Chapter 3: Risks And Benefits; Risks; Benefits - Dexcom G4 PLATINUM User Manual

CHAPTER 3: RISKS AND BENEFITS

3.1 RISKS

There are some known risks with using real-time CGM.
You will not get sensor glucose alerts when the alert function is turned off, your
transmitter and receiver are out of range, or when your receiver is not showing sensor
glucose readings. You might not notice alerts if you are unable to hear them or feel the
vibration. Sometimes your sensor glucose reading may be slightly different than your
blood glucose meter. For example, your blood glucose meter may show a blood glucose
value of 78 mg/dL, but your sensor glucose reading may show as 82 mg/dL. If your low
alert is set at 80 mg/dL, your system will not alert for a low glucose at this time because
82 mg/dL is still above your low alert setting. In most cases, the sensor glucose readings
will move in the right direction and will alert you of a high or low shortly after. If you do not
get an alert for any reason, and you do not take frequent blood glucose measurements
with your blood glucose meter, you might not be aware of low or high blood glucose
levels. If this happens, and your blood glucose levels are very high or low, there is a
remote chance you might need medical help.
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, 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 provider 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 may help you take action to
help avoid high or low glucose values.
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