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

Start date
Sep 25, 2023
Status verified
May 2025
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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