Omnipod 5 System for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Ruth Weinstock, MD
Principal Investigator
State University of New York - Upstate Medical University
Eric Renard, Pr
Principal Investigator
Lapeyronie Montpellier University Hospital
Are You a Good Fit for This Trial?
Adults aged 18-70 with Type 1 Diabetes for at least a year, currently on pump therapy, and familiar with insulin delivery concepts. They must be willing to use the Omnipod 5 system or their own pump with continuous glucose monitoring and have an A1C between 7.0-11.0%. Exclusions include severe hypoglycemia history, steroid treatment, skin conditions affecting device placement, certain medication use (except metformin), pregnancy/lactation without birth control, participation in other trials recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Standard Therapy Phase
Participants undergo a 14-day outpatient phase to collect baseline sensor and insulin data using their usual diabetes management routine
Randomized Treatment Phase
Participants are randomized to use either the Omnipod 5 system or their personal insulin pump with the study continuous glucose monitoring system for 90 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Omnipod 5 System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insulet Corporation
Lead Sponsor