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

Comprehensive Complication Index Clinical Trial

Official title:

Assessing the Effectiveness of Continuous Glucose Monitoring Compared With Conventional Monitoring in Enhancing Surgical Outcomes for Diabetic Patients: A Multi-center, Pragmatic, Randomized Controlled Trial in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331923
• Other study ID #: U1111-1305-0484
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Zhi F Gao, M.D.
• Phone: +86 15801249466
• Email: btchgzf[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10168
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Comprehensive Complication Index

Intervention

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.

Locations

Country	Name	City	State
China	Zhifeng Gao	Beijing	Beijing

Sponsors (43)

Lead Sponsor

Collaborator

Beijing Tsinghua Chang Gung Hospital

Affiliated Hospital of Jiangsu University, Air Force Military Medical University, China, Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Hospital, Beijing Tiantan Hospital, Beijing Tongren Hospital, Chinese PLA Central Hospital, Civil Aviation General Hospital, Creen Hospital-465, Emergency General Hospital, First Affiliated Hospital of Xinjiang Medical University, Fuzhou First Hospital, Haimen District Traditional Chinese Medicine Hospital, Henan Provincial Chest Hospital, Jilin City Hospital of Chemical Industry, Liaocheng People's Hospital, Mindong Hospital of Ningde, Peking University International Hospital, Peking University Shougang Hospital, Peng Ding Shan Shi Zhong Yi Yi Yuan, People's Hospital of Ningxia Hui Autonomous Region, Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital, Second Hospital of Shanxi Medical University, Shanghai Tong Ren Hospital, Siyang County Hospital of Traditional Chinese Medicine, Suzhou Municipal Hospital, Tang-Du Hospital, The 910th Hospital, The Fifth hospital of Deyang, The Fifth Hospital of Xiamen, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Anhui University of Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, The First People's Hospital of Changzhou, The First People's Hospital of Lianyungang, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Wang Jing Hospital, Wuhan Central Hospital, Yiyang Central Hospital, Yueyang Central Hospital, ZhuHai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehensive complication index	The investigators will use the online tool(www.assesssurgery.com)to calculate every participant's cumulative comprehensive complication index (CCI) at 30-day follow-up. CCI is a validated prognostic assessment tool that calculates the total score of all complications weighted by severity, ranging from 0 (no complications) to 100 (death) for each patient. Higher values represent a worse outcome.	At 30-day follow-up
Secondary	Postoperative complications	Postoperative complications will be diagnosed abased on signs, symptoms, laboratory and auxiliary examinations.	At 1-7 day postoperatively and 30-day follow-up
Secondary	Morality	Morality will be expressed by the number and percentage of occurrences.	At 30-day follow-up
Secondary	The length of the stay in the intensive care unit	The investigators will search the medical archives of participants.	The day when the subject is discharged from hospital.
Secondary	The length of hospital stay	The investigators will search the medical archives of participants.	The day when the subject is discharged from hospital.
Secondary	The overall hospitalization cost	The investigators will search the medical archives of participants.	The day when the subject is discharged from hospital.
Secondary	Perioperative glucose level	CGM group: using CGM device; Control group: using conventional glucose monitoring, such as arterial blood gas, biochemistry examinations.	Perioperative glucose level will be monitored from the day of the enrollment to 7 days (at least 3 days) postoperatively.