Trial to Investigate the in Silico Optimization of Insulin Treatments

Coronary Artery Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03895138
• Other study ID #: 20164
• Secondary ID: 5R21EB018052
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2019
• Source: University of Virginia
• Contact: Anna Buhle
• Phone: 4349898257
• Email: ab7ga[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

Other:
• Standard Glucommander Protocol (SGP)
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.
• Optimized Glucommander (OGM)
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.

Locations

Country	Name	City	State
United States	University of Vrginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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