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

NCT ID: NCT02194517

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-11-30

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).

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

control (B)

Patients performing CHO and FP exchanges calculation with standard method.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ELKa (A)

Patients counting CHO and FP exchanges with ELKa toolset.

Group Type: EXPERIMENTAL

ELKa

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Diet Control Toolset; ElkaPlus USB Scale; Elka toolset; Elka PC application

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnieszka Szypowska, Professor

Role: STUDY_CHAIR

Medical University of Warsaw

Agnieszka Kowalska, MD

Role: STUDY_DIRECTOR

Medical University of Warsaw

Locations

Medical University of Warsaw

Warsaw, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 28232949 (View on PubMed)

Other Identifiers

ELKA-01

Identifier Type: -

Identifier Source: org_study_id