CN113398380A - 药物注射和疾病管理系统、设备和方法 - Google Patents

药物注射和疾病管理系统、设备和方法 Download PDF

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CN113398380A
CN113398380A CN202110633211.9A CN202110633211A CN113398380A CN 113398380 A CN113398380 A CN 113398380A CN 202110633211 A CN202110633211 A CN 202110633211A CN 113398380 A CN113398380 A CN 113398380A
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insulin
user
meal
blood glucose
amount
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CN113398380B (zh
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莱恩·德斯伯勒
布莱恩·马兹利什
佩尔·约翰·斯约伦德
安德鲁·伯琴科
罗斯·内勒
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Bigfoot Biomedical Inc
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Abstract

本申请涉及药物注射和疾病管理系统、设备和方法。本公开的一个或更多个实施例可以包括胰岛素输送系统，其包括：胰岛素输送设备；用户界面，其包括多个用户可选择的图标或按钮，每个用户可选择的图标或按钮代表不同的膳食特征；存储器，其存储一个或更多个用户特定剂量参数；以及处理器，其与存储器通信并适于接收血糖数据。处理器还可适于基于用户特定剂量参数中的至少一个来确定与用户可选择的图标或按钮中的每个相关联的初始膳食特征。处理器还可适于基于血糖数据来更新与每个用户可选择图标或按钮相关联的膳食特征。

Description

药物注射和疾病管理系统、设备和方法
本申请是申请日为2017年9月27日，申请号为201780059522.0，发明名称为“药物注射和疾病管理系统、设备和方法”的申请的分案申请。
相关申请的交叉引用
依据《美国法典》第35编第119条(e)款特此提出对标题为“Personalizing PresetMeal Sizes in Insulin Delivery System”的第62/400,366号美国专利临时申请(’366临时申请)的2016年9月27日提交日的优先权利益的主张。’366临时申请的全部公开内容特此通过引用被并入。
领域
本公开涉及药物注射和疾病管理系统、设备和方法，特别是涉及糖尿病和/或胰岛素的输送的管理的那些系统、设备和方法。在一些实施例中，本文提供的系统、方法和设备可以为了获得关于一种或更多种药物剂量的推荐的目的而个性化用户可选择的膳食量，用于使用户输入膳食数据。在一些情况下，一个或更多个按钮(例如，用户可选择图标、物理按钮等)可以被个性化以描述要输送的胰岛素和/或要消耗的碳水化合物的量或量的范围。
背景
糖尿病是一种慢性代谢紊乱，其由人的胰腺不能产生足够量的激素、胰岛素引起，使得人的新陈代谢不能提供糖和淀粉的适当吸收。这种衰竭导致高血糖症，即血浆内存在过量的分析物，诸如葡萄糖。持续性高血糖症与多种严重症状和危及生命的长期并发症(诸如脱水、酮酸中毒、糖尿病昏迷、心血管疾病、慢性肾衰竭、视网膜损伤和伴有截肢肢端危险的神经损伤)相关联。血糖的自我监测和胰岛素的自我给药是用于治疗糖尿病的典型方法。“正确的”胰岛素剂量是血液中的葡萄糖的水平的函数。不足的胰岛素剂量不足可导致高血糖，且过多的胰岛素剂量可导致低血糖，其可导致笨拙、说话困难、困惑、知觉的失去、癫痫发作或死亡。因此，糖尿病患者(PWD)在确定胰岛素的适当剂量时面临相当大的认知负担。
为了帮助这种自我治疗，许多糖尿病相关设备(例如血糖仪、胰岛素泵等)配备有使用户输入所消耗(或即将消耗)的碳水化合物的数量的胰岛素推注计算器，推注计算器输出胰岛素推注剂量的推荐大小。尽管推注计算器消除了需要由用户在确定适当的胰岛素推注剂量时进行的一些计算，但是推注计算器仍然使用户背负确定在他们的膳食中的碳水化合物的数量的脑力任务，并且经常需要数据的手动输入。因此，存在对进一步减少在用户身上的认知负担同时提高推荐胰岛素推注剂量的准确性的方法、系统和设备的需要。
概述
本文提供的系统、设备和方法可以被配备成通过简化膳食通告过程和/或简化估计葡萄糖值(EVG)的收集来简化推荐胰岛素剂量的计算。可通过提供包括一个或更多个膳食通告按钮的用户界面来简化膳食通告过程，膳食通告按钮可以是触摸屏上的用户可选择图标、物理按钮、轻推转盘、语音激活命令等。在一些情况下，膳食通告按钮可以位于胰岛素输送设备的一部分上或胰岛素输送设备的附件上。在一些情况下，胰岛素输送设备可以是胰岛素笔，且剂量捕获笔帽包括膳食通告按钮。在一些情况下，胰岛素输送设备或其附件可以与远程用户界面设备(例如，智能手机上的移动应用程序)无线通信，并且膳食通告按钮可以在远程用户界面设备上(作为物理按钮或作为触摸屏上的用户可选择图标)。可以基于用户对系统的使用来个性化一个或更多个膳食通告按钮。这种个性化可以基于用户与各种按钮或特征交互(例如，用户选择针对推注的各种膳食量)，通过提供推注并测量推注随时间的推移的效应或者根据本公开的设备或系统的任何其他用途。
本公开的一个或更多个实施例可以包括胰岛素输送系统，其包括：胰岛素输送设备；用户界面，其包括多个用户可选择图标或按钮，每个用户可选择图标或按钮代表不同的膳食特征；存储器，其存储一个或更多个用户特定剂量参数；以及处理器，其与存储器通信并适于接收血糖数据。处理器还可适于基于用户特定剂量参数中的至少一个来确定与用户可选择图标或按钮中的每个相关联的初始膳食特征。处理器还可适于基于血糖数据来更新与每个用户可选择图标或按钮相关联的膳食特征。
根据本公开的一个或更多个设备、系统或方法，设备或系统可以包括血糖监测器或传感器。
根据本公开的一个或更多个设备、系统或方法，系统或设备可以包括扫描式葡萄糖监测器(flash glucose monitor)以及与处理器通信的系统近场通信电路，该扫描式葡萄糖监测器包括扫描式近场通信电路(flash near field communication circuit)。在这些和其他实施例中，处理器可适于在系统近场通信电路和扫描式近场通信电路被带入近场通信(NFC)通信距离内时经由NFC来接收血糖数据。
根据本公开的一个或更多个设备、系统或方法，系统或设备可以包括连续葡萄糖监测器，并且处理器可以适于以预定时间间隔从连续葡萄糖监测器接收无线通信。
根据本公开的一个或更多个设备、系统或方法，用户可选择图标或按钮可以各自最初代表以5克或10克增量的碳水化合物的量。
根据本公开的一个或更多个设备、系统或方法，最初由多个用户可选择图标或按钮中的每一个代表的碳水化合物的量可以基于糖尿病患者(PWD)的胰岛素敏感性因子(ISF)、碳水化合物比率(CR)、体重、年龄、总每日基础(TDB)率、长效胰岛素的每日剂量、胰岛素的体重平均总每日剂量(TDD)和/或其组合来确定。
根据本公开的一个或更多个设备、系统或方法，处理器还可以被配置为基于与用户可选择图标或按钮中的选定的用户可选择图标或按钮相关联的碳水化合物的量和/或血糖数据来确定胰岛素输送量。
根据本公开的一个或更多个设备、系统或方法，用户可选择图标或按钮可以各自表示补偿每顿餐所需的胰岛素的单位的数量，其被四舍五入到最接近的0.5单位。
根据本公开的一个或更多个设备、系统或方法，与多个用户可选择图标或按钮中的每一个相关联的膳食特征的更新可以根据在用户选择了给定的用户可选择图标或按钮之后的餐后血糖数据来确定。
