OmniPod 5 - Body Mass Index Results; Insulin Requirements

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Overview of the Omnipod 5 System Pivotal Clinical Study 2525 Overview of the Omnipod 5 System Pivotal Clinical Study
to the overall study population. Please note that the study was not designed to
determine dierences in benet or risk from each subgroup.
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)
(std dev)
34.4
(17.5)
37.2
(19.6)
2.9* 48.2
(21.0)
46.4
(18.1)
-
-1.8*
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 the standard-therapy phase and the 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 the standard-therapy phase and the Omnipod 5 System phase was statistically signicant