Dexcom G7 Receives FDA Clearance: The Most Accurate Continuous Glucose Monitoring System Cleared in the U.S.
- Dexcom G7 is now cleared in the U.S. for people with all Types of diabetes ages two years and older, giving more people than ever access to a powerfully simple diabetes management solution
- With an overall MARD of 8.2%, Dexcom G7 is the most accurate CGM cleared by the FDA,1 building on the trusted performance of Dexcom CGM, which is clinically proven to lower A1C, reduce hyper- and hypoglycemia and increase time in range 2,3
- Cleared as an integrated continuous glucose monitoring (iCGM) system, Dexcom G7 will be part of the most connected CGM ecosystem in the world,1 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 *
- As the number one covered CGM on the market,4 most Dexcom users pay less than those using other CGM systems1
SAN DIEGO–(BUSINESS WIRE)– DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today the FDA has cleared the next-generation Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with all Types of diabetes ages two years and older.
Dexcom G7 now offers a more powerful and easier to use system with a small, all-in-one wearable with no fingersticks or scanning required. (Photo: Business Wire)
“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. 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 components30-minute sensor warmup, fastest of any CGM on the market‡12-hour grace period to replace finished sensors for a more seamless transition between sessionsRedesigned and simplified mobile app with Dexcom Clarity integration§,||Improved alert settings for enhanced discretionRedesigned optional receiver that is smaller, with a more vibrant, easier to read displayIndicated for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2-17 years oldSmaller plastic components and packaging, resulting in less waste than the Dexcom G6 CGM System1||Dexcom G6 features included with Dexcom G7:No fingersticks,¶ scanning or calibrationReal-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 performance5Only CGM to offer a predictive low alert that can recognize potentially dangerous hypo-incidences before they occur|
Dexcom is working closely with its insulin pump partners to integrate Dexcom G7 into current and future automated insulin delivery systems as quickly as possible.
Proven performance with easy-to-use, customizable features
With Dexcom G7, the most recommended CGM brand among patients6 and healthcare providers7 now offers a more powerful and easier to use system with a small, all-in-one wearable, completely redesigned mobile app and no fingersticks¶ or scanning required. Dexcom G7 also offers a suite of customizable alerts that can warn of high or low glucose levels and help users spend more time in range.**,2 The system features a predictive low alert that provides a 20-minute advance warning of potentially dangerous low glucose levels so users can act quickly to avoid a hypoglycemic event. This critical feature continues to be at the forefront of the Dexcom experience, with more than 52 million Urgent Low Soon alerts acknowledged – more than 11 million of those in the middle of the night.1Users can also share information with loved ones and care teams anywhere, anytime through industry-leading remote monitoring and reporting capabilities.# These features, among others, helped Dexcom G7 earn recognition as a CES 2023 innovation awards honoree in the wearable technology, digital health category.
“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, non-intrusive 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.”
With the most coverage,4 more users pay less for the #1 preferred CGM6,7
As diabetes becomes increasingly prevalent, it’s more important than ever for all people with diabetes to have access to the best care and technology.
- Dexcom is the number one covered and most reimbursed CGM on the market4 with a third of patients with commercial coverage paying $0 out-of-pocketand the majority paying less than $40 per month††,8
- Dexcom has three times more patients paying $0 than competing CGM systems8 and is currently reimbursed by more than 97% of private insurance1 as well as Medicare nationwide and Medicaid in 45 states
- The recent proposed rule change from the Centers for Medicare and Medicaid Services to expand access to CGM for more people with diabetes, including those not on insulin therapy, has the potential to give millions more people in the US access to Dexcom CGM so they can more effectively manage their diabetes
“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, MD, 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 US 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.