Trial Outcomes & Findings for Perioperative Continuous Glucose Monitoring (NCT NCT05937373)

NCT ID: NCT05937373

Last Updated: 2025-12-24

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Day 7

Results posted on

2025-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitor Freestyle Libre 2 CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management	Standard of Care No study intervention-conventional glucose management with Freestyle Libre Pro CGM per subjects medical providers as standard of care
Overall Study STARTED	11	11
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuous Glucose Monitor Freestyle Libre 2 CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management	Standard of Care No study intervention-conventional glucose management with Freestyle Libre Pro CGM per subjects medical providers as standard of care
Overall Study Out of Window	2	0
Overall Study Device fell off prior to date of surgery	0	2

Baseline Characteristics

Perioperative Continuous Glucose Monitoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Glucose Monitor n=11 Participants 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	Standard of Care n=11 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	Total n=22 Participants Total of all reporting groups
Age, Continuous	72 years STANDARD_DEVIATION 5.67 • n=30 Participants	62 years STANDARD_DEVIATION 10.17 • n=30 Participants	67 years STANDARD_DEVIATION 9.63 • n=60 Participants
Sex: Female, Male Female	5 Participants n=30 Participants	2 Participants n=30 Participants	7 Participants n=60 Participants
Sex: Female, Male Male	6 Participants n=30 Participants	9 Participants n=30 Participants	15 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=30 Participants	11 Participants n=30 Participants	22 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	1 Participants n=30 Participants	1 Participants n=30 Participants	2 Participants n=60 Participants
Race (NIH/OMB) White	10 Participants n=30 Participants	10 Participants n=30 Participants	20 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants

PRIMARY outcome

Timeframe: Day 7

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=67 glucose values each group 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	Standard of Care n=99 glucose values each group 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
Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Fingerstick Values	4.32 Percentage of mmol/L Standard Deviation 18.41	8.08 Percentage of mmol/L Standard Deviation 37.73

PRIMARY outcome

Timeframe: Day 7

Population: 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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=67 unit analyzed - measured glucose value a 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	Standard of Care n=99 unit analyzed - measured glucose value a 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
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	1.20 percent difference in blood glucose valu Standard Deviation 16.41

SECONDARY outcome

Timeframe: 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

Proportion of patients who present on day of surgery with CGM still in place and functioning

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=11 Participants 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	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
Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working CGM	9 Participants	0 Participants

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=9 Participants 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	Standard of Care n=9 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
Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Interference Amount	0 Number of Discrepencies	0 Number of Discrepencies

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7

Population: VALUE NOT EVALUATED - Data not collected - patient satisfaction scores were not collected as a part of the data collection process

A patient satisfaction survey will be collected to further evaluate the patient's perspective of wearing a CGM in the perioperative period

Outcome measures

Outcome data not reported

Adverse Events

Continuous Glucose Monitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan R. Vishneski, MD

Wake Forest University Health Sciences

Phone: 336-306-0778

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place