Recruiting

Omnipod 6 vs. Omnipod 5

Sponsor:

Insulet Corporation

Code:

NCT07579702

Conditions

Type 2 Diabetes Mellitus

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Interventions

Omnipod 5 System

Omnipod 6 System

Study Details

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Type 1 Diabetes Mellitus

Study ID

NCT07579702

Start date

May 13, 2026

Status verified date

Jul, 2026

Completion date

Mar 24, 2027

Anticipated

Primary completion date

Feb 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Omnipod 5 System

experimental: Omnipod 6 System

Interventions

Omnipod 5 System

The Omnipod 5 System with the study CGM

Omnipod 6 System

The Omnipod 6 System with the study CGM

Primary outcome measure

  • Time in Range 70-180 mg/dL [ Time Frame: 13 weeks ]
  • Time <54 mg/dL [ Time Frame: 13 weeks ]
  • Time <70 mg/dL [ Time Frame: 13 weeks ]
  • Time >180 mg/dL [ Time Frame: 13 weeks ]
  • Time in Range 70-140 mg/dL [ Time Frame: 13 weeks ]
  • HbA1c [ Time Frame: 13 weeks ]
  • Mean sensor glucose [ Time Frame: 13 weeks ]
  • Time >250 mg/dL [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Trang Ly, MBBS, PhD

978-600-7000APClinical@insulet.com

Bonnie Dumais, RN

APClinical@insulet.com

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90022

Contacts

Martha Walker

323-605-4442mawalker@usc.edu

Principal Investigator:

Anne Peters

Sansum Diabetes Research Institute

Recruiting

Santa Barbara, California, United States, 93105

Contacts

Juliana Lopez

8057059465jlopez@sansum.org

Principal Investigator:

Kristin Castorino

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Estella Escobar

(720) 305-7817Estella.Escobar@cuanschutz.edu

Principal Investigator:

Gregory Forlenza

Yale

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Amy Steffen

203-737-8852amy.steffen@yale.edu

Principal Investigator:

Amy Steffen

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Principal Investigator:

Georgia Davis

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Evelyn Fronczyk

312-908-9002Evelyn.guevara@northwestern.ed

Principal Investigator:

Grazia Aleppo

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Kathy Bohanan

317-278-0651kkremer@iu.edu

Principal Investigator:

Viral Shah

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Louise Ambler-Osborn

617-975-8206louise.ambler-osborn@joslin.harvard.edu

Principal Investigator:

Lori Laffel

Henry Ford Health Systems

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Lydia Oehring

+1 (313) 916-3906loehrin1@hfhs.org

Principal Investigator:

Davida Kruger

Health Partners

Recruiting

Minneapolis, Minnesota, United States, 55416

Contacts

Stephanie Zimmerman

952-993-2048H.Zimmerman@HealthPartners.com

Principal Investigator:

Amy Criego

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Anh Nguyen

(832) 822-3870Anh.Nguyen2@bcm.edu

Principal Investigator:

Daniel DeSalvo

More Information

Sponsor

Insulet Corporation

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Omnipod
  • Automated Insulin Delivery
  • T2D
  • T1D
  • Type 2 Diabetes
  • Type 1 Diabetes
  • AID

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Insulet Corporation on 2026-08-03.