Clinical trial NCT06331923: Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Patients with Diabetes
Official title: Assessing the Effectiveness of Continuous Glucose Monitoring Compared with Conventional Monitoring in Enhancing Surgical Outcomes for Patients with Diabetes: a Multi-center, Parallel-arm, Randomized, Pragmatic Trial in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Comprehensive Complication Index
Keywords: comprehensive complication index
continuous glucose monitoring
perioperative
prognosis
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
name: Wang Jing Hospital
name: ZhuHai Hospital
name: Beijing Hospital
name: Siyang County Hospital of Traditional Chinese Medicine
name: Second Hospital of Shanxi Medical University
name: Henan Provincial Chest Hospital
name: Fuzhou First Hospital
name: Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital
name: The First Affiliated Hospital of Anhui University of Chinese Medicine
name: The First Affiliated Hospital of Zhengzhou University
name: Mindong Hospital of Ningde
name: The Fifth Hospital of Xiamen
name: People's Hospital of Ningxia Hui Autonomous Region
name: The First People's Hospital of Changzhou
name: The Fifth hospital of Deyang
name: Suzhou Municipal Hospital
name: Tang-Du Hospital
name: Yiyang Central Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Peng Ding Shan Shi Zhong Yi Yi Yuan
name: Yueyang Central Hospital
name: The First People's Hospital of Lianyungang
name: Haimen District Traditional Chinese Medicine Hospital
name: The 910th Hospital
name: The Second Affiliated Hospital of Zhejiang Chinese Medical University
name: Beijing Tiantan Hospital
name: Affiliated Hospital of Jiangsu University
name: Liaocheng People's Hospital
name: Beijing Chao Yang Hospital
name: Jilin City Hospital of Chemical Industry
name: Creen Hospital-465
name: Wuhan Central Hospital
name: Air Force Military Medical University, China
name: Shanghai Tong Ren Hospital
name: Beijing Anzhen Hospital
name: Emergency General Hospital
name: Beijing Tongren Hospital
name: Civil Aviation General Hospital
name: Peking University Shougang Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Chinese PLA Central Hospital
First posted: 2024-03-26
Enrollment: 10168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Abstract: Postoperative complications are important factors in reducing surgical quality and increasing healthcare costs. The CCI is an internationally recognized index to quantify postoperative complications. Patients with diabetes mellitus (DM) or IGT are more prone to developing dysglycemia during the perioperative period, which in turn leads to various types of complications and increased mortality, as evidenced by a significant increase in CCI. Our previous study confirmed that strict glucose management in the perioperative period can help reduce the incidence of postoperative complications such as surgical site infections (SSIs), but this strategy has not been replicated in the perioperative period due to the disadvantages of heavy and complex operations and the possible increased risk of concomitant hypoglycemia. CGM, with its advantages of portability, accuracy, real-time, and information-richness, has been used for precise glucose management in chronic diseases. A small number of prospective randomized controlled studies have previously demonstrated the existence of an improved effect of CGM on intraoperative glycemic management in major surgery. However, there are no real-world studies with large sample sizes to clarify the efficacy and safety of CGM in reducing CCI in patients with DM or IGT. This is where our research comes in. In this real-world study, we aim to clarify the role of perioperative CGM in improving both prognosis and efficacy of surgery.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged above 18 years;
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:

1. The patient refused;
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.

Primary outcomes:
measure: Comprehensive complication index
timeFrame: At 30-day follow-up
Secondary outcomes:
measure: Postoperative complications
timeFrame: At 1-7 day postoperatively and 30-day follow-up
measure: Mortality
timeFrame: At 30-day follow-up
measure: Perioperative glucose level
timeFrame: Perioperative glucose level will be monitored from the day of the enrollment to 7 days (at least 3 days) postoperatively.