根据本公开的一个或更多个设备、系统或方法，系统或设备可以包括扫描式葡萄糖监测器，该扫描式葡萄糖监测器包括扫描式近场通信电路，并且系统或设备还可以包括与处理器通信的一个或更多个系统近场通信电路。在这些和其它情况下，处理器可适于在一个或更多个系统近场通信电路和扫描式近场通信电路被带入近场通信(NFC)通信距离内时经由NFC来接收餐后血糖数据。另外，处理器可适于在胰岛素被输送或用户可选择图标或按钮之一已由用户选择之后的预定时间向用户发送通过使一个或更多个系统近场通信电路之一靠近扫描式葡萄糖监测器来取回餐后血糖数据的提示。
根据本公开的一个或更多个设备、系统或方法，用户界面可适于基于血糖数据和用户可选择图标或按钮之一的选择来显示推注推荐。
根据本公开的一个或更多个设备、系统或方法，处理器可以基于从下列项选择的因素来确定推注推荐：碳水化合物的数量除以PWD的碳水化合物与胰岛素的比率、在当前血糖水平和目标血糖水平之间的差除以PWD的胰岛素敏感性因子、来自血糖仪(BGM)的读数、来自连续葡萄糖监测器(CGM)的数据、血糖趋势数据、板载胰岛素(IOB)数据、板载碳水化合物(COB)数据、PWD是否锻炼或计划锻炼、PWD是否生病、PWD是否怀孕、PWD是否正经历月经、以及PWD是否已经消耗了某些药物。
根据本公开的一个或更多个设备、系统或方法，处理器还可以适于从胰岛素输送设备接收剂量数据，并且更新与用户可选择图标或按钮中的每个相关联的膳食特征可基于在用户已选择了用户可选择图标或按钮之后的餐后血糖数据、剂量数据或其组合。
根据本公开的一个或更多个设备、系统或方法，胰岛素输送设备可以包括胰岛素笔，并且用户界面可以是胰岛素笔的一部分、适于可逆地连接到胰岛素笔的笔附件的一部分、或者与胰岛素笔或其附件无线地通信的智能手机的移动应用程序的一部分。在这些和其它实施例中，设备或系统可适于检测在一个或更多个胰岛素笔中剩余的或由一个或更多个胰岛素笔输送的胰岛素的量。
根据本公开的一个或更多个设备、系统或方法，笔附件可适于可逆地连接到胰岛素笔，其中笔附件可包括笔帽，笔帽适于在放置或从胰岛素笔移除期间或当固定到胰岛素笔时检测在胰岛素笔中剩余的胰岛素的量。
根据本公开的一个或更多个设备、系统或方法，用户界面可以位于智能手机的移动应用程序上，其中智能手机还包括处理器，且胰岛素笔或其附件适于检测胰岛素量或输送数据，并将胰岛素量或输送数据无线地传递到处理器。
本公开的一个或更多个实施例可以包括胰岛素笔的帽，该帽包括：一个或更多个传感器，其适于检测在胰岛素笔内的柱塞的位置；以及用户界面，其包括适于通告膳食或进餐意图的一个或更多个用户可选择图标或按钮。
根据本公开的一个或更多个设备、系统或方法，帽可包括处理器和存储器，其中处理器可适于基于来自一个或更多个传感器的数据来确定胰岛素输送的时间和剂量，并将该信息存储在存储器中。
根据本公开的一个或更多个设备、系统或方法，用户界面可以包括适合于通告膳食或进餐意图的至少2个且不超过6个用户可选择图标或按钮，每个用户可选择图标或按钮代表为每个用户可选择图标或按钮存储在存储器中的不同膳食特征。
根据本公开的一个或更多个设备、系统或方法，用户界面可以包括适于至少部分基于一个或更多个用户可选择图标或按钮的选择来显示推荐剂量的显示部。
根据本公开的一个或更多个设备、系统或方法，帽可包括适于与血糖监测器或传感器通信的无线通信设备，其中显示部可适于显示当前血糖水平、当前变化率的指示、基于葡萄糖数据的推荐校正推注剂量或其组合。
根据本公开的一个或更多个设备、系统或方法，帽的无线通信设备可以包括NFC电路。
根据本公开的一个或更多个设备、系统或方法，设备或系统可以包括适于在一个或更多个用户可选择图标或按钮的选择之后的预定时间提示用户从血糖监测器或传感器获得血糖数据的信号器。
根据本公开的一个或更多个设备、系统或方法，设备或系统可以包括适于在来自血糖监测器或传感器的数据指示提供治疗的需要时提供警报的信号器。
根据本公开的一个或更多个设备、系统或方法，系统或设备可以包括处理器和存储器，该存储器存储一个或更多个用户可选择图标或按钮中的每一个的膳食特征，并且该处理器适于接收血糖数据并基于血糖数据来更新一个或更多个用户可选择图标或按钮中的每一个的膳食特征。
根据本公开的一个或更多个设备、系统或方法，该系统或设备可以包括存储器，该存储器可以基于一天中的时间来存储单个用户可选择图标或按钮的多个膳食特征。
根据本公开的一个或更多个设备、系统或方法，系统或设备可以包括帽，该帽还包括适于检测胰岛素笔的特征或在胰岛素笔中的胰岛素的类型的传感器、存储关于胰岛素笔的不同类型或胰岛素的不同类型的信息的存储器、以及确定胰岛素笔的类型或胰岛素的类型的处理器。
根据本公开的一个或更多个设备、系统或方法，系统或设备可以包括适于根据胰岛素笔的类型或胰岛素的类型来改变用户界面的处理器，其中一些类型的胰岛素或胰岛素笔导致不包括适于通告膳食或进餐意图的任何用户可选择图标或按钮的用户界面。
附图简述
图1A示出了假想的胰岛素输送系统，其包括胰岛素笔、葡萄糖监测器或传感器以及具有远程用户界面的远程用户界面设备。
图1B示出了远程用户界面设备的示例性膳食通告屏幕，其可以由图1A的远程用户界面设备显示。
图2A和2B描绘了具有第一示例性胰岛素笔帽的胰岛素笔，该第一示例性胰岛素笔帽具有本文公开的一些特征。
图3A和3B描绘了具有第二示例性胰岛素笔帽的胰岛素笔，该第二示例性胰岛素笔帽具有本文公开的一些特征。
图4显示了可被包括在图2A-3B的胰岛素笔帽中的内部部件的示意图。
图5A和5B描绘了一种示例性剂量捕获技术，其可以合并到图2A-3B的笔帽中。
图6A是用户可如何与本文提供的胰岛素笔帽交互的流程图。
图6B示出了在本文提供的某些方法、系统和设备的使用期间用户可以在笔帽上(或胰岛素输送笔上)看到的示例性用户界面。
图7示出了当使本文提供的某些方法、系统和设备准备好使用时用户可以在笔帽上(或胰岛素输送笔上)看到的示例性用户界面。
图8A和8B描绘了在本文提供的方法、系统和设备的一些实施例中可能出现在远程用户界面设备上的通知。
图9A和9B是说明膳食特征和用户特定剂量参数可以如何被发起或更新的图表。
图10A和10B描绘了用户在施用胰岛素之前可如何在扫描式葡萄糖监测器和胰岛素笔或胰岛素笔帽之间传输数据。
详细描述
胰岛素输送系统和设备以及用于输送胰岛素的方法可以被设计成在糖尿病患者(PWD)或他们的护理者决定施用胰岛素时最大限度地减轻他们的认知和活动负担。在一些实施例中，本文提供的方法、系统和设备可以在给PWD(或护理者)提供或不提供推荐的情况下被动地捕获糖尿病相关数据(例如，胰岛素输送数据、血糖数据等)。在一些实施例中，本文提供的方法、系统和设备可以提供关于胰岛素的适当剂量的指导。在一些实施例中，可以用胰岛素输送笔或注射器施用该剂量的胰岛素。在一些情况下，胰岛素可以是长效胰岛素。在一些情况下，胰岛素可以是速效胰岛素。在一些实施例中，胰岛素输送笔或其附件(例如，帽)可以检测从笔输送的胰岛素的量(或被设置为用于输送的胰岛素的量)。在一些情况下，胰岛素笔或其附件可以包括用户界面，该用户界面可以向用户显示数据或推荐和/或允许用户将数据输入胰岛素笔或附件内。下面的示例性系统包括具有剂量捕获笔帽的胰岛素输送笔，但是也可以设想可选的实施例，其中本文公开的功能被合并到胰岛素输送笔的其他附件或胰岛素输送笔本身中。
示例性胰岛素输送系统
图1A示出了一种假想的胰岛素输送系统100，其包括速效胰岛素(QAI)笔160(例如HumalogTM、NovologTM、ApidraTM)、长效胰岛素(LAI)笔170(例如LantusTM、LevemirTM、ToujeoTM、TresibaTM)、葡萄糖监测器或传感器150以及远程用户界面设备110。如所示，每个胰岛素笔160和170分别包括与系统100的其他部件无线地通信的剂量捕获笔帽182和184。如所示，笔可以包括用于使用户设置要输送的剂量的转盘161和171以及剂量指示器窗口162和172。在可选的系统中，胰岛素笔160和/或170本身可以包括剂量捕获技术和/或与系统100的其他部件无线地通信。关于可能的胰岛素笔和/或胰岛素笔帽的附加细节将在下面更详细地被公开。
