<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02194517</url>
  </required_header>
  <id_info>
    <org_study_id>ELKA-01</org_study_id>
    <nct_id>NCT02194517</nct_id>
  </id_info>
  <brief_title>Impact of ELKa, the Toolset for Food Exchanges Calculation on Metabolic Control in Pediatric Diabetic Patients.</brief_title>
  <official_title>Impact of ELKa, the Toolset for Prandial Insulin Dose Calculation on Metabolic Control in Children and Adolescent With Diabetes Type 1.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ELKa system is an advanced toolset which helps performing calculation of carbohydrate (CHO)&#xD;
      and fat/protein (FP) exchanges. It consists of ELKa software including database of various&#xD;
      meals and nutrients and ELKaPlus digital kitchen scale transmitting weight of products in a&#xD;
      real-time to a computer via universal serial bus (USB) port. After choosing the name of&#xD;
      particular product from the list, the program gives precise information about the amount of&#xD;
      CHO and FP exchanges in serving.&#xD;
&#xD;
      The aim of the study is to investigate the benefit of using ELKa toolset in comparison with&#xD;
      standard method of CHO and FP counting on metabolic control in type 1 diabetic children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, controlled, parallel, open-label 26-week clinical trial will be conducted in&#xD;
      106 pediatric patients with type 1 diabetes mellitus (DM). Patients will be randomly assigned&#xD;
      into two groups: the group A (n=53) using ELKa system for food exchange counting and the&#xD;
      group B (n= 53) using standard method.&#xD;
&#xD;
      The glycated hemoglobin levels will be measured in both groups at the beginning, after 3 and&#xD;
      6 months of observation. The group A also will be asked about the frequency of using the&#xD;
      toolset. We will also assess secondary endpoints (mentioned below).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c (glycated hemoglobin)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c (glycated hemoglobin)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELKa usage frequency</measure>
    <time_frame>3 months</time_frame>
    <description>Self-reported in questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELKa usage frequency</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported in questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post- prandial glycemia</measure>
    <time_frame>3 months</time_frame>
    <description>Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post- prandial glycemia</measure>
    <time_frame>6 months</time_frame>
    <description>Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean diurnal glucose level</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean diurnal glucose level</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean daily insulin dose [Insulin/kg/24h]</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean daily insulin dose [Insulin/kg/24h]</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI- standard deviation (BMI- sds)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI- standard deviation (BMI- sds)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia episodes and severe hypoglycemia events</measure>
    <time_frame>3 months</time_frame>
    <description>Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia episodes and severe hypoglycemia events</measure>
    <time_frame>6 months</time_frame>
    <description>Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Amplitude of Glycemic Excursions (MAGE)</measure>
    <time_frame>3 months</time_frame>
    <description>Measured in subgroup of patients with continuous glucose monitoring system (CGMS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Amplitude of Glycemic Excursions (MAGE)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured in subgroup of patients with CGMS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Area Under the Curve (AUC)</measure>
    <time_frame>3 months</time_frame>
    <description>Measured in subgroup of patients with CGMS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Area Under the Curve (AUC)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured in subgroup of patients with CGMS</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire regarded treatment satisfaction and wish to continuation.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>control (B)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients performing CHO and FP exchanges calculation with standard method.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ELKa (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients counting CHO and FP exchanges with ELKa toolset.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ELKa</intervention_name>
    <description>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.</description>
    <arm_group_label>ELKa (A)</arm_group_label>
    <other_name>Diet Control Toolset</other_name>
    <other_name>ElkaPlus USB Scale</other_name>
    <other_name>Elka toolset</other_name>
    <other_name>Elka PC application</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age under 18 y&#xD;
&#xD;
          -  Confirmed DM type 1&#xD;
&#xD;
          -  DM for &gt; 1 year&#xD;
&#xD;
          -  HbA1c ≤ 10%&#xD;
&#xD;
          -  Computer meeting ELKa system minimum requirements&#xD;
&#xD;
          -  Kitchen arrangement providing enough space for computer with ELKa system&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DM other than type 1&#xD;
&#xD;
          -  Duration of diabetes &lt; 1 year&#xD;
&#xD;
          -  Conventional insulin therapy&#xD;
&#xD;
          -  Nutritional disorders&#xD;
&#xD;
          -  Celiac disease recognized in less than 4 months before inclusion&#xD;
&#xD;
          -  Preceding experience with software&#xD;
&#xD;
          -  Expected 21 or more consecutive days pausing in system usage&#xD;
&#xD;
          -  Any medical condition, which, in the opinion of the investigator, would interfere with&#xD;
             the evaluation of the subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Agnieszka Szypowska, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Agnieszka Kowalska, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>March 16, 2015</last_update_submitted>
  <last_update_submitted_qc>March 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>diet control toolset</keyword>
  <keyword>food exchanges</keyword>
  <keyword>CHO</keyword>
  <keyword>FP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02194517
org study id: ELKA-01
nct id: NCT02194517
lead sponsor: 
has dmc: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: HbA1c (glycated hemoglobin)
time frame: 6 months
measure: HbA1c (glycated hemoglobin)
time frame: 3 months
measure: ELKa usage frequency
time frame: 3 months
description: Self-reported in questionnaire
measure: ELKa usage frequency
time frame: 6 months
description: Self-reported in questionnaire
measure: Post- prandial glycemia
time frame: 3 months
description: Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
measure: Post- prandial glycemia
time frame: 6 months
description: Mean post-prandial glycemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
measure: mean diurnal glucose level
time frame: 3 months
measure: mean diurnal glucose level
time frame: 6 months
measure: Mean daily insulin dose [Insulin/kg/24h]
time frame: 3 months
measure: Mean daily insulin dose [Insulin/kg/24h]
time frame: 6 months
measure: BMI- standard deviation (BMI- sds)
time frame: 3 months
measure: BMI- standard deviation (BMI- sds)
time frame: 6 months
measure: Hypoglycemia episodes and severe hypoglycemia events
time frame: 3 months
description: Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.
measure: Hypoglycemia episodes and severe hypoglycemia events
time frame: 6 months
description: Hypoglycemia defined as glycemia below 70 mg/dl and, separately, glycemia below 50 mg/dl. Self-reported.
measure: Mean Amplitude of Glycemic Excursions (MAGE)
time frame: 3 months
description: Measured in subgroup of patients with continuous glucose monitoring system (CGMS)
measure: Mean Amplitude of Glycemic Excursions (MAGE)
time frame: 6 months
description: Measured in subgroup of patients with CGMS
measure: Glucose Area Under the Curve (AUC)
time frame: 3 months
description: Measured in subgroup of patients with CGMS
measure: Glucose Area Under the Curve (AUC)
time frame: 6 months
description: Measured in subgroup of patients with CGMS
measure: Treatment satisfaction
time frame: 6 months
description: Questionnaire regarded treatment satisfaction and wish to continuation.
arm group label: control (B)
arm group type: No Intervention
description: Patients performing CHO and FP exchanges calculation with standard method.
arm group label: ELKa (A)
arm group type: Experimental
description: Patients counting CHO and FP exchanges with ELKa toolset.
intervention type: Device
intervention name: ELKa
description: 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.
arm group label: ELKa (A)
other name: Diet Control Toolset
other name: ElkaPlus USB Scale
other name: Elka toolset
other name: Elka PC application
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Agnieszka Szypowska, Professor
role: Study Chair
affiliation: Medical University of Warsaw
last name: Agnieszka Kowalska, MD
role: Study Director
affiliation: Medical University of Warsaw
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1