Registry for the Omnipod 5 System in Type 1 Diabetes Patients
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 · NCT06144554
This study is testing how safe and effective the Omnipod 5 insulin delivery system is for both kids and adults with Type 1 Diabetes over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2200 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Insulet Corporation (industry) |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06144554 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to gather real-world evidence on the safety and effectiveness of the Omnipod 5 insulin delivery system in both children and adults with Type 1 Diabetes. A minimum of 2,200 participants will be recruited, including various age groups and insulin-naïve users, to ensure comprehensive data collection over a 12-month follow-up period. Participants will be required to complete assessments and submit A1C samples at specified intervals throughout the study.
Who should consider this trial
Good fit: Ideal candidates include individuals with self-reported Type 1 Diabetes who have recently started or plan to start using the Omnipod 5 system.
Not a fit: Patients who are not using the Omnipod 5 system or those who are currently pregnant may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the real-world effectiveness of the Omnipod 5 system, potentially improving diabetes management for patients.
How similar studies have performed: Previous studies on similar insulin delivery systems have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Buffalo, New York
- Circuit Clinical — Buffalo, New York, United States (RECRUITING)
Study contacts
- Study coordinator: Trang Ly, MBBS, PhD
- Email: APClinical@insulet.com
- Phone: 978-600-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Omnipod, Automated Insulin Delivery, Registry