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The FreeStyle Libre 2 Flash Glucose Monitoring System Reader ("Reader") when used with a FreeStyle Libre 2 Plus Flash Glucose Monitoring System Sensor ("Sensor") is indicated for measuring interstitial fluid glucose levels in people (age 2 and older) with or without diabetes mellitus, including pregnant women. The Reader and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin.
The indication for children (age 2-12) is limited to those who are supervised by a caregiver who is at least 18 years of age. The caregiver is responsible for managing or assisting the child to manage the Reader and Sensor and also for interpreting or assisting the child to interpret Sensor glucose readings.
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