Diabetes MellitusIDEATelNCT00271739

Randomized Trial of Telemedicine for Diabetes Care

A study testing Telemedicine Unit (HTU) in people with Diabetes Mellitus, run by Columbia University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Diabetes Mellitus
What is being tested?: Telemedicine Unit (HTU)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,665 participants
Where: 2 sitesUnited States
Study dates: Dec 2000to May 2007
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Moderate or severe cognitive, visual, or physical impairment
The presence of severe co-morbid disease.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Columbia University
New York, New York, 10032
SUNY Upstate Medical University
Syracuse, New York, 13210

Other trials in United States

About this study

Official title: Informatics for Diabetes Education and Telemedicine (IDEATel)

Read the 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.

Conditions: Diabetes Mellitus
Being tested: Telemedicine Unit (HTU), usual care
Keywords: Telemedicine, Diabetes Mellitus
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telemedicine Unit (HTU)Device
Also called 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.
usual careOther
usual diabetes care, as provided by primary care providers

Study groups in NCT00271739
Study group	Role	What they receive
Telemedicine case management	Experimental	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). Receives: Device: Telemedicine Unit (HTU)
Usual care	Active comparator	usual care by primary care provider Receives: Other: usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin A1c Levels
Measured: 5 years
Blood Pressure Levels
Measured: 5 years
Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2000May 2007

First posted4 Jan 2006 (estimated)
Study startDec 2000
Primary completionMay 2007
Study completionMay 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,665 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00271739
Sponsor's protocol ID: AAAA5372
Other IDs: CMS 95-C-90998
Acronym: IDEATel
Status last verified: Aug 2023
First submitted: 30 Dec 2005
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 11751803
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.
PubMed 11751801
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 usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus. J Am Med Inform Assoc. 2006 Jan-Feb;13(1):40-51. doi: 10.1197/jamia.M1917. Epub 2005 Oct 12.
PubMed 16221935
Palta P, Golden SH, Teresi J, Palmas W, Weinstock RS, Shea S, Manly JJ, Luchsinger JA. Mild cognitive dysfunction does not affect diabetes mellitus control in minority elderly adults. J Am Geriatr Soc. 2014 Dec;62(12):2363-8. doi: 10.1111/jgs.13129. Epub 2014 Nov 29.
PubMed 25439094
Shea S, Kothari D, Teresi JA, Kong J, Eimicke JP, Lantigua RA, Palmas W, Weinstock RS. Social impact analysis of the effects of a telemedicine intervention to improve diabetes outcomes in an ethnically diverse, medically underserved population: findings from the IDEATel Study. Am J Public Health. 2013 Oct;103(10):1888-94. doi: 10.2105/AJPH.2012.300909. Epub 2013 Mar 14.
PubMed 23488491
Trief PM, Izquierdo R, Eimicke JP, Teresi JA, Goland R, Palmas W, Shea S, Weinstock RS. Adherence to diabetes self care for white, African-American and Hispanic American telemedicine participants: 5 year results from the IDEATel project. Ethn Health. 2013;18(1):83-96. doi: 10.1080/13557858.2012.700915. Epub 2012 Jul 5.
PubMed 22762449
Remler DK, Teresi JA, Weinstock RS, Ramirez M, Eimicke JP, Silver S, Shea S. Health care utilization and self-care behaviors of Medicare beneficiaries with diabetes: comparison of national and ethnically diverse underserved populations. Popul Health Manag. 2011 Feb;14(1):11-20. doi: 10.1089/pop.2010.0003. Epub 2011 Jan 17.
PubMed 21241171
Weinstock RS, Brooks G, Palmas W, Morin PC, Teresi JA, Eimicke JP, Silver S, Izquierdo R, Goland R, Shea S. Lessened decline in physical activity and impairment of older adults with diabetes with telemedicine and pedometer use: results from the IDEATel study. Age Ageing. 2011 Jan;40(1):98-105. doi: 10.1093/ageing/afq147. Epub 2010 Nov 16.
PubMed 21081539
Homenko DR, Morin PC, Eimicke JP, Teresi JA, Weinstock RS. Food insecurity and food choices in rural older adults with diabetes receiving nutrition education via telemedicine. J Nutr Educ Behav. 2010 Nov-Dec;42(6):404-9. doi: 10.1016/j.jneb.2009.08.001.
PubMed 21070978
West SP, Lagua C, Trief PM, Izquierdo R, Weinstock RS. Goal setting using telemedicine in rural underserved older adults with diabetes: experiences from the informatics for diabetes education and telemedicine project. Telemed J E Health. 2010 May;16(4):405-16. doi: 10.1089/tmj.2009.0136.
PubMed 20507198
Robinson KS, Morin PC, Shupe JA, Izquierdo R, Ploutz-Snyder R, Meyer S, Teresi JA, Starren J, Shea S, Weinstock RS. Use of three computer training methods in elderly underserved rural patients enrolled in a diabetes telemedicine program. Comput Inform Nurs. 2010 May-Jun;28(3):172-7. doi: 10.1097/NCN.0b013e3181d785d5.
PubMed 20431360
Palmas W, Shea S, Starren J, Teresi JA, Ganz ML, Burton TM, Pashos CL, Blustein J, Field L, Morin PC, Izquierdo RE, Silver S, Eimicke JP, Lantigua RA, Weinstock RS; IDEATel Consortium. Medicare payments, healthcare service use, and telemedicine implementation costs in a randomized trial comparing telemedicine case management with usual care in medically underserved participants with diabetes mellitus (IDEATel). J Am Med Inform Assoc. 2010 Mar-Apr;17(2):196-202. doi: 10.1136/jamia.2009.002592.
PubMed 20190064
Morin PC, Wolff LT, Eimicke JP, Teresi JA, Shea S, Weinstock RS. Record media used by primary care providers in medically underserved regions of upstate New York was not pivotal to clinical result in the Informatics for Diabetes Education and Telemedicine (IDEATel) project. Inform Prim Care. 2009;17(2):103-12. doi: 10.14236/jhi.v17i2.722.
PubMed 19807952
Sandberg J, Trief PM, Izquierdo R, Goland R, Morin PC, Palmas W, Larson CD, Strait JG, Shea S, Weinstock RS. A qualitative study of the experiences and satisfaction of direct telemedicine providers in diabetes case management. Telemed J E Health. 2009 Oct;15(8):742-50. doi: 10.1089/tmj.2009.0027.
PubMed 19780691
Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.
PubMed 19390093

