Dexcom G7 Continuous Glucose Monitor Approved by the FDA
Editor’s Note: For tips on navigating health insurance coverage in the U.S., visit our health insurance resources on Beyond Type 1 and Beyond Type 2.
On December 8, 2022, Dexcom, a company that manufactures continuous glucose monitors (CGMs) for blood sugar management, announced the U.S. Food and Drug Administration (FDA) approval for their next-generation product, the Dexcom G7 CGM. The G7 is approved for people with all types of diabetes ages 2 years and older.
In February of this year, Dexcom released clinical trial data demonstrating strong blood sugar measurement accuracy. Overall, CGMs are clinically shown to lower A1c levels and increase blood sugar time in range, leading to improved health outcomes for people living with diabetes.
The G7, cleared as an integrated CGM (iCGM), will be able to integrate with automated insulin delivery systems and can connect with wearables like the Apple Watch and other digital health apps to help wearers reach healthier blood sugar levels and decrease the burden of disease management.
The G7 differs in several notable ways from the previous generation product, the G6.
- The G7 is 60 percent smaller than the G6, with an all-in-one sensor and transmitter.
- The warm-up period has been cut down from two hours to 30 minutes.
- Now with a 12-hour grace period to replace finished sensors for a more seamless transition between sessions
Like the G6, the G7 does not require finger-stick calibration and sends real-time glucose readings to compatible devices every five minutes. The system alerts wearers to predicted low blood sugar levels before they occur, allowing for treatment to keep blood sugar levels in a healthy range.
The product comes with a redesigned mobile app, more customizable high and low blood sugar level alerts and the continued ability to share real-time blood sugar levels with loved ones and care teams.
In a press release announcing the approval, Kevin Sayer, chairman, president and CEO of Dexcom stated, “There’s a reason Dexcom has the best-selling real-time CGM on the market. 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. 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. G7 delivers squarely on that promise. And now that it has been cleared by the FDA, we look forward to making G7 commercially available in the coming months.”
The G6 will continue to be available for the foreseeable future, important not only to those using the G6 with existing automated insulin delivery systems but also for those who have gone through the vital process of health insurance approval to get access to the product.
As the G7 becomes available in the coming months, Dexcom is working with insulin pump companies, insurers and other necessary players to transition the use and integration of the G7.
To learn more about Dexcom G7 and for additional information about when it will be available in the US, visit Dexcom.com/G7.
