The Food and Drug Administration has selected Dexcom as the first participant in a new digital health pilot. This pilot will allow certain digital health devices to be exempted from FDA premarket authorization requirements while collecting real-world data through a complementary Medicare program.
Digital Health Pilot Details
Dexcom, which makes continuous glucose monitors, or CGMs, plans to implement an artificial intelligence-enabled glucose health program through the pilot. The program is intended to help screen for prediabetes and Type 2 diabetes.
The company plans to integrate data from its sensors, including its prescription G7 CGM and its over-the-counter Stelo device, along with contextual health information such as nutrition, physical activity, sleep and stress.
By bringing together all of this data, Dexcom hopes to give users and healthcare providers a more complete view of metabolic health, and to help improve glycemic control and lower blood sugar levels in people with prediabetes.
Background and Goals
The FDA announced plans for the Technology-Enabled Meaningful Patient Outcomes, or TEMPO, pilot last year amid a broader push for adoption of digital health and wearables. It coincides with a new program by the Centers for Medicare and Medicaid Services to fund the use of digital technologies for managing chronic conditions.
The pilot is intended to help the FDA and the CMS better understand how digital health technologies perform in real-world settings and how they can support efforts to improve care for people living with chronic diseases, the FDA said in its statement.
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This development is part of a larger trend where regulatory bodies are acknowledging the potential of digital health technologies to improve patient outcomes. By leveraging real-world data, these technologies can provide valuable insights into the management of chronic conditions, ultimately leading to better healthcare decisions.
The CMS program has four focus areas, covering conditions including hypertension, diabetes, heart disease, chronic kidney disease, musculoskeletal pain, anxiety and depression. It will run for 10 years, starting in July.
Participation and Next Steps
The FDA plans to accept up to 10 manufacturers in each of the CMS’ four focus areas. The agency is still considering statements of interest for participation and does not have a set deadline for when it will stop accepting them.
Dexcom said participating in the pilot will help it generate real-world evidence on how its glucose sensors and digital health programs can support earlier intervention strategies.
As the first participant in the pilot, Dexcom will play a key role in shaping the direction of digital health technologies in the management of chronic conditions.