FDA Clears Abbott Continuous Glucose Monitors for OTC Use

Abbott is one of several firms targeting wellness enthusiasts with a CGM that can be used by non-diabetics to track metabolic health

The United States Food and Drug Administration (FDA) has given Abbott clearance for two new over-the-counter continuous glucose monitoring (CGM) systems, including one that can be used by non-diabetics without a prescription.

Both wearables are based on the medical device and healthcare company’s FreeStyle Libre CGM technology, which roughly six million people use.

Abbott’s two CGM systems — Lingo and Libre Rio — are intended for two separate consumers. Lingo is designed for wellness seekers who want to understand how lifestyle choices can impact their health, whereas Libre Rio is for adults with Type 2 diabetes who don’t use insulin and manage their condition through lifestyle modifications.

“People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider,” explained Lisa Earnhardt, executive vice president and group president of Abbott’s medical devices division. “People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes.”

The Lingo system, worn on the upper arm for 14 days, tracks glucose and sends data to a coaching app, so the biowearable user can see what part food, exercise and daily stress can play in their health. The system also offers personalized insights and coaching to help users create healthy habits and “retrain” their metabolism. A waitlist has been created for interested users.

“Research has shown that overall lower glucose exposure in the general population is associated with reduced long-term risk (of) developing cardiovascular disease, diabetes, Alzheimer’s and certain cancers,” said cardiologist and medical director of El Camino Health Heart and Vascular Institute Fred St. Goar. “Making continuous glucose monitors widely available will undoubtedly have a dramatic effect on the overall health and well-being of the broader population.”

The Libre Rio, for adults with Type 2 diabetes who don’t require insulin, is placed on the back of the arm and measures extremely low or high glucose events, with a measurement range of 40-400 mg/dL.

CGM Space Attracts Investors

The stage has been set for CGMs to become the next wearable.

Earlier this year, the FDA also gave the green light to Dexcom , providing clearance for its over-the-counter CGM, Stelo Glucose Biosensor, which will be available to purchase online without a prescription this summer. Dexcom’s device is suited for those who don’t use insulin and either treat diabetes with oral medications or are just interested in seeing how diet and exercise impact their blood sugar levels.

Samsung executive Hon Pak told Bloomberg earlier this year that the company is also entering the glucose and continuous blood pressure monitoring game and is making a “significant investment” in health monitoring. While Pak didn’t provide a timeline, he indicated to the publication that he hopes noninvasive glucose monitoring could come to fruition within five years.

Last month, California-based Allez Health raised $60 million to expand manufacturing operations and prepare for tails and regulatory approval filings for a CGM biosensor platform that’s designed to be affordable.

Biolinq, another California-based company, has recently closed a $58 million financing round for its upper-arm wearable with tiny sensors that measure glucose just beneath the skin’s surface. The company plans to seek FDA approval for its device, which uses a color-changing interface (as opposed to an app) so users can quickly glance at the sensor and glean insight into their glucose levels.

Are Wearables the Future of Healthcare?

According to Future of Health webinar participant Neal Batra of Deloitte Consulting, who participated alongside an investment banking leader and the CEO of a medical device manufacturer, the cost of healthcare in the U.S. is “unsustainable” and is “generating worse outcomes” than other countries.

Batra also referenced the consumer-focused tech firms that are investing in health-supporting devices, which could steer consumers toward better health behaviors.

“We all agreed that transformation in healthcare is an inevitability,” he said. “Timing is the only real question. Device manufacturers, healthcare organizations, clinicians and investors may not want to take a wait-and-see approach. The Future of Health is coming, and it appears to be coming faster than we originally predicted.”

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