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    Retrospective retrofitting method to generate a continuous glucose concentration profile by exploiting continuous glucose monitoring sensor data and blood glucose measurements
    13.
    发明授权
    Retrospective retrofitting method to generate a continuous glucose concentration profile by exploiting continuous glucose monitoring sensor data and blood glucose measurements 有权

    公开(公告)号：US10299733B2

    公开(公告)日：2019-05-28

    申请号：US14770803

    申请日：2014-02-20

    Applicant: DexCom, Inc.

    Inventor： Claudio Cobelli ,  Simone Del Favero ,  Andrea Facchinetti ,  Giovanni Sparacino

    IPC: A61B5/00 ,  A61B5/145 ,  A61B5/1495

    Abstract: Continuous Glucose Monitoring (CGM) devices provide glucose concentration measurements in the subcutaneous tissue with limited accuracy and precision. Therefore, CGM readings cannot be incorporated in a straightforward manner in outcome metrics of clinical trials e.g. aimed to assess new glycaemic-regulation therapies. To define those outcome metrics, frequent Blood Glucose (BG) reference measurements are still needed, with consequent relevant difficulties in outpatient settings. Here we propose a “retrofitting” algorithm that produces a quasi continuous time BG profile by simultaneously exploiting the high accuracy of available BG references (possibly very sparsely collected) and the high temporal resolution of CGM data (usually noisy and affected by significant bias). The inputs of the algorithm are: a CGM time series; some reference BG measurements; a model of blood to interstitial glucose kinetics; and a model of the deterioration in time of sensor accuracy, together with (if available) a priori information (e.g. probabilistic distribution) on the parameters of the model. The algorithm first checks for the presence of possible artifacts or outliers on both CGM datastream and BG references, and then rescales the CGM time series by exploiting a retrospective calibration approach based on a regularized deconvolution method subject to the constraint of returning a profile laying within the confidence interval of the reference BG measurements. As output, the retrofitting algorithm produces an improved “retrofitted” quasi-continuous glucose concentration signal that is better (in terms of both accuracy and precision) than the CGM trace originally measured by the sensor. In clinical trials, the so-obtained retrofitted traces can be used to calculate solid outcome measures, avoiding the need of increasing the data collection burden at the patient level.

    ALERT SYSTEM FOR HYPO AND HYPERGLYCEMIA PREVENTION BASED ON CLINICAL RISK
    15.
    发明申请
    ALERT SYSTEM FOR HYPO AND HYPERGLYCEMIA PREVENTION BASED ON CLINICAL RISK 审中-公开
    基于临床风险的HYPO和HYPERGESMIMIA预防系统

    公开(公告)号：US20160361028A1

    公开(公告)日：2016-12-15

    申请号：US15239712

    申请日：2016-08-17

    Applicant: DexCom, Inc.

    Inventor： Giovanni Sparacino ,  Claudio Cobelli ,  Stefania Guerra ,  Andrea Facchinetti ,  Michele Schiavon

    IPC: A61B5/00 ,  A61B5/145

    CPC classification number: A61B5/7275 ,  A61B5/14532 ,  A61B5/7405 ,  A61B5/743 ,  A61B5/7455 ,  A61B5/746 ,  G16H50/30

    Abstract: A device for generating alerts for Hypo and Hyperglycemia Prevention from Continuous Glucose Monitoring (CGM) determines a dynamic risk based on both information of glucose level and a trend obtainable from a CGM signals. The device includes a display whose color depends on the DR (for example, red for high DR, green for low risk). When DR exceeds a certain threshold, alerts are generated to suggest the patient to pay attention to the current glucose reading and to its trend, both of which are shown on the display in numbers and symbols (e.g. an arrow with different slope or color).

    Abstract translation: 用于从连续葡萄糖监测（CGM）产生低血糖和高血糖预防的警报的装置基于葡萄糖水平的信息和从CGM信号获得的趋势来确定动态风险。 该设备包括一个显示器，其颜色取决于DR（例如，高DR的红色，低风险的绿色）。 当DR超过某个阈值时，产生警报以建议患者注意当前的葡萄糖读数及其趋势，这两者都以数字和符号（例如具有不同斜率或颜色的箭头）显示在显示器上。

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