Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children With Type 1 Diabetes and Primary Caregivers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Time in glucose target
研究概览
简要总结
The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.
详细描述
Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of children with T1DM, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. This leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes.
In this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or without impact on insulin administration and without alerts.
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
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Duration of diabetes ≥ 6 months
- •Insulin pump treatment ≥ 6 months
- •HbA1c ≤ 11%
- •Parental written informed consent
排除标准
- •. No parental consent
- •Physical or psychological disease likely to interfere with an appropriate conduct of the study
- •Current drug therapy knowing to interfere with glucose metabolism
- •Chronic sleep medication in the primary caregiver or the patient -
研究组 & 干预措施
CGM augmented pump with PLGS (A)
Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with integrated continuous glucose monitoring and predicted low glucose suspense (PLGS) Randomised cross over treatment during 5 weeks
干预措施: CGM augmented pump with PLGS , (Device)
Insulin pump with CGM (B)
Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks
干预措施: Insulin pump with CGM (Device)
结局指标
主要结局
Time in glucose target
时间窗: Last 6 days of treatment arm A and last 6 days of treatment arm B
Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM
次要结局
- Sleep quantity in patients and caregivers(baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B)
- hypoglycaemia fear in patients and caregivers(baseline and last week of treatment arm A and last week of treatment arm B)
- time below glucose target(Last 6 days of treatment arm A and last 6 days of treatment arm B)
- Time above glucose target(Last 6 days of treatment arm A and last 6 days of treatment arm B)
- perception of quality of sleep and quality of life in patients and caregivers(baseline and last week of treatment arm A and last week of treatment arm B)
研究者
Carine de Beaufort
Guest Professor , MD, PhD
Centre Hospitalier du Luxembourg