Dexcom G7 Continuous Glucose Monitoring System Gets FDA Clearance

Dexcom G7 offers new features with a 60% smaller, discreet wearable patch.

The Food and Drug Administration (FDA) has cleared the next-generation Dexcom G7 Continuous Glucose Monitoring (CGM) System for determining glucose levels in patients 2 years of age and older with diabetes.

Dexcom G7 offers new features to improve glycemic control with a 60% smaller, discreet wearable patch compared with the prior generation. The patch is worn on the back of the upper arm for patients 2 years of age and older or the upper buttocks for patients 2 to 17 years of age. The new device has a 30-minute sensor warm up and allows for a 12-hour grace period to replace finished sensors between sessions. 

Similar to the previous Dexcom G6 model, the G7 model continuously measures glucose levels and transmits readings every 5 minutes to a compatible display device (eg, mobile app). It does not require fingersticks or scanning and enables users to share glucose data with up to 10 followers. If the patient’s glucose level is too high or too low, it triggers an alarm to alert the patient.

The Dexcom G7 was evaluated in a study that included adults with either type 1 or type 2 diabetes. Over a period of 10.5 days, the system’s readings were compared against a lab test method to measure blood glucose. Results showed that the Dexcom G7 provided accurate glucose readings with an overall MARD (mean absolute relative difference) of 8.2%.

The Dexcom G7 model is expected to be commercially available in early 2023.

Reference

  1. Dexcom G7 receives FDA clearance: the most accurate continuous glucose monitoring system cleared in the US. News release. Dexcom, Inc. Accessed December 8, 2022. https://www.businesswire.com/news/home/20221208005302/en/Dexcom-G7-Receives-FDA-Clearance-The-Most-Accurate-Continuous-Glucose-Monitoring-System-Cleared-in-the-U.S.
  2. Garg SK, Kipnes M, Castorino K, et al. Accuracy and safety of Dexcom G7 Continuous Glucose Monitoring in adults with diabetes. Published online May 31, 2022. Diabetes Technology & Therapeutics. doi.org/10.1089/dia.2022.0011