Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
An Open, Parallel-group, Randomized, Interventional Study to Compare the Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed and improved glycemic control. However, previous U-healthcare service had some limitations, which needs specific devices to check blood glucose and send it to central system. Voice inception technique based U-healthcare service is expected to improve glycemic control without specific devices.
To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life between U-health care group (intervention) and conventional treatment group (control).
研究概览
详细说明
Ubiquitous healthcare for chronic disease such as diabetes is intensively developing field. Nowadays, various methods are tried to find the most effective and easiest way for supplying U-health care.
Here, researchers are going to investigate the efficacy and safety of voice inception technique based U-healthcare service.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Seongnam、大韩民国、463-707
- Seoul National University Bundang Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Type 2 diabetes
- age: 60 ~ 85 yrs
- HbA1c: 7.0%-11.0%
- Basal insulin or premixed insulin user
Exclusion Criteria:
- Type 1 diabetes
- short acting insulin or insulin pump user
- systemic corticosteroid administered within previous 6 months
- history of myocardial ischemia
- Heart failure, New York Heart Association (NYHA) Class II-IV
- Thyroid disease with abnormal thyroid function test
- Anti-obesity drugs or slimming products within previous 3 months
- severe liver or kidney disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：控制
常规治疗
|
|
|
实验性的：U-health care
voice inception technique based U-healthcare service
|
voice inception technique based U-healthcare service
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Changes of HbA1c
大体时间：24 weeks
|
24 weeks
|
|
Glucose Variability assessed by 3 day SMBG
大体时间：24 weeks
|
24 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Target goal of HbA1c (< 7.5%)
大体时间：24 Weeks
|
24 Weeks
|
|
Target goal of HbA1c (< 8.0%)
大体时间：24 Weeks
|
24 Weeks
|
|
Hypoglycemia
大体时间：24 Weeks
|
24 Weeks
|
|
Drug Compliance
大体时间：24 Weeks
|
24 Weeks
|
|
Self monitoring blood glucose compliance
大体时间：24 Weeks
|
24 Weeks
|
|
Weight change
大体时间：24 Weeks
|
24 Weeks
|
|
Quality of life assessed by SF36
大体时间：24 Weeks
|
24 Weeks
|
|
Diabetes Self-Care Activities
大体时间：24 Weeks
|
24 Weeks
|
|
Michigan Diabetes Knowledge Test
大体时间：24 Weeks
|
24 Weeks
|
合作者和调查者
调查人员
- 首席研究员：Soo Lim, MD, MPH, PhD、Seoul National University Bundang Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.