CN115088042A - 在闭环系统中个性化减少低血糖和/或高血糖 - Google Patents
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Abstract
本文描述的示例实施方案涉及闭环人工胰腺系统。人工胰腺系统旨在通过模拟健康胰腺的内分泌功能来自动和连续地控制用户的血糖水平。人工胰腺系统使用具有成本函数的闭环控制系统。惩罚函数有助于限制胰岛素的输注速率以试图避免低血糖和高血糖。然而,与在成本函数中针对用户胰岛素需求使用通用或基准参数的传统系统不同,示例实施方案可以在成本函数中使用反映用户个性化胰岛素需求的自定义参数。使用自定义参数会使成本函数在一段时间内产生更适合用户个性化胰岛素需求的胰岛素剂量。这有助于更好地避免低血糖和高血糖。
Description
相关申请的交叉引用
本申请要求于2020年2月12日提交的美国非临时申请序列号No.16/789,051的申请日的权益,该申请的全部内容通过全文引用包含在本文中。
背景技术
患有1型糖尿病的患者可以以不同的方式使用胰岛素输送来治疗。一种方法是根据需要手动给患者输送校正大剂量(bolus)的胰岛素。例如,如果患者的血糖水平为170mg/dL且目标血糖水平为120mg/dL,则可以手动给患者输送1U的大剂量(假设校正系数为1:50)。手动给患者输送这种大剂量有一些潜在的问题。患者可能会在大剂量中输送不当的胰岛素量。例如,用户需要的胰岛素量可能比1U的大剂量要少得多。已经输送的胰岛素无法从患者的血流中取回。因此,输送大剂量可能会使患者面临低血糖的风险。
另一种方法是由胰岛素泵系统自动输送胰岛素。一些胰岛素泵系统可以使用闭环控制系统来调节以固定的时间间隔(例如每5分钟)输送的胰岛素的量。控制系统使用的闭环算法可以对大的胰岛素输送施加惩罚,该惩罚在成本函数中与对葡萄糖水平偏移的惩罚相平衡。成本函数的使用通常会导致比手动输送大剂量更频繁的更少的胰岛素的输送。闭环系统可能比手动方法更频繁地重新评估患者的需求。
发明内容
根据示例实施方案,装置控制从人工胰腺向用户输送胰岛素。所述装置包括用于与葡萄糖监测仪对接的监测仪接口以从葡萄糖监测仪获得用户的葡萄糖读数。所述装置可以包括用于与人工胰腺通信的人工胰腺接口以控制向用户输送胰岛素。所述装置还可以包括被配置为实现控制回路以控制人工胰腺的胰岛素输送的处理器。处理器可以在输送剂量选项中选择具有最佳成本函数值的下一次输送的胰岛素输送剂量。成本函数可以具有反映剂量选项预测为用户产生的葡萄糖水平与用户的目标葡萄糖水平之间差异的葡萄糖成本分量。成本函数可以具有反映剂量选项与当前基准胰岛素剂量有何差异的胰岛素成本分量。进一步地,成本函数可以具有对葡萄糖成本分量进行加权的葡萄糖成本权重系数和对胰岛素成本分量进行加权的胰岛素成本权重系数。葡萄糖成本权重系数和胰岛素成本权重系数中的至少一个可以具有为用户自定义的值。
根据示例实施方案,方法由处理器执行。通过所述方法,从葡萄糖监测仪接收用户的葡萄糖读数。确定下一次从人工胰腺向用户输送胰岛素的剂量。所述确定包括将成本函数应用于给用户的多个可能的胰岛素剂量并选择可能的胰岛素剂量中在成本函数下具有最佳成本的一个剂量。成本函数具有反映剂量选项预测为用户产生的葡萄糖水平与用户的目标葡萄糖水平之间的差异的葡萄糖成本分量,以及反映剂量选项与当前基准胰岛素剂量有何差异的胰岛素成本分量。成本函数具有用于对葡萄糖成本分量进行加权的葡萄糖成本权重系数和用于对胰岛素成本分量进行加权的胰岛素成本权重系数。葡萄糖成本权重系数和胰岛素成本权重系数具有为用户自定义的值。人工胰腺被指导为用户输送选定的剂量。
非临时性计算机可读存储介质可以存储使处理器执行上述方法的计算机可读指令。
处理器可以通过人工胰腺接口指导人工胰腺输送选定的胰岛素输送剂量。在某些情况下,葡萄糖成本权重系数和胰岛素成本权重系数中只有一个具有为用户自定义的值。在其他情况下,葡萄糖成本权重系数和胰岛素成本权重系数两者都有为用户自定义的值。
葡萄糖成本权重系数的值可以是基准葡萄糖成本权重系数乘以指示代表用户的胰岛素需求的自定义值与代表胰岛素需求的基准值的比率的值。指示该比率的值可以是该比率的指数值。葡萄糖成本权重系数的值可以是基准葡萄糖成本权重系数乘以指示代表胰岛素需求的基准值与代表用户胰岛素需求的自定义值的比率的值。
胰岛素权重系数的值可以是基准胰岛素成本权重系数乘以指示代表用户的胰岛素需求的自定义值与代表胰岛素需求的基准值的比率的值。胰岛素成本权重系数的值可以是基准胰岛素成本权重系数乘以指示代表胰岛素需求的基准值与代表用户的胰岛素需求的自定义值的比率的值。
人工胰腺接口可以是无线通信接口。所述装置可以是移动计算装置、智能手机或胰岛素泵组件之一。处理器可以对用于确定为用户自定义的葡萄糖成本权重系数或胰岛素成本权重系数中至少一个的参数施加界限。处理器可以被配置为基于用户的胰岛素敏感性校正因子、用户的胰岛素与碳水化合物比率或用户的基础胰岛素水平中的至少一个来确定葡萄糖成本权重系数或胰岛素成本权重系数中的至少一个。葡萄糖成本权重系数和胰岛素成本权重系数中至少有一个可以具有为每日总胰岛素(TDI)用户自定义的值。
附图说明
图1A描述了说明性人工胰腺系统的简化框图。
图1B描述了可由人工胰腺系统的控制回路执行的步骤的流程图。
图2更详细地描述了说明性人工胰腺系统。
图3描述了管理装置可能的类型的示意图。
图4描述了用于使用成本函数计算成本的说明性步骤的流程图。
图5描述了为确定葡萄糖成本权重系数可执行的说明性步骤的流程图。
图6描述了为确定胰岛素成本权重系数可执行的说明性步骤的流程图。
图7描述了以具有非常高的每日胰岛素总量的用户为例的血糖水平曲线和胰岛素输送曲线的说明图。
图8描述了以具有低每日胰岛素总量的用户为例的血糖水平曲线和胰岛素输送曲线的说明图。
图9描述了在对惩罚函数中使用的参数使用界限时可执行的说明性步骤的流程图。
具体实施方式
用于输送胰岛素的传统闭环方法的一个困难是,该方法可能评估所有用户(例如,患者)的惩罚,而不考虑患者的每日胰岛素需求的差异。这种传统方法的结果对于每日胰岛素需求与正常值不同的用户(例如具有高胰岛素需求或低胰岛素需求的用户)可能是有问题的。示例实施方案试图通过使用捕捉用户的每日胰岛素需求的临床参数来针对这些每日胰岛素需求自定义成本函数来解决该问题。特别地,可以修改应用一个或多个惩罚的比率。对于高的每日胰岛素需求,所述比率可以偏向于对葡萄糖偏离进行更多的惩罚,而对胰岛素偏离进行更少的惩罚。对于低的每日胰岛素需求,所述比率可以偏向于对胰岛素偏移进行更多的惩罚,而对葡萄糖偏移进行更少的惩罚。
