User's Guide

164
The Bigfoot Unity
™
Diabetes Management System User Guide | Appendix C
Table 1b: Accuracy to YSI within CGM Glucose Ranges (Adult; n=144)
CGM
Glucose
Level
†
(mg/dL)
Number
of CGM-
Reference
Pairs
Percent
Within
±15
mg/dL
Percent
Within
±20
mg/dL
Percent
Within
±40
mg/dL
Percent
Within
±15%
Percent
Within
±20%
Percent
Within
±40%
Mean
bias
(mg/dL)
MARD
(%)
<54 518 85.9 93.8 99.4 -6.4 13.8
54-69 3012 89.5 94.2 99.1 -3.3 10.8
70-180 7785 76.5 86.6 99.2 -4.8 10.6
181-250 3037 89.1 95.0 99.9 -10.1 7.8
>250 4383 94.0 97.9 100.0 -6.3 6.1
†
System range is 40-400 mg/dL.
Table 1c: Accuracy to YSI within CGM Glucose Ranges (Pediatric; n=86)
CGM
Glucose
Level
†
(mg/dL)
Number
of CGM-
Reference
Pairs
Percent
Within
±15
mg/dL
Percent
Within
±20
mg/dL
Percent
Within
±40
mg/dL
Percent
Within
±15%
Percent
Within
±20%
Percent
Within
±40%
Mean
bias
(mg/dL)
MARD
(%)
<54 125 70.4 77.6 96.8 -10.9 17.8
54-69 772 86.5 90.4 96.9 -4.9 12.0
70-180 1963 76.9 86.6 98.5 -4.1 10.9
181-250 957 87.0 96.0 99.9 -11.7 8.1
>250 1269 93.5 98.1 99.7 -5.7 7.1
†
System range is 40-400 mg/dL.
Table 1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=86)
CGM
Glucose
Level
(mg/dL)
Number
of CGM-
Reference
Pairs
Percent
Within
±15
mg/dL
Percent
Within
±20
mg/dL
Percent
Within
±40
mg/dL
Percent
Within
±15%
Percent
Within
±20%
Percent
Within
±40%
Mean
bias
(mg/dL)
MARD
(%)
<54 440 91.1 97.5 100.0 7.4 15.5
54-69 3028 94.7 98.6 100.0 1.5 10.2
70-180 7504 77.5 86.9 99.4 -4.8 10.4
181-250 2937 87.9 93.7 99.7 -8.0 8.0
>250 4826 90.9 95.9 99.7 -11.8 6.9