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FreeStyle Libre 2 App Receives Clearance from US FDA for Diabetes Management

Abbott announced the FDA's clearance of their FreeStyle Libre 2 iOS app, which the company suggests is the only sensor-based glucose monitoring app that allows users to check their glucose with a compatible iPhone every minute with optional real-time glucose alarms, in a release on Aug. 2.

This article was originally published on HCPLive.com.

The US Food and Drug Administration (FDA) has cleared the Freestyle Libre 2 iOS application for continuous glucose monitoring in patients with diabetes, providing a comprehensive digital offering for the FreeStyle Libre 2 integrated continuous glucose monitoring system, according to a press release from Abbott.

Approval allows patients 4 years old and older with diabetes to get glucose readings on their compatible smartphones without the use of a reader.


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.


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.