Dexcom G4 PLATINUM User Manual page 96

Table 7. Percentage of System Readings
2-Hour Increments after Calibration
Time from
Study
2
Calibration
Original
0-2 hours
Advanced
Original
2-4 hours
Advanced
Original
4-6 hours
Advanced
Original
6-8 hours
Advanced
Original
8-10 hours
Advanced
Original
10-12 hours
Advanced
Original
12-14 hours
Advanced
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as
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.
Percent Percent
Number of
within within
paired
15/15% 20/20%
CGM-YSI
YSI
1929 78%
469 93%
1516 69%
389 90%
1547 69%
383 85%
1520 68%
380 79%
1555 71%
347 83%
1068 65%
295 80%
17 65%
0 --
1
within YSI Values with Data Stratified in
Percent
Percent
greater
within
than
30/30%
40/40%
YSI YSI
YSI
88% 96% 2%
97% 99% 0%
81% 91% 4%
97% 99% 0%
79% 91% 5%
91% 97% 2%
79% 92% 3%
90% 97% 2%
82% 92% 4%
92% 98% 0%
77% 91% 4%
90% 98% 0%
76% 82% 12%
-- -- --
(SW10050) or
Original
96
(SW10505).
Advanced