Indications for Use
The FreeStyle Libre Flash Glucose Monitoring System is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus. 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 to manage the FreeStyle Libre Flash Glucose Monitoring System and also for 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 when glucose levels are rising rapidly, glucose readings from the Sensor may be lower than blood glucose levels.
• In order to confirm hypoglycaemia or impending hypoglycaemia as reported by the Sensor.
• If symptoms do not match the FreeStyle Libre Flash Glucose Monitoring System reading. Do not ignore symptoms that may be due to low blood glucose or high blood glucose.
Contraindications
The FreeStyle Libre Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI).
WARNING:
• The FreeStyle Libre Flash Glucose Monitoring System contains small parts that may be dangerous if swallowed.
• During times of rapidly changing glucose (more than 0.1 mmol/L per minute), interstitial fluid glucose levels as measured by the FreeStyle Libre Flash Glucose Monitoring System Sensor may not accurately reflect blood glucose levels. Under these circumstances, check the Sensor glucose readings by conducting a fingerstick test using a blood glucose meter.
• In order to confirm hypoglycaemia or impending hypoglycaemia as reported by the FreeStyle Libre Flash Glucose Monitoring System Sensor, conduct a fingerstick test using a blood glucose meter.
• Do not ignore symptoms that may be due to low or high blood glucose. If you have symptoms that do not match the FreeStyle Libre Flash Glucose Monitoring System reading or suspect that your reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter. If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
For full indications for use and safety information, see more here.
