FDA Launches TEMPO Pilot with Dexcom to Advance Digital Health in Chronic Disease Management
FDA Launches TEMPO Pilot with Dexcom to Advance Digital Health in Chronic Disease Management

<p>On July 22, 2026, the U.S. Food and Drug Administration (FDA) announced Dexcom, Inc. as the inaugural participant in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program.</p><p>This initiative focuses on the Dexcom Glucose Health Program, which seeks to generate real-world evidence supporting the use of technology-enabled car...

  • Published date: 06-08-2026 10:03 AM

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On July 22, 2026, the U.S. Food and Drug Administration (FDA) announced Dexcom, Inc. as the inaugural participant in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program.

This initiative focuses on the Dexcom Glucose Health Program, which seeks to generate real-world evidence supporting the use of technology-enabled care for chronic disease management. Emphasis is placed on screening for prediabetes and type 2 diabetes, as well as improving glycemic control.

The evidence gathered through the CMS Innovation Center’s ACCESS model will inform clinicians and health systems about outcomes, safety, and coverage pathways for digital health devices, advancing care possibilities for patients with chronic conditions.

The FDA has selected Dexcom as the first participant in its TEMPO pilot program, aiming to generate real-world evidence for digital health devices.

<p>On July 22, 2026, the U.S. Food and Drug Administration (FDA) announced Dexcom, Inc. as the inaugural participant in its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program.</p><p>This initiative focuses on the Dexcom Glucose Health Program, which seeks to generate real-world evidence supporting the use of technology-enabled care for chronic disease management. Emphasis is placed on screening for prediabetes and type 2 diabetes, as well as improving glycemic control.</p><p>The evidence gathered through the CMS Innovation Center’s ACCESS model will inform clinicians and health systems about outcomes, safety, and coverage pathways for digital health devices, advancing care possibilities for patients with chronic conditions.</p>

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