Continuous Glucose Monitoring for Diabetes Surgery Patients

(CGM Trial)

Overseen By Lynnette Harris, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Neurosurgery, CGM placement limitation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how continuous glucose monitors (CGMs) can help manage blood sugar levels in people with diabetes undergoing surgery. Researchers aim to determine the practicality and effectiveness of placing a CGM before surgery and using it throughout the surgical period. Participants are divided into two groups: one will use the CGM, and the other will follow their usual diabetes care. Individuals with diabetes who plan to have surgery at Atrium Health Wake Forest Baptist and possess a compatible smartphone are well-suited for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes care during surgery.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that continuous glucose monitoring is safe for diabetes surgery patients?

Previous studies have shown that continuous glucose monitors (CGMs) are safe. They enable people with diabetes to track their blood sugar levels in real-time. Research indicates that these devices are generally well-tolerated by individuals with either Type 1 or Type 2 diabetes and have been used successfully to improve blood sugar control.

These devices are already widely used in managing diabetes, demonstrating a proven safety record. Studies have not reported any major safety concerns for people using CGMs. Occasionally, users may experience minor skin irritation where the device is attached, but this is usually not serious.

Overall, CGMs are considered a safe option for monitoring blood sugar levels. They quickly detect high or low levels, which can be especially helpful around surgery times. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Continuous Glucose Monitors (CGMs) for diabetes patients undergoing surgery because these devices offer real-time glucose monitoring. Unlike the standard practice of periodic blood glucose checks, CGMs provide continuous data, allowing for more precise and timely insulin adjustments. This continuous monitoring can help maintain optimal glucose levels during the surgery process, potentially reducing complications and improving patient outcomes.

What evidence suggests that continuous glucose monitoring is effective for diabetes surgery patients?

This trial will compare continuous glucose monitors (CGMs) with standard glucose management practices for surgery patients with diabetes. Studies have shown that CGMs provide real-time blood sugar information, aiding better glucose management during surgery. One study found that CGMs matched the effectiveness of regular blood sugar checks, with fewer high blood sugar instances. Another study suggested that CGMs might improve surgical outcomes for people with diabetes by maintaining more stable blood sugar levels. Early findings also indicate that using CGMs during surgery could enhance overall blood sugar control. This evidence highlights CGMs as a promising tool for managing blood sugar in surgery patients with diabetes. ^{1 3 6 7 8}

Who Is on the Research Team?

Susan Vishneski, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 18 or older with high blood sugar or diabetes and will have surgery at Atrium Health Wake Forest Baptist.

Smartphone compatible with Libre 2 phone application

Exclusion Criteria

I am scheduled for or have had brain surgery.

I am not having surgery that affects wearing a CGM on my upper arm.

Pregnant women will not be excluded from this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Assessment

Placement of Continuous Glucose Monitor (CGM) during preoperative clinic visit

1 day

1 visit (in-person)

Perioperative Monitoring

Utilization of CGM throughout the perioperative period to monitor blood glucose and manage insulin correction

7 days

Follow-up

Participants are monitored for safety and effectiveness after the perioperative period

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor

Trial Overview 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.

How Is the Trial Designed?

Group I: Continuous Glucose Monitor Experimental Treatment 1 Intervention

CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management

Group II: Standard of Care Active Control 1 Intervention

no study intervention-conventional glucose management per subjects medical providers as standard of care

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The real-time continuous glucose monitoring system (RT-CGMS) was found to be safe and accurate in monitoring glucose levels in patients undergoing cardiothoracic surgery, with 96.6% of sensor values aligning with accepted accuracy standards.

The activation of the alarm function on the RT-CGMS did not significantly impact glucose control, indicating that further research is needed to understand its potential benefits in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre- and postoperative accuracy and safety of a real-time continuous glucose monitoring system in cardiac surgical patients: a randomized pilot study. Logtenberg, SJ., Kleefstra, N., Snellen, FT., et al.[2009]

The Eirus intravascular microdialysis continuous glucose monitoring (MD-CGM) system demonstrated superior accuracy in glucose measurement compared to the FreeStyle Libre subcutaneous continuous glucose monitoring (SC-CGM) system in a study involving 26 cardiac surgery patients.

