CGM: Perioperative Continuous Glucose Monitoring

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05937373

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Device: Continuous Glucose monitor	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Exclusion Criteria:

Pregnant women will 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT05937373

Other Study ID Numbers:

IRB00097714

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Wake Forest University Health Sciences

A1c

blood glucose changes

hyperglycemic and hypoglycemic events

Study Results

No Results Posted as of Jul 10, 2023