Next-generation Dexcom G7 CGM receives FDA clearance for use in type 1 and type 2 diabetes
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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.
“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.
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Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
I am very excited about the FDA approval of the Dexcom G7. The pregnancy contraindication has been removed, which will hopefully mean increased access for my pregnant patients.
There are several enhancements from the Dexcom G6 as well as new features that offer more customization. The transmitter is about 60% smaller and now fully disposable, which will make life easier for people with diabetes. The warm-up time decreased from 2 hours to only 30 minutes, and a new sensor can be placed early to avoid any disruption in continuous glucose monitoring. For those using hybrid closed-loop insulin pumps, this means there will be no disruption in their automated insulin delivery.
The alerts are more customizable, allowing people to temporarily silence or delay alarms, which may help reduce diabetes distress due to alarm fatigue. And one of the best enhancements is combining the Dexcom CGM app with the CLARITY app so people can see their CGM key metrics on the same screen. It will also connect directly to Apple Watch.
I’m so excited and optimistic about CGM truly becoming a standard of care for all people with diabetes much the way meters have been for years. This is one of the top innovations for 2022.
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