed Detection Rate (%) 55 358 31.6 68.4 66 68.2 31.8 60 521 44.1 55.9 119 73.1 26.9 70 1,054 68.0 32.0 369 81.6 18.4 80 1,794 80.5 19.5 671 88.1 11.9 90 2,746 86.3 13.7 1,030 92.8 7.
The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are presented in Tables 5-C and 5-D. Tables 5-C and 5-D represent the hyperglycemic alert evaluation within 15 minutes of the YSI value in the study and the hypoglycemic event evaluation within 15 minutes of each hyperglycemic alert for adults and pediatrics, respectively. Hyperglycemic Alert Rate The Alert Rate shows how often the alert is right or wrong.
Table 5-C. Hyperglycemic Alert and Detection Rate Evaluations (Adults, n=159) Hyperglycemic Alert Level (mg/dL) Alerts # of alerts (n) Detections True False # of Correct Alert Alert events Detection Rate (%) Rate (%) (n) Rate (%) Missed Detection Rate (%) 120 37,061 97.5 2.5 12,664 97.6 2.4 140 32,148 97.2 2.8 11,175 96.8 3.2 180 23,424 96.6 3.4 8,455 95.2 4.8 200 19,586 96.0 4.0 7,265 93.6 6.4 220 15,689 95.6 4.4 6,143 91.2 8.8 240 12,279 94.6 5.4 5,007 88.
Table 5-D. Hyperglycemic Alert and Detection Rate Evaluations (Pediatrics*, n=165) Hyperglycemic Alert Level (mg/dL) Alerts # of alerts (n) Detections True False # of Correct Alert Alert events Detection Rate (%) Rate (%) (n) Rate (%) Missed Detection Rate (%) 120 11,683 97.3 2.7 3,930 97.8 2.2 140 10,113 96.2 3.8 3,388 97.7 2.3 180 6,821 93.4 6.6 2,366 94.7 5.3 200 5,190 93.3 6.7 1,874 91.2 8.8 220 4,096 90.4 9.6 1,453 91.7 8.3 240 3,068 86.9 13.1 1,093 90.2 9.
Sensor Stability Sensors can be worn for up to 10 days. Performance was estimated by calculating the percentage of G6 readings within 15 mg/dL or 15% (15/15%), 20 mg/dL or 20% (20/20%), and 40 mg/dL or 40% (40/40%), of the YSI values at the beginning (Day 1, 2), middle (Day 4, 5) and end (Day 7, 10) of the G6 lifecycle. For blood glucose values less than or equal to 70 mg/dL, the absolute difference in mg/dL between the two glucose results was calculated.
Table 6-B. Sensor Stability Relative to YSI (Accuracy over Time1) (Pediatrics*; n=165) Number of paired CGM-YSI MARD (%) Percent within 15/15% YSI (%) Percent within 20/20% YSI (%) Percent within 40/40% YSI (%) Beginning 2167 9.9 81.2 92.1 99.8 Middle 1268 9.1 83.1 93.7 99.8 End 2337 9.4 83.1 91.1 98.5 Wear Period * Includes pediatric subjects 6-17 years of age; no YSI measurements were taken for pediatric subjects 2-5 years of age. 1 CGM readings are within 40-400 mg/dL, inclusive.
Table 7-A. Sensor Survival Rate by Wear Day (Adults; n=164) Wear Day Number of Sensors Survival Rate (%) 1 162 99.4% 2 160 98.8% 3 158 98.8% 4 155 98.8% 5 154 98.1% 6 154 98.1% 7 150 96.8% 8 146 96.2% 9 144 94.9% 10 139* 93.5% * Includes sensors that survived more than 9.5 days (228 hours) of wear. Dexcom G6 System User Guide Appendix F: Technical Information LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
1.0 Survival Probability 0.8 0.6 0.4 0.2 # at Risk 164 162 160 158 155 154 154 150 146 144 139 1 1 0 0 1 0 2 1 2 2 # of Failures 1 1 2 3 0 0 2 3 0 3 # of Censored 0.0 0 1 2 3 4 5 6 7 8 9 10 Sensor Day Figure 1-A. Kaplan Meier Curve of Sensor Life (Adults; N = 164) Note: “# of Censored” refers to sensors excluded from the survival analysis due to reasons not related to the device (e.g.
