FDA Clears Freestyle Libre 2 iOS App For Diabetes Management

The US Food and Drug Administration (FDA) has cleared the Freestyle Libre 2 iOS application for continuous glucose monitoring in patients with diabetes.

The clearance for the Freestyle Libre 2 integrated system was granted to Abbott.

Its approval will allow patients ≥4 years old with diabetes to get glucose readings on their compatible smartphones without the use of a reader.

App

The app is designed to deliver personalized, up-to-the-minute glucose data for diabetes management in patients who are utilizing Freestyle Libre 2 glucose sensors.

After scanning the sensor with the Freestyle Libre 2 app, patients will receive their current glucose reading and trend arrow to help determine the impact of food, exercise, and lifestyle factors on diabetes management.

The Freestyle Libre 2 has a 14-day wear time and is accessible at pharmacies.

Other features include optional real-time glucose alarms to alert users of their glucose level, an 8-hour glucose history with trends, and integration with digital health tools to allow users to share their glucose readings with healthcare professionals.

Reaction

Jared Watkin, senior vice president, Diabetes Care, Abbott, said in a statement that the app will streamline how people manage their diabetes to empower users with accessible information on the go.

"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," Watkin said.

Kurt Midyett, MD, pediatric endocrinologist and medical director at Midwest Pediatric Specialists, noted in the same statement the importance of connected devices in managing chronic conditions remotely, particularly during the COVID-19 pandemic.

"Continuous glucose monitoring is one of the most significant health tech innovations in the last decade, and I see the life-changing benefits first-hand from my patients every day,” Midyett said. “As a doctor, it's invaluable to receive my patients' glucose data remotely via systems like LibreView – enabling more meaningful conversations with my patients, and ultimately, improving treatment decisions and their long-term health."

The iOS app will be available in the US to download for free in the App Store.