3
or low glucose alerts in blinded mode since these alerts are
deactivated. Taking frequent blood glucose measurements is
necessary to be aware of low or high blood glucose levels.
Inserting the sensor and wearing the adhesive patch might
cause infection, bleeding, pain or skin irritations (redness,
swelling, bruising, itching, scarring or skin discoloration).
There is a low chance of this happening. In the clinical study
for the Dexcom G4 PLATINUM System (which used the
same sensor as the Dexcom G4 PLATINUM Professional
System), only slight redness and swelling occurred in a
few patients. If any of these events happen, you might feel
discomfort in the area the sensor is inserted.
There is a remote chance that a sensor fragment could
remain under your skin if the sensor breaks while you are
wearing it. This did not happen in the clinical study for the
Dexcom G4 PLATINUM System. If you think a sensor has
broken under your skin, contact your healthcare professional
and call Dexcom's Technical Support. Sensor breakage may
cause some anxiety, but it is not a significant medical risk.
3.2 BENEFITS
Real-time CGM provides benefits beyond the information
you get from a blood glucose meter. It provides glucose
readings every five minutes for up to seven days to help you
detect trends and patterns in your glucose levels. This trend
information can help you see where your glucose is now
as well as where your glucose may be heading and how
fast you may be getting there. Understanding your glucose
trends and patterns may help you take action to help avoid
high or low glucose values by working with your healthcare
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Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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