An interventional study of Standard Glucommander Protocol (SGP) and Optimized Glucommander (OGM) in Coronary Artery Bypass, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by University of Virginia · Not applicable, Interventional, and Other
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.
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.
University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol
Other: Optimized Glucommander (OGM)
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.
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.
Exposure to risk of hypoglycemia
Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).
Time frame: 24 hours of post-operative hospital stay
Exposure to risk of hypoglycemia
Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).
Time frame: 48 hours of post-operative hospital stay
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University of Virginia