Diabetes Mellitus Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 68 |
| Est. completion date | August 31, 2024 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Kangbuk Samsung Hospital | DexCom, Inc. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Standard Deviation (SD) | SD value evaluated by CGM for 7 days after surgery | 1-7 days after surgery | |
| Secondary | Coefficient of variation (CV) | CV value evaluated by CGM for 7 days after surgery | 1-7 days after surgery | |
| Secondary | Mean glucose | Mean glucose value evaluated by CGM for 7 days after surgery | 1-7 days after surgery | |
| Secondary | Glucose management indicator (GMI) | GMI value evaluated by CGM for 7 days after surgery | 1-7 days after surgery | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Number of participants with pneumonia occurrence after surgery | Number of participants with pneumonia occurrence within 1 week after surgery | 1-7 days after surgery | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Mortality within 30 days of surgery | Mortality within 30 days of surgery | 1-30 days after surgery |
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