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Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System

NCT07579702 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-12

No results posted yet for this study

Summary

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

Conditions

Interventions

DEVICE

Omnipod 6 System

The Omnipod 6 System with the study CGM

DEVICE

Omnipod 5 System

The Omnipod 5 System with the study CGM

Sponsors & Collaborators

  • Insulet Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-11
Primary Completion
2027-02-01
Completion
2027-02-01
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579702 on ClinicalTrials.gov