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临床试验/NCT01157611
NCT01157611已完成不适用

The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2010年7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
57
试验地点
2
主要终点
change of the blood glucose

研究概览

简要总结

Purpose:

To evaluate the effects of online based mentoring program on the blood glucose and satisfaction score in type 1 diabetes patients. Peer group mentoring will be as effective as guidance by the doctors.

Methods:

80 type 1 patients will be randomly divided into two groups (e.g. mentoring program group and control group). All patients will receive routine check up and blood test for ordinary type 1 patients. In addition, program group patients should register their SMBG, exercise, food intake and insulin dose on the website designed for this study and receive advices of mentors from peer group. Every patient will submit questionnaire on the first day of the study and the last day(after 12 weeks) of the study.

详细描述

Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18, more than 6 month after the diagnosis of type 1 diabetes
  • HbA1c > 8% despite of multiple insulin injection or insulin pump
  • who are capable of using the internet

排除标准

  • pregnant women
  • who cannot use the internet
  • those who does not want to participate in the study

结局指标

主要结局

change of the blood glucose

时间窗: week 0 (baseline), 6, 12

HbA1c, Fructosamine

次要结局

  • satisfaction score(week 0 (baseline), 6, 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jae Hyeon Kim

Associate Professor

Samsung Medical Center

研究点 (2)

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