Breaking: FDA Clears Dexcom Stelo, First OTC Continuous Glucose Monitor

The FDA has cleared the Dexcom Stelo Glucose Biosensor System as the first OTC continuous glucose monitor (CGM). The device is an integrated CGM intended for use in adults aged 18 years and older who do not use insulin or in those without diabetes who wish to better understand how diet and exercise affect blood glucose levels.¹

For some of the 25 million individuals in the United States living with type 2 diabetes, Stelo offers those who do not use insulin—or those who do not have insurance coverage for CGM—another option to manage their disease alongside other diabetes medications.² For adults without diabetes, Stelo’s wearable sensor measures, records, and analyzes blood glucose levels at 15-minute intervals, displaying data in the accompanying smartphone app.

Of note, Stelo system is not cleared for use in individuals with problematic hypoglycemia as it is not designed to alert users of low blood sugar.

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, MD, JD, director of the Center for Devices and Radiological Health at the FDA, in a news release.¹ "Giving more individuals valuable information about their health, regardless of their access to a [physician] or health insurance, is an important step forward in advancing health equity for US patients.”

READ MORE: Know Labs Announces Wearable, Non-Invasive Continuous Glucose Monitor

“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,” said family physician Tamara Oser, MD, in a Dexcom press release.² “For people newly diagnosed with [T2D] or not taking insulin, these devices are often not covered by insurance, and Stelo presents an opportunity to provide valuable information that can impact their diabetes management.”

Clearance was based on data from a clinical study demonstrating that the Stelo Glucose Biosensor System performed similarly to other integrated CGM devices.

Stelo will be available to purchase online without a prescription in summer 2024.

READ MORE: CGM Resource Center

References

1. FDA clears first over-the-counter continuous glucose monitor. News release. FDA. March 5, 2025. Accessed March 5, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor

2. Stelo by Dexcom first glucose biosensor to be cleared by FDA as over-the-counter. News release. Dexcom. March 5, 2024. Accessed March 5, 2024. https://www.businesswire.com/news/home/20240305044213/en/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter