Computer Decision Support to Achieve Glycemic Control in the ICU

Phase 1

Completed

• Conditions: Hypoglycemia; Burns
• Interventions: Device: Endo Tool

• Registration Number: NCT00589589
• Lead Sponsor: United States Army Institute of Surgical Research

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).

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due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).

Study Timeline

• Study First Submitted: 2007-12-24
• Study Start: 2008-01
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-09
• Primary Completion: 2010-09
• Study Completion: 2011-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Endo Tool	-

Primary Outcome Measures

Name	Time	Method
Time spent in target glucose range of 80-110 mg/dL.	48 hours

Secondary Outcome Measures

Name	Time	Method
Time to achieve target glucose of 80-110 mg/dL and number of hypoglycemic events less than 80 and 50 mg/dL.	7 days

Trial Locations

Locations (1)

US Army Institute of Surgical Research; 🇺🇸 Fort Sam Houston, Texas, United States