Dexcom G4 Platinum User Manual page 174

14
Calibration Stability
The System must be calibrated every 12 hours. To demonstrate
performance of the System over a 12-hour calibration period, sensors
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 concentrations by calculating the
percentage of System readings within 15 mg/dL (0.9 mmol/L) or 15%,
20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL
(2.2 mmol/L) or 40% and greater than 40 mg/dL (2.2 mmol/L) or 40% of
the YSI values in Table 7.
Table 7. Percentage of System Readings within YSI
Values with Data Stratified in 2-Hour Increments after
Calibration (Pediatric Study)
Number
Time from
of paired
Calibration
CGM-YSI
0-2 hours
2-4 hours
4-6 hours
6-8 hours
8-10 hours
10-12 hours
12-14 hours
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
172 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
Percent
within
15/15%
YSI
648 65%
649 51%
630 51%
409 52%
296 53%
253 58%
37 32%
Percent Percent
within within
20/20% 30/30%
YSI YSI
75% 87%
67% 86%
61% 80%
68% 85%
69% 84%
74% 89%
38% 65%
Percent
Percent
greater
within
than
40/40%
40/40%
YSI
YSI
93% 7%
93% 7%
90% 10%
95% 5%
93% 7%
95% 5%
78% 22%