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

NCT06755788 | Not Yet Recruiting DMC

• 1 other identifier: 2023-I2M-CT-B-028
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Continuous Glucose Monitoring

Keywords

glycemic management; pancreaticoduodenectomy; time in range

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Intraoperative insulin dosage

  during surgery

• Intraoperative time above range (TAR)

  during surgery

• Intraoperative time below range (TBR)

  during surgery

• Intraoperative mean glucose

  during surgery

• Intraoperative coefficient of variation (CV)

  during surgery

Study Arms (2)

RT-CGM

EXPERIMENTAL

Intraoperative blood glucose monitoring and management based on a real-time RT-CGM system.

Device: RT-CGM

Control

OTHER

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

Interventions

RT-CGM DEVICE

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.

RT-CGM

Control DEVICE

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Officials

• Le Shen, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Le Shen, PhD

CONTACT

13810248138; pumchshenle@163.com

Le Zhang, Master

CONTACT

18801372430; 3240348551@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is blinded to participants; however, it is not feasible to blind the surgeons and anesthesiologists. The outcome assessors remain blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 1, 2025
• Study Start: December 25, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12