A Mobile and Web-Based Clinical Decision Support and Monitoring System for Diabetes Mellitus Patients in Primary Care
试验速览
- 阶段
- 不适用
- 主要终点
- fasting blood glucose
研究概览
简要总结
The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases screening, diagnosis, treatment and monitoring for the use of physicians and patients in primary care and to determine the effectiveness of the system. For validating the CDSMS for diabetes patients, randomized controlled trial will be conducted.A parallel single blind randomized controlled trial will be implemented. 10 physicians and their 439 patients are involved in the study. According to the results of screening which is done using developed CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the physicians. The recruited patients will register to the CDSMS with their accounts given by their physicians. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p<0,05. In the intervention group, the system recommendations on diagnosis, treatment and monitoring will be carried out as the final decision given by the physician. In the control group, physicians will treat DM patients as the general routine. Patients in both groups will be monitored for 6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory outcomes will be face-to-face assessed, others will be online self-assessed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being over age 40
- •Volunteer
- •Computer and Internet literacy
- •DM diagnosed or having at least one of diagnostic criteria.
- •These criteria;
- •HbA1c ≥ 6.5
- •FPG ≥ 126 mg / dl
- •2-hour postprandial glucose ≥ 200 mg / dl
- •Any time postprandial glucose ≥ 200 mg / dl
- •Diabetes symptoms
排除标准
- •Having a communication problem
- •Type 1 diabetes
- •MODY type DM
- •Level of psychiatric disorders in psychosis
- •Dementia ones
结局指标
主要结局
fasting blood glucose
时间窗: Change from baseline fasting blood glucose at 6 months
次要结局
未报告次要终点
研究者
Vildan Mevsim
Prof.Dr. Vildan MEVSİM, MD, PhD
Dokuz Eylul University
