Clinical trial NCT06755788: Effects of Intraoperative Glycemic Management Strategies Assisted with RT-CGM on TIR and Postoperative Recovery
Official title: Effects of Intraoperative Glycemic Management Strategies Assisted with RT-CGM on TIR and Postoperative Recovery During Pancreaticoduodenectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Continuous Glucose Monitoring
Keywords: glycemic management
pancreaticoduodenectomy
time in range
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative time in range (TIR)
timeFrame: during surgery
Secondary outcomes:
measure: Intraoperative insulin dosage
timeFrame: during surgery
measure: Intraoperative time above range (TAR)
timeFrame: during surgery
measure: Intraoperative time below range (TBR)
timeFrame: during surgery
measure: Intraoperative mean glucose
timeFrame: during surgery
measure: Intraoperative coefficient of variation (CV)
timeFrame: during surgery
measure: Postoperative time in range (TIR)
timeFrame: Throughout the 72 hours after surgery
measure: Postraoperative time above range (TAR)
timeFrame: Throughout the 72 hours after surgery
measure: Postoperative time below range (TBR)
timeFrame: Throughout the 72 hours after surgery
measure: Postoperative mean glucose
timeFrame: Throughout the 72 hours after surgery
measure: Postoperative coefficient of variation (CV)
timeFrame: Throughout the 72 hours after surgery
measure: Quality of Recovery-15 score on the third day after surgery
timeFrame: on the third day after surgery
measure: The rate of surgery-related complications
timeFrame: 30 days after surgery
measure: Quality of Recovery-15 score on the 30th day after surgery
timeFrame: on the 30th day after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Le Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References: