NCT06144554

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-25
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2023-11-22
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study