NCT06614127

Continuous Glucose Monitoring: A Pilot Study

Continuous Intraoperative Glucose Monitoring: A Pilot Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
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.
DEVICE	Dexcom G7® sensor placed in anterior thigh	For the "subjects with Dexcom G7® sensor place in anterior thigh" cohort, study personnel will place the Dexcom G7® sensor in the anterior thighs and the electrodispursive pad will be placed on the opposite thigh.

Timeline

• Start date: 2024-10-24
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-09-26
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study