RecruitingNCT06144554

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

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

Sponsor

Insulet Corporation

Enrollment

2,200 participants

Start Date

Sep 25, 2023

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes

Summary

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

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This is a registry study (not a treatment study) tracking real-world use of the Omnipod 5 system — a device that automatically delivers insulin based on continuous glucose readings — in children and adults with Type 1 diabetes. **You may be eligible if...** - You have self-reported Type 1 diabetes - You have just been prescribed and started using the Omnipod 5 system (within the past 2 weeks) or are about to start - You live in the United States and can speak and read English or Spanish - You are using certain approved fast-acting insulins (Humalog, Novolog, or Admelog) - You are not currently pregnant and have access to the internet **You may NOT be eligible if...** - You have sickle cell anemia or a hemoglobin disorder - You have received a blood transfusion within the last 3 months - You are an adult who is unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEOmnipod 5

The Omnipod 5 System consists of a tubeless insulin Pod and the Omnipod® 5 App, installed on a designated Controller or compatible Android smartphone. The Omnipod 5 System works with the Dexcom G6® Continuous Glucose Monitoring System to continuously adapt and automatically deliver insulin according to personal needs. Every two weeks while on the Omnipod 5 system, participants will receive a push notification to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment.