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ART41361-001_rev-A 2:18 pm 30 aug 2019
Instrument measurements (YSI). The accuracy of GM versus YSI reference was assessed by calculating the
percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 4.44 mmol/L
and above, and 0.83 mmol/L, 1.11 mmol/L, 1.67 mmol/L and 2.22 mmol/L for values below 4.44 mmol/L.
The results are presented in Table 1 for YSI reference. Overall, 90.5% of results were within ±1.11 mmol/L /
20% of YSI reference.
Table 1: Number and Percent of Results within YSI Reference
Agreement on Day 1 against YSI Reference
The accuracy of GM versus YSI reference on the first day of Sensor wear was assessed by calculating the
percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 4.44 mmol/L
and above, and within 0.83 mmol/L, 1.11 mmol/L, 1.67 mmol/L and 2.22 mmol/L for values below
4.44 mmol/L by hourly intervals. The results are presented in Table 2.
Table 2: Number and Percent of Results within YSI Reference
* (0-2] interval includes the 60 minute start-up time.
† Time interval is not divided to smaller segments due to small number of data pairs.
Overall Accuracy against YSI reference
Accuracy was measured by comparing the absolute relative difference between the System and reference
YSI glucose values. The absolute relative difference measures the level of disagreement between the
System and the reference value, but does not tell you whether the System glucose value was, on average,
higher or lower than the reference glucose value. The Mean Absolute Relative Difference gives an
indication of the average percent disagreement between the GM and the reference. Table 3 shows the
overall absolute difference measure. Overall, the Mean Absolute Relative Difference was 9.5% for the
comparison with YSI reference. The Median Absolute Relative Difference shows that half of the time the
System was within 7.3% of the YSI reference.
Table 3: Difference Measures with YSI Reference