Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference
The System reports glucose concentrations between 40 and 400 mg/dL. When the System
determines that glucose level is below 40 mg/dL, it will report as ‘LO’. When the System determines
that glucose level is above 400 mg/dL, it will report as ‘HI’.
Tables 2a and 2b
display the
concurrence between the CGM and YSI reference glucose when CGM reads ‘LO’. For example, in the
Adult study, when CGM reading was ‘LO’, YSI glucose values were less than 50 mg/dL 20.0% of the
time, less than 60 mg/dL 40.0% of the time, less than 70 mg/dL 40.0% of the time, less than
80 mg/dL 80.0% of the time, and equal to or above 80 mg/dL 20.0 % of the time.
Table 2a: Concurrence Analysis with ‘LO’ CGM Reading (Adult; n=144)
CGM-
Reference
Pairs
YSI (mg/dL)
N
<50
<60
<70
<80
≥80
n
1
2
2
4
1
5
Cumulative %
20.0
40.0
40.0
80.0
20.0
Table 2b: Concurrence Analysis with ‘LO’ CGM Reading (Pediatric*; n=129)
CGM-
Reference
Pairs
YSI (mg/dL)
N
<50
<60
<70
<80
≥80
n
0
1
2
2
0
2
Cumulative %
0.0
50.0
100.0
100.0
0.0
*
Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
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