Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Treatment satisfaction
研究概览
简要总结
A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.
The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.
详细描述
A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.
134 Patients with new onset Diabetes type 1, diagnosed 12 months previously at maximum will be enrolled.
The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with NPH insulin and than 12 weeks with insulin Glargine.
The study will consist of 4 clinical visits, taking place at -2, 0, 12 and 24 weeks. Height,weight,vital signs, HbA1c and insulin doses will be determined during the clinical visits.
Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.
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
- 7 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes diagnosed less than 12 months prior to study entry
- •Age: 7-20 years old.
- •HbA1c>/=8.0
- •Signing inform consent form
排除标准
- •Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study.
- •Patients participating in other device or drug studies.
- •Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC.
- •Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire.
研究组 & 干预措施
insulin Glargine + insulin Apidra
insulin Glargine + insulin Apidra
干预措施: insulin Glargine + Insulin Apidra (Drug)
结局指标
主要结局
Treatment satisfaction
时间窗: patients will complete DTSQ at months 0,12 and 24
次要结局
- Hypoglycemic events(patients will report in their diary every episode of hypoglycemia)
- HbA1c(value of Hba1C will be measured at screening visit and at the end of each study arm)
- 4 and 7 points glucose profile(patients will complete a diary before all clinical visits)
- Insulin doses(Insulin doses will be determined at baseline visit and every visit after)