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 range2,3
- 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)–$DXCM #Dexcom—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.
“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:
Dexcom G6 features included with Dexcom G7:
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.1 Users 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.
Visit Dexcom.com and get started with Dexcom G6 today to experience the benefits of CGM now. To learn more about Dexcom G7 and for additional information about when it will be available in the US, visit Dexcom.com/G7.
About DexCom, Inc.
Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, and with operations across Europe, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers and providers, Dexcom simplifies and improves diabetes management around the world. For more information about Dexcom CGM, visit www.dexcom.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements that are not purely historical regarding Dexcom’s or its management’s intentions, beliefs, expectations and strategies for the future, including statements with respect to timing of the commercial launch of G7 in the United States. All forward-looking statements and reasons why results might differ included in this press release are made as of the date of this release, based on information currently available to Dexcom, deal with future events, are subject to various risks and uncertainties, including risks and uncertainties relating to the commercial launch of G7 in the United States, including the availability of coverage for G7, the timing and accessibility of cash pay options, and successful and timely collaboration with partners to facilitate the integration of G7 with commercially available insulin pumps and any future automated insulin delivery systems, and actual results could differ materially from those anticipated in those forward-looking statements. The risks and uncertainties that may cause actual results to differ materially from Dexcom’s current expectations are more fully described in Dexcom’s Quarterly Report on Form 10-Q for the period ended September 30, 2022, as filed with the Securities and Exchange Commission on October 28, 2022. Except as required by law, Dexcom assumes no obligation to update any such forward-looking statement after the date of this report or to conform these forward-looking statements to actual results.
* Compatible smart devices sold separately. To view a list of compatible smart devices, visit dexcom.com/compatibility.
† Compared to a prior generation Dexcom CGM System.
‡ Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer.
§ Healthcare providers can register for Dexcom Clarity at clarity.dexcom.com/professional/registration.
|| An internet connection is required for patients to send their glucose data to Dexcom Clarity via a compatible smart device: dexcom.com/compatibility. Healthcare providers will only be able to view a patient’s glucose data if the patient elects to share it with them through Dexcom Clarity.
¶ If your glucose alerts and readings from Dexcom G7 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.
# Separate Dexcom Follow app and internet connection required. Internet connectivity required for data sharing. Users should always confirm readings on the Dexcom G7 app or receiver before making treatment decisions.
** Results obtained with a prior generation Dexcom CGM System.
†† Refers to estimated out-of-pocket cost for eligible commercially insured patients from the Dexcom CGM sensor when claims are adjudicated as a pharmacy benefit, and includes benefits and offerings through available Dexcom programs, such as the voucher program. Actual cost may vary and is subject to individual insurance coverage.
1Dexcom, data on file, 2022.
2Beck RW, et al. JAMA. 2017;317(4):371-378.
3 Welsh JB, et al. J Diabetes Sci Technol. 2022:19322968221099879.
4Managed Markets Insights & Technology, LLC. MMIT Analytics, June 2022.
5 Dexcom G7 User Guide.
6 dQ&A US Q1 2021 Diabetes Connections Patient Panel Report. 2021;69-72.
7 Seagrove HCP Survey, Q1 2021.
8IQVIA, February 2022.