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Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
RecruitingObservational study
Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Who can join
Ages 2 and older · All sexes
Full 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
About the study
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.
What is being tested
- Omnipod 5 (device)
Sponsor: Insulet Corporation · Participants: 2,200 · Started: Sep 25, 2023
Contact the study team
- Trang Ly, MBBS, PhD · Phone: 978-600-7000
- Julie Perkins · Phone: 978-600-7000
Official record on ClinicalTrials.gov — NCT06144554
Locations in the U.S.
| New York | Circuit Clinical, Buffalo |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.