Cardiac Disease, PreDiabetes, Diabetes Mellitus
Conditions
Keywords
continuous glucose monitoring
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.
Interventions
DEVICEDexcom G6
Glycemic control was monitored using CGM data for seven days following cardiac surgery
DEVICESMBG or venous/arterial blood glucose
Glycemic control was monitored using SMBG or venous/arterial blood glucose data for seven days following cardiac surgery
Sponsors
DexCom, Inc.
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Treatment group: glycemic control using CGM Control group: glycemic control using arterial/venous blood sampling and POCT glucose
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time within the target range of 100-180 mg/dL | 1-7 days after surgery | Time within the target range of 100-180 mg/dL as assessed by CGM for 7 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time within the target range of 100-140 mg/dL | 1-7 days after surgery | Time within the target range of 100-140 mg/dL as assessed by CGM for 7 days after surgery |
| Time within the target range of 70-180 mg/dL | 1-7 days after surgery | Time within the target range of 70-180 mg/dL as assessed by CGM for 7 days after surgery |
| Time to reach <70 mg/dL | 1-7 days after surgery | Time to reach \<70 mg/dL as assessed by CGM for 7 days after surgery |
| Time to reach <54 mg/dL | 1-7 days after surgery | Time to reach \<54 mg/dL as assessed by CGM for 7 days after surgery |
| Time to reach >180 mg/dL | 1-7 days after surgery | Time to reach \>180 mg/dL as assessed by CGM for 7 days after surgery |
| Time to reach >250 mg/dL | 1-7 days after surgery | Time to reach \>250 mg/dL as assessed by CGM for 7 days after surgery |
| Standard Deviation (SD) | 1-7 days after surgery | SD value evaluated by CGM for 7 days after surgery |
| Coefficient of variation (CV) | 1-7 days after surgery | CV value evaluated by CGM for 7 days after surgery |
| Mean glucose | 1-7 days after surgery | Mean glucose value evaluated by CGM for 7 days after surgery |
| Mortality within 30 days of surgery | 1-30 days after surgery | Mortality within 30 days of surgery |
| 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 of ICU hospitalization |
| 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 days hospitalized after surgery |
| Number of participants with pneumonia occurrence after surgery | 1-7 days after surgery | Number of participants with pneumonia occurrence within 1 week after surgery |
| Number of participants with wound infection occurrence after surgery | 1-7 days after surgery | Number of participants with wound infection occurrence within 1 week after surgery |
| Number of participants who underwent CRRT implementation after surgery | 1-7 days after surgery | Number of participants who underwent CRRT implementation within 1 week after surgery |
| Number of participants with Atrial fibrillation occurrence after surgery | 1-7 days after surgery | Number of participants with Atrial fibrillation occurrence within 1 week after surgery |
| Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery | 1-7 days after surgery | Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence within 1 week after surgery |
| Changes in concentration of serum CRP level after surgery | 1-7 days after surgery | Changes in concentration of serum CRP level after surgery (between baseline and peak value within 1 week after surgery) |
| Glucose management indicator (GMI) | 1-7 days after surgery | GMI value evaluated by CGM for 7 days after surgery |
Countries
South Korea
Contacts
Primary ContactCheol-Young Park, MD, PhD
Backup ContactSun Joon Moon, MD
Outcome results
None listed