胰腺外科术后扫描式持续葡萄糖监测应用的可靠性:一项多中心前瞻性队列研究的单中心二次分析

Reliability of Continuous Glucose Monitoring after Pancreatic Surgery: A Single-center Secondary Analysis of a Multi-center Prospective Cohort Study

  • 摘要: 目的 评估扫描式持续葡萄糖监测(continuous glucose monitoring,CGM)在胰腺外科术后应用的可靠性及其临床辅助决策的准确性。方法 本研究为一项多中心前瞻性队列研究的单中心回顾性二次分析,纳入2024年3月—2025年3月北京协和医院择期行胰腺外科手术的成年患者。所有患者于术前1 d在左上臂佩戴CGM传感器且持续至术后第7天;传感器每分钟测量组织间液葡萄糖,可实时扫描获取即时血糖值。同时,患者术后均进行床旁即时(point of care, POC)血糖检测。通过Gplus血糖管理系统及医院信息管理系统配对同一时间点的两种血糖值。采用平均绝对相对误差(mean absolute relative deviation,MARD)评估两种方法间的偏差程度,采用Bland-Altman分析评价二者的一致性,并采用Parkes误差栅格分析评价CGM在临床决策辅助中的准确性。结果 最终纳入255例患者,CGM设备佩戴中位时间为276.3(204.8,314.1)h。共获得829对CGM与POC血糖配对值。经计算,CGM数值与POC血糖值的MARD为14.1%。Bland-Altman分析示二者差值的均值为-18.72 mg/dL,95%一致性界限为-69.88~32.44 mg/dL;且随血糖水平升高,二者差异的离散程度逐渐增大,呈现明显异方差性。Parkes误差栅格分析显示,两组血糖偏差值位于A区及B区的比例为99.88%,表明CGM在辅助临床正确决策方面具有较高准确性。结论 扫描式CGM在胰腺外科术后血糖监测中总体可靠性良好,因监测偏差导致有害临床决策的风险较低。然而,其读数偏差随血糖水平升高而显著增大,提示在严重高血糖状态下,CGM监测值需结合床旁血糖检测进行临床校准与审慎解读。

     

    Abstract: Objective To evaluate the reliability of flash continuous glucose monitoring (CGM) and its accuracy in supporting clinical decision-making after pancreatic surgery. Methods This was a single‑center retrospective secondary analysis derived from a multicenter prospective cohort study. Adult patients undergoing elective pancreatic surgery at Peking Union Medical College Hospital between March 2024 and March 2025 were enrolled. All patients had a CGM sensor placed on the left upper arm one day before surgery, with monitoring continued until postoperative day 7. The sensor measured interstitial fluid glucose every minute and allowed real‑time scanning to obtain instant glucose values. In parallel, all patients underwent point‑of‑care (POC) blood glucose testing postoperatively. Paired glucose measurements at the same time points were identified using the Gplus glucose management system and the hospital information system. The mean absolute relative deviation (MARD) was calculated to assess the degree of deviation between the two methods. Agreement was evaluated using Bland‑Altman analysis, and the clinical accuracy of CGM for decision support was assessed using Parkes error grid analysis.Results A total of 255 patients were ultimately included, with a median CGM wear time of 276.3 (204.8, 314.1) hours. A total of 829 paired CGM and POC glucose values were obtained. The MARD between CGM values and POC glucose measurements was 14.1%. Bland‑Altman analysis showed a mean difference of -18.72 mg/dL between the two methods, with 95% limits of agreement ranging from -69.88 to 32.44 mg/dL. The dispersion of differences widened progressively with increasing glucose levels, indicating marked heteroscedasticity. Parkes error grid analysis demonstrated that 99.88% of the paired glucose deviations fell within zones A and B, suggesting high accuracy of CGM in supporting correct clinical decisions. Conclusion Flash CGM demonstrates generally satisfactory reliability for postoperative glucose monitoring following pancreatic surgery, with a low risk of harmful clinical decisions attributable to monitoring deviations. However, the measurement bias increases significantly with higher glucose levels, indicating that in the setting of severe hyperglycemia, CGM readings should be clinically calibrated and interpreted with caution in conjunction with point‑of‑care blood glucose testing.

     

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