Dexcom joins the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. It intends to provide a device for use in delivering care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model. This technology is intended to improve health outcomes for Americans managing certain chronic diseases.
San Diego-based Dexcom is a leader in continuous glucose monitoring (CGM) and biosensor technology. Its devices, such as the G7 CGM and the Stelo over-the-counter (OTC) sensor, support the management of diabetes.
The FDA said it plans to continue to evaluate the Dexcom Glucose Health Program for its intended use during the pilot. It intends to address two clinical use areas in the ACCESS Model.
Dexcom’s program aims to enable patients aligned to the ACCESS model and their healthcare professionals or caregivers to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights. This delivers informed decision-making and behavioral modifications. It also intends to aid in the screening for prediabetes and type 2 diabetes. The company also expects to contribute to improving glycemic control and lowering HbA1c in people with prediabetes.
More about the TEMPO pilot
Manufacturers participating in the FDA pilot collect, monitor and report real-world data for their devices. The FDA and CMS expect it to help them better understand how digital health technologies perform in real-world settings. They also expect insights into how to support efforts to improve care for chronic diseases.
Altogether, the FDA plans to select up to about 10 TEMPO pilot participants in each of four ACCESS Model clinical use areas. It also intends to select participants in alignment with the pilot’s strategic goals of promoting patient access, safeguarding patient safety and generating meaningful real-world data.
The FDA expects the ACCESS Model to expand access to new care options, such as the use of devices selected for TEMPO. Areas include common chronic conditions like certain cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
Dexcom said its participation builds on its continued investment in digital health and the expansion of glucose biosensing.
Commentary from FDA and Dexcom officials
Center for Devices and Radiological Health Director Dr. Michelle Tarver said:
“For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-changing. The selection of our first TEMPO participant marks a meaningful milestone as we pilot an approach, in partnership with the CMS Innovation Center, to meet patients where they are and generate the real-world evidence needed to ensure these technologies truly deliver for them.”
CMS Deputy Administrator and Director of the Innovation Center Abe Sutton said:
“The first TEMPO participant represents an important step toward modernizing how innovative technologies reach people with Medicare. 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.”
Dexcom CEO Jake Leach said:
“Glucose is one of the body’s most powerful health signals, providing immediate insight into a person’s overall health. Transforming this data into more personalized, 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. Being the first company selected by the FDA to participate in this pilot program marks another first for Dexcom and underscores our continued leadership in innovation.”
