Evaluation of Interests of the Functional Insulin Therapy (FIT Therapy) on Metabolic Control, Hypoglycemia Prevention and Life Quality of Diabetics Children Insulin-dependent Treated With Insulin Pump.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 88
- 试验地点
- 12
- 主要终点
- Variation in HbA1c
研究概览
简要总结
Evaluation of interests of the functional insulin therapy (FIT Therapy) on metabolic control, hypoglycemia prevention and life quality of diabetics children insulin-dependent treated with insulin pump.
详细描述
Open multicenter randomized study of one year, evaluating two groups of 44 children with diabetes mellitus (diabetes over 1 year) treated with insulin pump, one group by traditional way (fixed doses of insulin and meals providing stable quantities complex carbohydrates) and the other group by FIT Therapy.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 1-17 years
- •diabetic for at least 1 year
- •whose HbA1c is between 7.6 and 10% (7.6% <HbA1C <10%)
- •treated with insulin pump
- •agreeing to perform at least three blood glucose/day
- •willing to follow the treatment with functional insulin therapy if necessary
排除标准
- •Ages <1 year or> 17 years
- •Duration of diabetes <1 year
- •HbA1c <7.6% or HbA1c> 10%
- •Treatment-by multiple injections
- •Mental disability
- •Refusal to adhere to the constraints of the study
- •Language barrier, preventing any understanding or cooperation
- •Eating behavior-type anorexia or bulimia
- •Pregnancy
- •Use of alcohol or drugs
- •Severe chronic or genetic pathology other than diabetes
- •Participation in another clinical study or refusal to participate in the study
结局指标
主要结局
Variation in HbA1c
时间窗: One year
Variation in HbA1c from baseline in the study (M0) and 1 year later the beginning of the program (M12) for assess the importance of the FIT Therapy to improve metabolic control of children with diabetes mellitus treated with subcutaneous insulin pump.
次要结局
- Severe hypoglycemia over 6 months and quality of life(One year and six months)