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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-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
J) >350–400 65 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)
18.5%
(12/65)
64.6%
(42/65)
16.9%
(11/65)
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)
77.8%
(7/9)
11.1%
(1/9)
Table B-17: Concurrence of YSI values and SG readings using SG ranges on FST Day 1; 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 62 0.0%
(0/0)
37.1%
(23/62)
58.1%
(36/62)
4.8%
(3/62)
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) ≥40–60 247 2.4%
(6/247)
21.5%
(53/247)
58.7%
(145/247)
17.0%
(42/247)
0.4%
(1/247)
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) >60–80 429 0.2%
(1/429)
12.6%
(54/429)
52.0%
(223/429)
30.3%
(130/429)
4.4%
(19/429)
0.5%
(2/429)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
D) >80–120 1014 0.0%
(0/0)
0.1%
(1/1014)
5.3%
(54/1014)
70.7%
(717/1014)
20.4%
(207/
1014)
3.1
%
(31/1014)
0.4%
(4/1014)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120–160 973 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
9.1%
(89/973)
61.6%
(599/973)
24.8%
(241/973)
4.0%
(39/973)
0.5%
(5/973)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F) >160–200 633 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.3%
(2/633)
10.7%
(68/633)
56.7%
(359/633)
30.3%
(192/633)
1.9%
(12/633)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G) >200–250 497 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.2%
(1/497)
7.8%
(39/497)
64.6%
(321/497)
26.4%
(131/497)
1.0%
(5/497)
0.0%
(0/0)
0.0%
(0/0)
H) >250–300 224 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
12.9%
(29/224)
58.0%
(130/224)
23.7%
(53/224)
5.4%
(
12/224)
0.0%
(0/0)
I) >300–350 97 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)
19.6%
(19/97)
59.8%
(58/97)
18.6%
(18/97)
2.1%
(2/97)
J) >350–400 22 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)
27.3%
(6/22)
63.6%
(14/22)
9.1%
(2/22)
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 SG-YSI points on FST Day 1 was from 88 subjects.
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
A) <40 75 2.7%
(2/75)
44.0%
(33/75)
52.0%
(39/75)
1.3%
(1/75)
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)
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 337