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Best Practice Advisory Reminders for Diabetes
N/A
Waitlist Available
Led By Matthew Zapf, M.D.
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights
Study Summary
This trialwill test if a tool can help improve diabetes control by giving healthcare providers reminders and calculators. #diabetes
Who is the study for?
This trial is for patients with diabetes or high blood sugar who are undergoing surgery at specific Vanderbilt University Medical Center locations. They must have had insulin within the last 12 hours without a recent glucose check, or no glucose measurement in the past 2 hours.Check my eligibility
What is being tested?
The study tests if adding a best practice advisory (BPA), which includes an insulin dosing calculator, to existing reminders helps healthcare providers better manage hyperglycemia during surgery compared to standard care.See study design
What are the potential side effects?
Since this trial involves implementing a decision support tool rather than a drug, traditional side effects aren't expected. However, there may be risks related to potential inaccuracies in insulin dosing leading to hypo- or hyperglycemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pacu admission to discharge (1-3 hours post operatively)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pacu admission to discharge (1-3 hours post operatively)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hyperglycemia (glucose >180 mmol/dL)
Secondary outcome measures
Adherence to MPOG GLU-05
Adherence to Multicenter Perioperative Outcomes Group (MPOG) GLU-01
Glucose at first PACU measurement
+4 moreOther outcome measures
Incidence of first postoperative hypokalemia
Incidence of intraoperative hypokalemia
Incidence of surgical site infection
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BPA InterventionExperimental Treatment1 Intervention
The BPA intervention will test the delivery of the insulin calculator (BPA) which automates the standard insulin dosing protocol guidelines. When a patient meets the study criteria, the BPA will provide an automated notification through the electronic health record system. These automated notifications will pop up intraoperatively after the glucose check reminder in cases where the patient meets the study criteria. The provider is not forced to follow the recommendations of the insulin dosing calculator, rather it just serves as a reminder of best practices as defined by our department.
The intervention will be assessed using a sequential and repeated cross-over design at the institutional level with periods of time for wash in, wash out, control and study intervention.
Group II: ControlActive Control1 Intervention
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
663,957 Total Patients Enrolled
6 Trials studying Diabetes
27,591 Patients Enrolled for Diabetes
Matthew Zapf, M.D.Principal InvestigatorVanderbilt University Medical Center
Miklos Kertai, M.D., Ph.D.Principal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery at Vanderbilt and qualify for a glucose check.I have diabetes and haven't checked my blood sugar in the last 2 hours, or I took insulin in the last 12 hours without checking my blood sugar in the last hour.I am having surgery at a location other than the study site.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: BPA Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor actively looking for participants?
"According to clinicaltrials.gov, this particular medical trial has stopped recruiting patients for the time being; it was first posted on October 5th 2022 and last updated on October 26th 2022. Nevertheless, 241 other studies are presently looking for participants."
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