METHODS: This first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and β-Hydroxybutyrate were monitored to assess device performance.
RESULTS: Participants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained β-Hydroxybutyrate < 0.6 mmol/L throughout.
CONCLUSIONS: The ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted.
BACKGROUND: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.
方法:这项首次人体可行性研究招募了6名T1D患者。在九个小时的住院期间,参与者在临床监督下使用ULCIP。静脉葡萄糖,胰岛素,和β-羟基丁酸酯被监测以评估装置性能。
结果:参与者显示预期的血糖和血胰岛素水平,以响应程序化的基础和推注胰岛素给药。一名参与者出现轻度酮症,这是治疗,并没有复发时,一个新的泵水库放置。所有其他参与者均维持β-羟基丁酸<0.6mmol/L。
结论:ULCIP在有监督的住院环境中安全地向使用者提供胰岛素治疗。未来的工作应集中在纠正本试验中确定的泵硬件问题,并扩展设备功能以用于闭环控制。长期门诊研究是必要的。
背景:该试验于2023年12月11日在澳大利亚新西兰临床试验注册中心(ACTRN12623001288617)进行了前瞻性注册。