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INDICATIONS FOR USE
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real
time continuous glucose monitoring (CGM) device with alarms capability
indicated for the management of diabetes in persons age 4 and older.
It is intended to replace blood glucose testing for diabetes treatment
decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the
detection of episodes of hyperglycemia and hypoglycemia, facilitating
both acute and long-term therapy adjustments. Interpretation of the
System readings should be based on the glucose trends and several
sequential readings over time.
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 where the user manually controls
actions for therapy decisions.
What you need to understand in the
Indications For Use:
You can use the FreeStyle Libre 3 System if you’re 4 or older.
IMPORTANT:
• When you check your glucose, consider all the information
on your screen before deciding what to do or what treatment
decision to make.
• Don’t take a correction dose within 2 hours of your meal dose.
This may result in “insulin stacking” and low glucose.
WARNING:
The System can replace blood glucose testing except in the
below situations. These are the times when you need to do a
blood glucose test before deciding what to do or what treatment
decision to make as Sensor readings may not accurately reect
blood glucose levels:
Do a blood glucose test if you
think your glucose readings
are not correct or do not match
how you feel. Do not ignore
symptoms that may be due to
low or high glucose.
Do a blood glucose test when
you see the
symbol during
the rst 12 hours of wearing a
Sensor or the Sensor glucose
reading does not include a
Current Glucose number.