Clinical trial NCT02194517: Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.
Official title: Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: diabetes
diet control toolset
food exchanges
CHO
FP
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 106
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c (glycated hemoglobin)
timeFrame: 6 months
Secondary outcomes:
measure: HbA1c (glycated hemoglobin)
timeFrame: 3 months
measure: ELKa usage frequency
timeFrame: 3 months
measure: ELKa usage frequency
timeFrame: 6 months
measure: Post- prandial glycemia
timeFrame: 3 months
measure: Post- prandial glycemia
timeFrame: 6 months
measure: mean diurnal glucose level
timeFrame: 3 months
measure: mean diurnal glucose level
timeFrame: 6 months
measure: Mean daily insulin dose [Insulin/kg/24h]
timeFrame: 3 months
measure: Mean daily insulin dose [Insulin/kg/24h]
timeFrame: 6 months
measure: BMI- standard deviation (BMI- sds)
timeFrame: 3 months
measure: BMI- standard deviation (BMI- sds)
timeFrame: 6 months
measure: Hypoglycemia episodes and severe hypoglycemia events
timeFrame: 3 months
measure: Hypoglycemia episodes and severe hypoglycemia events
timeFrame: 6 months
measure: Mean Amplitude of Glycemic Excursions (MAGE)
timeFrame: 3 months
measure: Mean Amplitude of Glycemic Excursions (MAGE)
timeFrame: 6 months
measure: Glucose Area Under the Curve (AUC)
timeFrame: 3 months
measure: Glucose Area Under the Curve (AUC)
timeFrame: 6 months
Other outcomes:
measure: Treatment satisfaction
timeFrame: 6 months
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Agnieszka Szypowska, Professor
role: STUDY_CHAIR
affiliation: Medical University of Warsaw
name: Agnieszka Kowalska, MD
role: STUDY_DIRECTOR
References:
citation: Kowalska A, Piechowiak K, Ramotowska A, Szypowska A. Impact of ELKa, the Electronic Device for Prandial Insulin Dose Calculation, on Metabolic Control in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Controlled Trial. J Diabetes Res. 2017;2017:1708148. doi: 10.1155/2017/1708148. Epub 2017 Jan 23.