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Prepivotal Omnipod Horizon™ Automated Glucose Control System

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ClinicalTrials.gov Identifier: NCT04176731
Recruitment Status : Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : November 28, 2019
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 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and 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 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting.

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

During the hybrid closed-loop phase, subjects will be divided into two groups. The first group of subjects will commence the hybrid closed-loop phase in the hotel/rental house setting. On Study Day 3, subjects will transition to an outpatient setting for the remaining 12 days. After all subjects from the first group have completed the 2-day hotel/rental house phase, the second group of subjects may commence the hybrid closed-loop phase in an outpatient setting for 14-days.

During the hybrid closed-loop phase, all subjects will participate in specific target blood glucose (BG) challenges.

After each subject in the prepivotal study has successfully completed 14-days of hybrid-closed-loop, they may immediately transition to and enroll in the pivotal study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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: Prepivotal Evaluation of the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 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. Proportion of subjects with severe hypoglycemia [ Time Frame: hybrid closed-loop (14 days) ]
    Measure of serious device-related adverse events

  2. Proportion of subjects with diabetic ketoacidosis (DKA) [ Time Frame: hybrid closed-loop (14 days) ]
    Measure of serious device-related adverse events

  3. Target blood glucose (BG) challenge days (approximately hybrid closed-loop days 1-9) [ Time Frame: hybrid closed-loop (9 days) compared to standard therapy (14 days) ]
    Percentage of time in range 70-180 mg/dL

  4. Non-challenge days (approximately hybrid closed-loop days 10-14) [ Time Frame: hybrid closed-loop (5 days) compared to standard therapy (14 days) ]
    Percentage of time in range 70-180 mg/dL

  5. Overall (hybrid closed-loop days 1-14) [ Time Frame: hybrid closed-loop (14 days) compared to standard therapy (14 days) ]
    Percentage of time in range 70-180 mg/dL


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

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

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

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

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

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

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

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

  9. Standard deviation [ Time Frame: hybrid closed-loop (14 days) compared to the 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)

  10. Coefficient of variation [ Time Frame: hybrid closed-loop (14 days) compared to the 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)

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

  12. Percentage of time in hybrid closed-loop as proportion of overall device usage time [ Time Frame: hybrid closed-loop (14 days) ]
    Measure of system usage

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

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

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



Information from the National Library of Medicine

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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 set target glucose between 130-150 mg/dL each for approximately 72-hours on predefined days during the hybrid closed-loop phase
  8. Must be willing to extend their participation into the pivotal study if they continue to meet the protocol criteria
  9. Willing to wear the system continuously throughout the study
  10. A1C <10% at screening visit
  11. Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
  12. 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
  13. Able to read and speak English fluently
  14. Subject must be in an AT&T covered area
  15. 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 (as defined in Section 11.3.3) in the past 6 months
  3. History of DKA (as defined in Section 11.3.4) 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 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): NCT04176731


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
Palo Alto, California, United States, 94305
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80045
United States, Georgia
Atlanta Diabetes Not yet recruiting
Atlanta, Georgia, United States, 30318
Contact: Bruce Bode, MD       BruceBodeMD@atlantadiabetes.com   
Contact: Brooke Narron, RN       BNarron@atlantadiabetes.com   
United States, Minnesota
Park Nicollet Not yet recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Amy Criego, MD       amy.criego@parknicollet.com   
Contact: Aimee Grieme, RN       aimee.grieme@parknicollet.com   
United States, New York
Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Contact: Carol Levy, MD       carol.levy@mssm.edu   
Contact: Selassie Ogyaadu, MD       selassie.ogyaadu@mssm.edu   
United States, Virginia
University of Virginia Not yet recruiting
Charlottesville, Virginia, United States, 22904
Contact: Sue Brown, MD       SAB2F@hscmail.mcc.virginia.edu   
Contact: Emma Emory, RN       EE9M@hscmail.mcc.virginia.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: NCT04176731     History of Changes
Other Study ID Numbers: Horizon™ Prepivotal Study
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019
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
Pediatric Postmarket Surveillance of a Device Product: No
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