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Diabetes in the Elderly: Retrospective Study

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT01104168
Collaborator
Sanofi (Industry)
1,409
Enrollment
2
Locations
31
Duration (Months)
704.5
Patients Per Site
22.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults >80years of age. Management of hyperglycemia is challenging in the geriatric population in long-term facilities. Numerous factors place hospitalized patients at increased risk for hyperglycemia including aging, sedentary life, stress of medical and surgical comorbidities, and changes in antidiabetic regimen. In addition, elderly patients often experience changes in their nutritional intake and organ dysfunction which increase the risk of hypoglycemic events.

There are only a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities. In addition, no randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators will conduct a retrospective study to determine the prevalence of diabetes, comprehensively describe the management of diabetes, and to evaluate the impact of quality of care and glycemic control on clinical outcome in elderly subjects admitted to two large long-term care facilities: Grady Health System (GHS) and Veterans Administration Medical Center (VAMC) in Atlanta, Georgia between 1/01/08 to 12/31/08.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1409 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Diabetes Care in Nursing Home Residents
    Study Start Date :
    May 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Nursing home residents with diabetes

    Outcome Measures

    Primary Outcome Measures

    1. prevalence of diabetes [1 year]

    Secondary Outcome Measures

    1. differences in glycemic control [1 year]

      determine differences in glycemic control as measured by mean daily blood glucose concentration between different insulin regimens

    2. evaluate the impact of quality of care and glycemic control on clinical outcome in elderly subjects [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • ages 65+

    • diagnosis of diabetes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 A.G. Rhodes Homes Atlanta Georgia United States 30312
    2 Bud Terrace Homes Atlanta Georgia United States 30329

    Sponsors and Collaborators

    • Emory University
    • Sanofi

    Investigators

    • Principal Investigator: Guillermo Umpierrez, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guillermo Umpierrez, Professor of Medicine, Emory University
    ClinicalTrials.gov Identifier:
    NCT01104168
    Other Study ID Numbers:
    • IRB00035147
    First Posted:
    Apr 15, 2010
    Last Update Posted:
    Nov 14, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Guillermo Umpierrez, Professor of Medicine, Emory University
    diabetes
    elderly
    nursing home resident
    Additional relevant MeSH terms:
    Diabetes Mellitus

    Study Results

    No Results Posted as of Nov 14, 2013