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

August 14, 2012 updated by: David Baldwin, Rush University Medical Center

Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subcutaneous Insulin
Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours
Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous
Active Comparator: IV Regular Insulin
Intravenous Regular Insulin 0.1 units/kg/hour
Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous
Active Comparator: Intravenous Novolog Insulin
Intravenous Novolog Insulin 0.1 units/kg/hour
Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)

Aspart Insulin 0.2units/sq q 2 hours

Regular Insulin 0.1units/kg/hr intravenous

Aspart Insulin 0.1 units/kg/hr intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6
Time Frame: q 2 hours
q 2 hours
Hours to achieve blood glucose less than 200mg/dl
Time Frame: q 1 hour
q 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: David Baldwin, MD, Rush University Medical Center
  • Principal Investigator: Rema A Gupta, MD, Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Estimate)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05012103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe