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RECRUITING
NCT06144554

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

Sponsor: Insulet Corporation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2200

Start Date

2023-09-25

Completion Date

2027-09

Last Updated

2025-05-16

Healthy Volunteers

Not specified

Conditions

Interventions

DEVICE

Omnipod 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.

Locations (1)

Circuit Clinical

Buffalo, New York, United States