Use of Insulin Glargine to Treat Diabetic Ketoacidosis

June 12, 2018 updated by: Vanderbilt University Medical Center

Early Use of Insulin Glargine in Diabetic Ketoacidosis

The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.

The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

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
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Monroe Carell Children's Hospital

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

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with:
  • Established history of insulin dependent diabetes

AND:

  • Chief c/o hyperglycemia or vomiting
  • Venous pH < 7.24
  • Serum Bicarbonate < 18
  • Blood glucose > 150
  • Urinary Ketones

Exclusion Criteria:

  • Age < 6y.o.
  • New onset diabetes
  • Received IV insulin bolus prior to arrival to VCH Emergency Room (ER)
  • Venous pH > 7.24
  • Serum Bicarbonate > 18
  • Pregnancy
  • Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glargine
0.3u/kg of glargine, subcutaneously, once
Drug: glargine
0.3u/kg of glargine, subcutaneously, once
Placebo Comparator: Placebo
0.3u/kg of saline, subcutaneously, once
Drug: saline
0.3u/kg of saline, subcutaneously, once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Acidosis Correction
Time Frame: Minutes
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time on Insulin Drip
Time Frame: Minutes
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Minutes
Total Hospital Stay
Time Frame: Days
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Days

Collaborators and Investigators

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

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Sheila McMorrow, MD, Vanderbilt University

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

August 1, 2004

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040643

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.

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