NCT06372392Unknown不适用
Randomized Controlled Study of the Usage of Universal Fixed Meal Bolus Coefficients for the Control of Postprandial Hyperglycemia in the Users of Medtronic Minimed 780G Pumps
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time in range (TIR)
研究概览
简要总结
Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.
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
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes diagnosed at least 1 year ago
- •insulin in the dose 0,5-1,0 units/day/kg
- •MiniMed 780G pump usage at least 1 month.
排除标准
- •Active coeliac disease
- •Chronic disease possible to influence diabetes treatment
- •Acute disease at the moment of recruitment
研究组 & 干预措施
Universal coefficient
Experimental
With fixed meal bolus coefficients (TDD/300 breakfast and TDD/400 other meals)
干预措施: Universal meal coefficient utilization (Device)
Individualized coefficient
Active Comparator
With meal bolus coefficient individualized according to physician judgment's
干预措施: Universal meal coefficient utilization (Device)
结局指标
主要结局
Time in range (TIR)
时间窗: 4 weeks
Comparision of TIR between groups
次要结局
- TBR(4 weeks)
- auto-corrections %(4 weeks)
- coefficient of variability(4 weeks)
- TAR(4 weeks)
研究者
Aleksandr Peet
Pediatric endocrinologist (PI)
Tartu University Hospital
研究点 (1)
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