- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01691287
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
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Petah-TTikva, Israel, 49202
- Schneider Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Michael Method
14 group meeting, taking place once a week during 14 consecutive weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Metabolic Control measured as HbA1c level
Time Frame: at the end of the study - after 15 weeks
|
at the end of the study - after 15 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diabetes Quality of Life questionnaire (DQOLY)
Time Frame: At the end of the study- after 15 weeks
|
At the end of the study- after 15 weeks
|
Self assessment questionnaire
Time Frame: At the end of the study- after 15 weeks
|
At the end of the study- after 15 weeks
|
Number of severe hypoglycemic events
Time Frame: at the end of the study-after 15 weeks
|
at the end of the study-after 15 weeks
|
Number of Diabetic Keto Acidosis events
Time Frame: at the end of the study- after 15 weeks
|
at the end of the study- after 15 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rmc006444ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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