For years, blood glucose sensors have straddled the line between wellness and medicine. While most continuous glucose monitors are still found on the arms of people with diabetes, helping to dose insulin and catch dangerous overnight dips in glucose, a small batch of companies have quietly been prescribing them off-label, using the data streams to nudge users into habits that promote metabolic health and weight loss.
Then last summer, both Dexcom and Abbott began selling continuous glucose monitors (CGMs) without a prescription for about $100 a month, making it possible for any adult to monitor their blood glucose in real time, diabetes or not. As some startups begin selling over-the-counter CGMs directly to users alongside their apps, the tension between wellness and medicine has come into stark relief.
Dexcom Ventures-backed Signos on Wednesday announced that its app has been cleared as a medical device by the Food and Drug Administration to help users maintain a healthy weight when used with Dexcom’s Stelo CGM. In recent months, Nutrisense and Levels, the company co-founded by surgeon general nominee Casey Means, have also started selling Stelo to users, but the apps that analyze its blood glucose streams are still presented as general wellness products.
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