Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA

Rush

Status: Completed

Conditions: Diabetic Ketoacidosis

Treatments: Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00920725

05012103

Details and patient eligibility

About

The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: age 18 or older

• venous pH < 7.3 or arterial < 7.35

• at least 2 of the following 3:

  1. serum HCO3 < 18/anion gap > 16
  2. serum glucose > 300 mg/dl
  3. serum acetone positive

Exclusion Criteria:

• pregnant
• less than age 18

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Subcutaneous Insulin

Active Comparator group

Description:

Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours

Treatment:

Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

IV Regular Insulin

Active Comparator group

Description:

Intravenous Regular Insulin 0.1 units/kg/hour

Treatment:

Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Intravenous Novolog Insulin

Active Comparator group

Description:

Intravenous Novolog Insulin 0.1 units/kg/hour

Treatment:

Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)