measure: The length of the stay in the intensive care unit
timeFrame: At 30-day follow-up
measure: The overall hospitalization cost
timeFrame: At 30-day follow-up
Other outcomes:
measure: Incidence of postoperative infection
timeFrame: Within 30 days after surgery
measure: Incidence of major adverse cardiovascular event (MACE)
timeFrame: Within 30 days after surgery
measure: Incidence of stroke
timeFrame: Within 30 days after surgery
measure: The length of hospital stay
timeFrame: At 30-day follow-up
measure: Incidence of delirium
timeFrame: Within 30 days after surgery
Locations:
city: Beijing
country: China
facility: Zhifeng Gao
state: Beijing
Study officials:
affiliation: Peking University International Hospital
name: Lan Yao
role: PRINCIPAL_INVESTIGATOR
affiliation: Wangjing Hospital, China Academy of Chinese Medical Sciences
name: Hui Q Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: ZhuHai Hospital
name: Yan Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital
name: Qi Pan
role: PRINCIPAL_INVESTIGATOR
affiliation: Siyang County Hospital of Traditional Chinese Medicine
name: Jian H Jia
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Hospital of Shanxi Medical University
name: Yi K Zhu
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial Chest Hospital
name: Ke F Shi
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuzhou First Hospital
name: Fang F Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Pinggu District Hospital of Traditional Chinese Medicine
name: Xiu Zh Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Anhui University of Chinese Medicine
name: Feng Hong
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Ying J Hao
role: PRINCIPAL_INVESTIGATOR
affiliation: Mindong Hospital of Ningde
name: Yi Q Cai
role: PRINCIPAL_INVESTIGATOR
affiliation: Heze Hospital of Traditional Chinese Medicine
name: Lin Shen
role: PRINCIPAL_INVESTIGATOR
affiliation: The Fifth Hospital of Xiamen
name: Jin L Liang
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Ningxia Hui Autonomous Region
name: Zhen Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Changzhou
name: Hong W Ye
role: PRINCIPAL_INVESTIGATOR
affiliation: The Fifth hospital of Deyang
name: Qin Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Suzhou Municipal Hospital
name: Jian P Qiu
role: PRINCIPAL_INVESTIGATOR
affiliation: Tang-Du Hospital
name: Bo Liao
role: PRINCIPAL_INVESTIGATOR
affiliation: Yiyang Central Hospital
name: Xin J Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Anhui No.2 Provincial People's Hospital
name: Guo Sh Gu
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Li Quan
role: PRINCIPAL_INVESTIGATOR
affiliation: Peng Ding Shan Shi Zhong Yi Yi Yuan
name: Li R Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Lianyungang
name: Zhi B Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Haimen District Traditional Chinese Medicine Hospital
name: Xin Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Yueyang Central Hospital
name: Feng Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhe Cheng TCM Hospital
name: Xiao D Yin
role: PRINCIPAL_INVESTIGATOR
affiliation: The 910th Hospital
name: Li T Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Zhejiang Chinese Medical University
name: Yu Zh He
role: PRINCIPAL_INVESTIGATOR
affiliation: The first People's Hospital of Zhengzhou
name: Xiao M Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Yu H Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Jiangsu University
name: Peng Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Xiao Y Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaocheng People's Hospital Zhiheng Liu
name: Zhi H Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Chao Yang Hospital
name: Jin C Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: The People's Hospital of Nanchuan, Chongqing
name: Xue L Zhu
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhengzhou Orthopaedic Hospital
name: Wen T Si
role: PRINCIPAL_INVESTIGATOR
affiliation: Jilin City Hospital of Chemical Industry
name: Lei Ning
role: PRINCIPAL_INVESTIGATOR
affiliation: Creen Hospital-465
name: Li H Su
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Central Hospital
name: Zhong J Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Li P Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Military Medical University, China
name: Yu H Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Tong Ren hospital Shanghai Jiao Tong university school of medicine
name: Jiang M Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency General Hospital
name: Qing H Cheng
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tongren Hospital, CMU
name: Hui J Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Heilongjiang provincial hospital
name: Jun Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Civil Aviation General Hospital
name: Jun T Duan
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Shougang Hospital
name: Zheng G Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: The People's Hospital of Longhua, Shenzhen
name: Xin Kuang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Chang J Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA Central Hospital
name: Feng Liang
role: PRINCIPAL_INVESTIGATOR
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