Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Vanderbilt University Medical Center

Status: Completed

Conditions: Diabetic Ketoacidosis

Treatments: Drug: saline; Drug: glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT00179127

040643

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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75 participants in 2 patient groups, including a placebo group

Glargine

Experimental group

Description:

0.3u/kg of glargine, subcutaneously, once

Treatment:

Drug: glargine

Placebo

Placebo Comparator group

Description:

0.3u/kg of saline, subcutaneously, once

Treatment:

Drug: saline