NCT01345435已完成不适用
A Multi-center, Randomized, Parallel, Interventional, Open Label Trial to Compare Hemoglobin A1C-lowering Effect of Conventional Treatment and Smart Care Service in Patients With Type 2 Diabetes
CHANGHEE LEE4 个研究点 分布在 1 个国家目标入组 417 人开始时间: 2011年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 417
- 试验地点
- 4
- 主要终点
- Changes in Hemoglobin A1c
研究概览
简要总结
A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2 diabetes.
详细描述
- Objectives : To evaluate superiority in the Hemoglobin A1C -lowering effect of Smart Care Service compared to the conventional treatment in patients with type 2 diabetes.
- Test and control group
-
Control group : The subject group who is receiving any conventional treatment (hospital visit).
-
Test groups
-
Conventional treatment + remote monitoring group: The subject group who is receiving the health care services using conventional treatment (hospital visit) and remote monitoring.
-
Remote visit + remote monitoring group: The subject group who is receiving remote visit and remote monitoring using videotelephony
- Target Subject: Type II diabetes patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 20 years of age and under 60 years of age
- •Patients who are able to receive outpatient treatment with type II diabetes mellitus.
- •If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible.
- •Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%).
- •Patients who are able to understand the purpose of this trial and to read and write.
- •Patients who are able to use the Smart Care PC for this study.
- •Patients who have wired/wireless internet access at home.
- •Patients who participate voluntarily and sign the informed consent.
排除标准
- •Patients with type I diabetes mellitus
- •Patients who are using Bolus insulin (short-acting insulin) or insulin pump.
- •Patients who take medicines which can significantly affect glycemic control.
- •Patients with acute illness, untreated other disease or diabetic complications required additional treatment.
- •Patients currently being hospitalized or planning to hospitalize during the study period.
- •Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
- •Pregnant or lactating women.
- •Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
- •Patients with uncontrolled chronic lung disease.
- •Patients with known history of alcoholism, mental illness, or drug dependency.
- •Patients who have cognitive disorder or psychiatric problems
- •Patients who have participated in other clinical trial within 12 weeks prior to screening visit.
- •Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
研究组 & 干预措施
Telemonitoring group
Experimental
- A Smart Care PC, blood glucose meter and body composition analyzer will be provided
- transmitting the results to the Smart Care Server via Smart Care PC
- At Smart care Center,care manager will provide remote blood glucose monitoring and individual diabetes case management
干预措施: Telemonitoring group (Procedure)
Telemonitoring & Telemedicine group
Experimental
- A Smart Care PC, blood glucose meter and body composition analyzer will be provided
- transmitting the results to the Smart Care Server via Smart Care PC
- At Smart care Center,care manager will provide remote blood glucose monitoring and individual diabetes case management
- taking telemedicine through video telephone instead of visiting hospital
干预措施: Telemonitoring & Telemedicine (Procedure)
Control group
Other
- Blood glucose meter and body composition analyzer will be provided
- Self-monitoring Blood Glucose (SMBG)
干预措施: SMBG (Other)
结局指标
主要结局
Changes in Hemoglobin A1c
时间窗: 0 and 24 weeks
Changes in Hemoglobin A1c from baseline to 24 weeks visit. Reduce Hemoglobin A1c after study
次要结局
- Changes in body mass index (BMI)(0 and 24 weeks)
- Changes in lipid profile(0 and 24 weeks)
- Medication compliance(up to 24 weeks)
- Changes in FBS (Fasting blood sugar)(0 and 24 weeks)
- SMBG(Self-monitoring of blood glucose) compliance(up to 24 weeks)
- Percentage of subjects who achieved goal Hemoglobin A1c(0 and 24 weeks)
- Assessment of patients' satisfaction(24 weeks)
- Changes in body weight(0 and 24 weeks)
研究者
CHANGHEE LEE
Chief Research Engineer
LG Electronics Inc.
研究点 (4)
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