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Diabetes in the Elderly: Retrospective Study

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01104168
First received: April 9, 2010
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Diabetes Care in Nursing Home Residents

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • prevalence of diabetes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • differences in glycemic control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    determine differences in glycemic control as measured by mean daily blood glucose concentration between different insulin regimens

  • evaluate the impact of quality of care and glycemic control on clinical outcome in elderly subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1409
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nursing home residents with diabetes

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

older adults ages 65+ admitted to two large long-term care facilities

Criteria

Inclusion Criteria:

  • ages 65+
  • diagnosis of diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104168

Locations
United States, Georgia
A.G. Rhodes Homes
Atlanta, Georgia, United States, 30312
Bud Terrace Homes
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Sanofi
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01104168     History of Changes
Other Study ID Numbers: IRB00035147
Study First Received: April 9, 2010
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
diabetes
elderly
nursing home resident

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014