With new FDA clearance, Abbott Freestyle Libre users can ditch handheld readers for an app

The clearance brings US readers a feature long available in Europe, and paves the way for data plays.
By Jonah Comstock
09:34 am

Just a short while after securing a CE Mark for its second generation device, Abbott has been granted FDA clearance for FreeStyle LibreLink, a companion mobile app for its 10 to 14-day CGM.

The launch adds a long-awaited feature for US users that’s been available for some time in Europe: users will be able to scan their sensors with an app on their smartphone — and see their latest reading — rather than requiring a separate, proprietary handheld reader (although the reader will still be an option for those that prefer it).

The app will also be able to send data to Libre View, a cloud-based service that records glucose readings for patients and their physicians to reference later.

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Other features of the app include text-to-speech glucose readings, the ability to log smaller insulin doses, and support for 26 languages.

Why it matters

The feature might appear on the surface as merely a convenience play: users are more likely to have their phone on them in any given circumstance and the phone allows them to check glucose more discreetly.

But the connectivity play may prove to be more significant, Joel Goldsmith, Abbott’s senior director of digital platforms, told MobiHealthNews.

“It’s a connected device which means the data is being uploaded automatically into LibreView, which obviates the need to download that data manually from a Freestyle Libre reader, which does have a USB port,” he said. “So you can upload the data from the reader into LibreView if you choose, but that requires you to do something or the clinician to do something. Which, in an office visit that might only last 10 minutes, is one more thing for the physician or the clinical staff to deal with during that short-lived encounter.”

Having the data in the phone by default makes it much easier for patients to track trends and for the LibreLink app to integrate with other apps.

What’s the trend

Freestyle Libre is emblematic of a trend in diabetes management. As CGMs get smaller, cheaper, and easier to use, the once vast gulf between glucometer-based diabetes management for mostly Type 2 patients and CGM-based monitoring for mostly Type 1 patients is narrowing.

Competitors like Senseonics Eversense and Dexcom’s forthcoming collaboration with Verily promise ever-shrinking sensors and lengthening wear times, but Abbott has a strong foothold in the market with its unique Libre product.

This announcement comes on the heels of Abbott securing CE Mark clearance for it’s second generation version of Libre, now available in Europe.

On the record

“[We’re] creating a whole ecosystem around Freestyle Libre,” Goldsmith said. “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.”


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