FDA Names Dexcom First Participant in TEMPO Digital Health Pilot

The U.S. Food and Drug Administration on July 22 named Dexcom as the first manufacturer selected for its TEMPO pilot for digital health devices, a program that lets certain devices be used in Medicare's new outcome-based chronic care model while their makers collect real-world performance data, according to the FDA's announcement.

TEMPO stands for Technology-Enabled Meaningful Patient Outcomes. The selected product is the Dexcom Glucose Health Program, which the FDA said it "will continue to evaluate for its intended use during the pilot." The agency said the program is intended to address two clinical use areas in the ACCESS Model run by the Centers for Medicare & Medicaid Services Innovation Center.

What the Dexcom program is meant to do

According to the FDA, the program is intended to let patients aligned to the ACCESS Model, and their healthcare professionals or caregivers, monitor metabolic and nutritional status, receive tailored guidance and use real-time data and AI insights for decisions and behavior changes. The FDA described it as "an aid in the screening for prediabetes and type 2 diabetes through integrated digital health metrics," and said it may also help improve glycemic control and lower HbA1c in people with prediabetes.

"The selection of our first TEMPO participant marks a meaningful milestone as we pilot an approach, in partnership with the CMS Innovation Center, to meet patients where they are and generate the real-world evidence needed to ensure these technologies truly deliver for them," said Michelle Tarver, director of the FDA's Center for Devices and Radiological Health.

How TEMPO works

The FDA announced the voluntary pilot in December 2025 as a test of a risk-based enforcement approach for digital health devices aimed at cardio-kidney-metabolic, musculoskeletal and behavioral health conditions. Under it, participating manufacturers may ask the FDA to exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while they collect and share real-world data on device performance.

In the July 22 announcement, the FDA said participants will collect, monitor and report real-world data related to their devices' intended uses, whether the device is offered by the manufacturer itself as an ACCESS participant or by another ACCESS organization. ACCESS, whose first cohort began in July 2026, pays participating organizations for technology-supported care tied to measured health outcomes.

"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.

More participants to come

The FDA said it plans to select up to about 10 participants in each of four ACCESS clinical use areas, drawn from a broad range of U.S.-based manufacturers. Its considerations include potential risks to patient health, whether there is a reasonable expectation of patient benefit, plans for real-world data collection and reporting, and alignment with the outcomes ACCESS measures. The agency said it continues to consider statements of interest and has set no deadline for them.