Impact of an Intensive Monitoring on Glycaemic Control One Year After Initiating Continuous Subcutaneous Insulin Infusion in Children With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Impact on glycaemic control all along the study
研究概览
简要总结
More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion).
Several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.
Consequently, this real life study aims to compare two monitoring methods (standard versus intensive) in children initiating a CSII treatment and assess the impact on glycaemic control after one year.
详细描述
As CSII becomes more and more the gold standard therapy in children with type 1 diabetes, there have been some questions regarding the long-term effect of these treatments with some concerns on the inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.
The DCCT (Diabetes Control and Complications Trial) study has already shown in diabetic adults that intensification of treatment and follow-up could result in significative improvement of glycaemic control.
This study aims to test this hypothesis of significant improvement after one year following CSII initiation on glycaemic control.
Two parallel arms will be compared in real life conditions; one with standard recommendations-based follow-up by both diabetologists/pediatricians and service provider and the other with intensive follow-up with higher frequency of provider's nurses visits and personalization of patient status transferred to the physician for each diabetologists/pediatricians visit.
Thus, investigators could determine after one year if the glycaemic control is better with one or the other of these follow-up procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (<18 yo) with not controlled type 1 diabetes seen by diabetologists/paediatricians immediately following the initiation of CSII.
- •Children for whom it is the first initiation of CSII.
- •Children (or their parents if necessary) having read the information note and having dated and signed the informed consent form.
排除标准
- •Children with a history of diabetes less than 12 months.
- •Children with HbA1c values below 7.5 or above 10 before CSII initiation.
- •Children treated by CSII for more than 3 months.
结局指标
主要结局
Impact on glycaemic control all along the study
时间窗: Assessment and counting of all unplanned hospitalizations during the 12 months period
Unplanned hospitalization rate during the study Severe hypoglycemia during the study period
Impact on glycaemic control one year after CSII initiation
时间窗: HbA1c values at inclusion and last known measurement at the 12 months last visit
Evolution of HbA1c measurement between last measure before CSII initiation and 12 months after.
次要结局
- Impact on glycaemic control upon age classes(HbA1c values at inclusion and last known measurement at the 12 months last visit)