Dexcom is first to join FDA/CMS health tech pilot

The FDA has named Dexcom as the first medical device manufacturer that will take part in a pilot programme that could make it easier to bring digital health technologies (DHTs) for chronic diseases to patients more quickly.

First announced last December as part of a deregulatory drive under former FDA Commissioner Marty Makary, the TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot will assess the Dexcom Glucose Health Programme, an AI-powered system that integrates real-time glucose biosensor data with lifestyle factors like diet, sleep, and physical activity.

Aimed at people with type 2 diabetes and prediabetes, the platform combines a continuous glucose monitor device, which sends readings to a smartphone every few minutes, with software that provides glucose data and alerts for patients and their healthcare providers.

The pilot is running within the Centers for Medicare and Medicaid Services (CMS) recently launched ACCESS model, which is testing an outcome-aligned payment approach for Medicare aimed at improving access to approved healthtech that is used for people with chronic health conditions, including diabetes/prediabetes, high blood pressure, chronic musculoskeletal pain, and depression.

"The first TEMPO participant represents an important step toward modernising how innovative technologies reach people with Medicare," said CMS Deputy Administrator and Director of the Innovation Center, Abe Sutton.

"ACCESS provides a clear payment pathway that rewards measurable improvements in patient health rather than individual services, while TEMPO helps generate the real-world evidence needed to evaluate promising new technologies responsibly," he added.

The FDA intends to select up to 10 device manufacturers in each of four clinical areas – which have not already gone through the usual premarket authorisation process – in the initial phase of TEMPO.

Manufacturers participating in the pilot will collect, monitor, and report real-world data (RWD) relating to the intended uses of their devices to improve patient outcomes, according to the FDA.

"Glucose is one of the body's most powerful health signals, providing immediate insight into a person's overall health," according to Jake Leach, president and chief executive of Dexcom, who said that participating in the pilot "marks another first for Dexcom and underscores our continued leadership in innovation."

"Transforming this data into more personalised, proactive screening and preventive care has the potential to help millions of people make meaningful lifestyle changes before disease develops, while also generating the evidence needed to expand access to these technologies," he added.