Pramlintide Combined With Model Predictive Control Algorithm

Exclusion Criteria

• •Known hypersensitivity to SYMLIN or any of its components, including metacresol
• •Poor compliance with current insulin regimen
• •Poor compliance with prescribed self-blood glucose monitoring
• •HbA1c \<7 or \>9%
• •Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to enrollment
• •Active infection
• •Current use of dietary supplements (subjects may be enrolled if they stop taking dietary supplements two weeks prior to admission and for the duration of their participation)
• •Active gastroparesis
• •Use of drugs that stimulate gastrointestinal motility (e.g. metoclopramide)
• •Diabetic ketoacidosis in the past 3 months
• •Current treatment for a seizure disorder
• •Cystic fibrosis
• •Asthma requiring hospitalization or treatment with oral steroids within the past year
• •Presence of a uncontrolled adrenal disorder
• •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• •* Inpatient psychiatric treatment in the past 6 months
• •* Abnormal liver function (Transaminase \>2 times the upper limit of normal)
• •* Heart failure
• •* Coronary artery disease
• •* Arrhythmia
• •* Seizure disorder
• •* Any carcinogenic disease
• •* Creatinine concentration above the upper limit of normal for age and sex
• •* Active coronary artery disease
• •* Uncontrolled thyroid disease
• •* Use or abuse of alcohol
• •* Active kidney dialysis
• •* If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
• •* Note: adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
• •Addison's disease
• •Current use of a beta blocker medication
• •Hematocrit \< 36 (female), \<38 (male)
• •Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
• •Allergy to the sensor or to one of its components
• •Continued use of acetaminophen.