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Type 1 Diabetes MellitusNCT02194517

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

A study testing ELKa in people with Type 1 Diabetes Mellitus, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
ELKa
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 sitePoland
Study dates
Apr 2013to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Warsaw

    Warsaw

Other trials in Poland

About this study

Official title: Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.

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.

Read the 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).

Being tested
ELKa
Keywords
diabetes, diet control toolset, food exchanges, CHO, FP
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELKaDevice

    Also called Diet Control Toolset, ElkaPlus USB Scale, Elka toolset, Elka PC application

    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.

Study groups in NCT02194517
Study groupRoleWhat they receive
control (B)No interventionPatients performing CHO and FP exchanges calculation with standard method.
ELKa (A)ExperimentalPatients counting CHO and FP exchanges with ELKa toolset.
Receives: Device: ELKa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c (glycated hemoglobin)

    Measured: 6 months

Secondary outcomes (17)

  1. HbA1c (glycated hemoglobin)

    Measured: 3 months

  2. ELKa usage frequency

    Self-reported in questionnaire

    Measured: 3 months

  3. ELKa usage frequency

    Self-reported in questionnaire

    Measured: 6 months

  4. Post- prandial glycemia

    Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days

    Measured: 3 months

  5. Post- prandial glycemia

    Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days

    Measured: 6 months

  6. mean diurnal glucose level

    Measured: 3 months

  7. mean diurnal glucose level

    Measured: 6 months

  8. Mean daily insulin dose [Insulin/kg/24h]

    Measured: 3 months

  9. Mean daily insulin dose [Insulin/kg/24h]

    Measured: 6 months

  10. BMI- standard deviation (BMI- sds)

    Measured: 3 months

  11. BMI- standard deviation (BMI- sds)

    Measured: 6 months

  12. Hypoglycemia episodes and severe hypoglycemia events

    Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.

    Measured: 3 months

  13. Hypoglycemia episodes and severe hypoglycemia events

    Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.

    Measured: 6 months

  14. Mean Amplitude of Glycemic Excursions (MAGE)

    Measured in subgroup of patients with continuous glucose monitoring system (CGMS)

    Measured: 3 months

  15. Mean Amplitude of Glycemic Excursions (MAGE)

    Measured in subgroup of patients with CGMS

    Measured: 6 months

  16. Glucose Area Under the Curve (AUC)

    Measured in subgroup of patients with CGMS

    Measured: 3 months

  17. Glucose Area Under the Curve (AUC)

    Measured in subgroup of patients with CGMS

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionOct 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194517
Sponsor's protocol ID
ELKA-01
Status last verified
Jul 2014
First submitted
16 Jul 2014
Last updated
17 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28232949

Questions about this trial

What is this clinical trial studying?

A study testing ELKa in people with Type 1 Diabetes Mellitus, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (glycated hemoglobin) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02194517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.

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