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OpenTrials
Completed

NCT Number: NCT06338748

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

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.

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Key information

Conditions

Continuous Glucose Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Dexcom G7 used in blinded mode

Primary outcomes

  1. 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

    Time frame: 1 - 10 days

    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

  2. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • DexCom, Inc.

Registry information

Acronym: DexcomG7

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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