NCT02194517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

July 16, 2014

Last Update Submit

March 16, 2015

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetesdiet control toolsetfood exchangesCHOFP

Outcome Measures

Primary Outcomes (1)

  • HbA1c (glycated hemoglobin)

    6 months

Secondary Outcomes (17)

  • HbA1c (glycated hemoglobin)

    3 months

  • ELKa usage frequency

    3 months

  • ELKa usage frequency

    6 months

  • Post- prandial glycemia

    3 months

  • Post- prandial glycemia

    6 months

  • +12 more secondary outcomes

Other Outcomes (1)

  • Treatment satisfaction

    6 months

Study Arms (2)

control (B)

NO INTERVENTION

Patients performing CHO and FP exchanges calculation with standard method.

ELKa (A)

EXPERIMENTAL

Patients counting CHO and FP exchanges with ELKa toolset.

Device: ELKa

Interventions

ELKaDEVICE

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.

Also known as: Diet Control Toolset, ElkaPlus USB Scale, Elka toolset, Elka PC application
ELKa (A)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • DM other than type 1
  • Duration of diabetes \< 1 year
  • Conventional insulin therapy
  • Nutritional disorders
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw

Warsaw, Poland

Location

Related Publications (1)

  • 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.

    PMID: 28232949DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Agnieszka Szypowska, Professor

    Medical University of Warsaw

    STUDY CHAIR

  • Agnieszka Kowalska, MD

    Medical University of Warsaw

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 18, 2014

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

March 17, 2015

Record last verified: 2014-07

Locations

PL(1)