<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/NCT01691287</url>
  </required_header>
  <id_info>
    <org_study_id>rmc006444ctil</org_study_id>
    <nct_id>NCT01691287</nct_id>
  </id_info>
  <brief_title>MICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes</brief_title>
  <official_title>MICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal&#xD;
      checks of blood sugar levels, injecting insulin, changing eating habits and physical&#xD;
      exercise, which requires a real change in the life of the child &amp; adolescent and can cause&#xD;
      significant damage to the quality of life as well.&#xD;
&#xD;
      Compliance to treatment is a major challenge for all patients and mostly to adolescence,&#xD;
      which often worsen their diabetes control at that age.&#xD;
&#xD;
      The Michael Method is a unique, holistic program to develop and realize an individual's&#xD;
      emotional, intellectual and behavioral potential, which is based on the belief that every&#xD;
      human being can excel in every field they choose. The method was developed in 1988 by a&#xD;
      multi-disciplinary team of professional academic in Israel. Today the Israeli education&#xD;
      system implements the method in Junior High Schools and High Schools in diverse educational&#xD;
      sectors. The program is taught at many other various frameworks: teachers' continuing&#xD;
      education programs, colleges, programs run by the Ministries of Defense and Social Welfare,&#xD;
      the National Insurance Institute, the National Electric Corporation and in many other public&#xD;
      and private frameworks.&#xD;
&#xD;
      The proposed study is aimed to assess whether the Michael Method can be used as a tool for&#xD;
      improving metabolic control and quality of life among uncontrolled adolescence with type 1&#xD;
      diabetes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic Control measured as HbA1c level</measure>
    <time_frame>at the end of the study - after 15 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diabetes Quality of Life questionnaire (DQOLY)</measure>
    <time_frame>At the end of the study- after 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self assessment questionnaire</measure>
    <time_frame>At the end of the study- after 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of severe hypoglycemic events</measure>
    <time_frame>at the end of the study-after 15 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Diabetic Keto Acidosis events</measure>
    <time_frame>at the end of the study- after 15 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Michael Method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>14 group meeting, taking place once a week during 14 consecutive weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Michael Method</intervention_name>
    <arm_group_label>Michael Method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 Diabetes at least 1 year prior to study inclusion&#xD;
&#xD;
          -  12-17 years old&#xD;
&#xD;
          -  HbA1c &gt; 7.8%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Incapability to comply with all study requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Schneider Medical Center</name>
      <address>
        <city>Petah-TTikva</city>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>April 30, 2014</last_update_submitted>
  <last_update_submitted_qc>April 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Metabolic Control</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <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/NCT01691287
org study id: rmc006444ctil
nct id: NCT01691287
lead sponsor: 
has dmc: No
Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal
      checks of blood sugar levels, injecting insulin, changing eating habits and physical
      exercise, which requires a real change in the life of the child & adolescent and can cause
      significant damage to the quality of life as well.

      Compliance to treatment is a major challenge for all patients and mostly to adolescence,
      which often worsen their diabetes control at that age.

      The Michael Method is a unique, holistic program to develop and realize an individual's
      emotional, intellectual and behavioral potential, which is based on the belief that every
      human being can excel in every field they choose. The method was developed in 1988 by a
      multi-disciplinary team of professional academic in Israel. Today the Israeli education
      system implements the method in Junior High Schools and High Schools in diverse educational
      sectors. The program is taught at many other various frameworks: teachers' continuing
      education programs, colleges, programs run by the Ministries of Defense and Social Welfare,
      the National Insurance Institute, the National Electric Corporation and in many other public
      and private frameworks.

      The proposed study is aimed to assess whether the Michael Method can be used as a tool for
      improving metabolic control and quality of life among uncontrolled adolescence with type 1
      diabetes
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Metabolic Control measured as HbA1c level
time frame: at the end of the study - after 15 weeks
measure: Diabetes Quality of Life questionnaire (DQOLY)
time frame: At the end of the study- after 15 weeks
measure: Self assessment questionnaire
time frame: At the end of the study- after 15 weeks
measure: Number of severe hypoglycemic events
time frame: at the end of the study-after 15 weeks
measure: Number of Diabetic Keto Acidosis events
time frame: at the end of the study- after 15 weeks
arm group label: Michael Method
arm group type: Experimental
description: 14 group meeting, taking place once a week during 14 consecutive weeks
intervention type: Behavioral
intervention name: Michael Method
arm group label: Michael Method
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1