N/A
N=75
Use of Insulin Glargine to Treat Diabetic Ketoacidosis
Diabetic Ketoacidosis
Bottom Line
View on ClinicalTrials.gov: NCT00179127 ↗Enrolled (actual)
75
Serious AEs
—
Results posted
Jul 2018
Primary outcome: Primary: Time of Acidosis Correction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- glargine (Drug); saline (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time of Acidosis Correction |
— | — |
| SECONDARY Time on Insulin Drip |
— | — |
| SECONDARY Total Hospital Stay |
— | — |
Summary
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.
Eligibility Criteria
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 150
- Urinary Ketones
Exclusion Criteria
- Age 7.24
- Serum Bicarbonate > 18
- Pregnancy
- Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit
Data sourced from ClinicalTrials.gov (NCT00179127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.