Omnipod 5 System Compared to Pump Therapy

NCT05409131 | Completed Results FDA Device

• 1 other identifier: OP5-003 (G6 CSII)
• Study Type: interventional
• Target: 196
• Locations: 2 countries
• Sites: 14

Brief Summary

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. Participants in France will be offered an optional extension of 12 months of Omnipod 5 System use.

Conditions

Type 1 Diabetes

Keywords

T1D; Omnipod; Automated Insulin Delivery

Outcome Measures

Primary Outcomes (1)

• Percent of Time in Range 70-180 mg/dL

  Glucose metric from study continuous glucose monitoring system

  Comparing intervention group with control group during the 13-week study phase

Secondary Outcomes (11)

• Percent of Time <54 mg/dL (Non-inferiority)

  Comparing intervention group with control group at the end of the 13-week study phase

• Percent of Time >180 mg/dL

  Comparing intervention group with control group at the end of the 13-week study phase

• Mean Glucose

  Comparing intervention group with control group at the end of the 13-week study phase

• Change in HbA1c

  Baseline compared to end of study visit (Day -30 to Day 90)

• Percent of Time <70 mg/dL

  Comparing intervention group with control group at the end of the 13-week study phase

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Omnipod 5 System with Dexcom G6 continuous glucose monitoring system

Device: Omnipod 5 System

Control Arm

NO INTERVENTION

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

Interventions

Omnipod 5 System DEVICE

Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at time of consent 18-70 years of age
• Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
• On pump therapy for ≥ 3 months prior to screening and familiar with pump therapy concepts such as basal and bolus insulin delivery, and carbohydrate counting. Participants using automated insulin delivery (AID) devices, including devices with predictive low glucose suspend (PLGS), in the 3 months prior to screening, will be excluded from participating.
• A1C 7.0-11.0% by point-of-care taken at screening visit
• Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment
• Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study
• Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
• Willing to wear the system continuously throughout the study
• Willing and able to sign the Informed Consent Form (ICF)

You may not qualify if:

• Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions 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
• History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure
• Blood disorder or dyscrasia within 3 months prior to screening, including use of hydroxyurea, which in the investigator's opinion could interfere with determination of HbA1C.
• 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
• Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the Baseline Visit. Participants taking metformin should remain on a steady dose during study participation.
• Pregnant or lactating, or is a woman 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 5 half-lives (whichever is longer) prior to screening, 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

Sponsors & Collaborators

• Insulet Corporation: lead

Study Sites (14)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Atlanta Diabetes

Atlanta, Georgia, 30318, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

State University of New York, Upstate Medical University

Syracuse, New York, 13244, United States

Location

Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic)

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Hopital Sud-Francilien

Corbeil-Essonnes, France

Location

Hospices Civils de Lyon - Centre du diabete Diab-eCare

Lyon, France

Location

CHRU de Montpellier, Hopital Lapeyronie - Departement d'endocrinologie, Diabete, Nutrition

Montpellier, France

Location

Hopital Lariboisiere - Centre Universitaire du Diabete et de ses Complications

Paris, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Trang Ly
• Organization: Insulet Corporation

tly@insulet.com

9786007628

Study Officials

• Ruth Weinstock, MD

  State University of New York - Upstate Medical University

  STUDY CHAIR

• Eric Renard, Pr

  Lapeyronie Montpellier University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: July 7, 2022
• Primary Completion: September 14, 2023
• Study Completion: January 10, 2025
• Last Updated: September 16, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-08

Locations

US (10); FR (4)