A Feasibility Randomized Control Trial to Investigate the in Silico Optimization of Insulin Treatments
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Virginia
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Exposure to risk of hypoglycemia
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Optimized Glucommander (OGM)
CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol
Intervention: Optimized Glucommander (OGM) (Other)
Standard Glucommander Protocol (SGP)
CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations
Intervention: Standard Glucommander Protocol (SGP) (Other)
Outcomes
Primary Outcomes
Exposure to risk of hypoglycemia
Time Frame: 24 hours of post-operative hospital stay
Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).
Secondary Outcomes
- Exposure to risk of hypoglycemia(48 hours of post-operative hospital stay)
Investigators
Anthony McCall
Principal Investigator
University of Virginia