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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01104168
Other study ID # IRB00035147
Secondary ID
Status Completed
Phase N/A
First received April 9, 2010
Last updated November 12, 2013
Start date May 2010
Est. completion date December 2012

Study information

Verified date November 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1409
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- ages 65+

- diagnosis of diabetes

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States A.G. Rhodes Homes Atlanta Georgia
United States Bud Terrace Homes Atlanta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Emory University Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of diabetes 1 year No
Secondary differences in glycemic control determine differences in glycemic control as measured by mean daily blood glucose concentration between different insulin regimens 1 year No
Secondary evaluate the impact of quality of care and glycemic control on clinical outcome in elderly subjects 1 year No
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