Over-the-counter glucose monitor expands access to diabetes care
In March, the FDA approved the Dexcom Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor (CGM). This integrated CGM is for adults 18 and older who don’t use insulin, including those managing diabetes with oral medications or nondiabetics seeking to understand the effects of diet and exercise on blood sugar. It is not for use in people with problematic hypoglycemia. The Stelo system consists of a wearable sensor and a smartphone app that provides continuous glucose measurements and trends every 15 minutes. Users can wear each sensor for up to 15 days before replacement. Clinical data submitted to the FDA demonstrated performance comparable to other integrated CGMs, with reported adverse events including local infection, skin irritation, and discomfort. Patients are reminded that medical decisions should not be made without consulting a health care professional and they should not rely solely on the device’s output. This approval marks a step toward health equity, enabling individuals to access CGMs without a health care provider’s involvement.
Source: asamonitor.pub/3VOM5k4
Leave a Reply
You must be logged in to post a comment.