Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- HbA1c ≤ 10%
- Confirmed DM type 1
- DM for > 1 year
- ...
- HbA1c ≤ 10%
- Confirmed DM type 1
- DM for > 1 year
- Written informed consent
- Age under 18 y
- Kitchen arrangement providing enough space for computer with ELKa system
- Computer meeting ELKa system minimum requirements
Exclusion Criteria
- Conventional insulin therapy
- Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
- Expected 21 or more consecutive days pausing in system usage
- ...
- Conventional insulin therapy
- Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
- Expected 21 or more consecutive days pausing in system usage
- DM other than type 1
- Celiac disease recognized in less than 4 months before inclusion
- Nutritional disorders
- Preceding experience with software
- Duration of diabetes < 1 year
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
- HbA1c ≤ 10%
- Confirmed DM type 1
- DM for > 1 year
- ...
- HbA1c ≤ 10%
- Confirmed DM type 1
- DM for > 1 year
- Written informed consent
- Age under 18 y
- Kitchen arrangement providing enough space for computer with ELKa system
- Computer meeting ELKa system minimum requirements
Exclusion Criteria
- Conventional insulin therapy
- Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
- Expected 21 or more consecutive days pausing in system usage
- ...
- Conventional insulin therapy
- Any medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the subject
- Expected 21 or more consecutive days pausing in system usage
- DM other than type 1
- Celiac disease recognized in less than 4 months before inclusion
- Nutritional disorders
- Preceding experience with software
- Duration of diabetes < 1 year
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
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