TelemedicineTELEDIABNCT04789798
The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey
A study testing TeleDiab (Telemedicine) in people with Telemedicine and Telehealth, run by Istanbul University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Telemedicine, Telehealth
- What is being tested?
- TeleDiab (Telemedicine)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2013to 19 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- <18 and> 65years old
- Presence of Type 1 diabetes for less than 3 months or Type 2 diabetes not using insulin
About this study
Official title: The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey: Preliminary Results From The Randomised Controlled Telediab Trial
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.
Read the 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
- Being tested
- TeleDiab (Telemedicine), Usual care
- Keywords
- Telemedicine, Telehealth, Virtual care, Diabetes, Virtual visits
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 careOther
Usual diabetes care, as provided by primary care providers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TeleDiab (Telemedicine) |
| Usual Care | Active comparator | usual diabetes care, as provided by primary care providers in the hospital Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary glucose levels changes
Measured: Change in baseline capillary glucose levels (mg/dl) at 24th month
Home blood glucose measurement frequency
Measured: Change in baseline home blood glucose measurement frequency at 24th month
A1c measurement
Measured: Change in baseline A1c (%) measurement frequency at 24th month
Weight
Measured: Change in baseline weight (kg) measurement frequency at 24th month
BMI
Measured: Change in baseline BMI (kg/m2) measurement frequency at 24th month
Secondary outcomes (3)
Number of patients developing new diabetes complications within 24 months
retinopathy, peripheral neuropathy, autonomic neuropathy, nephropathy
Measured: Change from baseline to 24 months
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
Measured: 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
Measured: Change from baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start21 Oct 2013
- Primary completion19 Oct 2015
- Study completion19 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Turker, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789798
- Sponsor's protocol ID
- 2012/1461-1217
- Acronym
- TELEDIAB
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19390093
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Telemedicine to Optimize Metabolic Control in Patients With Diabetes in Turkey: Preliminary Results From The Randomised Controlled Telediab Trial
- ClinicalTrials.gov ID
- NCT04789798
- Acronym / sponsor ID
- TELEDIAB / 2012/1461-1217
- Conditions
- Telemedicine, Telehealth
- Keywords
- Telemedicine, Telehealth, Virtual care, Diabetes, Virtual visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 21 Oct 2013 (actual)
- Primary completion
- 19 Oct 2015 (actual)
- Study completion
- 19 Oct 2015 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TeleDiab (Telemedicine) | Experimental | Device: 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. |
| Usual Care | Active comparator | Other: Usual careusual diabetes care, as provided by primary care providers in the hospital |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- <18 and> 65years old
- Presence of Type 1 diabetes for less than 3 months or Type 2 diabetes not using insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | TeleDiab (Telemedicine) |
| Usual careUsual diabetes care, as provided by primary care providers | Other | Usual Care |
Primary outcome
Capillary glucose levels changes
Time frame: Change in baseline capillary glucose levels (mg/dl) at 24th month
Home blood glucose measurement frequency
Time frame: Change in baseline home blood glucose measurement frequency at 24th month
A1c measurement
Time frame: Change in baseline A1c (%) measurement frequency at 24th month
Weight
Time frame: Change in baseline weight (kg) measurement frequency at 24th month
BMI
Time frame: Change in baseline BMI (kg/m2) measurement frequency at 24th month
3 secondary outcomes
Number of patients developing new diabetes complications within 24 months
Time frame: Change from baseline to 24 months
Number of patients who developed new comorbidities in 24 months
Time frame: 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
Time frame: Change from baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 19390093Shea 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TeleDiab (Telemedicine) in people with Telemedicine and Telehealth, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary glucose levels changes (time frame: Change in baseline capillary glucose levels (mg/dl) at 24th month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04789798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.