Trial to Investigate the in Silico Optimization of Insulin Treatments

University of Virginia

Status: Unknown

Conditions: Coronary Artery Bypass

Treatments: Other: Standard Glucommander Protocol (SGP); Other: Optimized Glucommander (OGM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03895138

5R21EB018052 (U.S. NIH Grant/Contract)

20164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Standard Glucommander Protocol (SGP)

Active Comparator group

Description:

CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations

Treatment:

Other: Standard Glucommander Protocol (SGP)

Optimized Glucommander (OGM)

Experimental group

Description:

CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol

Treatment:

Other: Optimized Glucommander (OGM)