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Informatics for Diabetes Education and Telemedicine (IDEATel)
ClinicalTrials.gov ID: NCT00271739
Acronym / sponsor ID: IDEATel / AAAA5372
Conditions: Diabetes Mellitus
Keywords: Telemedicine, Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,665 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: State University of New York - Upstate Medical University
Study start: Dec 2000
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 4 Jan 2006 (estimated)
Results: Posted 10 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Telemedicine case management	Experimental	Device: 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).
Usual care	Active comparator	Other: usual careusual care by primary care provider

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

Moderate or severe cognitive, visual, or physical impairment
The presence of severe co-morbid disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telemedicine Unit (HTU)Also: HTUThis 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.	Device	Telemedicine case management
usual careusual diabetes care, as provided by primary care providers	Other	Usual care

Primary outcome

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

Results and safety

Results posted to the registry on 10 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telemedicine Case Management	844	729
Usual Care	821	716

Primary outcome: Hemoglobin A1c Levels

Time frame: 5 years. Mean (Standard Error). Unit: A1c percentage

Measure	Telemedicine Case Management n = 844	Usual Care n = 821
Value	7.09 (0.06)	7.38 (0.06)

Primary outcome: Blood Pressure Levels

Time frame: 5 years. Mean (Standard Error). Unit: mmHg

Measure	Telemedicine Case Management n = 844	Usual Care n = 821
Value	135.83 (0.87)	140.15 (0.86)

Primary outcome: Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol

Time frame: 5 years. Mean (Standard Error). Unit: mg/dL

Measure	Telemedicine Case Management n = 844	Usual Care n = 821
Value	91.13 (1.43)	94.97 (1.40)

