View Clinical Trial (Medical Research Study)
Diabetes Care in Nursing Home Residents: A Randomized Controlled Study
| City: |
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Atlanta |
| State: |
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Georgia |
| Zip Code: |
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30303 |
| Conditions: |
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Diabetes - Hyperglycemia |
| Purpose: |
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Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75
years and 40% of adults >80years of age. It is expected that the number of elderly people
suffering from diabetes will increase in the future, as general life expectancy is
increasing.
Nursing home residents with diabetes have higher rates of serious comorbidities and have
greater activity of daily living dependencies than other residents without diabetes. In
addition, persons with diabetes have higher risk of hypertension, heart disease, stroke
depression, cognitive impairment, and cardiovascular mortality than individuals without
diabetes.
There are 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; however, no previous 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. In addition, it is not known whether the use of basal insulin is superior to
treatment with sliding scale insulin (SSI) in long-term care facility residents with type 2
diabetes.
Accordingly, the investigators propose to conduct a prospective randomized control trial
comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale
regular insulin in the management of nursing home patients with T2DM.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Males or females > 60 years of age.
2. Blood glucose > 150 mg/dl and A1C > 7.5%.
3. A known history of T2DM, receiving either diet alone, oral monotherapy, or with any
combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide,
nateglinide, pioglitazone, rosiglitazone, sitagliptin).
4. Patients admitted for non-cardiac elective or emergency surgery or trauma.
Exclusion Criteria:
1. Subjects with increased blood glucose concentration, but without a known history of
diabetes (stress hyperglycemia).
2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state
(26).
3. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and
portal hypertension), corticosteroid therapy, or impaired renal function (creatinine
≥ 3.5 mg/dl).
4. Patients with recognized or suspected endocrine disorders associated with increased
insulin resistance, acromegaly, or hyperthyroidism
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| NCT ID: |
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NCT01131052 |
| Primary Contact: |
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Principal Investigator
Guillermo Umpierrez, MD
Emory SOM
Guillermo Umpierrez, MD
Phone: 404-778-1665
Email: geumpie@emory.edu
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| Backup Contact: |
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Email: dsmiley@emory.edu
Dawn Smiley, Md
Phone: 404-778-1664
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| Location Contact: |
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Atlanta, Georgia 30303
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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