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Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
ELKa
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring diabetes, diet control toolset, food exchanges, CHO, FP

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control (B)

ELKa (A)

Arm Description

Patients performing CHO and FP exchanges calculation with standard method.

Patients counting CHO and FP exchanges with ELKa toolset.

Outcomes

Primary Outcome Measures

HbA1c (glycated hemoglobin)

Secondary Outcome Measures

HbA1c (glycated hemoglobin)
ELKa usage frequency
Self-reported in questionnaire
ELKa usage frequency
Self-reported in questionnaire
Post- prandial glycemia
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
Post- prandial glycemia
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
mean diurnal glucose level
mean diurnal glucose level
Mean daily insulin dose [Insulin/kg/24h]
Mean daily insulin dose [Insulin/kg/24h]
BMI- standard deviation (BMI- sds)
BMI- standard deviation (BMI- sds)
Hypoglycemia episodes and severe hypoglycemia events
Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.
Hypoglycemia episodes and severe hypoglycemia events
Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.
Mean Amplitude of Glycemic Excursions (MAGE)
Measured in subgroup of patients with continuous glucose monitoring system (CGMS)
Mean Amplitude of Glycemic Excursions (MAGE)
Measured in subgroup of patients with CGMS
Glucose Area Under the Curve (AUC)
Measured in subgroup of patients with CGMS
Glucose Area Under the Curve (AUC)
Measured in subgroup of patients with CGMS

Full Information

First Posted
July 16, 2014
Last Updated
March 16, 2015
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02194517
Brief Title
Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.
Official Title
Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
diabetes, diet control toolset, food exchanges, CHO, FP

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control (B)
Arm Type
No Intervention
Arm Description
Patients performing CHO and FP exchanges calculation with standard method.
Arm Title
ELKa (A)
Arm Type
Experimental
Arm Description
Patients counting CHO and FP exchanges with ELKa toolset.
Intervention Type
Device
Intervention Name(s)
ELKa
Other Intervention Name(s)
Diet Control Toolset, ElkaPlus USB Scale, Elka toolset, Elka PC application
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c (glycated hemoglobin)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HbA1c (glycated hemoglobin)
Time Frame
3 months
Title
ELKa usage frequency
Description
Self-reported in questionnaire
Time Frame
3 months
Title
ELKa usage frequency
Description
Self-reported in questionnaire
Time Frame
6 months
Title
Post- prandial glycemia
Description
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
Time Frame
3 months
Title
Post- prandial glycemia
Description
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
Time Frame
6 months
Title
mean diurnal glucose level
Time Frame
3 months
Title
mean diurnal glucose level
Time Frame
6 months
Title
Mean daily insulin dose [Insulin/kg/24h]
Time Frame
3 months
Title
Mean daily insulin dose [Insulin/kg/24h]
Time Frame
6 months
Title
BMI- standard deviation (BMI- sds)
Time Frame
3 months
Title
BMI- standard deviation (BMI- sds)
Time Frame
6 months
Title
Hypoglycemia episodes and severe hypoglycemia events
Description
Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.
Time Frame
3 months
Title
Hypoglycemia episodes and severe hypoglycemia events
Description
Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.
Time Frame
6 months
Title
Mean Amplitude of Glycemic Excursions (MAGE)
Description
Measured in subgroup of patients with continuous glucose monitoring system (CGMS)
Time Frame
3 months
Title
Mean Amplitude of Glycemic Excursions (MAGE)
Description
Measured in subgroup of patients with CGMS
Time Frame
6 months
Title
Glucose Area Under the Curve (AUC)
Description
Measured in subgroup of patients with CGMS
Time Frame
3 months
Title
Glucose Area Under the Curve (AUC)
Description
Measured in subgroup of patients with CGMS
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Treatment satisfaction
Description
Questionnaire regarded treatment satisfaction and wish to continuation.
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnieszka Szypowska, Professor
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Agnieszka Kowalska, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Warsaw
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28232949
Citation
Kowalska A, Piechowiak K, Ramotowska A, Szypowska A. Impact of ELKa, the Electronic Device for Prandial Insulin Dose Calculation, on Metabolic Control in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Controlled Trial. J Diabetes Res. 2017;2017:1708148. doi: 10.1155/2017/1708148. Epub 2017 Jan 23.
Results Reference
derived

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Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.

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