The FDA has selected Dexcom, Inc. as the inaugural participant in its TEMPO digital health pilot program. Operating in coordination with the CMS Innovation Center's outcomes-based ACCESS model, this joint initiative represents a novel federal effort to align regulatory clearance with reimbursement pathways. Dexcom will deploy its AI-driven Glucose Health Program to monitor metabolic and nutritional metrics using G7 and Stelo sensors, generating real-world evidence to improve chronic disease management.
TEMPO pilot program launch
- ▪The U.S. Food and Drug Administration selected Dexcom, Inc. as the first participant in the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot Program.
- ▪The TEMPO pilot program is designed to adapt FDA evaluation processes to the rapid, iterative development of digital health technologies and evaluate their performance in real-world settings.
Real-world data collection framework
- ▪Manufacturers participating in the TEMPO pilot must collect, monitor, analyze, and report real-world data regarding the performance of their technologies and patient outcomes.
- ▪The TEMPO pilot program aims to generate real-world evidence to help the FDA and CMS understand how digital health technologies perform outside of controlled research settings.
Dexcom glucose health program
- ▪The Dexcom Glucose Health Program is designed to aid in screening for prediabetes and type 2 diabetes, improve glycemic control, and lower HbA1c levels.
- ▪Dexcom, Inc. will develop the Dexcom Glucose Health Program, an AI-driven initiative integrating data from its Dexcom G7 and Stelo devices with contextual health factors like nutrition, exercise, sleep, and stress.
ACCESS payment model
- ▪The ACCESS model targets technology-supported care options for chronic conditions, including specific cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
- ▪The CMS Innovation Center's ACCESS model, which began its first cohort in July 2026, establishes a payment pathway that rewards measurable improvements in patient health rather than individual services.
FDA participant selection criteria
- ▪The FDA plans to select up to 10 TEMPO pilot participants in each of the four ACCESS model clinical use areas, potentially incorporating up to 40 U.S.-based manufacturers.
- ▪FDA selection criteria for the TEMPO pilot include potential patient health risks, reasonable expectation of benefit, RWD collection plans, and alignment with ACCESS model outcomes.
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