Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
The study is a multicenter, randomized controlled trial to compare the safety and efficacy of
 insulin analogs and human insulins both during acute intravenous treatment and during the
 transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).
Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an
 estimated 100,000 admissions per year in the United States, DKA is also the leading cause of
 death in children with type 1 diabetes, and accounts for a significant proportion of
 admissions in adult patients with type 1 and type 2 diabetes. The mainstay in the treatment
 of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent
 subcutaneous (SC) injections of regular or rapid-acting insulin analogs. Multiple studies
 have reported successful protocols for insulin administration during the acute management of
 DKA, but they have failed to address the transition phase from IV to SC maintenance insulin
 regimen. The American Diabetes Association (ADA) position statement recommends the use of
 split-mixed insulin combination of regular and intermediate-acting insulin (NPH). This
 regimen, however, are associated with a high rate of hyperglycemia shortly after
 discontinuation of IV insulin and a risk of hypoglycemia during the hospital stay. Recently,
 the long-acting "basal" insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been
 shown to facilitate glycemic control with lower rate of hypoglycemic events than
 intermediate-acting insulin in subjects with type 1 and type 2 diabetes. This study aims i)
 to determine the effects of giving a dose of glargine insulin shortly after starting an
 intravenous insulin infusion on glycemic control, time to resolve DKA, and rate of
 hypoglycemia in patients with DKA, and ii) to compare the safety and efficacy of basal/bolus
 (glargine/glulisine) insulin versus the standard split-mixed insulin regimen of NPH and
 regular insulin after the resolution of DKA. The hypothesis is that basal (lantus®) insulin
 as compared to NPH insulin shortly after the start of insulin infusion will improve inpatient
 glycemic control in patients with DKA.
Inclusion Criteria:

 -  All patients admitted to Grady Memorial Hospital who meet diagnosis criteria of DKA
 and who are willing to participate in the study protocol will be considered candidates
 for inclusion into the study.

 -  Diagnostic Criteria for DKA: Blood glucose > 250 mg/dL, arterial or venous phenol
 hydroxylase (pH) < 7.3, serum bicarbonate < 18 milliequivalent/L, and moderate to
 severe ketonemia (acetoacetate ≥ 1:4 or βeta-hydroxybutyrate > 3 mmol).

 Exclusion Criteria:

 -  Hemodynamic instability (MAP < 50 or patients requiring pressor)

 -  Significant identifiable medical or surgical illness, including but not limited to:
 acute myocardial infarction, congestive heart failure; respiratory failure requiring
 mechanical ventilation; acute or chronic renal insufficiency (serum creatinine > 3.0
 mg/dl); end stage liver failure, and cirrhosis.

 -  Patients with dementia or persistent altered mental status that would prevent
 collection of consent form and reliable information.

 -  Pregnancy