Dexcom G7 Receives FDA Clearance: The Most Accurate Continuous Glucose Monitoring System Cleared in the U.S.

Rhea-AI Summary

Dexcom G7 has received FDA clearance for all diabetes types in individuals aged two and older. This next-generation continuous glucose monitoring (CGM) system boasts an overall MARD of 8.2%, making it the most accurate FDA-cleared CGM. With a 60% smaller, all-in-one wearable design, it offers a 30-minute sensor warmup and a suite of features including real-time connectivity with wearables and an upgraded mobile app. Furthermore, Dexcom's G7 is the number one covered CGM, with many users incurring low out-of-pocket costs.

Positive

• Dexcom G7 cleared for all diabetes types aged 2+.
• Overall MARD of 8.2% makes it the most accurate CGM cleared by the FDA.
• 60% smaller and all-in-one design enhances user experience.
• 30-minute sensor warmup, the fastest among CGMs.
• Improved alert settings support user management.
• Number one covered CGM with low out-of-pocket costs for many users.

Negative

• None.

• 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 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 Smaller 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 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 performance5 Only 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.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 CGM^6,7

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-pocket and 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.

¹ Dexcom, data on file, 2022.
² Beck RW, et al. JAMA. 2017;317(4):371-378.
³ Welsh JB, et al. J Diabetes Sci Technol. 2022:19322968221099879.
⁴ Managed 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.
⁸ IQVIA, February 2022.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221208005302/en/

Media Contact

James McIntosh

619-884-2118

james.mcintosh@dexcom.com

Investor Contact

Sean Christensen

858-203-6657

sean.christensen@dexcom.com

Source: DexCom, Inc.

FAQ

What is the FDA clearance status of Dexcom G7?

Dexcom G7 has received FDA clearance for individuals with all types of diabetes ages two years and older.

What is the accuracy of the Dexcom G7 continuous glucose monitoring system?

The Dexcom G7 boasts an overall MARD of 8.2%, making it the most accurate CGM approved by the FDA.

How does Dexcom G7 integrate with other devices?

Dexcom G7 features real-time connectivity that can integrate with insulin delivery systems, wearables like Apple Watch, and digital health apps.

What are the financial benefits of using Dexcom G7?

Dexcom is the number one covered CGM on the market, with many users paying less than $40 per month and a third of patients with commercial coverage paying $0 out-of-pocket.

When will Dexcom G7 be commercially available?

Dexcom plans to launch the G7 commercially in early 2023.