Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Not Applicable

Completed

• Conditions: Diabetic Ketoacidosis
• Interventions: Drug: glargine; Drug: saline

• Registration Number: NCT00179127
• Lead Sponsor: Vanderbilt University Medical Center

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

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2009-07
• Study Completion: 2012-09
• Results First Submitted: 2018-04-02
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-12
• Last Update Submitted: 2018-06-12
• Results First Posted: 2018-07-16
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glargine	glargine	0.3u/kg of glargine, subcutaneously, once
Placebo	saline	0.3u/kg of saline, subcutaneously, once

Primary Outcome Measures

Name	Time	Method
Time of Acidosis Correction	Minutes	Unable to find any data on this study. PI left Vanderbilt and there was not a publication.

Secondary Outcome Measures

Name	Time	Method
Time on Insulin Drip	Minutes	Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Total Hospital Stay	Days	Unable to find any data on this study. PI left Vanderbilt and there was not a publication.

Trial Locations

Locations (1)

Vanderbilt University Monroe Carell Children's Hospital; 🇺🇸 Nashville, Tennessee, United States