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A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System (NCT02897557)

The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
  • Device: Insulet Artificial Pancreas (AP) System
    Ages eligible for Study
    6 Years to 65 Years
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Subjects must meet all of the following criteria to be included in the study:
    • Age - For the adult cohort: age 18 to 65 years; adolescent cohort: age 12.0 to 17.9 years; pediatric cohort: age 6.0 to 11.9 years
    • Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.
    • Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day and A1C > 6% at screening
    • Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump for at least 6 months prior to start of study
    • Willing to use the study CGM device for one week prior to study start and for the duration of the study
    • Willing to use the OmniPod® Insulin Management System during the study
    • Willing to perform all SMBG testing with the study-approved glucose meter at the frequency specified in the study protocol
    • Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
    • Willing to refrain from use of acetaminophen, pseudoephedrine, and supplemental vitamin C (>2000 mg/daily) for the entire duration of participation in the study
    • Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. Subjects aged ≥ 8 years will be asked to sign an assent form.
    Exclusion Criteria:
    • Subjects who meet any of the following criteria will be excluded from the study:
    • A1c >10% at the Screening visit
    • One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
    • Hypoglycemic unawareness as determined by a score of 4 or more "R" responses on the Clarke Questionnaire
    • One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
    • Used non-insulin anti-diabetic medication within last 30 days
    • 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)
    • Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor on the abdomen
    • Known history of myocardial infarction (MI) or stroke within the past 6 months
    • Known history of seizure disorder
    • Known history of adrenal insufficiency
    • Current renal or hepatic disease
    • Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)
    • Currently undergoing cancer treatment
    • Currently undergoing systemic treatment with steroids or immunosuppressive medication
    • History of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants
    • Current illness that would interfere with participation in the study
    • Untreated or inadequately treated mental illness
    • Current alcohol abuse per investigator's judgment
    • Electrically-powered implants that may be susceptible to RF interference
    • Currently participating in another clinical study testing an investigational drug or device or participation in a clinical study during which an investigational drug was used within the preceding 30 days
    • 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.

    4 locations

    United States (4)
    • Stanford University
      Not specified
      Palo Alto, California, United States, 94305
    • William Sansum Diabetes Center
      Not specified
      Santa Barbara, California, United States, 93105
    • Diablo Clinical Research
      Not specified
      Walnut Creek, California, United States, 94598
    • University of Colorado Denver
      Not specified
      Denver, Colorado, United States, 80045
    31 August, 2016
    24 April, 2017
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