Diabetes in the Elderly: Prospective Study

Guillermo Umpierrez150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Diabetes

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 3 months

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

Time frame: 3 months

Mean of Weekly Fasting Blood Glucose Concentration

Mean weekly blood glucose concentration at 3 months

Time frame: 3 months

Secondary Outcomes

Mean Blood Glucose Concentration

Mean blood glucose concentration at baseline

Time frame: Baseline

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.

Time frame: Baseline

Mean of Daily Blood Glucose Concentration

Mean of daily blood glucose concentration at baseline

Time frame: Baseline

Mean of Glycosylated Hemoglobin (hbA1c)

Time frame: 3 months

Mean of Glycosylated Hemoglobin (hbA1c)

Time frame: 6 months

Diabetes in the Elderly: Prospective Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes