Omnipod 5 System Compared to Pump Therapy

August 27, 2025 updated by: Insulet Corporation

Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical 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.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth.

Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system.

Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system.

Following the 90-day outpatient phase, participants in France will be offered the option to transition to use the CE-marked commercial Omnipod 5 System for an additional 12 months with the French interface.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Corbeil-Essonnes, France
        • Hopital Sud-Francilien
      • Lyon, France
        • Hospices Civils de Lyon - Centre du diabete Diab-eCare
      • Montpellier, France
        • CHRU de Montpellier, Hopital Lapeyronie - Departement d'endocrinologie, Diabete, Nutrition
      • Paris, France
        • Hopital Lariboisiere - Centre Universitaire du Diabete et de ses Complications
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
      • Santa Barbara, California, United States, 93105
        • Sansum Diabetes Research Institute
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Denver
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • New York
      • Syracuse, New York, United States, 13244
        • State University of New York, Upstate Medical University
    • Texas
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic)
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age at time of consent 18-70 years of age
  2. Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
  3. 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.
  4. A1C 7.0-11.0% by point-of-care taken at screening visit
  5. Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment
  6. Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study
  7. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
  8. Willing to wear the system continuously throughout the study
  9. Willing and able to sign the Informed Consent Form (ICF)

Exclusion Criteria:

  1. 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
  2. History of severe hypoglycemia in the past 6 months
  3. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure
  4. 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.
  5. 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.
  6. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
  7. 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.
  8. 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)
  9. 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
  10. 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
  11. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention Arm
Omnipod 5 System with Dexcom G6 continuous glucose monitoring system
Device: Omnipod 5 System
Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.
No Intervention: Control Arm
Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of Time in Range 70-180 mg/dL
Time Frame: Comparing intervention group with control group during the 13-week study phase
Glucose metric from study continuous glucose monitoring system
Comparing intervention group with control group during the 13-week study phase

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Glucose
Time Frame: Comparing intervention group with control group at the end of the 13-week study phase
Glucose metric from study continuous glucose monitoring system
Comparing intervention group with control group at the end of the 13-week study phase
Percent of Time <54 mg/dL (Non-inferiority)
Time Frame: Comparing intervention group with control group at the end of the 13-week study phase
Glucose metric from study continuous glucose monitoring system
Comparing intervention group with control group at the end of the 13-week study phase
Percent of Time >180 mg/dL
Time Frame: Comparing intervention group with control group at the end of the 13-week study phase
Glucose metric from study continuous glucose monitoring system
Comparing intervention group with control group at the end of the 13-week study phase
Change in HbA1c
Time Frame: Baseline compared to end of study visit (Day -30 to Day 90)
Measures device effectiveness
Baseline compared to end of study visit (Day -30 to Day 90)
Percent of Time <70 mg/dL
Time Frame: Comparing intervention group with control group at the end of the 13-week study phase
Glucose metric from study continuous glucose monitoring system
Comparing intervention group with control group at the end of the 13-week study phase
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) Total Score
Time Frame: Baseline compared to end of study visit (Day -14 to Day 90)
A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome.
Baseline compared to end of study visit (Day -14 to Day 90)
Change in Hypoglycemic Confidence Scale (HCS) Total Score
Time Frame: Baseline compared to end of study visit (Day -14 to Day 90)
A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome.
Baseline compared to end of study visit (Day -14 to Day 90)
Change in Diabetes Quality of Life (DQOL)-Brief Total Score
Time Frame: Baseline compared to end of study visit (Day -14 to Day 90)
A questionnaire that assesses the relative burden of an intensive diabetes treatment regimen (15-item scale with 5 choices that range from 1 (Very Dissatisfied/All the Time) to 5 (Very Satisfied/Never)). The total score can range from 1 to 5, with a higher score indicating a better outcome.
Baseline compared to end of study visit (Day -14 to Day 90)
Proportion of Participants With T1-DDS MCID After 13 Weeks
Time Frame: Comparing intervention group with control group at the end of the 13-week study phase
Proportion of participants achieving a minimal clinically important difference (MCID) of ≥ 0.19 points (improvement) on the T1-DDS questionnaire total score at 13 weeks compared between treatment groups
Comparing intervention group with control group at the end of the 13-week study phase
Proportion of Participants With DQOL-brief Clinically Meaningful Improvement After 13 Weeks
Time Frame: Comparing intervention group with control group at the end of the 13-week study phase
Proportion of participants achieving a clinically meaningful improvement in the DQOL-brief total score after 13 weeks
Comparing intervention group with control group at the end of the 13-week study phase
Proportion of Participants With HCS Mean Score ≥ 3 After 13 Weeks
Time Frame: Comparing intervention group with control group at the end of the 13-week study phase
Secondary Effectiveness Endpoint of Proportion of Participants with HCS Mean Score ≥ 3 After 13 Weeks OP5
Comparing intervention group with control group at the end of the 13-week study phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insulet Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ruth Weinstock, MD, State University of New York - Upstate Medical University
  • Study Chair: Eric Renard, Pr, Lapeyronie Montpellier University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OP5-003 (G6 CSII)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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