本文描述的示例实施方案涉及闭环人工胰腺(AP)系统。所述闭环AP系统寻求通过模拟健康胰腺的内分泌功能来自动和持续地控制用户的血糖(BG)水平。所述AP系统使用具有成本函数的闭环控制系统。惩罚函数有助于限制胰岛素的输注速度以试图避免低血糖和高血糖。然而,与在成本函数中针对用户胰岛素需求使用通用或基准参数的传统系统不同,示例实施方案可以在成本函数中使用反映用户的个性化胰岛素需求的自定义参数。使用自定义参数会使成本函数随时间产生更适合用户的个性化胰岛素需求的胰岛素剂量。这有助于平滑用户对胰岛素输注的响应以及有助于更好地避免低血糖和高血糖。
在示例中,AP应用程序可由处理器执行以使系统能够监测用户的葡萄糖值,基于监测的葡萄糖值(例如BG浓度或BG测量值)和其他信息(例如用户提供的信息,如碳水化合物摄入量、用餐时间或类似信息)确定用户适当的胰岛素水平,并采取行动将用户的BG值保持在适当范围内。适当的BG值范围可以被认为是特定用户的目标BG值。例如,如果目标血BG值在80mg/dL至120mg/dL的范围(这是一个满足糖尿病治疗的临床护理标准的范围)内则可以接受。然而,如本文所述的AP应用程序可以考虑到用户的活动水平以更精确地建立目标BG值并可将目标BG值设定为例如110mg/dL等。如参照本文示例更详细描述的,AP应用程序可以利用监测到的BG值和其他信息生成命令并向包括例如泵在内的可穿戴药物输送装置发送命令,以控制向用户输送胰岛素,改变未来剂量的量或定时,以及控制其他功能。
图1A展示了适合于实施示例实施方案的AP系统100的示例的简化框图。示例AP系统100可包括控制器102、泵机构或其他流体提取机构104(下文称为“泵104”)和传感器108。控制器102、泵104和传感器108可以通过有线或无线通信路径相互通信耦合。例如,控制器102、泵104和传感器108中的每一个都可以配备可操作为通过如等的一种或多种通信协议进行通信的无线射频收发器。传感器108可以是葡萄糖监测仪,例如连续葡萄糖监测仪(CGM)108。例如,所述CGM 108可操作用于测量用户的BG值以生成测量的实际BG水平信号112。
如示例所示,控制器102可以接收期望的BG水平信号110,该信号可以是第一信号,指示用户期望的BG水平或范围。期望的BG水平信号110可以从与控制器或其他装置的用户界面接收到,或由自动确定用户的BG水平的算法接收到。传感器108可以耦合至用户并且可操作以测量用户的实际BG水平的近似值。测量BG值、实际BG水平、实际BG水平的近似测量值仅为用户的BG水平的近似值,应理解测量的BG水平可能存在误差。例如,所述误差可归因于许多因素,例如传感器108的用龄、传感器108在用户身体上的位置、环境因素(例如海拔、湿度、气压)等。术语测量BG值、实际BG水平、实际BG水平的近似测量值可以在整个说明书和附图中互换使用。响应于测量BG水平或值,传感器108生成表示测量BG值的信号。如示例所示,控制器102还可以通过通信路径从传感器108接收测量BG水平信号112,该信号可以是第二信号,指示用户的实际BG水平的近似测量值。
基于期望的BG水平信号110和测量的实际BG水平信号112,控制器102可以生成一个或多个控制信号114用于指导泵104的操作。例如,控制信号114之一可以使泵104通过输出端106向用户输送一定剂量的胰岛素116。例如,胰岛素的剂量116可以基于期望的BG水平信号110和实际BG信号水平112之间的差异来确定。上述提到的惩罚函数作为闭环控制系统的一部分在确定剂量时发挥了作用,对此将在后文描述。可以将胰岛素的剂量116确定为用于将用户的实际BG水平驱动至期望的BG水平的适当量的胰岛素。基于由控制信号114确定的泵104的操作,用户可以从泵104接收胰岛素116。
在各种示例中,AP系统100的一个或多个组件可以被整合到附着于用户的可穿戴或身体上的药物输送系统中。
图1B描述了AP系统的示例实施方案作为闭环控制系统的一部分在确定向用户输送什么剂量的胰岛素时可以执行的步骤的流程图130。最初,如上文关于图1A所述,BG水平读数由传感器108获得(132)。BG水平读数通过信号112发送到控制器102(134)。控制器102计算误差值作为测量的BG水平112和期望的BG水平110之间的差(136)。闭环控制系统试图在广泛的可能剂量范围内最小化成本函数的总惩罚。对可能的剂量应用成本函数,并选择具有最佳惩罚函数值的剂量(138)。根据惩罚函数的配置方式,最佳值可能是最小值或最高值。在示例实施方案中使用的惩罚函数将在下文中进一步描述。控制信号114可以由控制器102产生并发送到泵104以使泵将期望的胰岛素剂量输送给用户(140)。
示例AP系统100的简化框图提供了系统操作的一般说明。图2显示了可用于此类AP系统的装置的更详细实施方式的示例。
AP系统的各种示例包括可在系统中操作以根据糖尿病治疗计划管理糖尿病用户的治疗的可穿戴药物输送装置。所述糖尿病治疗计划可包括与胰岛素输送相关的多个参数,这些参数可由称为AP应用程序的计算机应用程序确定和修改。
如本文所述的可穿戴药物输送装置可包括控制器,该控制器可操作以通过AP应用程序指导可穿戴药物输送装置的操作。例如,可穿戴药物输送装置的控制器可以为用户提供操作的可选择的活动模式。在操作的活动模式下药物输送装置的操作可以降低用户在胰岛素敏感性增加期间发生低血糖的可能性,并且可以降低在用户胰岛素需求增加期间发生高血糖的可能性。操作的活动模式可由用户激活或可由控制器自动激活。控制器可以基于检测到的用户活动水平和/或检测到的用户的位置自动激活操作的活动模式。
图2说明了药物输送系统的示例。药物输送系统200可以包括药物输送装置202、管理装置206和BG传感器204。
在图2的示例中,药物输送装置202可以是由用户佩戴在用户身体上的可穿戴或身体上药物输送装置。如图2所示,药物输送装置202可以包括惯性测量单元(IMU)207。药物输送装置202可进一步包括泵机构224(在一些示例中该泵机构可以被称为药物提取机构或组件)以及针部署机构228。在各种示例中,泵机构224可以包括泵或柱塞(未示出)。
针部署组件228可以例如包括针(未示出)、插管(未示出)和用于将储存器225中储存的液体药物耦接到用户的任何其他流体路径部件。插管可以形成耦接用户和储存器225的流体路径部件的一部分。在针部署组件228被激活后,提供通往用户的流体路径(未示出),并且泵机构224可以将液体药物从储存器225中排出以通过流体路径将液体药物输送给用户。例如,流体路径可以包括将可穿戴药物输送装置202耦接到用户的管道(未示出)(例如,将插管耦接到储存器225的管道)。
