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Computer Decision Support to Achieve Glycemic Control in the ICU

Computer Decision Support to Achieve Glycemic Control in the ICU

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00589589
Acronym
EndoTool
Enrollment
24
Registered
2008-01-09
Start date
2008-01-31
Completion date
2011-01-31
Last updated
2015-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Hypoglycemia

Keywords

burns, hypoglycemia, hyperglycemia, glucose monitoring

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due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).

Interventions

DEVICEEndo Tool

Computer tool to help achieve glucose control

Sponsors

United States Army Institute of Surgical Research
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026