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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: ELKa

• Registration Number: NCT02194517
• Lead Sponsor: Medical University of Warsaw

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).

Study Timeline

• Study Start: 2013-04
• Status Verified: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ELKa (A)	ELKa	Patients counting CHO and FP exchanges with ELKa toolset.

Primary Outcome Measures

Name	Time	Method
HbA1c (glycated hemoglobin)	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Poland