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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Insulet Corporation
Study ID
NCT06144554
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omnipod 5 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Nov 22, 2023
Start date
Sep 25, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
2,200 participants (estimated)

Arms

  • Arm: Omnipod User
    All new users for the Omnipod 5 System will be required to register with Insulet's Podder Central. Users already in Podder Central will be required to log into their account before logging into the Omnipod 5 Controller if transitioning to the Omnipod 5 System. As part of the onboarding process, users will be invited to participate in this registry.

Primary Outcome Measure

Incidence rate of severe hypoglycemia [ Time Frame: From baseline to study completion, up to 12 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Circuit ClinicalBuffaloNew York14203
Carmina VanHAll
[email protected]
603-309-7690
Ashok Subramanian, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Buffalo, NY

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Circuit Clinical· Buffalo, NY

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