FreeStyle Libre 2 Important Safety Information

The information contained herein is available within the FreeStyle Libre 2 Flash Glucose Monitoring System user manual. Please read the User Manual prior to use. We recommend discussing the use of the FreeStyle Libre 2 system with your healthcare professional before use.

The full instruction manual for the FreeStyle Libre 2 Flash Glucose Monitoring system is available here.

Indications for Use

The FreeStyle Libre 2 Flash Glucose Monitoring System Reader (“Reader”) when used with a FreeStyle Libre 2 Flash Glucose Monitoring System Sensor (“Sensor”) is a real time, continuous glucose monitoring (CGM) device indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with insulin dependent diabetes mellitus. The reader and sensor are designed to replace blood glucose testing in the self management of diabetes, and to support manual dosing of insulin. 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 reader and sensor and also for interpreting or assisting the child to interpret sensor glucose readings. The system is also intended to autonomously communicate with digitally connected devices. The system can be used alone or in conjunction with these digitally connected devices only where the user manually controls actions for therapy decisions.

Contraindications

The FreeStyle Libre 2 Flash Glucose Monitoring System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. The sensor must be removed prior to Magnetic Resonance Imaging (MRI).

Warnings

• The system is only intended to be used by patients (aged 4 years and older) with insulin dependent diabetes mellitus.
• Healthcare professionals and consumers should be aware about the limitations of available scientific evidence for use of this device in any other groups of patients who require diabetes management.
• Do not ignore symptoms that may be due to low or high blood glucose. If you have symptoms that do not match the sensor glucose reading or alarm or suspect that your reading may be inaccurate, check the reading or alarm by conducting a fingerstick test using a blood glucose meter. If you are experiencing symptoms that are not consistent with your glucose readings or alarms, consult your healthcare professional.
• The FreeStyle Libre 2 Flash Glucose Monitoring System contains small parts that may be dangerous if swallowed.

Interfering Substances

System-Taking ascorbic acid (vitamin C) supplements while wearing the sensor may falsely raise sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins. See your healthcare professional to
understand how long ascorbic acid is active in your body.