可穿戴药物输送装置202可以进一步包括控制器221和通信接口装置226。控制器221可以用硬件、软件或其任何组合来实现。例如,所述控制器221可以是耦合到存储器的微处理器、逻辑电路、现场可编程门阵列(FPGA)、专用集成电路(ASIC)或微控制器。控制器221可以保持日期和时间以及由处理器执行的其他功能(例如,计算等)。控制器221可操作用于执行存储在存储器中的AP算法,该算法使控制器221能够指导药物输送装置202的操作。此外,控制器221可操作用于接收来自IMU207以及来自药物输送装置202的任何其他传感器(例如管理装置206或CGM 204上的传感器(例如,加速度计、位置服务应用程序等))或与之耦合的任何传感器(例如启用了全球定位系统(GPS)的装置)等的指示用户活动的数据或信息。
控制器221可以处理来自IMU 207或任何其他耦合的传感器的数据,以确定是否要向用户和/或用户的护理人员发送警报或其他通信,或者是否要调整药物输送装置202的操作模式。所述控制器221可以例如通过通信接口装置226提供警报。通信接口装置226可以向与药物输送装置202物理分离的一个或多个管理装置提供通信链路,管理装置例如包括用户和/或用户的护理人员(例如,父母)的管理装置206。由通信接口装置226提供的通信链路可以包括根据任何已知的通信协议或标准(如蓝牙或蜂窝标准)操作的任何有线或无线通信链路。
图2的示例进一步显示了与BG传感器204有关的药物输送装置202,例如,该BG传感器204可以是CGM。CGM 204可以与药物输送装置202物理分离或者可以是其集成组件。CGM204可以向控制器221提供指示测量或检测到的用户BG水平的数据。
管理装置206可以由用户或用户的护理人员维护和操作。管理装置206可以控制药物输送装置202的操作和/或可用于审查指示药物输送装置202的操作状态或用户状态的数据或其他信息。管理装置206可用于指导药物输送装置202的操作。管理装置206可以包括处理器261和存储器装置263。存储器装置262可以存储AP应用程序269,包括可以实现活动模式、高血糖保护模式和/或低血糖保护模式的编程代码。管理装置206可以通过一个或多个已知的有线或无线通信标准或协议从药物输送装置202接收警报、通知或其他通信。
药物输送系统200可操作用于实现AP应用程序,该应用程序包括用于确定指示用户的身体活动的可穿戴药物输送装置的移动的功能,实现活动模式、高血糖模式、低血糖模式以及其他功能,例如可穿戴药物输送装置的控制。药物输送系统200可以是自动药物输送系统,其可以包括可穿戴药物输送装置(泵)202、传感器204和个人糖尿病管理装置(PDM)206。
在示例中,可穿戴药物输送装置202可以附着于用户205的身体并且可以向用户输送任何治疗剂,包括任何药物或药品,例如胰岛素等。可穿戴药物输送装置202例如可以是用户穿戴的可穿戴装置。例如,可穿戴药物输送装置202可以直接耦合至用户(例如,通过粘合剂等直接附接到用户的身体部分和/或皮肤)。在示例中,可穿戴药物输送装置202的表面可以包括粘合剂以方便附着于用户。
可穿戴药物输送装置202关于从储存器225中排出药物以将药物输送给用户的操作可以被称为泵,或胰岛素泵。
在示例中,可穿戴药物输送装置202可以包括用于存储药物(例如胰岛素)的储存器225、用于将药物输送到用户身体内(可以是在皮下、腹膜内或静脉内进行)的针或插管(未示出)和泵机构(机械)224或用于将药物从储存器225通过针或插管(未示出)转移到用户中的其他驱动机构。储存器225可被配置为储存或容纳液体或流体,如胰岛素、吗啡或其他治疗药物。所述泵机构224可以与储存器225流体耦合,并与处理器221通信耦合。可穿戴药物输送装置202还可以包括电源(未示出),例如电池、压电装置等,用于向可穿戴药物输送装置202的泵机构224和/或其他组件(如处理器221、存储器223和通信装置226)提供电力。尽管未示出,但用于提供电力的电源可以类似地包括在传感器204、智能配件装置207和管理装置(PDM)206的每一个中。
在示例中,BG传感器204可以是与处理器261或221通信耦合的装置,并且可操作用于在预定的时间间隔,例如每5分钟等,测量BG值。BG传感器204可以向在相应装置上运行的AP应用程序提供多个BG测量值。例如,BG传感器204可以是连续的BG传感器,其周期性地向在相应装置上运行的AP应用程序提供BG测量值,例如大约每5、10、12分钟等。
可穿戴药物输送装置202还可以包括IMU 207。IMU 207可操作用于检测可以指示用户活动的各种运动参数(例如,加速度、减速度、速度、方位,例如滚动、俯仰、偏航、罗盘方向等)。例如,IMU 207可以响应于检测指示用户的任何身体状况的状态(例如用户的运动或位置)的可穿戴药物输送装置202的运动而输出信号。基于检测到的用户的活动,药物输送装置202可以调整与药物输送相关的操作,例如,通过实施如本文所讨论的活动模式。
当以正常操作模式操作时,可穿戴药物输送装置202可以基于由传感器204和/或管理装置(PDM)206提供的信息(例如,血糖测量值、来自惯性测量单元的输入、启用全球定位系统的装置、启用Wi-Fi的装置)向用户提供储存在储存器225中的胰岛素。
例如,可穿戴药物输送装置202可以包含模拟和/或数字电路,其可以实现为用于控制药物或治疗剂输送的控制器221(或处理器)。用于实现处理器221的电路可以包括离散的专用逻辑和/或组件、专用集成电路、微控制器或处理器,其执行软件指令、固件、编程指令或编程代码(例如,启用存储在存储器223中的AP应用程序229),以及其任何组合。例如,处理器221可以执行控制算法,如AP应用程序229,以及可使处理器221可操作以使泵在预定的时间间隔或根据需要向用户输送药物或治疗剂的剂量,以使BG测量值达到目标BG值的其他编程代码。例如,用户或第三方(如医疗保健提供者、可穿戴药物输送装置制造商等)可以使用在可穿戴药物输送装置202和管理装置206或其他装置(如医疗保健提供者设施处的计算装置)之间的有线或无线链路,如220,将剂量的大小和/或定时编程到例如AP应用程序229中。在示例中,泵或可穿戴药物输送装置202通过无线链路220,或通过例如来自智能配件装置207的291或来自传感器204的208的无线链路与管理装置的处理器261进行通信耦合。可穿戴药物输送装置的泵机构224可操作以接收来自处理器261的激励信号,并且响应于接收激励信号并从储存器225等排出胰岛素。