While both systems were reliable and complication-free, the SC-CGM system consistently reported lower glucose values than the reference method, indicating a potential issue with its accuracy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of 2 Different Continuous Glucose Monitoring Systems in Patients Undergoing Cardiac Surgery. Schierenbeck, F., Franco-Cereceda, A., Liska, J.[2018]

Subcutaneous continuous glucose monitoring (CGM) was successfully implemented in 20 perioperative settings, showing no side effects or electromagnetic interference, and providing accurate glucose readings compared to laboratory analyzers.

Despite the safety of CGM, 80% of monitored patients did not maintain safe plasma glucose levels during the perioperative period, highlighting the need for further studies to confirm the benefits of CGM in managing glucose levels in surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose sensing module - is it time to integrate it into real-time perioperative monitoring? An observational pilot study with subcutaneous sensors. Poljakova, I., Elsikova, E., Chlup, R., et al.[2014]

The Medtronic Enlite 2 continuous glucose monitor (CGM) demonstrated good performance in post-transplant patients, with 86.1% of readings classified as clinically accurate and a mean absolute relative difference of 11.0%.

Despite its effectiveness, the CGM required frequent recalibrations (8.3 times per day) in this critically ill population, indicating that while it is reliable, its use may be challenging due to the need for constant adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Continuous Glucose Monitoring in Patients After Total Pancreatectomy with Islet Autotransplantation. Forlenza, GP., Nathan, BM., Moran, A., et al.[2020]

Continuous glucose monitoring (CGM) technology has the potential to enhance perioperative glycemic management, which is crucial for improving postoperative outcomes such as wound infection and reoperation rates.

The study evaluated the accuracy of CGM against traditional methods (capillary point-of-care and arterial blood analysis) in two cases, highlighting its role as an adjunct in monitoring glucose levels during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Continuous Glucose Monitoring to Facilitate Perioperative Glycemic Management: A Case Report. DiGiusto, M., Wolf, RM., Arcara, KM., et al.[2021]

Continuous glucose monitoring (CGM) significantly improves diabetes management for insulin-requiring patients, particularly in type 1 diabetes, by providing real-time insights into glycemic fluctuations and allowing for better lifestyle and medication adjustments.

The review highlights that CGM can lead to improved hemoglobin A1c (A1C) levels, reduced hypoglycemia, and enhanced quality of life, suggesting its potential benefits for broader patient populations with proper education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. Klonoff, DC., Ahn, D., Drincic, A.[2022]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

Continuous glucose monitoring systems provide real-time glucose readings from interstitial fluid, significantly improving diabetes management for both type 1 and type 2 diabetes patients.

These systems help patients and healthcare providers analyze glucose patterns, leading to better glycemic control, reduced hemoglobin A1c levels, and fewer instances of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring for the Internist. Lee, GS., Lupsa, BC.[2022]

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.

Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. DeSalvo, D., Buckingham, B.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11508367/

The Performance of Continuous Glucose Monitoring During ... Continuous glucose monitoring (CGM) provides real-time glucose data, potentially improving glycemic control during surgery. However, the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11836829/

Assessing the effectiveness of continuous glucose monitoring ... This study is a pragmatic, randomised controlled trial to assess the effectiveness of continuous glucose monitoring (CGM) in enhancing surgical ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06331923

Assessing the Effectiveness of Continuous Glucose ... Assessing the Effectiveness of Continuous Glucose Monitoring Compared with Conventional Monitoring in Enhancing Surgical Outcomes for Patients with Diabetes ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16583

Perioperative use and accuracy of continuous glucose ... CGM was non-inferior to point-of-care glucose monitoring, with a trend towards improved hyperglycaemic control with fewer recurrent ...

5. journals.lww.com journals.lww.com/ejanaesthesiology/fulltext/2025/02000/continuous_peri_operative_glucose_monitoring_in.8.aspx

Continuous peri-operative glucose monitoring in ... To systematically assess the glycaemic profile and clinical outcome of patients equipped with a CGM device during the peri-operative period in noncardiac ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12409212/

Perioperative use and accuracy of continuous glucose ... Perioperative impairment of glycaemic control is associated with an increased risk of major postoperative complications, including infection, ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/15/2/e090664

Assessing the effectiveness of continuous glucose ... This study is a pragmatic, randomised controlled trial to assess the effectiveness of continuous glucose monitoring (CGM) in enhancing surgical outcomes in ...

8. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Continuous glucose monitoring systems have revolutionized diabetes management, significantly improving glycemic control in both Type 1 and Type 2 diabetes.