Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery (DexcomG7)

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.

Study Overview

• Status: Completed
• Conditions: Continuous Glucose Monitoring
• Intervention / Treatment: Device: Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; All patients will receive the Dexcom G7 continuous glucose monitor (CGM)	Device: Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode; Dexcom G7 used in blinded mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick point of care (POC) while patients are in the CVICU	Compare accuracy of glucose readings obtained from Dexcom G7 Compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick POC while patients are in the CVICU	1 - 10 days
Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors	Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors	1 - 10 days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Lansang Cecilia, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: 24-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No