Artificial Pancreas Control System in an Outpatient Setting
Condition: Type 1 Diabetes Mellitus
MeSH terms: 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 outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
Intervention MeSH terms: Pancrelipase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The objectives of this outpatient research study are (1) to assess the ability of this
      automated system to be operated by a subject with limited professional oversight; (2) to
      assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump
      controller) will reduce the frequency of hardware and data communication lapses seen in the
      previous system; and (3) to measure the degree of glucose control achievable with this
      automated system. The system will adjust blood glucose by administering insulin and glucagon.
      Insulin is a hormone that lowers blood glucose and will be given nearly continuously during
      this study. Glucagon raises blood glucose and will be automatically administered during
      hypoglycemia. Both are natural hormones made by people without diabetes. Each subject will
      have four devices placed on his abdomen: two Omnipod insulin pumps, one for delivering
      insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors for measuring
      glucose. The two sensors will feed glucose data into Motorola smart phone master controller,
      which will calculate the correct amount of insulin or glucagon to deliver. The system will
      then send the command to the correct Omnipod through the iDex pod controller.

      In this new system, the research subject will be able to monitor the progress of the study by
      use of the smart phone graphical user interface. The subject will have a companion with
      him/her during the entire study for safety purposes. Both the subject and companion will
      complete a training course on how to treat diabetic emergencies and how to operate the
      system. A study physician and technician will be in the hotel during each study and will be
      monitoring the study via a cloud-based data communication system. These studies will be
      carried out in a hotel setting.
    

Eligibility criteria:

        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.