Computer Decision Support to Achieve Glycemic Control in the ICU (EndoTool)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00589589|
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : September 3, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Burns Hypoglycemia||Device: Endo Tool||Phase 1|
This is a prospective, paired, randomized, cross-over design, with two groups: current standard of care using the USAISR Burn Center insulin titration nomogram (Appendix A) and insulin management using EndoTool™ (MD Scientific, LLC) decision support software. Patients will thus serve as their own controls.
Upon admission to the burn ICU, patients expected to require continuous insulin infusion for a minimum of 7 days will be placed on EndoTool™ CDSS for the first 24 hours of glycemic management. At the 24 hour mark the patients will be randomly assigned to either the CDSS or standard of care group in pairs. Thus, the first subject will be randomized to a group and the second subject will be placed in the alternate group. This method will ensure equal numbers of patients are enrolled in each group to eliminate bias of timing of intervention due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Computer Decision Support to Achieve Glycemic Control in the ICU|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||January 2011|
|Active Comparator: A||
Device: Endo Tool
Computer tool to help achieve glucose control
Other Name: Computer Software for glucose control
- Time spent in target glucose range of 80-110 mg/dL. [ Time Frame: 48 hours ]
- Time to achieve target glucose of 80-110 mg/dL and number of hypoglycemic events less than 80 and 50 mg/dL. [ Time Frame: 7 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): NCT00589589
|United States, Texas|
|US Army Institute of Surgical Research|
|Fort Sam Houston, Texas, United States, 78234|
|Principal Investigator:||Elizabeth A Mann, RN, MSN||United States Army Institute of Surgical Research|