葡萄糖监测器或传感器150可以是能够提供可用于估计一个或更多个血糖值的数据的任何合适的传感器设备和/或监测系统。如所示，葡萄糖监测器或传感器150可以是被配置为无线地传输血糖数据的传感器。例如，葡萄糖监测器或传感器150可以包括光通信设备、红外通信设备、无线通信设备(诸如天线)和/或芯片组(诸如蓝牙设备(例如蓝牙低功耗、经典蓝牙等)、近场通信(NFC)设备、802.6设备(例如，城域网(MAN)、Zigbee设备等)、WiFi设备、WiMax设备、蜂窝通信设施等)和/或诸如此类。葡萄糖监测器或传感器150可以与网络和/或在本公开中描述的任何其他设备或系统交换数据。在一些情况下，通过用户将系统的一个或更多个部件移动到葡萄糖监测器或传感器150附近以给葡萄糖监测器或传感器150供电或将血糖数据从葡萄糖监测器或传感器150传输到系统100的其他部件，用NFC设备询问葡萄糖监测器或传感器150。
如所示，远程用户界面设备110是智能手机，但是可以使用任何合适的远程用户界面设备，诸如计算机平板电脑、智能手机、可穿戴计算设备、智能手表、健身跟踪器、膝上型计算机、台式计算机、智能胰岛素笔(例如剂量捕获帽182和/或184)和/或其他合适的计算设备。如在所描绘的智能手机上运行的示例性移动应用的示例性用户界面中所示的，用户界面可以包括推注计算器按钮114和可选地其他按钮，用于使用户输入数据或请求推荐。示例性用户界面还可以包括过去、当前或预测的血糖数据的显示。如所示，用户界面包括来自前30分钟的历史数据的曲线123、具有投影数据的该曲线的延续124、示出当前(或最近)估计血糖值的点指示符122以及当前(或最近)估计血糖值的显示121。用户界面还可以包括解释葡萄糖数据的文本131、提供所建议的行动的文本132和133，诸如提供胰岛素、碳水化合物或其他治疗建议的文本132和/或建议用户获得血糖数据的文本133。在一些情况下，用户界面可以允许用户点击葡萄糖数据，或者以其他方式在移动应用程序中导航以获得更详细或更完整的血糖数据。
用户界面还可以描绘胰岛素数据。在一些情况下，用户界面可以指示板载胰岛素(IOB)的量135，这可能仅用于速效胰岛素。在一些情况下，IOB计算可以用于速效胰岛素和长效胰岛素。在一些情况下，用户界面可以显示速效和/或长效胰岛素的最近剂量的时间和/或量134。在一些情况下，用户界面可以允许用户点击胰岛素数据，或者以其他方式在移动应用程序中导航到更详细或更完整的胰岛素输送数据。在一些情况下，用户界面可以以任何合适的格式覆盖血糖数据和胰岛素输送数据，诸如血糖数据的定时相对于胰岛素输送数据的定时的图形显示。
在使用中，用户(例如PWD和/或护理者)可以使用系统100来获得关于适当胰岛素剂量的推荐。在即将到来的需要输送长效胰岛素的情况下，132的消息可能改变，以提供推荐的长效胰岛素剂量。在一些情况下，推荐剂量可能出现在笔帽184上。在用户想要输送速效胰岛素的推注的情况下，用户可以按推注计算器按钮114以进入推注计算器。尽管在本文提供的系统、方法和设备中可以使用任何合适的推注计算器，但是图1B描绘了可能的用户界面，其用于用户输入膳食通告为仅校正141、小号餐142、正常大小的餐143或大号餐144。在选择膳食量时，用户界面可以基于与相应按钮相关联的碳水化合物的数量并可选地基于血糖数据来提供推荐的推注剂量。
另外或者可选地，用于速效胰岛素笔160的剂量捕获笔帽可以包括允许用户通告小号餐、中号餐或大号餐的用户界面。图2A-3B描绘了具有按钮221-223和321-323的剂量捕获笔帽200和300的可能实施例，按钮221-223和321-323允许用户通告小(S)、中(M)或大(L)餐。在使用中，用户可以通告他们刚刚吃的或将要吃的餐是否是他们的正常膳食量(M)或更大(L)或更小(S)，并且本文提供的方法、设备和系统可以基于该通告并且可选地基于血糖数据(如果可用的话)来确定胰岛素的适当推注剂量。可选地，胰岛素笔可以包括剂量捕获技术，并且包括本文提供的用户界面，并且其被描述为在剂量捕获笔帽上。在一些情况下，具有剂量捕获能力的智能笔可以与远程用户界面(例如智能手机)无线地通信。
个性化膳食通告按钮
如上面所讨论的，本文提供的方法、设备和系统可以给用户提供膳食通告按钮，该按钮给用户提供减少的数量的膳食量选择选项，该选项可以基于用户的正常膳食量，可以因而减少在寻求为了进餐而施用胰岛素的用户身上的认知负担，同时提高胰岛素推注推荐的准确性。本节描述了本文提供的方法、系统和设备可以确定胰岛素的量和/或碳水化合物的量以与膳食选择按钮(例如，141-144、221-223、321-323)中的每个按钮相关联的方式。可选地，可以存在额外的按钮，诸如为用户指示小号餐或超大号餐的按钮，使得任何数量的按钮都在本公开的范围内。另外或可选地，该系统可以包括用于向本公开的系统或设备通告膳食的单个按钮、图标或模式。
在一些情况下，膳食通告按钮142-144、221-223、321-323中的每一个按钮可以与许多碳水化合物相关联，这些碳水化合物基于由用户为胰岛素输送系统输入的其他的用户特定的剂量参数(例如，总每日长效胰岛素剂量(例如，U/天)、总每日胰岛素剂量(例如，长效和速效的总量)、碳水化合物与胰岛素的比率、胰岛素敏感性因子、葡萄糖设定点或其组合)而针对用户进行个性化。在一些情况下，当图标或按钮基于在每顿餐的消耗后的葡萄糖反应而受到选择时，被分配给每个预设图标或按钮的碳水化合物的数量可以随着时间的推移基于对所消耗的每顿餐的大小的估计而被个性化。在一些情况下，分配给每个预设图标或按钮的碳水化合物的数量可以四舍五入到最接近的5克碳水化合物并被显示。在一些情况下，不显示每个按钮的碳水化合物数量。在一些情况下，用户可以为多个用户可选择的图标或按钮手动地输入个性化膳食量。在一些情况下，分配给每个用户可选择的图标或按钮的碳水化合物的数量可以最初设置在预定的起始点处，或者可以基于所输入的用户信息来确定，且然后基于对那个所选择的膳食量和推注的血糖反应随时间的推移来迭代地向上或向下调整。
在本文提供的设备上或系统中所包括的一个或更多个膳食通告按钮142-144、221-223、321-323的初始设置可以预先设置有预定的值或范围(例如，小＝20g或15-25g，中＝30g或30-45g，以及大＝50g或50-75g)。另外或可选地，可以基于所输入的用户数据或基于输入到本文提供的设备或系统中的一个或更多个用户特定的剂量参数来设置初始设置。在一些情况下，一个或更多个用户可选择的图标或按钮的初始设置可以基于最初输入或确定并编程的总的每日长效胰岛素(TDLAI)剂量(例如U/天)。例如，如由对应于超椭圆体的长轴的线表征的在LAI剂量[U/天]和几何平均膳食量[g]之间的关系是：μ*MS＝12.1*BR0.387。在几何平均膳食量[g]和几何标准偏差膳食量之间的关系是：σ*MS＝1.92-μ*MS/186，其中MS可代表膳食量，以及BR可代表胰岛素的基础率。因此，通过组合上述等式(可选地将膳食量组四舍五入到最接近的1、5或10克)，初始膳食量组可以对应于膳食量分布的预定百分位数。在一些情况下，可以根据人口统计数据来确定在典型膳食量和其他的用户特定的剂量参数之间的关系。在一些情况下，与每个用户可选择图标或按钮相关联的碳水化合物的数量可以显示在用户可选择的图标或按钮上和/或附近，这可以帮助用户理解如何使用胰岛素输送设备或系统来避免使用户非熟练化。例如，查看对每个膳食量假设的碳水化合物的数量帮助从碳水化合物方面考虑膳食的用户调整到使用按钮以指示膳食的量。另外，通过以被四舍五入到最接近的5克的显示数字开始，用户可以意识到精度是不需要的，因此也减少了用户身上的认知负担。另外，当系统反复为每个特定的用户可选择的图标或按钮个性化碳水化合物的量时，系统可以将以较小的单位(例如，1克)调整这些数字，以向用户展示系统正在调整与用户可选择的图标或按钮相关联的碳水化合物的数量。
在一些情况下，用户界面可以被配置成使得PWD可以与用户界面交互，以输入关于推注大小的默认选项之外的更详细信息。例如，PWD可以被呈递一系列预设大小，其通过选择大小并向上或向下滚动而容易以5g的增量调整。通过进一步与用户设备交互(例如，按压并按住膳食量)，用户可以有手动地输入推注大小或以1g的增量调整大小的选项。
