Concordance of Central Laboratory Hemoglobin A1c Measurements from Capillary Kits Compared to Venous Draws in the Insulin-Only Bionic Pancreas Pivotal Trial

在仅使用胰岛素的仿生胰腺关键性试验中,毛细血管试剂盒与静脉采血进行中心实验室糖化血红蛋白A1c测量的一致性比较

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Abstract

Capillary hemoglobin A1c (HbA1c) collection has grown in importance due to its convenience during situations such as the coronavirus disease 2019 (COVID-19) pandemic and virtual visits. The viability of capillary blood samples as an accurate alternative to venous samples has previously only been assessed in smaller sample sizes. In this brief report, 773 paired capillary and venous samples taken from 258 study participants in the Insulin-Only Bionic Pancreas Trial were analyzed at the University of Minnesota Advanced Research and Diagnostic Laboratory and assessed for HbA1c value congruency. Results showed that 97.7% of the capillary samples were within 5% of their respective venous measurement, and R(2) between the two HbA1c sources was 0.95. These results are consistent with previous studies that also reported high concordance between capillary and venous HbA1c values using the same laboratory method, providing further evidence that capillary HbA1c measurements are an accurate alternative to venous measurements. Clinical Trial Registration number: NCT04200313.

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