The U.S. Food and Drug Administration has selected Dexcom as the first manufacturer to participate in its Technology-Enabled Meaningful Patient Outcomes pilot, known as TEMPO, for digital health devices.

Announced on July 22, 2026, the selection moves TEMPO from a regulatory framework into its first manufacturer-specific implementation. Dexcom will participate through its Glucose Health Program, which the FDA will continue to evaluate for defined intended uses within chronic disease care.

What Dexcom will evaluate

The program is being considered in two clinical-use areas under the ACCESS model: early cardio-kidney-metabolic conditions and cardio-kidney-metabolic conditions. The FDA participant record describes an intended use that would allow eligible patients, healthcare professionals, and caregivers to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights.

The intended use under evaluation also includes assisting with screening for prediabetes and type 2 diabetes through integrated digital health metrics. The FDA says the program may contribute to improved glycemic control among people with prediabetes.

These are intended uses being evaluated through the pilot. They are not established clinical outcomes, and the FDA states that effectiveness for the participating uses has not yet been established by the agency.

How TEMPO and ACCESS fit together

TEMPO is connected to the Centers for Medicare & Medicaid Services Innovation Center's ACCESS model, a voluntary Medicare payment model for technology-supported chronic care. The model uses recurring payments linked to measurable health outcomes rather than payment for each individual service.

The TEMPO framework provides a corresponding regulatory pathway for certain digital health devices used within those care arrangements. A participating manufacturer may request that the FDA exercise enforcement discretion for specified requirements when its device is offered through an ACCESS arrangement for an accepted intended use.

That discretion is bounded. The FDA determines the applicable circumstances with each participant, and use of the device for the same pilot indication outside ACCESS falls outside TEMPO. Participating manufacturers are expected to collect, monitor, and report real-world performance data and ultimately seek the appropriate FDA marketing authorization.

The connection to Health AI

Dexcom's program includes access to what the FDA describes as AI insights, but the announcement is not an approval of a standalone AI system. Its broader relevance to Health AI is the way software, connected devices, patient support, payment, regulatory oversight, and real-world evidence are being evaluated within one defined program.

TEMPO may provide an early example of how AI-enabled functions are assessed as components of a larger digital health service rather than as isolated model outputs. The program places emphasis on intended use, clinical context, risk, measurable outcomes, and evidence collected after deployment.

Selection for TEMPO does not constitute FDA approval or clearance of the Dexcom Glucose Health Program for the uses under evaluation. The announcement does not state that a clinical trial has begun or that the program is immediately available for unrestricted use outside participating ACCESS arrangements.