Artificial Pancreas Control System in an Outpatient Setting

This is an interventional treatment trial for Type 1 Diabetes Mellitus Read More

Inclusion Criteria:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Male or female subjects 21 to 60 years of age.
• Current use of an insulin pump.
• Willingness to follow all study procedures and to stay with a companion during the outpatient test of the artificial pancreas.
• Willingness to sign informed consent and HIPAA documents.
• Willingness for the subject and companion to attend a training course on the system including emergency management of extremes of glucose.

Exclusion Criteria:

• Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
• Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
• Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2.
• Adrenal insufficiency
• Hematocrit of less than or equal to 34%.
• A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence.
• Congestive heart failure, NYHA class III or IV.
• Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
• Any active infection.
• Visual impairment preventing reading of glucose meter values or continuous glucose monitoring device.
• Physical impairment impeding the ability to use a glucose meter or continuous glucose monitoring device.
• Active foot ulceration.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
• Active malignancy, except basal cell or squamous cell skin cancers.
• Major surgical operation within 30 days prior to screening.
• Seizure disorder even if controlled by stable therapeutic regimen.
• Current administration of any beta blocker medication, clonidine, reserpine, or guanethidine
• Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
• Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
• Current administration of oral or parenteral corticosteroids.
• Use of an investigational drug within 30 days prior to screening.
• Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
• Allergy to aspart insulin.
• Allergy to glucagon.
• Past history of pheochromocytoma or a family history of MEN 2, neurofibromatosis, or von Hippel-Lindau disease.
• Insulin resistance requiring more than 200 units per day.
• Need for uninterrupted treatment of acetaminophen.
• History of hypoglycemic unawareness.
• C peptide level of ≥0.5 ng/ml
• Any reason the principal investigator deems exclusionary.