Abbott FreeStyle Libre 3 CGM System

 

What is the FreeStyle Libre 3 system?

The FreeStyle Libre 3 System is a continuous glucose monitoring system that sends glucose readings every minute directly to the patient's smartphone. It is the most accurate 14-day CGM system. It is the world’s smallest, thinnest, and most discreet sensor.

Is FreeStyle Libre 3 system an iCGM class system?

Yes. The FDA has cleared the FreeStyle Libre 3 System as an iCGM or integrated continuous glucose monitoring device. FreeStyle Libre 3 meets the accuracy and performance requirements for the iCGM designation, including unsurpassed 14 day accuracy for adults and children (age 4 and older).  For more information on iCGM, please refer to the FDA website.

Does the FreeStyle Libre 3 system include a reader?

No, it does not. The FreeStyle Libre 3 app is available on iOS and Android smartphones. No reader is available/required at this time.

What type of alarms are provided with the FreeStyle Libre 3 system?

The FreeStyle Libre 3 system offers optional low and high glucose alarms, signal loss alarms, and a mandatory urgent low glucose alarm. Notifications will only be received when alarms are turned on and the sensor is within 33 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 3 User’s Manual for more information.

Patient Types

The FreeStyle Libre 3 system is cleared for the management of both type 1 and type 2 diabetes in persons age 4 and older.

 

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