Status:
RECRUITING
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Lead Sponsor:
Insulet Corporation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2+ years
Brief Summary
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.
Detailed 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. A m...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT06144554
Start Date
September 25 2023
End Date
September 1 2027
Last Update
May 16 2025
Active Locations (1)
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1
Circuit Clinical
Buffalo, New York, United States, 14203