OmniPod 5 - Studies in very Young Children with Type 1 Diabetes

Overview of the Omnipod 5 System Pivotal Clinical Study 25
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25 Overview of the Omnipod 5 System Pivotal Clinical Study
25.2. Studies in Very Young Children with Type 1
Diabetes
Omnipod 5 Clinical Study in Very Young Children
e goal of this study was to assess the safety and eectiveness of the Omnipod 5
System in children with type 1 diabetes aged 2 to 5.9 years. is single-arm,
multicentre, prospective study enrolled 80 children.
A 2-week standard-therapy phase (usual insulin regimen) was followed by
3 months of Omnipod 5 System use in Automated Mode. e primary analysis
consisted of A1C and sensor glucose time in range (3.9–10 mmol/L,
70–180 mg/dL) results.
e primary safety endpoints included the incidence of severe hypoglycaemia
and diabetic ketoacidosis (DKA). An analysis of the secondary endpoints and
additional metrics was also performed. An analysis of the primary, secondary and
safety results are presented in the tables below.
Of the 80 participants enrolled, 100% completed the trial. e study population
consisted of children diagnosed with type 1 diabetes based on the investigator’s
clinical judgement. All participants were required to have an A1C <10.0% at
screening. Participants had to be living with a parent or legal guardian. No
participants with the following conditions were enrolled:
• History of severe hypoglycaemia or DKA in the past 6 months
• Sickle cell disease, adrenal insuciency, abnormal kidney function
(eGFR <45), haemophilia or any other bleeding disorders, untreated
thyroid disease
• Plans to receive a blood transfusion during the study
• Taking oral or injectable steroids or diabetes medications other than
metformin and insulin
e safety and eectiveness of the Omnipod 5 System in users with the conditions
above is unknown. Please note that the study exclusion list above is condensed
and does not include every exclusion criterion. e trial was registered at
clinicaltrials.gov, a national database of clinical trials in the United States, with ID
number NCT04476472. Full details of the study criteria can be found there.