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.
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Warsaw, 폴란드
- Medical University of Warsaw
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: control (B)
Patients performing CHO and FP exchanges calculation with standard method.
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실험적: ELKa (A)
Patients counting CHO and FP exchanges with ELKa toolset.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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HbA1c (glycated hemoglobin)
기간: 6 months
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HbA1c (glycated hemoglobin)
기간: 3 months
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3 months
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ELKa usage frequency
기간: 3 months
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Self-reported in questionnaire
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3 months
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ELKa usage frequency
기간: 6 months
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Self-reported in questionnaire
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6 months
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Post- prandial glycemia
기간: 3 months
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Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
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3 months
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Post- prandial glycemia
기간: 6 months
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Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
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6 months
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mean diurnal glucose level
기간: 3 months
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3 months
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mean diurnal glucose level
기간: 6 months
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6 months
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Mean daily insulin dose [Insulin/kg/24h]
기간: 3 months
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3 months
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Mean daily insulin dose [Insulin/kg/24h]
기간: 6 months
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6 months
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BMI- standard deviation (BMI- sds)
기간: 3 months
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3 months
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BMI- standard deviation (BMI- sds)
기간: 6 months
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6 months
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Hypoglycemia episodes and severe hypoglycemia events
기간: 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
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Hypoglycemia episodes and severe hypoglycemia events
기간: 6 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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6 months
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Mean Amplitude of Glycemic Excursions (MAGE)
기간: 3 months
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Measured in subgroup of patients with continuous glucose monitoring system (CGMS)
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3 months
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Mean Amplitude of Glycemic Excursions (MAGE)
기간: 6 months
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Measured in subgroup of patients with CGMS
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6 months
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Glucose Area Under the Curve (AUC)
기간: 3 months
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Measured in subgroup of patients with CGMS
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3 months
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Glucose Area Under the Curve (AUC)
기간: 6 months
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Measured in subgroup of patients with CGMS
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6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment satisfaction
기간: 6 months
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Questionnaire regarded treatment satisfaction and wish to continuation.
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6 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Agnieszka Szypowska, Professor, Medical University of Warsaw
- 연구 책임자: Agnieszka Kowalska, MD, Medical University of Warsaw
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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