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Pivotal Omnipod Horizon™ Automated Glucose Control System

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: NCT04196140
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Insulet Corporation

Brief Summary:
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 91-day (13-week) hybrid closed-loop phase conducted in an outpatient setting.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Omnipod Horizon™ Automated Glucose Control System Not Applicable

Detailed Description:

The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase.

Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 91-day (13-week) hybrid closed-loop phase conducted in an outpatient setting.

During the hybrid closed-loop phase, a subset of subjects will participate in 5-days of supervised meal and exercise challenges.

The hybrid closed-loop phase will begin on Study Day 1.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single-arm, multi-center, prospective clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes
Actual Study Start Date : December 30, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Treatment
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm.
Device: Omnipod Horizon™ Automated Glucose Control System
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery




Primary Outcome Measures :
  1. Incidence rate of severe hypoglycemia (events per person months) [ Time Frame: hybrid closed-loop (91 days) ]
    Measure of serious device-related adverse events

  2. Incidence rate of diabetic ketoacidosis (DKA) (events per person months) [ Time Frame: hybrid closed-loop (91 days) ]
    Measure of serious device-related adverse events

  3. End of study glycated hemoglobin (A1C) compared to baseline A1C [ Time Frame: Screening visit compared to end of study visit (Day-30 to Day 91) ]
    Measures device effectiveness

  4. Time in range 70-180 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) ]
    Measures device effectiveness


Secondary Outcome Measures :
  1. percent of time >180 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  2. percent of time <70 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  3. Mean glucose [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  4. percent of time in range 70-180 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  5. percent of time in range 70-140 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  6. percent of time >180 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  7. percent of time ≥ 250 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  8. percent of time ≥ 300 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  9. percent of time < 70 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  10. percent of time < 54 mg/dL [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)

  11. Standard deviation [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)

  12. Coefficient of variation [ Time Frame: hybrid closed-loop (91 days) compared to standard therapy (14 days) during the day, overnight, and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)

  13. Percentage of time in hybrid closed-loop as proportion of overall device usage time [ Time Frame: hybrid closed-loop (91 days) ]
    Measure of system usage

  14. Glucose management indicator (GMI) based on overall mean glucose [ Time Frame: hybrid closed-loop (91 days) compared to the standard therapy (14 days) ]
    Measurement of glucose management using overall glucose averages

  15. Total daily insulin (TDI) (units) [ Time Frame: hybrid closed-loop (91 days) compared to the standard therapy (14 days) ]
    Measure of insulin requirements

  16. Total daily insulin (TDI) (units/kg) [ Time Frame: hybrid closed-loop (91 days) compared to the standard therapy (14 days) ]
    Measure of insulin requirements

  17. Total daily basal insulin (units) [ Time Frame: hybrid closed-loop (91 days) compared to the standard therapy (14 days) ]
    Measure of insulin requirements

  18. Total daily basal insulin (units/kg) [ Time Frame: hybrid closed-loop (91 days) compared to the standard therapy (14 days) ]
    Measure of insulin requirements

  19. Total daily bolus insulin (units) [ Time Frame: hybrid closed-loop (91 days) compared to the standard therapy (14 days) ]
    Measure of insulin requirements

  20. Total daily bolus insulin (units/kg) [ Time Frame: hybrid closed-loop (91 days) compared to the standard therapy (14 days) ]
    Measure of insulin requirements

  21. Change from baseline in body mass index (BMI) (kg/m2) to end of study [ Time Frame: Screening visit compared to end of study visit (Day-30 to Day 91) ]
    Measure of change in weight

  22. Proportion of subjects demonstrating improvement in A1c from baseline at end of study [ Time Frame: Screening visit compared to end of study visit (Day-30 to Day 91) ]
    Measure of change in glucose control



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.


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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at time of consent/assent 6-70 years
  2. Subjects aged < 18 years must be living with parent/legal guardian
  3. Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment
  4. Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
  5. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
  6. Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
  7. Must be willing to travel to and participate in meal and exercise challenges during 5-days of the hybrid closed-loop phase
  8. Willing to wear the system continuously throughout the study
  9. A1C <10% at screening visit
  10. Must be willing to use the Dexcom App on the Omnipod Horizon™ Personal Diabetes Manager (PDM) as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
  11. Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight
  12. Able to read and speak English fluently
  13. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects aged < 18 years per State requirements.

