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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 B-18: Overall concurrence of YSI values and SG readings using SG ranges on FST Days 1, 3, and 7; Calibration every 12 hours, Arm.
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
B) ≥40–60 520 1.0%
(5/520)
41.9%
(218/520)
51.7%
(269/520)
5.4%
(28/520)
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 1238 0.2%
(2/
1238)
9.2%
(114/
1238)
70.3%
(870/
1238)
20.0%
(247/1238)
0.4%
(5/1238)
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 2722 0.0%
(0/0)
0.1%
(3/2722)
7.5%
(203/
2722)
74.0%
(2014/
2722)
17.7%
(481/
2722)
0.8%
(21/2722)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120–160 2348 0.0%
(0/0)
0.0%
(0/0)
0.
1%
(3/2348)
9.2%
(215/2348)
70.4%
(1652/
2348)
18.0%
(423/
2348)
2.3%
(54/2348)
0.0%
(1/2348)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F) >160–200 1614 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.1%
(2/1614)
9.4% (151/
1614)
64.7%
(1044/
1614)
24.8%
(400/
1614)
0.9%
(14/1614)
0.2%
(3/1614)
0.0%
(0/0)
0.0%
(0/0)
G) >200–250 1212 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.6%
(7/1212)
6.8%
(83/1212)
63.9%
(774/
1212)
27.3%
(331/
1212)
1.4%
(17/1212)
0.0%
(0/0)
0.0%
(0/0)
H) >250–300 556 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.2%
(1/556)
9.4%
(52/556)
65.1%
(362/556)
23.9%
(133/556)
1.4%
(8/556)
0.0%
(0/0)
I) >300–350 256 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)
18.0%
(46/256)
56.6%
(145/256)
24.6%
(63/256)
0.8%
(2/256)
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)
3.3%
(2/60)
16.7%
(10/60)
66.7%
(40/60)
13.3%
(8/60)
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)
55.6%
(5/9)
33.3%
(3/9)
Table B-19: Concurrence of YSI values and SG readings using SG ranges on FST Day 1; Calibration every 12 hours, Arm.
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 54 3.7%
(2/54)
29.6%
(16/54)
64.8%
(35/54)
1.9%
(1/54)
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) ≥40–60 168 1.8%
(3/168)
22.0%
(37/168)
64.3%
(108/168)
11.9%
(20/168)
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) >60–80 339 0.6%
(2/339)
11.2%
(38/339)
58.1%
(197/339)
29.2%
(99/339)
0.9%
(3/339)
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) >80–120 895 0.0%
(0/0)
0.3%
(3/895)
6.6%
(59/895)
69.8%
(625/895)
21.6%
(193/895)
1.7%
(
15/895)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120–160 803 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
10.0%
(80/803)
64.6%
(519/803)
21.4%
(172/803)
4.0%
(32/803)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F) >160–200 549 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.2%
(1/549)
8.9%
(49/549)
61.4%
(337/549)
28.1%
(154/
549)
1.5%
(8/549)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
338 Chapter 17