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OpenTrials
Completed

NCT Number: NCT04789798

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TeleDiab (Telemedicine)

Device

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.

Usual Care

Other

Usual diabetes care, as provided by primary care providers

Primary outcomes

  1. Capillary glucose levels changes

    Time frame: Change in baseline capillary glucose levels (mg/dl) at 24th month

  2. Home blood glucose measurement frequency

    Time frame: Change in baseline home blood glucose measurement frequency at 24th month

  3. A1c measurement

    Time frame: Change in baseline A1c (%) measurement frequency at 24th month

  4. Weight

    Time frame: Change in baseline weight (kg) measurement frequency at 24th month

  5. BMI

    Time frame: Change in baseline BMI (kg/m2) measurement frequency at 24th month

Secondary outcomes

  1. Number of patients developing new diabetes complications within 24 months

    Time frame: Change from baseline to 24 months

    retinopathy, peripheral neuropathy, autonomic neuropathy, nephropathy

  2. Number of patients who developed new comorbidities in 24 months

    Time frame: Change from baseline to 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

  3. The number of patients who added insulin to their oral antidiabetic medication or switched to oral antidiabetic medication by discontinuing insulin

    Time frame: Change from baseline to 24 months

Other outcomes

  1. Serum ALT levels

    Time frame: Change from baseline to 24 months

  2. Serum TSH levels

    Time frame: Change from baseline to 24 months

  3. Serum sT4 levels

    Time frame: Change from baseline to 24 months

  4. Serum LDL levels

    Time frame: Change from baseline to 24 months

  5. Serum HDL levels

    Time frame: Change from baseline to 24 months

  6. Serum triglyceride levels

    Time frame: Change from baseline to 24 months

  7. Serum BUN levels

    Time frame: Change from baseline to 24 months

  8. Serum creatinine levels

    Time frame: Change from baseline to 24 months

  9. Serum hemoglobine levels

    Time frame: Change from baseline to 24 months

  10. eGFR levels

    Time frame: Change from baseline to 24 months

  11. Urine microalbuminurea

    Time frame: Change from baseline to 24 months

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Acronym: TELEDIAB

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 10, 2021
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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