NCT06144554

Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Insulet Corporation·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Type 1 Diabetes
Drug/Device/Intervention
Omnipod 5
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Insulet Corporation
Location
Buffalo, United States of America
Timeline & enrollment
Phase
N/A
Start date
Sep 25, 2023
End date
Jan 28, 2026
Enrollment
2200 participants
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
Type 1 diabetes mellitusType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06144554
Type
Device Trial
About this record

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.