系统200中的装置,例如管理装置206、智能配件装置207和传感器204,也可操作用于执行各种功能,包括控制可穿戴药物输送装置202。例如,管理装置206可以包括通信装置264、处理器261和管理装置存储器263。所述管理装置存储器263可以存储包括编程代码的AP应用程序269的实例,所述编程代码当由处理器261执行时提供本文所述的过程实例。所述管理装置存储器263还可以存储用于提供参照本文示例描述的过程示例的编程代码。
虽然未示出,但系统200可以包括智能配件装置(例如)、其他制造商提供的包括眼镜在内的其他可穿戴智能装置、启用全球定位系统的可穿戴装置、可穿戴健身装置、智能服装等。与管理装置206类似,智能配件装置(未示出)也可操作以执行各种功能,包括控制可穿戴药物输送装置202。例如,所述智能配件装置可以包括通信装置、处理器和存储器。所述存储器可以存储AP应用程序的实例,包括用于提供参照本文所述示例描述的过程实例的编程代码。存储器还可以作为存储编程代码并且可操作用于存储与AP应用程序相关的数据。
系统200的传感器204可以是如上所述的CGM,其可以包括处理器241、存储器243、传感或测量装置244和通信装置246。存储器243可存储AP应用程序249的实例以及其他编程代码并且可操作用于存储与AP应用程序249相关的数据。AP应用程序249还可包括用于提供参照本文所述示例描述的过程示例的编程代码。
用于确定向用户输送药物或治疗剂(例如,作为大剂量)的指令(例如,药物或治疗剂的任何剂量的大小和/或时间)可以由可穿戴药物输送装置202在本地发出,或者可以远程发出并提供给可穿戴药物输送装置202。在本地确定药物或治疗剂输送的示例中,存储在与可穿戴药物输送装置202耦合的存储器223中的编程指令,例如AP应用程序229的实例,可用于由可穿戴药物输送装置202做决定。此外,可穿戴药物输送装置202可操作以通过通信装置226和通信链路288与可穿戴药物输送装置202通信,以及通过通信装置226和通信链路289与BG传感器204通信。
可替代地,远程指令可以由管理装置(PDM)206通过有线或无线链路提供给可穿戴药物输送装置202。如果存在于存储器263中,PDM 206可以配备有可执行AP应用程序269的实例的处理器261。存储器可以存储由处理器261执行的计算机可读指令。所述存储器可以包括用于存储可由处理器执行的指令的非临时性计算机可读存储介质。可穿戴药物输送装置202可以执行任何接收到的指令(源自内部或来自管理装置206)以将胰岛素输送给用户。通过这种方式,可以自动向用户输送胰岛素。
在各种示例中,可穿戴药物输送装置202可以通过无线通信链路288与管理装置206进行通信。管理装置206可以是电子装置,诸如例如智能手机、平板电脑、专用的糖尿病治疗管理装置等。可替代地,管理装置206可以是可穿戴无线配件装置,例如智能手表等。无线链路287-289可以是由任何已知无线标准提供的任何类型的无线链路。例如,无线链路287-289可以使可穿戴药物输送装置202、管理装置206和传感器204之间基于例如近场通信标准、蜂窝标准或任何其他无线光学或射频协议进行通信。
传感器204也可以通过例如粘合剂等耦合至用户并且可以提供关于用户的一个或多个医疗状况和/或身体属性的信息或数据。传感器204提供的信息或数据可用于调整可穿戴药物输送装置202的药物输送操作。例如,传感器204可以是可操作以测量BG并输出BG值或代表BG值的数据的葡萄糖传感器。例如,传感器204可以是提供周期性BG测量的葡萄糖监测仪、CGM,或提供BG测量的另一类型的装置或传感器。
传感器204可以包括处理器241、存储器243、传感/测量装置244和通信装置246。传感器204的通信装置246可以包括电子发射器、接收器和/或收发器,用于通过无线链路222与管理装置206通信或通过链路208与可穿戴药物输送装置202通信。传感/测量装置244可以包括一个或多个传感元件,例如BG测量元件、心率监测仪、血氧传感器元件等。处理器241可以包括离散的专用逻辑和/或组件、专用集成电路、微控制器或处理器,其执行存储在存储器(如存储器243)中的软件指令、固件、编程指令或其任何组合。例如,存储器243可以存储可由处理器241执行的AP应用程序249的实例。
尽管传感器204被描述为与可穿戴药物输送装置202分离,但在各个示例中,传感器204和可穿戴药物输送装置202可以并入同一个单元。也就是说,在一个或多个示例中,传感器204可以是可穿戴药物输送装置202的一部分并且包含在可穿戴药物输送装置202的同一壳体内(例如,传感器204可以定位在或嵌入在可穿戴药物输送装置202内)。由传感器204确定的葡萄糖监测数据(例如,测量的BG值)可以提供给可穿戴药物输送装置202、智能配件装置207和/或管理装置206,其可以使用测量的BG值来确定指示用户身体活动、活动模式、高血糖模式和高血糖模式的可穿戴药物输送装置的移动。
在示例中,管理装置206可以是个人糖尿病管理器。所述管理装置206可用于编程或调整可穿戴药物输送装置202和/或传感器204的操作。所述管理装置206可以是任何便携式电子设备,例如包括专用控制器(如处理器261)、智能手机,或平板电脑。在示例中,管理装置(PDM)206可以包括处理器261、管理装置存储器263,和通信装置264。管理装置206可以包含模拟和/或数字电路,可以实现为处理器261(或控制器),用于执行管理用户的BG水平的过程并控制药物或治疗剂向用户的输送。处理器261也可操作以执行存储在管理装置存储器263中的编程代码。例如,管理装置存储器263可操作用于存储可由处理器261执行的AP应用程序269。当执行AP应用程序269时,处理器261可操作用于执行各种功能,例如关于示例描述的那些功能。通信装置264可以是根据一个或多个射频协议运作的接收器、发射器或收发器。例如,通信装置264可以包括蜂窝收发器和蓝牙收发器,使管理装置206能够通过蜂窝收发器与数据网络通信,并与传感器204和可穿戴药物输送装置202通信。通信装置264的各个收发器可操作用于传输包含可由AP应用程序等使用或生成的信息的信号。可穿戴药物输送装置202和传感器204相应的通信装置226和246也可操作用于传输包含可由AP应用程序等使用或生成的信息的信号。
可穿戴药物输送装置202可以通过无线链路208与传感器204通信并且可以通过无线链路220与管理装置206通信。传感器204和管理装置206可以通过无线链路222进行通信。智能配件装置207,当存在时,可以分别通过无线链路287、288和289与可穿戴药物输送装置202、传感器204和管理装置206通信。无线链路287、288和289可以是使用已知无线标准或专有标准运行的任何类型的无线链路。例如,无线链路287、288和289可以通过相应的通信装置226、246和264提供基于Wi-Fi、近场通信标准、蜂窝标准或任何其他无线协议的通信链路。在一些示例中,可穿戴药物输送装置202和/或管理装置206可以分别包括用户界面227和268,例如键盘、触摸屏显示器、控制杆、按钮、麦克风、扬声器、显示器等,其可操作以允许用户输入信息以及允许管理装置输出信息以呈现给用户。
