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Completed

NCT Number: 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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Medical Center

Petah-TTikva, 49202, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Michael Method

Behavioral

Primary outcomes

  1. Metabolic Control measured as HbA1c level

    Time frame: at the end of the study - after 15 weeks

Secondary outcomes

  1. Diabetes Quality of Life questionnaire (DQOLY)

    Time frame: At the end of the study- after 15 weeks

  2. Self assessment questionnaire

    Time frame: At the end of the study- after 15 weeks

  3. Number of severe hypoglycemic events

    Time frame: at the end of the study-after 15 weeks

  4. Number of Diabetic Keto Acidosis events

    Time frame: at the end of the study- after 15 weeks

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 24, 2012
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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