Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

Not Applicable

Recruiting

• Conditions: PreDiabetes; Diabetes Mellitus; Cardiac Disease
• Interventions: Device: Dexcom G6; Device: SMBG or venous/arterial blood glucose

• Registration Number: NCT06275971
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-24
• Study First Submitted: 2024-01-30
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM arm	Dexcom G6	Glycemic control was monitored using CGM data for seven days following cardiac surgery
SMBG or venous/arterial glucose arm	SMBG or venous/arterial blood glucose	Glycemic control was monitored using SMBG or venous/arterial glucose data for seven days following cardiac surgery

Primary Outcome Measures

Name	Time	Method
Time within the target range of 100-180 mg/dL	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 Outcome Measures

Name	Time	Method
Coefficient of variation (CV)	1-7 days after surgery	CV value evaluated by CGM for 7 days after surgery
Standard Deviation (SD)	1-7 days after surgery	SD value evaluated by CGM for 7 days after surgery
Time to reach <54 mg/dL	1-7 days after surgery	Time to reach \<54 mg/dL as assessed by CGM for 7 days after surgery
Time to reach >180 mg/dL	1-7 days after surgery	Time to reach \>180 mg/dL as assessed by CGM for 7 days after surgery
Mean glucose	1-7 days after surgery	Mean glucose value evaluated by CGM for 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	Number of days of ICU hospitalization
Mortality within 30 days of surgery	1-30 days after surgery	Mortality within 30 days of surgery
Time within the target range of 100-140 mg/dL	1-7 days after surgery	Time within the target range of 100-140 mg/dL as assessed by CGM for 7 days after surgery
Time to reach <70 mg/dL	1-7 days after surgery	Time to reach \<70 mg/dL as assessed by CGM for 7 days after surgery
Number of participants with pneumonia occurrence after surgery	1-7 days after surgery	Number of participants with pneumonia occurrence within 1 week after surgery
Time within the target range of 70-180 mg/dL	1-7 days after surgery	Time within the target range of 70-180 mg/dL as assessed by CGM for 7 days after surgery
Time to reach >250 mg/dL	1-7 days after surgery	Time to reach \>250 mg/dL as assessed by CGM for 7 days after surgery
Number of participants who underwent CRRT implementation after surgery	1-7 days after surgery	Number of participants who underwent CRRT implementation within 1 week after surgery
Number of participants with Atrial fibrillation occurrence after surgery	1-7 days after surgery	Number of participants with Atrial fibrillation occurrence within 1 week after surgery
Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery	1-7 days after surgery	Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence within 1 week after surgery
Glucose management indicator (GMI)	1-7 days after surgery	GMI value evaluated by CGM for 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 days hospitalized after surgery
Number of participants with wound infection occurrence after surgery	1-7 days after surgery	Number of participants with wound infection occurrence within 1 week after surgery
Changes in concentration of serum CRP level after surgery	1-7 days after surgery	Changes in concentration of serum CRP level after surgery (between baseline and peak value within 1 week after surgery)

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of