Therapeutic Education in Very Young Children With Diabetes Mellitus. Evaluation of the Impact of a Specific Tool for Parents on Glycemic Control and Prevention of Acute Events (Hypoglycemia and Ketosis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- HbA1c 12 months after therapeutic education
研究概览
简要总结
DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management, over a period of 2 years. The investigators plan to include 300 type 1 diabetic children in 10 french hospitals.
详细描述
General frame : 1 inclusion / randomization visit and delivery of the educational tool for patients of the "Therapeutic Education" arm, then follow-up visits every 6 months during 24 months.
V0 - Inclusion / randomization visit - Verification of eligibility - Clinical examination and data report - Blood samples for lab tests (HbA1c assay)- Collection of signed consent form- DIAB-EDUC questionnaire (diabetes knowledge, treatment, quality of life, hypoglycaemia and emergency situations, parental stress)- Randomization - Education tool explanation and delivery by the physicians to parents randomized in " Experimental " arm
M6 - Visit at 6 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)
M12 - Visit at 12 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)- DIAB-EDUC questionnaire
M18 - Visit at 18 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with type 1 diabetes aged 1 to 6 years
- •Disease evolution more than 1 year
- •HbA1c > 8% or at least one acute accident (hypoglycemia or ketosis) during the last year
- •Specific information given to parents from the physicians and consent form signed by the parents
- •Physical examination of the children at enrolment- patient affiliated with or receiving health insurance
排除标准
- •Non-insulin dependent diabetes
- •Monogenic diabetes (MODY)
- •Severe co-morbidities- cognitive disabilities or psychosocial disadvantage compromising the therapeutic education
- •Children whose parents have a disorder of comprehension or expression of the French Language
- •Patients included in another interventional trial
结局指标
主要结局
HbA1c 12 months after therapeutic education
时间窗: 12 months
次要结局
- HbA1C 24 months after therapeutic education(24 months)
- Acute events number (hypoglycemia and ketosis) over a 12 and 24 months period(12 and 24 months)
- Evolution of the parental knowledge about the disease 12 and 24 months after therapeutic education (evaluated by questionnaire)(12 and 24 months)
- Evolution of the parental stress 12 and 24 months after therapeutic education (evaluated by questionnaire)(12 and 24 months)
- Evolution of the parental and child quality of life 12 and 24 months after therapeutic education (evaluated by questionnaire)(12 and 24 months)