Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorInsulet Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Omnipod 5
Treatment groups
2,200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov