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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01691287
First received: September 19, 2012
Last updated: January 1, 2013
Last verified: December 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes Quality of Life questionnaire (DQOLY) [ Time Frame: At the end of the study- after 15 weeks ] [ Designated as safety issue: No ]
  • Self assessment questionnaire [ Time Frame: At the end of the study- after 15 weeks ] [ Designated as safety issue: No ]
  • Number of severe hypoglycemic events [ Time Frame: at the end of the study-after 15 weeks ] [ Designated as safety issue: No ]
  • Number of Diabetic Keto Acidosis events [ Time Frame: at the end of the study- after 15 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: October 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691287

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

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01691287     History of Changes
Other Study ID Numbers: rmc006444ctil
Study First Received: September 19, 2012
Last Updated: January 1, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013