NCT06331923

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

April 12, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

March 18, 2024

Last Update Submit

March 26, 2025

Conditions

Comprehensive Complication Index

Keywords

comprehensive complication indexcontinuous glucose monitoringperioperativeprognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Postoperative complications

    At 1-7 day postoperatively and 30-day follow-up

  • Mortality

    At 30-day follow-up

  • Perioperative glucose level

    Perioperative glucose level will be monitored from the day of the enrollment to 7 days (at least 3 days) postoperatively.

  • The length of the stay in the intensive care unit

    At 30-day follow-up

  • The overall hospitalization cost

    At 30-day follow-up

Other Outcomes (5)

  • Incidence of postoperative infection

    Within 30 days after surgery

  • Incidence of major adverse cardiovascular event (MACE)

    Within 30 days after surgery

  • Incidence of stroke

    Within 30 days after surgery

  • +2 more other outcomes

Study Arms (2)

CGM group

EXPERIMENTAL

Participants who receive continuous glucose monitoring (CGM) during the perioperative period. Glucose monitoring should be continued until the 7th day after surgery or discharge.

Device: Continuous glucose monitoring (CGM) device

Control group

NO INTERVENTION

Perioperative blood glucose monitoring was performed according to institutional treatment guidelines.Glucose monitoring should be continued until the 7th day after surgery or discharge.

Interventions

Continuous glucose monitoring (CGM) deviceDEVICE

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.

CGM group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged above 18 years;
  • Patients with diabetes mellitus or impaired glucose tolerance;
  • Expected major thoracic and abdominal surgery (except cardiac surgery; including endoscopic surgery and robotic surgery), open orthopedic surgery, neurosurgery;
  • Volunteered for this study and written informed consent.

You may not qualify if:

  • The patient refused;
  • The time between wearing CGM sensor and surgical skin incision cannot meet 6 hours or more;
  • Expected monitoring time less than 72 hours in CGM group;
  • Patients had comorbidities that affected the evaluation of endpoints;
  • The attending physician thought that the patient had inappropriate indications for enrollment;
  • Participants were involved in other studies that interfered with the evaluation of the results of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhifeng Gao

Beijing, Beijing Municipality, 102218, China

RECRUITING

Related Publications (1)

  • Duan Y, Ding L, Gao Z, Wang Y, Cao H, Zhang H, Yao L. Assessing the effectiveness of continuous glucose monitoring compared with conventional monitoring in enhancing surgical outcomes for patients with diabetes: protocol for a multicentre, parallel-arm, randomised, pragmatic trial in China. BMJ Open. 2025 Feb 18;15(2):e090664. doi: 10.1136/bmjopen-2024-090664.

    PMID: 39965943DERIVED

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Lan Yao

    Peking University International Hospital

    PRINCIPAL INVESTIGATOR

  • Hui Q Xu

    Wangjing Hospital, China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Yan Liu

    ZhuHai Hospital

    PRINCIPAL INVESTIGATOR

  • Qi Pan

    Beijing Hospital

    PRINCIPAL INVESTIGATOR

  • Jian H Jia

    Siyang County Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Yi K Zhu

    Second Hospital of Shanxi Medical University

    PRINCIPAL INVESTIGATOR

  • Ke F Shi

    Henan Provincial Chest Hospital

    PRINCIPAL INVESTIGATOR

  • Fang F Zhang

    Fuzhou First Hospital

    PRINCIPAL INVESTIGATOR

  • Xiu Zh Wang

    Pinggu District Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Feng Hong

    The First Affiliated Hospital of Anhui University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Ying J Hao

