Clinical trial NCT06275971: Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients
Official title: Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
PreDiabetes
Diabetes Mellitus
Keywords: continuous glucose monitoring
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2024-02-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group: glycemic control using CGM Control group: glycemic control using arterial/venous blood sampling and POCT glucose
Primary purpose: TREATMENT

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.


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

  1. HbA1c 5.7% or more
  2. fasting blood glucose 100 mg/dL or more
  3. 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)

  1. Cases where severe weight gain and severe edema occur after surgery
  2. Cases where the surgery time is significantly longer than average
  3. Cases where cardiopulmonary bypass is used more than once during surgery
* Others who are deemed unsuitable for research progression at the researcher's discretion

Primary outcomes:
measure: Time within the target range of 100-180 mg/dL
timeFrame: 1-7 days after surgery
Secondary outcomes:
measure: Time within the target range of 100-140 mg/dL
timeFrame: 1-7 days after surgery
measure: Time within the target range of 70-180 mg/dL
timeFrame: 1-7 days after surgery
measure: Time to reach <70 mg/dL
timeFrame: 1-7 days after surgery
measure: Time to reach <54 mg/dL
timeFrame: 1-7 days after surgery
measure: Time to reach >180 mg/dL
timeFrame: 1-7 days after surgery
measure: Time to reach >250 mg/dL
timeFrame: 1-7 days after surgery
measure: Standard Deviation (SD)
timeFrame: 1-7 days after surgery
measure: Coefficient of variation (CV)
timeFrame: 1-7 days after surgery
measure: Mean glucose
timeFrame: 1-7 days after surgery
measure: Glucose management indicator (GMI)
timeFrame: 1-7 days after surgery
measure: Number of days of ICU hospitalization
timeFrame: 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
measure: Number of days hospitalized after surgery
timeFrame: 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
measure: Number of participants with pneumonia occurrence after surgery
timeFrame: 1-7 days after surgery
measure: Number of participants with wound infection occurrence after surgery
timeFrame: 1-7 days after surgery
measure: Number of participants who underwent CRRT implementation after surgery
timeFrame: 1-7 days after surgery
measure: Number of participants with Atrial fibrillation occurrence after surgery
timeFrame: 1-7 days after surgery
measure: Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery
timeFrame: 1-7 days after surgery
measure: Changes in concentration of serum CRP level after surgery
timeFrame: 1-7 days after surgery
measure: Mortality within 30 days of surgery
timeFrame: 1-30 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital, Sungkyunkwan University
name: Sun Joon Moon, MD
role: STUDY_DIRECTOR
References: