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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Glucose Variability assessed by 3 day SMBG
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •age: 60 ~ 85 yrs
- •HbA1c: 7.0%-11.0%
- •Basal insulin or premixed insulin user
排除标准
- •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
结局指标
主要结局
Glucose Variability assessed by 3 day SMBG
时间窗: 24 weeks
Changes of HbA1c
时间窗: 24 weeks
次要结局
- Target goal of HbA1c (< 7.5%)(24 Weeks)
- Target goal of HbA1c (< 8.0%)(24 Weeks)
- Michigan Diabetes Knowledge Test(24 Weeks)
- Hypoglycemia(24 Weeks)
- Drug Compliance(24 Weeks)
- Self monitoring blood glucose compliance(24 Weeks)
- Weight change(24 Weeks)
- Quality of life assessed by SF36(24 Weeks)
- Diabetes Self-Care Activities(24 Weeks)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital