User's Guide

167
The Bigfoot Unity
™
Diabetes Management System User Guide | Appendix C
Concurrence of System and Reference (CGM vs. YSI)
The percentage of concurring glucose values (CGM vs. YSI) in each
glucose reference range is presented for each CGM range in Tables 3a
and 3b and for each YSI range in Tables 3c and 3d. For example, in
the Adult study, when the System glucose readings were within the 81
to 120 mg/dL range, actual blood glucose values were between 40 and
60 mg/dL 0.2% of the time, between 61 and 80 mg/dL 11.0% of the
time, between 81 and 120 mg/dL 70.1% of the time, between 121 and
160 mg/dL 17.8% of the time, between 161 and 200 mg/dL 0.8% of
the time, and between 201 and 250 mg/dL 0.1% of the time.
Table 3a: Concurrence Analysis by CGM Glucose Level (Adult; n=144)
CGM
Glucose
Level
(mg/dL)
YSI Glucose Level (mg/dL)
N
<40 40-60 61-80
81-
120
121-
160
161-
200
201-
250
251-
300
301-
350
351-
400
>400
<40
†
20.0 20.0 40.0 20.0 . . . . . . .
5
40-60
0.4 52.9 43.3 3.3 . 0.1 . . . . .
1889
61-80
. 18.9 62.7 18.1 0.4 0.0 . . . . .
3090
81-120
. 0.2 11.0 70.1 17.8 0.8 0.1 . . . .
3040
121-
160
. . 0.1 9.1 69.9 18.9 1.6 0.3 0.2 . .
2407
161-
200
. . . . 10.6 60.6 26.9 1.6 0.3 . .
1745
201-
250
. . . . . 7.0 65.5 25.6 1.9 0.1 .
2181
251-
300
. . . . . 0.1 8.4 66.9 22.7 1.8 0.1
2327
301-
350
. . . . . . 0.4 13.6 68.8 16.0 1.2
1522
351-
400
. . . . . . 0.6 27.5 63.3 8.6
534
>400
†
. . . . . . . . 2.5 62.8 34.7
121
†
Levels out of System dynamic range.