Clinical trial NCT04789798: The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey
Official title: The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey: Preliminary Results From The Randomised Controlled Telediab Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Telehealth
Keywords: Telemedicine
Telehealth
Virtual care
Diabetes
Virtual visits
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Capillary glucose levels changes
timeFrame: Change in baseline capillary glucose levels (mg/dl) at 24th month
measure: Home blood glucose measurement frequency
timeFrame: Change in baseline home blood glucose measurement frequency at 24th month
measure: A1c measurement
timeFrame: Change in baseline A1c (%) measurement frequency at 24th month
measure: Weight
timeFrame: Change in baseline weight (kg) measurement frequency at 24th month
measure: BMI
timeFrame: Change in baseline BMI (kg/m2) measurement frequency at 24th month
Secondary outcomes:
measure: Number of patients developing new diabetes complications within 24 months
timeFrame: Change from baseline to 24 months
measure: Number of patients who developed new comorbidities in 24 months
timeFrame: Change from baseline to 24 months
measure: The number of patients who added insulin to their oral antidiabetic medication or switched to oral antidiabetic medication by discontinuing insulin
timeFrame: Change from baseline to 24 months
Other outcomes:
measure: Serum ALT levels
timeFrame: Change from baseline to 24 months
measure: Serum TSH levels
timeFrame: Change from baseline to 24 months
measure: Serum sT4 levels
timeFrame: Change from baseline to 24 months
measure: Serum LDL levels
timeFrame: Change from baseline to 24 months
measure: Serum HDL levels
timeFrame: Change from baseline to 24 months
measure: Serum triglyceride levels
timeFrame: Change from baseline to 24 months
measure: Serum BUN levels
timeFrame: Change from baseline to 24 months
measure: Serum creatinine levels
timeFrame: Change from baseline to 24 months
measure: Serum hemoglobine levels
timeFrame: Change from baseline to 24 months
measure: eGFR levels
timeFrame: Change from baseline to 24 months
measure: Urine microalbuminurea
timeFrame: Change from baseline to 24 months
Locations:
Study officials:
References:
citation: Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.