Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

NCT06275971 | Recruiting DMC FDA Device

• 1 other identifier: KBSMC 2022-07-006
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; PreDiabetes; Diabetes Mellitus

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Time within the target range of 100-140 mg/dL

  1-7 days after surgery

• Time within the target range of 70-180 mg/dL

  1-7 days after surgery

• Time to reach <70 mg/dL

  1-7 days after surgery

• Time to reach <54 mg/dL

  1-7 days after surgery

• Time to reach >180 mg/dL

  1-7 days after surgery

Study Arms (2)

CGM arm

EXPERIMENTAL

Glycemic control was monitored using CGM data for seven days following cardiac surgery

Device: Dexcom G6

SMBG or venous/arterial glucose arm

ACTIVE COMPARATOR

Glycemic control was monitored using SMBG or venous/arterial glucose data for seven days following cardiac surgery

Device: SMBG or venous/arterial blood glucose

Interventions

Dexcom G6 DEVICE

Glycemic control was monitored using CGM data for seven days following cardiac surgery

CGM arm

SMBG or venous/arterial blood glucose DEVICE

Glycemic control was monitored using SMBG or venous/arterial blood glucose data for seven days following cardiac surgery

SMBG or venous/arterial glucose arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• hours 75g-OGTT 140 mg/dL or more

You may not qualify if:

• 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
• Others who are deemed unsuitable for research progression at the researcher's discretion

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Related Publications (1)

• Moon SJ, Kim MS, Kim YT, Lee HE, Lee YW, Lee SJ, Chung ES, Park CY. Use of an insulin titration protocol based on continuous glucose monitoring in postoperative cardiac surgery patients with type 2 diabetes and prediabetes: a randomized controlled trial. Cardiovasc Diabetol. 2025 May 14;24(1):210. doi: 10.1186/s12933-025-02747-z.

  PMID: 40369552 DERIVED

MeSH Terms

Conditions

Heart Diseases; Prediabetic State; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sun Joon Moon, MD

  Kangbuk Samsung Hospital, Sungkyunkwan University

  STUDY DIRECTOR

Central Study Contacts

Cheol-Young Park, MD, PhD

CONTACT

+82220011550; cydoctor68@gmail.com

Sun Joon Moon, MD

CONTACT

+82220011550; ipleat.m@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD. PhD

Model Details: Treatment group: glycemic control using CGM Control group: glycemic control using arterial/venous blood sampling and POCT glucose

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 23, 2024
• Study Start: November 24, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)