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The Diabetes Telemonitoring (DiaTel) Study
This study is currently recruiting participants.
Verified by VA Pittsburgh Healthcare System, October 2005
Sponsored by: Department of Defense
Information provided by: VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT00245882
  Purpose

The purpose of this research study is to compare two different methods of helping veterans with diabetes better manage their disease. This study will compare an "Active Care Management" method using home-based technology and self-monitoring techniques with a lower-intensity "Care Coordination" method based on monthly telephone contact with a nurse.


Condition Intervention
Diabetes
Behavioral: Active Care Management
Behavioral: Care Coordination

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: The Diabetes Telemonitoring (DiaTel) Study

Further study details as provided by VA Pittsburgh Healthcare System:

Primary Outcome Measures:
  • Changes in the levels of HbA1c, BP, LDL-cholesterol, and triglycerides at three months and six months.

Secondary Outcome Measures:
  • Proportion of subjects in each cohort with HbA1c </= 7%, BP </= 130/80, LDL-cholesterol </= 100 mg/dl, and triglycerides </= 150 mg/dl at six months
  • Proxy measures for cost of care (number of outpatient clinic visits, emergency room visits, hospital bed days, and pharmacy costs)
  • For subjects not on insulin at enrollment, time to prescription of insulin
  • For subjects on insulin at enrollment, time to change in dose and/or type of insulin
  • Subject satisfaction with care
  • Factors influencing adherence to diabetes regimen

Estimated Enrollment: 200
Study Start Date: October 2005
Estimated Study Completion Date: July 2006
Detailed Description:

The objectives of this study are to design, implement, and evaluate two medical care initiatives of different levels of intensity for veterans with diabetes and suboptimal glycemic control. The higher-intensity initiative ("Active Care Management") will use home-based technology that enables home messaging and reminders for compliance with recommended guidelines for treatment, as well as self-monitoring of blood glucose, blood pressure, and weight. Data will be transmitted to health care providers. This initiative will feature active care management, including changes in medication and/or diet implemented by the study's certified registered nurse practitioner under the supervision of a study physician in collaboration with the subject's primary care provider (PCP).

The lower-intensity intiative ("Care Coordination") will consist of care coordination in the form of monthly monitoring of subjects via telephone by the study's research nurse who will refer the subject to his/her PCP as needed for additional care. Both initiatives represent a supplementation to current usual care practices for the treatment of diabetes in the VA.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. enrolled for primary care at a VA Pittsburgh Healthcare System (VAPHS)site with at least one visit from June 1, 2004 through May 31, 2005
  2. diagnosed with diabetes mellitus with at least 12 months of ongoing pharmacologic treatment (at least one oral hypoglycemic agent, insulin, or both)
  3. born in 1926 or later
  4. have an HbA1c level >/= 8.0% at the last assessment (between 6/1/04 and 5/31/05)
  5. have an HbA1c level >/= 8.0% (by finger stick) at the time of enrollment
  6. mentally competent to give informed consent

Exclusion Criteria:

  1. one or more visits to the VAPHS Diabetes Clinic from June 1, 2004 through May 31, 2005
  2. metastatic or inoperable cancer
  3. Child-Pugh Class B or C end-stage liver disease
  4. HIV/AIDS
  5. end-stage renal disease requiring dialysis
  6. ongoing home oxygen therapy
  7. a history of major organ transplant (i.e., heart, lung, kidney, liver)
  8. residence in an institution (e.g. nursing home, personal care home, or prison)
  9. incompatible telephone service (i.e., either none or digital)
  10. concurrent participation in any other research protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245882

Contacts
Contact: Lin Hough, MPH 412-688-6998 linda.hough@med.va.gov

Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Principal Investigator: Frederick R DeRubertis, MD            
Sub-Investigator: R. Harsha Rao, MD            
Sub-Investigator: David S Macpherson, MD, MPH            
Sub-Investigator: Mary Ann Sevick, ScD, RN            
Sub-Investigator: Roslyn A Stone, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Frederick R DeRubertis, MD VA Pittsburgh Healthcare System
  More Information

Study ID Numbers: 02324
Study First Received: October 27, 2005
Last Updated: October 28, 2005
ClinicalTrials.gov Identifier: NCT00245882  
Health Authority: United States: Federal Government

Keywords provided by VA Pittsburgh Healthcare System:
Quality improvement
Telehealth

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009