本文提供的方法、系统和设备可以使用任何合适的方法来更新与每个用户可选择的图标或按钮相关联的碳水化合物的数量。在一些情况下，方法、系统和设备可以使用餐后血糖数据(例如，在所通告的膳食后1小时至3小时之间)来评估PWD是否可能消耗比针对用户可选择的图标或按钮编程的碳水化合物明显更多或明显更少的碳水化合物。在一些情况下，一个或更多个餐后血糖阈值可用于评估在所消耗的碳水化合物的量和与所选择的用户可选择的膳食图标或按钮相关联的碳水化合物的量之间的匹配。例如，本文提供的方法、设备和系统可以向用户询问来自葡萄糖传感器、葡萄糖监测器或血糖仪的餐后血糖读数。在一些情况下，葡萄糖传感器可以是扫描式葡萄糖监测器，并且本文提供的方法、系统和设备可以提示用户在预定的餐后时间段询问扫描式葡萄糖监测器。如在本文所使用的，术语“扫描式葡萄糖监测器(flash glucose monitor)”可以指被配置为响应于设备的手动调用(通常通过物理信号(例如，按钮、轻敲等)或无线信号(例如，近场通信(NFC)、蓝牙通信等))来提供血糖读数的设备。这种血糖读数可以定期地被执行，并在设备被调用时被报告，或者可以在被调用时被采用。在一些情况下，这里提供的方法、设备和系统可以从连续血糖监测器接收餐后血糖数据。在一些情况下，本文提供的方法、系统和设备可以使用单个餐后血糖数据点，并将该数据点与在那个时间段期间的一个或更多个上阈值和一个或更多个下阈值进行比较，以确定与那个用户可选择的膳食图标或按钮相关联的碳水化合物的数量是否应该向上或向下调整。例如，如果用户选择了指示30克的碳水化合物的膳食的一般膳食图标，但2小时餐后血糖读数高于200mg/dL，则与那个图标或按钮相关联的克数可能被向上调整2克，如果它高于170mg/dL，则它可能被向上调整1克，如果它低于130mg/dL，则它可能减少1克，并且如果它低于100mg/dL，则它可能减少2克。因此，随着时间的推移，膳食图标将被调整为以匹配用户的围绕他们所吃的膳食的心智模型的方式更严密地类似于用户的典型消费模式。可以基于餐后时间、与膳食图标或按钮相关联的克数、CR、ISF和LAI的每日剂量以及PWD的设定点等来确定特定的阈值。
在一些情况下，可以基于一天中的时间来个性化膳食通告按钮。例如，在一些情况下，用户可能有更大的普通晚餐和更小的普通早餐，并且本文提供的方法、设备和系统可以基于一天中的时间来估计用户的碳水化合物的量。在一些情况下，碳水化合物的量和膳食量(S，M，L)可以一起显示，以帮助用户理解该个性化是用户的日常模式所特有的。在一些情况下，可以基于一周中的天来个性化按钮(例如，用户的周末膳食模式可能与在工作日期间明显不同)。
因为糖尿病是给PWD或他们的护理者(多个护理者)带来围绕确定胰岛素的适当剂量的重大认知负担的高度个人化的疾病，所以一些PWD或护理者开发了他们自己的用于估计胰岛素的适当剂量的技术(或心智模型)。尽管本文提供的方法、系统和设备可以适于向用户提供推荐，但是用户可以根据用户的偏好和用户对PWD将要吃什么和/或正在经历什么(例如，锻炼、疾病等)的特定知识来自由地给胰岛素分配剂量。在一些情况下，可以基于用户施用高于或低于胰岛素的推荐剂量的胰岛素的剂量的重复模式而使膳食通告按钮改变，使得膳食通告按钮开始与用户的关于典型膳食量的心智模型相匹配。然而，可以基于PWD的餐后血糖读数来确定基于实际剂量对由每个膳食通告按钮表示的碳水化合物的量的调整。例如，如果餐后血糖读数指示合适的剂量，则它可以指示用户的心智模型适合于那个膳食，并且系统因此可以调整膳食通告按钮以匹配用户的心智模型(例如，如果餐后血糖读数通常在预定范围内，则基于用户施用比对(S)膳食选择推荐的胰岛素更少的胰岛素的重复模式来减小对(S)膳食假设的膳食量)。然而，在一些情况下，本文提供的方法、设备和系统可以使用餐后血糖读数来确定用户的心智模型是否未能确定合适的剂量。在一些情况下，高或低的餐后血糖读数可以防止本文提供的方法、系统和设备基于膳食来调整膳食通告按钮(在基于膳食来调整膳食通告按钮的情况下，一个或更多个餐后血糖读数指示在剂量和膳食之间的不匹配)。例如，如果用户施用比选定小号餐所推荐的胰岛素更少的胰岛素并且具有一个或更多个高的餐后血糖读数，则本文提供的方法、系统和设备可以针对膳食通告按钮的个性化而忽略那个施用。在一些情况下，如果使用模式指示在用户的心智模型和PWD的生理和食物消耗模式之间的不匹配，并且如果用户持续忽略所推荐的剂量在某种程度上使PWD在餐后变高或变低，则本文提供的方法、系统和设备可以向用户提供通知。例如，如果用户持续地施用比所推荐的胰岛素更少的胰岛素并且在餐后持续地具有高血糖读数，则通知可以向用户指示用户应该考虑在进餐时间施用推荐剂量，以便实现更好的血糖控制。因此，在一些情况下，本文提供的方法、系统和设备可以被设计成改善在用户的心智模型和PWD的生理和食物消耗模式之间的匹配。
在一些情况下，远程用户界面设备110可以允许用户手动地将碳水化合物的特定数量输入到推注计算器中，用于特定膳食的推荐。在一些情况下，方法、系统和设备可以使用用户请求相同膳食量推荐的重复模式来更新膳食通告按钮的大小或添加另一膳食通告按钮。
剂量捕获笔帽
图1A描绘了一种系统，该系统可以包括剂量捕获笔帽182和184，该笔帽可以向葡萄糖监测器或传感器150和/或从葡萄糖监测器或传感器150传输数据和/或向远程用户界面设备110/从远程用户界面设备110传输数据。图1A中的笔帽可以包括或可以不包括用户界面。笔帽182和184可以使用任何合适的技术来确定已经从胰岛素笔160和170施用的胰岛素的量。在未示出的一些情况下，胰岛素笔160和170可以包括剂量捕获技术，并且可以与远程用户界面设备110和/或葡萄糖监测器或传感器150无线地通信。
图2A-3B描绘了笔帽200和300的可选实施例，其可与胰岛素笔一起使用以帮助PWD或护理者(用户)做出定量给药决定。
图2A和2B描绘了包括显示屏210的笔帽200的实施例，显示屏210可以显示所估计的葡萄糖值(EVG)212、EVG的单位211以及EVG的趋势指示符213。显示器还可以提供推荐剂量214和胰岛素的类型的标识215。笔帽200还可以包括膳食通告按钮221-223。另外，显示器还可以指示以前剂量的时间和量和/或IOB值，以提醒用户关于他们最近的剂量。尽管示出了三个膳食通告按钮，但是在一些情况下，笔帽可以不包括膳食通告按钮，并且膳食可以被通告在远程用户界面设备(例如图1A所示的设备110)上。在一些情况下，笔帽200可以包括单个膳食通告按钮。在一些情况下，笔帽200可以包括2到6个之间的不同膳食通告按钮。在一些情况下，笔帽200可以包括仅校正按钮。笔帽200还可以包括一个或更多个指示灯(诸如指示灯218)，其可以点亮以指示它正在传送数据，点亮以指示用户的注意是需要的，和/或点亮以指示剂量捕获功能是否正起作用。
图3A和3B描绘了包括触摸屏用户界面310的笔帽300的另一个实施例，触摸屏用户界面310可以包括按钮321-323并显示所估计的葡萄糖值(EVG)312、EVG的单位311、EVG的趋势指示符313、推荐剂量314和胰岛素的类型的标识315。另外，显示器还可以指示以前剂量的时间和量和/或IOB值，以提醒用户关于他们最近的剂量。尽管示出了三个膳食通告按钮，但是笔帽300的触摸屏用户界面310可以基于用户的偏好和/或胰岛素的类型来定制，以显示不同数量的膳食通告按钮321-323和/或不包括膳食通告按钮。例如，如果笔帽300被放置在长效胰岛素笔上，则它可能能够检测胰岛素的类型并在315处自动更新该显示以正确地识别胰岛素的类型，但是也移除膳食通告按钮321-323并用其他内容替换它们。
尽管笔帽182、184、200和300可以使用任何合适的技术来估计胰岛素剂量，但是图4、5A和5B描绘了可以用于检测胰岛素的剂量的笔帽部件的示例性实施例。
