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Completed

NCT Number: NCT00589589

Computer Decision Support to Achieve Glycemic Control in the ICU

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).

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Key information

Conditions

Burns Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

About this study

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intervention due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endo Tool

Device

Computer tool to help achieve glucose control

Other names: Computer Software for glucose control

Primary outcomes

  1. Time spent in target glucose range of 80-110 mg/dL.

    Time frame: 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.

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

United States Army Institute of Surgical Research

Fed

Registry information

Acronym: EndoTool

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jan 9, 2008
Registry last updated
Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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