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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 16
- 主要终点
- Difference in HbA1C From Baseline and 6 Months
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Conventional insulin pump therapy
Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII)
干预措施: Minimed Paradigm 512/712 Insulin pump (Device)
Minimed paradigm Real Time Sytem
Minimed paradigm Real Time Sytem
干预措施: Minimed paradigm Real Time Sytem (Device)
结局指标
主要结局
Difference in HbA1C From Baseline and 6 Months
时间窗: Baseline and 6 months
Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
次要结局
- Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.(Baseline and 6 months)
- Change From Baseline in Total Daily Dose (TDD)(Baseline and 6 months)