Use of Insulin Glargine to Treat Diabetic Ketoacidosis

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Sheila McMorrow, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00179127

First received: September 13, 2005

Last updated: June 20, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 20, 2012

Start Date ^ICMJE

August 2004

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time of acidosis correction [ Time Frame: Minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00179127 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time on insulin drip [ Time Frame: Minutes ] [ Designated as safety issue: No ]
Total hospital stay [ Time Frame: Days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Official Title ^ICMJE

Early Use of Insulin Glargine in Diabetic Ketoacidosis

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Ketoacidosis

Intervention ^ICMJE

Drug: glargine
0.3u/kg of glargine, subq, once
Drug: saline
0.3cc/kg of saline, subq, once

Study Arm (s)

Active Comparator: A
Intervention: Drug: glargine
Placebo Comparator: B
Intervention: Drug: saline

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2012

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ages 6-18 y.o. presenting to VCH E.R. 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 E.R.
Venous pH > 7.24
Serum Bicarbonate > 18
Pregnancy
Received glargine within 12 hours prior to arrival to VCH E.R./PCCU

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00179127

Other Study ID Numbers ^ICMJE

040643

Has Data Monitoring Committee

Responsible Party

Sheila McMorrow, Vanderbilt University

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Sheila McMorrow, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top