Perioperative Continuous Glucose Monitoring (CGM)

A Pilot Trial of Continuous Glucose Monitoring (CGM) Technology in Preoperative Assessment Clinic

To evaluate use of continuous glucose monitoring (CGM) technology in the preoperative setting: evaluate feasibility of placement of CGM during preoperative clinic visit with intent to utilize CGM throughout perioperative period.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose monitor; Other: Standard of Care

Detailed Description

To further study potential barriers related to loss of continuous glucose monitoring (CGM) data as it relates to use of electrocautery and grounding devices utilized in the perioperative setting. To assess how CGM technology could improve glycemic management in the perioperative setting, specifically in predicting and preventing hypoglycemic episodes as well as utilization for treating hyperglycemia with resultant improvement in patient morbidity, mortality, length of stay, and overall quality of life. CGM technology aids tremendously in data collection with recognition of glycemic patterns, as well as evaluating prediction of blood glucose changes including both hyperglycemic and hypoglycemic events. The availability of such a large volume of glycemic data has been shown to make a tremendous impact in patient care, resulting in statistically significant reductions in hemoglobin A1c, a decrease in hypoglycemia, a decrease in hospital admissions for diabetes complications, and improved overall quality of life and fear of hypoglycemia in patients using CGM technology.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants that are 18 years of age or older with hyperglycemia and/or diabetes mellitus who will be undergoing surgery at Atrium Health Wake Forest Baptist
• smartphone compatible with Libre 2 phone application

Exclusion Criteria:

• Pregnant women will not be excluded from this study
• Participants undergoing surgery that would limit the placement of Continuous Glucose Monitoring (CGM) to the posterior aspect of the upper extremity will be excluded from this study
• neurosurgical type of surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitor; CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management	Device: Continuous Glucose monitor; Perioperative glucose management beginning preoperative through postoperative monitoring
Active Comparator: Standard of Care; no study intervention-conventional glucose management per subjects medical providers as standard of care	Other: Standard of Care; no study intervention. participant follows current medical providers recommendations for glucose management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Fingerstick Values	Accuracy of CGM technology utilizing Dexcom G6 CGM and Freestyle Libre 2.0 CGM in the perioperative setting for glycemic management of patients with hyperglycemia and/or diabetes mellitus compared with current standard of care utilizing point of care blood glucose fingerstick Glucose values - Only Glucometers	Day 7
Disparities (Percentage Difference) in Continuous Glucose Monitoring (CGM) Accuracy - Comprehensive Metabolic Panel (CMP) / Basic Metabolic Panel (BMP)/ Blood Gas Values - Overall Number of Unit Analyzed (Glucose Values Each Group)	Accuracy of CGM technology utilizing Dexcom G6 CGM and Freestyle Libre 2.0 CGM in the perioperative setting for glycemic management of patients with hyperglycemia and/or diabetes mellitus compared with current standard of care utilizing serum and arterial glucose values - Comprehensive Metabolic Panel (CMP) / Basic Metabolic Panel (BMP)/ blood gas values For each CMP/BMP/Blood Gas Value recorded in the Electronic Medical Record during the period of CGM wear, a percentage difference was calculated between the measured glucose value and the corresponding CGM value.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working CGM	Proportion of patients who present on day of surgery with CGM still in place and functioning	Day 7
Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Interference Amount	Analysis of potential electrocautery interference in CGM data collection was performed through visual review of the CGM glucose data graphs for unexpected gaps or spikes during surgery. No such events were observed in the CGM outputs during the review. Disparities in CGM accuracy due to interference were reported as 0%.	Hour 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Scores	A patient satisfaction survey will be collected to further evaluate the patient's perspective of wearing a CGM in the perioperative period	Day 7

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Susan Vishneski, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Actual): May 21, 2024
• Study Completion (Actual): May 21, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: A1c; blood glucose changes; hyperglycemic and hypoglycemic events
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB00097714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No