Randomized Prospective Controlled Trial to Investigate the Effect of Continuous Glucose Monitoring on Post-operative Glucose Control in patients with Type 2 Diabetes Mellitus Undergoing Coronary Artery Bypass Grafting
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009537
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 96
? Who voluntarily submitted a written consent to participate in the study
? Age 19 years or older, 85 years or younger
? BMI 18.5 kg/m2 or higher, below 35 kg/m2
? Confirmed as type 2 diabetes by the time of screening
- Cases confirmed as type 2 diabetes are defined as follows:
- On diabetes medications
- HbA1c 6.5% or higer
- Plasma glucose 126 mg/dL or higher with at least 8 hours of fasting
- Cases with typical symptoms of hyperglycemia, such as polydipsia, polyuria, and weight loss with a random plasma glucose of 200 mg/dL or more
? Taking oral diabetic medications or insulin along with lifestyle changes for type 2 diabetes
? Coronary artery bypass grafting planned at the Thoracic and Cardiovascular Surgery Department of Seoul National University Hospital due to coronary artery disease accompanied with type 2 diabetes
? Agreed to control blood glucose only via insulin, and not oral diabetic medications, when blood glucose control is necessary during the study
? HbA1c between 6.0% and 9.0% within the last 30 days prior to the study participation
? Agreed to apply CGM provided in the study
? Provided a written consent after being informed of the plan and method of study
? Able to participate throughout the expected study period
? History of use of real-time CGM within the last 3 months prior to study
- However, recent history of use of a professional blinded CGM is not excluded.
- History of use of a CGM that scans intermittently is not excluded.
? BMI 35 kg/m2 or more
? In cases of an accompanying disease or situation that is considered to pose a threat to the patient's safety
- Ex. Uncontrolled chronic medical/psychological conditions considered inappropriate to participate or progress in the study including severe psychological disorder, diagnosed of or suspected eating disorder, severe malignant tumor on treatment. The forementioned comorbidites or conditions are to be determined by the researcher.
? AST(aspartate aminotransferase) or ALT(alanine aminotransferase) exceeding 4 times the upper limit of normal range
? Renal glomerular filtration rate less than 30 mL/min/1.73m2
? Oral injectable steroids planned to be administered that is considered to affect plasma glucose and HbA1c measurements
- Example 1: Repeated administration of high-dose steroid for inflammatory arthritis or inflammatory bowel disease
- Example 2: Repeated administration of lumbar epidural steroids
- However, steroid administration with a stable maintenance dose, such as in cases of rheumatoid arthritis or Addison’s disease, is not excluded.
? When unable to attach the sensor due to skin abnormalities (burns, excessive body hair, inflammation, infection, urticaria, tattoos) in all areas where the CGM sensor can be attached
? Having severe allergic reactions to medical adhesives
? Taking hydroxyurea
? Taking intravenous vitamin C
? When assessed difficult to participate in the study by the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method