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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM arm | Experimental | Glycemic control was monitored using CGM data for seven days following cardiac surgery |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 | Device | Glycemic control was monitored using CGM data for seven days following cardiac surgery |
|
| 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 |
| 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 |
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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
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)
Others who are deemed unsuitable for research progression at the researcher's discretion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheol-Young Park, MD, PhD | Contact | +82220011550 | cydoctor68@gmail.com | |
| Sun Joon Moon, MD | Contact | +82220011550 | ipleat.m@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sun Joon Moon, MD | Kangbuk Samsung Hospital, Sungkyunkwan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Recruiting | Seoul | 03181 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40369552 | Derived | 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. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Treatment group: glycemic control using CGM Control group: glycemic control using arterial/venous blood sampling and POCT glucose
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| 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 |
|
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 |
| D004700 | Endocrine System Diseases |