G7 Real-Time Continuous Glucose Monitoring System Demonstrates Accurate Glucose Readings and No Serious Adverse Events in Adults with Type 1 and Type 2 Diabetes

The accuracy and safety of the G7 real-time continuous glucose monitoring (RT-CGM) system was demonstrated over 10.5 days of use in adults with diabetes. In the study, adults with either type 1 or type 2 diabetes—either on intensive insulin therapy or not—wore G7 sensors concurrently on the upper arm and abdomen. Individuals were seen in clinic on days 1 or 2, 4 or 7, and on the second half of day 10 or the first half of day 11 for frequent comparisons with comparator blood glucose measurements obtained with the YSI 2300 Stat Plus glucose analyzer. After analyzing data from 316 participants (619 sensors, 77,774 matched pairs), overall mean absolute relative differences (MARD) between RT-CGM and YSI values for arm- and abdomen-placed sensors were 8.2% and 9.1%, respectively. In-clinic glucose manipulations and frequent blood glucose sampling confirmed accurate readings during euglycemia, hypoglycemia, and hyperglycemia (reflected as time in range [TIR], time below range [TBR], and time above range [TAR]), as well as during rapid glucose concentration change. Even at the highest rates of glucose concentration change, MARD values <10% were observed for arm-placed sensors and were <10.5% for abdomen-placed sensors. Offering a smaller size and added features, such as sensor/transmitter integration with a simplified insertion process, the G7 also demonstrated a favorable safety profile, with no serious adverse events reported during the study. With the recent FDA approval of the G7 RT-CGM system, payer professionals may well find value in the accuracy and safety data from this prospective multicenter single-arm study when they are developing coverage criteria.

Garg SK, et al. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. Diabetes Technol Ther. 2022;24(6):373-380.