在各个示例中,药物输送系统200可以是胰岛素药物输送系统。例如,可穿戴药物输送装置202可以是如美国专利No.7,303,549、美国专利No.7,137,964或者是美国专利No.6,740,059所述的(Insulet Corporation,Billerica,MA)胰岛素输送装置(其中每一个都通过引用整体并入本文)或另一种类型的胰岛素输送装置。
在示例中,药物输送系统200可以实施AP算法(和/或提供AP功能)以管理或控制向用户自动输送胰岛素(例如,维持血糖正常——血液中葡萄糖的正常水平)。AP应用程序可由可穿戴药物输送装置202和/或传感器204实现。所述AP应用程序可用于确定胰岛素输送的时间和剂量。在各个示例中,AP应用程序可以基于关于用户的已知信息(例如用户的性别、年龄、体重或身高)和/或收集的有关用户的身体属性或状况的信息(例如,来自传感器204)确定输送的时间和剂量。例如,AP应用程序可以基于用户通过传感器204的葡萄糖监测来确定合适的胰岛素输送。所述AP应用程序还可以允许用户调整胰岛素输送。例如,AP应用程序可以允许用户选择(例如,通过输入)用于输出到可穿戴药物输送装置202的命令,例如设置可穿戴药物输送装置的模式(例如活动模式、高血糖保护模式、低血糖保护模式)的命令,输送大剂量胰岛素等。在一个或多个示例中,AP应用程序的不同功能可以分布在管理装置206、可穿戴药物输送装置(泵)202或传感器204中的两个或多个之间。在其他示例中,AP应用程序的不同功能可由一个装置(如管理装置206、可穿戴药物输送装置(泵)202或传感器204)执行。在各个示例中,药物输送系统200可以包括如2016年11月22日提交的美国专利申请No.15/359,187和9月13日提交的美国专利申请No.16/570,125中描述的药物输送系统的特征或可以根据其功能操作,上述两个申请均通过引用整体并入本文。
如本文所述,药物输送系统200或其任何组件,例如可穿戴药物输送装置,可被认为提供AP功能或实现AP应用程序。因此,对AP应用程序(例如,其功能、操作或能力)的引用是为了方便并且可以指代和/或包括药物输送系统200或其任何组成组件(例如,可穿戴药物输送装置202和/或管理装置206)的操作和/或功能。所述药物输送系统200—例如,作为实现AP应用程序的胰岛素输送系统—可以被认为是使用传感器输入(例如,由传感器204收集的数据)的药物输送系统或基于AP应用程序的输送系统。
在示例中,药物输送装置202包括通信装置264,如上所述,该通信装置264可以是根据一种或多种射频协议(例如蓝牙、Wi-Fi、近场通信标准、蜂窝标准)进行操作的接收器、发射器或收发器,其可以使各装置与基于云的服务211通信。例如,来自传感器204或可穿戴药物输送装置(泵)202的输出可以通过通信装置264的收发器传输到基于云的服务211进行存储或处理。同样地,可穿戴药物输送装置202、管理装置206和传感器204可操作以通过通信链路288与基于云的服务211通信。
在示例中,每个相应装置202、206或207的相应接收器或收发器可操作用于接收包含可由传感器204传输的BG测量值数目的相应BG测量值的信号。每个相应装置202、206或207的相应处理器可操作用于将每一个相应BG测量值存储在相应的存储器(例如223、263或273)中。相应的BG测量值可以作为与AP算法(例如229、249或269)有关的数据存储。在另一个示例中,在管理装置206、智能配件装置207或传感器204中的任何一个上运行的AP应用程序可操作用于通过由相应的通信装置264、274、246实现的收发器传输控制信号,以便由可穿戴药物输送装置接收。在示例中,所述控制信号可以指示可穿戴药物输送装置202要排出的胰岛素量。
在示例中,装置202、204或206中的一个或多个可操作以分别通过有线通信链路277、278和279进行通信。基于云的服务(未示出)可以利用服务器和数据存储设备(未示出)。将药物输送系统200耦合至基于云的服务的通信链路可以是在系统200的相应装置202、204或206之间建立的蜂窝链路、Wi-Fi链路、蓝牙链路或其组合。例如,由基于云的服务提供的数据存储设备(未示出)可以存储匿名数据,例如用户体重、BG测量值、年龄、膳食碳水化合物信息等。此外,基于云的服务211可以处理来自多个用户的匿名数据,以提供与AP应用程序使用的各种参数相关的通用信息。例如,可以从匿名数据中得出与活动水平或特定锻炼或运动有关的基于年龄的通用目标BG值,这在用户选择活动模式(或高血糖保护模式,或低血糖保护模式)或系统200自动实施活动模式(或高血糖保护,或低血糖保护模式)时可能会有帮助。基于云的服务还可以为系统200提供处理服务,例如执行参考后面的示例描述的过程。
可穿戴药物输送装置202还可以包括用户界面227。所述用户界面227可以包括用于用户将数据输入到药物输送装置202的任何机构,诸如例如按钮、旋钮、开关、触摸屏显示器或任何其他用户交互组件。所述用户界面227可以包括用于药物输送装置202将数据传达给用户的任何机构,并且可以包括例如显示器、触摸屏显示器或用于提供视觉、听觉或触觉(例如振动)输出(例如作为警报)的任何部件。为了简洁和解释,所述用户界面227还可以包括未在图2中具体示出的附加组件。例如,用户界面227可以包括用于接收来自用户或护理人员(例如,父母或护士)的输入或向其提供输出的一个或多个用户输入或输出组件、输出可见警报的显示器、输出声音的扬声器、或输出触觉指示器以提醒用户或护理人员潜在活动模式的振动装置、电源(例如,电池)等。例如,对用户界面227的输入可以通过指纹传感器、触觉输入传感器、按钮、触摸屏显示器、开关等。在另一个替代方案中,可以通过与可穿戴药物输送装置202的控制器221通信耦合的管理装置206来请求操作的活动模式。通常,用户可以生成指令,这些指令可以作为用户偏好存储在存储器(例如223或263)中,它们指定系统200何时进入操作的活动模式。
本文描述了由系统200执行的各种操作场景和过程示例。例如,系统200可操作用于实施与包括高血糖保护模式和低血糖保护模式的活动模式相关的过程示例,如下文详述。
