Coronary Artery BypassNCT03895138
Trial to Investigate the in Silico Optimization of Insulin Treatments
A study testing Standard Glucommander Protocol (SGP) and Optimized Glucommander (OGM) in people with Coronary Artery Bypass, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Standard Glucommander Protocol (SGP) and Optimized Glucommander (OGM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Vrginia
Charlottesville, Virginia, 22901
Anna Buhle, 434-989-8257, ab7ga@virginia.edu
Leon S Farhi, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Bypass
- Being tested
- Standard Glucommander Protocol (SGP), Optimized Glucommander (OGM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Optimized Glucommander (OGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to risk of hypoglycemia
Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).
Measured: 24 hours of post-operative hospital stay
Secondary outcomes (1)
Exposure to risk of hypoglycemia
Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).
Measured: 48 hours of post-operative hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start19 Mar 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Anthony McCall, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895138
- Sponsor's protocol ID
- 20164
- Other IDs
- 5R21EB018052
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomized Control Trial to Investigate the in Silico Optimization of Insulin Treatments
- ClinicalTrials.gov ID
- NCT03895138
- Acronym / sponsor ID
- 20164
- Conditions
- Coronary Artery Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Standard Glucommander Protocol (SGP) | Active comparator | Other: Standard Glucommander Protocol (SGP)CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations |
| Optimized Glucommander (OGM) | Experimental | Other: Optimized Glucommander (OGM)CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Standard Glucommander Protocol (SGP) |
| 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 | Optimized Glucommander (OGM) |
Primary outcome
Exposure to risk of hypoglycemia
Time frame: 24 hours of post-operative hospital stay
Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).
1 secondary outcome
Exposure to risk of hypoglycemia
Time frame: 48 hours of post-operative hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Glucommander Protocol (SGP) and Optimized Glucommander (OGM) in people with Coronary Artery Bypass, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Buhle (4349898257, ab7ga@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure to risk of hypoglycemia (time frame: 24 hours of post-operative hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.