图4描绘了示例性笔帽400的内部部件的表示。如所示，笔帽可以包括一个或更多个显示器410、一个或更多个按钮420和一个或更多个信号器416，每个由处理系统432控制。处理系统432包括处理器434、数据存储装置(或存储器)436和通信子系统440。通信子系统440可以实现在笔帽和远程用户界面设备(例如，图1A中的110)或葡萄糖传感器或监测器(例如，图1A中的150)之间的无线通信。在一些情况下，通信子系统440可以包括近场通信(NFC)芯片。在一些情况下，通信子系统440可以包括蓝牙低功耗(BLE)芯片。在一些情况下，通信子系统440可以包括光通信设备、红外通信设备、无线通信设备(诸如天线)和/或芯片组(诸如蓝牙设备(例如蓝牙低功耗、经典蓝牙等)、近场通信(NFC)设备、802.6设备(例如，城域网(MAN)、Zigbee设备等)、WiFi设备、WiMax设备、蜂窝通信设施等)和/或诸如此类。在这些和其他情况下，通信子系统440可以与网络和/或在本公开中描述的任何其他设备或系统交换数据。笔帽400包括电源450，其可以是可充电的或不可充电的电池。处理系统可以从来自笔类型检测器490的数据中确定笔类型。处理系统还可以使用一个或更多个光学或位置传感器和/或微动开关(诸如微动开关480)、光学传感器(多个光学传感器)470和位置传感器(多个位置传感器)460来确定在胰岛素输送笔内的柱塞的位置。图5A和5B示出了在笔帽400内的位置传感器460、微动开关480和光学传感器470的布置。光学传感器470可以包括位于胰岛素输送笔的相对侧上的灯471和感光体472，使得光穿过胰岛素小瓶163并被感光体472接收，直到胰岛素笔160的柱塞164经过光学传感器470为止。胰岛素笔160的尖端被滑块462接纳，滑块462在笔内滑动以触发具有触发器482的微动开关480，以告诉笔帽使用光学传感器470来识别柱塞164何时经过光学传感器470。来自位置传感器460(其包括弹簧464、滑块462和接近度传感器466)的数据确定当柱塞经过光学传感器470时胰岛素笔插入笔帽内的距离，并因而确定在胰岛素小瓶163中剩余的胰岛素的量。来自笔帽400的先前使用的数据随后可用于估计输送给患者的胰岛素的量。在特此通过引用以其整体并入的PCT公布WO 2017/009724 A1中公开了关于可以如何使用这种剂量捕获技术的更多细节。
剂量捕获设备/系统的示例性使用
图6A是描述用户在进食时可如何使用本文提供的方法、系统和设备来决定给胰岛素分配剂量的流程图。如所示，过程600开始于用户在步骤610中决定吃一些东西(或者决定为已经吃掉的食物注射推注)，后面是用户在步骤620中取回笔式注射器。在取回笔式注射器之后，用户可以决定在步骤640中通告膳食和/或在步骤630中取回葡萄糖数据，这可以以任一顺序出现。在通告膳食和/或取回葡萄糖数据之后，用户可以在步骤650中查看可能出现在笔帽上的或者可能出现在远程用户界面设备上的剂量推荐。在查看该推荐之后，用户可以因此决定输送多少胰岛素并在步骤660中输送胰岛素。
图6B描绘了当用户遵循过程600时用户的笔帽的示例性用户界面显示。如所示，用户屏幕611可以指示系统是活动的，并且显示关于最近剂量的数据612(诸如类型、量和一天中的时间)和/或IOB值613。如果用户在步骤630中获得指示低血糖状况的血糖值，则用户屏幕631可以指示用户应该消耗碳水化合物，并且可以继续显示关于最近剂量和/或所估计的IOB的信息。如果用户在步骤630中获得指示高血糖状况的血糖值，则用户屏幕636可以指示用户应该给胰岛素分配剂量并提供所推荐的剂量，并且可以继续显示关于最近剂量和/或所估计的IOB的信息。在一些情况下，所推荐的剂量可以指示用户应该添加到他们针对膳食以其他方式服用的剂量中的量。如果用户随后在步骤640中输入膳食通告，则用户屏幕641可以出现并指示所推荐的胰岛素剂量，以说明膳食和当前EGV。然而，当笔帽检测到某事出了问题或以其他方式需要用户的注意时，用户屏幕671可以在任何时间出现。在一些情况下，按下笔帽上的按钮可使笔帽上的用户屏幕显示更多信息和/或用户屏幕671可在远程用户界面设备(诸如图1A中的设备110)上指导用户对系统的问题进行故障排除。
当用户在步骤660中施用胰岛素时，所施用的胰岛素的量可以不同于所推荐的剂量，和/或该推荐可以仅仅是用户调整他们的对于膳食施用多少的心智模型，例如，在用户没有做出膳食通告并且基于用户屏幕636对胰岛素分配剂量的情况下。如在用户屏幕636中所示的，剂量推荐可以在括号中被指示，以指示应该用于校正升高的血糖水平的胰岛素的量，且因此用户可以将该量添加到用户通常对膳食施用的胰岛素的量中。因此，本文提供的方法、系统和设备可以基于由用户输送的胰岛素的量来在用户的心智模型中推断对一顿膳食所吃的碳水化合物的量。例如，如果用户在步骤630中从葡萄糖传感器或监测器取回EGV并且看到除了他们通常服用的药以外还服用3单位的Humarlog的推荐且然后定量给药10单位的Humarlog，那么本文提供的方法、系统和设备可以推断出用户吃了一顿饭并且基于推注大小来估计膳食的量。然后，系统可以使用估计的膳食量来进一步个性化膳食通告按钮(例如，按钮142-144、221-223和321-323)和用户特定的剂量参数。另外，在一些情况下，用户将通告膳食，但是施用与所推荐的量不同的胰岛素量，在这种情况下，本文提供的方法、系统和设备可以忽略用于个性化膳食通告按钮(例如，按钮142-144、221-223和321-323)的那次施用的餐后数据，或者使用餐后数据来更新用户特定剂量参数。例如，如果用户将要吃在用户的对中号餐的心智模型和用户的对大号餐的心智模型之间的膳食，则用户可以取回EGV(例如，在步骤630中)并看类似于用户屏幕636的屏幕以找出校正剂量的量，且然后通告作为中号餐的膳食(例如，在步骤640中)以查看类似于用户屏幕641的屏幕，且然后再次通告作为大号餐的膳食(例如，再次进行步骤640)以查看不同的推荐，以及然后用户可以在这两个推荐之间输送一定量的胰岛素。本文提供的方法、系统和设备可以使用来自剂量捕获技术的数据来估计实际上输送的胰岛素的量，并使用该胰岛素输送数据来确定每餐的估计量，而不管用户是否通告膳食或遵循推荐。另外，对于推荐的偏离和餐后葡萄糖数据的变化可用于确定对由每个膳食通告按钮(例如，按钮142-144、221-223和321-323)表示的碳水化合物的数量的调整，使得它们匹配用户的心智模型，如上面所讨论的。
在许多情况下，用户将使用他们自己的用于对膳食施用胰岛素的推注的心智模型，并且仅使用该系统以在获得EGV(例如，在步骤630中)并查看类似于用户屏幕631或636的屏幕之后确定校正剂量，在一些情况下，该屏幕可以仅指示校正剂量或者可以显示两个推荐：(a)如果用户仅试图纠正高血糖或低血糖状况，则推荐是要定量给药的量或要吃的建议，以及(b)如果用户正在进食，则推荐是对用户一般将会定量给药多少剂量的改变。在一些情况下，基于降低低血糖状况的风险，计算可以使用不同的方程式。在一些情况下，如果用户正在进食，用于改变用户的一般胰岛素剂量的量的计算可以与基于用户对于膳食来说过量或不足地定量给药胰岛素的剂量的检测到的模式的调整合并，以便针对在用户的心智模型与PWD的生理和食物消耗模式之间的检测到的不匹配来进行调整。
图10A和10B描绘了用于用户可以如何从葡萄糖传感器取回血糖值的示例性系统，该葡萄糖传感器可以通过在葡萄糖传感器50附近挥动笔帽1005(可选地使用挥动运动1005)使用近场通信来进行通信。帽可以包括近场通信芯片1182。在挥动之后，显示器1010可以出现在笔帽1005上。
无线通信与配对过程
