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ManualsBrandsMedtronic MiniMed ManualsElectronicsThe NGP BLE (M994838A001) connect system is an insulin pump therapy management system.
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Table E-19: Overall concurrence of YSI values and SG readings using YSI 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
Number
of Paired
SG-YSI
SG (mg/dL)
<40 ≥40–60 >60–80 >80–120 >120–
160
>160–
200
>200–
250
>250–
300
>300–
350
>350–
400
>400
B) ≥40-60 4 100.0%
(4/4)
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)
0.0%
(0/0)
C) >60-80 22 13.6%
(3/22)
27.3%
(6/22)
31.8%
(7/22)
27.3%
(6/22)
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 68 1.5%
(1/68)
11.8%
(8/68)
13.2%
(9/68)
58.8%
(40/68)
14.7%
(10/68)
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 74 0.0% (0/0) 0.0%
(0/0)
6.8%
(5/74)
23.0%
(17/74)
56.8%
(42/74)
13.5%
(10/74)
0.0%
(0/0)
0.0%
(0/0)
0.
0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
F) >160-200 76 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
18.4%
(14/76)
72.4%
(55/76)
9.2%
(7/76)
0.0%
(0/0)
0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
67 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
3.0%
(2/67)
19.4%
(13/67)
73.1%
(49/67)
4.5%
(3/67)
0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
27 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
44.4%
(12/27)
48.1%
(13/27)
7.4%
(2/27)
0.0%
(0/0)
0.0%
(0/0)
I) >300-350 3 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%
(3/3)
0.0%
(0/0)
0.0%
(0/0)
J) >350-400 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)
0.0%
(0/0)
50
.0%
(1/2)
50.0%
(1/2)
0.0%
(0/0)
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 14 subjects.
Table E-20: Overall concurrence of YSI values and SG readings using YSI 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
Number
of Paired
SG-YSI
SG (mg/dL)
<40 ≥40–60 >60–80 >80–120 >120–160 >160–200 >200–
250
>250–
300
>300–
350
>350–
400
>400
B) ≥40-60 11 36.4%
(4/11)
63.6%
(7/11)
0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
C) >60-80 30 6.7%
(2/30)
10.0%
(3/30)
50.0%
(15/30)
33.3%
(10/30)
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) >80-120 144 0.7%
(1/144)
1.4%
(2/144)
7.6%
(11/144)
80.6%
(116/144)
9.7%
(14/144)
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
164 0.0%
(0/0)
0.0%
(0/0)
1.8%
(3/164)
16.5%
(27/164)
67.1%
(110/164)
14.0%
(23/164)
0.6%
(1/164)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F)
>160-200
140 0.0%
(0/0)
0.0%
(0/0)
0.
0% (0/0) 0.0% (0/0) 14.3%
(20/140)
75.0%
(105/140)
10.7%
(15/140)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
127 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 1.6%
(2/127)
42.5%
(54/127)
51.2%
(65/127)
4.7%
(6/127)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
53 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 41.5%
(22/53)
39.6%
(21/53)
17.0%
(9/53)
1.9%
(1/53)
0.0%
(0/0)
I)
>300-350
18 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) 38.9%
(7/18)
38.9%
(7/18)
22.2%
(4/18)
0.0%
(0/0)
J)
>350-400
60.0%
(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)
16.7%
(1/6)
83.3%
(5/6)
0.0%
(0/0)
362 Chapter 17