Type 1 Diabetes Mellitus Clinical Trial
Official title:
Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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