Sensor Stability Relative To Smbg (Accuracy Over Time) - (Pediatric, Ages 2-17 Years); Sensor Stability - Dexcom G5 User Manual

Table 8-C. Sensor Stability Relative to SMBG (Accuracy Over Time
(Pediatric, Ages 2-17 Years)
Day
of Study
2
Wear
Original
Day
1
Software 505
Original
Day
2
Software 505
Original
Day
3
Software 505
Original
Day
4
Software 505
Original
Day
5
Software 505
Original
Day
6
Software 505
Original
Day
7
Software 505
CGM readings are within 40 to 400 mg/dL, inclusive.
1
Both sets of study data are presented and are labeled as
2
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 included in
Table 8-A and 8-B showing consistent accuracy and sensor stability over the 7-day life of the sensor.
Dexcom G5 Mobile System User Guide
Technical Information
Number
Mean
of
Absolute
Paired
Percent
CGM-
Differences
SMBG
3216 18.8%
893 14.8%
2148 16.2%
436 13.2%
1977 15.2%
441 13.8%
2830 14.0%
850 10.7%
1768 15.4%
374 11.4%
1704 14.3%
410 12.3%
2675 12.4%
860 11.3%
Median Percent
Absolute Within
Percent 15/15%
Differences SMBG
14.2% 53%
10.7% 64%
12.4% 60%
10.4% 69%
11.0% 63%
11.3% 66%
10.9% 66%
8.5% 79%
10.7% 67%
8.7% 74%
9.8% 68%
9.2% 72%
9.2% 72%
8.6% 79%
Original
(SW10050) or
) -
1
Percent Percent
Within Within
20/20% 30/30%
SMBG SMBG
65% 81%
79% 91%
74% 87%
81% 95%
76% 89%
77% 91%
79% 91%
91% 97%
78% 90%
86% 96%
79% 90%
80% 93%
83% 94%
90% 96%
Software
Percent
Greater
Than
40/40%
SMBG
10%
5%
6%
3%
5%
2%
4%
1%
5%
1%
4%
2%
3%
2%
327