Abbott Secures CE Mark for Freestyle Libre 2 with Optional Real-Time Alarms

By October 10, 2018wearable

About 60 million people with diabetes in the European Region now have the choice to be alerted in real-time of hypoglycemia (low glucose levels1) or hyperglycemia (high glucose levels1) through the FreeStyle® Libre 2 system, a continuous glucose monitoring system (CGM). Abbott Laboratories has secured CE Mark (Conformité Européenne) for its next-gen FreeStyle Libre 2 system, which successfully replaces self-monitoring of blood glucose without the use of finger sticks2 and now offers optional glucose alarms for patients who need them.

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Abbott will be gradually rolling out the device in Europe starting in the next few weeks, and it will be offered as the same price as the first-generation device.

“The FreeStyle Libre 2 system is designed to further empower people with diabetes by providing a choice about how they want to use alarms—which can be a valuable feature for a specific group of people managing their diabetes,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “We′re committed to developing the latest health technology to help people lead fuller lives. Our goal is to make FreeStyle Libre widely accessible, which includes offering additional features at no additional cost to our customers.”

Using Bluetooth technology3, the FreeStyle Libre 2 system provides an easy-to-use customizable alarm system for hypoglycemia and hyperglycemia, and a technical feature that notifies the user of signal loss (e.g., when the sensor is not communicating with the reader). In these instances, the user will be notified through sound or vibration. The users are still able to scan their FreeStyle Libre 2 sensor as often as desired to see their glucose reading, trends and patterns, and eight-hour history.

Abbott freestyle libre 2
Image: Abbott

“Enabling patients to have optional alarms with the FreeStyle Libre 2 system provides them with even more freedom in managing their condition,” said Jens Kröger, M.D., specialist of Internal Medicine and Diabetology at the Center of Diabetology Bergedorf in Hamburg, Germany, and chairman of diabetesDE. “For some patients who are unaware of the hypoglycemia episodes they may be experiencing — especially during sleep — having alarms can be important. Or, for the parents of children with diabetes, alarms can provide peace of mind.”

Critics have hailed the Freestyle Libre as a revelation for diabetics because it gives them some of the same benefits as a Continuous Glucose Monitoring, but is less intrusive, smaller and less expensive. However, it still lacks some functionalities when compared with CGMs from Dexcom and Medtronic. Update should make Libre even more competitive with other CGMs.

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The FreeStyle Libre system is the No. 1 sensor-based glucose monitoring system used worldwide, and is currently being used by more than 800,000 people across 44 countries. Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 31 countries, including France, Germany, Japan, the United Kingdom, and the United State.