User`s guide

198 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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Table 8. Sensor Stability (Accuracy over Time)
Day of
Wear
Number
of paired
CGM-YSI
Mean
Absolute
Percent
Differences
(%)
Median
Absolute
Percent
Differences
(%)
Percent
within
15/15%
YSI
Percent
within
20/20%
YSI
Percent
within
30/30%
YSI
Percent
within
40/40%
YSI
Percent
greater
than
40/40%
YSI
Day 1 3023 16.7% 13.2% 59% 71% 86% 94% 6%
Day 4 3108 11.4% 8.2% 77% 87% 95% 98% 2%
Day 7 3021 11.9% 8.9% 76% 87% 95% 98% 2%
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Precision of System Readings
In the study, 36 participants wore two Systems. This was to look at how
similarly two Systems function on the same patient (sensor precision).
Precision was evaluated by comparing the glucose readings from the
two Systems worn on the same subject at the same time. Results
showed that System readings from the two sensors generally agreed
witheachotherwithin9%(absolutepercentdifference)witha7%
coefcientofvariation.
Sensor Life
Sensors may be worn for up to 7 days (168 hours). To estimate how
long a sensor will work over 7 days, 108 sensors were evaluated to
determine how many days/hours of readings each sensor provided.
Ninety-fourpercent(94%)ofthesensorslasteduntilDay7(145-168
hours).Therewere6(4%)sensorsthatendedearly,fourofwhichlasted
more than 3 days.
Number of Readings Provided
The System is capable of providing a reading up to every 5 minutes,
or up to 288 readings per day. For a variety of reasons, the System
may not display a glucose reading and readings are “skipped.” Table
9 estimates the number of readings you can expect to receive from