Loading clinical trials...
Loading clinical trials...
Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
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.
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. A minimum of 2,200 Type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. The minimum number of completed participants is as follows: * 150 participants aged 2-5 * 300 participants aged 6-13 * 300 participants aged 14-17 * 900 participants aged 18+ In addition to the enrollment targets above, a minimum of 1100 Omnipod-naïve users, 880 pump-naïve users, and 110 CGM-naïve users will be recruited. Participants are expected to be followed for 12 months.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
Circuit Clinical
Buffalo, New York, United States
Start Date
September 25, 2023
Primary Completion Date
June 1, 2027
Completion Date
September 1, 2027
Last Updated
May 16, 2025
2,200
ESTIMATED participants
Omnipod 5
DEVICE
Lead Sponsor
Insulet Corporation
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07455994