Manualshelf

Product Info

ManualsBrandsMedtronic MiniMed ManualsElectronicsThe NGP BLE (M994838A001) connect system is an insulin pump therapy management system.
51525354555657585960
Table Of Contents
Table B-15: Concurrence of YSI values and SG readings using SG ranges on FST Day 1; Calibration every 12 hours, Abdomen
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
F) >160–200 662 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.3%
(2/662)
9.1%
(60/662)
52.6%
(348/662)
35.3%
(234/662)
2.7%
(18/662)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G) >200–250 515 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
6.2%
(32/515)
56.3%
(290/515)
33.8%
(174/515)
3.3%
(17/515)
0.4%
(2/515)
0.0%
(0/0)
H) >250–300 202 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
9.4%
(19/202)
55.0%
(111/202)
32.2%
(65/202)
3.5%
(7/202)
0.0%
(0/0)
I) >300–350 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)
20.0%
(18/90)
54.4%
(49/90)
23.3%
(21/90)
2.2%
(2/90)
J) >350–400 24 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)
4.2%
(1/24)
37.5%
(9/24)
50.0%
(12/24)
8.3%
(2/24)
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)
0.0%
(0/0)
0.0%
(0/0)
100.0%
(1/1)
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 88 subjects.
Table B-16: 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,
Abdomen.
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) <40 123 0.0%
(0/0)
52.0%
(64/123)
44.7%
(55/123)
3.3%
(4/123)
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) ≥40–60 686 1.3%
(9/686)
31.6%
(217/
686)
57.0%
(391/686)
9.9%
(68/686)
0.1%
(1/686)
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 1303 0.2%
(2/
1303)
8.1%
(106/
1303)
63.4%
(826/
1303)
26.2%
(342/1303)
1.9%
(25/1303)
0.2%
(2/1303)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
D) >80–120 2864 0.0%
(0/0)
0.0%
(1/2864)
6.5%
(1
86/
2864)
74.5%
(2133/
2864)
17.5%
(502/
2864)
1.3%
(36/2864)
0.2%
(6/2864)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120–160 2681 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
9.0%
(241/2681)
69.9%
(1874/
2681)
19.1%
(512/
2681)
1.8%
(49/2681)
0.2%
(5/2681)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F) >160–200 1820 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.1%
(2/1820)
10.3%
(188/
1820)
63.6%
(1157/
1820)
24.9%
(454/
1820)
1.0%
(19/1820)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G) >200–250 1314 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.5%
(7/1314)
8.5%
(112/
1314)
65.3%
(858/
1314)
24.6%
(323/
1314)
1.1%
(14/1314)
0.0%
(0/0)
0.0%
(0/0)
H) >250–300 652 0.0%
(0/0)
0.0%
(0
/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.3%
(2/652)
11.3%
(74/652)
63.5%
(414/652)
22.9%
(149/652)
2.0%
(13/652)
0.0%
(0/0)
I) >300–350 279 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)
17.9%
(50/279)
59.5%
(166/279)
21.1%
(59/279)
1.4%
(4/279)
336 Chapter 17