Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Patients with Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tsinghua Chang Gung Hospital

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

10,168 Participants
are divided into 2 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