Actively Recruiting
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Led by Insulet Corporation · Updated on 2026-05-04
2200
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Humalog U-100, Novolog, or Admelog insulin during the study
- Able to read and speak English or Spanish fluently and reside full time in the United States
- Willing to collect A1C samples using a home kit and send them to the study lab at baseline and at 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 study end
- Not currently pregnant or planning pregnancy within 12 months and using reliable birth control
- Access to internet via phone, tablet, or computer to use the registry online platform
- Willing to provide prior CGM and insulin delivery data if available
- Willing and able to provide informed consent or have a parent/guardian able to consent as applicable
You will not qualify if you...
- Diagnosed with sickle cell anemia or other hemoglobinopathy
- Planned blood transfusions during the study or blood transfusion within 3 months prior to starting Omnipod 5
- Adults unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Circuit Clinical
Buffalo, New York, United States, 14203
Actively Recruiting
Research Team
T
Trang Ly, MBBS, PhD
CONTACT
J
Julie Perkins
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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