The FDA has selected Dexcom as the first participant in its Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, also known as TEMPO. The company plans to offer the Dexcom Glucose Health Program for use in care expected to be covered by CMS’ ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model.
The FDA will continue evaluating the Dexcom Glucose Health Program for its intended use during the pilot, according to a July 22 news release. The program is intended to help patients participating in the ACCESS model and their healthcare professionals or caregivers monitor metabolic and nutritional status, receive tailored guidance and access real-time data and AI insights. It is also intended to aid in screening for prediabetes and Type 2 diabetes and may help improve glycemic control and lower HbA1c in people with prediabetes.
Manufacturers participating in the TEMPO pilot will collect, monitor and report real-world data on their devices’ intended uses to help the FDA and CMS evaluate how digital health technologies perform in real-world settings and support care for people with chronic diseases.
The FDA said it plans to select up to about 10 TEMPO pilot participants in each of four ACCESS model clinical use areas. The ACCESS model’s first cohort began in July 2026 and is intended to expand access to technology-supported care options for certain cardio-kidney-metabolic, musculoskeletal and behavioral health conditions.
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