FDA Approves Abbott's Over-the-Counter Injectible Sensors That Can Monitor Glucose Levels in Real-Time

By Thea Felicity

Jun 10, 2024 11:56 AM EDT

Robert Ford, chairman and chief executive officer of Abbott Laboratories, unveils a portfolio of Lingo biosensors for health monitoring during the company's keynote at the Consumer Electronics Show (CES) on January 6, 2022 in Las Vegas, Nevada.
(Photo : PATRICK T. FALLON/AFP via Getty Images)

On Monday, June 10, Abbott Laboratories announced that it received FDA clearance for two new continuous glucose monitoring systems. Abbott designed these devices, which will be available over the counter without a prescription. 

Continuous glucose monitors (CGMs) are compact sensors that pierce the skin. They provide real-time tracking of glucose levels and are primarily used to assist individuals with diabetes. 

On a larger scale, this development's importance lies in its potential to reach a broader population beyond traditional diabetes patients. 

Abbott's latest offerings, Libre Rio and Lingo, cater to distinct demographics. 

While Libre Rio targets Type 2 diabetes patients who do not require insulin, Lingo is tailored for consumers striving to enhance their overall health and wellness.

With this advancement, users of the Lingo system can wear a biosensor on their upper arm for 14-day intervals, accessing personalized coaching via a mobile app to optimize metabolic health. 

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Abbott's Over-the-Counter CGM

According to CNBC, Abbott's move to introduce over-the-counter CGMs is a major shift in accessibility, potentially benefitting consumers seeking innovative health technologies. 

Besides, Abbott's initiative also fits the competitive market trend, where other companies, like Signos, use CGMs to help with weight loss and metabolic health. While Libre Rio marks Abbott's inaugural over-the-counter offering for diabetes patients in the U.S., the company already has a history of providing CGMs without prescriptions in other countries over the past decade.

However, leadership in the industry will hinge on how well their over-the-counter CGMs perform.

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