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In a significant development for diabetes management, the U.S. Food and Drug Administration (FDA) has granted clearance for the marketing of the first over-the-counter continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System, designed for individuals 18 years and older who do not use insulin, marks a groundbreaking step in empowering users to monitor their blood glucose levels without the involvement of a healthcare provider.
The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) that offers continuous glucose monitoring capabilities to individuals managing their diabetes with oral medications or those without diabetes seeking insights into how diet and exercise affect their blood sugar levels. Notably, this system is not intended for individuals with problematic hypoglycemia (low blood sugar), as it does not provide alerts for this potentially dangerous condition.
Dr. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, highlighted the significance of expanding access to CGMs, stating, “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.”
The Stelo Glucose Biosensor System utilizes a wearable sensor paired with a smartphone or other smart device application to continuously measure, record, analyze, and display glucose values for users aged 18 and above who are not on insulin and do not experience problematic hypoglycemia. Each sensor can be worn for up to 15 days before replacement, providing users with glucose measurements and trends every 15 minutes through the accompanying app. However, users are advised not to make medical decisions solely based on the device’s output without consulting their healthcare provider.
Clinical data submitted to the FDA demonstrated that the device performed comparably to other iCGMs, with reported adverse events including local infection, skin irritation, and discomfort.
The clearance of the Dexcom Stelo Glucose Biosensor System aligns with the FDA’s commitment to advancing health equity by promoting innovation that enhances access to care and wellness in home settings. As the CGM becomes available to consumers, it holds the potential to revolutionize diabetes management by providing individuals with greater control over their health and facilitating informed decision-making regarding blood glucose levels.
