Use of Insulin Glargine to Treat Diabetic Ketoacidosis
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|ClinicalTrials.gov Identifier: NCT00179127|
Recruitment Status : Unknown
Verified June 2012 by Sheila McMorrow, Vanderbilt University.
Recruitment status was: Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : June 21, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Ketoacidosis||Drug: glargine Drug: saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Early Use of Insulin Glargine in Diabetic Ketoacidosis|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||September 2012|
|Active Comparator: A||
0.3u/kg of glargine, subq, once
|Placebo Comparator: B||
0.3cc/kg of saline, subq, once
- Time of acidosis correction [ Time Frame: Minutes ]
- Time on insulin drip [ Time Frame: Minutes ]
- Total hospital stay [ Time Frame: Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179127
|United States, Tennessee|
|Vanderbilt University Monroe Carell Children's Hospital|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Sheila McMorrow, MD||Vanderbilt University|