NCT02572856

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
2.8 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2021

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 31, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

October 5, 2015

Results QC Date

March 17, 2023

Last Update Submit

August 9, 2023

Conditions

Diabetes

Keywords

Feasibilitycontinuous glucose monitorsurgery

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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)