Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Disease PreDiabetes Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CGM arm

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

Group Type EXPERIMENTAL

Dexcom G6

Intervention Type DEVICE

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

SMBG or venous/arterial glucose arm

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

Group Type ACTIVE_COMPARATOR

SMBG or venous/arterial blood glucose

Intervention Type DEVICE

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

Interventions

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Dexcom G6

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No