Randomized Trial of Telemedicine for Diabetes Care

Diabetes Mellitus Clinical Trial

— IDEATel  

Official title:

Informatics for Diabetes Education and Telemedicine (IDEATel)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271739
• Other study ID #: AAAA5372
• Secondary ID: CMS 95-C-90998
• Status: Completed
• Phase: N/A
• Start date: December 2000
• Est. completion date: May 2007

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1665
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Telemedicine Unit (HTU)
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:
• usual care
usual diabetes care, as provided by primary care providers

Locations

Country	Name	City	State
United States	Columbia University	New York	New York
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Shea S, Starren J, Weinstock RS, Knudson PE, Teresi J, Holmes D, Palmas W, Field L, Goland R, Tuck C, Hripcsak G, Capps L, Liss D. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design. J Am Med Inform Assoc. 2002 Jan-Feb;9(1):49-62. doi: 10.1136/jamia.2002.0090049. — View Citation

Shea S, Weinstock RS, Starren J, Teresi J, Palmas W, Field L, Morin P, Goland R, Izquierdo RE, Wolff LT, Ashraf M, Hilliman C, Silver S, Meyer S, Holmes D, Petkova E, Capps L, Lantigua RA. A randomized trial comparing telemedicine case management with usu — View Citation

Starren J, Hripcsak G, Sengupta S, Abbruscato CR, Knudson PE, Weinstock RS, Shea S. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) project: technical implementation. J Am Med Inform Assoc. 2002 Jan-Feb;9(1):25-36. doi: 10.1136/jamia.2002.0090025. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c Levels		5 years
Primary	Blood Pressure Levels		5 years
Primary	Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol		5 years