Perioperative Continuous Glucose Monitoring

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous Glucose monitor
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitor<br>CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management | Device: Continuous Glucose monitor<br>* Perioperative glucose management beginning preoperative through postoperative monitoring<br>|
| Active Comparator: Standard of Care<br>no study intervention-conventional glucose management per subjects medical providers as standard of care | Other: Standard of Care<br>* no study intervention. participant follows current medical providers recommendations for glucose management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A1c, blood glucose changes, hyperglycemic and hypoglycemic events