The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey: Preliminary Results From The Randomised Controlled Telediab Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Weight
研究概览
简要总结
The direct and indirect costs of treating diabetes are high. 10-15% of the health budgets of many countries are spent on diabetes treatment. Most of these expenses are due to the treatment and follow-up costs of complications seen in patients who are not well monitored and whose metabolic control is not achieved. the rapid increase in diabetes causes polyclinic and hospital services to become more intense. Despite the increasing number of patients, both performance and due to non-physician occupational groups' insufficiency (Diabetes Dietician, Diabetes Nurse), patients can only be given an appointment once a year, and patients cannot be allocated sufficient time during the appointment. Since these problems are valid worldwide, Telemedicine programs are designed to provide easy, cheap, and practical follow-up and treatment of many chronic diseases in various states of the USA and many developed European countries.
详细描述
The project is designed as a randomized controlled trial with approximately 100 subjects receiving a telemedicine intervention and approximately 100 receiving usual care. Eligibility requires having diabetes and being a Medicare beneficiary.
This program, called "TeleDiab" for the first time in our country, was designed in cooperation with the Istanbul University Rectorate and the local telecommunication company Turkcell. Its implementation was carried out as a pilot project in the Department of Endocrinology and Metabolic Diseases of Istanbul Medical Faculty in the follow-up and treatment of diabetic patients. Subjects are randomized to receive telemedicine case management or usual care for diabetes.
This project, it is aimed to evaluate the "TeleDiab" program developed for use in diabetic patients in terms of applicability, practicality, effectiveness, and cost-effectiveness. In this way, it was aimed to compare the electronically followed patient group with a similar patient group routinely followed in terms of glycemic control, treatment compliance, complications, and comorbid diseases 6 months and 1 year later.
The intervention utilizes a home telemedicine unit (HTU). The HTU is a specially designed, web-enabled device with a data port connected to a home glucometer and home blood pressure cuff whereby measurements obtained with these devices can be directly uploaded to a computer database. A diabetes nurse and a practitioner case manager interact regularly with intervention participants through videoconference via the HTU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for TeleDiab group:
- •Have known Type 1 diabetes for at least 3 months or Type 2 diabetes using basal-bolus insulin
- •Being between the ages of 18-65
- •Istanbul University Istanbul Medical Faculty Internal Diseases Department, Endocrinology and Being registered and being monitored in the Metabolic Diseases BD, Diabetes Outpatient Clinic
- •To be able to measure blood glucose from the fingertip (couplings) at home
- •To be able to measure blood pressure at home
- •To be able to use computers and smartphones
- •Instead of electronic directives and recommendations of the physician or diabetes nurse be able to bring
- •Agree to participate in the study.
- •for the control group:
- •Have known Type 1 diabetes for at least 3 months or Type 2 diabetes using basal-bolus insulin
- •Being between the ages of 18-65
- •Istanbul University Istanbul Medical Faculty Internal Diseases Department, Endocrinology and Being registered and being monitored in the Metabolic Diseases BD, Diabetes Outpatient Clinic
- •Inability to use computer and smartphone
- •Failure to follow the electronic directives and recommendations of the physician or diabetes nurse
排除标准
- •<18 and> 65years old
- •Presence of Type 1 diabetes for less than 3 months or Type 2 diabetes not using insulin
结局指标
主要结局
Weight
时间窗: Change in baseline weight (kg) measurement frequency at 24th month
Capillary glucose levels changes
时间窗: Change in baseline capillary glucose levels (mg/dl) at 24th month
Home blood glucose measurement frequency
时间窗: Change in baseline home blood glucose measurement frequency at 24th month
A1c measurement
时间窗: Change in baseline A1c (%) measurement frequency at 24th month
BMI
时间窗: Change in baseline BMI (kg/m2) measurement frequency at 24th month
次要结局
- Number of patients who developed new comorbidities in 24 months(Change from baseline to 24 months)
- The number of patients who added insulin to their oral antidiabetic medication or switched to oral antidiabetic medication by discontinuing insulin(Change from baseline to 24 months)
- Number of patients developing new diabetes complications within 24 months(Change from baseline to 24 months)
研究者
Fulya Turker
MD, PhD; Academician; Principle Investigator
Istanbul University