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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Michael Method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 Diabetes at least 1 year prior to study inclusion 12-17 years old HbA1c > 7.8% Exclusion Criteria: - Incapability to comply with all study requirements

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Michael Method<br>14 group meeting, taking place once a week during 14 consecutive weeks | Behavioral: Michael Method<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Control measured as HbA1c level |  | at the end of the study - after 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Quality of Life questionnaire (DQOLY) |  | At the end of the study- after 15 weeks | 
| Self assessment questionnaire |  | At the end of the study- after 15 weeks | 
| Number of severe hypoglycemic events |  | at the end of the study-after 15 weeks | 
| Number of Diabetic Keto Acidosis events |  | at the end of the study- after 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Metabolic Control, Quality of Life