Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.
Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
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.
研究概览
详细说明
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).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Warsaw、波兰
- Medical University of Warsaw
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：control (B)
Patients performing CHO and FP exchanges calculation with standard method.
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实验性的：ELKa (A)
Patients counting CHO and FP exchanges with ELKa toolset.
|
ELKa should be used for every meal preparation.
After choosing the name of particular product from the list, the program will give precise information about the amount of CHO and FP exchanges in serving.
No standard calculation of exchanges need to be performed.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
HbA1c (glycated hemoglobin)
大体时间：6 months
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HbA1c (glycated hemoglobin)
大体时间：3 months
|
3 months
|
|
|
ELKa usage frequency
大体时间：3 months
|
Self-reported in questionnaire
|
3 months
|
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ELKa usage frequency
大体时间：6 months
|
Self-reported in questionnaire
|
6 months
|
|
Post- prandial glycemia
大体时间：3 months
|
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
|
3 months
|
|
Post- prandial glycemia
大体时间：6 months
|
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
|
6 months
|
|
mean diurnal glucose level
大体时间：3 months
|
3 months
|
|
|
mean diurnal glucose level
大体时间：6 months
|
6 months
|
|
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Mean daily insulin dose [Insulin/kg/24h]
大体时间：3 months
|
3 months
|
|
|
Mean daily insulin dose [Insulin/kg/24h]
大体时间：6 months
|
6 months
|
|
|
BMI- standard deviation (BMI- sds)
大体时间：3 months
|
3 months
|
|
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BMI- standard deviation (BMI- sds)
大体时间：6 months
|
6 months
|
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Hypoglycemia episodes and severe hypoglycemia events
大体时间：3 months
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Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl.
Self-reported.
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3 months
|
|
Hypoglycemia episodes and severe hypoglycemia events
大体时间：6 months
|
Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl.
Self-reported.
|
6 months
|
|
Mean Amplitude of Glycemic Excursions (MAGE)
大体时间：3 months
|
Measured in subgroup of patients with continuous glucose monitoring system (CGMS)
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3 months
|
|
Mean Amplitude of Glycemic Excursions (MAGE)
大体时间：6 months
|
Measured in subgroup of patients with CGMS
|
6 months
|
|
Glucose Area Under the Curve (AUC)
大体时间：3 months
|
Measured in subgroup of patients with CGMS
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3 months
|
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Glucose Area Under the Curve (AUC)
大体时间：6 months
|
Measured in subgroup of patients with CGMS
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6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment satisfaction
大体时间：6 months
|
Questionnaire regarded treatment satisfaction and wish to continuation.
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6 months
|
合作者和调查者
调查人员
- 学习椅：Agnieszka Szypowska, Professor、Medical University of Warsaw
- 研究主任：Agnieszka Kowalska, MD、Medical University of Warsaw
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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