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

Insulet

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Device: Omnipod 5

Study type: Observational

Funder types: Industry

Identifiers

NCT06144554

Post-Market Registry

Details and patient eligibility

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.

Full 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 minimum of 2,200 Type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. The minimum number of completed participants is as follows:

• 150 participants aged 2-5
• 300 participants aged 6-13
• 300 participants aged 14-17
• 900 participants aged 18+

In addition to the enrollment targets above, a minimum of 1100 Omnipod-naïve users, 880 pump-naïve users, and 110 CGM-naïve users will be recruited.

Participants are expected to be followed for 12 months.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

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

Trial design

2,200 participants in 1 patient group

Omnipod User

Description:

All new users for the Omnipod 5 System will be required to register with Insulet's Podder Central. Users already in Podder Central will be required to log into their account before logging into the Omnipod 5 Controller if transitioning to the Omnipod 5 System. As part of the onboarding process, users will be invited to participate in this registry.

Treatment:

Device: Omnipod 5