Abbott Enters U.S. Consumer Biowearables Market With Lingo and Libre Rio

Recent FDA clearance of two new over-the-counter continuous glucose monitoring systems broadens Abbott’s leading position in biowearables.

Strategy and Strength|Jun.24, 2024

Abbott’s world-leading1 FreeStyle Libre portfolio of continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes2. And now the technology that powers the best-selling medical device in history will be available to U.S. consumers with and without diabetes through two over-the-counter CGM systems cleared by the FDA.

Lingo, our consumer biowearable first announced during Chairman and CEO Robert Ford’s keynote at CES, allows us to expand beyond diabetes care and enter a new market: consumers who are looking to improve their overall health and wellness. Unlike health- and fitness-focused wearable devices, Lingo truly monitors what’s happening inside your body via a tiny filament that rests just under the skin of the upper arm. The Lingo biosensor, which can be worn for 14 days, tracks blood glucose levels, while its accompanying app provides personalized, real-time insights and customized coaching to help people create healthy eating habits, retrain their metabolism and improve their overall well-being.

Lingo launched in the United Kingdom in early 2024, and we plan to make it available to U.S. consumers in the summer of 2024.

A Growing Libre Portfolio

The FDA also cleared Libre Rio, Abbott’s first over-the-counter CGM system for people with diabetes in the United States. Libre Rio is designed for people ages 18 years and older with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.

While FreeStyle Libre systems have been available over the counter in more than 50 countries over the past decade, they have been available only through prescription in the U.S. By removing the prescription requirement, Libre Rio may make it easier for Americans with diabetes to try a CGM and begin to see progress toward their health goals, empowering them with information to discuss with their healthcare provider at their next visit.

The Path to $10B

FDA clearance of Lingo and Libre Rio is one element of Abbott’s path to grow the Libre portfolio to $10 billion in annual revenue by 2028, which we plan to do by:

  • Expanding coverage by ensuring payers around the world recognize the value that Libre brings to patients, providers and healthcare systems.
  • Expanding connectivity by partnering with other companies, from insulin delivery device manufacturers to other health and wellness leaders, to drive the next wave of diabetes innovation.
  • Enhancing our existing offerings through ongoing improvements to the digital user experience and launching new features, such as our work to develop a sensor that monitors both glucose and ketone levels.
  • Expanding into new consumer segments, as with Lingo empowering healthy people to stay healthy and have a deeper understanding of their metabolism. 

References

1Data on file. Abbott Diabetes Care. Data based on the number of patients assigned to each manufacturer.

2 Data on file. Abbott Diabetes Care. 

Important safety information

FREESTYLE LIBRE SYSTEMS

Failure to use FreeStyle Libre systems as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose reading and alarms (if enabled) do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.

About Libre Rio:

Libre Rio is an over-the-counter integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons ages 18 and older. Failure to use Libre Rio as instructed in labeling may result in missing a severe low or high glucose event. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions.

About Lingo:

The Lingo Glucose System is intended for users 18 years and older not on insulin. It is NOT intended for diagnosis of diseases, including diabetes.  

The Lingo program does not guarantee that everyone will achieve the same results as individual responses may vary. Consult your healthcare professional before making changes to your diet or exercise regimen or if you have an eating disorder or a history of eating disorders.