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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years and older
Sex
All sexes
Healthy volunteers
Not stated
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants are expected to be followed for 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects information about how safe the Omnipod 5 system is and how well it works in daily life. It is for children and adults with type 1 diabetes who have just started using the system or plan to start soon.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Report that you have type 1 diabetes.
  • Have been prescribed and received Omnipod 5, and have used it for no more than 2 weeks or plan to start within 2 weeks.
  • Agree to use only these U-100 insulins during the study: Humalog U-100, Novolog, or Admelog.
  • Read and speak English or Spanish (when available) fluently, live full time in the United States, and have internet access on a phone, tablet, or computer.
  • Use a home kit to collect A1C samples and mail them to the study lab at the start and at 3, 6, 9, and 12 months. A1C measures average blood sugar.
  • Complete study check-ins every 2 weeks and questionnaires at the start, at 6 months, and at the end or when you leave the study.
  • Not be pregnant or plan to become pregnant in the next 12 months, and use reliable birth control.
  • Be able and willing to agree to join the study, with a parent or guardian's permission when needed.

Who can't join

  • Have sickle cell anemia or another hemoglobin disorder, which affects the protein in red blood cells that carries oxygen.
  • Plan to receive donated blood during the study, or received it within 3 months before starting Omnipod 5.
  • Be an adult who cannot give informed consent, meaning you cannot understand the study and agree to join.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY