Dexcom G4 Professional User's Guide download pdf (Page 196)

196 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System

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 your 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timewithinthe15minute

period before or after your blood sugar goes above 200 mg/dL (11.1

mmol/L).

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.

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Dexcom G4 Professional User's Guide Page 196