Trial to Investigate the in Silico Optimization of Insulin Treatments

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Bypass
• Intervention / Treatment: Other: Standard Glucommander Protocol (SGP); Other: Optimized Glucommander (OGM)

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Recruiting
      • University of Vrginia
      • Contact: Anna Buhle; Phone Number: 434-989-8257; Email: ab7ga@virginia.edu
      • Sub-Investigator: Leon S Farhi, PhD
      • Principal Investigator: Anthony L McCall, MD, PhD
      • Sub-Investigator: Jennifer Kirby, MD
      • Sub-Investigator: Anna Buhle
      • Sub-Investigator: Gorav Ailawadi
      • Sub-Investigator: J. Michael Cosner
      • Sub-Investigator: John Kern
      • Sub-Investigator: Irving Kron
      • Sub-Investigator: Stephen Patek, PhD
      • Sub-Investigator: Rachel Simon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Glucommander Protocol (SGP); 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); 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.
EXPERIMENTAL: Optimized Glucommander (OGM); CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2018
• Primary Completion (ANTICIPATED): April 30, 2019
• Study Completion (ANTICIPATED): April 30, 2019

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (ACTUAL): March 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 20164; 5R21EB018052 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No