FDA Clears Dexcom G7 15 Day CGM System

The US Food and Drug Administration (FDA) has granted clearance to the Dexcom G7 15-day continuous glucose monitoring (CGM) system for individuals aged 18 years and older with diabetes.1

Announced by Dexcom on April 10, 2025, the G7 CGM now boasts the longest-lasting CGM system with 15.5 days of wear and best-in-class accuracy with a mean absolute relative difference (MARD) of 8.0%.

“Dexcom G7 15 Day makes managing diabetes even easier with its extended wear and greater accuracy,” said Satish Garg, MD, Barbara Davis Center for Diabetes at the University of Colorado School of Medicine. “Data recently released during the 18th International Advanced Technologies and Treatments for Diabetes conference in Amsterdam supports that G7 15 Day is the most accurate CGM for adults.”1

The approval builds on the well-established Dexcom CGM platform, which has been shown to clinically reduce hemoglobin A1c (HbA1c) and hyper- and hypoglycemic events, and boost time-in-range for people with diabetes.

Dexcom indicates the G7 platform offers a waterproof sensor, the ability to connect directly to an individual’s Apple Watch, and automated activity logging, with a 12-hour grace period for an uninterrupted transition for sensor replacement. Integration with the Dexcom Clarity application allows patients to view glucose patterns and statistics via interactive reports and share with caregivers and family members.

A prospective, multicenter study evaluating the performance and safety of the G7 15 Day enrolled 130 adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) at six clinical sites in the US. Individuals on intensive insulin therapy participated in clinical sessions with deliberate glucose manipulations to determine accuracy, measured by MARD.2

With an overall MARD of 8.0, the %15/15, %20/20, %30/30, and %40/40 agreement rates were 87.7%, 94.2%, 98.9%, and 99.8%, respectively. User experiences were broadly positive, and no serious adverse events were identified.

“The approval of Dexcom G7 15 marks another major innovation for Dexcom,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “By listening ot the needs of our users, we’re proud to offer the longest lasting wearable and most accurate CGM, giving people the knowledge to better control their diabetes with our best-in-class technology.”1

In its announcement, Dexcom indicated its intention to work closely with insulin pump partners to ensure that the G7 15 Day CGM will be compatible with automated insulin delivery (AID) systems upon US launch, expected in the second half of 2025.

“This milestone sets a new standard in CGM and is a testament to our continued leadership in glucose biosensing,” Leach added. “We look forward to bringing it to market in the second half of this year, but in the meantime, we encourage our users to upgrade to our current G7 system to gain the benefits of the most connected CGM brand in the world.”

References

1. Dexcom, inc. - dexcom G7 15 Day receives FDA clearance: The longest lasting wearable and most accurate CGM system. April 10, 2025. Accessed April 10, 2025. https://investors.dexcom.com/news/news-details/2025/Dexcom-G7-15-Day-Receives-FDA-Clearance-the-Longest-Lasting-Wearable-and-Most-Accurate-CGM-System/default.aspx.

2. Garg SK, Bailey TS, Castorino K, et al. Accuracy of the 15.5-Day G7 iCGM in Adults with Diabetes. Diabetes Technol Ther. Published online March 20, 2025. doi:10.1089/dia.2025.0139