Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194517
• Other study ID #: ELKA-01
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: March 16, 2015
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2014
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• ELKa
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.

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment satisfaction	Questionnaire regarded treatment satisfaction and wish to continuation.	6 months	No
Primary	HbA1c (glycated hemoglobin)		6 months	Yes
Secondary	HbA1c (glycated hemoglobin)		3 months	Yes
Secondary	ELKa usage frequency	Self-reported in questionnaire	3 months	No
Secondary	ELKa usage frequency	Self-reported in questionnaire	6 months	No
Secondary	Post- prandial glycemia	Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days	3 months	No
Secondary	Post- prandial glycemia	Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days	6 months	No
Secondary	mean diurnal glucose level		3 months	No
Secondary	mean diurnal glucose level		6 months	No
Secondary	Mean daily insulin dose [Insulin/kg/24h]		3 months	No
Secondary	Mean daily insulin dose [Insulin/kg/24h]		6 months	No
Secondary	BMI- standard deviation (BMI- sds)		3 months	No
Secondary	BMI- standard deviation (BMI- sds)		6 months	No
Secondary	Hypoglycemia episodes and severe hypoglycemia events	Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.	3 months	No
Secondary	Hypoglycemia episodes and severe hypoglycemia events	Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.	6 months	No
Secondary	Mean Amplitude of Glycemic Excursions (MAGE)	Measured in subgroup of patients with continuous glucose monitoring system (CGMS)	3 months	No
Secondary	Mean Amplitude of Glycemic Excursions (MAGE)	Measured in subgroup of patients with CGMS	6 months	No
Secondary	Glucose Area Under the Curve (AUC)	Measured in subgroup of patients with CGMS	3 months	No
Secondary	Glucose Area Under the Curve (AUC)	Measured in subgroup of patients with CGMS	6 months	No