BGM设备准确性的进步
与家庭使用相比,今年的重点涉及BGM的准确性。从这个意义上讲,准确性意味着符合监管标准的设备(例如,CLIA放弃了Nova Biomedical Statsstrip),但也与可能影响BGM准确性的分析前因子有关。我们听到了FDA糖尿病诊断设备分支机构团队负责人Leslie Landree博士。她指出,目前尚未获得FDA批准的YSI 2900很快将逐步淘汰YSI 2300,这表示糖尿病治疗的真正变化。
Harnessing technology to develop smarter CGMs
我们还了解到,与10天版本相比,Abbott提供了14天自由泳Libre的betway必威怎么提款Mard(平均绝对相对差异)的见解。同时,Medtronic介绍了有关潜在的自我校准传感器利用电化学阻抗光谱(EIS)技术的最新消息。
In addition to well established manufacturers, several emerging developers presented updates on their progress. Waveform showed an internal study demonstrating that its Cascade CGM system, which is scheduled for commercialization in 2019, performed relatively on par with available CGM products.
Biorasis continued the development of its Glucowizzard implantable CGM (measuring 0.75 x 6 mm) that transmits glucose data to a smart watch. Notably, Lifecare showcased how it is leveraging 3D printing technology to develop a CGM device, enabling faster iterations of its designs during the development process. Posters presented by PercuSense, Eyesense, and a research group from the University of North Carolina (led by Dr. Koji Sode) on CGM development, underscore the growing focus in this category.
令人鼓舞的是,Convatec正在开发具有CGM探针和重新设计的胰岛素套管的单个车上产品,这表明该领域正在取得进步。太平洋糖尿病技术还正在开发单个CGM传感器和胰岛素输注产品。Capbio提供了有关开发限制组织炎症的套管的详细信息,从而使胰岛素吸收更大,并具有更大的磨损时间。综上所述,这些技术进步强调了对更安全,更舒适的车身设备的需求日益增长。
推动援助系统的发展
引起浓厚兴趣的领域集中在互操作设备的进度上,从而导致辅助系统开发的进步。FDA成员领导的小组会议强调了建立质量标准(例如,ICGM标准和数字健康预认证)的必要性,以确保糖尿病患者的安全性,同时加速辅助系统的监管途径。必威手机APP
While AID systems have certainly improved diabetes management, inherent challenges such as multiple on-body products (separate CGM sensor and insulin infusion set), cannula occlusions, and skin irritations are still key developmental hurdles to overcome.
This event showed that there is growing evidence that wearable AID devices will play a larger role in diabetes management, while accuracy of sensor-based devices is improving.
展望未来
尽管今年的DTM强调了该领域的不同事态发展,但我们期待在2019年2月在德国柏林举行的糖尿病(ATTD)会议的高级技术和治疗中看到更多进展,我们希望在那里见到您。必威官方在线