患有糖尿病的人使用Afrezza吸入胰岛素希望很快能够访问一个名为Bluhale的新蓝牙配件,这将帮助他们知道他们是否正确服用药物并获得了全剂量。这个想法是要建立此内容,以最终跟踪和共享所有用户的数据。
California-basedMannkind Corp开始展示2017年Bluhale的早期原型,这是一种小型电声设备,可捕捉到干粉吸入器上,并跟踪服用的胰岛素量。它测量了使用过程中产生的声音,这表明吸入压力,如果适当地吸入了afrezza,则会闪烁绿灯,如果没有吸入,则闪烁红灯。
初始版本被用作医疗保健专业人员的培训工具,允许医生查看跟踪数据(与Android,iPhone和Microsoft设备兼容),然后为如何最好地使用Afrezza提供患者的建议。
Soon, an updated version will allow Afrezza users to track their own doses and timing. It will work with a companion app for smartphones and other devices, bringing a data-sharing connectivity function to make Afrezza more compatible with modern diabetes tech like连续的葡萄糖监测器(CGM)。
曼肯德首席执行官迈克尔·卡斯塔纳(Michael Castagna)告诉《糖尿病》:“患者不必查看任何软件或查看应用程序,只需寻找绿色或红灯即可。”“这对他们来说非常简单且用户友好。”
This development ought to spark a vote of confidence, given the lower-than-expected sales of Afrezza through the years. But things are looking up as the company’s financial picture improves and this data-tracking add-on becomes more of a reality.
糖尿病敏首先遇到这个Bluhale Tech在2016年,在美国糖尿病协会的科学会议上的博览会地板上,卡斯塔纳(Castagna)在2017年底首次发布这些原型时,在推特上发布了两种彩色蓝色吸入器适配器样品的图片。
适配器连接到当前迪亚mboat inhaler where the Afrezza powder cartridge fits inside. The cartridges are color-coded to indicate dose amounts: blue for 4 unit, green for 8 unit, and yellow for 12 unit.
该公司长期以来一直表示,它还正在探索直接在基础吸入器本身中建立连接性,或者是否最好将吸入器和蓝色配件保持分开。制造能力,访问和负担能力都在该决定中发挥作用。
Eventually, Castagna’s vision for this BluHale tech — especially if they’re able to add fiber-optics recognition — would be to enable full Afrezza dose tracking and recognition of the color of each cartridge used, so the system would automatically know which cartridges are being used more, along with data integration with existing apps and platforms.
也就是说,Mannkind不打算为Afrezza用户创建自己的移动应用程序或平台,而是想与现有解决方案合作,以便Afrezza数据可以通过其他平台和应用程序共享。Castagna希望看到一个一天的Afrezza吸入器图标可能会出现在Dexcom CGM应用程序上,例如现在存在的胰岛素注射图标,而不仅仅是胰岛素注射图标。
最初,曼肯德(Mannkind)计划在2019年推出一个以消费者为中心的蓝哈(Bluhale),但延误将其延续到2020年。然后,据Castagna称,COVID-19-19的大流行命中率更高,并延迟了临床试验工作,他们希望带来带来的。这是2021年实现的。
Pandemic-related delays and a change in administration at the Food and Drug Administration (FDA) have slowed the regulatory process even further, and a global computer chip shortage — hitting many industries from automotive to consumer technology and medical devices — have impacted MannKind’s development of BluHale.
As of July 2021, Castagna says they are waiting on more feedback from the FDA and hope to get BluHale finalized so it can become available in 2022.
Of course, existing Afrezza users can continue using the regular Dreamboat inhaler without BluHale.
MannKind is exploring the best ways to sell BluHale alongside Afrezza — perhaps for $20 on Amazon, or maybe through a subscription or different model. Nothing’s been finalized yet, Castagna says.
最初,曼肯德(Mannkind)仔细考虑了自动与付款人共享剂量数据的想法,以便更好地监控处方填充模式。但是,在考虑并与患者交谈之后,他们选择不在患者的隐私问题上做到这一点。(谢谢您的收听,Mannkind!)
Mannkind希望很快聘请数字数据专家来检查数据收集的所有方面,以及使用匿名数据影响保险承保范围的所有机会。
“We have to start putting our money where our mouth is,” Castagna said.
我们鼓励我们在糖尿病的雷达上看到剂量跟踪 - 使Afrezza在数字工具的背景下更有用 - 我们渴望看到接下来会发生什么。