An interventional study of Telemedicine Unit (HTU) and usual care in Diabetes Mellitus, sponsored by Columbia University. Completed at 2 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1,665 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
usual care by primary care provider
Other: usual care
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.
Also known as: HTU
usual diabetes care, as provided by primary care providers
Hemoglobin A1c Levels
Time frame: 5 years
Blood Pressure Levels
Time frame: 5 years
Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol
Time frame: 5 years
| Milestone | Telemedicine Case Management | Usual Care |
|---|---|---|
| Started | 844 | 821 |
| Completed | 729 | 716 |
| Not completed | 115 | 105 |
| A1c percentage | Telemedicine Case Management | Usual Care |
|---|---|---|
| Hemoglobin A1c Levels | 7.09 ± 0.06 | 7.38 ± 0.06 |
| mmHg | Telemedicine Case Management | Usual Care |
|---|---|---|
| Blood Pressure Levels | 135.83 ± 0.87 | 140.15 ± 0.86 |
| mg/dL | Telemedicine Case Management | Usual Care |
|---|---|---|
| Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol | 91.13 ± 1.43 | 94.97 ± 1.40 |
Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telemedicine Case Management | — | 0/844 (0%) | 0/844 (0%) |
| Usual Care | — | 0/821 (0%) | 0/821 (0%) |
| Age, Continuous(years) | Telemedicine Case Management | Usual Care | Total |
|---|---|---|---|
| Mean | 70.8 ± 6.5 | 70.9 ± 6.8 | 70.8 ± 6.7 |
| Sex: Female, Male(Participants) | Telemedicine Case Management | Usual Care | Total |
|---|---|---|---|
| Female | 536 | 510 | 1046 |
| Male | 308 | 311 | 619 |
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Columbia University