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

NCT ID: NCT04789798

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-21
• Study Completion Date: 2015-10-19

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.

Conditions

Telemedicine; Telehealth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TeleDiab (Telemedicine)

TeleDiab program components consist of:

1. Electronic transmission of capillary blood glucose measurement results

2. Electronic transmission of blood pressure measurements

3. Synchronized video-conferencing, secure messaging

4. Access to clinical data from patient files when necessary

5. Reminding of routine follow-up tests and examinations

6. Providing web-based educational materials to patients.

Group Type: EXPERIMENTAL

TeleDiab (Telemedicine)

Intervention Type: DEVICE

TeleDiab program components consist of:

1. Electronic transmission of capillary blood glucose measurement results

2. Electronic transmission of blood pressure measurements

3. Synchronized video-conferencing, secure messaging

4. Access to clinical data from patient files when necessary

5. Reminding of routine follow-up tests and examinations

6. Providing web-based educational materials to patients.

Usual Care

usual diabetes care, as provided by primary care providers in the hospital

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Usual diabetes care, as provided by primary care providers

Interventions

TeleDiab (Telemedicine)

TeleDiab program components consist of:

1. Electronic transmission of capillary blood glucose measurement results

2. Electronic transmission of blood pressure measurements

3. Synchronized video-conferencing, secure messaging

4. Access to clinical data from patient files when necessary

5. Reminding of routine follow-up tests and examinations

6. Providing web-based educational materials to patients.

Intervention Type: DEVICE

Usual care

Usual diabetes care, as provided by primary care providers

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Fulya Turker

MD, PhD; Academician; Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 19390093 (View on PubMed)

Other Identifiers

2012/1461-1217

Identifier Type: -

Identifier Source: org_study_id