Back to Trials
NCT07579702NARecruiting

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

Insulet Corporation

Start Date

5/13/2026

Completion Date

2/1/2027

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.

Detailed Description

Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5. After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses

Eligibility Criteria

Age Range: 14 years to 75 years

Inclusion Criteria: * Age at time of consent 14-75 years (inclusive) * Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment * Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation * HbA1c ≥ 7.5% * Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user * Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user * Currently using a continuous glucose monitor * Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents. * Participant agrees to provide their own insulin for the duration of the study * Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol * Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol * If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes. * Willing to wear the system continuously throughout the study * 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 adolescent participants aged \< 18 years per local regulatory requirements * Able to read and understand English and operate the study device in English * If of childbearing potential, willing and able to have pregnancy testing Exclusion Criteria: * Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk * Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening * Any planned surgery during the study which could be considered major in the judgment of the investigator * 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. * History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure * Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement * Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c * Use of hydroxyurea * Plans to receive blood transfusion over the course of the study * Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study * Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening. * Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening * Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner). * Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period * Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment * Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Interventions

DEVICE

Omnipod 5 System

DEVICE

Omnipod 6 System

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Type 2 Diabetes MellitusType 1 Diabetes Mellitus

Locations

University of Southern California

Los Angeles, California 90022

United States

Sansum Diabetes Research Institute

Santa Barbara, California 93105

United States

University of Colorado

Aurora, Colorado 80045

United States

Yale

New Haven, Connecticut 06511

United States

University of South Florida

Tampa, Florida 33612

United States

Emory University

Atlanta, Georgia 30308

United States

Northwestern University

Chicago, Illinois 60611

United States

Indiana University

Indianapolis, Indiana 46202

United States

Joslin Diabetes Center

Boston, Massachusetts 02215

United States

Henry Ford Health Systems

Detroit, Michigan 48202

United States

Health Partners

Minneapolis, Minnesota 55416

United States

Baylor College of Medicine

Houston, Texas 77030

United States