Abbott Gets FDA Clearance for Two Over-the-Counter CGMs


Abbott Laboratories announced on June 10, 2024 that two new over-the-counter (OTC) continuous glucose monitoring (CGM) devices had received FDA clearance.

These two devices—one aimed at health-conscious consumers and the other at people with diabetes—are modeled after the company’s FreeStyle Libre, which sells for over $1 billion annually and is available on prescription for people with diabetes.

What is Libre Rio?

Libre Rio, a new over-the-counter CGM, is intended for people ages 18 and older with type 2 diabetes who do not take insulin and who usually control their condition by changing their lifestyle modifications.

Libre Rio is the first over-the-counter CGM system with a measurement range of 40-400 mg/dL, allowing for measurement of extremely low or high blood-sugar events.

According to RBC Capital Markets analyst Shagun Singh, 24.5 million people with type 2 diabetes who do not take insulin now have access to a CGM thanks to the FDA’s approval of Libre Rio.

What is Lingo?

For those without diabetes who wish to enhance their health and wellness, Lingo is an over-the-counter CGM.

Lingo is designed for consumers 18 years of age and older who are looking to improve their overall health and wellness.

Lingo will assist with blood-sugar monitoring and can assist you in comprehending the real-time effects of various eating habits, exercise, sleep, and stress on blood sugar levels.

For two weeks, the upper arm-worn Lingo sensor continuously transmits glucose readings to a smartphone coaching app.

Libre Rio and Lingo will compete with Dexcom’s Stelo, which in March 2024 became the first continuous glucose monitor to be approved by the FDA for OTC sales.

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WRITTEN BY Daniel Trecroci, POSTED 06/11/24, UPDATED 06/11/24

Dan has written about diabetes for more than 20 years. He was one of Diabetes Health's first recruits, and throughout his 10 + years as Managing Editor he wrote/published thousands of articles and helped establish Diabetes Health as the premiere resource for people with diabetes. He later became the Content Manager for OneTouchGold—Johnson & Johnson/LifeScan’s official digital publication for its metering-technology customers. Under his leadership, OneTouchGold received the Web Marketing Association’s award for “Best Health & Wellness" web site. Dan has also written for the Diabetes Research Institute, dLife, diaTribe, Healthline, CareDx, Pendulum Therapeutics, and Hero Bread.