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Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Primary Purpose

Diabetic Ketoacidosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
glargine
saline
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Ketoacidosis focused on measuring Pediatrics, Diabetes, Emergency Care, Endocrinology, Critical Care

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Monroe Carell Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glargine

Placebo

Arm Description

0.3u/kg of glargine, subcutaneously, once

0.3u/kg of saline, subcutaneously, once

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
June 12, 2018
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00179127
Brief Title
Use of Insulin Glargine to Treat Diabetic Ketoacidosis
Official Title
Early Use of Insulin Glargine in Diabetic Ketoacidosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis
Keywords
Pediatrics, Diabetes, Emergency Care, Endocrinology, Critical Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glargine
Arm Type
Experimental
Arm Description
0.3u/kg of glargine, subcutaneously, once
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.3u/kg of saline, subcutaneously, once
Intervention Type
Drug
Intervention Name(s)
glargine
Intervention Description
0.3u/kg of glargine, subcutaneously, once
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
0.3u/kg of saline, subcutaneously, once
Primary Outcome Measure Information:
Title
Time of Acidosis Correction
Description
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Time Frame
Minutes
Secondary Outcome Measure Information:
Title
Time on Insulin Drip
Description
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Time Frame
Minutes
Title
Total Hospital Stay
Description
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Time Frame
Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila McMorrow, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Monroe Carell Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Use of Insulin Glargine to Treat Diabetic Ketoacidosis

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