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。

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