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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691287
First Posted: September 24, 2012
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rabin Medical Center
  Purpose

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


Condition Intervention
Type 1 Diabetes Behavioral: Michael Method

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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Metabolic Control measured as HbA1c level [ Time Frame: at the end of the study - after 15 weeks ]

Secondary Outcome Measures:
  • Diabetes Quality of Life questionnaire (DQOLY) [ Time Frame: At the end of the study- after 15 weeks ]
  • Self assessment questionnaire [ Time Frame: 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 ]
  • Number of Diabetic Keto Acidosis events [ Time Frame: at the end of the study- after 15 weeks ]

Enrollment: 23
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Michael Method
14 group meeting, taking place once a week during 14 consecutive weeks
Behavioral: Michael Method

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691287


Locations
Israel
Schneider Medical Center
Petah-TTikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
  More Information

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01691287     History of Changes
Other Study ID Numbers: rmc006444ctil
First Submitted: September 19, 2012
First Posted: September 24, 2012
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Rabin Medical Center:
Type 1 Diabetes
Metabolic Control
Quality of Life

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases