Diabetes in the Elderly: Prospective Study
Condition: Diabetes; Hyperglycemia
MeSH terms: Diabetes Mellitus; Hyperglycemia
Intervention: Insulin Glargine; Insulin; Insulin glulisine
Intervention description: glargine once a day; sliding scale regular insulin (SSRI) given before meals and at bedtime as needed; glulisine given as needed before meals
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: elderly populations; diabetes

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.
    

Eligibility criteria:

        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