Conditions: Type 2 Diabetes Inpatient Hyperglycemia
Keywords: diabetes post-op complications inpatient hyperglycemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Glargine once daily plus glulisine given before meals plus supplemental glulisine for BG \> 140 arm 2: Sliding scale regular insulin four-times daily achs.

Interventions: intervention 1: Insulin glargine intervention 2: Regular insulin intervention 3: Insulin glulisine
Intervention descriptions: intervention 1: Insulin glargine once daily SQ intervention 2: Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO intervention 3: scheduled glulisine given SQ at mealtime TID; none given if patient NPO

Protocol document: