Diabetes in the Elderly: Prospective Study

Study Overview
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Brief Summary
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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.

Official Title
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Diabetes Care in Nursing Home Residents: A Randomized Controlled Study

Conditions
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Hyperglycemia, Diabetes

Intervention / Treatment
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* Drug: Insulin Glargine
* Drug: Insulin
* Drug: Insulin glulisine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BASAL PLUS<br>Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed | Drug: Insulin Glargine<br>* glargine once a day<br>* Other names: Lantus;Drug: Insulin glulisine<br>* glulisine given as needed before meals<br>* Other names: Apridra;|
| Active Comparator: sliding scale regular insulin (SSRI)<br>Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed | Drug: Insulin<br>* sliding scale regular insulin (SSRI) given before meals and at bedtime as needed<br>* Other names: Novolin R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Mean of Weekly Fasting Blood Glucose Concentration | Mean weekly blood glucose concentration at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blood Glucose Concentration | Mean blood glucose concentration at baseline | 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. | Baseline | 
| Mean of Daily Blood Glucose Concentration | Mean of daily blood glucose concentration at baseline | 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. | 3 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly populations, diabetes