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August 3, 2021updated 01 Nov 2021 8:47am

US FDA approves Abbott’s app for diabetes management

The FreeStyle Libre 2 iOS app is designed to facilitate remote monitoring, real-time alerts and data sharing.

The US Food and Drug Administration (FDA) has approved the Abbott FreeStyle Libre 2 iOS application for checking glucose levels to manage diabetes.

The accessible and cost-effective sensor-based glucose monitoring app permits customers to read their glucose levels on compatible iPhones without requiring a reader.

It facilitates a complete digital offering for Abbott’s FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system.

Indicated for use in adults, as well as children aged four years and above with diabetes, the new app can offer customised glucose data every minute for those who are using FreeStyle Libre 2 glucose sensors.

Users can scan the sensor with the app to access the present glucose reading and trend arrow, which provides an understanding of the impact food, exercise and other lifestyle factors can have on their diabetes.

The FreeStyle Libre app, through the LibreLinkUp app, can help caregivers monitor patients remotely and receive alarms in real-time. The LibreLinkUp app also enables easy sharing of glucose data obtained with the new app.

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Abbott diabetes care senior vice-president Jared Watkin said: “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.

“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.”

The new app offers optional glucose alarms in real-time, to warn users when glucose levels rise or drop.

Furthermore, with every-minute readings and an eight-hour glucose history, including a complete view of trends, the app has a precision of 14 days.

Apart from the LibreLinkUp app, the FreeStyle Libre 2 iOS app can be connected to Abbott’s Cloud-based data management platform, LibreView.

Abbott noted that the FreeStyle Libre 2 has a wear time of 14 days, making it the longest-lasting iCGM sensor presently available in the market.

Last month, Abbott unveiled its new insertable cardiac monitor, Jot Dx, in the US to enhance precise diagnosis of hard to detect abnormal heart rhythms and lower data burden.

Separately, Abbott Laboratories has agreed to pay $160m to settle claims against two of its units, Arriva Medical and Alere, for violating the False Claims Act.

In September 2017, Abbott acquired Arriva and its parent company, Alere.

The US Department of Justice alleged that Arriva and Alere submitted false claims to Medicare by providing kickbacks to Medicare beneficiaries, ineligible patients, or those who were deceased.

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