Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

Kangbuk Samsung Hospital1 site in 1 country68 target enrollmentNovember 24, 2022

ConditionsCardiac Disease PreDiabetes Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiac Disease
Sponsor: Kangbuk Samsung Hospital
Enrollment: 68
Locations: 1
Primary Endpoint: Time within the target range of 100-180 mg/dL
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring.

Registry

clinicaltrials.gov

Start Date

November 24, 2022

End Date

August 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kangbuk Samsung Hospital

Responsible Party

Principal Investigator

Cheol-Young Park

Professor, MD. PhD

Kangbuk Samsung Hospital, Sungkyunkwan University

Eligibility Criteria

Inclusion Criteria

•Subjects waiting for Elective Cardiac Surgery (CABG, Cardiac Valve Operation, Congenital heart anomaly surgery, aortic surgery, etc.)
•Subjects over the age of 18
•Patients with type 2 diabetes
•Patients with prediabetes
•HbA1c 5.7% or more
•fasting blood glucose 100 mg/dL or more
•2 hours 75g-OGTT 140 mg/dL or more

Exclusion Criteria

•Emergency surgery patients
•Patients performing co-operation other than cardiac surgery
•Patients with type 1 diabetes
•Total Pancreatectomy patients
•Patients with high surgical severity (STS score of 8 or more or EURO score of 5 or more)
•Patients who do not consent to the study
•Severe patients who are deemed difficult to continue research during surgery (excluded at the researcher's discretion)
•Cases where severe weight gain and severe edema occur after surgery
•Cases where the surgery time is significantly longer than average
•Cases where cardiopulmonary bypass is used more than once during surgery

Outcomes

Primary Outcomes

Time within the target range of 100-180 mg/dL

Time Frame: 1-7 days after surgery

Time within the target range of 100-180 mg/dL as assessed by CGM for 7 days after surgery

Secondary Outcomes

Standard Deviation (SD)(1-7 days after surgery)
Number of days of ICU hospitalization(From 1 day after surgery until the date of ICU discharge or date of death from any cause, whichever came first, asessed up to 30 days)
Time to reach <54 mg/dL(1-7 days after surgery)
Time to reach >180 mg/dL(1-7 days after surgery)
Mean glucose(1-7 days after surgery)
Mortality within 30 days of surgery(1-30 days after surgery)
Time within the target range of 100-140 mg/dL(1-7 days after surgery)
Time to reach <70 mg/dL(1-7 days after surgery)
Coefficient of variation (CV)(1-7 days after surgery)
Number of participants with pneumonia occurrence after surgery(1-7 days after surgery)
Time within the target range of 70-180 mg/dL(1-7 days after surgery)
Time to reach >250 mg/dL(1-7 days after surgery)
Number of participants who underwent CRRT implementation after surgery(1-7 days after surgery)
Number of participants with Atrial fibrillation occurrence after surgery(1-7 days after surgery)
Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery(1-7 days after surgery)
Glucose management indicator (GMI)(1-7 days after surgery)
Number of days hospitalized after surgery(From 1 day after surgery until the date of hospital discharge or date of death from any cause, whichever came first, asessed up to 30 days)
Number of participants with wound infection occurrence after surgery(1-7 days after surgery)
Changes in concentration of serum CRP level after surgery(1-7 days after surgery)