Trial to Investigate the in Silico Optimization of Insulin Treatments

NCT03895138 | Unknown

• 2 other identifiers: 201645R21EB018052
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exposure to risk of hypoglycemia

  48 hours of post-operative hospital stay

Study Arms (2)

Standard Glucommander Protocol (SGP)

ACTIVE COMPARATOR

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)

Optimized Glucommander (OGM)

EXPERIMENTAL

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

Other: Optimized Glucommander (OGM)

Interventions

Standard Glucommander Protocol (SGP) OTHER

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.

Standard Glucommander Protocol (SGP)

Optimized Glucommander (OGM) OTHER

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.

Optimized Glucommander (OGM)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Vrginia

Charlottesville, Virginia, 22901, United States

RECRUITING

Central Study Contacts

Anna Buhle

CONTACT

4349898257; ab7ga@virginia.edu

leon farhi, PhD

CONTACT

4342966583; leon@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects with CABG or open heart valve surgery will be enrolled in the study. They will be randomized to receive one of the following treatments: 1. Standard Glucommander Protocol (SGP) 2. Optimized Glucommander (OGM)

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 29, 2019
• Study Start: March 19, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-02

Locations

US (1)