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

NCT06338748 | Completed FDA Device

• 1 other identifier: 24-157
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Single Arm

OTHER

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

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

Interventions

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

Dexcom G7 used in blinded mode

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• DexCom, Inc.: collaborator

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Lansang Cecilia, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study will involve using blinded Dexcom G7 continuous glucose monitoring (CGM) devices
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 1, 2024
• Study Start: November 2, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)