Dexcom SEVEN User Manual page 122

table 8. Continuous error Grid Combined point and rate rating table
Accurate Readings
Benign Errors
Inaccurate Readings
CALIBRATION STABILITY
Calibrate the Seven System every 12 hours. To demonstrate performance of the Seven
System over a 12-hour calibration period, 94 Sensors were evaluated to verify that
performance remains consistent over the 12-hour calibration period. Seven Systems were
evaluated in 4 hour increments after calibration. Performance was estimated at each
4-hour interval and stratified by glucose concentrations by calculating the percentage of
Seven System readings within 20%, 30% and greater than 40% of the YSI readings. See the
table below.
118 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
™
Hypoglycemia
(YSI<= 70 mg/dl)
(4% of the data)
76%
0%
24%
Euglycemia
(70< YSI <=180 mg/dl)
(51% of the data)
97%
2%
1%
Hyperglycemia
(YSI >180 mg/dl)
(45% of the data)
94%
3%
3%