OmniPod 5 - Glycaemic Results by Baseline Treatment

Overview of the Omnipod 5 System Pivotal Clinical Study 25
292
25 Overview of the Omnipod 5 System Pivotal Clinical Study
Glycaemic Results by Baseline Treatment
e table below provides information on the average glycaemic results at baseline
(or during the standard-therapy phase) and the 3-month Omnipod 5 System
treatment phase, analysed by baseline treatment (standard therapy). Standard
therapy consisted of multiple daily insulin injections (MDI) or insulin pump use.
Time in range (3.9–10 mmol/L, 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 <3.9 mmol/L (<70 mg/dL) improved in
adolescents and adults regardless of baseline therapy, but remained unchanged in
children.
Subgroup Analysis of Average Glycaemic 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
3.9–10 mmol/L,
70–180 mg/dL
52% 69%* 53% 68%*
% Time <3.9 mmol/L
(<70 mg/dL)
1.54% 1.41% 1.38% 1.49%
A1C% 7.7% 6.7%* 7.7% 7.0%*
*Change between the standard-therapy phase and the Omnipod 5 System phase was statistically
signicant
‡
Values presented for % Time <3.9 mmol/L (<70 mg/dL) are medians; the remaining values in the table
are averages.
Subgroup Analysis of Average Glycaemic Results by Baseline Treatment
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
3.9–10 mmol/L,
70–180 mg/dL
60% 72%* 66% 74%*
% Time <3.9 mmol/L
(<70 mg/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 <3.9 mmol/L (<70 mg/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 glycaemic improvement