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

Medical University of Warsaw

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: ELKa

Study type: Interventional

Funder types: Other

Identifiers

NCT02194517

ELKA-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 106 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

control (B)

No Intervention group

Description:

Patients performing CHO and FP exchanges calculation with standard method.

ELKa (A)

Experimental group

Description:

Patients counting CHO and FP exchanges with ELKa toolset.

Treatment:

Device: ELKa