Trial to Investigate the in Silico Optimization of Insulin Treatments

Not Applicable

• Conditions: Coronary Artery Bypass
• Interventions: Other: Optimized Glucommander (OGM); Other: Standard Glucommander Protocol (SGP)

• Registration Number: NCT03895138
• Lead Sponsor: University of Virginia

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-03-19
• Status Verified: 2019-02
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Study First Posted: 2019-03-29
• Last Update Posted: 2019-03-29
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Patients admitted for CABG and/or open heart valve surgery
2. Must have a 0.05 initial multiplier setting for the Glucommander based on the manufacturers recommendations
3. Age of 40-75, inclusive

Exclusion Criteria

1. History of severe hypoglycemia within six months of hospital admission
2. Currently undergoing dialysis or renal replacement therapy
3. Women of childbearing potential
4. Patients with endocarditis needing valve replacement
5. Participation in another clinical trial at the time of screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimized Glucommander (OGM)	Optimized Glucommander (OGM)	CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol
Standard Glucommander Protocol (SGP)	Standard Glucommander Protocol (SGP)	CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations

Primary Outcome Measures

Name	Time	Method
Exposure to risk of hypoglycemia	24 hours of post-operative hospital stay	Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).

Secondary Outcome Measures

Name	Time	Method
Exposure to risk of hypoglycemia	48 hours of post-operative hospital stay	Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).

Trial Locations

Locations (1)

University of Vrginia; 🇺🇸 Charlottesville, Virginia, United States