Duan Yi, Ding Lin, Gao Zhifeng, Wang Yutong, Cao Han, Zhang Huan, Yao Lan
Department of Anesthesiology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.
Department of Anaesthesiology, Peking University International Hospital, Beijing, China.
BMJ Open. 2025 Feb 18;15(2):e090664. doi: 10.1136/bmjopen-2024-090664.
The Comprehensive Complication Index (CCI) is an internationally recognised indicator of postoperative complications. During the perioperative period, patients with diabetes mellitus (DM) or impaired glucose tolerance (IGT) may experience a significant increase in the CCI associated with glucose-related complications and increased mortality. Continuous glucose monitoring (CGM) offers advantages such as portability, accuracy, real-time monitoring and rich information. However, few large-scale studies have investigated the effectiveness and safety of CGM in reducing CCI during major surgeries.
This study is a multicentre, parallel-arm, randomised pragmatic trial to investigate whether CGM improves clinical outcomes in patients with type 1 or type 2 DM or IGT undergoing major surgery relative to conventional monitoring. This study is planned to be conducted in 50 secondary or tertiary hospitals in China. Eligible patients aged 18 years or older with DM or IGT undergoing elective major surgery will be recruited during a baseline screening period of 3 days before surgery. Eligible patients will be randomly assigned to receive CGM or conventional monitoring in a 1:1 ratio. The primary endpoint measure is the CCI score within 30 postoperative days. The margin of superiority is -12.0. A total of 10 168 participants will achieve 90% power to detect a clinically important difference of -13.0 between the means in the primary outcome. This trial includes multiple statistical analysis steps. For the primary outcome, a covariance model will be used to compare the difference in CCI within 30 days postoperatively between the two groups after adjusting for baseline and centre effects.
This trial has been approved by the Ethics Committee of Beijing Tsinghua Changgung Hospital (No. 23684-0-02) and its corresponding branch centres. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to a peer-reviewed journal.
NCT06331923.
综合并发症指数（CCI）是国际公认的术后并发症指标。在围手术期，糖尿病（DM）或糖耐量受损（IGT）患者的CCI可能会因与血糖相关的并发症而显著升高，死亡率也会增加。持续葡萄糖监测（CGM）具有便携、准确、实时监测和信息丰富等优点。然而，很少有大规模研究调查CGM在大型手术中降低CCI的有效性和安全性。
本研究是一项多中心、平行组、随机实用试验，旨在调查相对于传统监测，CGM是否能改善1型或2型DM或IGT患者在接受大型手术时的临床结局。本研究计划在中国的50家二级或三级医院进行。符合条件的18岁及以上患有DM或IGT且接受择期大型手术的患者将在术前3天的基线筛查期内招募。符合条件的患者将以1:1的比例随机分配接受CGM或传统监测。主要终点指标是术后30天内的CCI评分。优势幅度为-12.0。共有10168名参与者将有90%的把握度检测出主要结局中两组均值之间-13.0的临床重要差异。本试验包括多个统计分析步骤。对于主要结局，将使用协方差模型在调整基线和中心效应后比较两组术后30天内CCI的差异。
本试验已获得北京清华长庚医院伦理委员会（编号23684-0-02）及其相应分中心的批准。将从参与研究的所有受试者处获得知情同意。主要试验结果将提交给同行评审期刊发表。
NCT06331923。
