The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey: Preliminary Results From The Randomised Controlled Telediab Trial

Conditions
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Telemedicine, Telehealth

Intervention / Treatment
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* Device: TeleDiab (Telemedicine)
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: <18 and> 65years old Presence of Type 1 diabetes for less than 3 months or Type 2 diabetes not using insulin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TeleDiab (Telemedicine)<br>TeleDiab program components consist of: Electronic transmission of capillary blood glucose measurement results Electronic transmission of blood pressure measurements Synchronized video-conferencing, secure messaging Access to clinical data from patient files when necessary Reminding of routine follow-up tests and examinations Providing web-based educational materials to patients. | Device: TeleDiab (Telemedicine)<br>* TeleDiab program components consist of: Electronic transmission of capillary blood glucose measurement results Electronic transmission of blood pressure measurements Synchronized video-conferencing, secure messaging Access to clinical data from patient files when necessary Reminding of routine follow-up tests and examinations Providing web-based educational materials to patients.<br>|
| Active Comparator: Usual Care<br>usual diabetes care, as provided by primary care providers in the hospital | Other: Usual care<br>* Usual diabetes care, as provided by primary care providers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capillary glucose levels changes |  | Change in baseline capillary glucose levels (mg/dl) at 24th month | 
| Home blood glucose measurement frequency |  | Change in baseline home blood glucose measurement frequency at 24th month | 
| A1c measurement |  | Change in baseline A1c (%) measurement frequency at 24th month | 
| Weight |  | Change in baseline weight (kg) measurement frequency at 24th month | 
| BMI |  | Change in baseline BMI (kg/m2) measurement frequency at 24th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients developing new diabetes complications within 24 months | retinopathy, peripheral neuropathy, autonomic neuropathy, nephropathy | Change from baseline to 24 months | 
| Number of patients who developed new comorbidities in 24 months | hyperlipidemia, hypertension, coronary artery disease, stroke, peripheral artery disease, general obesity, central obesity, clinical or subclinical hypo or hyperthyroidism, autoimmune trioiditis, celiac disease; gluten enteropathy, other | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Telehealth, Virtual care, Diabetes, Virtual visits