obtain a good blood glucose control with the paradigm real time system

Conditions: Type 1 Diabetes

Summary: 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

Eligibility criteria:
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.

Keywords: improvement of the blood glucose control