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