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ART41361-001_rev-A 2:18 pm 30 aug 2019
* Levels out of system dynamic range.
Concurrence Analysis by Glucose Trend Arrow
Trend Arrow accuracy of the System, as assessed by concurrence analysis, is presented in Table 7. For
example, when the trend arrow indicated that glucose was changing slowly (-0.06 to 0.06 mmol/L/min ( )
), actual glucose levels in the body were falling quickly ( ) 0.2% of the time, falling ( ) 2.6% of the time,
changing slowly ( ) 86.6% of the time, rising ( ) 4.2% of the time, and were rising quickly ( ) 0.6% of
the time.
Table 7: Concurrence Analysis by Glucose Trend Arrow
* Glucose rate of change not available due to the time difference between glucose readings exceeding 30 minutes.
† Glucose Trend Arrow not available.
Agreement with 'LO' and 'HI' GM Reading against YSI Reference
The System reports glucose concentrations between 2.2 and 27.8 mmol/L. When the System determines
that glucose level is below 2.2 mmol/L, it will report as 'LO'. When the System determines that glucose
level is above 27.8 mmol/L, it will report as 'HI'. Table 8 displays the concurrence between the GM and YSI
reference glucose when GM reads 'LO'. For example, when GM reading was 'LO', YSI glucose values were
less than 2.2 mmol/L 0.0% of the time, equal to or above 2.2 mmol/L 100.0% of the time, above 2.8 mmol/L
84.2% of the time, above 3.3 mmol/L 57.9% of the time, above 3.9 mmol/L 36.8% of the time, and above
4.4 mmol/L 21.1% of the time.
Table 8: Concurrence Analysis with 'LO' GM Reading