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Clinical Trials/NCT01691287
NCT01691287
Completed
Not Applicable

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

Rabin Medical Center1 site in 1 country23 target enrollmentOctober 2012
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Rabin Medical Center
Enrollment
23
Locations
1
Primary Endpoint
Metabolic Control measured as HbA1c level
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Metabolic Control measured as HbA1c level

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

Secondary Outcomes

  • Number of Diabetic Keto Acidosis events(at the end of the study- after 15 weeks)
  • 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)

Study Sites (1)

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