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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: ELKa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control (B)<br>Patients performing CHO and FP exchanges calculation with standard method. | |
| Experimental: ELKa (A)<br>Patients counting CHO and FP exchanges with ELKa toolset. | Device: ELKa<br>* 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.<br>* Other names: Elka PC application;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycated hemoglobin) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycated hemoglobin) |  | 3 months | 
| ELKa usage frequency | Self-reported in questionnaire | 3 months | 
| ELKa usage frequency | Self-reported in questionnaire | 6 months | 
| Post- prandial glycemia | Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days | 3 months | 
| Post- prandial glycemia | Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days | 6 months | 
| mean diurnal glucose level |  | 3 months | 
| mean diurnal glucose level |  | 6 months | 
| Mean daily insulin dose [Insulin/kg/24h] |  | 3 months | 
| Mean daily insulin dose [Insulin/kg/24h] |  | 6 months | 
| BMI- standard deviation (BMI- sds) |  | 3 months | 
| BMI- standard deviation (BMI- sds) |  | 6 months | 
| Hypoglycemia episodes and severe hypoglycemia events | Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported. | 3 months | 
| Hypoglycemia episodes and severe hypoglycemia events | 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) | Measured in subgroup of patients with continuous glucose monitoring system (CGMS) | 3 months | 
| Mean Amplitude of Glycemic Excursions (MAGE) | Measured in subgroup of patients with CGMS | 6 months | 
| Glucose Area Under the Curve (AUC) | Measured in subgroup of patients with CGMS | 3 months | 
| Glucose Area Under the Curve (AUC) | Measured in subgroup of patients with CGMS | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, diet control toolset, food exchanges, CHO, FP