Dexcom G7 approved by FDA to treat all types of diabetes

Dexcom G7 is now cleared by the Food and Drug Administration for people with all types of diabetes ages 2 years old and older. 

With an overall MARD of 8.2%, Dexcom G7 builds on the trusted performance of Dexcom CGM, which is clinically proven to lower A1C, reduce hyper- and hypoglycemia and increase time in range, the company said.

Cleared as an integrated continuous glucose monitoring system, Dexcom G7 will be part of the most connected CGM ecosystem in the world, with real-time connectivity that can drive integrated insulin delivery systems, connect with wearables like the Apple Watch and integrate with popular digital health apps.

[Read more: Enhancing diabetes prevention and care services]  

As the No. 1 covered CGM on the market, most Dexcom users pay less than those using other CGM systems, the company said.

“There’s a reason Dexcom has the bestselling 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. 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.”

New features with Dexcom G7:

• 60% smaller, all-in-one, discreet wearable, easier to use with fewer components;
• 30-minute sensor warmup, fastest of any CGM on the market;
• 12-hour grace period to replace finished sensors for a more seamless transition between sessions;
• Redesigned and simplified mobile app with Dexcom Clarity integration;
• Improved alert settings for enhanced discretion;
• Redesigned optional receiver that is smaller, with a more vibrant, easier to read display;
• Indicated for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2-17 years old; and
• Smaller plastic components and packaging, resulting in less waste than the Dexcom G6 CGM System.

Dexcom G6 features included with Dexcom G7:

• No fingersticks, scanning or calibration;
• Real-time glucose readings sent automatically every 5 minutes to a compatible display device;
• Integration with the world’s largest connected CGM ecosystem (including Apple Watch, Garmin and other digital health apps);
• Remote monitoring, enabling users to share glucose data with up to 10 followers;
• Proven Dexcom accuracy and performance; and
• Only CGM to offer a predictive low alert that can recognize potentially dangerous hypo-incidences before they occur.

Dexcom said it is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible.

[Read more: Diabetes goes digital: Innovative technologies are revolutionizing diabetes care and monitoring]

“The first thing that stood out to me when I started using the Dexcom CGM was how easy it was to use,” said Zac Harmon, a Dexcom Warrior and blues musician. “It’s small, nonintrusive and has been the biggest part of my diabetes journey. It feels like it was made just for me, so I can focus more on what’s really important in my life.”

“Dexcom G7 is so simple and easy to use that it should be prescribed to every person with Type 1 and Type 2 diabetes,” said Thomas Grace, a primary care physician in Findlay, Ohio. “G7 isn’t just great for people with diabetes, it’s great for healthcare professionals as well. 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. With its exceptional accuracy and ease of use, I’m confident G7 will be a game changer for my patients.”

Dexcom expects to initiate a U.S. launch of Dexcom G7 in early 2023. To facilitate immediate access to G7 for as many users as possible, the company will have accessible cash pay options in place as the company transitions coverage availability for G7.