FDA Clears Dexcom G7 CGM System for Persons with T1D and T2D

The US Food and Drug Administration has cleared the Dexcom G7 Continuous Glucose Monitoring (CGM) system for people with both type 1 and type 2 diabetes aged ≥2 years, according to a Dexcom company announcement on December 8.

Dexcom expects to initiate the US launch of the G7 CGM System early in 2023.

“G7 isn’t just great for people with diabetes, it’s great for healthcare professionals as well,” said Thomas Grace, MD, a primary care physician in Findlay, Ohio, in the company statement. "The integration of Dexcom Clarity into the mobile app provides easy access to retrospective insights about a patient’s glycemic management during in person or telehealth appointments.” Findlay lauds the system’s ease of use and “exceptional accuracy” and predicts it will be a “gamechanger” for his patients with diabetes.

Like the previous G6 generation CGM, the Dexcom G7 system requires no fingersticks, scanning or calibration, the statement says. Other key features retained from the earlier system include the ability to send real-time glucose readings automatically every 5 minutes to a compatible device and the ability to share glucose data with up to 10 followers. The Dexcom CGM is the only system that offers a predictive low alert that "can recognize potentially dangerous indidences of hypoglycemia before they occur," Dexcom says.

The company highlights new features as well that distinguish the G7 from its predecessors including:

• 60% smaller, all-in-one discreet wearable, with fewer components
• 30-minute sensor warmup
• Improved alert settings
• 12-hour grace period to replace finished sensors
• Redesigned mobile app
• Indicated for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2 to 17 years

Dexcom notes that it is working closely with its partners who provide insulin pumps to integrate Dexcom G7 into current automated insulin delivery systems as quickly as possible. Also, in order to facilitate immediate access, the company will offer accessible cash pay options as the company transitions coverage availability.

“There’s a reason Dexcom has the best-selling real-time CGM on the market,” said Kevin Sayer, chairman, president and CEO of Dexcom. “For more than a decade, we’ve pioneered generation after generation of sensing technology that consistently delivers improved accuracy, reliability and a simpler user experience, giving people greater control of their diabetes.”