Kamecke Ulrike, Waldenmaier Delia, Haug Cornelia, Ziegler Ralph, Freckmann Guido
1 Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
2 Diabetes Clinic for Children and Adolescents, Muenster, Germany.
J Diabetes Sci Technol. 2019 Jan;13(1):60-67. doi: 10.1177/1932296818788349. Epub 2018 Jul 13.
Adequate testing of delivery accuracy of insulin pumps is under discussion. Especially for patch pumps, test settings are challenging. In addition, evaluation and presentation of accuracy results in a way that is reasonable and useful for clinicians, not only for technicians, is important.
Test setups based on IEC 60601-2-24 were used and, in addition, different setups for patch pumps were compared to identify an adequate alternative for pumps without external infusion set. These setups are applicable for both bolus and basal rate accuracy testing. In addition, evaluation procedures considering clinical relevance were compiled.
A setup for patch pumps that provides reliable results could be realized. Evaluation of basal rate accuracy data should also consider the actual clinical use of insulin pumps and thus, deviating from IEC 60601-2-24, compose the whole measurement period without excluding the first 24 hours. In addition to the presentation using trumpet curves, accuracy of 1-hour windows should be evaluated and displayed.
This article proposes an approach on how to test, evaluate, and present bolus and basal rate accuracy of insulin pumps from a clinical perspective.
胰岛素泵输注准确性的充分测试正在讨论中。特别是对于贴片式胰岛素泵，测试设置具有挑战性。此外，以一种对临床医生合理且有用的方式评估和呈现准确性结果很重要，而不仅仅是对技术人员。
使用了基于IEC 60601-2-24的测试设置，此外，还比较了贴片式胰岛素泵的不同设置，以确定适用于无外部输注装置的胰岛素泵的合适替代方案。这些设置适用于大剂量和基础率准确性测试。此外，还编制了考虑临床相关性的评估程序。
可以实现一种能提供可靠结果的贴片式胰岛素泵设置。基础率准确性数据的评估还应考虑胰岛素泵的实际临床使用情况，因此，与IEC 60601-2-24不同，应在不排除前24小时的情况下构成整个测量期。除了使用喇叭曲线进行呈现外，还应评估和显示1小时时间段的准确性。
本文从临床角度提出了一种关于如何测试、评估和呈现胰岛素泵大剂量和基础率准确性的方法。
