NCT01131052

Diabetes in the Elderly: Prospective Study

Diabetes Care in Nursing Home Residents: A Randomized Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Guillermo Umpierrez · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Diabetes
• Hyperglycemia

Interventions

Type	Name	Description
DRUG	Insulin Glargine	glargine once a day
DRUG	Insulin	sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
DRUG	Insulin glulisine	glulisine given as needed before meals

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-05-26
• Last updated: 2014-12-31
• Results posted: 2014-12-31

Locations

1 site across 1 country: United States