Effects of Intraoperative Glycemic Management Strategies Assisted with RT-CGM on TIR and Postoperative Recovery

Effects of Intraoperative Glycemic Management Strategies Assisted with RT-CGM on TIR and Postoperative Recovery During Pancreaticoduodenectomy: a Randomized Controlled Trial

The purpose of this study is to investigate the effect of intraoperative blood glucose management based on real-time continuous glucose monitoring ( RT-CGM) on time in range (TIR) and postoperative recovery during pancreaticoduodenectomy. The primary outcome is intraoperative TIR. Additionally, it aims to compare the differences in other glucose metrics, quality of postoperative recovery, and 30-day postoperative complications and mortality between the two glycemic management methods .

Study Overview

• Status: Not yet recruiting
• Conditions: Continuous Glucose Monitoring
• Intervention / Treatment: Device: RT-CGM; Device: Control

Detailed Description

Pancreaticoduodenectomy (PD) is the standard surgical procedure for treating malignancies of the pancreatic head, distal bile duct, and periampullary region. Due to its extensive scope, high demands for anastomosis, and prolonged operative time, PD is considered one of the most complex surgeries in general surgery. Perioperative management of PD presents unique challenges, particularly in glycemic control. In addition to stress-induced hyperglycemia caused by surgery, Patients with PD are more prone to perioperative glycemic disturbances compared to other surgeries. The main reasons include insulin resistance, resection of pancreatic tissue during surgery, and early postoperative nutritional support. However, perioperative glycemic management guidelines often receive limited attention. Several studies have reported low adherence to recommendations for glycemic monitoring and insulin administration among healthcare professionals. This issue is also evident during the perioperative period of PD, where demanding workloads may lead to neglect of glycemic management, and insulin therapy poses risks of hypoglycemia.

Continuous glucose monitoring (CGM) technology uses subcutaneous electrodes to monitor interstitial glucose levels electronically. RT-CGM provides continuous, comprehensive, and reliable glycemic data, capturing trends and fluctuations in glucose levels, and identifying hidden hyperglycemia and hypoglycemia. It overcomes the limitations of traditional glucose monitoring, such as pain from finger pricks, delayed assessments, and an inability to reflect glucose variability. The latest diabetes guidelines in China and the United States incorporate Time in Range (TIR), derived from CGM, as a new metric for glycemic control. CGM is gradually being used in glycemic management for diabetic patients, and its efficacy and safety have been consistently demonstrated in randomized controlled trials and real-world studies. A randomized controlled trial involving 299 patients with type 2 diabetes showed that CGM improved TIR by 7.9% over 12 months compared to fingerstick glucose monitoring.

Pancreaticoduodenectomy (PD) is the standard surgical procedure for treating malignancies of the pancreatic head, distal bile duct, and periampullary region. Due to its extensive scope, the high demands for anastomosis, and prolonged operative time, PD is considered one of the most complex surgeries in general surgery. Perioperative management of PD presents unique challenges, particularly in glycemic control. In addition to stress-induced hyperglycemia caused by surgery, patients undergoing PD are more susceptible to perioperative glycemic disturbances than those undergoing other types of surgery. The primary factors contributing to this include insulin resistance, the resection of pancreatic tissue during surgery, and early postoperative nutritional support. However, perioperative glycemic management guidelines often receive limited attention, with several studies reporting poor adherence to recommendations for glycemic monitoring and insulin administration among healthcare professionals. This issue is particularly evident during the perioperative period of PD, where heavy workloads may lead to neglect of glycemic management, and insulin therapy may increase the risk of hypoglycemia.

Continuous glucose monitoring (CGM) technology uses subcutaneous electrodes to electronically monitor interstitial glucose levels. Real-time CGM (RT-CGM) provides continuous, comprehensive, and reliable glycemic data, capturing glucose trends and fluctuations while identifying hidden hyperglycemia and hypoglycemia. It overcomes the limitations of traditional glucose monitoring, such as pain from finger pricks, delayed assessments, and an inability to reflect glucose variability. Both China and the United States have incorporated Time in Range (TIR) from CGM data as a key metric for glycemic control in their latest diabetes guidelines. CGM is increasingly used for managing glycemia in diabetic patients, with its efficacy and safety consistently demonstrated in randomized controlled trials and real-world studies. For instance, a randomized controlled trial with 299 patients with type 2 diabetes found that CGM improved TIR by 7.9% over 12 months compared to fingerstick glucose monitoring.

