Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy

Exclusion Criteria

• •Is pregnant or planning to become pregnant during the course of the study
• •Has suffered two or more documented events of severe hypoglycemia without warning of impending low glucose levels, within the previous 12 months
• •Currently using oral or injectable steroids or immunosuppressant medications
• •Use of any other pharmaceutical agent, other than insulin to treat diabetes, within the three months prior to screening;
• •Has a current history of alcohol or drug abuse
• •Has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), or thromboembolic disease in the 3 months prior to screening
• •Has uncontrolled hypertension (diastolic blood pressure \>100 mmHg and/or sustained systolic level \[3 successive readings\] \> 160). Subjects who are taking antihypertensive medication will not be excluded provided they are maintained at a stable dose for 3 months prior to screening
• •Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
• •Is undergoing renal dialysis, including hemodialysis and continuous ambulatory peritoneal dialysis (CAPD)
• •Has evidence of any allergic dermatological condition (e.g., severe adhesive sensitivity)
• •Has recurrent episodes of skin infections or history of staphylococcus infection carrier state
• •Has potential for lack of compliance or any other issue that may preclude the subject from satisfactory participation in the study, based on Investigatory judgment