Recruitment

Recruitment Status
Completed

Inclusion Criterias

Computer meeting ELKa system minimum requirements
Kitchen arrangement providing enough space for computer with ELKa system
HbA1c ≤ 10%
...
Computer meeting ELKa system minimum requirements
Kitchen arrangement providing enough space for computer with ELKa system
HbA1c ≤ 10%
DM for > 1 year
Written informed consent
Age under 18 y
Confirmed DM type 1

Exclusion Criterias

Expected 21 or more consecutive days pausing in system usage
Preceding experience with software
Duration of diabetes < 1 year
...
Expected 21 or more consecutive days pausing in system usage
Preceding experience with software
Duration of diabetes < 1 year
Conventional insulin therapy
Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
DM other than type 1
Celiac disease recognized in less than 4 months before inclusion
Nutritional disorders

Summary

Conditions
Type 1 Diabetes Mellitus
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Younger than 18 years
Gender
Both males and females

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 stan...

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).

Inclusion Criterias

Computer meeting ELKa system minimum requirements
Kitchen arrangement providing enough space for computer with ELKa system
HbA1c ≤ 10%
...
Computer meeting ELKa system minimum requirements
Kitchen arrangement providing enough space for computer with ELKa system
HbA1c ≤ 10%
DM for > 1 year
Written informed consent
Age under 18 y
Confirmed DM type 1

Exclusion Criterias

Expected 21 or more consecutive days pausing in system usage
Preceding experience with software
Duration of diabetes < 1 year
...
Expected 21 or more consecutive days pausing in system usage
Preceding experience with software
Duration of diabetes < 1 year
Conventional insulin therapy
Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
DM other than type 1
Celiac disease recognized in less than 4 months before inclusion
Nutritional disorders

Locations

Warsaw
Warsaw

Tracking Information

NCT #
NCT02194517
Collaborators
Not Provided
Investigators
Study Chair: Agnieszka Szypowska, Professor Medical University of Warsaw Study Director: Agnieszka Kowalska, MD Medical University of Warsaw