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Table H- 15: Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Day 1; Calibration every 12
hours, Abdomen
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
0I
>200-25
0
>250-30
0
>300-35
0
>350-40
0
>400
J)
>350-400
------------
Note: For the blank Cells (-), there are no paired points in this reference range.
Table H- 16: 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, Abdomen
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------------
C) >60-80 1 0.0%
(0/0)
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)
D)
>80-120
11 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
63.6%
(7/11)
36.4%
(4/11)
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
10 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
20.0%
(2/10)
60.0%
(6/10)
20.0%
(2/10)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F)
>160-200
11 0.0%
(0/0)
0.0%
(0
/0)
0.0%
(0/0)
0.0%
(0/0)
18.2%
(2/11)
63.6%
(7/11)
18.2%
(2/11)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
60.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
16.7%
(1/6)
0.0%
(0/0)
33.3%
(2/6)
50.0%
(3/6)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
19 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
26.3%
(5/19)
42.1%
(8/19)
21.1%
(4/19)
5.3%
(1/19)
5.3%
(1/19)
I)
>300-350
50.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
20.0%
(1/5)
20.0%
(1/5)
60.0%
(3/5)
0.0%
(0/0)
0.0%
(0/0)
J)
>350-400
------------
Note: For the blank Cells (-), there are no paired points in this reference range.
Table H-17: Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Day 1; Calibration 3 or 4
times a day, Abdomen
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
C) >60-80------------
670G Performance Data and Technical Information
670G Performance Data and Technical Information 385