Perioperative Continuous Glucose Monitoring

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Standard of Care; Device: Continuous Glucose monitor

• Registration Number: NCT05937373
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-10
• Study Start: 2023-08-04
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	no study intervention-conventional glucose management per subjects medical providers as standard of care
Continuous Glucose Monitor	Continuous Glucose monitor	CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management

Primary Outcome Measures

Name	Time	Method
Disparities in Continuous Glucose Monitoring (CGM) accuracy - fingerstick values	Day 7	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 values
Disparities in Continuous Glucose Monitoring (CGM) accuracy - serum and arterial glucose values	Day 7	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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction Scores	Day 7	A patient satisfaction survey will be collected to further evaluate the patient's perspective of wearing a CGM in the perioperative period
Proportion of patients with functioning Continuous Glucose Monitoring (CGM)	Day 7	Proportion of patients who present on day of surgery with CGM still in place and functioning
Disparities in Continuous Glucose Monitoring (CGM) accuracy - interference amount	Hour 24	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 interference with intraoperative devices utilized in the operating room in regards to potential signal loss from CGM device

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States