Ranjan Ajenthen G, Schmidt Signe, Nørgaard Kirsten
Clinical Translational Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Diabetes Obes Metab. 2025 Jun;27(6):3145-3153. doi: 10.1111/dom.16326. Epub 2025 Mar 24.
To evaluate the efficacy and safety of faster-acting insulin aspart (faster aspart) compared with insulin aspart in adults with type 1 diabetes (T1D) using a non-automated insulin pump and continuous glucose monitoring (CGM).
This double-blinded crossover study randomly assigned participants to start with either faster aspart or insulin aspart for 16 weeks, followed by a 3-week washout period, then switching to the alternate therapy for another 16 weeks. Insulin pump settings were adjusted every 3 weeks. The primary outcome was time in range (TIR: 3.9-10.0 mmol/L). Secondary outcomes included other CGM metrics and HbA1c.
Forty adults (20 males) with a median age of 54 years, T1D duration of 27 years, and HbA1c of 59 mmol/mol (7.5%) were included. At the study end, TIR was (mean ± SD) 60.6 ± 12.1% for insulin aspart and 62.5 ± 12.3% for faster aspart, p = 0.24 (primary endpoint). The baseline-adjusted estimated treatment difference (ETD) for TIR was 6.0% (95%CI: 2.2;9.9), p = 0.002; time above range (>10.0 mmol/L) was -5.7% (-9.8; -1.6), p = 0.007; and time below range (<3.9 mmol/L) was -0.4% (-1.1;0.4), p = 0.30-all in favour of faster aspart. Faster aspart significantly improved the coefficient of variation (34.0 ± 3.7% vs. 35.9 ± 4.9%, p = 0.02) and the HbA1c levels (ETD -1.9 (-3.7; -0.2) mmol/mol or - 0.18% (-0.34;-0.02), p = 0.03). No significant differences were observed in severe adverse events, including severe hypoglycaemia and diabetic ketoacidosis. Faster aspart had more injection site reactions than insulin aspart (p = 0.03).
Faster aspart improved baseline-adjusted TIR, TAR, CV and HbA1c after 16 weeks with frequent insulin pump adjustments but had a higher incidence of injection site reactions.
使用非自动胰岛素泵和持续葡萄糖监测（CGM）评估门冬胰岛素速效制剂（速效门冬胰岛素）与门冬胰岛素相比，在1型糖尿病（T1D）成人患者中的疗效和安全性。
这项双盲交叉研究将参与者随机分配，先使用速效门冬胰岛素或门冬胰岛素治疗16周，随后有3周的洗脱期，然后换用另一种治疗方法再治疗16周。每3周调整一次胰岛素泵设置。主要结局指标是血糖在目标范围内的时间（TIR：3.9 - 10.0 mmol/L）。次要结局指标包括其他CGM指标和糖化血红蛋白（HbA1c）。
纳入了40名成年人（20名男性），中位年龄54岁，T1D病程27年，HbA1c为59 mmol/mol（7.5%）。在研究结束时，门冬胰岛素组的TIR为（均值±标准差）60.6±12.1%，速效门冬胰岛素组为62.5±12.3%，p = 0.24（主要终点）。TIR的基线调整后估计治疗差异（ETD）为6.0%（95%CI：2.2；9.9），p = 0.002；血糖高于目标范围（>10.0 mmol/L）的时间为 -5.7%（-9.8；-1.6），p = 0.007；血糖低于目标范围（<3.9 mmol/L）的时间为 -0.4%（-1.1；0.4），p = 0.30，所有结果均有利于速效门冬胰岛素。速效门冬胰岛素显著改善了变异系数（34.0±3.7% vs. 35.9±4.9%，p = 0.02）和HbA1c水平（ETD -1.9（-3.7；-0.2）mmol/mol或 -0.18%（-0.34；-0.02），p = 0.03）。在严重不良事件方面未观察到显著差异，包括严重低血糖和糖尿病酮症酸中毒。速效门冬胰岛素的注射部位反应比门冬胰岛素更多（p = 0.03）。
在频繁调整胰岛素泵的情况下，速效门冬胰岛素在16周后改善了基线调整后的TIR、TAR、CV和HbA1c，但注射部位反应的发生率较高。
