Dexcom Announced as First Participant Selected for FDA's TEMPO Digital Health Devices Pilot Program

Participation advances the company’s vision and regulatory pathway for earlier intervention, screening for prediabetes and Type 2 diabetes and empowerment

SAN DIEGO--(BUSINESS WIRE)--Dexcom (NASDAQ: DXCM), the global leader in glucose biosensing, today announced it is the first company selected by the U.S. Food and Drug Administration (FDA) to participate in the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot Program, a first-of-its-kind initiative designed to evaluate innovative digital health technologies that improve chronic disease management while generating real-world evidence.

Participation in the TEMPO pilot will allow Dexcom to implement an AI-powered glucose health program that integrates data from Dexcom G7 and Stelo with contextual health information such as nutrition, physical activity, sleep and stress, to deliver more personalized insights for healthcare professionals and program eligible users. The program leverages Dexcom's industry-leading clinician software platform, to provide healthcare professionals with a more comprehensive view of metabolic health, helping them monitor progress and personalize therapy at a population level. The program is also intended as an aid in the screening of 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 pilot will support Dexcom's efforts to generate real-world evidence evaluating how glucose biosensing technology and AI-enabled digital health programs advance earlier intervention strategies, including research focused on prediabetes and Type 2 diabetes, and future efforts to collect evidence for broader cardiometabolic health outcomes.

“Glucose is one of the body's most powerful health signals, providing immediate insight into a person’s overall health,” said Jake Leach, president and CEO of Dexcom. “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."

The FDA launched the TEMPO pilot to evaluate a new regulatory approach for certain digital health technologies that support chronic disease management while collecting real-world performance data. The initiative is part of the agency's broader effort to accelerate access to innovative digital health solutions while maintaining patient safety.

Dexcom's participation builds on the company's continued investment in digital health and expanding the role of glucose biosensing across the continuum of care. The company continues to advance technologies that help people and healthcare professionals better understand the relationship between glucose and lifestyle factors to enable more personalized health decisions.

To learn more about the portfolio of Dexcom glucose biosensors, visit Dexcom.com.

About Dexcom

Dexcom empowers people to take control of health through innovative biosensing technology. Founded in 1999, Dexcom has pioneered and set the standard in glucose biosensing for more than 25 years. Its technology has transformed how people manage diabetes and track their glucose, helping them feel more in control and live more confidently.

Dexcom. Discover what you’re made of. For more information, visit Dexcom.com.

Category: IR