新型閉環胰島素輸送系統可用於1型糖尿病
FDA approves new closed-loop insulin delivery system for people with Type 1 diabetes
美食品藥品監管局批准新型閉環胰島素輸送系統用於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，美食品藥品監管局批准了一款新型軟件系統，糖尿病患者可以通過該系統自定義治療方式並自動調整胰島素水平。該系統將於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.
這項名爲Control-IQ的技術由Tandem Diabetes Care公司製造，可與血糖傳感器和胰島素泵連接，並根據1型糖尿病患者的血糖水平自動增加、減少或停止胰島素輸送。1型糖尿病患者自身無法產生胰島素來調節血糖（又稱葡萄糖），所以需要藉助外部設備獲取每日所需胰島素。目前，許多糖尿病患者需要自行調整他們每天注射的胰島素劑量。閉環胰島素輸送系統設備則爲用戶帶來了方便——可按需在設備上進行調整。
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.
近期發表在《新英格蘭醫學期刊》上的爲期六個月的臨牀試驗表明，與自行調整胰島素劑量的1型糖尿病患者相比，使用Control-IQ設備和Tandem公司T:slim X2胰島素泵的患者出現高血糖或低血糖的情況更少。此外，這些患者的血糖在目標範圍內的時間也更久。
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.
其它閉環系統也已獲得美食品藥品監管局的批准。該軟件與其它系統的一個主要區別在於它被認爲是“可配合使用的”。也就是說，使用該軟件時，不強制用戶使用Tandem Diabetes Care公司的配套產品。他們也可以使用經美國食品藥品監管局批准的其它血糖傳感器和胰島素泵以打造個性化系統。
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可與Tandem Diabetes Care公司的T:slim X2胰島素泵（於2019年2月被批准可配合使用）以及Dexcom Inc公司的G6連續血糖監測器（於2018年被指定爲可配合使用）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.
如果該軟件系統確定用戶的血糖水平過高，它也可以自動輸送校正劑量的速效胰島素。這也是它與市場上其它閉環系統的另一個不同點，後者輸送連續的低劑量胰島素（稱爲基礎劑量）以保持血糖水平穩定，但不會自動輸送校正的劑量。
