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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: ELKa

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).

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control (B); Patients performing CHO and FP exchanges calculation with standard method.
Experimental: ELKa (A); Patients counting CHO and FP exchanges with ELKa toolset.	Device: ELKa; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment satisfaction	Questionnaire regarded treatment satisfaction and wish to continuation.	6 months

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Chair: Agnieszka Szypowska, Professor, Medical University of Warsaw; Study Director: Agnieszka Kowalska, MD, Medical University of Warsaw

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: diabetes; diet control toolset; food exchanges; CHO; FP
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: ELKA-01