Insulet Artificial Pancreas Early Feasibility Study

Trial ID or NCT#

NCT02897557

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 6 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Subjects must meet all of the following criteria to be included in the study:
    1. 1. 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 years2. Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment.3. Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day and A1C \> 6% at screening4. Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump for at least 6 months prior to start of study5. Willing to use the study CGM device for one week prior to study start and for the duration of the study6. Willing to use the OmniPod® Insulin Management System during the study7. Willing to perform all SMBG testing with the study-approved glucose meter at the frequency specified in the study protocol8. Willing to abide by meal recommendations for breakfast, lunch and dinner during the study9. Willing to refrain from use of acetaminophen, pseudoephedrine, and supplemental vitamin C (\>2000 mg/daily) for the entire duration of participation in the study10. 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:
  1. Subjects who meet any of the following criteria will be excluded from the study:
    1. 1. A1c \>10% at the Screening visit2. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months3. Hypoglycemic unawareness as determined by a score of 4 or more "R" responses on the Clarke Questionnaire4. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months5. Used non-insulin anti-diabetic medication within last 30 days6. 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)7. 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 abdomen8. Known history of myocardial infarction (MI) or stroke within the past 6 months9. Known history of seizure disorder10. Known history of adrenal insufficiency11. Current renal or hepatic disease12. Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)13. Currently undergoing cancer treatment14. Currently undergoing systemic treatment with steroids or immunosuppressive medication15. History of any chronic infections that would interfere with participation in the study or place study personnel at undue risk due to blood-borne contaminants16. Current illness that would interfere with participation in the study17. Untreated or inadequately treated mental illness18. Current alcohol abuse per investigator's judgment19. Electrically-powered implants that may be susceptible to RF interference20. 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 days21. 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.
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Investigator(s)

Bruce Buckingham
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus

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Contact

Bruce Buckingham, MD

View on ClinicalTrials.gov