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The Bigfoot Unity
™
Diabetes Management System User Guide | Appendix C
Table 2b: Concurrence Analysis with ‘< 40 mg/dL’ CGM Reading
(Pediatric; n=86)
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
Tables 2c and 2d
display the concurrence between the CGM and
YSI reference glucose when CGM reads ‘> 400 mg/dL’. In the Adult
study, when CGM reading was ‘> 400 mg/dL’, YSI glucose values were
above 350 mg/dL 97.5% of the time, above 300 mg/dL 100.0% of the
time, above 250 mg/dL 100.0 % of the time, and less than or equal to
250 mg/dL 0.0% of the time.
Table 2c: Concurrence Analysis with ‘> 400 mg/dL’ CGM Reading
(Adult; n=144)
CGM-Reference
Pairs
YSI (mg/dL)
N
> 350
> 300
> 250
≤ 250
n
118
121
121
0
121
Cumulative %
97.5
100.0
100.0
0.0
Table 2d: Concurrence Analysis with ‘> 400 mg/dL’ CGM Reading
(Pediatric; n=86)
CGM-Reference
Pairs
YSI (mg/dL)
N
> 350
> 300
> 250
≤ 250
n
26
28
30
0
30
Cumulative %
86.7
93.3
100.0
0.0