再次参考图1A，本文提供的系统可以包括都可以彼此无线地通信的一个、两个或更多个笔帽182和184(或者可选地，图2A-3B中的笔帽200和300)、远程用户界面设备110(例如，智能手机)和葡萄糖传感器或监测器150(例如，扫描式葡萄糖监测器、连续葡萄糖监测器、血糖仪)。在一些情况下，葡萄糖传感器或监测器150可以是适于通过近场通信来与笔帽182或184通信的扫描式葡萄糖监测器。在一些情况下，葡萄糖传感器或监测器150可以是适于通过无线电信号(诸如，使用蓝牙低功耗协议的无线电信号)来与笔帽182或184通信的连续葡萄糖监测器。另外或可选地，这种通信可以通过NFC、WiFi、Zigbee、经典蓝牙或任何其他通信协议、设备或技术而出现。在一些情况下，扫描式葡萄糖监测器或连续葡萄糖监测器可能需要配对过程以便与其他设备通信，和/或在它准备被使用之前可能需要预热期。例如，广播设备(其可以是(1)扫描式葡萄糖监测器/连续葡萄糖监测器、葡萄糖传感器或监测器150或(2)笔帽182或184或根据本公开的其他处理设备)可以广播由其他设备接收的配对信号，其后一系列数据交换或握手可以出现以在两个设备之间建立安全的通信会话。在一些情况下，可以通过调用笔帽182或184的一个或更多个按钮来便于这种配对过程。另外或可选地，可以使用与葡萄糖传感器或监测器150或笔帽182或184中的一个或两个配对或以其他方式耦合的用户界面设备来调用配对过程。
图7示出了开始使用系统(诸如在图1A中描绘的系统)的示例性过程700。在用户屏幕711中，笔帽可以包括欢迎屏幕，欢迎屏幕包括指示笔帽尚未配对的连接指示符712。连接指示符712可以包括指示在系统可被使用之前必须完成的步骤的段。在一些情况下，屏幕可以在远程用户界面设备(例如，图1A中的设备110)上，指示用户应该如何使笔帽与远程用户界面设备配对。在步骤720中，用户可以接收使远程用户界面设备(例如智能手机)与在远程用户界面设备上的笔帽或笔帽配对的指令。在远程用户界面设备与笔帽的成功配对之后，屏幕721可以出现为指示与远程用户界面设备的成功配对。随后在步骤730中，用于将笔帽和/或远程用户界面连接到葡萄糖传感器或监测器150的指令可以出现在笔帽或远程用户界面上。在一些情况下，葡萄糖传感器或监测器150可以是使用近场通信的扫描式葡萄糖监测器，并且这里提供的方法、设备和系统可以指示用户在葡萄糖传感器或监测器150和远程用户界面设备之间创建近场通信链路和/或与笔帽182或184创建近场通信链路，以建立通信链路。在屏幕731中，笔帽用户屏幕可以指示传感器或监测器正在预热，可能带有递减计数时钟。在屏幕736中，笔帽用户屏幕可以指示葡萄糖传感器或监测器150已经准备好使用(在预热期已经完成之后)。屏幕741也可以在系统的使用期间或在配对过程期间的任何时间出现，以指示配对失败，且然后将用户返回到步骤720或730以修复配对问题。例如，葡萄糖传感器和监测器可以具有使用寿命(例如，3天、7天、10天、14天)，并且在使用寿命之后需要更换，因此屏幕741可以在葡萄糖传感器或监测器过期之后出现，并且用户可以在步骤730中查看用于更换传感器或监测器并将系统连接到新的葡萄糖传感器或监测器的指令。此外，如果在与远程用户界面设备通信时存在问题，则屏幕741可出现，并使用户回到步骤720以连接新的远程用户界面设备或重新连接远程用户界面设备。
被动和主动信息收集
本文提供的方法、设备和系统可以适于被动地收集关于胰岛素使用和用户饮食模式的信息而不需要用户执行额外的步骤，但是可被用来在用户要求时帮助用户确定适当的行动。因此，本文提供的方法、系统和设备可以使用在胰岛素笔中的或附着到胰岛素笔的剂量捕获技术来估计输送给糖尿病患者(PWD)的胰岛素的量。另外，所估计的血糖值(EGV)可以通过如上面所讨论的无线通信被推或拉到笔帽和/或远程用户界面设备，并且可供用户利用来帮助用户做出胰岛素输送决定。在一些情况下，葡萄糖传感器或监测器150可以是需要用户交互来取回EGV的扫描式葡萄糖监测器。在一些情况下，包括扫描式葡萄糖监测器的系统可以从扫描式葡萄糖监测器的询问中接收当前的EGV和过去的EGV，其可以由本文提供的方法、设备和系统用来做出治疗推荐和更新用户特定的剂量参数。
在一些情况下，方法、设备和系统可以包括用户提示，以基于对用户的风险来向用户请求信息或请求用户获得EGV，和/或获得数据。例如，如上面所讨论的，餐后数据可用于更新膳食通告按钮。此外，餐后数据可用于更新其他用户特定剂量参数。此外，在进餐后，用户冒有高血糖或低血糖状况的、升高的风险。因此，在一些情况下，本文提供的方法、系统和设备可以请求用户获得EGV。例如，在图8A中，远程用户界面设备110可以包括在施用推注剂量的胰岛素后90分钟显示的通知810，以便鼓励用户扫描扫描式葡萄糖监测器。可选地，通知810可以请求用户从任何其他合适的葡萄糖监测器或传感器(例如，从需要手指针刺的血糖仪等)获得血糖数据。可选地，通知810可以出现在笔帽或智能胰岛素笔上。通过获得餐后血糖数据，这里提供的方法、系统和设备可以(a)确定校正剂量是否可能是慎重的和/或(b)确定如何个性化膳食通告按钮。
本文提供的方法、设备和系统还可以寻求来自用户的关于用户的心智模型的反馈，特别是在用户未能通告膳食量的情况下。例如，在一些情况下，用户确定速效胰岛素的剂量可以遵循图6B中所示的步骤，但是在用户屏幕636中看到所建议的校正剂量后突然停止通告膳食，而替代地仅仅是针对膳食的推注。如上面所讨论的，本文提供的方法、系统和设备可以基于在所推荐的校正剂量和实际剂量之间的差异来估计膳食的碳水化合物的数量。在一些情况下，当用户访问远程用户界面时，本文提供的方法、设备和系统可以寻求来自用户的关于碳水化合物的估计数量的确认。例如，图8B描绘了可能出现在远程用户界面设备110上的消息820，该消息820请求用户通过选择YES(是)821来确认PWD吃了特别大小的膳食，或者通过选择NO(否)822来否认PWD吃了特别大小的膳食。在一些情况下，消息820可以在血糖数据被取回后出现。在一些情况下，消息820可以使用多个血糖值来确定膳食的可能定时和膳食的可能大小，其可以不同于基于胰岛素量而推断的碳水化合物的量。另外或可选地，即使没有来自PWD的关于膳食量的输入，或者甚至没有关于PWD是否消耗了膳食，本公开的方法、系统和设备也可以利用PWD的估计膳食量继续进行分析和/或数据收集。在一些情况下，在基于餐后血糖值和胰岛素输送数据的估计膳食量与仅基于胰岛素输送数据的估计膳食量之间的差异可指示在用户的心智模型与PWD的生理和食物消耗之间的不匹配。在一些情况下，消息820可以是被动的(即，没有可听警报)，但是当用户看远程用户界面设备或在远程用户界面设备上为系统打开移动应用程序时可供用户利用来回答。在一些情况下，消息820可以提供向用户显示方法、系统和设备理解用户的使用模式的见解，以便建立用户对设备和系统的信任。在一些情况下，用户可以选择按钮823来提供关于推注的附加细节。在进餐后从用户接收到的数据然后可用于产生对膳食通告按钮142-144、221-223、321-323的更新。
计算和更新推荐、用户特定剂量参数和活性胰岛素
本文提供的方法、设备和系统可以使用用于做出推荐、用于更新用户特定剂量参数(例如，人的ISF、CR、总每日LAI剂量等)以及用于估计不起作用的胰岛素的量(例如，用于计算IOB)的任何合适的技术。在一些情况下，用户特定剂量参数可以根据一天中的时间而变化。在一些情况下，可以使用在用户特定剂量参数之间的固定关系来确定用户特定剂量参数。例如，在一些情况(诸如患有1型糖尿病的用户)下，在总每日LAI和PWD的碳水化合物与胰岛素比率以及PWD的胰岛素敏感性因子之间的固定关系可以基于固定的数学关系。在一些情况下，可以通过图9A和9B中所示的绘制线915、925、935、945、955、965、975或985之一或者在线915和945之间以及在线955和985之间的任何绘制线来确定关系。通过有在总每日LAI和ISF和CR之间的固定的数学关系，本文提供的方法、系统和设备可以将CR和ISF更新为PWD对胰岛素随时间的过去的变化的响应。
在一些情况下，方法、系统和设备可以向用户做出推荐，以基于空腹血糖读数(例如，在PWD进食前的早晨获取的血糖读数)来调整LAI的剂量。在一些情况下，本文提供的方法、设备和系统可以基于空腹血糖读数高于阈值而增加了设定数量的单位(例如，0.5单位)，并且基于空腹血糖读数低于不同的较低阈值而减少LAI的推荐剂量。在一些情况下，如果用户未能在适当的时间输送LAI，则方法、设备和系统可以提供关于LAI和速效胰岛素(QAI)的剂量的推荐。