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

  • Yi Q Cai

    Mindong Hospital of Ningde

    PRINCIPAL INVESTIGATOR

  • Lin Shen

    Heze Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Jin L Liang

    The Fifth Hospital of Xiamen

    PRINCIPAL INVESTIGATOR

  • Zhen Wang

    People's Hospital of Ningxia Hui Autonomous Region

    PRINCIPAL INVESTIGATOR

  • Hong W Ye

    The First People's Hospital of Changzhou

    PRINCIPAL INVESTIGATOR

  • Qin Wang

    The Fifth hospital of Deyang

    PRINCIPAL INVESTIGATOR

  • Jian P Qiu

    Suzhou Municipal Hospital

    PRINCIPAL INVESTIGATOR

  • Bo Liao

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

  • Xin J Liu

    Yiyang Central Hospital

    PRINCIPAL INVESTIGATOR

  • Guo Sh Gu

    Anhui No.2 Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

  • Li Quan

    First Affiliated Hospital of Xinjiang Medical University

    PRINCIPAL INVESTIGATOR

  • Li R Ma

    Peng Ding Shan Shi Zhong Yi Yi Yuan

    PRINCIPAL INVESTIGATOR

  • Zhi B Zhao

    The First People's Hospital of Lianyungang

    PRINCIPAL INVESTIGATOR

  • Xin Lu

    Haimen District Traditional Chinese Medicine Hospital

    PRINCIPAL INVESTIGATOR

  • Feng Zhou

    Yueyang Central Hospital

    PRINCIPAL INVESTIGATOR

  • Xiao D Yin

    Zhe Cheng TCM Hospital

    PRINCIPAL INVESTIGATOR

  • Li T Zhang

    The 910th Hospital

    PRINCIPAL INVESTIGATOR

  • Yu Zh He

    The Second Affiliated Hospital of Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

  • Xiao M Zhang

    The first People's Hospital of Zhengzhou

    PRINCIPAL INVESTIGATOR

  • Yu H Jiang

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

  • Peng Jiang

    Affiliated Hospital of Jiangsu University

    PRINCIPAL INVESTIGATOR

  • Xiao Y Li

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

  • Zhi H Liu

    Liaocheng People's Hospital Zhiheng Liu

    PRINCIPAL INVESTIGATOR

  • Jin C Yang

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

  • Xue L Zhu

    The People's Hospital of Nanchuan, Chongqing

    PRINCIPAL INVESTIGATOR

  • Wen T Si

    Zhengzhou Orthopaedic Hospital

    PRINCIPAL INVESTIGATOR

  • Lei Ning

    Jilin City Hospital of Chemical Industry

    PRINCIPAL INVESTIGATOR

  • Li H Su

    Creen Hospital-465

    PRINCIPAL INVESTIGATOR

  • Zhong J Wang

    Wuhan Central Hospital

    PRINCIPAL INVESTIGATOR

  • Li P Ma

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

  • Yu H Xu

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

  • Jiang M Yu

    Tong Ren hospital Shanghai Jiao Tong university school of medicine

    PRINCIPAL INVESTIGATOR

  • Qing H Cheng

    Emergency General Hospital

    PRINCIPAL INVESTIGATOR

  • Hui J Wang

    Beijing Tongren Hospital, CMU

    PRINCIPAL INVESTIGATOR

  • Jun Wu

    Heilongjiang provincial hospital

    PRINCIPAL INVESTIGATOR

  • Jun T Duan

    Civil Aviation General Hospital

    PRINCIPAL INVESTIGATOR

  • Zheng G Guo

    Peking University Shougang Hospital

    PRINCIPAL INVESTIGATOR

  • Xin Kuang

    The People's Hospital of Longhua, Shenzhen

    PRINCIPAL INVESTIGATOR

  • Chang J Yu

    The First Affiliated Hospital of Anhui Medical University

    PRINCIPAL INVESTIGATOR

  • Feng Liang

    Chinese PLA Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi F Gao, M.D.

CONTACT

+86 15801249466btchgzf@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director, Department of Anesthesiology

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 26, 2024

Study Start

April 12, 2024

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

March 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

The data are not publicly available due to containing information that could compromise the privacy of research participants. The data that support the findings of this study are available on request from the corresponding author.

Locations

CN(1)