Abbott’s FreeStyle Libre 2 App Receives FDA Clearance


Editor’s Note: As of November 23, 2021 the FDA has now cleared the FreeStyle Libre 2 app for Android use in the United States as well. 

On Aug 2, 2021, Abbott announced the approval of the Abbott FreeStye Libre 2 iOS App from the U.S. Food and Drug Administration. This clearance follows the FDA approval of the FreeStyle Libre 2 system on June 15, 2020.

The app is approved for adults and children, 4 years and older, with diabetes. Users of the app can access blood glucose readings directly from their iPhones without using the reader and the app is compatible with the FreeStyle Libre 2, a 14-day CGM system that transmits data every minute with customizable high and low alerts.

“The demands of living with diabetes can be overwhelming and there’s a critical need to improve the way people with diabetes manage their condition–easily, affordably, accurately–and in a way that seamlessly fits into their everyday lives,” Jared Watkin, senior vice president of Abbott said in a press release.

One notable benefit is the app’s ability for caregivers of individuals with diabetes to remotely monitor their loved one’s blood glucose levels and get real time alarms using the LibreLinkUp app.

“The pandemic taught us the importance of connected devices in managing chronic conditions remotely, and we continue to see the benefit from the latest advances in digital health,” Kurt Midyett, MD, pediatric endocrinologist and medical director at Midwest Pediatric Specialists, said in a press release.

According to a Gallup Poll, one in five Americans utilize mobile apps to track their health statistics, underscoring the importance of mobile applications for health monitoring and diabetes management.

The LibreLink App has long been available for the previous generation (FreeStyle Libre 14-Day) system, adding convenience for the user who does not want to carry around an additional device. The approval of the FreeStyle Libre 2 app has been highly anticipated and is likely to lead to an uptick in adoption of the device, as it will eliminate the need to carry a glucose reader.

Both systems allow users to scan their glucose readings anytime and the sensors can be worn for up to 14 days.

“The FreeStyle Libre 2 iOS app streamlines how people manage their diabetes on their iPhones–empowering users with the information they need 24/7 while improving their health on the go,” said Watkin.

The app is now free to download on the App Store soon and allows users to use their current blood glucose readings to inform their food intake, exercise and other lifestyle factors that impact their diabetes.

This content mentions Abbott, an active partner of Beyond Type 1 at the time of publication.

News coverage by the Beyond Type 1 team is operated independently from any content partnerships. Beyond Type 1 maintains full editorial control of all content published on our platforms.

WRITTEN BY Kayla Hui, MPH, POSTED 08/02/21, UPDATED 12/05/22

Kayla Hui is the health reporter for Beyond Type 1 covering diabetes, chronic illnesses and health inequities. She received her Masters in Public Health from the Boston University School of Public Health. Kayla won a Pulitzer Center fellowship and Slants Foundation award in 2020 for her project on the mental health of Chinese immigrant truck drivers. Her published work can be found at Healthline, Verywell Health, Pulitzer Center and more. Outside of work, Kayla enjoys rock climbing, baking and buying plants she doesn’t need. You can follow Kayla on Twitter at @kaylanhui.