Dexcom G4 Platinum User Manual page 175

Sensor Stability Relative to YSI
Sensors can be worn for up to 7 days. Performance was estimated by
calculating the percentage of System readings within 15 mg/dL (0.9
mmol/L) or 15%, 20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L)
or 30% , 40 mg/dL (2.2 mmol/L) or 40% and greater than 40 mg/dL (2.2
mmol/L) or 40% of the YSI values at the beginning (Day 1), middle (Day
4) and end (Day 7) of the System lifecycle. The average and median
of the absolute percent differences are included in Table 8 showing
consistent accuracy and sensor stability over the 7-day life of the sensor.
Table 8. Sensor Stability Relative to YSI (Accuracy over
Time, Pediatric Study)
Number
Day of
of paired
Wear
CGM-YSI
Day 1 1016
Day 4 810
Day 7 1096
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Precision of System Readings
In the study, all subjects 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 10% (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
Mean Median
Absolute Absolute
Percent Percent
Differences Differences
(%) (%)
21.2 15.8
16.0 13.9
15.1 11.3
Dexcom G4 PLATINUM (Pediatric) System User's Guide
Percent Percent Percent
within within within
15/15% 20/20% 30/30%
YSI YSI YSI
48% 61% 78%
52% 66% 87%
63% 76% 89%
Percent
Percent
greater
within
than
40/40%
40/40%
YSI
YSI
85% 15%
97% 3%
96% 4%
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