Diabetes in the Elderly: Prospective Study



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:60 - Any
Updated:3/1/2014
Start Date:March 2011
End Date:December 2013
Contact:Guillermo Umpierrez, MD
Email:geumpie@emory.edu
Phone:404-778-1665

Use our guide to learn which trials are right for you!

Diabetes Care in Nursing Home Residents: A Randomized Controlled Study

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.


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
We found this trial at
1
site
Atlanta, Georgia 30303
?
mi
from
Atlanta, GA
Click here to add this to my saved trials