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

To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion

In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.

The long-term clinical benefit of tight glycemic control in people with diabetes is well known . HbA1c generally assesses the average/long term quality of glycemic control, it has been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic patients

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.

Exclusion Criteria:

• Hearing or vision impairment so that alarms cannot be recognized.
• Alcohol or drug abuses other than nicotine.
• Allergy to sensor or components of the sensor.
• Allergy to insulin infusion set or components of the insulin infusion set.
• Patient is pregnant or of child-bearing potential during the study.
• Patient does not have a reliable support person or the patient is unwilling to comply with the provisions of the protocol.
• Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions.
• Patients participating in other device or drug studies will be excluded.
• Patients may participate in this study only once.