Dexcom selected as first participant in FDA's TEMPO pilot

Dexcom (NASDAQ: DXCM) has been selected as the first company to participate in the U.S. Food and Drug Administration's Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot Program, according to a press release from the company.

The TEMPO pilot is an FDA initiative designed to evaluate digital health technologies that support chronic disease management while collecting real-world performance data. The program aims to accelerate access to digital health solutions while maintaining patient safety.

As part of its participation, Dexcom plans to implement an AI-powered glucose health program that integrates data from its Dexcom G7 and Stelo devices with contextual health information including nutrition, physical activity, sleep, and stress. The program is intended to deliver personalized insights for healthcare professionals and eligible users through Dexcom's clinician software platform.

The program is also intended 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.

"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. "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 pilot will support Dexcom's efforts to generate real-world evidence on how glucose biosensing technology and AI-enabled digital health programs support earlier intervention strategies related to prediabetes and Type 2 diabetes.

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