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Trial to Investigate the in Silico Optimization of Insulin Treatments

NCT03895138 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-03-29

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • University of Virginia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895138 on ClinicalTrials.gov