Abbott has announced the FDA clearance of two innovative over-the-counter continuous glucose monitors (CGMs): the Lingo and the Libre Rio. These advancements mark a significant shift in the accessibility and application of CGM technology, previously limited to insulin-dependent diabetes management.

The Lingo CGM targets health-conscious consumers who want to gain deeper insights into their metabolic health. Designed as a consumer wearable, Lingo monitors glucose levels in the interstitial fluid—found between cells—just under the skin. Unlike traditional blood glucose measurement, this method provides real-time data on how lifestyle factors like diet, exercise, and stress impact glucose levels. Users can view this data via a smartphone app, receiving coaching and insights without the need for a prescription. However, it’s important to note that Lingo is not intended to diagnose metabolic disorders or guide diabetes treatment.

On the other hand, the Libre Rio is tailored specifically for Type 2 diabetics who manage their condition through lifestyle modifications rather than insulin. This CGM offers a wide tracking range from 40 to 400 mg/dL, helping individuals better understand and manage their glucose levels. By providing this technology over the counter, Abbott aims to enhance the self-management tools available to a broader audience of diabetics.

The introduction of these OTC CGMs underscores a growing trend among medical device makers to expand the use of glucose monitoring technology beyond traditional diabetes management. For instance, Dexcom has also entered the market with its Stelo CGM, designed for non-insulin-dependent Type 2 diabetics, which received FDA clearance earlier this year.

The push for OTC CGMs reflects a broader movement towards more accessible health monitoring solutions. Typically, CGMs require a prescription, which can be a barrier for individuals who might benefit from using them but do not have a medical necessity. By eliminating this hurdle, these devices could empower people with prediabetes or Type 2 diabetes to better monitor and manage their condition. Furthermore, startups like Nutrisense and Levels are exploring the benefits of CGMs for non-diabetics, aiming to enhance weight management, athletic performance, and overall metabolic health. However, the efficacy of CGMs in non-diabetic populations remains an area for further research.

Article written by Victoria Song



The Verge