Diabetes Mellitus
Conditions
Keywords
A1c, blood glucose changes, hyperglycemic and hypoglycemic events
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.
Interventions
DEVICEContinuous Glucose monitor
Perioperative glucose management beginning preoperative through postoperative monitoring
OTHERStandard of Care
no study intervention. participant follows current medical providers recommendations for glucose management
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Fingerstick Values | Day 7 | 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 |
| 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) | Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working CGM | Day 7 | Proportion of patients who present on day of surgery with CGM still in place and functioning |
| Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Interference Amount | Hour 24 | 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%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Scores | Day 7 | A patient satisfaction survey will be collected to further evaluate the patient's perspective of wearing a CGM in the perioperative period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| 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 | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Device fell off prior to date of surgery | 0 | 2 |
| Overall Study | Out of Window | 2 | 0 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Continuous Glucose Monitor |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 10.17 | 67 years STANDARD_DEVIATION 9.63 | 72 years STANDARD_DEVIATION 5.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
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
Time frame: Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitor | Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Fingerstick Values | 4.32 Percentage of mmol/L | Standard Deviation 18.41 |
| Standard of Care | Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Fingerstick Values | 8.08 Percentage of mmol/L | Standard Deviation 37.73 |
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.
Time frame: Day 7
Population: overall number of unit analyzed (glucose values each group)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitor | 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) | 4.18 percent difference in blood glucose valu | Standard Deviation 15.86 |
| Standard of Care | 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) | 1.20 percent difference in blood glucose valu | Standard Deviation 16.41 |
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%.
Time frame: Hour 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Glucose Monitor | Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Interference Amount | 0 Number of Discrepencies |
| Standard of Care | Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Interference Amount | 0 Number of Discrepencies |
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
Time frame: Day 7
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitor | Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working CGM | 9 Participants |
| Standard of Care | Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working CGM | 0 Participants |
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
Time frame: Day 7
Population: VALUE NOT EVALUATED - Data not collected - patient satisfaction scores were not collected as a part of the data collection process