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 and capillary blood glucose
values (BG) over the 14 day wear is presented in
Table 10
and
Table 11
. The accuracy of GM
versus YSI reference and BG reference was assessed by calculating the percentage of System
readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above,
and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are
presented in
Table 12
for GM vs. YSI reference and in
Table 13
for GM vs. BG reference.
Table 10: Difference Measures by Day (YSI Reference)
YSI
Reference
Day
Number of GM-
Reference Pairs
Median Absolute
Relative Difference (%)
Mean Absolute
Relative Difference (%)
1
2117
11.4
13.8
2-5
4036
11.0
13.3
6-9
2919
10.2
12.3
10-13
2214
8.4
10.4
14
1037
7.3
9.6
58