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

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.

Conditions

Type 1 Diabetes

Study Overview

Study Details

Study overview

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.

Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

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

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

Buffalo

Circuit Clinical, Buffalo, New York, United States, 14203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

2 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Insulet Corporation,

Study Record Dates

2026-01-28