Department of Kinesiology and Health Education, College of Education, The University of Texas at Austin, Austin, Texas.
Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
Sci Diabetes Self Manag Care. 2022 Aug;48(4):204-212. doi: 10.1177/26350106221100536. Epub 2022 Jun 4.
The purpose of the study was to determine the feasibility of implementing A1C self-testing at home using the A1CNow® Self Check and to compare the accuracy of the A1CNow to a reference standard in African Americans with type 2 diabetes (T2D).
African American adults with T2D were recruited from 13 different churches (N = 123). Phase 1, conducted during the early phase of the COVID-19 pandemic, examined the feasibility of A1C assessment using the A1CNow performed at home by untrained participants. Phase 2, conducted when in-person research resumed, compared A1C values concurrently measured using the A1CNow and the DCA Vantage™ Analyzer (reference standard) collected by research staff at church testing sites.
In Phase 1, 98.8% of participants successfully completed at least 1 at-home A1C test; the overall failure rate was 24.7%. In Phase 2, the failure rate of staff-performed A1CNow testing was 4.4%. The Bland-Altman plot reveals that A1CNow values were 0.68% lower than DCA values, and the mean differences (A1CNow minus DCA) ranged from -2.6% to 1.2% with a limit of agreement between -1.9% to 0.5%.
A1C self-testing is feasible for use in community settings involving African American adults with T2D. The A1CNow Self-Check underestimated A1C values when compared with the reference standard. Ongoing improvements in point-of-care devices have the potential to expand research and clinical care, especially in underserved communities.
本研究旨在确定使用 A1CNow® Self Check 在家中进行 A1C 自我检测的可行性，并比较 A1CNow 在患有 2 型糖尿病（T2D）的非裔美国人中的准确性与参考标准的差异。
从 13 个不同的教堂招募了患有 T2D 的非裔美国成年人（N=123）。第 1 阶段在 COVID-19 大流行的早期进行，研究了未经训练的参与者在家中使用 A1CNow 进行 A1C 评估的可行性。第 2 阶段在恢复现场研究时进行，比较了由研究人员在教堂检测点同时使用 A1CNow 和 DCA Vantage™分析仪（参考标准）测量的 A1C 值。
在第 1 阶段，98.8%的参与者成功完成了至少 1 次家庭 A1C 测试；总体失败率为 24.7%。在第 2 阶段，工作人员进行的 A1CNow 测试失败率为 4.4%。Bland-Altman 图显示，A1CNow 值比 DCA 值低 0.68%，平均差值（A1CNow 减去 DCA）范围为-2.6%至 1.2%，一致性界限为-1.9%至 0.5%。
A1C 自我检测在涉及患有 T2D 的非裔美国成年人的社区环境中是可行的。与参考标准相比，A1CNow Self-Check 低估了 A1C 值。即时检测设备的持续改进有可能扩大研究和临床护理范围，尤其是在服务不足的社区。
