Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Patients with Diabetes
NCT ID: NCT06331923
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
10168 participants
INTERVENTIONAL
2024-04-12
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes
NCT07007676
Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
NCT01992965
The Application of Continuous Blood Glucose Monitoring in Optimizing the Management of Type 2 Diabetes
NCT07097415
Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital
NCT05941286
Clinical Evaluation of Non-invasive Blood Glucose Meter
NCT06796322
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is an investigator-initiated, multi-center, pragmatic,1:1ratio randomized, parallel-group, controlled trial which consisted of a 1 to 3-day screening period, and a 7-day(at least 3-day) intervention period, with a final evaluation at day 30. A total of approximately 10168 patients (≥ 18 years of age) with DM or IGT undergoing elective surgeries (including major thoracoabdominal surgery \[excluding cardiac surgery\], open orthopedic surgery, or neurosurgery) will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized into two groups (CGM group versus C group) according to the 1:1 ratio after offering informed content.
Glucose monitoring models:
1. CGM group: A CGM prescription will be issued by the attending physician at least 6 hours before surgery. The primary nurse in charge will educate the participant and their family members on the proper wearing and connection of the CGM device. The calibration frequency and interval of preoperative and postoperative glucose monitoring devices will be determined based on institutional diagnostic and treatment guidelines and the requirements of the monitoring device used. Intraoperative glucose calibration will be performed immediately upon admission, immediately after surgical incision, every 2 hours after surgical incision, and at the completion of wound closure.
2. C group: Perioperative glucose monitoring will be conducted based on institutional diagnostic and treatment guidelines.
3. Glucose/blood glucose monitoring will be continued for both groups of patients until postoperative day 7 or discharge.
Perioperative glucose management:
1. Preoperatively: For elective surgery, preoperative fasting blood glucose/glucose ≤10 mmol/L and HbA1c≤7.0%. For emergency surgery, the decision whether the participant's current blood glucose level is acceptable for surgical treatment is based on institutional practice and the experience of the physician in charge.
2. Intraoperatively: Blood glucose level will be set at 4.5-10mmol/L. Participants in both groups will be given glucose to elevate blood glucose when blood glucose was found to be≤4.5 mmol/L, or insulin when blood glucose was found to be ≥10 mmol/L. Drug dosages and administration methods will follow the medical practice of the institution and the anaesthesiologist in charge. In the CGM group, if mean amplitude of glycemic excursions (MAGE) ≥3.9 mmol/L or largest amplitude of glycemic excursions (LAGE)≥4.4 mmol/L was found in the last 2 h, the dose or rate of glucose/insulin administration will be adjusted as appropriate.
3. Postoperatively: The target of blood glucose management in the early postoperative period is 4.5-7.8 mmol/L. According to the institutional practice and the supervising physician's experience, participants in both groups will be treated with glucose to elevate blood glucose when blood glucose was found to be ≤4.5 mmol/L, and will be treated with insulin to lower blood glucose when blood glucose was found to be ≥7.8 mmol/L.In the CGM group, if excessive blood glucose variability was found, including coefficient of variation (CV)≥36%, LAGE≥4.4 mmol/L, postprandial glucose excursions of three dinners (PPGE)≥2.2mmol/L, standard deviation of blood glucose (SDBG)≥2.0 mmol/L or time in range (TIR)≤70%, an endocrinologist will aid in adjusting the blood glucose management programme.
The primary objective is to observe the improvement of CGM on the surgical outcomes of participants with DM or IGT, including a reduction in the CCI, overall postoperative infection rate, major adverse cardiovascular events (MACE) rate, and shortened postoperative hospital stay within 30 days after surgery.
The study consists of 9 visits including the day of screening and randomization,1,2,3,4,5,6,7 and 30-day follow-up postoperatively.
Demographic information, symptoms and signs, laboratory test, auxiliary examinations, CCIs will be recorded during the program. The trial is anticipated to last from April 2024 to December 2025 with 10168 subjects recruited from 50 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by the ethics committee of Beijing Tsinghua Chang Gung Hospital and corresponding branch centers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CGM group
Participants who receive continuous glucose monitoring (CGM) during the perioperative period. Glucose monitoring should be continued until the 7th day after surgery or discharge.
