118 | SEVEN
™
CONTINUOUS GLUCOSE MONITORING SYSTEM
Table 8. Continuous Error Grid Combined Point and Rate Rating Table
Hypoglycemia
(YSI<= 70 mg/dl)
(4% of the data)
Euglycemia
(70< YSI <=180 mg/dl)
(51% of the data)
Hyperglycemia
(YSI >180 mg/dl)
(45% of the data)
Accurate Readings 76% 97% 94%
Benign Errors 0% 2% 3%
Inaccurate Readings 24% 1% 3%
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.
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