Trial to Investigate the in Silico Optimization of Insulin Treatments
NCT ID: NCT03895138
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2018-03-19
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Standard Glucommander Protocol (SGP)
2. Optimized Glucommander (OGM)
OTHER
NONE
Study Groups
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Standard Glucommander Protocol (SGP)
CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations
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.
Optimized Glucommander (OGM)
CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
75 Years
ALL
No
Sponsors
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National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
University of Virginia
OTHER
Responsible Party
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Anthony McCall
Principal Investigator
Locations
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University of Vrginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Anna Buhle
Role: primary
Other Identifiers
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20164
Identifier Type: -
Identifier Source: org_study_id