Continuous Glucose Monitoring: A Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-24

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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

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Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Continuous glucose monitoring site: upper arm

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

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

Intervention Type DEVICE

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: anterior thigh

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

Dexcom G7® sensor placed in anterior thigh

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No