Krouwer Consulting, Sherborn, MA, USA.
J Diabetes Sci Technol. 2022 Jan;16(1):228-232. doi: 10.1177/1932296820951872. Epub 2020 Sep 3.
US Food and Drug Administration adverse event data for 2019 were analyzed for two insulin pumps and two continuous glucose monitors (CGMs). The analyses were selective-they were guided by the text described in the adverse events. They included (1) percent using auto mode for the Medtronic 670G pump, (2) distributions of hyper and hypo glucose values for Medtronic and Tandem pumps, (3) a Parkes error grid for Dexcom CGM vs glucose meter when the complaint was inaccuracy, and (4) the most frequent events for Abbott Freestyle. We found that for the 670G pump, there were more hypo events when auto mode was on than when auto mode was off. With Dexcom CGMs, users complained about inaccurate result when most results were in the B zone. With the Abbott Freestyle, the most frequent adverse event was an allergic skin reaction.
分析了美国食品和药物管理局 2019 年的两份胰岛素泵和两份连续血糖监测仪（CGM）的不良事件数据。这些分析是有选择性的，它们是根据不良事件中描述的文本进行指导的。它们包括：（1）美敦力 670G 泵自动模式的使用率；（2）美敦力和 Tandem 泵高血糖和低血糖值的分布；（3）当投诉不准确时，德康 CGM 与血糖仪的 Parkes 误差网格；（4）雅培自由式的最常见事件。我们发现，对于 670G 泵，自动模式开启时发生低血糖事件的次数多于自动模式关闭时。对于德康 CGM，当大多数结果处于 B 区时，用户抱怨结果不准确。对于雅培自由式，最常见的不良事件是过敏皮肤反应。
