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Completed

NCT Number: NCT00271739

Randomized Trial of Telemedicine for Diabetes Care

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine Unit (HTU)

Device

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.

Other names: HTU

Usual Care

Other

usual diabetes care, as provided by primary care providers

Primary outcomes

  1. Hemoglobin A1c Levels

    Time frame: 5 years

  2. Blood Pressure Levels

    Time frame: 5 years

  3. Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • State University of New York - Upstate Medical University

Registry information

Official study title

Informatics for Diabetes Education and Telemedicine (IDEATel)

Acronym: IDEATel

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Jan 4, 2006
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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