Manualshelf

Product Info

ManualsBrandsMedtronic MiniMed ManualsElectronicsThe NGP BLE (M994838A001) connect system is an insulin pump therapy management system.
51525354555657585960
Table Of Contents
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
G) >200–250 355 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.3%
(1/355)
7.9%
(28/355)
63.9%
(227/
355)
27.0%
(96/355)
0.8%
(3/355)
0.0%
(0/0)
0.0%
(0/0)
H) >250–300 175 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
10.9%
(19/175)
65.7%
(115/175)
21.1%
(37/175)
2.3%
(4/175)
0.0%
(0/0)
I) >300–350 91 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)
20.9%
(19/91)
52.7%
(48/91)
24.2%
(22/91)
2.2%
(2/91)
J) >350–400 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)
13.3%
(2/15)
33.3%
(5/15)
53.3%
(8/15)
0.0%
(0/0)
K) >400 10.0%
(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%
(1/1)
0.0%
(0/0)
0.0%
(0/0)
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 82 subjects.
Table B-20: Overall concurrence of YSI values and SG readings using SG ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day,
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 73 2.7%
(2/73)
45.2%
(33/73)
50.7%
(37/73)
1.4%
(1/73)
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) ≥40–60 503 1.0%
(5/503)
45.9%
(231/503)
48.3%
(243/503)
4.8%
(24/503)
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 1291 0.2%
(2/
1291)
8.9%
(115/
1291)
72.3%
(933/
1291)
18.4%
(237/1291)
0.3%
(4/1291)
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 2756 0.0%
(0/0)
0.1%
(3/2756)
7.0%
(194/
27
56)
75.9%
(2092/
2756)
16.5%
(456/
2756)
0.4%
(11/
2756)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120–160 2442 0.0%
(0/0)
0.0%
(0/0)
0.1%
(2/2442)
9.3%
(228/2442)
71.4%
(1743/
2442)
18.0%
(439/
2442)
1.2%
(30/2442)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F) >160–200 1588 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.1%
(2/1588)
9.4% (150/
1588)
66.3%
(1053/
1588)
23.5%
(373/
1588)
0.6%
(9/1588)
0.1%
(1/1588)
0.0%
(0/0)
0.0%
(0/0)
G) >200–250 1246 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.5%
(6/1246)
7.4%
(92/
1246)
65.7%
(818/
1246)
25.1%
(313/
1246)
1.4%
(17/1246)
0.0%
(0/0)
0.0%
(0/0)
H) >250–300 613 0.0%
(0/0)
0.0%
(0/0)
0.
0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.2%
(1/613)
8.6%
(53/613)
65.1%
(399/613)
24.6%
(151/613)
1.5%
(9/613)
0.0%
(0/0)
I) >300–350 271 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)
16.2%
(44/271)
59.8%
(162/271)
23.2%
(63/271)
0.7%
(2/271)
J) >350–400 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)
0.0%
(0/0)
4.9%
(3/61)
11.5%
(7/61)
70.5%
(43/61)
13.1%
(8/61)
■
670G Performance Data and Technical Information
670G Performance Data and Technical Information 339