Fact checked byJill Rollet

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December 08, 2022
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Next-generation Dexcom G7 CGM receives FDA clearance for use in type 1 and type 2 diabetes

Fact checked byJill Rollet
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The FDA has granted clearance to a next-generation continuous glucose monitoring system for people with all types of diabetes aged 2 years and older, according to a press release.

Dexcom’s G7 CGM is the latest system from the company to receive clearance from the FDA. In a study published in the Journal of Diabetes Science and Technology in June 2022, the Dexcom G7 had an adjusted mean absolute relative difference (MARD) between CGM and laboratory blood glucose values of 8.2% when worn on the arm and 9.1% when worn on the abdomen, an improvement on the 9.9% MARD observed in the abdomen worn G6 device.

Sign outside FDA HQ in Washington, DC.
The FDA has cleared the Dexcom G7 CGM device for use in people aged 2 years and older with type 1 or type 2 diabetes. Source: Adobe Stock

“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,” Kevin Sawyer, chairman, president and CEO of Dexcom, said in a press release. “When we set out to design G7, our goal was simple: to make the most powerful, easy-to-use CGM available for people with diabetes, whether they have type 1 or type 2 diabetes. G7 delivers squarely on that promise.”

The Dexcom G7 has several changes from the G6, including a 60% smaller size, a 30-minute sensor warmup, a 12-hour grace period to replace finished sensors, a redesigned and simplified mobile app, improved alert settings designed to enhance discretion, a redesigned optional receiver and smaller plastics components and packaging.

As an integrated CGM, the G7 features real-time connectivity with wearable devices, such as the Apple Watch, and can be integrated into popular digital health apps. In the press release, Dexcom stated it is working with its insulin pump partners to integrate the G7 into current and future automated insulin delivery systems as soon as possible. The company anticipates making the G7 commercially available in the U.S. in the coming months.

Reference:

  • Welsh JB, et al. J Diabetes Sci Technol. 2022;doi:10.1177/19322968221099879.