Abbott secures CE-Mark for real-time glucose monitoring device

29 September 2020 (Last Updated September 29th, 2020 17:21)

Abbott has received CE Mark approval for its FreeStyle Libre 3 system for people living with diabetes in Europe.

Abbott secures CE-Mark for real-time glucose monitoring device
Abbott’s next-generation FreeStyle Libre 3 system was developed for people with diabetes. Credit: Abbott.

Abbott has received CE Mark approval for its FreeStyle Libre 3 system for people living with diabetes in Europe.

The system offers real-time glucose readings automatically and continuously while the FreeStyle Libre 3 mobile app enables users to view their real-time glucose levels, glucose history and trend arrows, indicating changes in their glucose levels.

Additionally, the FreeStyle Libre 3 system features a self-applied CGM sensor and offers 14-day wear-time.

The sensor can be easily applied with a one-piece applicator and can be worn on the back of the upper arm, unlike usual glucose monitors that need to be worn on the fingertip.

Abbott Diabetes Care senior vice-president Jared Watkin said: “Abbott won’t stop innovating when there’s room to raise the bar. We’ve done that again with FreeStyle Libre 3, the smallest sensor that delivers life-changing benefits and best-in-class accuracy.

“People living with diabetes are at the centre of our design process, and we made our next-generation technology even more discreet for a better user experience to make managing diabetes as easy and seamless as possible.”

The company said it has priced the new FreeStyle Libre 3 system the same as previous generations of the device to enable people living with diabetes to access and benefit from the significant technological advancements.

Watkin said: “Since we launched the first disposable glucose sensor in 2014, we’ve always believed all people with diabetes should have access to high-quality, accurate and affordable diabetes technologies.

“That’s why Abbott disrupted the traditional notion that CGMs have to sacrifice quality or accuracy for affordability, and we built our FreeStyle Libre family of products to deliver unparalleled results at a lower cost than any other CGM available.”

Abbott’s FreeStyle Libre portfolio is clinically proven to improve glucose control, increase time in target glucose range, decrease time in high glucose levels and low glucose levels, as well as reduce HbA1c and average glucose levels over a three-month period.

Moreover, the data also shows that the use of the FreeStyle Libre system reduces the number of diabetes-related hospital admissions and work absentee rates.

The FreeStyle Libre 3 system will be available in Europe in the next few months.

Last week, Abbott received CE Mark for fourth-generation MitraClip Transcatheter Mitral Valve Repair System, its latest minimally invasive mitral valve repair device.