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

Telemedicine Clinical Trial

— TELEDIAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04789798
• Other study ID #: 2012/1461-1217
• Status: Completed
• Phase: N/A
• Start date: October 21, 2013
• Est. completion date: October 19, 2015

Study information

• Verified date: March 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 19, 2015
• Est. primary completion date: October 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Telehealth
• Telemedicine

Intervention

Device:
• TeleDiab (Telemedicine)
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.

Other:
• Usual care
Usual diabetes care, as provided by primary care providers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum ALT levels		Change from baseline to 24 months
Other	Serum TSH levels		Change from baseline to 24 months
Other	Serum sT4 levels		Change from baseline to 24 months
Other	Serum LDL levels		Change from baseline to 24 months
Other	Serum HDL levels		Change from baseline to 24 months
Other	Serum triglyceride levels		Change from baseline to 24 months
Other	Serum BUN levels		Change from baseline to 24 months
Other	Serum creatinine levels		Change from baseline to 24 months
Other	Serum hemoglobine levels		Change from baseline to 24 months
Other	eGFR levels		Change from baseline to 24 months
Other	Urine microalbuminurea		Change from baseline to 24 months
Primary	Capillary glucose levels changes		Change in baseline capillary glucose levels (mg/dl) at 24th month
Primary	Home blood glucose measurement frequency		Change in baseline home blood glucose measurement frequency at 24th month
Primary	A1c measurement		Change in baseline A1c (%) measurement frequency at 24th month
Primary	Weight		Change in baseline weight (kg) measurement frequency at 24th month
Primary	BMI		Change in baseline BMI (kg/m2) measurement frequency at 24th month
Secondary	Number of patients developing new diabetes complications within 24 months	retinopathy, peripheral neuropathy, autonomic neuropathy, nephropathy	Change from baseline to 24 months
Secondary	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
Secondary	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