Use of Insulin Glargine to Treat Diabetic Ketoacidosis

NCT00179127 | Completed Results

• 1 other identifier: 040643
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Ketoacidosis

Keywords

Pediatrics; Diabetes; Emergency Care; Endocrinology; Critical Care

Outcome Measures

Primary Outcomes (1)

• Time of Acidosis Correction

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

  Minutes

Secondary Outcomes (2)

• Time on Insulin Drip

  Minutes

• Total Hospital Stay

  Days

Study Arms (2)

Glargine

EXPERIMENTAL

0.3u/kg of glargine, subcutaneously, once

Drug: glargine

Placebo

PLACEBO COMPARATOR

0.3u/kg of saline, subcutaneously, once

Drug: saline

Interventions

glargine DRUG

0.3u/kg of glargine, subcutaneously, once

Glargine

saline DRUG

0.3u/kg of saline, subcutaneously, once

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Monroe Carell Children's Hospital

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis; Diabetes Mellitus

Interventions

Insulin Glargine; Sodium Chloride

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Sheila McMorrow
• Organization: Vanderbilt University Medical Center

615-343-8332

Study Officials

• Sheila McMorrow, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2012
• Last Updated: July 16, 2018
• Results First Posted: July 16, 2018

Record last verified: 2018-06

Locations

US (1)