User's Guide

173
The Bigfoot Unity
™
Diabetes Management System User Guide | Appendix C
Table 5a: Low Glucose Alert Performance (Adult; n=144)
Low Glucose
Alert level
(mg/dL)
Alert Rate Detection Rate
Number of
Events (n)
True Alert
Rate (%)
False Alert
Rate (%)
Number of
Events (n)
Correct
Detection
Rate (%)
Missed
Detection
Rate (%)
70 21504 86.0 14.0 3652 89.3 10.7
Table 5b: Low Glucose Alert Performance (Pediatric; n=186)
Low Glucose
Alert level
(mg/dL)
Alert Rate Detection Rate
Number of
Events (n)
True Alert
Rate (%)
False Alert
Rate (%)
Number of
Events (n)
Correct
Detection
Rate (%)
Missed
Detection
Rate (%)
70 1133 80.1 19.7 800 93.5 6.5
Sensor Accuracy Over Time
The Sensor can be worn for up to 14 days. The percentage of System
readings within YSI values and the Mean Absolute Relative Difference
(MARD) is presented for the following different wear periods in
Tables 6a and 6b: Beginning (Adult: 144 Subjects, Day 1, 2 or 3;
Pediatric: 35 Subjects, Day 1 or 2) Early Middle (Adult: 91 Subjects,
Day 7 or 8; Pediatric: 35 Subjects, Day 7 or 8), Late Middle (Adult: 55
Subjects, Day 9 or 12; Pediatric: 34 Subjects, Day 9 or 12), and End
(Adult: 76 Subjects, Day 13 or 14; Pediatric: 42 Subjects, Day 13 or
14). For values 70 mg/dL and above, the percentage of readings within
15%, 20%, and 40% of the YSI value was calculated. For values below
70 mg/dL, the percentage of readings within 15 mg/dL, 20 mg/dL, and
40 mg/dL of the YSI value was calculated.
Table 6a: Sensor Accuracy Relative to YSI over the wear duration
(Adult; n=144)
Wear Period
Number of
CGM-reference
pairs
MARD (%)
Within
±15% /
±15 mg/dL
Within
±20% /
±20 mg/dL
Within
±40% /
±40 mg/dL
Beginning 6955 9.9 83.4 90.4 99.3
Early Middle 4522 8.5 87.7 94.5 99.8
Late Middle 3503 8.8 86.8 93.4 99.7
End 3755 9.1 86.4 92.9 100.0