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

NCT04789798 | Completed

• 1 other identifier: 2012/1461-1217
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Telemedicine; Telehealth

Keywords

Telemedicine; Telehealth; Virtual care; Diabetes; Virtual visits

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Number of patients developing new diabetes complications within 24 months

  Change from baseline to 24 months

• Number of patients who developed new comorbidities in 24 months

  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

Other Outcomes (11)

• Serum ALT levels

  Change from baseline to 24 months

• Serum TSH levels

  Change from baseline to 24 months

• Serum sT4 levels

  Change from baseline to 24 months

Study Arms (2)

TeleDiab (Telemedicine)

EXPERIMENTAL

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.

Device: TeleDiab (Telemedicine)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

TeleDiab (Telemedicine) 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.

TeleDiab (Telemedicine)

Usual care OTHER

Usual diabetes care, as provided by primary care providers

Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<18 and\> 65years old
• Presence of Type 1 diabetes for less than 3 months or Type 2 diabetes not using insulin

Sponsors & Collaborators

• Istanbul University: lead

Related 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.

  PMID: 19390093 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD; Academician; Principle Investigator

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: October 21, 2013
• Primary Completion: October 19, 2015
• Study Completion: October 19, 2015
• Last Updated: March 11, 2021

Record last verified: 2021-03