在示例中,药物输送装置202可以作为AP系统(例如,作为AP系统100的一部分)操作和/或可以通过AP应用程序实现技术或算法,AP应用程序控制和提供与AP系统的基本上所有方面或至少其部分相关的功能。因此,本文提到的AP系统或AP算法可以指由在药物输送装置202上执行的AP应用程序实现以提供AP系统的特征和功能的技术或算法。药物输送装置202可以以开环或闭环方式操作以向用户提供胰岛素。
额外特征可以作为AP应用程序的一部分来实现,例如活动模式、高血糖模式、低血糖模式等。例如,当执行编程代码时,药物输送装置202启用AP应用程序的活动模式、高血糖模式、低血糖模式等。当执行包括用于活动模式、高血糖模式和低血糖模式的编程代码的AP应用程序时,AP应用程序可以调整操作,例如检测指示用户身体活动的可穿戴药物输送装置的运动或移动。例如,IMU 207可以检测引起用户的身体活动的运动特征(例如,诸如跳跃、跳舞、跑步、举重、骑自行车等的移动)的可穿戴药物输送装置202的运动和移动。此外,参考图3所述,IMU 207可包括全球定位系统,该系统可检测可穿戴药物输送装置202的位置。可替代地,或者除此以外,可穿戴药物输送装置202也可以利用Wi-Fi定位服务来确定可穿戴药物输送装置202的位置。例如,AP算法可以从与可在特定时间输入用户将要进行身体活动的指示的用户的重复交互中学习。可替代地,或者除此以外,可穿戴药物输送装置202可以在检测到特定的位置(例如,健身房、运动场、体育场、跑道等)时确定用户将要增加他们的身体活动。
管理装置(参见例如图2的206)可以采用许多不同的形式。图3示出了说明管理装置302的不同可能形式的图300。例如,管理装置302可以在智能手机304中实现。使用智能手机304作为管理装置302的好处包括用户通常已经拥有智能手机304,并且AP应用程序可以容易地安装在智能手机304上。管理装置302也可以是自定义控制器装置306,例如上文所描述的。管理装置302也可以是移动计算装置308,如平板电脑、笔记本电脑、可穿戴计算装置等。最后,管理装置302可以是另一种类型的计算装置310,例如桌面计算装置。
为了理解在示例实施方案的惩罚函数中使用自定义参数的价值,回顾可用于胰岛素输送系统通用成本函数是有帮助的。通用成本函数可表示为:
J(Irec)=Q(f(Irec)-Gtarget)n+R(Irec-Ib)m
其中J是总惩罚,Irec是针对总惩罚评估的当前推荐的胰岛素输送量,Q是葡萄糖偏移的系数,f(Irec)是将推荐的胰岛素输送量与相应的预期葡萄糖值关联的任何通用函数,Gtarget是当前的控制目标,R是胰岛素偏移的系数,Ib是当前的基准胰岛素输送量,以及n和m是代表对葡萄糖和/或胰岛素偏移的惩罚进行任意缩放的通用系数。
项(f(Irec)-Gtarget)可以看作是输送推荐胰岛素剂量的葡萄糖成本。函数f(Irec)是将推荐的胰岛素输送剂量与用户的相应预期葡萄糖水平相关联的函数。因此,对于葡萄糖水平未达到目标水平会受到惩罚。项(Irec-Ib)可以看作是输送推荐剂量的胰岛素的胰岛素成本。对于与基础剂量不同的胰岛素输送剂量会受到惩罚。Q可以看作是对葡萄糖成本进行加权的葡萄糖成本权重系数,以及R可以看作是对胰岛素成本进行加权的胰岛素成本权重系数。在大多数情况下,n和m的值可以设置为2。
在一般情况下,系数Q和R对所有用户都是固定的。因此,如果R固定为1000并使用二次缩放比例,则高于基础2U的胰岛素偏移可能对所有用户造成4000的惩罚。这包括具有变化的每日胰岛素需求的用户。对于每日总胰岛素(TDI)需求为10U的用户来说,2U的输送量代表了每天需要的全部胰岛素的20%的输送量。相比之下,对于TDI为100U的用户的,2U的输送量代表了用户的每日胰岛素需求的2%。因此,由于R系数权重导致的相同惩罚可能会导致胰岛素输送剂量代表各用户的TDI的大大不同的量。
如果Q的值固定为10,高于葡萄糖目标50mg/dL的葡萄糖偏移导致上述两个用户的成本为25000。尽管其中一个TDI为10U的用户需要比TDI为100U的用户少10倍的胰岛素来使葡萄糖下降50mg/dL,但情况仍然如此。此示例假设应用TDI/1800的1800规则(例如,10/1800或1/180)来确定产生1mg/dL葡萄糖下降所需的胰岛素比率。对于TDI为10U的用户,50mg/dL的下降需要50/180U或0.28U。另一方面,对于TDI为100U的用户,比率为100/1800或1/18,需要的胰岛素量为50/18或2.8U。鉴于这种差异,有必要基于TDI或每日胰岛素需求的另一指标来对系数Q和R进行缩放。
因此,成本函数应考虑到用户不同的每日胰岛素需求。示例实施方案试图考虑这种不同的需求,并可提供系数Q和R的适当缩放。
示例实施方案可以修改系数Q和R以考虑用户不同的每日胰岛素需求。在一个实施方案中,系数的计算方法是:
在这些等式中,Qbase和Rbase构成标准基准系数,适合于具有与Pbase等价的通用临床参数的用户。P是用户的实际胰岛素需求的自定义值。
l和o的值可以设置为具有反映对用户参数变化的依赖程度的值。在某些情况下,l或o的值可以为零,以便相关联的权重Q或R不使用缩放的成本权重系数。
给定上述Q和R系数的公式,示例实施方案的惩罚函数可以表示为:
Q和R系数的所述公式对葡萄糖偏移和胰岛素偏移的惩罚进行了缩放。葡萄糖偏移是BG水平与目标BG水平不同的情况,而胰岛素偏移是胰岛素剂量与基础胰岛素剂量不同的情况。葡萄糖偏移的成本随着更高的参数(例如,)而增加,而胰岛素偏移的成本随着更低的参数(例如,)而增加。因此,对于胰岛素需求很大的用户来说,成本很高,这意味着需要较大量的胰岛素才能将高葡萄糖偏移恢复到目标。同样,对于胰岛素需求小的用户,胰岛素偏移的成本很高,这意味着任何胰岛素输送都是用户的每日胰岛素需求的较大部分。
图4描述了流程图400,其总结了可用于根据所提议的胰岛素剂量的惩罚函数计算成本的说明性步骤。控制器可以确定葡萄糖成本分量,例如(f(Irec)-Gtarget)n(402)。控制器计算葡萄糖成本权重系数,例如(404)。控制器还可以计算胰岛素成本分量,例如(Irec-Ib)m(406)。控制器可以计算胰岛素成本权重系数,例如(408)。最后,控制器可以根据上述惩罚函数的等式完成胰岛素剂量的成本计算(410)。该成本是针对每个提议的胰岛素剂量确定的,以确定具有最佳成本的剂量(例如,最低成本剂量)。
在确定葡萄糖成本权重系数时,不同的公式可用于不同的示例实施方案。图5提供了可执行以确定葡萄糖成本权重系数的说明性步骤的流程图500。首先,确定参数(例如,Pbase)的基准值(502)。在使用TDI的情况下,该值可能是120U。接着,计算用于缩放Qbase的比率有两个选项。在上述示例的情况下,计算自定义值与基准值的比率(例如,)(504)。反之,也可以计算倒数比率。倒数值为基准与自定义值的比率(506)。接着,指数值(例如,l)可应用于该比率(506)。
