Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02194517
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: ELKa Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.
Study Start Date : April 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
No Intervention: control (B)
Patients performing CHO and FP exchanges calculation with standard method.
Experimental: ELKa (A)
Patients counting CHO and FP exchanges with ELKa toolset.
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.
Other Names:
  • Diet Control Toolset
  • ElkaPlus USB Scale
  • Elka toolset
  • Elka PC application




Primary Outcome Measures :
  1. HbA1c (glycated hemoglobin) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. HbA1c (glycated hemoglobin) [ Time Frame: 3 months ]
  2. ELKa usage frequency [ Time Frame: 3 months ]
    Self-reported in questionnaire

  3. ELKa usage frequency [ Time Frame: 6 months ]
    Self-reported in questionnaire

  4. Post- prandial glycemia [ Time Frame: 3 months ]
    Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days

  5. Post- prandial glycemia [ Time Frame: 6 months ]
    Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days

  6. mean diurnal glucose level [ Time Frame: 3 months ]
  7. mean diurnal glucose level [ Time Frame: 6 months ]
  8. Mean daily insulin dose [Insulin/kg/24h] [ Time Frame: 3 months ]
  9. Mean daily insulin dose [Insulin/kg/24h] [ Time Frame: 6 months ]
  10. BMI- standard deviation (BMI- sds) [ Time Frame: 3 months ]
  11. BMI- standard deviation (BMI- sds) [ Time Frame: 6 months ]
  12. Hypoglycemia episodes and severe hypoglycemia events [ Time Frame: 3 months ]
    Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.

  13. Hypoglycemia episodes and severe hypoglycemia events [ Time Frame: 6 months ]
    Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.

  14. Mean Amplitude of Glycemic Excursions (MAGE) [ Time Frame: 3 months ]
    Measured in subgroup of patients with continuous glucose monitoring system (CGMS)

  15. Mean Amplitude of Glycemic Excursions (MAGE) [ Time Frame: 6 months ]
    Measured in subgroup of patients with CGMS

  16. Glucose Area Under the Curve (AUC) [ Time Frame: 3 months ]
    Measured in subgroup of patients with CGMS

  17. Glucose Area Under the Curve (AUC) [ Time Frame: 6 months ]
    Measured in subgroup of patients with CGMS


Other Outcome Measures:
  1. Treatment satisfaction [ Time Frame: 6 months ]
    Questionnaire regarded treatment satisfaction and wish to continuation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194517


Locations
Layout table for location information
Poland
Medical University of Warsaw
Warsaw, Poland
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Layout table for investigator information
Study Chair: Agnieszka Szypowska, Professor Medical University of Warsaw
Study Director: Agnieszka Kowalska, MD Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02194517    
Other Study ID Numbers: ELKA-01
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: July 2014
Keywords provided by Medical University of Warsaw:
diabetes
diet control toolset
food exchanges
CHO
FP
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases