Computer Decision Support to Achieve Glycemic Control in the ICU
EndoTool
1 other identifier
interventional
24
1 country
1
Brief Summary
This study is intended to fill the knowledge gap regarding the burn population with research that achieves scientific merit. we will determine the effectiveness of the computer decision support system (CDSS) to facilitate glucose management in the critically ill burn patient. The EndoTool™ computer decision support system will achieve glycemic control (defined as 80-110 mg/dL) in a shorter time, reduce glycemic excursion outside of target range, and reduce incidence of hypoglycemia (blood glucose less than 50 mg/dL) in the critically ill burn patient compared to the standard of care USAISR insulin titration protocol (Appendix A).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2008
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedFirst Posted
Study publicly available on registry
January 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedSeptember 3, 2015
September 1, 2015
2.7 years
December 24, 2007
September 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time spent in target glucose range of 80-110 mg/dL.
48 hours
Secondary Outcomes (1)
Time to achieve target glucose of 80-110 mg/dL and number of hypoglycemic events less than 80 and 50 mg/dL.
7 days
Study Arms (1)
A
ACTIVE COMPARATORInterventions
Computer tool to help achieve glucose control
Eligibility Criteria
You may qualify if:
- years or older
- military or civilian burns on continuous insulin infusion for 7 days
You may not qualify if:
- not expected to receive insulin for 7 days
- less than 18 years old
- enrolled in the Continuous Glucose monitoring Study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234, United States
Related Publications (1)
Van den Berghe G, Wouters PJ, Bouillon R, Weekers F, Verwaest C, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P. Outcome benefit of intensive insulin therapy in the critically ill: Insulin dose versus glycemic control. Crit Care Med. 2003 Feb;31(2):359-66. doi: 10.1097/01.CCM.0000045568.12881.10.
PMID: 12576937BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth A Mann, RN, MSN
United States Army Institute of Surgical Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Administrator
Study Record Dates
First Submitted
December 24, 2007
First Posted
January 9, 2008
Study Start
January 1, 2008
Primary Completion
September 1, 2010
Study Completion
January 1, 2011
Last Updated
September 3, 2015
Record last verified: 2015-09