Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Computer Decision Support to Achieve Glycemic Control in the ICU (EndoTool)

This study has been completed.
Information provided by (Responsible Party):
Elizabeth Mann, United States Army Institute of Surgical Research Identifier:
First received: December 24, 2007
Last updated: September 1, 2015
Last verified: September 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 Intervention Phase
Device: Endo Tool
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Computer Decision Support to Achieve Glycemic Control in the ICU

Resource links provided by NLM:

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Time spent in target glucose range of 80-110 mg/dL. [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Device: Endo Tool
Computer tool to help achieve glucose control
Other Name: Computer Software for glucose control

Detailed Description:

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).


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years or older
  • military or civilian burns on continuous insulin infusion for 7 days

Exclusion Criteria:

  • not expected to receive insulin for 7 days
  • less than 18 years old
  • enrolled in the Continuous Glucose monitoring Study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00589589

United States, Texas
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Principal Investigator: Elizabeth A Mann, RN, MSN United States Army Institute of Surgical Research
  More Information

Responsible Party: Elizabeth Mann, Administrator, United States Army Institute of Surgical Research Identifier: NCT00589589     History of Changes
Other Study ID Numbers: H-07-040
Study First Received: December 24, 2007
Last Updated: September 1, 2015

Keywords provided by United States Army Institute of Surgical Research:
glucose monitoring

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 25, 2017