Dexcom G4 Professional User Manual page 199

14
Table 8. Sensor Stability (Accuracy over Time)
Number
Day of
of paired
Wear
CGM-YSI Differences
Day 1 3023
Day 4 3108
Day 7 3021
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%
coefficient 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
198 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Mean Median
Absolute Absolute
Percent Percent
Differences
(%) (%)
16.7% 13.2%
11.4% 8.2%
11.9% 8.9%
Percent Percent Percent
within within within
15/15% 20/20% 30/30%
YSI YSI YSI
59% 71% 86%
77% 87% 95%
76% 87% 95%
Percent
Percent
greater
within
than
40/40%
40/40%
YSI
YSI
94% 6%
98% 2%
98% 2%