NCT06230276招募中不适用
How do the Currently Available HCL Systems Manage Missed Meal Bolus? The Comparison of Glycemic Outcomes After Missed Meal Bolus Between MiniMed 780G, Tandem Control-IQ and Ypsomed CamAPS
Zdeněk Šumník2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.
研究概览
简要总结
The goal of this interventional study is to compare glycemic outcomes after missed meal bolus in children and adolescents with type 1 diabetes (CwD) treated by one of the three most common used types of hybrid closed loop (HCL) systems - Medtronic MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS. The main questions it aims to answer are:
- Do the glycemic outcomes (area under the curve of glucose concentration change, maximal glucose rise from baseline, time to maximal glucose rise from baseline, CGM parameters) vary after missed meal bolus among different types of HCL systems?
- Does the type of insulin analog influence glycemic outcomes after a missed meal bolus?
Participants will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with type 1 diabetes (CwD) 9.00-18.99 years old
- •use of continuous glucose monitoring (CGM) >70% of the time 14 days before a regular check-up in the outpatient clinic
- •HCL use (MiniMed 780G, Tandem Control-IQ or Ypsomed CamAPS) >3 months
- •duration of T1D >2 years
- •baseline HbA1c level <58 mmol/mol (7.5%)
- •weight > 30 kilograms
- •without any medication influencing glycemia (f.e. gliflozins, systemic corticosteroids...)
- •signed informed consent form with the study
排除标准
- 未提供
结局指标
主要结局
Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.
时间窗: 4 hour after a meal
次要结局
- Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin ultra-rapid lispro(4 hours after a meal)
- Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin aspart.(4 hours after a meal)
- Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.(4 hours after a meal)
- Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using different types of insulin analogs(4 hours after a meal)
- Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.(4 hours after a meal)
- Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs(4 hours after a meal)
- Difference in CGM parameters 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems.(4 hours after a meal)
- Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs(4 hours after a meal)
研究者
Zdeněk Šumník
Head of the Department of Pediatrics
University Hospital, Motol
研究点 (2)
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