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 by Baseline Treatment
e table below provides information on the average glycemic results at baseline
(or during standard therapy phase) and the 3-month Omnipod 5 System
treatment phase analyzed by baseline treatment (standard therapy). Standard
therapy consisted of multiple daily insulin injections (MDI) or insulin pump
use. Time in range (70-180 mg/dL) and A1C were improved aer 3 months of
Omnipod 5 System use regardless of baseline treatment type. Aer 3 months
of Omnipod 5 System use, time <70mg/dL improved in adolescents and adults
regardless of baseline therapy, but remained unchanged in children.
Subgroup Analysis of Average Glycemic Results by Baseline Treatment in
Children (6 to 13.9 years)
Characteristic
MDI (n=13) Insulin Pump (n=99)
Standard
erapy
Omnipod 5
Standard
erapy
Omnipod 5
% Time in range 70-
180mg/dL
52% 69%* 53% 68%*
% Time <70mg/dL
‡
1.54% 1.41% 1.38% 1.49%
A1C% 7.7% 6.7%* 7.7% 7.0%*
*Change between standard therapy phase and Omnipod 5 System phase was statistically signicant
‡
Values presented for % Time <70mg/dL are medians, the remaining values in the table are averages .
Subgroup Analysis of Average Glycemic Results by BaselineTreatment in
Adolescents and Adults (14 to 70 years)
Characteristic
MDI (n=20) Insulin Pump (n=105)
Standard
erapy
Omnipod 5 Standard
erapy
Omnipod 5
% Time in range 70-
180mg/dL
60% 72%* 66% 74%*
% Time <70mg/dL
‡
2.38% 0.79%* 1.93% 1.16%*
A1C% 7.6% 7.0%* 7.1% 6.7%*
*Change between baseline/standard therapy and the Omnipod 5 System phase was statistically
signicant.
‡
Values presented for % Time below 70mg/dL are medians, the remaining values in the table are
averages.
An analysis by baseline demographic characteristics, including those mentioned
in the subgroup analyses above, demonstrated similar glycemic improvement
as the overall study population. Please note that the study was not designed to
determine dierences in benet or risk from each subgroup.