FDA selects Dexcom as first participant for TEMPO pilot to advance real-world evidence in digital health

The FDA has selected Dexcom as the first participant in its TEMPO pilot, as the agency begins testing how real-world evidence generated during routine care can be incorporated into the evaluation of digital health technologies.

The Baseline

• Dexcom has become the first manufacturer selected for the FDA's TEMPO pilot.
• The company's AI-enabled glucose health program will generate real-world data through the CMS ACCESS model.
• The program is intended to support screening for prediabetes and type 2 diabetes, while providing personalized guidance using glucose and other health data.

The US Food and Drug Administration (FDA) has selected Dexcom as the first manufacturer to participate in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, marking the first implementation of a regulatory initiative designed to evaluate digital health technologies through supervised real-world use.

Announced in late 2025 in partnership with the Centers for Medicare & Medicaid Services (CMS) Innovation Center, the TEMPO pilot allows selected manufacturers to generate real-world data (RWD) while their technologies are used in care delivered through the CMS Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. The evidence collected is intended to support future FDA marketing authorization while helping regulators better understand how digital health technologies perform in routine clinical practice.

Describing the selection as "a meaningful milestone," Michelle Tarver, MD, PhD, Director of the FDA's Center for Devices and Radiological Health, said the pilot is intended to "meet patients where they are and generate the real-world evidence needed to ensure these technologies truly deliver for them."

Dexcom will participate in the pilot with its Glucose Health Program, an AI-enabled digital health platform that combines data from the company's Dexcom G7 and Stelo glucose biosensors with information on nutrition, physical activity, sleep, and stress. According to both the FDA and Dexcom, the program is intended to help patients, healthcare professionals, and caregivers monitor metabolic and nutritional status, receive tailored guidance, and access real-time insights to support decision-making and behavior change.

The program also designed to support screening for prediabetes and type 2 diabetes using integrated digital health metrics and may contribute to improving glycemic control and reducing HbA1c in people with prediabetes. During the pilot, the FDA will continue evaluating the program for these intended uses.

The selection represents an important milestone for the TEMPO initiative, which was established to explore whether structured real-world evidence (RWE) generation can help bridge the gap between innovation, regulatory evaluation, and Medicare payment. Rather than evaluating technologies solely through traditional premarket studies, the pilot will enable selected digital health devices to be assessed in routine care while manufacturers collect, monitor, and report RWD under defined regulatory safeguards.

Manufacturers participating in TEMPO are expected to share these data with the FDA and ultimately use them, alongside other supporting evidence, as part of future marketing authorization submissions.

The FDA intends to select a further ten US-based manufacturers in each of four clinical areas covered by the ACCESS model, including cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions. Participant selection considers factors including potential patient benefit, safety, plans for RWD collection and analysis, and alignment with the outcomes measured under ACCESS.

The announcement also represents the first practical example of the FDA's broader move toward incorporating RWE into the evaluation of digital health technologies. Rather than replacing existing regulatory pathways, TEMPO is intended to test whether structured evidence generated during routine care can complement traditional regulatory review while maintaining patient safety.

The ACCESS model, which began July 2026, provides the payment framework for this approach, rewarding participating organizations based on measurable improvements in patient outcomes rather than individual healthcare services. Running the two programs in parallel allows the FDA and CMS to evaluate both technology performance and outcomes within the same real-world care environment. Explaining this dual purpose, Abe Sutton, CMS Deputy Administrator and Director of the CMS Innovation Center, said:

“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.”

The FDA said it will continue accepting statements of interest from manufacturers wishing to participate in the pilot and has not announced a closing date for applications.