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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-17: Overall concurrence of YSI values and SG readings using YSI 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
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
C) >60-80 90.0%
(0/0)
0.0%
(0/0)
55.6%
(5/9)
44.4%
(4/9)
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 46 0.0%
(0/0)
2.2%
(1/46)
10.9%
(5/46)
67.4%
(31/46)
19.6%
(9/46)
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 85 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
16.5%
(14/85)
60.0%
(51/85)
22.4%
(19/85)
1.2%
(1/85)
0.0% (0/0) 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
F) >160-200 91 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
2.2%
(2/91)
16.5%
(15/91)
70.3%
(64/91)
11.0%
(10/91)
0.0% (0/0) 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
76 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 1.3%
(1/76)
27.6%
(21/76)
68.4%
(5
2/76)
2.6%
(2/76)
0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
31 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 38.7%
(12/31)
58.1%
(18/31)
3.2%
(1/31)
0.0%
(0/0)
0.0%
(0/0)
I) >300-350 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) 0.0% (0/0) 29.6%
(8/27)
70.4%
(19/27)
0.0%
(0/0)
0.0%
(0/0)
J) >350-400 70.0%
(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) 57.1%
(4/7)
42.9%
(3/7)
0.0%
(0/0)
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 15 subjects.
Table E-18: Overall concurrence of YSI values and SG readings using YSI 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
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 37 8.1%
(3/37)
24.3%
(9/37)
43.2%
(16/37)
24.3%
(9/37)
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) >80-120 156 0.6%
(1/156)
5.1%
(8/156)
9.0%
(14/156)
75.6%
(118/156)
9.6%
(15/156)
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
170 0.0%
(0/0)
0.0%
(0/0)
2.9%
(5/170)
16.5%
(28/170)
67.6%
(115/170)
12.9%
(22/170)
0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F)
>160-200
144 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 16.0%
(23/144)
75.7%
(109/144)
8.3%
(12/144)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
130 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 2.3%
(3/130)
38.5%
(50/130)
56.2%
(73/130)
3.1%
(4/130)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
49 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 40.8%
(20/49)
53.1%
(26/49)
6.1%
(3/49)
0.0%
(0/0)
0.0%
(0/0)
I)
>300-350
15 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) 33.3%
(5/15)
60.0%
(9/15)
6.7%
(1/15)
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)
50.0%
(3/6)
50.0%
(3/6)
0.0%
(0/0)
■
670G Performance Data and Technical Information
670G Performance Data and Technical Information 361