Perioperative Continuous Glucose Monitoring

NCT05937373 | Terminated Results FDA Device

• 1 other identifier: IRB00097714
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

A1c; blood glucose changes; hyperglycemic and hypoglycemic events

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working CGM

  Day 7

• Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Interference Amount

  Hour 24

Other Outcomes (1)

• Patient Satisfaction Scores

  Day 7

Study Arms (2)

Continuous Glucose Monitor

EXPERIMENTAL

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

Device: Continuous Glucose monitor

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Standard of Care OTHER

no study intervention. participant follows current medical providers recommendations for glucose management

Standard of Care

Continuous Glucose monitor DEVICE

Perioperative glucose management beginning preoperative through postoperative monitoring

Continuous Glucose Monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Susan R. Vishneski, MD
• Organization: Wake Forest University Health Sciences

svishnes@wakehealth.edu

336-306-0778

Study Officials

• Susan Vishneski, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 10, 2023
• Study Start: August 4, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)