本文提供的方法、设备和系统可以通过从EGV中减去目标血糖值并使那个数字除以胰岛素敏感性因子(ISF)且然后减去IOB来计算推荐的校正剂量。本文提供的方法、设备和系统还可以通过使与食品通告按钮相关联的碳水化合物的数量除以为PWD存储的碳水化合物与胰岛素的比率(CR)来计算针对食品消耗的推荐推注。相反，如果PWD在计算校正推注之后输送胰岛素的推注而不输入膳食并且该推注不同于推荐校正推注，则本文提供的方法、系统和设备可以通过从所输送的胰岛素的量中减去推荐校正推注并将使那个数字乘以为用户存储的CR来计算针对膳食推断出的碳水化合物的量。换句话说，推断出的碳水化合物＝(所输送的胰岛素的推注-推荐校正推注)*CR。本文提供的方法、系统和设备然后可以在计算预测血糖水平时使用计算出的所推断的碳水化合物，其可以用于向PWD发出警报或警告(例如，预测性低血糖或预测性高血糖警报或警告)。在一些情况下，推荐校正推注可能是负的。在一些情况下，当用户没有输入或取回EGV和/或没有使系统计算推荐校正剂量时，本文提供的设备、系统和方法可以通过使剂量乘以CR来计算所推断的碳水化合物的量。通过使方法、系统和设备推断出碳水化合物的数量，本文提供的方法、设备和系统可以匹配用户的心智模型而不需要用户输入数据。
用于2型糖尿病的治疗的系统
在一些情况下，本文提供的方法、系统和设备可用于治疗患有2型糖尿病的人(PWT2D)，并针对2型糖尿病(T2D)的治疗而个性化胰岛素治疗。例如，图1A所示的系统可用于PWT2D的治疗。
常常通过缓慢地添加治疗来治疗2型糖尿病。最初，可以建议PWT2D控制他们的饮食并锻炼，以便防止高血糖水平，其可以通过记录用BGM获取的血糖读数来被复查。如果饮食和锻炼不足以实现血糖控制——其可由小于7％的HBA1C值和小于110mg/dL的空腹/餐前血糖读数定义(但可基于多个因素被个性化)，那么PWT2D可开始被设计为降低血糖水平的各种药物(如GLP-1RA或SGLT-2i或DPP-4i)的治疗。如果这些药物不能实现适当的血糖控制，那么PWT2D可以在有或没有使用其他药物的情况下使用LAI的一次或两次注射来开始胰岛素治疗。本文提供的系统、设备和方法可用于帮助PWT2D创建血糖读数的数据日志，将膳食记入文件，以及提醒何时获取餐后血糖读数(即使PWT2D不在胰岛素治疗中)。
如果PWT2D正在服用LAI而不是针对膳食的QAI，则除了将BGM数据和膳食记入文件并发出提醒之外，本文提供的方法和系统还可用于对LAI注射进行调整。当本文提供的系统和方法开始时，医疗保健服务的用户和/或提供者可以基于PWT2D的先前LAI治疗来设定LAI的初始量。如果PWT2D第一次开始LAI治疗，则当PWT2D使系统开始时，每天的LAI的总单位可以被设定为大约0.2U/kg或者在0.1和0.3U/kg之间的任何量。例如，如果PWT2D具有小于8％的A1C，则医疗保健提供者通常可将总LAI治疗设定在0.1和0.2U/kg之间。如果PWT2D具有大于8％的A1C，则医疗保健提供者通常可将总LAI治疗设定在0.2和0.3U/kg之间。例如，重100kg且具有8％的A1C的PWT2D可以使医疗保健服务的提供者将LAI的总每日剂量设定在20个单位(例如，在上午8点的10个单位和在晚上8点的10个单位)处。在一些情况下，移动应用程序可以包括用于使PWT2D或其医疗保健提供者进入初始LAI治疗的界面，该界面可以稍后被更新或调整(都通过下面提供的算法或手动地更新或调整)。在一些情况下，LAI治疗最初可以由医疗保健提供者在通过云连接到移动应用程序的远程web界面中设定和/或更新。在一些情况下，本文提供的方法和系统可能需要合格的医疗保健专业人员输入或确认初始LAI治疗。
本文提供的方法、设备和系统可以通过跟踪血糖数据和LAI注射来使用和调节LAI治疗。在一些情况下，如果在一段时间(例如，1天、2天、3天、5天、7天或更长时间)期间的平均空腹血糖读数超过阈值，则LAI可以被向上调整。在一些情况下，调整的量可取决于平均空腹血糖值超过阈值多少。例如，在一些情况下，在110和140mg/dL之间的3天平均空腹血糖值将导致每天1单位LAI的增加，在140和180mg/dL之间的3天平均空腹血糖值将导致LAI增加10％，以及至少180mg/dL的3天平均空腹血糖值将导致LAI增加20％。在一些情况下，LAI的百分比的增加可以与超过110mg/dL的2或3天平均值线性地成比例。
在一些情况下，如果任何血糖读数低于阈值(这可以是低血糖或者指示低血糖的风险)，则LAI可以被向下调整。该下降可以与低血糖读数成比例。在一些情况下，如果血糖读数在40和70mg/dL之间，则LAI将降低10-20％之间，且小于40mg/dL的血糖读数将导致在20-40％之间的降低。在一些情况下，本文提供的方法和系统对于约70mg/dL的读数将LAI降低10％，对于约40mg/dL的读数将它降低20％，以及对于约30mg/dL或更小的读数将它降低40％。
通常，如果LAI治疗正在实现血糖控制，则系统不应该产生矛盾的向上和向下调整。此外，血糖控制应该导致低血糖的缺少，防止大于110mg/dL的空腹和餐前血糖读数和小于7％的A1C。如果方法和系统在由医疗保健提供者预设或设定的足够长的时间段(例如1个月、2个月等)后未能实现血糖控制，则该系统可以向医疗保健提供者发送消息以指示额外的治疗可以被考虑，额外的治疗包括药物(如GLP-1RA或SGLT-2i或DPP-4i)或者使用LAI和QAI治疗。如果除QAI之外的其他药物被添加到治疗，则系统可以如上所述继续调整LAI，并确定在足够长的时间段(例如，1个月、2个月等)后血糖控制是否实现。
如果PWT2D从单独的LAI治疗切换到同时使用LAI和QAI的治疗，则医疗保健提供者可以只为一些膳食或者为所有膳食切换到QAI。例如，在一些情况下，医疗服务提供者可能将LAI减少10％或5个单位，并将最大的膳食的膳食QAI推注设定在那个10％值或5个单位的值处，潜在地为额外的膳食增加膳食QAI推注(如果那未能实现血糖控制)。在一些情况下，医疗保健提供者可能决定将LAI减少50％，并将膳食QAI剂量设定在等于LAI的减小的值处，可能对不同的膳食估计不同的量。不考虑LAI和膳食QAI推注的剂量以及由医疗保健提供者设定的时间，本文提供的方法和系统可以基于血糖读数来对LAI和QAI注射都进行调整。对于任何空腹血糖读数，可以使用上面讨论的相同的准则来减少或增加每天的LAI总单位。可以通过在那餐后的跑步平均血糖读数高于高阈值的情况下增加每个膳食QAI推注以及在餐后血糖读数低于低阈值的情况下减少每个膳食QAI推注来调整每个膳食QAI推注。例如，如果在进餐后2小时的餐后血糖读数在70和40mg/dL之间，则那餐的膳食QAI推注将减少10和20％之间，以及如果餐后血糖读数低于40mg/dL，则膳食QAI推注将减少20和40％之间。高于140mg/dL的餐后血糖读数可例如导致系统将那餐的膳食QAI推注增加10％或者那餐的QAI增加1-2个单位之间。因此，本文提出的系统和方法可以个性化膳食QAI膳食推注的大小，这可以是由于PWT2D的典型膳食量或胰岛素敏感性和碳水化合物与胰岛素比率在一天期间的变化而导致的。如果膳食QAI推注产生高度可变的餐后血糖读数，本文提供的系统也可以向用户发出通知，向PWT2D指示膳食量应该保持大致恒定。
本文提供的系统、设备和方法还可以为用户或医疗保健提供者标记不寻常的情况，并建议额外的任务。例如，在一些情况下，用户可具有130mg/dL的餐后血糖读数，但以大于160mg/dL的空腹血糖读数醒来，这可能指示PWT2D可能经历夜间低血糖水平，随后是由于生物反应(例如，胰高血糖素从肝脏中释放)而引起的血糖水平的反弹，因此系统可能建议在夜间偶尔额外的血糖读数。夜间低血糖水平可能指示对调整晚餐QAI推注或LAI的单位的需要。在一些情况下，本文提供的方法和系统可以具有关于与医疗保健提供者的下一次约会的数据，并请求PWT2D在直到约会前的几天进行额外的血糖测量。
基于系统的推断
在一些情况下，本公开的方法、设备或系统可以通过观察和/或分析根据本公开收集的数据来推断某些信息。例如，可以做出关于膳食是否被消耗、所消耗的膳食的量、胰岛素的推注是否被接收到和/或接收到的胰岛素的推注的大小的推断。