Table 7-B. Sensor Survival Rate by Wear Day (Pediatrics; n=210) Wear Day Number of Sensors Survival Rate (%) 1 206 99.0% 2 204 99.0% 3 196 97.1% 4 193 95.6% 5 184 91.1% 6 175 88.6% 7 164 85.5% 8 157 83.4% 9 146 79.2% 10 142* 76.8% * Includes sensors that survived more than 9.5 days (228 hours) of wear. Dexcom G6 System User Guide Appendix F: Technical Information LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
1.0 Survival Probability 0.8 0.6 0.4 0.2 # at Risk 210 206 204 196 193 184 175 164 157 146 142 # of Failures 2 0 4 3 9 5 6 4 8 4 # of Censored 2 2 4 0 0 4 5 3 3 0 0.0 0 1 2 3 4 5 6 7 8 9 10 Sensor Day Figure 1-B. Kaplan Meier Curve of Sensor Life (Pediatrics; N = 210) Note: “# of Censored” refers to sensors excluded from the survival analysis due to reasons not related to the device (e.g.
Number of Readings Provided The G6 is capable of providing a reading every 5 minutes, or up to 288 readings per day. For a variety of reasons, the G6 may not display a glucose reading and readings are “skipped.” The percentage of readings you can expect to receive from the G6 over the sensor life is 98.6%. More than 97% of the sensors captured readings at least 90% of the time. For the G6 with auto-applicator, approximately 99% of the sensors displayed reading every 5 minutes at least 90% of the time.
Precision of System Readings A subset of randomly selected subjects wore two Systems at the same time (n=67). This was to look at how similarly two Systems function on the same subject (sensor precision) under the same condition. Precision was evaluated by comparing the glucose readings from the two Systems worn on the same subject at the same time on the same location. Table 9 shows that the readings from the two sensors generally agreed with each other.
Study 2 Overview The purpose of the Study 2 was to assess the performance of the System with an automatic sensor applicator, which is the final G6 CGM System configuration. The automatic applicator was designed to provide more consistent sensor insertions. The study was a prospective, multi-center, single-arm study that enrolled 76 subjects at four (4) US clinical sites. No glucose manipulations were performed in this substudy.
Table 10. G6 Accuracy to YSI (n=62) Patient Population Number Total number Percent within of of paired 20/20% subjects CGM-YSI YSI Day 1 Percent within 20/20%YSI MARD (%) Overall 62 3,532 93.5 (89.9) 91.1 9.0 Auto-app (≥18 years) 25 2,145 91.9 (86.6) 91.0 9.8 Auto-app (6-17 years old) 37 1,387 95.8 (92.3) 91.3 7.7 Patient Comfort (Study 2 - Automatic Applicator) Enrolled patients were asked to complete questionnaires on comfort and ease of use of the G6 with automatic applicator.
Adverse Events No serious adverse events (AEs) or device-related serious adverse events occurred during the studies. There was a total of 24 mild to moderate AEs which occurred during the studies (among 374 sensors). 13 of these AEs occurred due to either skin irritation, such as erythema (redness) or edema (swelling), at the sensor needle insertion area or around the adhesive area, or mild to moderate excoriation and infection. F.
Transmitter and Receiver Product Specifications Model G6 Transmitter Memory Storage N/A Electrical Safety Internally Powered Class Battery Longevity 3 months (Typical) Battery Charging Non-rechargeable Time Ambient temperature is Operational 50°F–107.
Transmitter and Receiver Product Specifications Model Alarm Audible Output TX/RX Frequencies G6 Transmitter Dexcom Receiver N/A 50 dBSPL at 3 feet 2.402–2.480 GHz Bandwidth 1.07 MHz 1.39 MHz Maximum Output Power 1.0 mW EIRP 2.
Electromagnetic Immunity and Emissions Declaration and Guidance The transmitter and receiver are intended for use in the electromagnetic environment specified in the next table. The customer or the user of the transmitter should ensure that it is used in such an environment.
Immunity Test Radiated and Conducted Fields Aircraft use Transmitter Compliance Receiver Compliance Level Level FAA RTCA /DO-160 edition G Section 20 Category T. Can be used on aircraft according to the directions provided by the operator of the aircraft Electromagnetic interference can still occur in the home health care environment as control over the EMC environment cannot be guaranteed. An interference event can be recognized by gaps in G6 readings or gross inaccuracies.
