Computer Decision Support to Achieve Glycemic Control in the ICU

Burns Clinical Trial

— EndoTool  

Official title:

Computer Decision Support to Achieve Glycemic Control in the ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589589
• Other study ID #: H-07-040
• Status: Completed
• Phase: Phase 1
• First received: December 24, 2007
• Last updated: September 1, 2015
• Start date: January 2008
• Est. completion date: January 2011

Study information

• Verified date: September 2015
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Burns
• Hypoglycemia

Intervention

Device:
• Endo Tool
Computer tool to help achieve glucose control

Locations

Country	Name	City	State
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

Van den Berghe G, Wouters PJ, Bouillon R, Weekers F, Verwaest C, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P. Outcome benefit of intensive insulin therapy in the critically ill: Insulin dose versus glycemic control. Crit Care Med. 2003 Feb;31(2):359-66. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent in target glucose range of 80-110 mg/dL.		48 hours	No
Secondary	Time to achieve target glucose of 80-110 mg/dL and number of hypoglycemic events less than 80 and 50 mg/dL.		7 days	No