Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (Italy)

Exclusion Criteria

• •1. Severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic ketoacidosis within the 12 months prior to enrollment.
• •2. Pregnancy; breast feeding, or intention of becoming pregnant.
• •3. Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg).
• •4. Conditions which may increase the risks associated with possible hypoglycemia, such as any active 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.
• •5. Self-reported hypoglycemia unawareness.
• •6. History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans.
• •7. Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants).
• •8. Anticoagulant therapy other than aspirin.
• •9. Oral steroids.
• •10. Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions.
• •11. Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment).
• •12. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• •13. Known current or recent alcohol or drug abuse.
• •14. Medical conditions that would make operating a CGM, the DiAs cell phone or insulin pump difficult (e.g. blindness, severe arthritis, immobility).
• •15. Any skin condition that prevents sensor or pump placement on the abdomen or arm (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis).
• •16. In adherence with the One Touch Ultra 2 User Guide, subjects with hematocrit levels less than 30% and above 55% will be excluded.
• •17. Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥three times the upper reference limit.
• •18. Impaired renal function measured as creatinine \>1.2 times above the upper limit of normal.
• •19. Uncontrolled microvascular (diabetic) complications, such as current proliferative diabetic retinopathy or macular edema, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment.
• •20. Active gastroparesis requiring current medical therapy.
• •21. 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.
• •22. Uncontrolled thyroid disease.
• •23. Known bleeding diathesis or dyscrasia.
• •24. Known allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor.
• •25. Active enrollment in another clinical trial.
• •26. Use of anti-diabetic agents other than continuous subcutaneous insulin infusion (CSII) including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-IV inhibitors, glucagon-like peptide 1 agonists, and alpha-glucosidase inhibitors
• •27. Subjects with basal rates less than 0.01U/hr.