Dexcom G4 Professional User's Guide download pdf (Page 197)

Dexcom G4 PLATINUM Professional System User’s Guide | 197

Table 7. Percentage of System Readings within YSI

Values with Data Stratied in 2-Hour Increments after

Calibration

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 1929 78% 88% 96% 98% 2%

2-4 hours 1516 69% 81% 91% 96% 4%

4-6 hours 1547 69% 79% 91% 95% 5%

6-8 hours 1520 68% 79% 92% 97% 3%

8-10 hours 1555 71% 82% 92% 96% 4%

10-12 hours 1068 65% 77% 91% 96% 4%

12-14 hours 17 65% 76% 82% 88% 12%

NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),

inclusive.

Sensor Stability

Sensors can be worn for up to 7 days. To verify sensor performance

over time, 108 sensors were evaluated across the 7-day wear period.

Performance was estimated 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at

the beginning (Day 1), middle (Day 4) and end (Day 7) of the System

lifecycle. The average and median of the absolute percent differences

are included in Table 8 showing consistent accuracy and sensor stability

over the 7-day life of the sensor.

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