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

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.

Conditions

• Comprehensive Complication Index

Interventions

DEVICE

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.

Sponsors & Collaborators

• Peking University International Hospital

  collaborator OTHER

• Wang Jing Hospital

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Siyang County Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• Henan Provincial Chest Hospital

  collaborator OTHER

• Fuzhou First Hospital

  collaborator UNKNOWN

• Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui University of Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Mindong Hospital of Ningde

  collaborator UNKNOWN

• The Fifth Hospital of Xiamen

  collaborator UNKNOWN

• People's Hospital of Ningxia Hui Autonomous Region

  collaborator OTHER

• The First People's Hospital of Changzhou

  collaborator OTHER

• The Fifth hospital of Deyang

  collaborator UNKNOWN

• Suzhou Municipal Hospital

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Yiyang Central Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Peng Ding Shan Shi Zhong Yi Yi Yuan

  collaborator UNKNOWN

• Yueyang Central Hospital

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• Haimen District Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• The 910th Hospital

  collaborator UNKNOWN

• The Second Affiliated Hospital of Zhejiang Chinese Medical University

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Affiliated Hospital of Jiangsu University

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Jilin City Hospital of Chemical Industry

  collaborator UNKNOWN

• Creen Hospital-465

  collaborator UNKNOWN

• Wuhan Central Hospital

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Shanghai Tong Ren Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Emergency General Hospital

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• Civil Aviation General Hospital

  collaborator OTHER

• Peking University Shougang Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Chinese PLA Central Hospital

  collaborator UNKNOWN

• Beijing Tsinghua Chang Gung Hospital

  lead OTHER

Principal Investigators

• Lan Yao · Peking University International Hospital

• Hui Q Xu · Wangjing Hospital, China Academy of Chinese Medical Sciences

• Yan Liu · ZhuHai Hospital

• Qi Pan · Beijing Hospital

• Jian H Jia · Siyang County Hospital of Traditional Chinese Medicine

• Yi K Zhu · Second Hospital of Shanxi Medical University

• Ke F Shi · Henan Provincial Chest Hospital

• Fang F Zhang · Fuzhou First Hospital

• Xiu Zh Wang · Pinggu District Hospital of Traditional Chinese Medicine

• Feng Hong · The First Affiliated Hospital of Anhui University of Chinese Medicine

• Ying J Hao · The First Affiliated Hospital of Zhengzhou University

• Yi Q Cai · Mindong Hospital of Ningde

• Lin Shen · Heze Hospital of Traditional Chinese Medicine

• Jin L Liang · The Fifth Hospital of Xiamen

• Zhen Wang · People's Hospital of Ningxia Hui Autonomous Region

• Hong W Ye · The First People's Hospital of Changzhou

• Qin Wang · The Fifth hospital of Deyang

• Jian P Qiu · Suzhou Municipal Hospital

• Bo Liao · Tang-Du Hospital

• Xin J Liu · Yiyang Central Hospital

• Guo Sh Gu · Anhui No.2 Provincial People's Hospital

• Li Quan · First Affiliated Hospital of Xinjiang Medical University

• Li R Ma · Peng Ding Shan Shi Zhong Yi Yi Yuan

• Zhi B Zhao · The First People's Hospital of Lianyungang

• Xin Lu · Haimen District Traditional Chinese Medicine Hospital

• Feng Zhou · Yueyang Central Hospital

• Xiao D Yin · Zhe Cheng TCM Hospital

• Li T Zhang · The 910th Hospital

• Yu Zh He · The Second Affiliated Hospital of Zhejiang Chinese Medical University

• Xiao M Zhang · The first People's Hospital of Zhengzhou

• Yu H Jiang · Beijing Tiantan Hospital

• Peng Jiang · Affiliated Hospital of Jiangsu University

• Xiao Y Li · The First Affiliated Hospital of Zhengzhou University

• Zhi H Liu · Liaocheng People's Hospital Zhiheng Liu

• Jin C Yang · Beijing Chao Yang Hospital

• Xue L Zhu · The People's Hospital of Nanchuan, Chongqing

• Wen T Si · Zhengzhou Orthopaedic Hospital

• Lei Ning · Jilin City Hospital of Chemical Industry

• Li H Su · Creen Hospital-465

• Zhong J Wang · Wuhan Central Hospital

• Li P Ma · Beijing Anzhen Hospital

• Yu H Xu · Air Force Military Medical University, China

• Jiang M Yu · Tong Ren hospital Shanghai Jiao Tong university school of medicine

• Qing H Cheng · Emergency General Hospital

• Hui J Wang · Beijing Tongren Hospital, CMU

• Jun Wu · Heilongjiang provincial hospital

• Jun T Duan · Civil Aviation General Hospital

• Zheng G Guo · Peking University Shougang Hospital

• Xin Kuang · The People's Hospital of Longhua, Shenzhen

• Chang J Yu · The First Affiliated Hospital of Anhui Medical University

• Feng Liang · Chinese PLA Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-12

Primary Completion

2025-10-31

Completion

2025-12-31

Countries

• China

Study Locations