Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- HbA1c (glycated hemoglobin)
Study Overview
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 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.
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: 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
ELKa (A)
Patients counting CHO and FP exchanges with ELKa toolset.
Intervention: ELKa (Device)
control (B)
Patients performing CHO and FP exchanges calculation with standard method.
Outcomes
Primary Outcomes
HbA1c (glycated hemoglobin)
Time Frame: 6 months
Secondary Outcomes
- Post- prandial glycemia(6 months)
- mean diurnal glucose level(6 months)
- ELKa usage frequency(6 months)
- HbA1c (glycated hemoglobin)(3 months)
- Mean daily insulin dose [Insulin/kg/24h](6 months)
- BMI- standard deviation (BMI- sds)(6 months)
- Hypoglycemia episodes and severe hypoglycemia events(6 months)
- Mean Amplitude of Glycemic Excursions (MAGE)(6 months)
- Glucose Area Under the Curve (AUC)(6 months)
- ELKa usage frequency(3 months)
- Post- prandial glycemia(3 months)
- mean diurnal glucose level(3 months)
- Mean daily insulin dose [Insulin/kg/24h](3 months)
- BMI- standard deviation (BMI- sds)(3 months)
- Hypoglycemia episodes and severe hypoglycemia events(3 months)
- Mean Amplitude of Glycemic Excursions (MAGE)(3 months)
- Glucose Area Under the Curve (AUC)(3 months)