Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes - Trial NCT06144554
Access comprehensive clinical trial information for NCT06144554 through Pure Global AI's free database. This phase not specified trial is sponsored by Insulet Corporation and is currently Recruiting. The study focuses on Type 1 Diabetes. Target enrollment is 2200 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Insulet Corporation
Timeline & Enrollment
N/A
Sep 25, 2023
Jan 28, 2026
Primary Outcome
Incidence rate of severe hypoglycemia,Incidence rate of DKA,A1c at 3, 6, 9 and 12 months,Percentage of time 54 mg/dL,Percentage of time 70 mg/dL,Percentage of time 180 mg/dL,Percentage of time 250 mg/dL,Percentage of time in range 70-180 mg/dL,Mean Glucose mg/dL,Standard deviation of glucose mg/dL,Glucose management indicator %,Percentage of participants achieving A1C 7%,Percentage of participants with time in range 70%,Percentage of participants with time below range (70mg/dL) of 4%,Insulin Usage,Body Mass Index (BMI) or BMI z-score,EQ-5D (inclusive of the Visual Analogue Scale (VAS)),Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE),System Usability Scale (SUS),Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature,Incidence rate of prolonged hyperglycemia (events per person months),Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL,Glucose Outcomes during the 4-hour post-bolus period using the SmartBolus Calculator: o Percentage of time 54 mg/dL o Percentage of time in range 70-180 mg/dL
Summary
This is a decentralized observational clinical registry to collect real-world evidence
 related to the safety and effectiveness of the Omnipod 5 system in children and adults with
 Type 1 Diabetes.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06144554
Device Trial