Clinical Trial: Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Basal Insulin in the Management of Patients With Diabetic Ketoacidosis

Brief Summary:

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.

Detailed Summary:
Sponsor: Emory University

Current Primary Outcome: Mean Daily Blood Glucose Concentration After the Resolution of DKA [ Time Frame: 1 year ]

Original Primary Outcome: The primary outcome of the study is to determine differences in glycemic control as measured by mean daily blood glucose concentration between treatment groups once DKA has resolved and the insulin drip is discontinued. [ Time Frame: BG acqhs ]

Current Secondary Outcome:

• Mean Daily Blood Glucose Concentration While on the Insulin Drip [ Time Frame: blood glucose (BG) before meals and at bedtime ]
  determine differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA)
• Frequency of Hypoglycemia [ Time Frame: blood glucose (BG) before meals, at bedtime and as needed ]
  differences between treatment groups in the number of hypoglycemic events (blood glucose < 60 mg/dl) between hours 12 to 36 (second day)
• Frequency of Hyperglycemia [ Time Frame: blood glucose (BG) before meals, at bedtime and as needed ]
  differences between treatment groups in the number of hyperglycemic episodes (blood glucose > 200 mg/dl).

Original Secondary Outcome: differences between treatment groups in any of the following measures: number of hypoglycemic events (blood glucose < 60 mg/dl) between hours 12 to 36 (second day), number of hyperglycemic episodes (blood glucose > 200 mg/dl). [ Time Frame: BG acqhs and prn ]

Information By: Emory University

Dates:
Date Received: December 28, 2007
Date Started: December 2007
Date Completion:
Last Updated: November 12, 2013
Last Verified: November 2013