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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TeleDiab (Telemedicine) | Experimental | TeleDiab program components consist of:
|
|
| Usual Care | Active Comparator | usual diabetes care, as provided by primary care providers in the hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TeleDiab (Telemedicine) | Device | TeleDiab program components consist of:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients developing new diabetes complications within 24 months | retinopathy, peripheral neuropathy, autonomic neuropathy, nephropathy | Change from baseline to 24 months |
| Number of patients who developed new comorbidities in 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum ALT levels | Change from baseline to 24 months | |
| Serum TSH levels | Change from baseline to 24 months | |
| Serum sT4 levels |
Inclusion Criteria:
for TeleDiab group:
for the control group:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19390093 | Background | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Usual care | Other | Usual diabetes care, as provided by primary care providers |
|
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 |
| 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 |
| Change from baseline to 24 months |
| Serum LDL levels | Change from baseline to 24 months |
| Serum HDL levels | Change from baseline to 24 months |
| Serum triglyceride levels | Change from baseline to 24 months |
| Serum BUN levels | Change from baseline to 24 months |
| Serum creatinine levels | Change from baseline to 24 months |
| Serum hemoglobine levels | Change from baseline to 24 months |
| eGFR levels | Change from baseline to 24 months |
| Urine microalbuminurea | Change from baseline to 24 months |