Omnipod 5 System for Type 1 Diabetes

Recruiting at 13 trial locations

Overseen By Bonnie Dumais, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Insulet Corporation

Must be taking: U-100 insulin

Must not be taking: Systemic steroids

Disqualifiers: Severe hypoglycemia, DKA, unstable cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

196 Participants Needed

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

Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.

Willing to wear the system continuously throughout the study

Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment

Exclusion Criteria

You have experienced very low blood sugar levels in the past 6 months.

Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed.

Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Therapy Phase

Participants undergo a 14-day outpatient phase to collect baseline sensor and insulin data using their usual diabetes management routine

2 weeks

2 visits (in-person or virtual)

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

13 weeks

6 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omnipod 5 System

Trial Overview The trial is testing the Omnipod 5 System against personal insulin pumps over a period of about three months. Participants will first undergo a standard therapy phase for two weeks before using either the new system or continuing their current pump therapy alongside continuous glucose monitoring.

How Is the Trial Designed?

Group I: Intervention Arm Active Control 1 Intervention

Omnipod 5 System with Dexcom G6 continuous glucose monitoring system

Group II: Control Arm Active Control 1 Intervention

Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system

Who Is Running the Clinical Trial?

Insulet Corporation

Lead Sponsor

Trials

23

Recruited

19,600+