Clinical and Computational Research, Abbott Diabetes Care, Alameda, California, USA.
Institute of Epidemiology and Medical Biometry, Central Institute for Biomedical Technology, University of Ulm, Ulm, Germany.
Diabetes Technol Ther. 2021 Jun;23(6):452-459. doi: 10.1089/dia.2020.0553. Epub 2021 May 26.
Glycated hemoglobin A1c (HbA1c) is a key biomarker in the glycemic management of individuals with diabetes, but the relationship with glucose levels can be variable. A recent kinetic model has described a calculated HbA1c (cHbA1c) that is individual specific. Our aim was to validate the routine clinical use of this glucose metric in younger individuals with diabetes under real-life settings. We retrieved HbA1c and glucose data from the German-Austrian-Swiss-Luxembourgian diabetes follow-up (DPV) registry, which covers pediatric individuals with type 1 diabetes (T1D). The new glycemic measure, cHbA1c, uses two individual parameters identified by data sections that contain continuous glucose data between two laboratory HbA1c measurements. The cHbA1c was prospectively validated using longitudinal HbA1c data. Continuous glucose monitoring data from 352 T1D individuals in 13 clinics were analyzed together with HbA1c that ranged between 4.9% and 10.6%. In the prospective analysis, absolute deviations of estimated HbA1c (eHbA1c), glucose management indicator (GMI), and cHbA1c compared with laboratory HbA1c were (median [interquartile range]): 1.01 (0.50, 1.75), 0.46 (0.21, 084) and 0.26 (0.12, 0.46), giving an average bias of 0.6, 0.4 and 0.0, respectively, in National Glycohemoglobin Standardization Program (NGSP) % unit. For eHbA1c and GMI only 25% and 54% of subjects were within ±0.5% of laboratory HbA1c values, whereas 82% of cHbA1c were within ±0.5% of laboratory HbA1c results. Our data show the superior performance of cHbA1c compared with eHbA1c and GMI at reflecting laboratory HbA1c. These data indicate that cHbA1c can be potentially used instead in laboratory HbA1c, at least in younger individuals with T1D.
糖化血红蛋白 A1c(HbA1c)是糖尿病患者血糖管理的关键生物标志物,但与血糖水平的关系可能存在差异。最近的动力学模型描述了一种个体特异性的计算 HbA1c(cHbA1c)。我们的目的是在现实环境下验证这种葡萄糖指标在年轻糖尿病患者中的常规临床应用。
我们从德国-奥地利-瑞士-卢森堡糖尿病随访(DPV)登记处检索了 HbA1c 和血糖数据,该登记处涵盖了 1 型糖尿病(T1D)的儿科患者。新的血糖指标 cHbA1c 使用两个个体参数,这些参数是通过包含两次实验室 HbA1c 测量之间连续血糖数据的数据部分确定的。使用纵向 HbA1c 数据对 cHbA1c 进行了前瞻性验证。
对来自 13 个诊所的 352 名 T1D 患者的连续血糖监测数据和范围在 4.9%至 10.6%之间的 HbA1c 进行了分析。在前瞻性分析中,与实验室 HbA1c 相比,估计的 HbA1c(eHbA1c)、血糖管理指标(GMI)和 cHbA1c 的绝对偏差(中位数[四分位距])为:1.01(0.50,1.75)、0.46(0.21,0.84)和 0.26(0.12,0.46),在国家糖化血红蛋白标准化计划(NGSP)%单位中,平均偏差分别为 0.6、0.4 和 0.0。对于 eHbA1c 和 GMI,只有 25%和 54%的受试者在实验室 HbA1c 值的±0.5%范围内,而 82%的 cHbA1c 在±0.5%的实验室 HbA1c 结果范围内。
我们的数据显示,cHbA1c 比 eHbA1c 和 GMI 更能反映实验室 HbA1c,性能更优。这些数据表明,cHbA1c 至少在年轻的 T1D 患者中可以替代实验室 HbA1c 进行使用。