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Table B-14: Overall concurrence of YSI values and SG readings using SG ranges on FST Days 1, 3, and 7; Calibration every 12 hours,
Abdomen
Percent of matched pairs in each YSI glucose range for each SG range (mg/dL)
SG ranges
(mg/dL)
Number
of paired
SG-YSI
YSI Glucose Range (mg/dL)
<40 ≥40–60 >60–80 >80–120 >120–
160
>160–
200
>200–
250
>250–
300
>300–
350
>350–
400
>400
A) <40 154 0.0%
(0/0)
50.0%
(77/154)
47.4%
(73/154)
2.6%
(4/154)
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)
B) ≥40–60 781 1.2%
(9/781)
30.7%
(240/781)
57.2%
(447/781)
10.6%
(83/781)
0.3%
(2/781)
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 1350 0.2%
(3/1350)
8.3%
(112/
1350)
60.1%
(811/
1350)
29.2%
(394/
1350)
2.1%
(28/1350)
0.1%
(2/1350)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
D) >80–120 2953 0.0%
(0/0)
0.0%
(1/2953)
6.3%
(
185/
2953)
73.0%
(2157/
2953)
18.2%
(537/
2953)
2.0%
(60/2953)
0.4%
(13/2953)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120–160 2784 0.0%
(0/0)
0.0%
(0/0)
0.1%
(2/2784)
8.8%
(245/
2784)
67.7%
(1885/
2784)
20.3%
(565/
2784)
2.8%
(79/2784)
0.3%
(8/2784)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F) >160–200 1875 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.1%
(2/1875)
10.0%
(188/
1875)
60.2%
(1128/
1875)
28.2%
(529/
1875)
1.5%
(28/1875)
0.0%
(0/0))
0.0%
(0/0)
0.0%
(0/0)
G) >200–250 1382 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.3%
(4/1382)
8.0%
(111/
1382)
61.1%
(844/
1382)
28.1%
(389/
1382)
2.3%
(32/1382)
0.1%
(2/1382)
0.0%
(0/0)
H) >250–300 608 0.0%
(0/0)
0.
0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.3%
(2/608)
10.9%
(66/608)
61.2%
(372/608)
25.5%
(155/608)
2.1%
(13/608)
0.0%
(0/0)
I) >300–350 286 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
1.0%
(3/286)
19.9%
(57/286)
55.2%
(158/286)
22.4%
(64/286)
1.4%
(4/286)
J) >350–400 71 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)
1.4%
(1/71)
29.6%
(21/71)
53.5%
(38/71)
15.5%
(11/71)
K) >400 90.0%
(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)
11.1%
(1/9)
77.8%
(7/9)
11.1%
(1/9)
Table B-15: Concurrence of YSI values and SG readings using SG ranges on FST Day 1; Calibration every 12 hours, Abdomen
Percent of matched pairs in each YSI glucose range for each SG range (mg/dL)
SG ranges
(mg/dL)
Number
of paired
SG-YSI
YSI Glucose Range (mg/dL)
<40 ≥40–60 >60–80 >80–120 >120–
160
>160–
200
>200–
250
>250–
300
>300–
350
>350–
400
>400
A) <40 71 0.0%
(0/0)
38.0%
(27/71)
57.7%
(41/71)
4.2%
(3/71)
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)
B) ≥40–60 278 2.2%
(6/278)
23.0%
(64/278)
55.8%
(155/278)
18.7%
(52/278)
0.4%
(1/278)
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) >60–80 474 0.4%
(2/474)
12.0%
(57/474)
47.7%
(226/474)
34.8%
(165/474)
4.6%
(22/474)
0.4%
(2/474)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
D) >80–120 1071 0.0%
(0/0)
0.1%
(1/1071)
4.6%
(49/1071)
66.6%
(713/
1071)
23.4%
(251/
10
71)
4.5%
(48/1071)
0.8%
(9/1071)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120–160 978 0.0%
(0/0)
0.0%
(0/0)
0.1%
(1/978)
8.3%
(81/978)
58.4%
(571/978)
26.8%
(262/978)
5.9%
(58/978)
0.5%
(5/978)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
670G Performance Data and Technical Information
670G Performance Data and Technical Information 335