User`s guide

Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 173
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)
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 1016 21.2 15.8 48% 61% 78% 85% 15%
Day 4 810 16.0 13.9 52% 66% 87% 97% 3%
Day 7 1096 15.1 11.3 63% 76% 89% 96% 4%
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%
coefcientofvariation.
Sensor Life
Sensors may be worn for up to 7 days (168 hours). To estimate how long