About the FreeStyle Libre 2 System
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real-time alarms capability indicated for the management of diabetes in persons age 4 and older.
The system consists of two primary components: a sensor that transmits via Bluetooth Low Energy (BLE) and a BLE-enabled display device (Reader). The sensor is single-use and disposable, and can be worn for up to 14 days.
The system provides continuous glucose measurements every minute, displaying glucose levels, trends, and alerts. The user can determine their treatment based on the glucose values provided by the system.
The system is designed to be used where the user utilizes CGM information to manually control actions for therapy decisions, but it must not be used with automated insulin dosing (AID) systems, including full closed loop, hybrid closed loop, and insulin suspend systems.
How it Works
The FreeStyle Libre 2 System uses an electrochemical sensor to monitor glucose levels in the interstitial fluid (ISF). The sensor incorporates both the subcutaneously implanted sensor and associated electronics.
The sensor uses a glucose oxidase enzyme to oxidize glucose and transfer electrons to a metal electrode, producing a current. The strength of the current is proportional to the amount of glucose present in the interstitial fluid.
The system converts the electrical current signal to a glucose value (in mg/dL) for display on the handheld Reader.
Manual:
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