Abbott receives CE Mark for smallest real-time Glucose Monitoring Sensor

Abbott, a global leader in continuous glucose monitoring (CGM) technology, announced it has been awarded CE Mark (Conformité Européenne) for its next-generation FreeStyle Libre 3 system, which is now officially licensed for use by people living with diabetes in Europe.

The smallest, real-time glucose monitoring sensor (GCM) – FreeStyle Libre 3

The FreeStyle Libre 3 technology provides continuous, real-time glucose readings automatically delivered to smartphones every minute, offering unsurpassed 14-day accuracy in the smallest and thinnest sensor design at the same affordable price as previous versions of the device.

Jared Watkin, senior vice president, Diabetes Care, Abbott 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 center 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.”

No more fingersticks

The FreeStyle Libre 3 system integrates the longest-lasting, self-applied CGM sensor available with 14-day wear time. With a one-piece applicator, the sensor is easy to add and is positioned on the back of the upper arm, eliminating the need for uncomfortable fingersticks to display glucose levels.

Abbott’s FreeStyle Libre 3 device will be priced the same as the previous model in order to enable as many people living with diabetes as possible to access and benefit from the major developments in technology.

VP Watkin added:

“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.”

Real-time glucose levels at a glance

The FreeStyle Libre 3 system blends into the lives of people with diabetes smoothly. The device includes the FreeStyle Libre 3 mobile app, in addition to the sensor, which is intended to allow users to monitor and display their real-time glucose levels, glucose history, and pattern arrows that demonstrate how their glucose varies with just a glance on their smartphone. With a simpler and more discreet sensor, Abbott developed the next-generation FreeStyle Libre 3 device to be more environmentally friendly, decreasing the overall volume by more than 70 percent. With a 41 percent reduction in plastic usage and 43 percent reduction in carton paper, the latest sensor configuration aligns with Abbott’s continuing commitment to sustainability.

Abbott will be introducing the FreeStyle Libre 3 system in Europe over the coming months. Clinically, the FreeStyle Libre portfolio has been proven to boost glucose control, increase time in the target glucose range, decrease time in hyperglycemia (high glucose levels) and hypoglycemia (low glucose levels), and lower HbA1c (average glucose levels over a three-month period) – all factors contributing to better health outcomes.

Data also suggest the use of the FreeStyle Libre system decreases diabetes-related hospital visits and job absentee rates to help boost quality of life.

As the #1 sensor-based glucose tracking device used in the U.S. and worldwide, Abbott’s FreeStyle Libre portfolio has transformed the lives of more than 2 million people in more than 50 countries by delivering open and affordable revolutionary technology. In 37 nations, including Canada, France, Germ Libre, Abbott has secured partial or complete reimbursement for the FreeStyle Libre product.

About Abbott

Abbott is a world pioneer in healthcare that lets individuals at all levels of life live more fully. With leading players and brands in diagnostics, medical equipment, wellness and licensed generic drugs, our range of life-changing innovations covers the breadth of healthcare. In more than 160 nations, our 107,000 coworkers represent individuals.


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