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Omnipod 5 System Compared to Pump Therapy

NCT05409131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-09-16

Study results available
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Summary

Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.

Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.

Conditions

Interventions

DEVICE

Omnipod 5 System

Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.

Sponsors & Collaborators

  • Insulet Corporation

    lead INDUSTRY

Principal Investigators

  • Ruth Weinstock, MD · State University of New York - Upstate Medical University

  • Eric Renard, Pr · Lapeyronie Montpellier University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2023-09-14
Completion
2025-01-10
FDA Device
Yes

Countries

  • United States
  • France

Study Locations

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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 NCT05409131 on ClinicalTrials.gov