User's Manual

G4-Global System User’s Guide | 129
Table 1. Percentage of G4-Global Receiver Results Falling Within 20, 30,
and Greater Than 40 Percent of the Paired YSI Results, at Various Glucose
Concentrations
YSI
Readings
(mg/dL)
Number
of Paired
Readings
% of
G4-Global
Receiver
Readings
Within 20%*
% of
G4-Global
Receiver
Readings
Within 30%*
% of
G4-Global
Receiver Readings
Greater than
40%* of YSI
40-400 1827 76% 90% 5%
40-80 277 73% 87% 6%
81-180 801 74% 89% 5%
181-300 563 81% 93% 3%
301-400 186 75% 95% 2%
* For the 40-80 mg/dL range the absolute difference is presented as the difference in
mg/dL
between the G4-Global Receiver and YSI, rather than the percent.
The agreement of the G4-Global Receiver to blood glucose levels was
assessed by calculating the percentage of G4-Global Receiver readings that
were within 20%, 30%, and greater than 40% of the YSI readings. For readings
less than or equal to 80 mg/dL the difference in mg/dL between the two glucose
readings was calculated. For readings greater than 80 mg/dL the percent
difference (%) from the YSI reading was calculated. The percentages of total
readings within 20 mg/dL or 20%, 30 mg/dL or 30%, or greater than 40 mg/dL
or 40% were then calculated. The total number of data pairs considered in this
analysis was 1,827. Results are shown in Table 1.
The G4-Global Receiver reports glucose concentrations between 40 and
400 mg/dL. When the G4-Global Receiver determines the glucose level is
below 40 mg/dL, it displays “LOW” in the Receiver Status Box. When the
G4-Global Receiver determines that the glucose level is above 400 mg/dL,
it displays “HIGH” in the Receiver Status Box. The ability of the G4-Global
Receiver to accurately report these occurrences is assessed by looking at the
actual blood glucose concentrations (as determined by the YSI analyzer) when
“LOW” or “HIGH” are reported.
Section 11.1
Placeholder for G4-Global Receiver Pivotal Study Results