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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
106
ELKa should be used for every meal preparation. After choosing the name of particular product from the list, the program will give precise information about the amount of CHO and FP exchanges in serving. No standard calculation of exchanges need to be performed.
Medical University of Warsaw
Warsaw, Poland
HbA1c (glycated hemoglobin)
Time frame: 6 months
HbA1c (glycated hemoglobin)
Time frame: 3 months
ELKa usage frequency
Self-reported in questionnaire
Time frame: 3 months
ELKa usage frequency
Self-reported in questionnaire
Time frame: 6 months
Post- prandial glycemia
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
Time frame: 3 months
Post- prandial glycemia
Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
Time frame: 6 months
mean diurnal glucose level
Time frame: 3 months
mean diurnal glucose level
Time frame: 6 months
Mean daily insulin dose [Insulin/kg/24h]
Time frame: 3 months
Mean daily insulin dose [Insulin/kg/24h]
Time frame: 6 months
BMI- standard deviation (BMI- sds)
Time frame: 3 months
BMI- standard deviation (BMI- sds)
Time frame: 6 months
Hypoglycemia episodes and severe hypoglycemia events
Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.
Time frame: 3 months
Hypoglycemia episodes and severe hypoglycemia events
Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.
Time frame: 6 months
Mean Amplitude of Glycemic Excursions (MAGE)
Measured in subgroup of patients with continuous glucose monitoring system (CGMS)
Time frame: 3 months
Mean Amplitude of Glycemic Excursions (MAGE)
Measured in subgroup of patients with CGMS
Time frame: 6 months
Glucose Area Under the Curve (AUC)
Measured in subgroup of patients with CGMS
Time frame: 3 months
Glucose Area Under the Curve (AUC)
Measured in subgroup of patients with CGMS
Time frame: 6 months
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