The FDA has announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot: Dexcom, Inc.
Dexcom’s Glucose Health Program is intended to “enable patients aligned to the ACCESS [Advancing Chronic Care with Effective, Scalable Solutions] model and their healthcare professionals or caregivers to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for informed decision-making and behavioral modifications. The program is intended as an aid in the screening for prediabetes and type 2 diabetes through integrated digital health metrics. It may also contribute to improving glycemic control and lowering HbA1c in people with prediabetes.”
The manufacturer, as part of the TEMPO pilot, will “collect, monitor, and report real-world data (RWD) relating to the intended uses of their devices to improve patient outcomes, whether the device is offered by the manufacturer itself as an ACCESS participant or by another participating ACCESS organization.”
Dexcom is the first of ten planned pilot participants. The FDA “intends to select participants in alignment with the TEMPO pilot’s strategic goals of promoting patient access, safeguarding patient safety, and generating meaningful RWD in connection with the ACCESS model.”
