Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331923
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-18
Brief Title:
Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Diabetic Patients
Sponsor:
Beijing Tsinghua Chang Gung Hospital
Organization:
Beijing Tsinghua Chang Gung Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 pragmatic11ratio randomized parallel-group controlled trial which consisted of a 1 to 3-day screening period and a 7-dayat 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 11 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 Glucoseblood 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 glucoseglucose 10 mmolL and HbA1c70 For emergency surgery the decision whether the participants 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 45-10mmolL Participants in both groups will be given glucose to elevate blood glucose when blood glucose was found to be45 mmolL or insulin when blood glucose was found to be 10 mmolL 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 39 mmolL or largest amplitude of glycemic excursions LAGE44 mmolL was found in the last 2 h the dose or rate of glucoseinsulin administration will be adjusted as appropriate
3 Postoperatively The target of blood glucose management in the early postoperative period is 45-78 mmolL According to the institutional practice and the supervising physicians experience participants in both groups will be treated with glucose to elevate blood glucose when blood glucose was found to be 45 mmolL and will be treated with insulin to lower blood glucose when blood glucose was found to be 78 mmolLIn the CGM group if excessive blood glucose variability was found including coefficient of variation CV36 LAGE44 mmolL postprandial glucose excursions of three dinners PPGE22mmolL standard deviation of blood glucose SDBG20 mmolL or time in range TIR70 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 randomization1234567 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
This is an investigator-initiated multi-center pragmatic11ratio randomized parallel-group controlled trial which consisted of a 1 to 3-day screening period and a 7-dayat 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 11 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 Glucoseblood 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 glucoseglucose 10 mmolL and HbA1c70 For emergency surgery the decision whether the participants 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 45-10mmolL Participants in both groups will be given glucose to elevate blood glucose when blood glucose was found to be45 mmolL or insulin when blood glucose was found to be 10 mmolL 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 39 mmolL or largest amplitude of glycemic excursions LAGE44 mmolL was found in the last 2 h the dose or rate of glucoseinsulin administration will be adjusted as appropriate
3 Postoperatively The target of blood glucose management in the early postoperative period is 45-78 mmolL According to the institutional practice and the supervising physicians experience participants in both groups will be treated with glucose to elevate blood glucose when blood glucose was found to be 45 mmolL and will be treated with insulin to lower blood glucose when blood glucose was found to be 78 mmolLIn the CGM group if excessive blood glucose variability was found including coefficient of variation CV36 LAGE44 mmolL postprandial glucose excursions of three dinners PPGE22mmolL standard deviation of blood glucose SDBG20 mmolL or time in range TIR70 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 randomization1234567 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None