San Diego, July 22, 2026
Dexcom announced that it has become the first company selected by the U.S. Food and Drug Administration (FDA) to participate in the newly launched Technology-Enabled Meaningful Patient Outcomes (TEMPO) Digital Health Devices Pilot Program. The initiative is designed to evaluate innovative digital health technologies that improve chronic disease management while generating real-world clinical evidence to support future regulatory decision-making. Through the program, Dexcom will deploy an AI-powered glucose health platform that integrates data from the Dexcom G7 and Stelo glucose biosensors with lifestyle information including nutrition, physical activity, sleep, and stress. The program is intended to support earlier intervention, improve screening for prediabetes and Type 2 diabetes, and provide healthcare professionals with personalized metabolic insights to enhance patient care.
AI-Powered Platform Combines Glucose Data with Lifestyle Insights
As part of the FDA TEMPO Pilot Program, Dexcom will utilize its advanced clinician software platform to combine continuous glucose monitoring data with multiple health indicators, creating a more comprehensive picture of an individual’s metabolic health. The integrated system is designed to help healthcare professionals monitor patient progress, personalize treatment strategies, and manage larger patient populations more effectively. In addition to supporting diabetes management, the program is intended to assist with the screening of prediabetes and Type 2 diabetes by evaluating digital health metrics alongside glucose patterns. The company also believes the AI-enabled platform may contribute to improved glycemic control and lower HbA1c levels in individuals with prediabetes by encouraging earlier lifestyle interventions based on personalized health information.
Pilot Supports Real-World Evidence Generation
The TEMPO Pilot Program was established by the FDA to explore new regulatory approaches for digital health technologies capable of improving chronic disease management while collecting real-world performance data. Through participation in the initiative, Dexcom aims to generate scientific evidence demonstrating how glucose biosensing technology and artificial intelligence can enable earlier disease detection, preventive healthcare strategies, and improved cardiometabolic outcomes. The research will focus on evaluating how AI-driven digital health programs can identify individuals at risk of developing prediabetes and Type 2 diabetes while supporting future regulatory efforts to expand the use of digital health technologies across broader metabolic disease indications. The program also aligns with the FDA’s objective of accelerating patient access to innovative digital medical technologies without compromising safety or clinical effectiveness.
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Dexcom Continues Expanding Digital Health Innovation
The selection as the first participant in the FDA TEMPO Pilot Program reinforces Dexcom’s leadership in glucose biosensing and digital healthcare innovation. The company continues investing in technologies that help individuals and healthcare professionals better understand the relationship between glucose levels, daily lifestyle behaviors, and overall metabolic health. By integrating continuous glucose monitoring, artificial intelligence, and real-world clinical evidence generation, Dexcom aims to expand the role of glucose monitoring beyond traditional diabetes management toward preventive healthcare, early disease detection, and personalized medicine. Participation in the FDA pilot represents another important milestone in the company’s strategy to advance next-generation AI-enabled digital health solutions that support improved chronic disease management and empower patients to make more informed health decisions.
Source:Dexcom press release
