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Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery

NCT ID: NCT06338748

Last Updated: 2025-11-12

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

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-02

Study Completion Date

2025-12-31

Brief Summary

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This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated.

Detailed Description

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The Dexcom G7 will be placed either by an anesthesiologist or nurse anesthetist, or critical care physician, nurse or nurse manager upon arrival to CVICU, post cardiac surgery.

Standard of care:

Accuchek will be done per standard of care for post operative patients that are in ICU

Conditions

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Continuous Glucose Monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients undergoing heart surgery at the Cleveland Clinic (main campus) who would normally be tested for high sugar levels by poking a finger and using a test strip.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

The study will involve using blinded Dexcom G7 continuous glucose monitoring (CGM) devices

Study Groups

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Single Arm

All patients will receive the Dexcom G7 continuous glucose monitor (CGM)

Group Type OTHER

Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode

Intervention Type DEVICE

Dexcom G7 used in blinded mode

Interventions

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Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode

Dexcom G7 used in blinded mode

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 years old and above
* Planned cardiothoracic surgery
* Planned admission to Cleveland Clinic Main Campus building J5 or J6 or Q5 cardiovascular intensive care unit (CVICU) followed by transfer to the step down unit
* With or without known diabetes (as 75% of patients entering the CVICU have hyperglycemia requiring intravenous insulin infusion)
* If with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary (such as due to glucocorticoids or pancreatitis

Exclusion Criteria

* Allergy to the material of the continuous glucose monitoring systems (CGMS) or the adhesive to be used
* Skin conditions precluding the use of the CGMS
* Pregnancy
* Other conditions that the investigators deem inappropriate for the study
* Patients receiving mechanical circulatory assist devices
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lansang Cecilia, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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24-157

Identifier Type: -

Identifier Source: org_study_id