To evaluate glucose control using fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) delivered by the MiniMed Advanced Hybrid Closed-Loop (AHCL) system in adults with type 1 diabetes.

In this randomized, open-label, crossover study, participants were assigned to receive faster aspart or IAsp in random order. Stages 1 and 2 comprised of 6 weeks in closed loop, preceded by 2 weeks in open loop. This was followed by stage 3, whereby participants changed directly back to the insulin formulation used in stage 1 for 1 week in closed loop. Participants chose their own meals except for two standardized meal tests, a missed meal bolus and late meal bolus. The primary outcome was the percentage of time sensor glucose values were from 70 to 180 mg/dL (time in range [TIR]).

Twenty-five adults (52% male) were recruited; the median (interquartile range) age was 48 (37, 57) years, and the median HbA_1c was 7.0% (6.6, 7.2) (53 [49, 55] mmol/mol). Faster aspart demonstrated greater overall TIR compared with IAsp (82.3% [78.5, 83.7] vs. 79.6% [77.0, 83.4], respectively; mean difference 1.9% [0.5, 3.3]; P = 0.007). Four-hour postprandial glucose TIR was higher using faster aspart compared with IAsp for all meals combined (73.6% [69.4, 80.2] vs. 72.1% [64.5, 78.5], respectively; median difference 3.5% [1.0, 7.3]; P = 0.003). There was no ketoacidosis or severe hypoglycemia.

Faster aspart safely improved glucose control compared with IAsp in a group of adults with well-controlled type 1 diabetes using AHCL. The modest improvement was mainly related to mealtime glycemia. While the primary outcome demonstrated statistical significance, the clinical impact may be small, given an overall difference in TIR of 1.9%.

与 MiniMed 高级混合闭环 (AHCL) 系统提供的门冬胰岛素 (IAsp) 相比，评估使用速效门冬胰岛素 (faster aspart) 对成人 1 型糖尿病患者的血糖控制情况。

在这项随机、开放标签、交叉研究中，参与者被分配以随机顺序接受更快的门冬氨酸或 IAsp。阶段 1 和 2 包括 6 周的闭环，然后是 2 周的开环。接下来是第 3 阶段，参与者直接改回第 1 阶段使用的胰岛素配方，持续 1 周。参与者选择自己的膳食，除了两个标准化的膳食测试，一个错过的进餐推注和延迟进餐推注。主要结果是时间传感器葡萄糖值从 70 到 180 mg/dL（时间范围 [TIR]）的百分比。

招募了 25 名成年人（52% 为男性）；中位（四分位距）年龄为 48 (37, 57) 岁，中位 HbA _1c为 7.0% (6.6, 7.2) (53 [49, 55] mmol/mol)。与 IAsp 相比，更快的门冬显示出更高的整体 TIR（分别为 82.3% [78.5, 83.7] 和 79.6% [77.0, 83.4]；平均差异为 1.9% [0.5, 3.3]；P = 0.007）。与 IAsp 相比，对于所有餐食，使用快门冬的餐后四小时血糖 TIR 更高（分别为 73.6% [69.4, 80.2] 和 72.1% [64.5, 78.5]；中位差异为 3.5% [1.0, 7.3]；P = 0.003）。没有酮症酸中毒或严重低血糖。

在一组使用 AHCL 控制良好的 1 型糖尿病成人中，与 IAsp 相比，更快的门冬氨酸安全地改善了血糖控制。适度改善主要与进餐时血糖有关。虽然主要结果显示了统计学显着性，但考虑到 TIR 的总体差异为 1.9%，临床影响可能很小。