Abbott Gets CE Mark for New Glucose Monitoring System

Abbott has earned the CE mark for its Freestyle Libre Flash glucose monitoring system, a new glucose sensing technology for people with diabetes. The system purportedly eliminates the need for routine finger pricks, reading glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days. No finger prick calibration is needed with this system, a key differentiator from current continuous glucose monitoring systems. The system will be available in seven countries across Europe in the coming weeks.

The Freestyle Libre system consists of a small, round sensor—approximately the size of a quarter—worn on the back of the upper arm, which measures glucose every minute in interstitial fluid through a small (5 mm long, 0.4 mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad. A reader is scanned over the sensor to get a glucose result painlessly in less than one second. Scanning can take place while the sensor is under clothing2, making testing more discreet and convenient. Each scan displays a real-time glucose result, a historical trend and the direction the glucose is heading. The reader holds up to 90 days of data, providing a historical snapshot of glucose levels over time. The Freestyle Libre system software is designed for the data to be presented in a user-friendly, visual chart for both healthcare professionals and patients, driving a more productive discussion around treatment and any necessary modification.

“The Freestyle Libre System fulfills a major need for people living with diabetes,” said Robert Ford, senior vice president, Diabetes Care, Abbott. “Our customers told us that the pain, inconvenience and indiscretion of finger pricking were the key reasons they weren’t managing their diabetes as well as they should. Addressing these concerns has guided the development of FreeStyle Libre—a transformational product designed to not only remove the pain of finger pricking but also seamlessly integrate into their daily lives.”

According to the International Diabetes Federation, there are 382 million people globally living with diabetes, more than 56 million of whom live in Europe, and that number is projected to increase by more than 20 percent by the year 2035. The Freestyle Libre system is hoped to eliminate the challenges of routine glucose monitoring for people with diabetes, enabling them to maintain a better understanding of their glucose levels.

“For decades, people with diabetes have had to prick their fingers routinely to check their glucose levels,” said Cliff Bailey, professor of clinical science and director of biomedical sciences research at Aston University in Birmingham, England. “The pain and inconvenience of finger pricks has contributed to less frequent testing and suboptimal diabetes management. By eliminating the need for routine finger pricks, the Freestyle Libre system will significantly advance the field of glucose monitoring. It offers a convenient and painless way to get more frequent glucose readings, which should help to improve diabetes management.”

Abbott Laboratories is based outside Chicago, Ill., and Abbott Diabetes Care is based in Alameda, Calif.