Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Diabetic Ketoacidosis Clinical Trial

Official title:

Early Use of Insulin Glargine in Diabetic Ketoacidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179127
• Other study ID #: 040643
• Status: Completed
• Phase: N/A
• Start date: August 2004
• Est. completion date: September 2012

Study information

• Verified date: June 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2012
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Diabetic Ketoacidosis
• Ketosis

Intervention

Drug:
• glargine
0.3u/kg of glargine, subcutaneously, once
• saline
0.3u/kg of saline, subcutaneously, once

Locations

Country	Name	City	State
United States	Vanderbilt University Monroe Carell Children's Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of Acidosis Correction	Unable to find any data on this study. PI left Vanderbilt and there was not a publication.	Minutes
Secondary	Time on Insulin Drip	Unable to find any data on this study. PI left Vanderbilt and there was not a publication.	Minutes
Secondary	Total Hospital Stay	Unable to find any data on this study. PI left Vanderbilt and there was not a publication.	Days