Abbott receives FDA approval for two over-the-counter diabetes trackers

Abbott Laboratories said Monday that the U.S. Food and Drug Administration has offered for sale two new over-the-counter continuous glucose monitoring systems, devices that could provide greater access to millions of people with diabetes.

Abbott said its Lingo device is designed for general consumers who want to improve their overall health and well-being, while the other FDA-approved device, known as Rio, is intended for adults with type 2 diabetes who do not use insulin and their diabetes typically manage through lifestyle changes. In the US alone, there are more than 38 million Americans with diabetes.

“There is no one-size-fits-all approach to glucose monitoring. That’s why we’ve designed different products for different people – all based on the same industry-leading biowearable technology,” said Lisa Earnhardt, executive vice president and group president. of Abbott’s medical devices division. “People with diabetes need certain features, such as tracking medications or sharing data with a healthcare provider. People without diabetes need several features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes.”

The approvals come as Abbott, which already has a best-selling continuous glucose monitor for diabetes management known as Libre, which generates more than $5 billion in annual sales, is developing a new line of biowearables, including Lingo and Rio, which measure glucose levels, ketones and give milk.

This new category of consumer biowearables, which bond under the skin to provide more accurate and accurate data about what’s happening inside a person’s body, is the latest evolution in medical devices for Abbott. The healthcare company is already known for its nutritional franchise led by Similac baby food, established pharmaceuticals and diagnostic tests for everything from the HIV virus and cancer to its best-selling range of tests for Covid viruses and their latest variants.

Robert Ford, CEO of Abbott, opened a window on the company’s efforts to commercialize biowearables during a keynote address last year at the HLTH conference in Las Vegas.

“We’re creating a new consumer biowearable that not only tracks your glucose levels, but uses AI to deliver a personalized coaching plan to help you develop healthier habits and motivate you to do the hardest thing: adjust and adapt your behavior and habits. ‘, said Abbott CEO Robert Ford at HLTH 2023.

Ford highlighted the differences between Lingo and the company’s already best-selling Libre franchise.

“Lingo starts by establishing a baseline measurement of your body’s glucose levels and their fluctuations through the sensor worn on your arm,” said Ford at HLTH. “The technology assesses how your diet, exercise, sleep and other factors affect your glucose. And that is unique for every person.”

A “coaching algorithm” shows the patient or user where they can improve, providing recommendations and an individualized action plan for their ongoing healthcare decision-making.

“The core of this coaching is something we call the ‘Lingo Count,’” Ford said. “The Lingo biosensor tracks your glucose levels in real time and assigns a value to each glucose peak. The more you peak, the more Lingo counts you collect. And your goal every day is not to exceed your daily Lingo Count.”

At HLTH, Ford emphasized that biowearables like Lingo have the potential to be more than just devices for people with diabetes. Abbott highlights the long-term potential of “the convergence of health and technology” beyond the already gigantic diabetes market.

“We believe that access to this kind of knowledge will motivate us to take action – to make better decisions in the best interests of our health and well-being,” Ford said last fall. “And if we can make the experience intuitive – even enjoyable and satisfying – we can help influence behavior change and create healthier people and societies.”