- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05409131
Omnipod 5 System Compared to Pump Therapy
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Trang Ly, MBBS
- Phone Number: (978) 600-7000
- Email: APClinical@insulet.com
Study Contact Backup
- Name: Bonnie Dumais, RN
- Phone Number: (978) 600-7000
- Email: APClinical@insulet.com
Study Locations
-
-
-
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
-
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
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 |
Intervention / Treatment |
---|---|
Active Comparator: Intervention Arm
Omnipod 5 System with Dexcom G6 continuous glucose monitoring 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
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Change in A1C
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 (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.
|
Baseline compared to end of study visit (Day -14 to Day 90)
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OP5-003 (G6 CSII)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Type 1 Diabetes
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesTerminated
Clinical Trials on Omnipod 5 System
-
Insulet CorporationRecruitingDiabetes Mellitus, Type 1Belgium, France, United Kingdom
-
Emory UniversityJaeb Center for Health Research; Insulet CorporationCompletedDiabetes MellitusUnited States
-
Insulet CorporationCompleted
-
Insulet CorporationJaeb Center for Health ResearchCompleted
-
Insulet CorporationRecruitingType 1 DiabetesUnited States
-
Insulet CorporationCompletedType 2 Diabetes MellitusUnited States
-
University Hospital, MontpellierHopital Universitaire Robert-Debre; University Hospital, Angers; University of... and other collaboratorsNot yet recruiting
-
Insulet CorporationCompletedType 1 DiabetesUnited States
-
Milton S. Hershey Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsNot yet recruitingDiabetes Mellitus, Type 1United States, Australia, United Kingdom
-
Rabin Medical CenterCompleted