类似地,如图6的流程图600所示,可以以不同方式确定胰岛素成本权重系数Q。首先,确定基准胰岛素成本权重系数(例如Qbase)(602)。用于缩放基准胰岛素成本权重系数的比率可以确定为每日胰岛素需求的基准参数与用户自定义的每日胰岛素需求的比率(例如,)(604)。另外,也可以使用反比(例如,)(606)。可以如上所述分配比率的指数(608)。
可以在图7的图表700、702和704中看到成本权重系数的缩放效果。这些图表700、702和704是针对TDI为非常高的115U的用户。图表700显示了使用非缩放成本权重系数在最坏情况下的用户BG水平随时间的变化,图表702显示了这种情况下的胰岛素输送量随时间的变化。图表700的第一部分708显示了BG水平的曲线710从大约午夜开始并延伸到上午5:00左右的很长一段时间内保持在250mg/dL以上,因为如图表702中的曲线712所示,直到上午3:00左右,胰岛素的输送量在很长一段时间内没有增加到0.2U以上。这是对胰岛素偏移的高权重的结果。
相反,在缩放成本权重系数的情况下,胰岛素的剂量增加得更快(例如,从上午12:00开始的0.3U),并在更早的时间内保持升高达更长时间,如图表704中的曲线714所示。这导致升高的葡萄糖水平更快地降低。如上所述,对于有胰岛素抗性的用户,缩放可以允许输送更大剂量的胰岛素。
通过缩放,胰岛素偏移的惩罚减少且葡萄糖偏移的惩罚增加。此外,曲线710进入了低血糖风险的范围,如图表702的第二部分709中下午9点到下午12点之间的夜晚时间段使用非缩放成本权重系数的区域716和718所示。这是因为相对于用户每小时约2U的输入基础而言,胰岛素的惩罚相对较高。因此,很难在不招致大的惩罚的情况下使剂量与基础相差很多。
相反,在缩放成本权重系数的情况下,胰岛素偏移惩罚没有那么大,所以胰岛素量可以变化更多并且避免长时间的低血糖风险(见曲线714上的剂量从下午7:30左右开始下降到0U,直到下午9:00)。
图8显示了对于具有非常低的15U的TDI的用户的示例的类似图表800、802和804。图表800通过间隔5分钟的曲线810显示了用户的BG水平随的时间变化。区域816和818带有阴影。如图所示,用户的血糖水平在上午12:00至上午1:00之间迅速增加,超过200mg/dL并徘徊在300mg/dL附近。因此,患者在这一间隔内血糖过高。如图表802中的曲线812所示,没有缩放成本权重系数的系统继续推荐接近4倍约束(例如,4x基础)的输送剂量达超过一个小时。作为响应,用户的BG水平急剧下降,导致上午4:00至上午5:00之间的低血糖,这是因为在没有违反约束的情况下输送了过多的胰岛素。当胰岛素的输送响应于低血糖而停止时,葡萄糖水平会达到峰值并超过目标值。
相比之下,在缩放成本权重系数的情况下,当用户的葡萄糖水平开始下降时,如图表804中的曲线814所示,输送的胰岛素量减少并且减少得更快。这是因为对于这样的用户,对胰岛素偏移的惩罚较高而对葡萄糖偏移的惩罚较低。因此,避免了过冲和由此产生的低血糖。这也可以避免因响应低血糖而停止胰岛素导致的高血糖。
成本权重系数的值可以被限制以不超过下限和/或上限。图9显示了可执行以使用这种界限的步骤的流程图900。在一个示例中,参数P的值按以下方法计算:
P=min(max(Pactual,Plow),Phigh)
这导致成本函数为:
因此,为实现这些界限,计算用户的胰岛素需求的自定义参数Pactual(902)。确定上限Phigh和下限Plow(904)。确定界限Phigh和Plow中的最小值,并与Pactual比较以确定一个最大的值(例如,最大值),该最大值用作成本权重系数的比率中的值P(906)。界限的使用可能有助于保持比率不会过大或过小。
可以修改成本函数以考虑除TDI之外的用户特定值。例如,成本函数可以包括其他临床参数,例如基础、校正因子或胰岛素与碳水化合物的比率。缩放不需要依赖于像TDI的单个参数,而是可以依赖于多个参数的组合。具体地,在早期的表示中由P表示的变量通常定义了用户的实际胰岛素需求。然而,尽管用户的胰岛素需求通常可以通过TDI来定义,但他们的需求也可以通过他们的基础参数、校正因子参数或胰岛素与碳水化合物的比率参数来定义。
例如,通用基准临床参数Pbase可以定义为典型的1型糖尿病患者的整体人群的平均TDI。另一方面,该参数也可以定义为典型的1型糖尿病患者的平均基础参数。
在可替代的实施方案中,Pbase也可以被定义为TDI的平均值和基础参数的平均值的不同组合,如以下公式:
其中WTDI和Wbasal表示TDI和基础参数的权重,以计算成本函数对每个参数的依赖性。值得重点注意的是,TDI和基础参数都与用户的胰岛素需求有直接关系,即用户的胰岛素需求越高,值就越高,从而形成该形式的等式。因此,Pactual可以类似地定义为:
在进一步的实施方案中,可以用与上述等式中的TDI和基础类似的方式使用校正因子。然而,校正因子和类似参数的值会随着胰岛素需求的减少而增加,反之亦然;因此,Pbase和Pactual可以按以下等式计算:
所有三个参数(或其它参数)的组合可以用于如上计算Pbase和Pactual。在一个实施方案中,这些计算可以表示成下面的等式:
其它有直接关系(即胰岛素需求的增加导致临床参数值的增加)的参数可以添加到Pbase和PPctual等式的分母上,以及具有相反关系(即胰岛素需求的增加导致临床参数值的减少)的参数可以添加到Pbase和Pactual等式的分母上。
虽然本发明在此已相对于示例实施方案进行了描述,但可以理解的是,在不偏离所附权利要求书中定义的本发明的预期范围的情况下,可以对形式和细节进行各种改变。
Claims (30)
1.一种用于控制从人工胰腺向用户输送胰岛素的装置,包括:
与葡萄糖监测仪的监测仪接口,用于从葡萄糖监测仪获得用户的葡萄糖读数;
人工胰腺接口,用于与人工胰腺通信以控制向用户输送胰岛素;
处理器,被配置为实现控制回路以控制人工胰腺输送胰岛素,其中处理器在输送剂量选项中选择具有最佳成本函数值的用于下一次输送的胰岛素输送剂量,并且其中所述成本函数:
具有反映剂量选项预测为用户产生的葡萄糖水平与用户的目标葡萄糖水平之间的差异的葡萄糖成本分量,
具有反映剂量选项与当前基准胰岛素剂量有何差异的胰岛素成本分量,
具有用于对葡萄糖成本分量进行加权的葡萄糖成本权重系数,
具有用于对胰岛素成本分量进行加权的胰岛素成本权重系数,以及
