Continuous Glucose Monitoring: A Pilot Study

Active, not recruiting

• Conditions: Anesthesia
• Interventions: Device: Dexcom G7® sensor placed in upper arm and positioned over deltoid; Device: Dexcom G7® sensor placed in anterior thigh

• Registration Number: NCT06614127
• Lead Sponsor: Loma Linda University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-26
• Study Start: 2024-10-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Continuous glucose monitoring site: upper arm	Dexcom G7® sensor placed in upper arm and positioned over deltoid	Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed in upper arm over the deltoid
Continuous glucose monitoring site: anterior thigh	Dexcom G7® sensor placed in anterior thigh	Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed on the anterior aspect of the thigh

Primary Outcome Measures

Name	Time	Method
Effect of DexCom G7® sensor position on receiver connectivity during and after electrocautery use.	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.

Trial Locations

Locations (1)

Loma Linda University Troesch Medical Center; 🇺🇸 Loma Linda, California, United States