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Recruiting NCT06144554

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

Trial Parameters

Condition Type 1 Diabetes
Sponsor Insulet Corporation
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,200
Sex ALL
Min Age 2 Years
Max Age N/A
Start Date 2023-09-25
Completion 2027-06
Interventions
Omnipod 5

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Self-reported type 1 diabetes 2. Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks 3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog 4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States 5. Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months 6. Willing and able to complete registry assessments every two weeks 7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal) 8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control 9. Access to internet via phone, tablet and/or computer to use the registry online platfo

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