Dexcom G5 MOBILE User Manual page 316

Table 7-B. Percentage of System Readings
Stratified in 2-Hour Increments after Calibration (Pediatric)
Time From
Calibration
0-2 hours
Software 505
2-4 hours
Software 505
4-6 hours
Software 505
6-8 hours
Software 505
8-10 hours
Software 505
10-12 hours
Software 505
12-14 hours
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
(SW10505).
Calibration Stability
The System must be calibrated every 12 hours. To demonstrate performance of the System over a
12-hour calibration period, Systems were evaluated to verify that performance remains consistent
over the 12-hour calibration period. Systems were evaluated in 2-hour increments after calibration.
Performance was estimated at each 2-hour interval and stratified by glucose values 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 in Tables 7-A and 7-B.
Dexcom G5 Mobile System User Guide
Technical Information
Number
Study of Paired
2
CGM-YSI
Original
648
545
Original
649
460
Original 630
428
Original
409
325
Original
296
305
Original
253
198
Original 37
1
Within YSI Values with Data
1
Percent Percent
Within Within
15/15% 20/20%
YSI YSI
65% 75%
83% 91%
51% 67%
72% 89%
51% 61%
77% 88%
52% 68%
88% 92%
53% 69%
86% 93%
58% 74%
89% 94%
32% 38%
100% 100%
Original
(SW10050) or
Percent
Percent
Greater
Within
Than
30/30%
40/40%
YSI
YSI
87% 7%
97% 1%
86% 7%
96% 2%
80% 10%
95% 2%
85% 5%
94% 3%
84% 7%
97% 1%
89% 5%
98% 0%
65% 22%
100% 0%
Software 505
314