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临床试验/NCT01691287
NCT01691287已完成不适用

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 Center2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Metabolic Control measured as HbA1c level

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Type 1 Diabetes at least 1 year prior to study inclusion
  • 12-17 years old
  • HbA1c > 7.8%

排除标准

  • Incapability to comply with all study requirements

结局指标

主要结局

Metabolic Control measured as HbA1c level

时间窗: at the end of the study - after 15 weeks

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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