Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; PreDiabetes; Cardiac Disease
• Intervention / Treatment: Device: Dexcom G6; Device: SMBG or venous/arterial blood glucose

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheol-Young Park, MD, PhD; Phone Number: +82220011550; Email: cydoctor68@gmail.com
• Study Contact Backup: Name: Sun Joon Moon, MD; Phone Number: +82220011550; Email: ipleat.m@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03181
    • Recruiting
    • Kangbuk Samsung Hospital
    • Contact: Sun Joon Moon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM arm; Glycemic control was monitored using CGM data for seven days following cardiac surgery	Device: Dexcom G6; Glycemic control was monitored using CGM data for seven days following cardiac surgery
Active Comparator: SMBG or venous/arterial glucose arm; Glycemic control was monitored using SMBG or venous/arterial glucose data for seven days following cardiac surgery	Device: SMBG or venous/arterial blood glucose; Glycemic control was monitored using SMBG or venous/arterial blood glucose data for seven days following cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time within the target range of 100-180 mg/dL	Time within the target range of 100-180 mg/dL as assessed by CGM for 7 days after surgery	1-7 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Collaborators: DexCom, Inc.
• Investigators: Study Director: Sun Joon Moon, MD, Kangbuk Samsung Hospital, Sungkyunkwan University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: continuous glucose monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: KBSMC 2022-07-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes