About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Continuous glucose monitoring (CGM) device
Treatment groups
Sponsors and collaborators
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