Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery
Condition: Type 2 Diabetes; Inpatient Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: Insulin glargine; Regular insulin; Insulin glulisine
Intervention description: Insulin glargine once daily SQ; Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO; scheduled glulisine given SQ at mealtime TID; none given if patient NPO
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: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: diabetes; post-op complications; inpatient hyperglycemia

Summary:

      High blood glucose levels in surgical patients with diabetes are associated with increased
      risk of medical complications and death. Improved glucose control with insulin injections may
      improve clinical outcome and prevent some of the hospital complications. In patients who have
      undergone surgery, high blood glucose increases the risk of wound infection, kidney failure
      and death. It is not known; however, what is the best insulin regimen in patients who will
      undergo surgery. The use of repeated injections of regular insulin is commonly used for
      glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus®
      and Apidra® insulins has been shown to improve glucose control with lower rate of
      hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted
      to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental
      glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital
      complications than treatment with regular insulin per sliding scale (SSRI). The present study
      aims to determine which insulin treatment is best for glucose control in hospitalized
      patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment
      of patients with diabetes by the FDA.

      Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial
      Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta,
      Georgia. A total of ~94 patients will be recruited at each institution.

      A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial
      will be completed in order to determine differences in hospitalization cost between basal
      bolus insulin and SSI regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females between the ages of 18 and 80 years admitted to a general surgery
             service.

          2. Patients admitted for non-cardiac elective or emergency surgery or trauma.

          3. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or
             any combination of oral antidiabetic agents (sulfonylureas, metformin,
             thiazolidinediones).

          4. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without
             laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive
             serum or urinary ketones).

        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,
             or ketonuria.

          3. Acute critical illness or CABG surgery expected to require prolonged admission to a
             critical care unit (ICU, CCU, SICU, Neuro ICU).

          4. Patients with clinically relevant hepatic disease or impaired renal function, as shown
             by a serum creatinine ≥ 3.5 mg/dl.

          5. Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study.

          6. Female subjects are pregnant or breast feeding at time of enrollment into the study.