在一些情况下，本公开的方法、设备或系统可以分析历史血糖读数，并记录当血糖水平升高时的时刻，尤其是在进餐时间左右。通过观察上升的血糖水平，可以做出关于膳食的消耗的推断。另外或可选地，使用用户特定的参数(例如，碳水化合物与胰岛素的比率(CR)、胰岛素敏感性因子(ISF)、板载胰岛素(IOB)等)和/或历史数据，可以基于血糖水平的变化量和关于PWD的膳食量而收集的数据来推断膳食的量。例如，如果已知量的胰岛素作为针对膳食的推注而被重复地给予PWD并且已知的响应被预期针对预期的膳食量，则该响应的变化可以传达膳食量的变化。
在一些情况下，本公开的方法、设备或系统可以分析历史血糖读数，并记录当血糖水平下降时的时间。例如，可以基于血糖水平的降低(血糖水平的降低基于与膳食相关联的预期推注)来做出用户是否已经接收到胰岛素的推注的推断。例如，跟随有血糖水平的降低的在进餐时间左右的血糖水平的初始增加可以指示用户实际上确实接收到针对膳食的推注。另外或可选地，使用用户特定参数和/或历史数据，可以估计推注的大小。例如，如果膳食量是已知的(或估计的)并且典型响应对于PWD是已知的(或预期到的)，则血糖水平的降低可以允许本公开的方法、设备或系统推断推注大小。在一些情况下，本公开的方法、设备或系统可以使用推断来充当安全检查，以验证PWD接收到与膳食相关联的推注。例如，PWD可以使用推注的胰岛素笔，其不与本公开的系统或设备的其他部件通信，并且这种方法可以验证推注针对膳食被给出。
在一些情况下，血糖水平的预期变化可以合并由于LAI、QAI和所消耗的碳水化合物而导致的预期血糖水平的重叠。这种数据可以被推断、从一个或更多个传感器或设备读取或者由用户或PWD输入。
本文描述的实施例可以包括其包含各种计算机硬件或软件模块的专用或通用计算机的使用，如下文更详细讨论的。
本文描述的各种实施例可以使用计算机可读介质来实现，计算机可读介质用于携带或具有存储在其上的计算机可执行指令或数据结构。这样的计算机可读介质可以是可以由通用或专用计算机访问的任何可用的介质。作为示例而非限制，这种计算机可读介质可以包括非暂态计算机可读存储介质，包括随机存取存储器(RAM)、只读存储器(ROM)、电可擦除可编程只读存储器(EEPROM)、光盘只读存储器(CD-ROM)或其他光盘存储设备、磁盘存储设备或其他磁性存储设备、闪存设备(例如固态存储设备)或任何其他存储介质，这些存储介质可以用于携带或存储采用计算机可执行指令或数据结构的形式的期望的程序代码，并且可以由通用或专用计算机访问。上述项的组合也可被包括在计算机可读介质的范围内。
计算机可执行指令包括例如使通用计算机、专用计算机或专用处理设备(例如，一个或更多个处理器)执行某个功能或功能组的指令和数据。尽管已经以结构特征和/或方法行动所特有的语言描述了主题，但应理解，在所附权利要求中定义的主题不一定限于上面描述的特定特征或行动。相反，上面描述的特征和行动被公开作为实现权利要求的示例形式。
在本文(包括在权利要求中)表示的任何范围被认为给出了它们的最广泛的可能解释。例如，除非另外明确提及，否则范围将包括它们的端点(例如，“在X和Y之间”的范围将包括X和Y)。另外，使用术语“近似”或“大约”描述的范围应被理解为给出与本领域中的技术人员的理解一致的最广泛的含义。另外，术语“近似”包括在10％(或5％)内或在制造公差或典型公差内的任何数。
在本文列举的所有示例和条件语言旨在为了教学目的，以帮助读者理解本公开和由发明人为促进本领域所贡献的概念，并且应被解释为不限于这样特别列举的示例和条件。尽管已经详细描述了本公开的实施例，但是应当理解，可以对其进行各种改变、替换和变更而不偏离本公开的精神和范围。

Claims (19)

1.一种装置，包括：
用户界面，所述用户界面被配置为向用户显示数据以及一个或更多个剂量推荐；
存储器，所述存储器用于存储信息，其中所述信息包括用户特定剂量参数；以及
处理器，所述处理器用于接收血糖数据，所述处理器与所述存储器通信以响应于所述用户特定剂量参数和所述血糖数据确定校正剂量的量。
2.根据权利要求1所述的装置，其中，所述剂量推荐中的一个是所述校正剂量的量的指示。
3.根据权利要求1所述的装置，其中，存储在所述存储器处的所述信息包括针对膳食要施用的胰岛素量。
4.根据权利要求3所述的装置，其中，所述剂量推荐中的一个是针对所述膳食要施用的所述胰岛素量的指示。
5.根据权利要求1所述的装置，其中，存储在所述存储器处的所述信息包括针对多次膳食要施用的相应胰岛素量。
6.根据权利要求5所述的装置，其中，所述剂量推荐是针对多次膳食要施用的所述相应胰岛素量的指示。
7.根据权利要求1所述的装置，其中，存储在所述存储器处的所述信息包括针对膳食要施用的胰岛素量；并且其中所述剂量推荐中的一个是胰岛素的单位数的指示，胰岛素的单位数表示针对所述膳食要施用的所述胰岛素量以及用于校正升高的血糖水平的胰岛素的添加量。
8.根据权利要求1所述的装置，其中，存储在所述存储器处的所述信息包括针对膳食要施用的胰岛素量；并且其中所述剂量推荐是胰岛素的多个单位数的多个指示，胰岛素的多个单位数表示针对所述膳食要施用的所述胰岛素量以及用于校正升高的血糖水平的额外的胰岛素量。
9.根据权利要求1所述的装置，其中，所述血糖数据包括来自血糖仪的一个或更多个读数或者来自连续葡萄糖监测器的数据。
10.一种系统，包括：
胰岛素输送设备；
葡萄糖监测器或传感器，所述葡萄糖监测器或传感器用于提供血糖数据；以及
所述胰岛素输送设备的附件，包括：
用户界面，所述用户界面被配置为向用户显示数据以及一个或更多个剂量推荐；
存储器，所述存储器用于存储信息，其中所述信息包括用户特定剂量参数；以及
处理器，所述处理器用于接收所述血糖数据，所述处理器与所述存储器通信以响应于所述用户特定剂量参数和所述血糖数据确定校正剂量的量。
11.根据权利要求10所述的系统，其中，所述剂量推荐中的一个是所述校正剂量的量的指示。
12.根据权利要求10所述的系统，其中，存储在所述存储器处的所述信息包括针对膳食要施用的胰岛素量。
13.根据权利要求12所述的系统，其中，所述剂量推荐中的一个是针对所述膳食要施用的所述胰岛素量的指示。
14.根据权利要求10所述的系统，其中，存储在所述存储器处的所述信息包括针对多次膳食要施用的相应胰岛素量。
15.根据权利要求14所述的系统，其中，所述剂量推荐是针对多次膳食要施用的所述相应胰岛素量的指示。
16.根据权利要求10所述的系统，其中，存储在所述存储器处的所述信息包括针对膳食要施用的胰岛素量；并且其中所述剂量推荐中的一个是胰岛素的单位数的指示，胰岛素的单位数表示针对所述膳食要施用的所述胰岛素量以及用于校正升高的血糖水平的胰岛素的添加量。
17.根据权利要求10所述的系统，其中，存储在所述存储器处的所述信息包括针对膳食要施用的胰岛素量；并且其中所述剂量推荐是胰岛素的多个单位数的多个指示，胰岛素的多个单位数表示针对所述膳食要施用的所述胰岛素量以及用于校正升高的血糖水平的额外的胰岛素量。
18.根据权利要求10所述的系统，其中，所述血糖数据包括来自血糖仪的一个或更多个读数或者来自连续葡萄糖监测器的数据。
19.根据权利要求10所述的系统，其中，所述胰岛素输送设备的所述附件与所述葡萄糖监测器或传感器无线通信。
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US20180089395A1 (en) 2018-03-29
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US10426896B2 (en) 2019-10-01
WO2018064219A1 (en) 2018-04-05
US11806514B2 (en) 2023-11-07
CN109789264B (zh) 2021-06-22
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US11229751B2 (en) 2022-01-25
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