NCT06144554 Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
| NCT ID | NCT06144554 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insulet Corporation |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,200 participants |
| Start Date | 2023-09-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,200 participants in total. It began in 2023-09-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 platform 10. Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided) 11. Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable Exclusion Criteria: 1. Diagnosed with sickle cell anemia and/or hemoglobinopathy 2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5 3. Adults that are unable to provide informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06144554 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06144554 currently recruiting?
Yes, NCT06144554 is actively recruiting participants. Contact the research team at APClinical@insulet.com for enrollment information.
Where is the NCT06144554 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT06144554 clinical trial?
NCT06144554 is sponsored by Insulet Corporation. The trial plans to enroll 2,200 participants.
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