Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay
Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay
Few randomized studies have focused on the optimal management of non-ICU patients with type 2
 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen
 with analogs and human insulins in general medicine patients admitted to a University
 Hospital in Asuncion, Paraguay.
Few randomized intervention inpatient trials have been conducted in Latin America to
 determine optimal treatment regimens for patients with type 2 diabetes. In the absence of
 regional guidelines, most international societies in Latin America recommend following
 international guidelines for the management of hospitalized patients with diabetes. However,
 hospital resources, admission cause and inpatient glycemic control differ among countries. In
 the US, the leading cause of admission to the hospital in patients with diabetes is
 cardiovascular disease, whereas infections and acute complications of diabetes are more
 common than cardiovascular disease in some countries. The safety and efficacy of insulin
 regimens in non-ICU setting in Latin countries have not been determined. Objective: to
 compare the efficacy and safety of a basal-bolus regimen using insulin analogs with glargine
 once daily plus glulisine before meals to human insulin with NPH twice daily and regular
 insulin before meals in medicine patients with type 2 diabetes Outcome measures. To determine
 differences in glycemic control between groups as measured by mean daily BG concentration
 during the hospital stay. Secondary outcomes included differences between treatment groups in
 any of the following measures: number of hypoglycemic events (BG <70 mg/dL and <40 mg/dL),
 total daily dose of insulin, length of hospital stay, hospital complications and mortality.
Inclusion Criteria:

 -  Age >18 years

 -  History of type 2 diabetes > 1 month

 -  Treatment with diet alone, any combination of oral antidiabetic agents, and/or insulin
 prior to admission

 -  Absence of diabetic ketoacidosis

 Exclusion Criteria:

 -  No history of diabetes

 -  Subjects expected to undergo surgery during the hospitalization course

 -  Clinically relevant hepatic disease

 -  Impaired renal function (serum creatinine ≥ 3.0 mg/dL)

 -  Pregnancy

 -  Any mental condition rendering the subject unable to give informed consent