Adverse events

Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telemedicine Case Management	0 of 844 (0%)	0 of 844 (0%)	Not reported
Usual Care	0 of 821 (0%)	0 of 821 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11751803Shea 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.
Background: PubMed 11751801Starren 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.
Results publication: PubMed 16221935Shea 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 usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus. J Am Med Inform Assoc. 2006 Jan-Feb;13(1):40-51. doi: 10.1197/jamia.M1917. Epub 2005 Oct 12.
Derived from this study: PubMed 25439094Palta P, Golden SH, Teresi J, Palmas W, Weinstock RS, Shea S, Manly JJ, Luchsinger JA. Mild cognitive dysfunction does not affect diabetes mellitus control in minority elderly adults. J Am Geriatr Soc. 2014 Dec;62(12):2363-8. doi: 10.1111/jgs.13129. Epub 2014 Nov 29.
Derived from this study: PubMed 23488491Shea S, Kothari D, Teresi JA, Kong J, Eimicke JP, Lantigua RA, Palmas W, Weinstock RS. Social impact analysis of the effects of a telemedicine intervention to improve diabetes outcomes in an ethnically diverse, medically underserved population: findings from the IDEATel Study. Am J Public Health. 2013 Oct;103(10):1888-94. doi: 10.2105/AJPH.2012.300909. Epub 2013 Mar 14.
Derived from this study: PubMed 22762449Trief PM, Izquierdo R, Eimicke JP, Teresi JA, Goland R, Palmas W, Shea S, Weinstock RS. Adherence to diabetes self care for white, African-American and Hispanic American telemedicine participants: 5 year results from the IDEATel project. Ethn Health. 2013;18(1):83-96. doi: 10.1080/13557858.2012.700915. Epub 2012 Jul 5.
Derived from this study: PubMed 21241171Remler DK, Teresi JA, Weinstock RS, Ramirez M, Eimicke JP, Silver S, Shea S. Health care utilization and self-care behaviors of Medicare beneficiaries with diabetes: comparison of national and ethnically diverse underserved populations. Popul Health Manag. 2011 Feb;14(1):11-20. doi: 10.1089/pop.2010.0003. Epub 2011 Jan 17.
Derived from this study: PubMed 21081539Weinstock RS, Brooks G, Palmas W, Morin PC, Teresi JA, Eimicke JP, Silver S, Izquierdo R, Goland R, Shea S. Lessened decline in physical activity and impairment of older adults with diabetes with telemedicine and pedometer use: results from the IDEATel study. Age Ageing. 2011 Jan;40(1):98-105. doi: 10.1093/ageing/afq147. Epub 2010 Nov 16.
Derived from this study: PubMed 21070978Homenko DR, Morin PC, Eimicke JP, Teresi JA, Weinstock RS. Food insecurity and food choices in rural older adults with diabetes receiving nutrition education via telemedicine. J Nutr Educ Behav. 2010 Nov-Dec;42(6):404-9. doi: 10.1016/j.jneb.2009.08.001.
Derived from this study: PubMed 20507198West SP, Lagua C, Trief PM, Izquierdo R, Weinstock RS. Goal setting using telemedicine in rural underserved older adults with diabetes: experiences from the informatics for diabetes education and telemedicine project. Telemed J E Health. 2010 May;16(4):405-16. doi: 10.1089/tmj.2009.0136.
Derived from this study: PubMed 20431360Robinson KS, Morin PC, Shupe JA, Izquierdo R, Ploutz-Snyder R, Meyer S, Teresi JA, Starren J, Shea S, Weinstock RS. Use of three computer training methods in elderly underserved rural patients enrolled in a diabetes telemedicine program. Comput Inform Nurs. 2010 May-Jun;28(3):172-7. doi: 10.1097/NCN.0b013e3181d785d5.
Derived from this study: PubMed 20190064Palmas W, Shea S, Starren J, Teresi JA, Ganz ML, Burton TM, Pashos CL, Blustein J, Field L, Morin PC, Izquierdo RE, Silver S, Eimicke JP, Lantigua RA, Weinstock RS; IDEATel Consortium. Medicare payments, healthcare service use, and telemedicine implementation costs in a randomized trial comparing telemedicine case management with usual care in medically underserved participants with diabetes mellitus (IDEATel). J Am Med Inform Assoc. 2010 Mar-Apr;17(2):196-202. doi: 10.1136/jamia.2009.002592.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Shea, MD principal investigator

Columbia University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine Unit (HTU) in people with Diabetes Mellitus, run by Columbia University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c Levels (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00271739, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.