Electromagnetic Emissions Specifications Emissions Test Compliance Radio Frequency Emissions Group 1, Class B CISPR 11/FCC part 15 Radio Frequency Emissions Aircraft Use Meets FAA RTCA /DO-160 edition G Section 21, Category M for in-cabin use. F.3 FCC Compliance Statements This G6 CGM transmitter and receiver comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2.
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Appendix G | 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 Dexcom G6® Continuous Glucose Monitoring System (G6). For a listing of what they mean, see below. You may also reference the Symbols Glossary at dexcom.com/symbols.
Do Not Reuse Do Not Use if Package Is Damaged Electrical Equipment Designed Primarily for Indoor Use Humidity Limitation Input IP22: Protection Against Insertion of Large Objects and Dripping Water IP28: Protection Against Insertion of Large Objects and Immersion in Water Keep Away from Heat Keep Dry Manufacturer MR MR Unsafe Dexcom G6 System User Guide Appendix G: Label Symbols LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
PN Part Number Prescription Required Refer to Instruction Manual/Booklet SN STERILE R Serial Number Sterile by Radiation Temperature Limitation Type BF Applied Part Use By Date Dexcom G6 System User Guide Appendix G: Label Symbols LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
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Appendix H | Alarm/Alerts Vibrations and Sounds H.1 App: System Alerts Screen Default Default Default On Sound Vibration Change Settings Override Mute YES Fixed Alert Beep YES NO YES YES Fixed Alert Beep YES NO YES YES Fixed Alert Beep YES NO YES YES Silent Alert NO NO NO YES Fixed Alert Beep YES NO YES Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default Default Default On Sound Vibration Change Settings Override Mute YES Fixed Alert Beep YES NO NO YES Silent Alert NO NO NO YES Silent Alert NO NO NO YES Fixed Alert Beep YES NO NO YES Fixed Alert Beep YES NO YES Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default Default Default On Sound Vibration Change Settings Override Mute YES Fixed Alert Beep YES NO YES YES Fixed Alert Beep YES NO NO YES Fixed Alert Beep YES NO NO YES Silent Alert NO NO NO Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default Default Default On Sound Vibration Change Settings Override Mute YES Silent Alert NO NO NO YES Fixed Alert Beep YES NO YES YES Fixed Alert Beep YES NO YES Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default Default Default On Sound Vibration YES Fixed Alert Beep Change Settings Override Mute NO YES Editable Settings Override Mute YES H.
Screen Default Default Default On Sound Vibration Editable Settings Override Mute Enable/Disable (default is enabled) YES Low Alert YES Notify Below (default is 80 mg/dL) YES Repeat (default is Never) Sound (default is Low Alert) Enable/Disable (default is enabled) YES High Alert YES Notify Above (default is 200 mg/dL) YES Repeat (default is Never) Sound (default is High Alert) Enable/Disable (default is disabled) NO Rise Rate YES Notify Above (default is 3 mg/dL/min) YES Sound (default
Screen Default Default Default On Sound Vibration Editable Settings Override Mute Enable/Disable (default is disabled) NO Fall Rate YES Notify Below (default is 3 mg/dL/min) YES Sound (default is Fall Rate) YES YES Signal Loss Alert Signal Loss Alert Enable/Disable NO YES Sound (default is Signal Loss Alert) Enable/Disable (default is disabled) Sound (default is Signal Loss Alert) Android YES Apple NO YES H.3 Receiver: System Alerts No editable settings.
Screen Default On Default Vibration Default Sound Yes 1 – 1 second 1 – 1 second medium tone vibe beep Yes 1 – 1 second 1 – 1 second medium tone vibe beep Yes Silent Notes Sensor warmup is done. No need to calibrate to get G6 readings. Silent Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default On Default Vibration Default Sound Yes 1 – 1 second 1 – 1 second medium tone vibe beep Yes 1 – 1 second 1 – 1 second medium tone vibe beep Yes 1 – 1 second 1 – 1 second medium tone vibe beep Notes Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default On Yes Default Vibration Default Sound 1 – 1 second 1 – 1 second medium tone vibe beep Notes Pairing Failed First notification includes sound for: Yes 1 – 1 second 1 – 1 second medium tone vibe beep • Urgent Low Alarm • Urgent Low Soon Alert • Sensor Failed Alert • Transmitter Alert Yes Silent Silent Silent Sensor Shutoff Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default On Yes Default Vibration Default Sound 1 – 1 second 1 – 1 second medium tone vibe beep Yes 1 – 1 second 1 – 1 second medium tone vibe beep Yes 1 – 1 second 1 – 1 second medium tone vibe beep Notes Sensor Shutoff Can’t restart sensor once it has been stopped. After trying to restart, transmitter determines if sensor has been restarted and stops it if it has.
