Randomized Trial of Telemedicine for Diabetes Care

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: usual care; Device: Telemedicine Unit (HTU)

• Registration Number: NCT00271739
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2005-12-30
• Study First Submitted QC: 2005-12-30
• Study First Posted: 2006-01-04
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Results First Submitted: 2011-02-28
• Results First Submitted QC: 2011-07-13
• Results First Posted: 2011-08-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1665

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	usual care	usual care by primary care provider
Telemedicine case management	Telemedicine Unit (HTU)	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).

Primary Outcome Measures

Name	Time	Method
Blood Pressure Levels	5 years
Hemoglobin A1c Levels	5 years
Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol	5 years

Trial Locations

Locations (2)

Columbia University; 🇺🇸 New York, New York, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States