Continuous Glucose Monitoring: A Pilot Study

Loma Linda University (LLU)

Status: Active, not recruiting

Conditions: Anesthesia

Treatments: Device: Dexcom G7® sensor placed in upper arm and positioned over deltoid; Device: Dexcom G7® sensor placed in anterior thigh

Study type: Observational

Funder types: Other

Identifiers

NCT06614127

IRB 5230596

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Continuous glucose monitoring site: upper arm

Description:

Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed in upper arm over the deltoid

Treatment:

Device: Dexcom G7® sensor placed in upper arm and positioned over deltoid

Continuous glucose monitoring site: anterior thigh

Description:

Adult, non-cardiothoracic surgical patients with Dexcom G7® sensor placed on the anterior aspect of the thigh

Treatment:

Device: Dexcom G7® sensor placed in anterior thigh