Omnipod Systems for Type 1 Diabetes

(STRIVE Trial)

Recruiting at 9 trial locations

Overseen By Bonnie Dumais, RN

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Insulet Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting. Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.

Research Team

Gregory Forlenza, MD

Principal Investigator

Barbara Davis Center

Eligibility Criteria

This trial is for individuals with Type 1 Diabetes, including those with diabetic retinopathy. Participants will use the Omnipod insulin management systems and must be willing to attend about 5 in-person visits. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent participants aged < 18 years per state requirements

If of childbearing potential, willing and able to have pregnancy testing

Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol

Exclusion Criteria

Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk

History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions

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

Treatment Details

Interventions

• Omnipod 5 SmartAdjust 2.0 System (Insulin Delivery System)
• Omnipod 5 System (Insulin Delivery System)

Trial Overview The study compares two insulin delivery systems: the new Omnipod 5 SmartAdjust 2.0 System versus the existing Omnipod 5 System. It's a cross-over study where participants switch between systems after four weeks and everyone uses the new system in the final period.

Participant Groups

Group I: Omnipod 5 SmartAdjust 2.0 System Experimental Treatment 2 Interventions

A subset of participants will begin the study using the Omnipod 5 SmartAdjust 2.0 System then switch to the comparator, and back again to the experimental system.

Group II: Omnipod 5 System Active Control 2 Interventions

A subset of participants will begin the study using the Omnipod 5 System then switch to the experimental system for the remainder of the study.

Who Is Running the Clinical Trial?

Insulet Corporation

Lead Sponsor

Trials

23

Recruited

19,600+