N/A N=40 Supportive Care

Accuracy of the Dexcom G6 Continuous Glucose Monitoring System Following Cardiac Surgery

Surgery--Complications

Bottom Line

View on ClinicalTrials.gov: NCT04569240 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements) — 817 matched clinical glucose measure

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dexcom G6 continuous glucose monitor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Matching Glucose Measurements (CGM Versus Blood Glucose Measurements)	817	—
PRIMARY Glucose Readings From Continuous Glucose Monitor (CGM) Versus Point of Care Glucose	817; 280	—

Summary

This is a prospective longitudinal study to study the agreement between a novel 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 glucose using the Accuchek Inform II on the regular floors, and the CGMS at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors.

Eligibility Criteria

Inclusion Criteria

Age 18 years and above
Planned cardiovascular surgery
Planned admission to Cleveland Clinic Main Campus J5 or J6 or Q5 cardiovascular ICU (CVICU) post-operatively
With or without known diabetes; if with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary

Exclusion Criteria

Allergy to the material of the CGMS or the adhesive to be used
Skin conditions precluding the use of the CGMS
Pregnancy
Other conditions that investigators deem inappropriate for the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04569240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.