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FDA approves new closed-loop insulin delivery system for people with Type 1 diabetes
美食品药品监管局批准新型闭环胰岛素输送系统用于1型糖尿病
A new software system that will let people with diabetes customize their treatment and automatically adjust their insulin levels was just approved for use by the Food and Drug Administration. It will reach patients in January 2020.
近日，美食品药品监管局批准了一款新型软件系统，糖尿病患者可以通过该系统自定义治疗方式并自动调整胰岛素水平。该系统将于2020年1月投入使用。
The technology, called Control-IQ, is manufactured by Tandem Diabetes Care and connects with blood glucose sensors and insulin pumps to automatically increase, decrease, or stop the delivery of insulin in response to the glucose levels of people with Type 1 diabetes. People with Type 1 diabetes can't produce their own insulin, which regulates blood sugar (aka glucose), so they need to take it from an external source every day. Currently, many patients with diabetes have to manually adjust the amount of insulin they receive throughout the day. With this kind of device, called a closed-loop system, users can instead rely on the device to adjust as needed.
这项名为Control-IQ的技术由Tandem Diabetes Care公司制造，可与血糖传感器和胰岛素泵连接，并根据1型糖尿病患者的血糖水平自动增加、减少或停止胰岛素输送。1型糖尿病患者自身无法产生胰岛素来调节血糖（又称葡萄糖），所以需要借助外部设备获取每日所需胰岛素。目前，许多糖尿病患者需要自行调整他们每天注射的胰岛素剂量。闭环胰岛素输送系统设备则为用户带来了方便——可按需在设备上进行调整。
People with Type 1 diabetes using Control-IQ with Tandem's t:slim X2 insulin pump had fewer instances of high or low blood sugar than people manually adjusting the insulin, according to a six-month clinical trial recently published in The New England Journal of Medicine. Those patients also spent more time with blood sugar levels within their targeted range.
近期发表在《新英格兰医学期刊》上的为期六个月的临床试验表明，与自行调整胰岛素剂量的1型糖尿病患者相比，使用Control-IQ设备和Tandem公司T:slim X2胰岛素泵的患者出现高血糖或低血糖的情况更少。此外，这些患者的血糖在目标范围内的时间也更久。
Other closed-loop systems have also gotten FDA approval. One central difference with this software is that it is considered "interoperable." That means users are not locked into using products by Tandem Diabetes Care. They can build a personalized system using other sensors and pumps that have the same designation from the FDA.
其它闭环系统也已获得美食品药品监管局的批准。该软件与其它系统的一个主要区别在于它被认为是“可配合使用的”。也就是说，使用该软件时，不强制用户使用Tandem Diabetes Care公司的配套产品。他们也可以使用经美国食品药品监管局批准的其它血糖传感器和胰岛素泵以打造个性化系统。
Control-IQ can currently be used with Tandem Diabetes Care's t:slim X2 insulin pump, which was approved as interoperable in February 2019, and Dexcom Inc’s G6 continuous glucose monitor, which was designated as interoperable in 2018.
目前，Control-IQ可与Tandem Diabetes Care公司的T:slim X2胰岛素泵（于2019年2月被批准可配合使用）以及Dexcom Inc公司的G6连续血糖监测器（于2018年被指定为可配合使用）配合使用。
The software system can also automatically deliver a corrective dose of fast-acting insulin if it determines that a user’s blood sugar levels are too high. That sets it apart from other closed-loop systems on the market, which deliver a continuous low dose of insulin, known as a basal rate, to keep blood sugar levels steady, but don't automatically deliver corrective doses.
如果该软件系统确定用户的血糖水平过高，它也可以自动输送校正剂量的速效胰岛素。这也是它与市场上其它闭环系统的另一个不同点，后者输送连续的低剂量胰岛素（称为基础剂量）以保持血糖水平稳定，但不会自动输送校正的剂量。
译文属可可原创，仅供学习交流使用，未经许可请勿转载
