Diabetes in the Elderly: Prospective Study

Diabetes Clinical Trial

— DMElderly  

Official title:

Diabetes Care in Nursing Home Residents: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131052
• Other study ID #: IRB00038789
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2010
• Last updated: December 18, 2014
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

Drug:
• Insulin Glargine
glargine once a day
• Insulin
sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
• Insulin glulisine
glulisine given as needed before meals

Locations

Country	Name	City	State
United States	Guillermo Umpierrez	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Guillermo Umpierrez

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL	Mean weekly blood glucose concentration less than 70 mg/dL at 3 months	3 months	No
Primary	Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL	Mean weekly blood glucose concentration less than 40 mg/dL at 3 months	3 months	No
Primary	Mean of Weekly Fasting Blood Glucose Concentration	Mean weekly blood glucose concentration at 3 months	3 months	No
Secondary	Mean Blood Glucose Concentration	Mean blood glucose concentration at baseline	Baseline	No
Secondary	Mean of Glycosylated Hemoglobin (hbA1c)	Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.	Baseline	No
Secondary	Mean of Daily Blood Glucose Concentration	Mean of daily blood glucose concentration at baseline	Baseline	No
Secondary	Mean of Glycosylated Hemoglobin (hbA1c)	Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.	3 months	No
Secondary	Mean of Glycosylated Hemoglobin (hbA1c)	Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.	6 months	No