Description
The FreeStyle Libre system is a continuous glucose monitoring system that consists of a smartphone app or a handheld reader and a glucose sensor worn on the back of the upper arm. The system is designed to replace blood glucose testing in the self-management of diabetes, with the exception of when glucose levels are falling rapidly or when glucose levels are rising rapidly.
The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a smartphone app or a handheld reader and a glucose sensor worn on the back of the upper arm.
The indication for children (age 4 - 17) 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 in managing the FreeStyle Libre Flash Glucose Monitoring System and interpreting or assisting the child to interpret FreeStyle Libre readings.
It is designed to replace blood glucose testing in the self-management of diabetes with the exceptions listed below. Under the following circumstances, use a blood glucose meter to check the current glucose readings from the FreeStyle Libre Flash Glucose Monitoring System Sensor:
During times of rapidly changing glucose levels, interstitial glucose levels as measured by the Sensor and reported as current may not accurately reflect blood glucose levels.
When glucose levels are falling rapidly, glucose readings from the Sensor may be higher than blood glucose levels.
Conversely, glucose readings from the Sensor may be lower than blood glucose levels when glucose levels are rising rapidly.
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