Dexcom G5 - Calibration Stability; Percentage of System Readings Within YSI Values with Data Stratified in 2-Hour Increments after Calibration (Pediatric)

Dexcom G5 Mobile System User Guide
324Technical Information
Table 7-B. Percentage of System Readings
1
Within YSI Values with Data
Stratified in 2-Hour Increments after Calibration (Pediatric)
Time From
Calibration
Study
2
Number
of paired
CGM-YSI
Percent
within
15/15%
YSI
Percent
within
20/20%
YSI
Percent
within
30/30%
YSI
Percent
greater
Than
40/40%
YSI
0-2 hours
Original 648 65% 75% 87% 7%
Software 505 545 83% 91% 97% 1%
2-4 hours
Original 649 51% 67% 86% 7%
Software 505 460 72% 89% 96% 2%
4-6 hours
Original 630 51% 61% 80% 10%
Software 505 428 77% 88% 95% 2%
6-8 hours
Original 409 52% 68% 85% 5%
Software 505 325 88% 92% 94% 3%
8-10 hours
Original 296 53% 69% 84% 7%
Software 505 305 86% 93% 97% 1%
10-12 hours
Original 253 58% 74% 89% 5%
Software 505 198 89% 94% 98% 0%
12-14 hours
Original 37 32% 38% 65% 22%
Software 505 1 100% 100% 100% 100%
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).
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 Table 7-A and 7-B.