Lowering Postprandial Hyperglycemia With Dual-wave Insulin Boluses in Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
研究概览
简要总结
To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
详细描述
Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
Primary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Trial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase.
Trial population A total of 30 subjects with type 1 diabetes.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.
- •Insulin pump and CGM initiated at least 3 months prior to the recruitment.
- •Estimated HbA1c based on the 14-days CGM report above 8.5%.
- •Daily insulin dose of more than 0.5 international units per kilogram.
排除标准
- •Subjects with known diabetes complications.
- •Elevated tissue transglutaminase IgA antibodies in the last two years.
- •Children who developed an acute viral infections during the week preceding the recruitment.
- •Exclusion criteria after the Run-in period
- •Basal insulin proportion > 55% of daily insulin dose.
- •Children with any symptoms of an infectious disease or acutely sick during the last two weeks.
- •Estimated HbA1c > 8.5% based on the 14-days CGM report.
研究组 & 干预措施
Standard-bolus
Standard boluses for all meal
干预措施: Standard bolus (Device)
Dual-bolus
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m
干预措施: Dual-bolus (Device)
结局指标
主要结局
Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
时间窗: 14 days
To compare time in range duration during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time in range (3.9-10 mmol/L) will be measured.
次要结局
- Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.(14 days)
- Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus(14 days)
研究者
Aleksandr Peet
pediatric endocrinologist, MD, PhD
Tartu University Hospital