Exclusion Criteria:

  1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
  2. History of severe hypoglycemia in the past 6 months
  3. History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
  4. Diagnosed with sickle cell disease
  5. Diagnosed with hemophilia or any other bleeding disorders
  6. Plans to receive blood transfusion over the course of the study
  7. Currently diagnosed with anorexia nervosa or bulimia
  8. Acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis
  9. History of adrenal insufficiency
  10. Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the course of the study
  11. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
  12. Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
  13. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
  14. Current or known history of coronary artery disease that is not stable with medical management, 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 previous 12-months.
  15. For subjects >50 years old or with diabetes duration >20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)
  16. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
  17. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
  18. Participation in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System within the preceding 30-days or intends to participate during the study period
  19. 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

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): NCT04196140


Contacts
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Contact: Trang Ly, MBBS (978) 600-7000 APClinical@insulet.com
Contact: Bonnie Dumais, RN (978) 600-7708 APClinical@insulet.com

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Bruce Buckingham, MD       bbendo@stanford.edu   
Contact: Ryan Kingman       rkingman@stanford.edu   
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Jordan Pinsker, MD       jpinsker@sansum.org   
Contact: Molly Piper       mpiper@sansum.org   
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Gregory Forlenza, MD       gregory.forlenza@ucdenver.edu   
Contact: Cari Berget, RN       cari.berget@cuanschutz.edu   
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Viral Shah, MD       viral.shah@ucdenver.edu   
Contact: Prakriti Joshee       prakriti.joshee@cuanschutz.edu   
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: Jennifer Sherr, MD       jennifer.sherr@yale.edu   
Contact: Lori Carria       lori.carria@yale.edu   
United States, Georgia
Atlanta Diabetes Recruiting
Atlanta, Georgia, United States, 30318
Contact: Bruce Bode, MD       brucebodemd@atlantadiabetes.com   
Contact: Brooke Narron, FNP       bnarron@atlantadiabetes.com   
East Coast Institute for Research Recruiting
Macon, Georgia, United States, 31210
Contact: Thomas Jones, MD       drtjones1@gmail.com   
Contact: Alicia Castelot       Alicia.Castelot@eastcoastresearch.net   
United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Grazia Aleppo, MD       Grazia.Aleppo@nm.org   
Contact: Dinah Torres-Quinones       dinah@northwestern.edu   
United States, Iowa
Iowa Diabetes Recruiting
West Des Moines, Iowa, United States, 50265
Contact: Anuj Bhargava, MD       anuj.bhargava@mydiabeteshome.com   
Contact: Lisa Borg       lsmith@iowadiabetes.com   
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lori Laffel, MD       Lori.Laffel@joslin.harvard.edu   
Contact: Lindsay Roethke       Lindsay.Roethke@joslin.harvard.edu   
United States, Minnesota
International Diabetes Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Aimee Grieme, RN       aimee.grieme@parknicollet.com   
Contact: Alina Punel       alina.punel@parknicollet.com   
Principal Investigator: Anders Carlson, MD         
Principal Investigator: Amy Criego, MD         
United States, New York
Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Carol Levy, MD       carol.levy@mssm.edu   
Contact: Selassie Ogyaadu, MD       selassie.ogyaadu@mssm.edu   
SUNY Syracuse Recruiting
Syracuse, New York, United States, 13244
Contact: Ruth Weinstock, MD       WEINSTOR@upstate.edu   
Contact: Suzan Bzdick, RN       bzdicks@upstate.edu   
United States, Ohio
University Hospitals Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sarah MacLeish, DO       Sarah.MacLeish2@uhhospitals.org   
Contact: Terri Casey, RN       terri.casey@uhhospitals.org   
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Daniel DeSalvo, MD       daniel.desalvo@bcm.edu   
Contact: Sopar Seributra, BSN       pars@bcm.edu   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Sue Brown, MD       SAB2F@hscmail.mcc.virginia.edu   
Contact: Emma Emory, RN       EE9M@hscmail.mcc.virginia.edu   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Irl Hirsch, MD       ihirsch@uw.edu   
Contact: Kay Houser       khouser@uw.edu   
Sponsors and Collaborators
Insulet Corporation
Investigators
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Study Chair: Bruce Buckingham, MD Stanford University
Study Chair: Sue Brown, MD University of Virginia

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Responsible Party: Insulet Corporation
ClinicalTrials.gov Identifier: NCT04196140    
Other Study ID Numbers: Horizon™ Pivotal Study
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Insulet Corporation:
T1D
Omnipod
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases