User`s guide
168 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System
14
Table 8. Sensor Stability (Accuracy over Time)
Day of
Wear
1
Study
2
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
greater
than
40/40%
YSI
Day 1
Original
3023 16.7% 13.2% 59% 71% 86% 6%
Software
505
680 10.7% 7.9% 77% 84% 96% 2%
Day 4
Original
3108 11.4% 8.2% 77% 87% 95% 2%
Software
505
777 8.0% 6.4% 89% 96% 99% 0%
Day 7
Original
3021 11.9% 8.9% 76% 87% 95% 2%
Software
505
806 8.5% 7.2% 90% 97% 99% 0%
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original
(SW10050) or Software 505 (SW10505).
Sensor Stability
Sensors can be worn for up to 7 days. To verify sensor performance
over time, 72 subjects were evaluated with the Original System across
the 7-day wear period while 50 subjects were evaluated with the
Software 505 System across the 7-day wear period. Performance was
estimated by calculating the percentage of System readings within 15
mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30% , 40 mg/dL or 40%
and greater than 40 mg/dL 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.