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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Annette R. McClinton, United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00589589
First received: December 24, 2007
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  Purpose

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
Burns
Hypoglycemia
 Device: Endo Tool
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

Drug Information available for: Dextrose
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589589

Locations
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
Investigators
Principal Investigator: Elizabeth A Mann, RN, MSN United States Army Institute of Surgical Research
  More Information

Publications:

Responsible Party: Annette R. McClinton, Administrator, United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00589589     History of Changes
Other Study ID Numbers: H-07-040
Study First Received: December 24, 2007
Last Updated: September 12, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013