FDA Approves Abbott’s Libre Rio and Lingo Over-the-Counter CGMs

Updated 9/10/24

Two new over-the-counter CGMs were recently approved by the FDA. The were both created by Abbott and use Abbott’s FreeStyle Libre technology, but they were designed for two very different purposes. These latest over-the-counter CGM systems join Dexcom’s Stelo as the only CGM options in the U.S. that you can get without a prescription – which is a very big deal for people living with type 2 diabetes.

Libre Rio Over-the-Counter CGM for People with Type 2 Diabetes

The Libre Rio is Abbot’s first over-the-counter CGM designed specifically for people with type 2 diabetes who are not on insulin.

As an Abbott over-the-counter CGM, it offers an iCGM system intended for adults 18 and over, particularly those who manage their diabetes through lifestyle modifications like nutrition and exercise.

Libre Rio consists of a sensor placed on the back of the arm for 14 days, and a reader or a compatible smartphone app which displays blood sugar measurements. The Libre Rio system can detect blood sugars between 40-400 mg/dL, so it’s able to measure extremely low or extremely high glucose values.

The FDA’s approval of Libre Rio will hopefully make it easier for many people with type 2 diabetes to utilize CGM technology since they will be able to purchase this device without a prescription. CGMs have been shown to significantly help people improve glucose control, lower A1c, decrease diabetes-related hospital admissions, and improve quality of life.

No information has been released yet regarding market launch dates or pricing.

Lingo: A Wellness-Focused Over-the-Counter CGM

Abbott’s Lingo CGM was designed for people 18 and older who simply want to better understand and improve their general health and wellness. Lingo was not created to diagnose diseases or be used by people with diabetes. It does track glucose, but it also provides personalized insights and customized coaching to help people create healthy habits, retrain their metabolism, and improve their overall well-being.

Lingo streams glucose data via a sensor worn on the upper arm to a coaching app on a smartphone. This app provides insights into the user’s reactions to food, exercise, and other lifestyle factors, empowering them to make informed decisions.

Lingo is available in the U.K. and in the U.S.  Visit hellolingo.com for pricing information.

Why Over-the-Counter CGMs are a Big Deal

The approval of over-the-counter CGMs like Libre Rio and Lingo is a major development in the healthcare world. Previously, continuous glucose monitors were only available through a prescription, which limited access for many people. Now, anyone can purchase these devices, expanding the potential for better health management not only for those with diabetes but also for individuals focused on preventative health and wellness.

Over-the-counter CGMs represent a paradigm shift toward more accessible, affordable, and empowering healthcare. As more people begin using these devices, we could see a broader adoption of data-driven health decisions, especially for conditions like prediabetes and metabolic syndrome, where glucose monitoring can play a crucial role.

Revolutionizing Healthcare with Over-the-Counter CGMs

Whether you’re managing type 2 diabetes with the Libre Rio or optimizing your wellness with Lingo, these CGM options make it easier than ever to monitor your health in real time. For those with type 2 diabetes, it’s essential to understand why CGMs are so valuable, even for people not on insulin. The Association of Diabetes Care and Education Specialists provides helpful information on CGM choices based on your individual needs. With the FDA’s approval of over-the-counter CGMs, we are entering a new era of accessible, proactive health management that empowers people to take charge of their well-being.