We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Omnipod 5 System Compared to Pump Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05409131
Recruitment Status : Recruiting
First Posted : June 8, 2022
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Insulet Corporation

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Omnipod 5 System Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Change in A1C [ Time Frame: Baseline compared to end of study visit (Day -30 to Day 90) ]
    Measures device effectiveness

  5. 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

  6. 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.

  7. 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.

  8. Change in Diabetes Quality of Life (DQL)-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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05409131


Contacts
Layout table for location contacts
Contact: Trang Ly, MBBS (978) 600-7000 APClinical@insulet.com
Contact: Bonnie Dumais, RN (978) 600-7000 APClinical@insulet.com

Locations
Layout table for location information
United States, California
Stanford University School of Medicine Active, not recruiting
Palo Alto, California, United States, 94304
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Kristin Castorino, MD       kcastorino@sansum.org   
Contact: Mei Mei Church       mchurch@sansum.org   
United States, Colorado
University of Colorado Denver Active, not recruiting
Denver, Colorado, United States, 80045
United States, Georgia
Atlanta Diabetes Active, not recruiting
Atlanta, Georgia, United States, 30318
United States, Illinois
Northwestern University Active, not recruiting
Evanston, Illinois, United States, 60208
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lori Laffel, MD       Lori.Laffel@joslin.harvard.edu   
Contact: Louise Ambler-Osborn       Louise.Ambler-Osborn@joslin.harvard.edu   
United States, New York
State University of New York, Upstate Medical University Active, not recruiting
Syracuse, New York, United States, 13244
United States, Texas
Diabetes & Glandular Disease Clinic, P.A. (DGD Clinic) Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Sue Brown, MD       SAB2F@hscmail.mcc.virginia.edu   
Contact: Morgan Fuller       mf2nu@hscmail.mcc.virginia.edu   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Irl Hirsch, MD       ihirsch@uw.edu   
Contact: Xenia Averkiou       averkiou@uw.edu   
France
Hopital Sud-Francilien Not yet recruiting
Corbeil-Essonnes, France
Contact: Alfred Penfornis, Pr       alfred.penfornis@chsf.fr   
Hospices Civils de Lyon - Centre du diabete Diab-eCare Not yet recruiting
Lyon, France
Contact: Charles Thivolet, Pr       charles.thivolet@chu-lyon.fr   
CHRU de Montpellier, Hopital Lapeyronie - Departement d'endocrinologie, Diabete, Nutrition Not yet recruiting
Montpellier, France
Contact: Eric Renard, Pr       e-renard@chu-montpellier.fr   
Hopital Lariboisiere - Centre Universitaire du Diabete et de ses Complications Not yet recruiting
Paris, France
Contact: Jean-Pierre Riveline, Pr       jeanpierre.riveline@aphp.fr   
Sponsors and Collaborators
Insulet Corporation
Investigators
Layout table for investigator information
Study Chair: Ruth Weinstock, MD State University of New York - Upstate Medical University
Study Chair: Eric Renard, Pr Lapeyronie Montpellier University Hospital
Layout table for additonal information
Responsible Party: Insulet Corporation
ClinicalTrials.gov Identifier: NCT05409131    
Other Study ID Numbers: OP5-003 (G6 CSII)
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: June 2022

Layout table for additional information
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
Keywords provided by Insulet Corporation:
T1D
Omnipod
Automated Insulin Delivery
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases