Dexcom G5 Mobile - Page 319

Dexcom G5 Mobile System User Guide
317Technical Information
Table 8-C. Sensor Stability Relative to SMBG (Accuracy Over Time
1
) -
(Pediatric, Ages 2-17 Years)
Day
of
Wear
Study
2
Number
of
Paired
CGM-
SMBG
Mean
Absolute
Percent
Differences
Median
Absolute
Percent
Differences
Percent
Within
15/15%
SMBG
Percent
Within
20/20%
SMBG
Percent
Within
30/30%
SMBG
Percent
Greater
than
40/40%
SMBG
Day
1
Original 3216 18.8% 14.2% 53% 65% 81% 10%
Software 505 893 14.8% 10.7% 64% 79% 91% 5%
Day
2
Original 2148 16.2% 12.4% 60% 74% 87% 6%
Software 505 436 13.2% 10.4% 69% 81% 95% 3%
Day
3
Original 1977 15.2% 11.0% 63% 76% 89% 5%
Software 505 441 13.8% 11.3% 66% 77% 91% 2%
Day
4
Original 2830 14.0% 10.9% 66% 79% 91% 4%
Software 505 850 10.7% 8.5% 79% 91% 97% 1%
Day
5
Original 1768 15.4% 10.7% 67% 78% 90% 5%
Software 505 374 11.4% 8.7% 74% 86% 96% 1%
Day
6
Original 1704 14.3% 9.8% 68% 79% 90% 4%
Software 505 410 12.3% 9.2% 72% 80% 93% 2%
Day
7
Original 2675 12.4% 9.2% 72% 83% 94% 3%
Software 505 860 11.3% 8.6% 79% 90% 96% 2%
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
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 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