Continuous Glucose Monitoring: A Pilot Study

August 11, 2026 updated by: Melissa McCabe, Loma Linda University

Continuous Intraoperative Glucose Monitoring: A Pilot Study

The purpose of this study is to evaluate connectivity of the FDA approved DexCom G7® continuous glucose monitor in the operating room. Continuous glucose monitors are applied to the skin and a thin sampling filament is inserted into the skin and measures blood sugar in the interstitial fluid. The DexCom G7® is used regularly outside of the operating room to monitor blood sugar, however the use of the device in the operating room environment has been limited by connectivity issues. This study will assess device connectivity at different monitoring sites.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This feasibility pilot study will assess connectivity of the DexCom G7® continuous glucose monitoring device (CGM) in the operating room environment at different locations on the body. The investigators believe device connectivity is affected by use of electrocautery. The monitoring sites were selected to limit electromagnetic interference from electrocautery.

One cohort will have the CGM device placed on the deltoid and the electrodispersive pad placed on the thigh and the other cohort will have the CGM device placed on the thigh with the electrodispersive pad on the opposite thigh.

Study personnel will note when electrocautery is used throughout the surgery and observe if the DexCom G7® continues to maintain connectivity with the receiver and provides a glucose reading. Comparing the timing of electrocautery use with connectivity to the DexCom G7® receiver provides important insight to the relationship between electrocautery and device connectivity.

The CGM readings will solely be used for feasibility purposes for this study and not for determining interventions for the subjects.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Troesch Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult abdominal and general surgical patients.

Description

Inclusion Criteria:

  • Adults age 18 and above able to consent for themselves
  • Willingness and ability to participate in study procedures
  • Surgery length estimated 3 hours or longer

Exclusion Criteria:

  • Cardiothoracic surgical patients
  • Plan for intraoperative radiologic imaging
  • Patients on IV infusion of insulin prior to surgery
  • Anemia with hemoglobin less than 7
  • Patients on hydroxyurea
  • Patients with known adhesive allergies
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Continuous glucose monitoring site: upper arm
Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed in upper arm over the deltoid
Device: Dexcom G7® sensor placed in upper arm and positioned over deltoid
For the "subjects with Dexcom G7® sensor placed in the upper arm and positioned over the deltoid" cohort, study personnel will place the Dexcom G7® sensor on the subjects' deltoid and the electrodispursive pad on the thigh.
Continuous glucose monitoring site: lateral thigh
Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed on the lateral aspect of the thigh
Device: Dexcom G7® sensor placed in lateral thigh
For the "subjects with Dexcom G7® sensor place in lateral thigh" cohort, study personnel will place the Dexcom G7® sensor in the lateral thigh and the electrodispursive pad will be placed on the opposite thigh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of DexCom G7® sensor position on receiver connectivity during and after electrocautery use.
Time Frame: Change between baseline at start of procedure and completion of procedure, up to 6 hours.

Connectivity will be recorded continuously from start to finish of the procedure.

The percentage of time the Dexcom G7® device remains connected during the subject's surgical case will be measured. The effect of electrocautery on CGM connectivity will be assessed by comparing the start and stop times in connectivity to the start and stop times of electrocautery. Connectivity time greater than 80% is considered highly effective. Connectivity time between 20% and 80% is considered effective. Connectivity time less than 20% is considered sub-optimal.
Change between baseline at start of procedure and completion of procedure, up to 6 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Study Chair: Richard L Applegate, MD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Actual)

August 1, 2025

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB 5230596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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