Outpatient Control-to-Range: System and Monitoring Testing

INCLUSION CRITERIA

• ≥21 and 90 mmHg and/or systolic blood pressure >160 mmHg)
• Conditions which may increase the risk of hypoglycemia such as any cardiac disorder/arrhythmia, uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation
• Hematocrit 1.2 times above the upper limit of normal
• Uncontrolled microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as current proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment
• Active gastroparesis requiring current medical therapy
• If taking 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
• Known bleeding diathesis or dyscrasia
• Known allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor
• Active enrollment in another clinical trial
• Unwillingness to withhold dietary supplements two weeks prior to admission and for the duration of the study participation
• Use of anti-diabetic agents other than CSII including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-IV inhibitors, glucagon-like peptide 1 agonists, and alpha-glucosidase inhibitors
• Subjects with basal rates less than 0.05.

RESTRICTIONS ON USE OF OTHER DRUGS OR TREATMENTS.

• Use of anti-diabetic agents other than CSII including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-IV inhibitors, glucagon-like peptide 1 agonists, and alpha-glucosidase inhibitors.
• Oral steroids are excluded
• Anticoagulant therapy other than aspirin is excluded
• Acetaminophen will not be allowed while the continuous glucose monitor is in use
• Dietary supplements will be withheld two weeks prior to admission and for the duration of study participation
• Medications that block symptoms of hypoglycemia, including but not limited to beta blockers