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ART41361-001_rev-A 2:18 pm 30 aug 2019
Table 9 displays the concurrence between the GM and YSI reference glucose when GM reads 'HI'. For
example, when GM reading was 'HI', YSI glucose values were less than or equal to 11.1 mmol/L 0.0% of
the time, above 11.1 mmol/L 100.0% of the time, above 16.7 mmol/L 100.0% of the time, above
22.2 mmol/L 100.0% of the time, and above 27.8 mmol/L 7.7% of the time.
Table 9: Concurrence Analysis with 'HI' GM Reading
Accuracy by Day of Wear
The Sensor can be worn for up to 14 days. To show Sensor performance over time, the absolute relative
difference between the System and reference YSI glucose values over the wear duration is presented in
Table 10.
Table 10: Difference Measures by Day: (YSI Reference)
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 of 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 11.
Table 11: Number and Percent of Results within YSI Reference
System Glucose Availability
The System is designed to produce a glucose reading after each user-initiated scan that is performed after
the start-up time, through the wear period. Table 12 shows the number of available glucose readings
reported by all Sensors and the expected number based on the total number of scan attempts. Results are
shown for Sensors which produced at least one GM reading during the clinical study over the total wear
period. The percentage of available GM readings is presented in comparison to the number of expected
GM readings. Overall, 99.7% of GM readings (18606 GM readings out of an expected 18666) were available.
Table 12: GM Availability
Detection of Hypoglycaemic and Hyperglycaemic Events
Table 13 shows the accuracy of the System's Glucose Messages in informing the user of low or high