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Continuous Glucose Monitoring for Diabetes Surgery Patients (CGM Trial)
N/A
Recruiting
Led By Susan Vishneski, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 24
Awards & highlights
CGM Trial Summary
This trial looks at if using a continuous glucose monitoring device can help with surgery. It tests if it can be placed before the surgery and used during the surgery.
Who is the study for?
This trial is for adults 18 or older with high blood sugar or diabetes who are scheduled for surgery at Atrium Health Wake Forest Baptist. It's not open to pregnant women or those whose surgery would interfere with placing a glucose monitor on the back of the upper arm.Check my eligibility
What is being tested?
The study is testing if using a Continuous Glucose Monitor (CGM) before, during, and after surgery can be done easily and helps manage blood sugar levels better than standard care without this technology.See study design
What are the potential side effects?
While specific side effects aren't listed, CGMs may cause skin irritation where they attach, possible allergic reactions to adhesive materials, and there might be inaccuracies in glucose readings that need attention.
CGM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hour 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disparities in Continuous Glucose Monitoring (CGM) accuracy - fingerstick values
Disparities in Continuous Glucose Monitoring (CGM) accuracy - serum and arterial glucose values
Secondary outcome measures
Disparities in Continuous Glucose Monitoring (CGM) accuracy - interference amount
Patient satisfaction Scores
Proportion of patients with functioning Continuous Glucose Monitoring (CGM)
CGM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose MonitorExperimental Treatment1 Intervention
CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management
Group II: Standard of CareActive Control1 Intervention
no study intervention-conventional glucose management per subjects medical providers as standard of care
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,510 Total Patients Enrolled
8 Trials studying Diabetes
6,888 Patients Enrolled for Diabetes
Susan Vishneski, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for or have had brain surgery.I am not having surgery that affects wearing a CGM on my upper arm.I am 18 or older with high blood sugar or diabetes and will have surgery at Atrium Health Wake Forest Baptist.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Continuous Glucose Monitor
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.
Are there any available vacancies in this clinical experiment?
"According to clinicaltrials.gov, this medical trial is no longer actively recruiting patients; the original post was published on July 1st 2023 and the most recent update occurred days later. However, 1176 alternative studies are still open for enrolment at this time."
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