The FDA has given the green light to two new Abbott over-the-counter continuous glucose monitors.

• On Monday, Abbott declared that it has obtained FDA approval for two new CGMs that can be purchased without a prescription.
• A real-time glucose tracking sensor, known as a CGM, is implanted under the skin of individuals with diabetes.
• The Libre Rio system by Abbott is intended for Type 2 diabetes patients who do not use insulin, whereas Lingo is aimed at consumers seeking to enhance their health and wellness.

On Monday, the U.S. Food and Drug Administration approved two new over-the-counter continuous glucose monitoring systems, one for people without diabetes.

A CGM is a small sensor that tracks a person's glucose levels in real time by poking through the skin and wirelessly transmitting data to a smartphone. These devices are primarily used by patients with diabetes to alert users, their families, and their doctors to emergencies.

Abbott's existing CGMs are already used by 6 million patients across 60 countries, and the company sees significant market opportunity with the launch of a consumer-facing CGM, which could reach an entirely new population of 38.4 million people living with diabetes in the U.S. alone.

Libre Rio, one of Abbott's new systems, is designed for Type 2 diabetes patients who do not use insulin, while Lingo, the company's second system, is aimed at consumers looking to enhance their health and wellness.

Lingo users will wear a biosensor on their upper arm for 14 days at a time and track their glucose data within a coaching app on their phone. The company said that participants will receive customized coaching based on their data, which can help them "retrain their metabolism and improve their overall wellbeing."

Some companies, such as Signos, employ CGMs to aid individuals in losing weight and enhancing their metabolic health. However, users may require a valid CGM prescription to participate in these programs. Abbott's new over-the-counter product could make it more accessible for some consumers.

Libre Rio is Abbott's first over-the-counter diabetes management device available in the U.S., though other CGMs within its portfolio have been available without a prescription in other countries for over a decade. Libre Rio is designed for Type 2 patients who usually manage their diabetes with lifestyle modifications, the company said.

In March, Abbott's competitor, which also offers CGM systems, received FDA approval for its first-ever over-the-counter CGM.