Abbott’s FreeStyle Libre 2 CGM Awarded CE Mark

People living with diabetes in Europe will 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 today announced that it has secured CE mark (Conformité Européenne) for its FreeStyle Libre 2 system—the next generation of FreeStyle Libre, which safely and successfully replaces self-monitoring of blood glucose without the use of finger sticks² and now offers optional glucose alarms for patients who need them.
 
“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.”
 
How It Works: Alarm. Scan. Act.
Utilizing Bluetooth technology³, the FreeStyle Libre 2 system enables the feature of optional alarms. The FreeStyle Libre 2 system provides an easy-to-use alarm experience by offering customizable alarms for low glucose and high glucose, and a technical feature that notifies the user of signal loss (e.g., when the sensor is not communicating with the reader). In the event of these instances, the system will alert the user through sound or vibration (based on the user′s personal preference). The user continues to be able to scan their FreeStyle Libre 2 sensor as often as desired to see their glucose reading, trends and patterns, and eight-hour history.

Based on the information provided, the user can act upon this information to take appropriate action as needed when it comes to decisions around medication or diet. Those who do not want the alarms can choose to leave them turned off to avoid being disrupted by unwanted alarms.
 
The Importance of Optional Alarms 
“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.”
 
Dr. Kröger added, “FreeStyle Libre has transformed the lives of many of my patients in how they monitor their glucose levels, and now with the FreeStyle Libre 2 with optional glucose alarms even more patients can benefit from this revolutionary technology.”
 
Abbott′s FreeStyle Libre 2 system will be launched on a rolling basis throughout Europe, starting in the coming weeks. Abbott aims to make the FreeStyle Libre 2 system available in other countries outside of Europe, based on in-country approvals. The price of the FreeStyle Libre 2 system with additional features will be the same as the original FreeStyle Libre system.
 
The FreeStyle Libre system is the #1 sensor-based glucose monitoring system used worldwide⁴ now being used by more than 800,000 people across 44 countries.⁵ Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 31 countries, including France, Germany, Japan, the United Kingdom, and the U.S.
 
References
¹ Low glucose is defined as 140 mg/dL; ADA (American Diabetes Association), CDA (Canadian Diabetes Association) and EMA (European Medicines Agency) 
² A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycemia or impending hypoglycemia is reported by the System or when symptoms do not match the System readings 
³ FreeStyle Libre 2 system uses Bluetooth low energy 
⁴ Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre system compared to the number of users for other leading personal use sensor-based glucose monitoring systems 
⁵ Data on file, Abbott Diabetes Care