FDA Clears First OTC Continuous Glucose Monitoring, Dexcom Stelo Glucose Biosensor System

The FDA has cleared marketing for the first over-the-counter continuous glucose monitoring (CGM), the Dexcom Stelo Glucose Biosensor System, which is an integrated CGM (iCGM) for individuals aged 18 years and older who do not use insulin, or individuals who treat diabetes with oral medication. Further, it can also be used by those without diabetes who may want to understand how diet and exercise can impact blood sugar levels, according to a press release from the FDA.¹

According to a press release from Dexcom, CGMs play a large role in the management of type 2 diabetes (T2D), and studies have shown that CGMs are associated with clinically meaningful improvements in time in rage, A1c, and quality of life, whether used with diabetes and weight management medication or used alone.²

“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,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for [US] patients.”¹

The Stelo Glucose Biosensor System is a wearable sensor that goes on the back of the arm and can be paired using an application to the user’s smartphone or other smart device.^1,2 It continuously measures, records, analyzes, and displays glucose values and presents blood glucose measurements and trends every 15 minutes via the application. The sensor can be worn up to 15 days before needing to be replaced, and the FDA says users should not make medical decisions based on the outputs of the device without talking to their health care provider, according to the press release.¹

Data from a clinical study was sent to the FDA that showed the device performed similarly to other iCGMs, and the adverse events included local infection, skin irritation, and pain or discomfort, according to the press release.¹

“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,” Tamara Oser, MD, a family physician at the University of Colorado’s School of Medicine, said in a press release from Dexcom. “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.”²

The system is not for individuals who have hypoglycemia, and the system will not alert that patient population of drops in low blood sugar.¹

According to the press release from Dexcom, Stelo will be available for purchase online and without a prescription starting in summer 2024. The company said providing this device over-the-counter will make it easier for individuals to have access to CGM technology and will also provide options for those who do not have insurance coverage for CGM, according to the press release.²

References

1. FDA Clears First Over-the-Counter Continuous Glucose Monitor. News release. FDA. March 5, 2024. 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