Randomized Trial of Telemedicine for Diabetes Care

Study Overview
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Brief Summary
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The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy, acceptability, and cost-effectiveness of telemedicine case management to provide diabetes care to elderly Medicare beneficiaries residing in medically underserved areas of New York State.

Detailed Description
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The project is designed as a randomized controlled trial with approximately 750 subjects receiving a telemedicine intervention and approximately 750 receiving usual care. Eligibility requires having diabetes, being a Medicare beneficiary, and living in a medically underserved area. The project is conducted in New York City, in northern Manhattan (urban component), and in rural upstate New York through a consortion of participating institutions based at the State University of New York (SUNY) Upstate Medical University at Syracuse (rural component). Subjects are randomized to receive telemedicine case management or usual care for diabetes. 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 case manager interacts regularly with intervention participants through videoconference via the HTU.

Official Title
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Informatics for Diabetes Education and Telemedicine (IDEATel)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Telemedicine Unit (HTU)
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 55 years or greater Being a current Medicare beneficiary (verified by the Centers for Medicare and Medicaid Services) Having diabetes mellitus as defined by a physician's diagnosis and being on treatment with diet, an oral hypoglycemic agent, or insulin Residence in a federally designated medically underserved area (either of two federal designations, Medically Underserved Area [MUA] or Health Manpower Shortage Area [HPSA]) in New York Sate Fluency in either English or Spanish Exclusion Criteria: Moderate or severe cognitive, visual, or physical impairment The presence of severe co-morbid disease.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine case management<br>Telemedicine visits conducted by a registered nurse (RN) with remote monitoring of blood pressure (BP) and blood glucose through the use of a telemedicine home unit (HTU). | Device: Telemedicine Unit (HTU)<br>* This study involves the deployment of a home telemedicine unit (HTU). The HTU provides 3 critical functions for patients: videoconferencing, access to information resources and e-mail through a web-enabled workstation, and medical data acquisition through an electronic device interface. The HTUs also included a glucometer and a blood pressure cuff interfaced directly with the HTU.<br>* Other names: HTU;|
| Active Comparator: Usual care<br>usual care by primary care provider | Other: usual care<br>* usual diabetes care, as provided by primary care providers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c Levels |  | 5 years | 
| Blood Pressure Levels |  | 5 years | 
| Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Diabetes Mellitus