Obtain a Good Blood Glucose Control With the Paradigm Real Time System

Inclusion Criteria

• •Patient has signed informed consent form prior to study entry.
• •Patients have been diagnosed with Type 1 DM at least 12 months prior to inclusion.
• •Patients should have been received diabetes care from the investigator of each center at least 3 months prior to inclusion.
• •Patients have been treated with multiple daily injections and use rapid Insulin Analog for their meal prior to study entry.
• •Have an HbA1c value ≥ 8 %.
• •Pediatric patients must be aged between 2 and 18 years old and adult patients be aged between 19 and 65 years old.
• •Patients must perform at least 3 self-monitoring blood glucose finger-sticks daily.
• •Patients from PRT group must be willing to wear sensors and transmitter connected to the pump Paradigm® Real-Time for up to 24 weeks and to change sensors, insulin infusion sets and reservoirs every 3 days (\~60 times during the study period ).
• •Patients from CSII group must be willing to wear an insulin pump, change insulin infusion sets, and reservoirs every 3 days (\~60 times during the study period ).
• •Patient is required to use the Paradigm® Real-Time system at least 70% of the time during the study period.
• •Patients in both groups are required to wear at the beginning and the end of the study a CGMS for 3 days. and to perform 6 self-monitoring blood glucose finger-sticks daily during the 3 days.
• •Patients must be willing to undergo all study procedures, to receive a technical training to understand how to use the Paradigm® Real-Time System or the Insulin Pump depending of the randomization.
• •Patients must agree to receive a training on how to adapt their insulin doses to their meals, how to calculate and apply corrective treatment.