Real-world study of the Omnipod 5 insulin system in type 1 diabetes
Collects real-world safety and effectiveness data on Omnipod 5 in people with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Key facts
- Where
- Buffalo, United StatesSee the site
Where in United States
- Circuit ClinicalBuffalo, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insulet Corporation
- Trial code
- NCT06144554
- Record updated
- 1 July 2026
- Original description
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.Read full original descriptionShow less
Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
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.
Inclusion: 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.
Exclusion: Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5; Diagnosed with sickle cell anemia and/or hemoglobinopathy; Adults that are unable to provide informed consent.