Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

Kangbuk Samsung Hospital

Status: Enrolling

Conditions: Cardiac Disease; Diabetes Mellitus; PreDiabetes

Treatments: Device: Dexcom G6; Device: SMBG or venous/arterial blood glucose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06275971

KBSMC 2022-07-006

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

CGM arm

Experimental group

Description:

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

Treatment:

Device: Dexcom G6

SMBG or venous/arterial glucose arm

Active Comparator group

Description:

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

Treatment:

Device: SMBG or venous/arterial blood glucose