User's Manual

138 | Continuous Glucose Monitoring System
11
The Continuous Error Grid was also used to determine if the G4-Global Receiver
results are “clinically acceptable.” The Continuous Error Grid looks at how closely
the G4-Global Receiver readings match to the YSI Analyzer and also how closely
the G4-Global Receiver glucose rate of change (how fast the glucose rises or
falls) compares to the actual blood glucose rate of change measured by the YSI.
The data is evaluated in 3 zones: clinically accurate readings, benign errors, and
clinically inaccurate readings. See the table below for the G4-Global Receiver
accuracy by glucose range. There were 1,827 paired points evaluated.
Table 7. Continuous Error Grid Combined Point and Rate Rating Table
Hypoglycemia
(YSI<= 70 mg/dL)
(8% of the data)
Euglycemia
(70< YSI <=180 mg/dL)
(51% of the data)
Hyperglycemia
(YSI >180 mg/dL)
(41% of the data)
Accurate
Readings
61% 97% 94%
Benign Errors 1% 2% 2%
Inaccurate
Readings
39% 1% 5%
Section 11.1
Placeholder for G4-Global Receiver Pivotal Study Results