Users Manual Part 7

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Overview of Omnipod 5 System Pivotal Clinical Study 2525 Overview of Omnipod 5 System Pivotal Clinical Study
Glycemic Results Overnight (12:00AM to 6:00AM)
Characteristic
Children (6 to 13.9 years)
(n=112)
Adolescents & Adults (14 to 70
years)
(n=128)
Stan-
dard
erapy
Omnip-
od 5
Change Stan-
dard
erapy
Omnip-
od 5
Change
Avg % time 70-
180mg/dL
(std dev)
55.3%
(19.0%)
78.1%
(10.8%)
22.9%* 64.3%
(19.5%)
78.1%
(13.9%)
13.8%*
Avg sensor glu-
cose, mg/dL
(std dev)
177
(35)
149
(17)
-29* 160
(34)
149
(21)
-11*
Avg standard de-
viation of sensor
glucose, mg/dL
(std dev)
61
(15)
48
(12)
-13* 56
(17)
44
(13)
-12*
Avg coecient of
variation of sen-
sor glucose, %
(std dev)
34.6%
(7.1%)
31.9%
(5.6%)
-2.8%* 35.0%
(7.9%)
28.9%
(5.8%)
-6.2%*
Percentage time
in glucose range,
%
Median
% <54mg/dL
(Q1,Q3)
0.00%
(0.00,
0.30)
0.09%
(0.02,
0.32)
0.02% 0.00%
(0.00,
1.06)
0.09%
(0.02,
0.30)
0.00%*
Median
% <70mg/dL
(Q1,Q3)
0.78%
(0.00,
2.84)
0.78%
(0.37,
1.49)
0.01%* 2.07%
(0.50,
5.54)
0.82%
(0.31,
1.62)
-0.86%*
Avg % >180mg/
dL
(std dev)
42.2%
(20.0%)
20.7%
(10.8%)
-21.5%* 32.1%
(20.2%)
20.7%
(14.1%)
-11.3%*
Avg % ≥250mg/
dL
(std dev)
16.3%
(15.0%)
5.4%
(5.1%)
-10.9%* 10.6%
(12.7%)
4.8%
(7.0%)
-5.7%*
Avg % ≥300mg/
dL
(std dev)
6.7%
(9.1%)
1.8
(2.5%)
-4.8%* 4.2%
(8.0%)
1.5%
(3.1%)
-2.7%*
*Change between standard therapy phase and Omnipod 5 System phase was statistically signicant