This trial is active, not recruiting.

Condition diabetic ketoacidosis
Treatments glargine, saline
Sponsor Vanderbilt University
Start date August 2004
End date July 2009
Trial size 75 participants
Trial identifier NCT00179127, 040643


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
0.3u/kg of glargine, subq, once
(Placebo Comparator)
0.3cc/kg of saline, subq, once

Primary Outcomes

Time of acidosis correction
time frame: Minutes

Secondary Outcomes

Time on insulin drip
time frame: Minutes
Total hospital stay
time frame: Days

Eligibility Criteria

Male or female participants from 6 years up to 18 years old.

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

Additional Information

Official title Early Use of Insulin Glargine in Diabetic Ketoacidosis
Principal investigator Sheila McMorrow, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Vanderbilt University.