User`s guide

172 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
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stratied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 Stratied in 2-Hour Increments after
Calibration (Pediatric Study)
Time from
Calibration
Number
of paired
CGM-YSI
Percent
within
15/15%
YSI
Percent
within
20/20%
YSI
Percent
within
30/30%
YSI
Percent
within
40/40%
YSI
Percent
greater
than
40/40%
YSI
0-2 hours 648 65% 75% 87% 93% 7%
2-4 hours 649 51% 67% 86% 93% 7%
4-6 hours 630 51% 61% 80% 90% 10%
6-8 hours 409 52% 68% 85% 95% 5%
8-10 hours 296 53% 69% 84% 93% 7%
10-12 hours 253 58% 74% 89% 95% 5%
12-14 hours 37 32% 38% 65% 78% 22%
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.