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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691287
• Other study ID #: rmc006444ctil
• Status: Completed
• Phase: N/A
• First received: September 19, 2012
• Last updated: April 30, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Michael Method

Locations

Country	Name	City	State
Israel	Schneider Medical Center	Petah-TTikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Control measured as HbA1c level		at the end of the study - after 15 weeks	No
Secondary	Diabetes Quality of Life questionnaire (DQOLY)		At the end of the study- after 15 weeks	No
Secondary	Self assessment questionnaire		At the end of the study- after 15 weeks	No
Secondary	Number of severe hypoglycemic events		at the end of the study-after 15 weeks	No
Secondary	Number of Diabetic Keto Acidosis events		at the end of the study- after 15 weeks	No