Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Patients with Diabetes
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
Beijing Tsinghua Chang Gung Hospital
10,168 participants
Apr 12, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Patients aged above 18 years;
- Patients with diabetes mellitus or impaired glucose tolerance;
- Expected major thoracic and abdominal surgery (except cardiac surgery; including endoscopic surgery and robotic surgery), open orthopedic surgery, neurosurgery;
- Volunteered for this study and written informed consent.
Exclusion Criteria6
- The patient refused;
- The time between wearing CGM sensor and surgical skin incision cannot meet 6 hours or more;
- Expected monitoring time less than 72 hours in CGM group;
- Patients had comorbidities that affected the evaluation of endpoints;
- The attending physician thought that the patient had inappropriate indications for enrollment;
- Participants were involved in other studies that interfered with the evaluation of the results of this study.
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Interventions
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(1)
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NCT06331923