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.
Control group
Perioperative blood glucose monitoring was performed according to institutional treatment guidelines.Glucose monitoring should be continued until the 7th day after surgery or discharge.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with diabetes mellitus or impaired glucose tolerance;
3. Expected major thoracic and abdominal surgery (except cardiac surgery; including endoscopic surgery and robotic surgery), open orthopedic surgery, neurosurgery;
4. Volunteered for this study and written informed consent.
Exclusion Criteria
2. The time between wearing CGM sensor and surgical skin incision cannot meet 6 hours or more;
3. Expected monitoring time less than 72 hours in CGM group;
4. Patients had comorbidities that affected the evaluation of endpoints;
5. The attending physician thought that the patient had inappropriate indications for enrollment;
6. Participants were involved in other studies that interfered with the evaluation of the results of this study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University International Hospital
OTHER
Wang Jing Hospital
OTHER
ZhuHai Hospital
OTHER
Beijing Hospital
OTHER_GOV
Siyang County Hospital of Traditional Chinese Medicine
UNKNOWN
Second Hospital of Shanxi Medical University
OTHER
Henan Provincial Chest Hospital
OTHER
Fuzhou First Hospital
UNKNOWN
Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital
OTHER
The First Affiliated Hospital of Anhui University of Chinese Medicine
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Mindong Hospital of Ningde
UNKNOWN
The Fifth Hospital of Xiamen
UNKNOWN
People's Hospital of Ningxia Hui Autonomous Region
OTHER
The First People's Hospital of Changzhou
OTHER
The Fifth hospital of Deyang
UNKNOWN
Suzhou Municipal Hospital
OTHER
Tang-Du Hospital
OTHER
Yiyang Central Hospital
UNKNOWN
First Affiliated Hospital of Xinjiang Medical University
OTHER
Peng Ding Shan Shi Zhong Yi Yi Yuan
UNKNOWN
Yueyang Central Hospital
OTHER
The First People's Hospital of Lianyungang
OTHER
Haimen District Traditional Chinese Medicine Hospital
UNKNOWN
The 910th Hospital
UNKNOWN
The Second Affiliated Hospital of Zhejiang Chinese Medical University
OTHER
Beijing Tiantan Hospital
OTHER
Affiliated Hospital of Jiangsu University
OTHER
Liaocheng People's Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Jilin City Hospital of Chemical Industry
UNKNOWN
Creen Hospital-465
UNKNOWN
Wuhan Central Hospital
OTHER
Air Force Military Medical University, China
OTHER
Shanghai Tong Ren Hospital
OTHER
Beijing Anzhen Hospital
OTHER
Emergency General Hospital
OTHER
Beijing Tongren Hospital
OTHER
Civil Aviation General Hospital
OTHER
Peking University Shougang Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Chinese PLA Central Hospital
UNKNOWN
Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhifeng Gao
Deputy director, Department of Anesthesiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lan Yao
Role: PRINCIPAL_INVESTIGATOR
Peking University International Hospital
Hui Q Xu
Role: PRINCIPAL_INVESTIGATOR
Wangjing Hospital, China Academy of Chinese Medical Sciences
Yan Liu
Role: PRINCIPAL_INVESTIGATOR
ZhuHai Hospital
Qi Pan
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Jian H Jia
Role: PRINCIPAL_INVESTIGATOR
Siyang County Hospital of Traditional Chinese Medicine
Yi K Zhu
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Shanxi Medical University
Ke F Shi
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Chest Hospital
Fang F Zhang
Role: PRINCIPAL_INVESTIGATOR
Fuzhou First Hospital
Xiu Zh Wang
Role: PRINCIPAL_INVESTIGATOR
Pinggu District Hospital of Traditional Chinese Medicine
