Wellcome-MRC Institute of Metabolic Science, Metabolic Research Laboratories, University of Cambridge, Cambridge, United Kingdom.
Department of Diabetes, Royal Free London NHS Foundation Trust, London, United Kingdom.
Diabetes Technol Ther. 2023 Dec;25(12):856-863. doi: 10.1089/dia.2023.0262.
To evaluate hybrid closed-loop with ultra-rapid insulin lispro (Lyumjev) compared with hybrid closed-loop with standard insulin lispro in adults with type 1 diabetes. In a single-center, double-blind, randomized, crossover study, 28 adults with type 1 diabetes (mean ± standard deviation [SD]: age 44.5 ± 10.7 years, glycated hemoglobin (HbA1c) 7.1 ± 0.9% [54 ± 10 mmol/mol]) underwent two 8-week periods comparing hybrid closed-loop with ultra-rapid insulin lispro and hybrid closed-loop with standard insulin lispro in random order. The same CamAPS FX closed-loop algorithm was used in both periods. In an intention-to-treat analysis, the proportion of time sensor glucose was in target range (3.9-10 mmol/L [70-180 mg/dL]; primary endpoint) was greater with ultra-rapid lispro compared with standard insulin lispro (mean ± SD: 78.7 ± 9.8% vs. 76.2 ± 9.6%; mean difference 2.5 percentage points [95% confidence interval 0.8 to 4.2]; = 0.005). Mean sensor glucose was lower with ultra-rapid lispro compared with standard insulin lispro (7.9 ± 0.8 mmol/L [142 ± 14 mg/dL] vs. 8.1 ± 0.9 mmol/L [146 ± 16 mg/dL]; = 0.048). The proportion of time with sensor glucose <3.9 mmol/L [70 mg/dL] was similar between interventions (median [interquartile range] ultra-rapid lispro 2.3% [1.3%-2.7%] vs. standard insulin lispro 2.1% [1.4%-3.3%]; = 0.33). No severe hypoglycemia or ketoacidosis occurred. The use of ultra-rapid lispro with CamAPS FX hybrid closed-loop increases time in range and reduces mean glucose with no difference in hypoglycemia compared with standard insulin lispro in adults with type 1 diabetes. Trial registration number NCT05257460.
评估与标准胰岛素赖脯脲相比，超快速胰岛素赖脯脲（Lyumjev）联合混合闭环系统在 1 型糖尿病成人患者中的应用。在一项单中心、双盲、随机、交叉研究中，28 例 1 型糖尿病成人（平均±标准差[SD]：年龄 44.5±10.7 岁，糖化血红蛋白[HbA1c]7.1±0.9%[54±10mmol/mol]）先后接受了 2 个 8 周的治疗期，分别比较超快速胰岛素赖脯脲和标准胰岛素赖脯脲联合混合闭环系统的效果，两种治疗期均采用相同的 CamAPS FX 闭环算法。意向治疗分析显示，与标准胰岛素赖脯脲相比，超快速胰岛素赖脯脲组传感器葡萄糖处于目标范围内（3.9-10mmol/L[70-180mg/dL]；主要终点）的时间比例更高（平均±SD：78.7±9.8%比 76.2±9.6%；平均差值 2.5 个百分点[95%置信区间 0.8 至 4.2]； = 0.005）。与标准胰岛素赖脯脲相比，超快速胰岛素赖脯脲组传感器葡萄糖水平更低（7.9±0.8mmol/L[142±14mg/dL]比 8.1±0.9mmol/L[146±16mg/dL]； = 0.048）。两种干预措施之间传感器葡萄糖<3.9mmol/L[70mg/dL]的时间比例相似（超快速胰岛素赖脯脲中位数[四分位间距]2.3%[1.3%-2.7%]比标准胰岛素赖脯脲 2.1%[1.4%-3.3%]； = 0.33）。没有发生严重低血糖或酮症酸中毒。在 1 型糖尿病成人患者中，与标准胰岛素赖脯脲相比，使用超快速胰岛素赖脯脲联合 CamAPS FX 混合闭环系统可增加达标时间并降低平均血糖，而低血糖发生率无差异。临床试验注册号 NCT05257460。