In recent years, the use of CGM has expanded to hospitalized patients, and its adoption is growing in clinical settings. However, compared to medical inpatients and ICU patients, surgical patients rarely use CGM, and studies on its use during surgery are limited. CGM systems measure interstitial glucose every minute and provide real-time alerts for values outside the target range. These alerts help clinicians intervene promptly to manage perioperative hyperglycemia or hypoglycemia, minimizing risks and reducing the burden of traditional blood glucose testing on both patients and medical staff. This study explores the benefits of CGM-assisted glycemic management during PD, promoting dynamic and precise glycemic control during PD.

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Le Shen, PhD; Phone Number: 13810248138; Email: pumchshenle@163.com
• Study Contact Backup: Name: Le Zhang, Master; Phone Number: 18801372430; Email: 3240348551@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18
• Scheduled for pancreaticoduodenectomy
• ASA classification I-III

Exclusion Criteria:

• Emergency surgery
• scheduled for MRI the day before surgery
• Allergy to CGM sensor
• Communication barriers or refusal to participate
• BMI < 18.5 kg/m²

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RT-CGM; Intraoperative blood glucose monitoring and management based on a real-time RT-CGM system.	Device: RT-CGM; In the RT-CGM group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol/L, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. RT-CGM monitoring will also be employed during surgery. A tablet in the operating room will be configured with low and high glucose alerts set at 3.9 mmol/L and 10.0 mmol/L, respectively. When an alarm is triggered, arterial blood gases will be rechecked, and glucose levels will be adjusted based on the arterial blood glucose results. If interstitial glucose values do not reach the intervention threshold, arterial blood gas measurements are recommended every 30 minutes.
Other: Control; Patients enrolled in the control group will have the CGM sensor attached the day before surgery but the CGM , interstitial glucose readings, and alerts will be masked during the operation.	Device: Control; In the control group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol/L, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. CGM monitoring will also be employed during surgery, but the CGM interstitial glucose readings and alerts will be masked during the operation. The final intraoperative glucose management approach will be determined by the anesthesiologist, considering the patient's condition and surgical circumstances. The anesthesiologist can choose the intravenous insulin adjustment protocol we recommend.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative time in range (TIR)	Time in range (TIR) from CGM generally refers to the percentage of time that glucose levels stay within a target range (3.9-10 mmol/L)	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative insulin dosage	unit	during surgery
Intraoperative time above range (TAR)	Time above range (TAR) from CGM generally refers to the percentage of time glucose levels exceed the upper limit of the target range (>180 mg/dL).	during surgery
Intraoperative time below range (TBR)	Time below range (TBR) from CGM generally refers to the percentage of time glucose levels fall below the lower limit of the target range (<70 mg/dL).	during surgery
Intraoperative mean glucose	The average glucose level recorded by the CGM over a specified period	during surgery
Intraoperative coefficient of variation (CV)	Coefficient of variation (CV) from CGM generally refers to the degree of fluctuation in glucose levels, typically expressed as a percentage of the coefficient of variation.	during surgery
Postoperative time in range (TIR)	Time in range (TIR) from CGM generally refers to the percentage of time that glucose levels stay within a target range (3.9-10 mmol/L)	Throughout the 72 hours after surgery
Postraoperative time above range (TAR)	Time above range (TAR) from CGM generally refers to the percentage of time glucose levels exceed the upper limit of the target range (>180 mg/dL).	Throughout the 72 hours after surgery
Postoperative time below range (TBR)	Time below range (TBR) from CGM generally refers to the percentage of time glucose levels fall below the lower limit of the target range (<70 mg/dL).	Throughout the 72 hours after surgery
Postoperative mean glucose	The average glucose level recorded by the CGM over a specified period	Throughout the 72 hours after surgery
Postoperative coefficient of variation (CV)	Coefficient of variation (CV) from CGM generally refers to the degree of fluctuation in glucose levels, typically expressed as a percentage of the coefficient of variation.	Throughout the 72 hours after surgery
Quality of Recovery-15 score on the third day after surgery	Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score ranging from 0 to 150 is the Quality of Recovery-15 score of the patient. A higher score indicates a better quality of recovery.	on the third day after surgery
The rate of surgery-related complications	surgery-related complications including clinically relevent postoperative pancreatic fistula,bile leakage,chyle leak,postpancreatectomy hemorrhage,abdominal infection,delayed gastric emptying.	30 days after surgery
Quality of Recovery-15 score on the 30th day after surgery	Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score ranging from 0 to 150 is the Quality of Recovery-15 score of the patient. A higher score indicates a better quality of recovery.	on the 30th day after surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Le Shen, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy; time in range; glycemic management
• Other Study ID Numbers: 2023-I2M-CT-B-028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No