NCT06144554Recruiting
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2200 (estimated)
- First submitted
- 10 Nov 2023
- Start date
- 25 Sept 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- Insulet Corporation
- Diseases
- Type 1 diabetes
- NCT number
- NCT06144554
What you commit to
- Study type: Observational
- Planned participants: 2200
- From 25 Sept 2023 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
Other
- Diagnosed with sickle cell anemia and/or hemoglobinopathy
- Adults that are unable to provide informed consent
Who the study is looking for
- Self-reported type 1 diabetes
- 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
- Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
- Able to read and speak English or Spanish (when available) fluently and reside full time in the United States
- 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
- Willing and able to complete registry assessments every two weeks
- Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)
- Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control
- Access to internet via phone, tablet and/or computer to use the registry online platform
- 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)
- Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable
Age in the registry: 2 years to - · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Circuit Clinical Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.