Continuous Glucose Monitoring During and After Surgery

NCT02572856 | Completed Results FDA Device

• 2 other identifiers: STUDY00003457IIS-2014-028
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

During surgery and after surgery elevated blood glucose levels can lead to poor outcome such as wound infections. Current technology does not allow close monitoring of glucose levels often resulting in poor management of glucose levels. In this study, the investigators will evaluate the feasibility of using a continuous glucose monitor (Dexcom Gen 6 Professional) during and after surgery. Such a monitor has the potential of monitoring glucose levels continuously and in real-time, thus allowing better glucose management

Conditions

Diabetes

Keywords

Feasibility; continuous glucose monitor; surgery

Outcome Measures

Primary Outcomes (3)

• Safety and Feasibility Evaluation - Number of Unanticipated Safety Issues

  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

  After 4 patients (2 months)

• Mean Absolute Relative Difference for CGM and POC Glucose Measurements

  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.

  10 months

• Feasibility of Instrument: Count of CGM Instrument Issues

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

  After 4 participants (2 months)

Study Arms (1)

CGM patients

EXPERIMENTAL

Apply continuous glucose monitor, calibrate and make glucose measurements. Measurements are blinded to the care provider

Device: Continuous Glucose Monitor (CGM)

Interventions

Continuous Glucose Monitor (CGM) DEVICE

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.

CGM patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 18 years) diabetic (both Type 1 \& 2) patients who are self-monitoring glucose levels (via finger stick measurements) two to three times daily.
• Scheduled to have elective general surgery at UW Medical Center. Preferably target Surgery A- Orthopedic/GYN surgery/Bariatric patients.
• Proposed case duration \> 2 hour case.

You may not qualify if:

• Pregnant and lactating females
• MRI, CT \& Diathermy procedure

Sponsors & Collaborators

• University of Washington: lead
• DexCom, Inc.: collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: David Flum, MD
• Organization: University of Washington Medical Center

daveflum@uw.edu

206 616-5440

Study Officials

• Irl B Hirsch, MD

  University of Washington

  STUDY CHAIR

• David Flum

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Surgery

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 9, 2015
• Study Start: August 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: November 16, 2021
• Last Updated: August 31, 2023
• Results First Posted: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)