Last week, the U.S. Food and Drug Administration (FDA) announced the inaugural manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The manufacturer, Dexcom, Inc., a company that develops a line of continuous glucose monitoring systems, plans to offer a device to support 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.

The Dexcom Glucose Health Program is designed to enable patients aligned with the ACCESS Model, along with their healthcare professionals or caregivers, to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights to support informed decision-making and behavior changes. The program is intended to aid in screening for prediabetes and type 2 diabetes through integrated digital health metrics. It may also help improve glycemic control and lower HbA1c in people with prediabetes.

According to the FDA press release, manufacturers participating in 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.

The TEMPO pilot will help the FDA and CMS better understand how digital health technologies perform in real-world settings and how they may support efforts to improve care for people living with chronic diseases.

The FDA plans to select up to ten TEMPO pilot participants in each of four ACCESS model clinical use areas (early Cardio-Kidney-Metabolic (eCKM), Cardio-Kidney-Metabolic (CKM), Musculoskeletal (MSK), and Behavioral Health (BH)) who represent a broad spectrum of manufacturers and are US-based. The FDA also intends to select participants in line with the TEMPO pilot’s strategic goals of promoting patient access, safeguarding patient safety, and generating meaningful RWD in connection with the ACCESS model. The FDA’s considerations include, among other things, potential risks to patient health, safety, or welfare; whether there is a reasonable expectation that the device could provide patient benefit; plans for RWD collection, monitoring, analysis, and reporting; and alignment with the outcomes to be measured in the ACCESS model.

The FDA, in connection with the ACCESS model, launched the TEMPO pilot to align with the rapid, iterative nature of digital health device development, expand patient access to innovative technologies for specific clinical use areas, and safeguard patient safety. The ACCESS model, whose first cohort began in July 2026, aims to expand access to new technology-supported care options, such as devices selected for the TEMPO pilot, to help people improve their health and prevent and manage common chronic conditions, including certain cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.