其中葡萄糖成本权重系数和胰岛素成本权重系数中至少一个具有为用户自定义的值。
2.按照权利要求1所述的装置,其中处理器通过人工胰腺接口指导人工胰腺输送选择的胰岛素输送剂量。
3.按照权利要求1所述的装置,其中葡萄糖成本权重系数和胰岛素成本权重系数中只有一个具有为用户自定义的值。
4.按照权利要求1所述的装置,其中葡萄糖成本权重系数和胰岛素成本权重系数两者都具有为用户自定义的值。
5.按照权利要求1所述的装置,其中葡萄糖成本权重系数的值是基准葡萄糖成本权重系数乘以指示代表用户的胰岛素需求的自定义值与代表胰岛素需求的基准值的比率的值。
6.按照权利要求5所述的装置,其中指示所述比率的值是该比率的指数值。
7.按照权利要求1所述的装置,其中胰岛素成本权重系数的值是基准胰岛素成本权重系数乘以指示代表胰岛素需求的基准值与代表用户的胰岛素需求的自定义值的比率的值。
8.按照权利要求7所述的装置,其中指示所述比率的值是该比率的指数值。
9.按照权利要求1所述的装置,其中葡萄糖成本权重系数的值是基准葡萄糖成本权重系数乘以指示代表胰岛素需求的基准值与代表用户的胰岛素需求的自定义值的比率的值。
10.按照权利要求1所述的装置,其中胰岛素成本权重系数的值是基准胰岛素成本权重系数乘以指示代表用户的胰岛素需求的自定义值与代表胰岛素需求的基准值的比率的值。
11.按照权利要求1所述的装置,其中人工胰腺接口为无线通信接口。
12.按照权利要求1所述的装置,其中所述装置是移动计算装置、智能手机或胰岛素泵组件中的一个。
13.按照权利要求1所述的装置,其中处理器对用于确定为用户自定义的葡萄糖成本权重系数或胰岛素成本权重系数中至少一个的参数施加界限。
14.按照权利要求13所述的装置,其中所述参数是指示用户的胰岛素需求的值。
15.按照权利要求1所述的装置,其中处理器被配置为基于用户的胰岛素敏感性校正因子、用户的胰岛素与碳水化合物比率或用户的基础胰岛素水平中的至少一个来确定葡萄糖成本权重系数或胰岛素成本权重系数中的至少一个。
16.按照权利要求1所述的装置,其中葡萄糖成本权重系数和胰岛素成本权重系数中的至少一个具有为每日总胰岛素(TDI)用户自定义的值。
17.一种由处理器执行的方法,包括:
从葡萄糖监测仪接收用户的葡萄糖读数;
确定下一次从人工胰腺向用户输送胰岛素的剂量,其中所述确定包括:
将成本函数应用于给用户的多个可能的胰岛素剂量,和
从可能的胰岛素剂量中选择在成本函数下具有最佳成本的一个剂量;
其中成本函数:
具有反映剂量选项预测为用户产生的葡萄糖水平与用户的目标葡萄糖水平之间的差异的葡萄糖成本分量,
具有反映剂量选项与当前基准胰岛素剂量有何差异的胰岛素成本分量,
具有用于对葡萄糖成本分量进行加权的葡萄糖成本权重系数,和
具有用于对胰岛素成本分量进行加权的胰岛素成本权重系数;
其中葡萄糖成本权重系数和胰岛素成本权重系数具有为用户自定义的值;和
指导人工胰腺将选择的剂量输送给用户。
18.一种存储计算机可读指令的非临时性计算机可读存储装置,所述指令使装置的处理器执行以下操作:
从葡萄糖监测仪接收用户的葡萄糖读数;
确定下一次从人工胰腺向用户输送胰岛素的剂量,其中所述确定包括:
将成本函数应用于给用户的多个可能的胰岛素剂量,和
从可能的胰岛素剂量中选择在成本函数下具有最佳成本的一个剂量;
其中成本函数:
具有反映剂量选项预测为用户产生的葡萄糖水平与用户的目标葡萄糖水平之间的差异的葡萄糖成本分量,
具有反映剂量选项与当前基准胰岛素剂量有何差异的胰岛素成本分量,
具有用于对葡萄糖成本分量进行加权的葡萄糖成本权重系数,和
具有用于对胰岛素成本分量进行加权的胰岛素成本权重系数;
其中葡萄糖成本权重系数和胰岛素成本权重系数具有为用户自定义的值;和
指导人工胰腺将选择的剂量输送给用户。
19.根据权利要求18所述的非临时性计算机可读存储介质,其中葡萄糖成本权重系数和胰岛素成本权重系数中只有一个具有为用户自定义的值。
20.根据权利要求18所述的非临时性计算机可读存储介质,其中葡萄糖成本权重系数和胰岛素成本权重系数两者都具有为用户自定义的值。
21.根据权利要求18所述的非临时性计算机可读存储介质,其中葡萄糖成本权重系数的值是基准葡萄糖成本权重系数乘以指示代表用户的胰岛素需求的自定义值与代表胰岛素需求的基准值的比率的值。
22.根据权利要求21所述的非临时性计算机可读存储介质,其中指示所述比率的值是该比率的指数值。
23.根据权利要求18所述的非临时性计算机可读存储介质,其中胰岛素成本权重系数的值是基准胰岛素成本权重系数乘以指示代表胰岛素需求的基准值与代表用户的胰岛素需求的自定义值的比率的值。
24.根据权利要求23所述的非临时性计算机可读存储介质,其中指示所述比率的值是该比率的指数值。
25.根据权利要求18所述的非临时性计算机可读存储介质,其中葡萄糖成本权重系数的值是基准胰岛素成本权重系数乘以指示代表胰岛素需求的基准值与代表用户的胰岛素需求的自定义值的比率的值。
26.根据权利要求18所述的非临时性计算机可读存储介质,其中葡萄糖成本权重系数的值是基准胰岛素成本权重系数乘以指示代表胰岛素需求的基准值与代表用户的胰岛素需求的自定义值的比率的值。
27.根据权利要求18所述的非临时性计算机可读存储介质,进一步存储用于确定为用户自定义的葡萄糖成本权重系数或胰岛素成本权重系数中至少一个的参数施加界限的指令。
28.根据权利要求27所述的非临时性计算机可读存储介质,其中所述参数是指示用户的胰岛素需求的值。
29.根据权利要求18所述的非临时性计算机可读存储介质,其中确定葡萄糖成本权重系数或胰岛素成本权重系数中的至少一个是基于用户的胰岛素敏感性校正因子、用户的胰岛素与碳水化合物比率或用户的基础胰岛素水平中的至少一个进行的。
30.根据权利要求18所述的非临时性计算机可读存储介质,其中葡萄糖成本权重系数和胰岛素成本权重系数中的至少一个具有为每日总胰岛素(TDI)用户自定义的值。
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2020
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JP2023515776A (ja) | 2023-04-14 |
WO2021163326A1 (en) | 2021-08-19 |
US20210244881A1 (en) | 2021-08-12 |
CA3166071A1 (en) | 2021-08-19 |
JP7463533B2 (ja) | 2024-04-08 |
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