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Table Of Contents
Table H-18. Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Days 1, 3, and 7; Calibration
every 12 hours, Buttock
YSI
Glucose
Ranges
(mg/dL)
Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range
SG (mg/dL)
Number
of
Paired
SG-YSI
40 ≥40-60 >60-80 >80-120 >120-16
0
>160-20
0
>200-25
0
>250-30
0
>300-35
0
>350-40
0
>400
J)
>350-400
10.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
100.0%
(1/1)
0.0%
(0/0)
Table H-19. Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Day 1; Calibration every 12
hours, Buttock
YSI
Glucose
Ranges
(mg/dL)
Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range
SG (mg/dL)
Number
of
Paired
SG-YSI
<40 ≥40-60 >60-80 >80-120 >120-16
0
>160-20
0
>200-25
0
>250-30
0
>300-35
0
>350-40
0
>400
B) ≥40-60 1 0.0%
(0/0)
100.0%
(1/1)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
C) >60-80 10 0.0%
(0/0)
30.0%
(3/10)
40.0%
(4/10)
30.0%
(3/10)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
D)
>80-120
14 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
78.6%
(11/14)
21.4%
(3/14)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E)
>120-160
21 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
14
.3%
(3/21)
47.6%
(10/21)
38.1%
(8/21)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F)
>160-200
19 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
31.6%
(6/19)
47.4%
(9/19)
21.1%
(4/19)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
11 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
18.2%
(2/11)
72.7%
(8/11)
9.1%
(1/11)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
12 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
8.3%
(1/12)
16.7%
(2/12)
58.3%
(7/12)
16.7%
(2/12)
0.0%
(0/0)
0.0%
(0/0)
I)
>300-350
40.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0
/0)
0.0%
(0/0)
50.0%
(2/4)
25.0%
(1/4)
25.0%
(1/4)
0.0%
(0/0)
J)
>350-400
10.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
100.0%
(1/1)
0.0%
(0/0)
Table H-20. Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Days 1, 3, and 7; Calibration
3 or 4 times a day, Buttock
YSI
Glucose
Ranges
(mg/dL)
Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range
SG (mg/dL)
Number
of
Paired
SG-YSI
<40 ≥40-60 >60-80 >80-120 >120-16
0
>160-20
0
>200-25
0
>250-30
0
>300-35
0
>350-40
0
>400
B) ≥40-60 2 0.0%
(0/0)
50.0%
(1/2)
0.0%
(0/0)
50.0%
(1/2)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
670G Performance Data and Technical Information
670G Performance Data and Technical Information 387