DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy

Exclusion Criteria

• •1. An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
• •2. Concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patients' safety
• •3. Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:
• •* Subject has unstable or rapidly progressive renal disease or is receiving dialysis
• •* Subject has active proliferative retinopathy
• •* Active gastroparesis
• •4. Participation in any other interventional study
• •5. Female subject who is pregnant or planning to become pregnant within the planned study duration
• •6. Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
• •7. Drug or alcohol abuse.