FDA Approves Freestyle Libre Mobile App Enabling Users to Ditch Handheld Reader

Image: Freestyle Libre

The US Food and Drug Administration (FDA) approved a mobile app for use with the Freestyle Libre 10-day and 14-day CGM systems, allowing diabetics to monitor their glucose levels on their compatible iPhone devices, said a press release. The FDA clearance adds a long-awaited feature for users in the US that has been available for some time in Europe.

Related Senseonics Gets FDA Approval for Long-Term Implantable CGM Eversense

With the FreeStyle LibreLink app on their smartphone, users can scan their sensors and see their latest reading in real-time rather than requiring a separate, proprietary handheld reader. Users can also assess their 8-hour glucose history, and see a directional arrow indicating how their glucose is changing.

The data can also be sent to Libre View via the app. Libre View is a cloud-based service that records glucose readings for patients and their physicians to reference later. The reports visualize trends and patterns to help patients understand how well they are controlling their glucose.

The app supports 26 languages. Its other features are text-to-speech glucose readings, a larger, high-resolution display, and the ability to log smaller insulin doses (0.1 U vs. 0.5 U).

Freestyle Libre Mobile App
Image: Freestyle Libre

“We’re committed to liberating people from the many hassles of diabetes management through our life-changing technology and tools,” Jared Watkin, senior vice president of Diabetes Care at Abbott, said in the releasee. “The FreeStyle LibreLink app is a digital health tool that integrates glucose data directly on a compatible smartphone so all of the mobile apps that people use every day are in one convenient place. This is another step forward in making glucose monitoring seamlessly fit into a patient’s daily lifestyle – helping them live a fuller, healthier life.”

As Wearable Technologies reported last July, Abbott secured CE mark for Freestyle Libre 2 with optional real-time alarms.

FreeStyle LibreLink app will be free to download through the Apple App Store in the coming weeks, according to Abbott. Once available, patients will be able to pair the FreeStyle Libre or FreeStyle Libre 14-day sensors with the app. The Android version of the app is currently under development.

“[We’re] creating a whole ecosystem around Freestyle Libre,” Joel Goldsmith, Abbott’s senior director of digital platforms, told MobiHealthNews. “It starts with the sensor, which clearly is still the hero of the story. But now we’re layering on a set of digital health tools, we’re augmenting and expanding the capabilities of the sensor itself. And I think it’s safe to say we’re at the early stages of that happening.”