Trial Outcomes & Findings for Continuous Glucose Monitoring During and After Surgery (NCT NCT02572856)

Results Overview

After CGM has been applied on the first 4 patients, the study team will evaluate the safety and feasibility of using CGM. Specifically, the team will check whether there are unanticipated adverse events such as rashes or discomfort

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

After 4 patients (2 months)

Results posted on

2023-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	CGM Patients Apply continuous glucose monitor, calibrate and make glucose measurements. Measurements are blinded to the care provider Continuous Glucose Monitor (CGM): Apply Dexcom Gen 6 Professional CGM sensor at least 2.5 hours prior to surgery Configure CGM so that its measurements are blinded. Setup CGM to make continuous glucose measurements during and after surgery. Download CGM measurement data after study and compare measurements against glucose measurements made for clinical care.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CGM Patients n=10 Participants Apply continuous glucose monitor, calibrate and make glucose measurements. Measurements are blinded to the care provider Continuous Glucose Monitor (CGM): Apply Dexcom Gen 6 Professional CGM sensor at least 2.5 hours prior to surgery Configure CGM so that its measurements are blinded. Setup CGM to make continuous glucose measurements during and after surgery. Download CGM measurement data after study and compare measurements against glucose measurements made for clinical care.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=10 Participants
Age, Categorical >=65 years	4 Participants n=10 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 6.3 • n=10 Participants
Sex: Female, Male Female	8 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants
Baseline A1C	57.4 mmol/mol STANDARD_DEVIATION 14.2 • n=10 Participants

PRIMARY outcome

Timeframe: After 4 patients (2 months)

Population: Safety was assessed after 4 participants were enrolled; MARD was assessed after 10 participants were enrolled. The study stopped enrollment earlier than planned.

After CGM has been applied on the first 4 patients, the study team will evaluate the safety and feasibility of using CGM. Specifically, the team will check whether there are unanticipated adverse events such as rashes or discomfort

Outcome measures

Outcome measures
Measure	CGM Patients n=4 Participants Apply continuous glucose monitor, calibrate and make glucose measurements. Measurements are blinded to the care provider Continuous Glucose Monitor (CGM): Apply Dexcom Gen 6 Professional CGM sensor at least 2.5 hours prior to surgery Configure CGM so that its measurements are blinded. Setup CGM to make continuous glucose measurements during and after surgery. Download CGM measurement data after study and compare measurements against glucose measurements made for clinical care.
Safety and Feasibility Evaluation - Number of Unanticipated Safety Issues	0 Number of unanticipated safety events

PRIMARY outcome

Timeframe: 10 months

Population: One patient was excluded from analysis due to incorrect insertion protocol.

Compare glucose measurements made by a Dexcom G4 Professional Continuous Glucose Monitor (CGM) against point of care glucose meter (Accu-Check Inform II, Roche Diagnostics), during the intraoperative and postoperative phases. Measured as mean absolute relative difference (MARD) for CGM glucose values compared with the POC glucose measurements.

Outcome measures

Outcome measures
Measure	CGM Patients n=9 Participants Apply continuous glucose monitor, calibrate and make glucose measurements. Measurements are blinded to the care provider Continuous Glucose Monitor (CGM): Apply Dexcom Gen 6 Professional CGM sensor at least 2.5 hours prior to surgery Configure CGM so that its measurements are blinded. Setup CGM to make continuous glucose measurements during and after surgery. Download CGM measurement data after study and compare measurements against glucose measurements made for clinical care.
Mean Absolute Relative Difference for CGM and POC Glucose Measurements	9.4 % of mean absolute relative difference Standard Deviation 7.7

PRIMARY outcome

Timeframe: After 4 participants (2 months)

After 4 participants (2 months), the study team will assess the number of instrument breaks

Outcome measures

Outcome measures
Measure	CGM Patients n=4 Participants Apply continuous glucose monitor, calibrate and make glucose measurements. Measurements are blinded to the care provider Continuous Glucose Monitor (CGM): Apply Dexcom Gen 6 Professional CGM sensor at least 2.5 hours prior to surgery Configure CGM so that its measurements are blinded. Setup CGM to make continuous glucose measurements during and after surgery. Download CGM measurement data after study and compare measurements against glucose measurements made for clinical care.
Feasibility of Instrument: Count of CGM Instrument Issues	0 number of instrument breaks

Adverse Events

CGM Patients

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

David Flum, MD

University of Washington Medical Center

Phone: 206 616-5440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place