Perioperative Continuous Glucose Monitoring (CGM)

Wake Forest University (WFU)

Status: Terminated

Conditions: Diabetes Mellitus

Treatments: Other: Standard of Care; Device: Continuous Glucose monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05937373

IRB00097714

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Continuous Glucose Monitor

Experimental group

Description:

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

Treatment:

Device: Continuous Glucose monitor

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care