Computer Decision Support to Achieve Glycemic Control in the ICU

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due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).

Official Title
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Computer Decision Support to Achieve Glycemic Control in the ICU

Conditions
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Burns, Hypoglycemia

Intervention / Treatment
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* Device: Endo Tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Device: Endo Tool<br>* Computer tool to help achieve glucose control<br>* Other names: Computer Software for glucose control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in target glucose range of 80-110 mg/dL. |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burns, hypoglycemia, hyperglycemia, glucose monitoring