Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes: Study of Insulin Sensitivity in the 2 Types of Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Mixed measurement of insulin secretion and insulin resistance
研究概览
简要总结
This is an open multicentre, randomized study to compare two treatment arms. One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®.
In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who have provided written informed consent
- •Age > 18 years
- •Patients with type 2 diabetes treated with insulin using a basal / bolus strategy for at least 6 months
- •Doses of insulin > 0.7 U / Kg / d
- •HbA1c ≥ 7.5 %
- •Without OAD for at least 4 weeks (sulfamides, Incretines, glinides, acarbose) except Metformin
- •BMI ≥ 28.5 kg / m2
- •Diabetes diagnosed for at least 10 years
- •Patients able to monitor themselves and manage an insulin pump.
排除标准
- •Patients treated with glitazones during the 3 months preceding inclusion
- •Patients with proliferative ischemic retinopathy not treated by laser
- •BMI < 28.5 kg / m2
- •Presence of implantable material ( CI MRI )
- •Pacemaker ( CI MRI )
- •Pregnancy, breast feeding
- •Medically significant physical or psychiatric inability, patients under guardianship or wards of court
- •The practice of violent sports
- •Poor conditions of hygiene
- •Professional environment of extreme cold or heat.
研究组 & 干预措施
Intensified multiple injections
干预措施: LEVEMIR (Drug)
Pumps
干预措施: APIDRA (Drug)
结局指标
主要结局
Mixed measurement of insulin secretion and insulin resistance
时间窗: Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment
次要结局
- Decrease in the time spent in baseline and prandial hyperglycemia(During the 6 months following initiation of the treatment)