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Dexcom G7 15 Day CGM System Cleared by FDA
The extended wear benefit is augmented by the G7 15 Day CGM system's superior evidence-based accuracy, with a MARD of 8.0%
The US FDA today cleared the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System for individuals aged 18 years and older with diabetes, extending sensor wear time to 15.5 days and providing improved accuracy, according to a news release from the company.1
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The clearance makes the monitoring system the longest-lasting available wearable glucose monitoring technology for diabetes management.
The DexCom G7 15 Day has demonstrated an overall mean absolute relative difference (MARD) of 8.0%,2 accuracy exceeding that of previous Dexcom generations. The more than 2-week wear capability means less frequent sensor replacement for individuals with diabetes and, importantly, reduced monthly waste, DexCom observed.1 The benefits accrue without compromising the precision in glucose measurement essential for therapeutic decision-making.
The G7 15 Day system builds upon the proven clinical benefits of DexCom CGM technology, which has been shown clinically to lower HbA1c, reduce hyperglycemia and hypoglycemia episodes, and increase time in range for individuals with diabetes.1
"DexCom G7 15 Day makes managing diabetes even easier with its extended wear and greater accuracy," Satish Garg, MD, professor of medicine and pediatrics, at the Barbara David Center for Diabetes at the University of Colorado School of Medicine, noted in the DexCom announcement. "Data recently released2 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
For pediatric patients ages 2 to 18 years, the standard DexCom G7 remains the approved option, as the 15-day extended wear version is currently only cleared for adults.
Clinical Research Supports Accuracy
The G7 15 Day system was evaluated in a prospective multicenter study, results of which were published in Diabetes Technology & Therapeutics in March. The study assessed the performance and safety of the sensor in 130 adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) using intensive insulin therapy at 6 clinical sites in the US. Participants attended clinic sessions where glucose was deliberately manipulated under closely monitored conditions in order to determine sensor accuracy, as 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. "The device exceeded iCGM performance goals, and user experiences were broadly positive," study authors wrote. There were no serious adverse events reported.2
The system retains key features from the standard G7 platform augmented by the extended wear capabilities. It remains waterproof with the ability to withstand submersion up to eight feet for 24 hours. The platform maintains direct connectivity with Apple Watch, so users can monitor glucose levels without carrying their smartphones. Additional features include automated activity logging, meal tracking, medication logging, and integration with Dexcom Clarity for pattern analysis.
DexCom expects to launch the product commercially in the second half of 2025 and meanwhile is collaborating with insulin pump manufacturers to ensure G7 15 Day CGM compatibility with current automated insulin delivery systems.
The company continues to maintain its DexComClarity integration, allowing healthcare providers to remotely monitor patient glucose patterns and trends through interactive reports, provided patients consent to share their data.
"The approval of DexComG7 15 Day marks another major innovation for Dexcom," Jake Leach, executive vice president and chief operating officer at Dexcom, said in the statement. "By listening to 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."
