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Randomized Trial of Telemedicine for Diabetes Care (IDEATel)

This study has been completed.
Sponsor:
Collaborator:
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
Steven J. Shea, Columbia University
ClinicalTrials.gov Identifier:
NCT00271739
First received: December 30, 2005
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
Results First Received: February 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Diabetes Mellitus
Interventions: Device: Telemedicine Unit (HTU)
Other: usual care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Telemedicine Case Management Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
Usual Care Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.

Participant Flow:   Overall Study
    Telemedicine Case Management     Usual Care  
STARTED     844     821  
COMPLETED     729     716  
NOT COMPLETED     115     105  



  Baseline Characteristics
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Reporting Groups
  Description
Telemedicine Case Management Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
Usual Care Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
Total Total of all reporting groups

Baseline Measures
    Telemedicine Case Management     Usual Care     Total  
Number of Participants  
[units: participants]
 		  844     821     1665  
Age  
[units: years]
Mean ± Standard Deviation 		  70.8  ± 6.5     70.9  ± 6.8     70.8  ± 6.7  
Gender  
[units: participants]
 		     
Female     536     510     1046  
Male     308     311     619  



  Outcome Measures
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1.  Primary:   Hemoglobin A1c Levels   [ Time Frame: 5 years ]
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2.  Primary:   Blood Pressure Levels   [ Time Frame: 5 years ]
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3.  Primary:   Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol   [ Time Frame: 5 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Walter Palmas, M.D.
Organization: Columbia University
phone: 212-305-3163
e-mail: wp56@columbia.edu


Publications of Results:

Other Publications:

Publications automatically indexed to this study:


Responsible Party: Steven J. Shea, Columbia University
ClinicalTrials.gov Identifier: NCT00271739     History of Changes
Other Study ID Numbers: AAAA5372, CMS 95-C-90998
Study First Received: December 30, 2005
Results First Received: February 28, 2011
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board