USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes

Exclusion Criteria

• •1. Admission for diabetic ketoacidosis in the 12 months prior to enrollment
• •2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• •3. History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
• •4. Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
• •5. Cystic fibrosis
• •6. 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
• •* Presence of a known adrenal disorder
• •* Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
• •* Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
• •* Active gastroparesis
• •* 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
• •* Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
• •* Abuse of alcohol or recreational drugs
• •* Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
• •* Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg).
• •* Oral steroids
• •* Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months.
• •7. A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
• •8. Basal Rates \<0.01 units/hour.
• •9. Current use of the following drugs and supplements:
• •* Acetaminophen
• •* Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, glucagon-like peptide (GLP)-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
• •* Beta blockers
• •* Any other medication that the investigator believes is a contraindication to the subject's participation