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FDA Clears Abbott’s New Glucose Monitors for Over-the-Counter Sales

ByHuey Yee Ong

Jun 16, 2024

FDA Clears Abbott’s New Glucose Monitors for Over-the-Counter Sales

Abbott Laboratories has received clearance from the U.S. Food and Drug Administration (FDA) to market two new continuous glucose monitoring (CGM) systems, the Libre Rio and Lingo, available over the counter without a prescription.

This approval introduces significant advancements in glucose monitoring technology accessible to the general public, including non-diabetic individuals seeking to improve their health and wellness.

How Do Continuous Glucose Monitors Work?

Continuous glucose monitors are small sensors that penetrate the skin to track glucose levels continuously. These devices wirelessly transmit data to a smartphone, providing real-time glucose readings. Traditionally used by diabetes patients to monitor their glucose levels, CGMs help in alerting not only the users but also their families and healthcare providers to potential health emergencies.

The Libre Rio system is specifically designed for individuals with Type 2 diabetes who do not use insulin in their treatment regime. This system is aimed at those who manage their diabetes primarily through lifestyle modifications. Libre Rio represents Abbott’s first over-the-counter CGM product for diabetics in the U.S., although the company has been marketing similar non-prescription CGMs in various other countries for the past decade.

On the other hand, the Lingo system is designed for a general consumer base interested in wellness and health optimization. Users of Lingo wear a biosensor on their upper arm for 14 days, during which they can monitor their glucose data through a specialized coaching app on their smartphones. The app provides personalized coaching, offering advice tailored to the user’s data to help retrain their metabolism and enhance overall well-being.

Impact on the CGM Market

The market potential for these new products is considerable, given Abbott’s report that its existing CGMs are already in use by around 6 million patients across 60 countries. With an estimated 38.4 million people in the U.S. alone living with diabetes, the introduction of a consumer-facing, over-the-counter CGM could significantly expand Abbott’s market reach.

Moreover, these devices could potentially make glucose monitoring more accessible to the general population, which includes people participating in wellness programs like those offered by companies such as Signos, which typically require a prescription for CGM use.

This approval comes shortly after a similar market move by Abbott’s competitor, Dexcom, which also received FDA approval for its first over-the-counter CGM system in March.


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Featured Image courtesy of Isaac Owens on Unsplash

Huey Yee Ong

Hello, from one tech geek to another. Not your beloved TechCrunch writer, but a writer with an avid interest in the fast-paced tech scenes and all the latest tech mojo. I bring with me a unique take towards tech with a honed applied psychology perspective to make tech news digestible. In other words, I deliver tech news that is easy to read.

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