PDF(Pubmed)
Abstract：
BACKGROUND: Use of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices.
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.
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.
摘要：
背景：使用连续皮下胰岛素输注（CSII）已被证明可以改善1型糖尿病（T1D）的血糖结果，但是高成本限制了可访问性。为了解决这个问题，一个可互操作的，开发了开源的超低成本胰岛素泵（ULCIP），并且先前已证明其在标准化实验室测试中具有与商业模型相当的输送准确性。本研究旨在评估最新的ULCIP体内，评估其可行性，作为那些无法负担商业设备的人的负担得起的替代品。
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。
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。
