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lack of research funding support
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitor | Experimental | CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management |
|
| Standard of Care | Active Comparator | no study intervention-conventional glucose management per subjects medical providers as standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose monitor | Device | Perioperative glucose management beginning preoperative through postoperative monitoring |
|
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Vishneski, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Glucose Monitor | Freestyle Libre 2 CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management |
| FG001 | Standard of Care | No study intervention-conventional glucose management with Freestyle Libre Pro CGM per subjects medical providers as standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Glucose Monitor | CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management Continuous Glucose monitor: Perioperative glucose management beginning preoperative through postoperative monitoring |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | Percentage of mmol/L | Day 7 | glucose values each group | glucose values each group |
|
Day 7
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Glucose Monitor | CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management Continuous Glucose monitor: Perioperative glucose management beginning preoperative through postoperative monitoring |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan R. Vishneski, MD | Wake Forest University Health Sciences | 336-306-0778 | svishnes@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2024 | Jul 23, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 3, 2024 | Mar 26, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | no study intervention. participant follows current medical providers recommendations for glucose management |
|
Analysis of potential electrocautery interference in CGM data collection was performed through visual review of the CGM glucose data graphs for unexpected gaps or spikes during surgery. No such events were observed in the CGM outputs during the review. Disparities in CGM accuracy due to interference were reported as 0%. |
| Hour 24 |
no study intervention-conventional glucose management per subjects medical providers as standard of care Standard of Care: no study intervention. participant follows current medical providers recommendations for glucose management |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
no study intervention-conventional glucose management per subjects medical providers as standard of care Standard of Care: no study intervention. participant follows current medical providers recommendations for glucose management |
|
|
| Primary | 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. | overall number of unit analyzed (glucose values each group) | Posted | Mean | Standard Deviation | percent difference in blood glucose valu | Day 7 | unit analyzed - measured glucose value a | unit analyzed - measured glucose value a |
|
|
|
| Other Pre-specified | 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 | VALUE NOT EVALUATED - Data not collected - patient satisfaction scores were not collected as a part of the data collection process | Posted | Day 7 |
|
|
| Secondary | Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working CGM | Proportion of patients who present on day of surgery with CGM still in place and functioning | no study intervention-conventional glucose management per subjects medical providers as standard of care Standard of Care: no study intervention. participant follows current medical providers recommendations for glucose management | Posted | Count of Participants | Participants | Day 7 |
|
|
|
| Secondary | Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Interference Amount | Analysis of potential electrocautery interference in CGM data collection was performed through visual review of the CGM glucose data graphs for unexpected gaps or spikes during surgery. No such events were observed in the CGM outputs during the review. Disparities in CGM accuracy due to interference were reported as 0%. | Posted | Number | Number of Discrepencies | Hour 24 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Standard of Care | no study intervention-conventional glucose management per subjects medical providers as standard of care Standard of Care: no study intervention. participant follows current medical providers recommendations for glucose management | 0 | 11 | 0 | 11 | 0 | 11 |
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