Abbott's FreeStyle Libre 2 glucose-monitoring system, which comes with optional real-time alarms for high and low glucose levels, has been granted today a CE Mark for use in European Union countries.
The FreeStyle Libre continuously measures glucose levels with a small sensor worn on the back of the upper arm for 14 days and provides glucose readings via a scanner that the user waves over, and is therefore sometimes referred to as "flash" glucose monitoring. Fingerstick readings aren't required for calibration or making treatment decisions.
The original FreeStyle Libre was approved in the European Union in 2014 and in the United States in 2017. It is less expensive than other continuous glucose monitors and is used widely in Europe. But in the United States, the lack of alarms has been viewed by some as a disadvantage for patients with type 1 diabetes.
With Libre 2, patients can choose to customize either audible or vibration alarms for low and high glucose values as well as a signal loss. Those who don't want the alarms can choose to leave them turned off.
In an Abbott statement, Jens Kröger, MD, of the Center of Diabetology Bergedorf, Hamburg, Germany, explains, "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."
"However," he adds, "some of my patients experience 'alarm fatigue' with other traditional continuous glucose-monitoring devices because they may not have the option to turn off some alarms."
The Libre 2 will be launched on a rolling basis throughout the European Union in the coming weeks. Abbott also expects to make the system available in other countries, including the United States, but no timetable is yetavailable.
The new version will be sold at the same price as the original FreeStyle Libre system.
Kommentar www red DiabetologNytt
På EASD idag gavs också besked om att Libre är godkänd nu också för gravida kvinnor med diabetes dvs det finns tillräckliga med studier för detta godkännande.
Precisionen har också generellt förbättrats med MARD Mean Absolute Relative Difference på 9.5 proc för vuxna och 9.4 proc för barn
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