Perioperative Continuous Glucose Monitoring

Diabetes Mellitus Clinical Trial

— CGM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937373
• Other study ID #: IRB00097714
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: Susan Vishneski, MD
• Phone: 336-716-4498
• Email: svishnes[@]wakehealh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Continuous Glucose monitor
Perioperative glucose management beginning preoperative through postoperative monitoring

Other:
• Standard of Care
no study intervention. participant follows current medical providers recommendations for glucose management

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 values	Day 7
Primary	Disparities in Continuous Glucose Monitoring (CGM) accuracy - serum and arterial glucose 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 serum and arterial glucose values	Day 7
Secondary	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
Secondary	Proportion of patients with functioning Continuous Glucose Monitoring (CGM)	Proportion of patients who present on day of surgery with CGM still in place and functioning	Day 7
Secondary	Disparities in Continuous Glucose Monitoring (CGM) accuracy - interference amount	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	Hour 24