Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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

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 Criteria

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

Exclusion Criteria

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

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