The Food and Drug Administration on Wednesday named Dexcom, Inc. as the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a program designed to generate real-world evidence for digital health technologies used in care for chronic conditions.
The TEMPO pilot is tied to the Centers for Medicare & Medicaid Services Innovation Center’s ACCESS Model, a payment framework that rewards measurable improvements in patient health rather than individual services. Its first cohort began in July 2026 and aims to expand access to technology-supported care for people managing cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
Dexcom’s Glucose Health Program is intended to help patients in the ACCESS Model and their healthcare providers monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for decision-making. The program is designed as an aid in screening for prediabetes and type 2 diabetes through integrated digital health metrics and may contribute to improving glycemic control and lowering HbA1c in people with prediabetes. The FDA said it will continue evaluating the program for its intended use during the pilot.
“The first TEMPO participant represents an important step toward modernizing how innovative technologies reach people with Medicare,” said CMS Deputy Administrator and Innovation Center Director Abe Sutton. “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.”
CDRH Director Michelle Tarver called the selection a meaningful milestone in the agency’s effort to meet patients where they are and generate the evidence needed to ensure digital health technologies deliver on their promise.
The FDA plans to select up to about ten TEMPO participants in each of four ACCESS Model clinical use areas, reflecting a broad spectrum of U.S.-based manufacturers. Selection criteria include potential risks to patient safety, reasonable expectation of patient benefit, plans for real-world data collection and reporting, and alignment with ACCESS Model outcomes. The agency continues to accept statements of interest with no specified deadline.
Source: FDA Press Release
