Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Vanderbilt University Medical Center75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Ketoacidosis

Interventions

glargineDRUG

0.3u/kg of glargine, subcutaneously, once

salineDRUG

0.3u/kg of saline, subcutaneously, once

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University Monroe Carell Children's Hospital

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Time of Acidosis Correction

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

Time frame: Minutes

Secondary Outcomes

Time on Insulin Drip

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

Time frame: Minutes

Total Hospital Stay

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

Time frame: Days

Data from ClinicalTrials.gov

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