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Use of Insulin Glargine to Treat Diabetic Ketoacidosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Sheila McMorrow, Vanderbilt University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179127
First Posted: September 15, 2005
Last Update Posted: June 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheila McMorrow, Vanderbilt University
  Purpose

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.


Condition Intervention
Diabetic Ketoacidosis Drug: glargine Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Early Use of Insulin Glargine in Diabetic Ketoacidosis

Resource links provided by NLM:


Further study details as provided by Sheila McMorrow, Vanderbilt University:

Primary Outcome Measures:
  • Time of acidosis correction [ Time Frame: Minutes ]

Secondary Outcome Measures:
  • Time on insulin drip [ Time Frame: Minutes ]
  • Total hospital stay [ Time Frame: Days ]

Enrollment: 75
Study Start Date: August 2004
Estimated Study Completion Date: September 2012
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: glargine
0.3u/kg of glargine, subq, once
Placebo Comparator: B Drug: saline
0.3cc/kg of saline, subq, once

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179127


Locations
United States, Tennessee
Vanderbilt University Monroe Carell Children's Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Sheila McMorrow, MD Vanderbilt University
  More Information

Responsible Party: Sheila McMorrow, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00179127     History of Changes
Other Study ID Numbers: 040643
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Sheila McMorrow, Vanderbilt University:
Pediatrics
Diabetes
Emergency Care
Endocrinology
Critical Care

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs