Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

Recruiting now

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT06144554

Run by

Insulet Corporation

People needed

2200

Starts

2023-09-25

Expected to finish

2028-09-01

Last updated by the study team

2026-07-01

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Diagnosed with sickle cell anemia and/or hemoglobinopathy
• Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
• Adults that are unable to provide informed consent

Where it is running

• Circuit Clinical — Buffalo, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.