Abbott claims FDA clearances for pair of over-the-counter diabetes trackers

Abbott’s diabetes division thought joining the over-the-counter market looked so nice they did it twice. The company has collected FDA clearances for two separate continuous glucose monitoring systems, the Libre Rio and the Lingo. 

Both are built off Abbott’s mainstay wearable CGM, the FreeStyle Libre. While the Libre Rio is designed for adults with Type 2 diabetes who are not taking insulin—but who may be taking medications such as GLP-1s—the Lingo carries a more general “health and wellness” focus, aimed at providing blood sugar data to the curious consumer.

“There is no one-size-fits-all approach for glucose monitoring, which is why we’ve designed different products for different people—all based on the same world-leading biowearable technology,” Lisa Earnhardt, president of Abbott's medical device group, said in a statement

Both systems are worn on the upper arm and can be linked to a smartphone app; the Libre Rio is rated for 15 days of use, and the Lingo for 14.

“People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider. People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes,” Earnhardt said.

This year saw the FDA clear its first over-the-counter CGM, with a green light for Dexcom’s Stelo sensor in early March. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients,” the agency’s device center director, Jeff Shuren, said in a statement at the time. 

Dexcom has estimated that the number of people in the U.S. with Type 2 diabetes that don’t need insulin—plus those who may simply want to better understand the effects of diet and exercise—may reach as high as 25 million.

And while Abbott’s current FreeStyle Libre systems for Type 1, Type 2 and gestational diabetes require a prescription in the U.S.—though they can be purchased over-the-counter internationally—the company said it believes the availability of a system like the Libre Rio will make it easier to try out a CGM for the first time.

At the same time, wearable blood sugar trackers have been popping up on the shelves of new sellers, such as tech big-box Best Buy, as medtech companies begin to expand into new retail channels and strategies.