Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- HbA1c (glycated hemoglobin)
研究概览
简要总结
ELKa system is an advanced toolset which helps performing calculation of carbohydrate (CHO) and fat/protein (FP) exchanges. It consists of ELKa software including database of various meals and nutrients and ELKaPlus digital kitchen scale transmitting weight of products in a real-time to a computer via universal serial bus (USB) port. After choosing the name of particular product from the list, the program gives precise information about the amount of CHO and FP exchanges in serving.
The aim of the study is to investigate the benefit of using ELKa toolset in comparison with standard method of CHO and FP counting on metabolic control in type 1 diabetic children.
详细描述
A randomized, controlled, parallel, open-label 26-week clinical trial will be conducted in 106 pediatric patients with type 1 diabetes mellitus (DM). Patients will be randomly assigned into two groups: the group A (n=53) using ELKa system for food exchange counting and the group B (n= 53) using standard method.
The glycated hemoglobin levels will be measured in both groups at the beginning, after 3 and 6 months of observation. The group A also will be asked about the frequency of using the toolset. We will also assess secondary endpoints (mentioned below).
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 18 y
- •Confirmed DM type 1
- •DM for > 1 year
- •HbA1c ≤ 10%
- •Computer meeting ELKa system minimum requirements
- •Kitchen arrangement providing enough space for computer with ELKa system
- •Written informed consent
排除标准
- •DM other than type 1
- •Duration of diabetes < 1 year
- •Conventional insulin therapy
- •Nutritional disorders
- •Celiac disease recognized in less than 4 months before inclusion
- •Preceding experience with software
- •Expected 21 or more consecutive days pausing in system usage
- •Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
结局指标
主要结局
HbA1c (glycated hemoglobin)
时间窗: 6 months
次要结局
- HbA1c (glycated hemoglobin)(3 months)
- ELKa usage frequency(6 months)
- Post- prandial glycemia(6 months)
- mean diurnal glucose level(6 months)
- Mean daily insulin dose [Insulin/kg/24h](6 months)
- BMI- standard deviation (BMI- sds)(6 months)
- Hypoglycemia episodes and severe hypoglycemia events(6 months)
- Mean Amplitude of Glycemic Excursions (MAGE)(6 months)
- Glucose Area Under the Curve (AUC)(6 months)