Users Manual Part 7

Overview of Omnipod 5 System Pivotal Clinical Study 25
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25 Overview of Omnipod 5 System Pivotal Clinical Study
Insulin Requirements
e table below provides information on the average insulin requirements
during the standard therapy phase and the 3-month Omnipod 5 System phase.
Total daily insulin requirements increased in children and decreased slightly in
adolescents and adults.
Characteristic
Children (6 to 13.9 years)
(n=112)
Adolescents & Adults (14 to 70
years)
(n=128)
Standard
erapy
Omnip-
od 5
Change Standard
erapy
Omnip-
od 5
Change
Avg total daily
insulin, U/kg
(std dev)
0.85
(0.24)
0.92
(0.25)
0.07* 0.61
(0.22)
0.59
(0.21)
-0.02*
Avg total daily
basal insulin,
U/kg
(std dev)
0.36
(0.13)
0.47
(0.15)
0.10* 0.31
(0.11)
0.30
(0.11)
-0.01
Avg total daily
bolus insulin,
U/kg
(std dev)
0.48
(0.18)
0.45
(0.13)
-0.03* 0.31
(0.16)
0.29
(0.12)
-0.01
*Change between standard therapy phase and Omnipod 5 System phase was statistically signicant
Body Mass Index Results
e table below provides information on the average body mass index (BMI),
which is a measure of weight adjusted for height, and BMI z-score, which is a
measure of weight adjusted for height, sex, and age, during the standard therapy
phase and the 3-month Omnipod 5 System phase in children. Although BMI
increased in children, the BMI z-score remained unchanged.
Characteristic
Children (6 to 13.9 years)
n=112
Standard erapy Omnipod 5 Change
BMI, kg/m
2
(std dev)
18.6
(3.2)
19.2
(3.6)
0.54*
BMI z-score
(std dev)
0.4
(0.8)
0.4
(0.8)
0.03
*Change between standard therapy phase and Omnipod 5 System phase was statistically signicant