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Completed

NCT Number: NCT00179127

Use of Insulin Glargine to Treat Diabetic Ketoacidosis

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.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Monroe Carell Children's Hospital

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glargine

Drug

0.3u/kg of glargine, subcutaneously, once

Saline

Drug

0.3u/kg of saline, subcutaneously, once

Primary outcomes

  1. Time of Acidosis Correction

    Time frame: Minutes

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

Secondary outcomes

  1. Time on Insulin Drip

    Time frame: Minutes

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

  2. Total Hospital Stay

    Time frame: Days

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Early Use of Insulin Glargine in Diabetic Ketoacidosis

Important dates

Study start
2004
Primary completion
2009
Study completion
2012
First posted
Sep 15, 2005
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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