Status:
COMPLETED
Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.
Lead Sponsor:
Medical University of Warsaw
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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 nutrien...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02194517
Start Date
April 1 2013
End Date
November 1 2014
Last Update
March 17 2015
Active Locations (1)
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1
Medical University of Warsaw
Warsaw, Poland