Deka的自动胰岛素输送系统由患者主导的应用程序提供动力，获得美国食品药品监督管理局批准-动脉网

Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance

MedTech Dive 等信源发布 2024-03-21 11:04

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Dive Brief:

潜水简介：

Deka Research & Development has received 510(k) clearance for the Twiist automated insulin delivery (AID) system, the company’s partner Sequel Med Tech said Monday.

Deka Research&Development公司的合作伙伴Sequel Med Tech周一表示，该公司的Twiist自动胰岛素输送（AID）系统已获得510（k）许可。

Sequel, which will sell the system, worked with Deka and Tidepool on the product. Deka was founded by the inventor who commercialized the first wearable insulin pump. Tidepool is behind Loop, a patient-led automated insulin dosing app.

Sequel将销售该系统，与Deka和Tidepool合作开发该产品。Deka由发明者创立，他将第一个可穿戴式胰岛素泵商业化。Tidepol支持Loop，这是一款由患者主导的自动胰岛素给药应用程序。

Twiist combines Deka drug delivery technology with the Loop algorithm to create what Sequel says is the first system that directly measures the volume and flow of insulin delivered with every micro-dose.

Twiist将Deka药物输送技术与Loop算法相结合，创建了Sequel所说的第一个直接测量每个微剂量输送的胰岛素体积和流量的系统。

Dive Insight:

潜水洞察：

Tidepool is a nonprofit that grew out of grassroots work by diabetes patients to build their own systems. The work resulted in 510(k) clearance for Tidepool Loop at the start of 2023. In theory, Loop gave users the option to pair their preferred insulin pumps and continuous glucose monitors. The caveat was that no insulin pumps were authorized for use with third-party controllers. .

Tidepool是一家非营利性组织，由糖尿病患者的基层工作发展而来，旨在建立自己的系统。2023年初，这项工作为潮滩环流带来了510（k）的间隙。理论上，Loop为用户提供了将他们首选的胰岛素泵和连续血糖监测仪配对的选项。需要注意的是，没有任何胰岛素泵被授权与第三方控制器一起使用。。

The Food and Drug Administration’s clearance of Twiist positions Sequel to sell an AID system powered by Tidepool’s algorithm. Twiist is cleared for use in people aged 6 years and older with Type 1 diabetes.

美国食品和药物管理局（FDA）对Twiist positions的批准是出售由Tidepool算法驱动的援助系统的续集。Twiist被批准用于6岁及以上的1型糖尿病患者。

People with Type 1 diabetes can already choose between multiple pumps. Deka cited Tandem Diabetes Care’s T:slim X2 insulin pump as the predicate device when it received clearance for its Ace Pump System in 2023. Companies including Medtronic and Insulet compete with Tandem for the market.

1型糖尿病患者已经可以在多个泵之间进行选择。Deka在2023年获得Ace泵系统的许可时，引用了Tandem Diabetes Care的T:slim X2胰岛素泵作为替代设备。美敦力（Medtronic）和Isulet等公司与Tandem争夺市场。

Sequel sees Twiist’s direct measurement of every micro-dose of insulin and its ability to “integrate with the latest available innovation” as differentiators. Sequel plans to provide more information as it gets closer to launching the system.

续集将Twist对每种微量胰岛素的直接测量及其“与最新可用创新相结合”的能力视为与众不同之处。Sequel计划在系统即将启动时提供更多信息。

The company’s statement lacks a timeline for launch and the Twiist website only says “coming soon.” Sequel expects to distribute the device through the pharmacy channel so more people with Type 1 diabetes have a “convenient, affordable way to get started on an AID system,” CEO and co-founder Alan Lotvin said in a statement.

该公司的声明没有推出时间表，Twiist网站只说“很快就会推出”。Sequel预计将通过药房渠道分发该设备，以便更多1型糖尿病患者“以一种方便、实惠的方式开始使用援助系统”，首席执行官兼联合创始人艾伦·洛文在声明中表示。