RECRUITING

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

Conditions

Type 1 Diabetes Omnipod Automated Insulin Delivery Registry

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-25

Study Completion:2026-01-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06144554

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.

Ages Eligible for Study:2 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Trang Ly, MBBS, PhD

CONTACT

978-600-7628

tly@insulet.com

Julie Perkins

CONTACT

978-600-7951

jperkins@insulet.com

Study Locations (Sites)

Circuit Clinical

Buffalo, New York, 14203

United States

Collaborators and Investigators

Sponsor: Insulet Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-25

Study Completion Date2026-01-28

Study Record Updates

Study Start Date2023-09-25

Study Completion Date2026-01-28

Terms related to this study

Keywords Provided by Researchers

Type 1 Diabetes
Omnipod
Automated Insulin Delivery
Registry

Additional Relevant MeSH Terms

Type 1 Diabetes