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1型糖尿病闭环胰岛素输送的恩帕格利嗪附加疗法
作者：小柯机器人 发布时间：2022/5/22 0:31:05

美国西奈山医院Bruce A. Perkins研究组完成empagliflozin对1型糖尿病闭环胰岛素输送附加治疗的临床试验。2022年5月12日，《自然—医学》杂志在线发表了这项成果。

研究人员评估了empagliflozin 25 mg d-1作为闭环系统输送胰岛素的附加疗法的血糖疗效和安全性。研究人员在成人中进行了一项2×2因子的随机、安慰剂对照、交叉的两中心试验，评估了4周的闭环输送与传感器增强泵（SAP）疗法，以及empagliflozin与安慰剂。主要结果是在葡萄糖目标范围（3.9-10.0 mmol l-1）内的时间。主要比较是empagliflozin与安慰剂在闭环疗法或SAP疗法中的各次比较；其余的比较是以其意义为条件。27名随机参与者中有24人被纳入最终分析。
 
与安慰剂相比，empagliflozin在闭环疗法中使目标范围内的时间增加了7.2%，在SAP疗法中增加了11.4%。与SAP疗法和empagliflozin相比，闭环疗法加empagliflozin可将目标范围内的时间提高6.1%，但与SAP疗法加安慰剂相比，闭环疗法和empagliflozin的组合可提高17.5%。虽然在任何干预期间都没有发生糖尿病酮症酸中毒或严重低血糖，但使用empagliflozin时，不复杂的酮症事件更为常见。empagliflozin 25 mg d-1添加到自动胰岛素输送中可改善血糖控制，但与安慰剂相比会增加酮体浓度和酮症。
 
据了解，目前有必要优化1型糖尿病的闭环自动胰岛素输送。
 
附：英文原文
 
Title: Empagliflozin add-on therapy to closed-loop insulin delivery in type 1 diabetes: a 2 × 2 factorial randomized crossover trial

Author: Haidar, Ahmad, Lovblom, Leif Erik, Cardinez, Nancy, Gouchie-Provencher, Nikita, Orszag, Andrej, Tsoukas, Michael A., Falappa, C. Marcelo, Jafar, Adnan, Ghanbari, Milad, Eldelekli, Devrim, Rutkowski, Joanna, Yale, Jean-Franois, Perkins, Bruce A.

Issue&Volume: 2022-05-12

Abstract: There is a need to optimize closed-loop automated insulin delivery in type 1 diabetes. We assessed the glycemic efficacy and safety of empagliflozin 25mgd1 as add-on therapy to insulin delivery with a closed-loop system. We performed a 2×2 factorial randomized, placebo-controlled, crossover two-center trial in adults, assessing 4 weeks of closed-loop delivery versus sensor-augmented pump (SAP) therapy and empagliflozin versus placebo. The primary outcome was time spent in the glucose target range (3.9–10.0mmoll1). Primary comparisons were empagliflozin versus placebo in each of closed-loop or SAP therapy; the remaining comparisons were conditional on its significance. Twenty-four of 27 randomized participants were included in the final analysis. Compared to placebo, empagliflozin improved time in target range with closed-loop therapy by 7.2% and in SAP therapy by 11.4%. Closed-loop therapy plus empagliflozin improved time in target range compared to SAP therapy plus empagliflozin by 6.1% but by 17.5% for the combination of closed-loop therapy and empagliflozin compared to SAP therapy plus placebo. While no diabetic ketoacidosis or severe hypoglycemia occurred during any intervention, uncomplicated ketosis events were more common on empagliflozin. Empagliflozin 25mgd1 added to automated insulin delivery improves glycemic control but increases ketone concentration and ketosis compared to placebo.

DOI: 10.1038/s41591-022-01805-3

Source: https://www.nature.com/articles/s41591-022-01805-3

期刊信息

Nature Medicine：《自然—医学》，创刊于1995年。隶属于施普林格·自然出版集团，最新IF：30.641
官方网址：https://www.nature.com/nm/
投稿链接：https://mts-nmed.nature.com/cgi-bin/main.plex