FDA Selects Dexcom as First Participant in TEMPO Digital Health Device Pilot Program

Jul 22, 2026

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.