Clinical trial NCT05937373: Perioperative Continuous Glucose Monitoring
Official title: A Pilot Trial of Continuous Glucose Monitoring (CGM) Technology in Preoperative Assessment Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: A1c
blood glucose changes
hyperglycemic and hypoglycemic events
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disparities in Continuous Glucose Monitoring (CGM) accuracy - fingerstick values
timeFrame: Day 7
measure: Disparities in Continuous Glucose Monitoring (CGM) accuracy - serum and arterial glucose values
timeFrame: Day 7
Secondary outcomes:
measure: Patient satisfaction Scores
timeFrame: Day 7
measure: Proportion of patients with functioning Continuous Glucose Monitoring (CGM)
timeFrame: Day 7
measure: Disparities in Continuous Glucose Monitoring (CGM) accuracy - interference amount
timeFrame: Hour 24
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Susan Vishneski, MD
role: PRINCIPAL_INVESTIGATOR
References: