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
Demographics
Baseline characteristics including demographics of the subjects at the start of the
3-month Omnipod 5 treatment phase are provided in the table below.
Baseline Characteristics at Omnipod 5 Treatment Phase Start (N=240)
Characteristic
Children
(6 to 13.9 years)
Adolescents & Adults
(14 to 70 years)
n 112 128
Age (years) ± SD 10.3 ± 2.2 36.9 ± 13.9
Duration of diabetes
(years)
4.7 ± 2.6 17.9 ± 11.6
A1C
§
7.67% ± 0.95% 7.16% ± 0.86%
Daily insulin dose (U/kg)
¥
0.85 ± 0.24 0.61 ± 0.22
Body mass index (BMI) 18.6 ± 3.2 26.6 ± 4.7
Female sex 60 (53.6%) 78 (60.9%)
Previous
¶
or current con-
tinuous glucose monitor
(CGM) use
108 (96.4%) 126 (98.4%)
Previous
¶
or current pump
use
100 (89.3%) 115 (89.8%)
Race / Ethnicity
‡
White 110 (98.2%) 118 (92.2%)
Hispanic or Latino 8 (7.1%) 10 (7.8%)
Black or African Amer-
ican
5 (4.5%) 5 (3.9%)
Asian 3 (2.7%) 2 (1.6%)
Native Hawaiian or other
Pacic Islander
1 (0.9%) 0 (0.0%)
American Indian or
Alaska Native
0 (0.0%) 4 (3.1%)
Plus-minus values are average ± standard deviation; results reported with number in brackets
aerwards represent number of subjects (% of subjects).
§
Glycated hemoglobin determined from laboratory assessment.
¥
Baseline total daily insulin dose was determined from data collected during the standard therapy
phase.
¶
Previous use is dened as having used the device for any duration in the past.
‡
Race and ethnicity were reported by the subjects. Groups are not mutually exclusive .