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Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Patients With Diabetes
Sponsor: Beijing Tsinghua Chang Gung Hospital
Summary
The goal of this multi-center, pragmatic, randomized controlled trial is to assess the effectiveness of continuous glucose monitoring (CGM) compared with conventional monitoring in enhancing surgical outcomes for diabetic patients. The main questions it aims to answer are: * To assess the effectiveness of CGM compared with conventional monitoring in reducing the comprehensive complication index (CCI) for patients with diabetes or impaired glucose tolerance (IGT) within 30 days after surgery. * To analyze the impact of different age groups, types of surgery, preoperative levels of HbA1c, and preoperative 24h glycemic variations on the improvement of surgical outcomes under the CGM model. Participants will receive CGM prescribed by the attending physician for at least 6 hours before surgery. Glucose monitoring should be continued until the 7th day after surgery or discharge. The investigators will compare conventional monitoring group to see if CGM could reduce the CCIs for patients with diabetes or impaired glucose tolerance within 30 days after surgery.
Official title: Assessing the Effectiveness of Continuous Glucose Monitoring Compared With Conventional Monitoring in Enhancing Surgical Outcomes for Patients With Diabetes: a Multi-center, Parallel-arm, Randomized, Pragmatic Trial in China
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
9877
Start Date
2024-04-12
Completion Date
2026-05-11
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Continuous glucose monitoring (CGM) device
Continuous glucose monitoring (CGM) will be prescribed by the attending physician for at least 6 hours before surgery. The supervising nurse will educate the patient and their family on the correct wearing and connection of the CGM device. The calibration frequency and interval of glucose monitoring devices before and after surgery should be determined according to institutional treatment guidelines and the requirements of the monitoring device used. Intraoperative glucose calibration should be done immediately upon entering the operating room, immediately after skin incision, every 2 hours after skin incision, and at the end of wound closure. Glucose monitoring should be continued until the 7th day after surgery or discharge.
Locations (8)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Department of Anesthesiology, Emergency General Hospital
Beijing, China
Department of Anesthesiology, Peking University International Hospital
Beijing, China
Department of Anesthesiology, Peking University Shougang Hospital
Beijing, China
Department of Endocrinology and Metabolism, Fuzhou First General Hospital Affiliated with Fujian Medical University
Fuzhou, China
Department of Anesthesiology, Yueyang Central Hospital
Hunan, China
Department of Endocrinology, Jilin Chemical Hospital
Jilin City, China
Department of Endocrinology and Metabolism, The Second Hospital of Shanxi Medical University
Shanxi, China