Diabetes in the Elderly: Prospective Study

Phase 4

Completed

Conditions: Diabetes
Hyperglycemia

Interventions: Drug: Insulin
Drug: Insulin Glargine
Drug: Insulin glulisine

Registration Number: NCT01131052

Lead Sponsor: Guillermo Umpierrez

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

Inclusion Criteria

Males or females > 60 years of age.
Blood glucose > 150 mg/dl and A1C > 7.5%.
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).
Patients admitted for non-cardiac elective or emergency surgery or trauma.

Exclusion Criteria

Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26).
Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BASAL PLUS	Insulin glulisine	Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed
sliding scale regular insulin (SSRI)	Insulin	Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
BASAL PLUS	Insulin Glargine	Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed

Primary Outcome Measures

Name	Time	Method
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL	3 months	Mean weekly blood glucose concentration less than 70 mg/dL at 3 months
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL	3 months	Mean weekly blood glucose concentration less than 40 mg/dL at 3 months
Mean of Weekly Fasting Blood Glucose Concentration	3 months	Mean weekly blood glucose concentration at 3 months

Secondary Outcome Measures

Name	Time	Method
Mean Blood Glucose Concentration	Baseline	Mean blood glucose concentration at baseline
Mean of Glycosylated Hemoglobin (hbA1c)	6 months	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.
Mean of Daily Blood Glucose Concentration	Baseline	Mean of daily blood glucose concentration at baseline