Dexcom G4 User Manual page 135

Hyperglycemia Detection Rate
The Detection Rate shows how often the device recognizes and alerts you
to an episode of hyperglycemia or how often it misses such an event. The
Hyperglycemia Detection Rate is the % of time the blood glucose level was at or
above the alert setting and the device alarmed within 15 minutes before or after
the blood glucose was at or above the alert settings. The Hyperglycemia Missed
Detection Rate is the % of time the blood glucose was at or above the alert
setting, but the device did not alarm within 15 minutes before or after the blood
glucose was at or above the alert setting.
For example, if you set the High Glucose alert to 200 mg/dL (11.1 mmol/L), how
often will your alarm alert you if your blood glucose goes at or above 200 mg/dL
(11.1 mmol/L)? If your blood sugar goes above 200 mg/dL (11.1 mmol/L), you
can expect your alarm to sound 97% of the time and not to sound approximately
3% of the time within the 15 minute period before or after your blood sugar goes
above 200 mg/dL (11.1 mmol/L).
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 20 mg/dL
(1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30% or 40 mg/dL (2.2 mmol/L) 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 5 showing consistent accuracy and sensor stability over the
7-day life of the sensor.
Table 5. Sensor Stability (Accuracy over Time)
Number
Day of
of Paired
Wear
CGM-YSI
Differences (%)
Day 1 3023
Day 4 3108
Day 7 3021
Mean Median
Absolute Absolute
Percent Percent
Differences (%)
16.7% 13.2%
11.4% 8.2%
11.9% 8.9%
Percent Percent Percent
within within within
20/20% 30/30% 40/40%
YSI* YSI*
71% 86% 94%
87% 95% 98%
87% 95% 98%
Dexcom G4 User's Guide
YSI*
| 135