Feng Hong
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Anhui University of Chinese Medicine
Ying J Hao
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Yi Q Cai
Role: PRINCIPAL_INVESTIGATOR
Mindong Hospital of Ningde
Lin Shen
Role: PRINCIPAL_INVESTIGATOR
Heze Hospital of Traditional Chinese Medicine
Jin L Liang
Role: PRINCIPAL_INVESTIGATOR
The Fifth Hospital of Xiamen
Zhen Wang
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Ningxia Hui Autonomous Region
Hong W Ye
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Changzhou
Qin Wang
Role: PRINCIPAL_INVESTIGATOR
The Fifth hospital of Deyang
Jian P Qiu
Role: PRINCIPAL_INVESTIGATOR
Suzhou Municipal Hospital
Bo Liao
Role: PRINCIPAL_INVESTIGATOR
Tang-Du Hospital
Xin J Liu
Role: PRINCIPAL_INVESTIGATOR
Yiyang Central Hospital
Guo Sh Gu
Role: PRINCIPAL_INVESTIGATOR
Anhui No.2 Provincial People's Hospital
Li Quan
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Xinjiang Medical University
Li R Ma
Role: PRINCIPAL_INVESTIGATOR
Peng Ding Shan Shi Zhong Yi Yi Yuan
Zhi B Zhao
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Lianyungang
Xin Lu
Role: PRINCIPAL_INVESTIGATOR
Haimen District Traditional Chinese Medicine Hospital
Feng Zhou
Role: PRINCIPAL_INVESTIGATOR
Yueyang Central Hospital
Xiao D Yin
Role: PRINCIPAL_INVESTIGATOR
Zhe Cheng TCM Hospital
Li T Zhang
Role: PRINCIPAL_INVESTIGATOR
The 910th Hospital
Yu Zh He
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Xiao M Zhang
Role: PRINCIPAL_INVESTIGATOR
The first People's Hospital of Zhengzhou
Yu H Jiang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Peng Jiang
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Jiangsu University
Xiao Y Li
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Zhi H Liu
Role: PRINCIPAL_INVESTIGATOR
Liaocheng People's Hospital Zhiheng Liu
Jin C Yang
Role: PRINCIPAL_INVESTIGATOR
Beijing Chao Yang Hospital
Xue L Zhu
Role: PRINCIPAL_INVESTIGATOR
The People's Hospital of Nanchuan, Chongqing
Wen T Si
Role: PRINCIPAL_INVESTIGATOR
Zhengzhou Orthopaedic Hospital
Lei Ning
Role: PRINCIPAL_INVESTIGATOR
Jilin City Hospital of Chemical Industry
Li H Su
Role: PRINCIPAL_INVESTIGATOR
Creen Hospital-465
Zhong J Wang
Role: PRINCIPAL_INVESTIGATOR
Wuhan Central Hospital
Li P Ma
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Yu H Xu
Role: PRINCIPAL_INVESTIGATOR
Air Force Military Medical University, China
Jiang M Yu
Role: PRINCIPAL_INVESTIGATOR
Tong Ren hospital Shanghai Jiao Tong university school of medicine
Qing H Cheng
Role: PRINCIPAL_INVESTIGATOR
Emergency General Hospital
Hui J Wang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital, CMU
Jun Wu
Role: PRINCIPAL_INVESTIGATOR
Heilongjiang provincial hospital
Jun T Duan
Role: PRINCIPAL_INVESTIGATOR
Civil Aviation General Hospital
Zheng G Guo
Role: PRINCIPAL_INVESTIGATOR
Peking University Shougang Hospital
Xin Kuang
Role: PRINCIPAL_INVESTIGATOR
The People's Hospital of Longhua, Shenzhen
Chang J Yu
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Anhui Medical University
Feng Liang
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA Central Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhifeng Gao
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Duan Y, Ding L, Gao Z, Wang Y, Cao H, Zhang H, Yao L. Assessing the effectiveness of continuous glucose monitoring compared with conventional monitoring in enhancing surgical outcomes for patients with diabetes: protocol for a multicentre, parallel-arm, randomised, pragmatic trial in China. BMJ Open. 2025 Feb 18;15(2):e090664. doi: 10.1136/bmjopen-2024-090664.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1305-0484
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.