FDA selects Dexcom for digital health pilot

WASHINGTON – The U.S. Food and Drug Administration (FDA) has selected Dexcom as the first participant in its Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO. The pilot, conducted in partnership with the CMS Innovation Center, is designed to evaluate how digital health technologies perform in real-world settings while expanding access to technology-enabled care for people with Medicare. The program is intended to help patients participating in CMS’s ACCESS Model, along with their health care professionals or caregivers, to monitor metabolic and nutritional status, receive tailored guidance and use real-time data and artificial intelligence insights to inform decisions and behavioral changes. “ACCESS provides a clear payment pathway that rewards measurable improvements in patient health rather than individual services, while TEMPO helps generate the real-world evidence needed to evaluate promising new technologies responsibly,” said Abe Sutton, CMS deputy administrator and director of the Innovation Center. Dexcom’s Glucose Health Program will continue to undergo FDA evaluation during the pilot. The program is intended to support screening for prediabetes and Type 2 diabetes through integrated digital health metrics. It may also help improve glycemic control and lower HbA1c in people with prediabetes. Manufacturers participating in TEMPO will collect, monitor and report real-world data related to the intended uses of their devices. The FDA and CMS will use that information to assess patient outcomes, safety and the performance of digital health technologies in real-world settings. The ACCESS Model’s first cohort began in July 2026 and focuses on technology-supported care for chronic conditions, including cardio-kidney-metabolic, musculoskeletal and behavioral health conditions. The FDA plans to select up to approximately 10 TEMPO participants in each of four ACCESS clinical use areas.