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Completed

NCT Number: NCT02194517

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw

Warsaw, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELKa

Device

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.

Other names: Diet Control Toolset, ElkaPlus USB Scale, Elka toolset, Elka PC application

Primary outcomes

  1. HbA1c (glycated hemoglobin)

    Time frame: 6 months

Secondary outcomes

  1. HbA1c (glycated hemoglobin)

    Time frame: 3 months

  2. ELKa usage frequency

    Time frame: 3 months

    Self-reported in questionnaire

  3. ELKa usage frequency

    Time frame: 6 months

    Self-reported in questionnaire

  4. Post- prandial glycemia

    Time frame: 3 months

    Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days

  5. Post- prandial glycemia

    Time frame: 6 months

    Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days

  6. mean diurnal glucose level

    Time frame: 3 months

  7. mean diurnal glucose level

    Time frame: 6 months

  8. Mean daily insulin dose [Insulin/kg/24h]

    Time frame: 3 months

  9. Mean daily insulin dose [Insulin/kg/24h]

    Time frame: 6 months

  10. BMI- standard deviation (BMI- sds)

    Time frame: 3 months

  11. BMI- standard deviation (BMI- sds)

    Time frame: 6 months

  12. Hypoglycemia episodes and severe hypoglycemia events

    Time frame: 3 months

    Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.

  13. Hypoglycemia episodes and severe hypoglycemia events

    Time frame: 6 months

    Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.

  14. Mean Amplitude of Glycemic Excursions (MAGE)

    Time frame: 3 months

    Measured in subgroup of patients with continuous glucose monitoring system (CGMS)

  15. Mean Amplitude of Glycemic Excursions (MAGE)

    Time frame: 6 months

    Measured in subgroup of patients with CGMS

  16. Glucose Area Under the Curve (AUC)

    Time frame: 3 months

    Measured in subgroup of patients with CGMS

  17. Glucose Area Under the Curve (AUC)

    Time frame: 6 months

    Measured in subgroup of patients with CGMS

Other outcomes

  1. Treatment satisfaction

    Time frame: 6 months

    Questionnaire regarded treatment satisfaction and wish to continuation.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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