Randomized, Cross Over, Controlled, Multi-centric Study to Assess Whether Type 1 Diabetic Patients in Sub-optimal Glycemic Control Can Improve Using the Continuous Glucose Values of the MiniMed Paradigm REAL-Time Insulin Pump System Versus the MiniMed Paradigm Insulin Pump
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 8
- 主要终点
- HbA1c at 6 Month
研究概览
简要总结
The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
- •Sub-optimal glycemic control (7.5%<HbA1c<9.5%).
- •Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
- •Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
- •Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.
排除标准
- •Existing pregnancy or intention to conceive (as assessed by investigator).
- •Hearing or vision impairment so that glucose display and alarms cannot be recognized.
- •Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
- •History of hypoglycemic unawareness as assessed by the investigator.
- •Alcohol or drug abuse, other than nicotine.
- •Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
- •Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index >35 and children Body Mass Index > 2 standard deviations. for age) as assessed by the investigator.
- •Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
- •For pediatric subjects: does not have a reliable support person.
- •Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
- •Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
研究组 & 干预措施
Off/On
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]
4 month wash out period
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]
干预措施: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System) (Device)
On/Off
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]
4 month wash out period
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]
干预措施: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump) (Device)
结局指标
主要结局
HbA1c at 6 Month
时间窗: 6 months
The end of period difference in HbA1c after 6 months of treatment
次要结局
- Number of Severe Hypoglycemia Events(6 months)
- Postprandial Glycaemia(6 months)
- Diabetic Ketoacidosis Events(6 months)
- Glycemic Variability(6 months)
- Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)(6 months)
- Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)(6 months)