Trial to Investigate the in Silico Optimization of Insulin Treatments

Study Overview
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Brief Summary
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The primary objective of this study is to assess the performance of an in silico designed alternative protocol for control of stress hyperglycemia of inpatients treated for Coronary Artery Bypass Graft (CABG) or valve replacement surgery in the University of Virginia cardiothoracic ICU.

Detailed Description
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The hypothesis of the study is that settings for the Glucommander protocol can be optimized in silico to achieve statistically improved low blood glucose index (LBGI) within the subpopulation of CABG and valve replacement patients who both receive Glucommander-based insulin therapy and meet Manufacturer's guidelines for starting with an initial multiplier value of .052, without risking clinically significant increase in exposure to hyperglycemia.

Official Title
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A Feasibility Randomized Control Trial to Investigate the in Silico Optimization of Insulin Treatments

Conditions
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Coronary Artery Bypass

Intervention / Treatment
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* Other: Standard Glucommander Protocol (SGP)
* Other: Optimized Glucommander (OGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted for CABG and/or open heart valve surgery Must have a 0.05 initial multiplier setting for the Glucommander based on the manufacturers recommendations Age of 40-75, inclusive Exclusion Criteria: History of severe hypoglycemia within six months of hospital admission Currently undergoing dialysis or renal replacement therapy Women of childbearing potential Patients with endocarditis needing valve replacement Participation in another clinical trial at the time of screening.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects with CABG or open heart valve surgery will be enrolled in the study. They will be randomized to receive one of the following treatments: Standard Glucommander Protocol (SGP) Optimized Glucommander (OGM)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Glucommander Protocol (SGP)<br>CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations | Other: Standard Glucommander Protocol (SGP)<br>* Subjects receive standard Glucommander-based insulin therapy from the clinical staff of U.Va.'s cardiothoracic ICU and follow manufacturer's guidelines for starting with an initial multiplier value of .05.<br>|
| Experimental: Optimized Glucommander (OGM)<br>CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol | Other: Optimized Glucommander (OGM)<br>* The experimental arm of the study involves treating subjects with a lower initial multiplier (.02 versus .05), a higher set of BG thresholds (140-180 mg/dl vs 120-160) in the first eight (8) hours of care for avoidance of hypoglycemia in that time period, and a requirement for consistent hourly-or-faster sampling of BG (as opposed to the Glucommander recommendation which is dependent on the trajectory of BG and can sometimes allow intervals of two hours between samples). After the eight (8) hours, the Glucommander is set back to the standard protocol for the entire duration of the subject's post-operative hospital stay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to risk of hypoglycemia | Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI). | 24 hours of post-operative hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to risk of hypoglycemia | Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI). | 48 hours of post-operative hospital stay |