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ManualsBrandsMedtronic MiniMed ManualsElectronicsThe NGP BLE (M994838A001) connect system is an insulin pump therapy management system.
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Table Of Contents
Table E-15: Overall concurrence of YSI values and SG readings using YSI 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
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
D) >80-120 50 0.0%
(0/0)
6.0%
(3/50)
8.0%
(4/50)
62.0%
(31/50)
24.0%
(12/50)
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 94 0.0%
(0/0)
0.0%
(0/0)
1.1%
(1/94)
19.1%
(18/94)
58.5%
(55/94)
20.2%
(19/94)
1.1%
(1/94)
0.0% (0/0) 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
F) >160-200 95 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
2.1%
(2/95)
17.9%
(17/95)
69.5%
(66/95)
10.5%
(10/95)
0.0% (0/0) 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
83 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 1.2%
(1/83)
27.7%
(23/83)
68.7%
(57/83)
2.4%
(2/83)
0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
34 0.0%
(0/0)
0.0%
(0
/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 44.1%
(15/34)
52.9%
(18/34)
2.9%
(1/34)
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) 37.0%
(10/27)
63.0%
(17/27)
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) 100.0%
(7/7)
0.0%
(0/0)
0.0%
(0/0)
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 16 subjects.
Table E-16: 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,
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
B) ≥40-60 20.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 100.0%
(2/2)
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)
C) >60-80 18 0.0%
(0/0)
0.0%
(0/0)
61.1%
(11/18)
38.9%
(7/18)
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)
D) >80-120 120 0.0%
(0/0)
3.3%
(4/120)
15.8%
(19/120)
67.5%
(81/120)
13.3%
(16/120)
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
162 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 17.9%
(29/162)
64.8%
(105/162)
16.7%
(27/162)
0.6%
(1/162)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F)
>160-200
161 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 1.2%
(2/161)
25
.5%
(41/161)
65.2%
(105/161)
8.1%
(13/161)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
145 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 1.4%
(2/145)
42.8%
(62/145)
53.8%
(78/145)
2.1%
(3/145)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
61 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 32.8%
(20/61)
65.6%
(40/61)
1.6%
(1/61)
0.0%
(0/0)
0.0%
(0/0)
I) >300-350 32 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) 37.5%
(12/32)
62.5%
(20/32)
0.0%
(0/0)
0.0%
(0/0)
J)
>350-400
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)
55.6%
(5/9)
44.4%
(4/9)
0.0%
(0/0)
360 Chapter 17