NCT02194517

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2014-07-18
• Last updated: 2015-03-17

Locations

1 site across 1 country: Poland