Artificial Pancreas Control System in an Inpatient Setting
Condition: Type I Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Artificial Pancreas Control Software
Intervention description: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm.
Intervention MeSH terms: Pancrelipase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: glucose sensors; artificial pancreas; Diabetes Mellitus

Summary:

      The purpose of this study is to verify an automated system of blood glucose control in Type I
      Diabetics. The automated system consists of the investigational Artificial Pancreas Control
      software (APC), two blood glucose sensors, and two hormone pumps, one for delivering insulin
      to lower blood sugar, and the second for delivering glucagon to raise blood sugar. The blood
      glucose sensors relays information to the Artificial Pancreas software, which uses the
      Adaptive Proportional Device algorithm to determine the rate of insulin and glucagon infusion
      by the hormone pumps. In prior studies, the Adaptive Proportional Device algorithm has been
      verified, but required manual input into the computer and hormone pumps. This study differs
      in that it uses a fully automated system under the control of the Artificial Pancreas Control
      software. The importance of this change is that it is the next step to enable outpatient use
      of automated, closed loop blood glucose control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 1 diabetes mellitus for at least 1 year.

          -  Male or female subjects 21 to 65 years of age.

          -  Current use of an insulin pump.

          -  Willingness to follow all study procedures, including attending all clinic visits.

          -  Willingness to sign informed consent and HIPAA documents.

        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 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 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.

          -  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.

          -  Intolerance of mild hypoglycemia (glucose 60-70 mg/dl).

          -  History of hypoglycemic unawareness.

          -  Insulin antibody level of ≥ 100 µUnits/ml.

          -  C peptide level of ≥0.5 ng/ml.

          -  Any concurrent illness, other than diabetes, that is not controlled by a stable
             therapeutic regimen.

          -  Any reason the principal investigator deems exclusionary