An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas

Exclusion Criteria

• •Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
• •Subject has a history of diagnosed medical eating disorder
• •Subject has a history of visual impairment which would not allow subject to participate
• •Subject has an active skin condition that would affect sensor placement
• •Subject has adhesive allergies
• •Subjects requiring an intermediate or long-acting insulin (such as NPH, Neutral Protamine Hagedorn, detemir or glargine)
• •Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)
• •Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
• •Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial
• •Subject has active Graves' disease
• •Subjects with inadequately treated thyroid disease or celiac disease
• •History of liver disease Renal failure on dialysis
• •Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes
• •Any known history of coronary artery disease
• •Abnormal EKG (electrocardiogram) consistent with coronary artery disease or increased risk of malignant arrhythmia
• •Congestive heart failure (established history of congestive heart failure , lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)
• •History of transient ischemic attack (TIA) or stroke
• •Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants
• •History of hypoglycemic seizures (grand-mal) or coma in the last year
• •History of pheochromocytoma:
• •episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension
• •paroxysms of tachycardia, pallor, or headache
• •personal or family history of MEN 2A (multiple endocrine neoplasia), MEN 2B, neurofibromatosis, or von Hippel-Lindau disease
• •History of adrenal disease or tumor
• •Hypertension with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 despite treatment
• •Untreated or inadequately treated mental illness
• •Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
• •Unable to completely avoid acetaminophen for duration of study
• •Established history of allergy or severe reaction to adhesive or tape that must be used in the study
• •History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
• •History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
• •Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring)
• •Any factors that, in the opinion of the site principal investigator or overall principal investigator, would interfere with the safe completion of the study