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.
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.
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;
Parallel
Continuous glucose monitoring (CGM) device
DeviceContinuous 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.
Comprehensive complication index
The investigators will use the online tool（www.assesssurgery.com）to calculate every participant's cumulative comprehensive complication index (CCI) at 30-day follow-up. CCI is a validated prognostic assessment tool that calculates the total score of all complications weighted by severity, ranging from 0 (no complications) to 100 (death) for each patient. Higher values represent a worse outcome.
Postoperative complications
Postoperative complications will be diagnosed abased on signs, symptoms, laboratory and auxiliary examinations.
Mortality
Mortality will be expressed by the number and percentage of occurrences.
Perioperative glucose level
CGM group: using CGM device; Control group: using conventional glucose monitoring, such as arterial blood gas, biochemistry examinations.
The length of the stay in the intensive care unit
The investigators will search the medical archives of participants.
Incidence of postoperative infection
Postoperative infection will be expressed by the number and percentage of occurrences.
Incidence of major adverse cardiovascular event (MACE)
MACE includes cardiovascular death, myocardial infarction, stroke, urgent revascularization, hospitalization for heart failure, recurrent angina, and severe arrhythmias. MACE rate will be expressed by the number and percentage of occurrences.
Incidence of stroke
Stroke will be assessed through clinical manifestations, auxiliary examinations, and relevant scale (National Institute of Health Stroke Scale \[NIHSS\]). NIHSS scale rangs from 0 to 42 for each patient. Higher values represent a worse outcome. Stroke rate will be expressed by the number and percentage of occurrences.
The length of hospital stay
The investigators will search the medical archives of participants.
Click on the lead sponsor to view all of their trials.
Beijing Tsinghua Chang Gung Hospital
Lead sponsor
Peking University International Hospital
Collaborator
Wang Jing Hospital
Collaborator
ZhuHai Hospital
Collaborator
Beijing Hospital
Collaborator
Siyang County Hospital of Traditional Chinese Medicine
Collaborator
Second Hospital of Shanxi Medical University
Collaborator
Henan Provincial Chest Hospital
Collaborator
Fuzhou First Hospital
Collaborator
Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital
Collaborator
The First Affiliated Hospital of Anhui University of Chinese Medicine
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Mindong Hospital of Ningde
Collaborator
The Fifth Hospital of Xiamen
Collaborator
People's Hospital of Ningxia Hui Autonomous Region
Collaborator
The First People's Hospital of Changzhou
Collaborator
The Fifth hospital of Deyang
Collaborator
Suzhou Municipal Hospital
Collaborator
Tang-Du Hospital
Collaborator
Yiyang Central Hospital
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Peng Ding Shan Shi Zhong Yi Yi Yuan
Collaborator
Yueyang Central Hospital
Collaborator
The First People's Hospital of Lianyungang
Collaborator
Haimen District Traditional Chinese Medicine Hospital
Collaborator
The 910th Hospital
Collaborator
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Collaborator
Beijing Tiantan Hospital
Collaborator
Affiliated Hospital of Jiangsu University
Collaborator
Liaocheng People's Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
Jilin City Hospital of Chemical Industry
Collaborator
Creen Hospital-465
Collaborator
Wuhan Central Hospital
Collaborator
Air Force Military Medical University, China
Collaborator
Shanghai Tong Ren Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
Emergency General Hospital
Collaborator
Beijing Tongren Hospital
Collaborator
Civil Aviation General Hospital
Collaborator
Peking University Shougang Hospital
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Chinese PLA General Hospital
Collaborator
