Dexcom Kicks Off FDA’s TEMPO Digital Health Device Pilot

Dexcom announced that it was the first company selected to participate in the U.S. Food and Drug Administration’s (FDA) Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program.

The TEMPO pilot was designed to evaluate innovative digital health technologies to help manage chronic diseases while collecting real-world evidence. Participation lets Dexcom implement an artificial intelligence (AI)-powered glucose health program that merges data from its G7 and Stelo continuous glucose monitors (CGMs) and health information like nutrition, physical activity, sleep, and stress.

The San Diego-based company hopes to provide a more complete picture of metabolic health by monitoring progress and personalizing therapy at the population level. It also aims to advance earlier intervention strategies for diabetes (including Type 2 and prediabetes) by marrying its glucose biosensing tech with AI-enabled digital health metrics.

Dexcom plans to collect additional data on cardiometabolic outcomes in diabetes, as well.

“Glucose is one of the body’s most powerful health signals, providing immediate insight into a person’s overall health,” said President and CEO Jake Leach. “Transforming this data into more personalized, proactive screening and preventive care has the potential to help millions of people make meaningful lifestyle changes before disease develops, while also generating the evidence needed to expand access to these technologies. Being the first company selected by the FDA to participate in this pilot program marks another first for Dexcom and underscores our continued leadership in innovation.”

More about the FDA’s TEMPO Digital Health Devices Pilot

Dexcom will offer its CGM devices for care—covered under CMS’ ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model—for the TEMPO pilot. The ACCESS model, whose first cohort launched this month, aims to expand access to technology-enabled care, including devices used in the TEMPO pilot, for preventing and managing common chronic conditions.

“The first TEMPO participant represents an important step toward modernizing how innovative technologies reach people with Medicare,” said CMS Deputy Administrator and Director of the Innovation Center 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.”

FDA and CMS said the TEMPO pilot should help the agencies better understand how digital health tech performs in the real world and how they can better support improving care for people suffering from chronic conditions.

“For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-changing,” said Center for Devices and Radiological Health Director Michelle Tarver, MD, Ph.D. “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.”