OmniPod 5 - Page 298

Overview of the Omnipod 5 System Pivotal Clinical Study 25
290
25 Overview of the Omnipod 5 System Pivotal Clinical Study
Glycaemic 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
3.9–10 mmol/L,
70–180 mg/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 glucose,
mmol/L, mg/dL
(std dev)
9.8, 177
(1.9, 35)
8.3, 149
(0.9, 17)
-1.6, -29* 8.9, 160
(1.9, 34)
8.3, 149
(1.2, 21)
-0.6, -11*
Avg standard
deviation of sensor
glucose, mmol/L,
mg/dL
(std dev)
3.4, 61
(0.8, 15)
2.7, 48
(0.7, 12)
-0.7, -13* 3.1, 56
(0.9, 17)
2.4, 44
(0.7, 13)
-0.7, -12*
Avg coecient of
variation of sensor
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
% <3 mmol/L
<54 mg/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
% <3.9 mmol/L,
<70 mg/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 % >10 mmol/L,
>180 mg/dL
(std dev)
42.2%
(20.0%)
20.7%
(10.8%)
-21.5%* 32.1%
(20.2%)
20.7%
(14.1%)
-11.3%*
Avg %
≥13.9 mmol/L,
≥250 mg/dL
(std dev)
16.3%
(15.0%)
5.4%
(5.1%)
-10.9%* 10.6%
(12.7%)
4.8%
(7.0%)
-5.7%*
Avg %
≥16.7 mmol/L,
≥300 mg/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 the standard-therapy phase and the Omnipod 5 System phase was statistically
signicant