Screen Default On Yes Default Vibration Default Sound Notes 1 – 1 second 1 – 1 second medium tone vibe beep First notification includes sound for: Yes 1 – 1 second 1 – 1 second medium tone vibe beep • Urgent Low Alarm • Urgent Low Soon Alert • Sensor Failed Alert • Transmitter Alert Yes Silent Silent Recoverable error Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default On Yes Default Vibration Default Sound 1 – 1 second 1 – 1 second medium tone vibe beep Notes Set time alarm H.
Screen Default On Yes Default Vibration 3 – 1/3 second vibes, 1/3 seconds apart Default Sound Editable Settings 3 – 1/3 second low tone beeps, 1/3 seconds apart Can be turned on/off by the user EGV <= Low alarm level value Can be turned on/off by the user Yes 6 vibes, progressively shorter in length 6 beeps, progressively shorter in length First notification includes sound for: • Urgent Low Alarm • Urgent Low Soon Alert • Sensor Failed Alert • Transmitter Alert No 2 – 1/2 second vibes, 1/2 se
Screen Default On Default Vibration Default Sound No 3 – 1/3 second vibes, 1/3 seconds apart Yes 1 – 1 second 1 – 1 second medium tone vibe beep Editable Settings 3 – 1/3 second low tone Can be turned on/off beeps, 1/3 by the user seconds apart Can be turned on/off by the user Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Screen Default On Yes Default Vibration Default Sound 1 – 1 second 1 – 1 second medium tone vibe beep Editable Settings Can be turned on/off by the user EGV <= 55 mg/dL First notification includes sound for: Yes 4 – 200 ms vibes 4 – 1/4 second • Urgent Low Alarm low tone • Urgent Low Soon beeps, 1/4 Alert seconds apart • Sensor Failed Alert • Transmitter alert Dexcom G6 System User Guide Appendix H: Alarm/Alerts Vibrations and Sounds LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
Index Alarm Calibration App recommended settings, 150 Entering into app, 97 Confirming, 148 Entering into receiver, 101 Notifications, 133 Errors, 331 Receiver beeps and vibrations, 159 Notifications, 331, 338 What is an, 133 Overview, 93 Alarm and alerts Preparing for, 95 Changing receiver, 283 What is, 93 Customizing, 150 When to calibrate, 94 Alerts Confirming, 148 Why is calibration important, 93 CGM System Default, 150 Basic maintenance, 275 Low/High Glucose, 140, 141 Different m
Follower Alerts, 196 Glucose Information Attaching transmitter, 81 Definition, 16 Ending, 207 Rate of change arrows, 119 Ending 10-day, 207 Trend screen, 113 Ending early, 254 Rate of change arrows, 119 Inserting sensor, 75 Receiver Prepping for sensor insertion, 71 Initial setup, 63 Preventing sensor failures, 279 Trend screen, 118 Receiver: starting a Session, 87 Safety statement Starting a, 85 Contraindications, 20 Starting with app, 86 Indications, 20 Warmup, 85 Warnings, 21 Sensor I
© 2018 Dexcom, Inc. All rights reserved. Covered by patents dexcom.com/patents. Dexcom, Dexcom G4, Dexcom G5, Dexcom G5 Dexcom, Dexcom G6, Dexcom SHARE, SHARE, Dexcom FOLLOW, Dexcom CARE, and Dexcom CLARITY are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. Bluetooth is a registered trademark owned by Bluetooth SIG. Apple is a registered trademark owned by Apple Inc. Android is a registered trademark owned by Alphabet Inc.
Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA Phone: 1.858.200.0200 Tech Support: 1.888.738.3646 Web: dexcom.com LBL014003 Rev XXX MT23976 © 2018 Dexcom, Inc. All rights reserved. LBL014003 Rev XXX Artwork, G6 CGM System User Guide US.
