Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference
The System reports glucose concentrations between 40 and 500 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 500 mg/dL, it will report as ‘HI’. Table 8 displays the concurrence between
the CGM and YSI reference glucose when CGM reads ‘LO’. For example, in the clinical study, when
CGM reading was ‘LO’, YSI glucose values were less than 40 mg/dL 0.0% of the time, equal to or above
40 mg/dL 100.0% of the time, above 50 mg/dL 83.3% of the time, above 60 mg/dL 55.6% of the
time, above 70 mg/dL 33.3% of the time, and above 80 mg/dL 22.2% of the time.
Table 8: Concurrence Analysis with ‘LO’ CGM Reading
YSI (mg/dL)
N
<40 ≥40 >50 >60 >70 >80
% of CGM points in YSI range
0.0 100.0 83.3 55.6 33.3 22.2
Number of CGM points in YSI range 0 18 15 10 6 4 18
Table 9 displays the concurrence between the CGM and YSI reference glucose when CGM reads ‘HI’.
For example, in the clinical study, when CGM reading was ‘HI’, YSI glucose values were less than or
equal to 200 mg/dL 0% of the time, above 200 mg/dL 100% of the time, above 300 mg/dL 100% of
the time, above 400 mg/dL 100% of the time, and above 500 mg/dL 7.7% of the time.
Table 9: Concurrence Analysis with ‘HI’ CGM Reading
YSI (mg/dL)
N
≤200 >200 >300 >400 >500
% of CGM points in YSI range
0.0 100.0 100.0 100.0 7.7
Number of CGM points in YSI range 0 13 13 13 1 13
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