Abbott’s FreeStyle Libre Gains CE Mark In Europe
The perks of a fingerprick-free life just added a new dimension for those in Europe living with T1D.
Earlier this month, Abbott announced that its FreeStyle Libre 2 system had secured CE Mark clearance in the European Union. The system will be launched on a rolling basis throughout Europe, starting in the coming weeks, according to the company.
Offering new, customizable high and low BGL alerts, the FreeStyle Libre 2 builds on the relatively groundbreaking advances that were offered by the original FreeStyle Libre, mainly the ability to read and continuously monitor BGLs without using fingerstick tests. The Libre, which had been available in Europe since 2014 and received U.S. FDA approval in the fall of 2017, became the latest in the long line of diabetes tech touted as “life changing.” With an overwhelmingly positive response from users, it has turned out to be one of the few such devices that lives up to the hype.
The original Libre was the first approved blood glucose monitoring device that didn’t require require fingerstick tests at all, not even for calibration. The device instead came factory-calibrated. While there are slight differences between the U.S. and European model, at its core the system consists of a round, quarter-sized replaceable sensor worn on the back of the upper arm for up to 14 days and a thin, pocket-sized reader. A small wire comes off the sensor and is inserted into the skin. When a user swipes the reader over the censor, a glucose reading is produced along with trend data.
The FreeStyle 2 has sought to improve the original design by adding several optional glucose alarms for patients who need them.
According to Abbot, the FreeStyle Libre 2 provides an easy-to-use alarm experience by offering customizable alarms for low glucose and high glucose levels. The device uses Bluetooth technology to enable the optional alarms. It also offers a new safety feature that notifies the user of signal loss in the event that the sensor stops communicating with the reader for some reason. In those instances, the system will notify a user of the dropped connection through a sound or vibration alert (you pick your preference).
“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 for Diabetes Care at Abbott in a press release. “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.”
Like with the initial Libre, Libre 2 users are still able to scan their sensor as often as desired to see their glucose reading, trends and patterns, and access an eight-hour history.
The idea is that based on the scanned BGL trend information and the data provided by alerts, a user can act more quickly and with more information to take appropriate action to modify insulin dosing or dietary elements.
Those who do not want the alarms can choose to leave them off to avoid unwanted disruptions.
“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., a 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.”
Abbott said it hopes to make the FreeStyle Libre 2 system available in other countries outside of Europe in the near future based on the approval process country-by-country. It has also said the FreeStyle Libre 2 system with additional features will be the same price as the original FreeStyle Libre system.
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