Insulet Artificial Pancreas Early Feasibility Study

Not Recruiting

Trial ID: 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.

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

Stanford Investigator(s)

Bruce Buckingham
Bruce Buckingham

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


Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study:

   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 years

   2. 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 screening

   4. 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

   5. Willing to use the study CGM device for one week prior to study start and for the
   duration of the study

   6. Willing to use the OmniPod® Insulin Management System during the study

   7. Willing to perform all SMBG testing with the study-approved glucose meter at the
   frequency specified in the study protocol

   8. Willing to abide by meal recommendations for breakfast, lunch and dinner during the

   9. Willing to refrain from use of acetaminophen, pseudoephedrine, and supplemental
   vitamin C (>2000 mg/daily) for the entire duration of participation in the study

10. 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:

   1. A1c >10% at the Screening visit

   2. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or
   hospitalization within the past 6 months

   3. Hypoglycemic unawareness as determined by a score of 4 or more "R" responses on the
   Clarke Questionnaire

   4. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization
   within the past 6 months

   5. Used non-insulin anti-diabetic medication within last 30 days

   6. 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 abdomen

   8. Known history of myocardial infarction (MI) or stroke within the past 6 months

   9. Known history of seizure disorder

10. Known history of adrenal insufficiency

11. Current renal or hepatic disease

12. Untreated or unstable hypothyroidism or celiac disease (per investigator's judgment)

13. Currently undergoing cancer treatment

14. Currently undergoing systemic treatment with steroids or immunosuppressive medication

15. 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

16. Current illness that would interfere with participation in the study

17. Untreated or inadequately treated mental illness

18. Current alcohol abuse per investigator's judgment

19. Electrically-powered implants that may be susceptible to RF interference

20. 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

21. 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


device: Insulet Artificial Pancreas (AP) System

device: Insulet Artificial Pancreas (AP) System

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Bruce Buckingham, MD