Please select the eligibility criteria that correspond to the clinical trial below.
Title: RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery)
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.


Options:
A: 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.
B: Inclusion Criteria:

* Type 1 diabetes
* Treated with insulin for at least 12 months
* Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or
* Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan.

Exclusion Criteria:

* Previous birth of child with a major congenital malformation
* More than 2 previous multiple miscarriages or stillbirths
* Severe hyperemesis gravidarum, requiring hospitalisation, according to Investigator judgement
* Subjects being treated for infertility
* Proliferative retinopathy or maculopathy requiring acute treatment
* Drug or alcohol abuse
* Impaired renal, hepatic or cardiac function
C: Inclusion Criteria:

* Type 1 Diabetes
D: Inclusion Criteria:

* Subjects with type 2 diabetes
* Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
* HbA1c at least 7.5% and below 10.0%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic and/or renal function
* Cardiac diseases
* Uncontrolled hypertension
* Known hypoglycemia unawareness or recurrent major hypoglycemia

Answer: A