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.
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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