Dexcom G5 User Manual page 291

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
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as
Software 505 (SW10505).
Dexcom G5 Mobile System User Guide
Technical Information
Number of
2
Study Paired
CGM-YSI
Original 648
545
Original 649
460
Original 630
428
Original 409
325
Original 296
305
Original 253
198
Original 37
1
1
Within YSI Values With Data
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
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%
(SW10050) or
291