连续血糖监测(CGM)在患有先天性高胰岛素血症(CHI)等小儿低血糖的患者中越来越受欢迎。但没有标准的准确性或相关的临床风险的措施是可用的。因此,CHI中CGM准确性的少量先前评估是不完整的。我们旨在开发一种新颖的低血糖错误网格(HEG),用于根据适用于大型配对(CGM/血糖)数据集的专家共识意见对CHI患者进行CGM评估。
在英国两个卓越中心定期管理CHI的儿科内分泌学顾问被要求在一个假设模型中完成一份关于葡萄糖截止值和相关CGM错误的预期风险的问卷。利用整理的信息以数学方式生成HEG,然后由专家批准,共识意见。十名CHI患者接受了DexcomG6CGM监测12周,并用ContourNextOne血糖仪进行了自我监测血糖(SMBG),以测试HEG的应用,并为CHI患者提供准确性评估。
CGM性能次优,基于1441个CGM和SMBG的成对值显示19.3%的平均绝对相对差(MARD)和仅45%的低血糖(葡萄糖<3.5mmol/L(63mg/dL))敏感性。当数据仅限于实际使用时,HEG提供了CGM错误的临床背景,其中15%被专家共识归类为中度风险。这提供了与现有糖尿病错误网格形成对比的风险概况,加强其在低血糖CGM准确性临床评估中的应用。
低血糖错误网格,根据英国专家的共识意见,CGM推荐作为常规临床使用的独立工具的准确性不足.然而,CGM相对于SMBG的次优准确性不会降低该患者组中CGM的替代用途,例如用作数字表型工具。HEG可在GitHub上免费获得,供其他研究人员使用,以评估患者人群的准确性并验证这些发现。
Continuous Glucose Monitoring (CGM) is gaining in popularity for patients with paediatric hypoglycaemia disorders such as Congenital Hyperinsulinism (CHI), but no standard measures of accuracy or associated clinical risk are available. The small number of prior assessments of CGM accuracy in CHI have thus been incomplete. We aimed to develop a novel Hypoglycaemia Error Grid (HEG) for CGM assessment for those with CHI based on expert
consensus opinion applied to a large paired (CGM/blood glucose) dataset.
Paediatric endocrinology consultants regularly managing CHI in the two UK centres of excellence were asked to complete a questionnaire regarding glucose cutoffs and associated anticipated risks of CGM errors in a hypothetical model. Collated information was utilised to mathematically generate the HEG which was then approved by expert,
consensus opinion. Ten patients with CHI underwent 12 weeks of monitoring with a Dexcom G6 CGM and self-monitored blood glucose (SMBG) with a Contour Next One glucometer to test application of the HEG and provide an assessment of accuracy for those with CHI.
CGM performance was suboptimal, based on 1441 paired values of CGM and SMBG showing Mean Absolute Relative Difference (MARD) of 19.3% and hypoglycaemia (glucose <3.5mmol/L (63mg/dL)) sensitivity of only 45%. The HEG provided clinical context to CGM errors with 15% classified as moderate risk by expert
consensus when data was restricted to that of practical use. This provides a contrasting risk profile from existing diabetes error grids, reinforcing its utility in the clinical assessment of CGM accuracy in hypoglycaemia.
The Hypoglycaemia Error Grid, based on UK expert
consensus opinion has demonstrated inadequate accuracy of CGM to recommend as a standalone tool for routine clinical use. However, suboptimal accuracy of CGM relative to SMBG does not detract from alternative uses of CGM in this patient group, such as use as a digital phenotyping tool. The HEG is freely available on GitHub for use by other researchers to assess accuracy in their patient populations and validate these findings.