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Diabetes in the Elderly: Retrospective Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104168
First Posted: April 15, 2010
Last Update Posted: November 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
  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 Guillermo Umpierrez, Emory University:

Primary Outcome Measures:
  • prevalence of diabetes [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • differences in glycemic control [ Time Frame: 1 year ]
    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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01104168     History of Changes
Other Study ID Numbers: IRB00035147
First Submitted: April 9, 2010
First Posted: April 15, 2010
Last Update Posted: November 14, 2013
Last Verified: November 2013

Keywords provided by Guillermo Umpierrez, Emory University:
diabetes
elderly
nursing home resident

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