JP7356583B2 - 食事及び修正インシュリンボーラス量による血糖変化率調整 - Google Patents
食事及び修正インシュリンボーラス量による血糖変化率調整 Download PDFInfo
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- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
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Description
本出願は、2019年9月13日に出願され「食事及び修正インシュリンボーラス量による血糖変化率の調整」と題された米国特許出願第16/570125号明細書の優先権を主張する。上記出願の内容は参照により本明細書に援用される。
[構成1]
プロセッサにより実行可能なプログラムコードを具現化した非一時的なコンピュータ可読媒体であって、前記プロセッサは前記プログラムコードの実行時に機能を実行するよう動作可能であり、前記機能は、
幾つかの血糖測定値をある期間に渡り受信することと、
前記幾つかの血糖測定値中の最新の血糖測定値に基づいて修正ボーラス投与量を計算することと、
前記期間中の前記幾つかの血糖測定値から血糖値の変化率を求めることと、
求めた前記変化率及び前記最新の血糖測定値を使用して改定ボーラス投与量を計算することと、
前記修正ボーラス投与量及び前記改定ボーラス投与量に対して関数を適用することと、
前記関数の出力に基づいて最終インシュリン値を決定すること、
決定された前記最終インシュリン値を使用してインシュリンボーラス投与量を設定することと、
設定された前記インシュリンボーラス投与量に従ってインシュリンの送出を実行することと、
を含む、非一時的なコンピュータ可読媒体。
[構成2]
前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に、
前記最新の血糖測定値と目標血糖値との差を求めることと、
パーソナライズされたインシュリン値を提供するために求めた前記差に対してインシュリン感度因子を適用することと、
前記パーソナライズされたインシュリン値に対してインシュリン調整因子を適用することと、
を含む機能を実行することにより前記修正ボーラス投与量を計算するよう動作可能である、構成1に記載の非一時的なコンピュータ可読媒体。
[構成3]
前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に、
時間パラメータの表にアクセスすることと、
前記最新の血糖測定値をユーザ応答時間の予測に使用して、インシュリン投与に対する前記ユーザ応答時間の前記予測に基づいて時間パラメータを選択することと、
前記時間パラメータを求めた前記変化率に適用することと、
を含む機能を実行することにより前記改定ボーラス投与量を計算するよう動作可能である、構成1に記載の非一時的なコンピュータ可読媒体。
[構成4]
前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に
前記最新の血糖測定値を取得することと、
変化率に時間パラメータを乗算することにより変化率修正因子を求めることと、
求めた前記変化率修正因子を使用して前記最新の血糖測定値を修正することと、
修正された前記最新の血糖測定値と目標血糖値との差を求めることと、
前記改定ボーラス投与量を提供するために求めた前記差に対してインシュリン感度因子を適用することと、
を含む機能を実行することにより前記改定ボーラス投与量を計算するよう動作可能である、構成1に記載の非一時的なコンピュータ可読媒体。
[構成5]
前記プロセッサは前記プログラムコードの実行時に、
食事ボーラスの指示が出力されるか、又は修正ボーラスの指示が出力されるかを決定する機能を含む更なる機能を実行するよう動作可能である、構成1に記載の非一時的なコンピュータ可読媒体。
[構成6]
前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に
食事ボーラスの前記指示が送出されることに応じて、炭水化物の量を取得することと、
炭水化物のグラム数に対するインシュリンの単位数を示すインシュリン/カーボ比値を取得することと、
取得された前記炭水化物の量及び前記インシュリン/カーボ比値を使用して食事パラメータを生成することと、
前記食事パラメータを前記修正ボーラス投与量に加算することにより食事修正ボーラス投与量を生成することと、
前記食事パラメータを前記改定ボーラス投与量に加算することにより食事改定ボーラス投与量を生成することと、
前記関数中の食事ボーラス投与量を前記修正ボーラス投与量で置き換え、前記食事改定ボーラス投与量を前記改定ボーラス投与量に置き換えることと、
前記食事修正ボーラス投与量及び前記食事改定ボーラス投与量を使用した前記関数の前記出力に基づいて、前記インシュリンボーラス投与量として前記食事ボーラス投与量を設定することと、
を行う機能を含む機能を実行するよう動作可能である、構成5に記載の非一時的なコンピュータ可読媒体。
[構成7]
前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に
修正ボーラスが送出される前記指示を決定することに応じて、前記インシュリンボーラス投与量に基づいてボーラスの送出を実行することと、
を行う機能を含む機能を実行するよう動作可能である、構成5に記載の非一時的なコンピュータ可読媒体。
[構成8]
プロセッサと、
プログラムコードと、人工膵臓アプリケーションを記憶し、前記人工膵臓アプリケーションに関連したデータを記憶するように動作可能であり、前記プログラムコード及び前記人工膵臓アプリケーションは前記プロセッサにより実行可能であるメモリと、
前記人工膵臓アプリケーションにより使用可能な、又は前記人工膵臓アプリケーションにより生成される情報を含んだ信号を受信し送信するように動作可能である送受信器と、
を備え、
前記プロセッサは前記人工膵臓アプリケーションの実行時にインシュリンの送出を制御するよう動作可能であり、また、
幾つかの血糖測定値を取得することと、
前記幾つかの血糖測定値中の最新の血糖測定値に基づいて修正ボーラス投与量を計算することと、
ある期間中の前記幾つかの血糖測定値から血糖値の変化率を求めること、
求めた前記変化率及び前記最新の血糖測定値を使用して改定ボーラス投与量を計算することと、
前記修正ボーラス投与量及び前記改定ボーラス投与量に対して関数を適用することと、
前記関数の出力に基づいて最終インシュリン値を求めることと、
求めた前記最終インシュリン値を使用してインシュリンボーラス投与量を設定することと、
設定された前記インシュリンボーラス投与量に従ってインシュリンの送出を実行することと、
を行う機能を含む機能を実行するよう動作可能である、装置。
[構成9]
ユーザへ取り外し可能なように装着可能なポンプ機構と、
インシュリンを収容するよう動作可能であり、前記ポンプ機構に流動的に接続されたリザーバと、
を更に備え、
前記ポンプ機構は前記プロセッサに通信可能に接続され、
前記プロセッサからの実行信号に応答して前記設定されたインシュリンボーラス投与量に従ってインシュリンを前記リザーバから排出するよう動作可能である、
構成8に記載の装置。
[構成10]
前記プロセッサは前記幾つかの血糖測定値を取得する際に、
前記送受信器から前記幾つかの血糖測定値中のそれぞれの血糖測定値を含む信号を受信することと、
前記各血糖測定値を前記メモリに記憶することと、
を行うよう動作可能である、構成8に記載の装置。
[構成11]
前記プロセッサは、設定された前記インシュリンボーラス投与量に従ったインシュリン送出の実行時に、
医療機器による受信のために前記送受信器を介して制御信号を送信し、前記制御信号は医療機器により排出されるべきインシュリンの量を示すよう動作可能である、
構成8に記載の装置。
[構成12]
前記プロセッサへ通信可能に接続され、予め定義した時間間隔にて血糖値を測定するように動作可能である血糖センサを更に備え、前記血糖センサは前記幾つかの血糖測定値を提供する、構成8に記載の装置。
[構成13]
前記プロセッサは前記修正ボーラス投与量の計算時に、
前記最新の血糖測定値と目標血糖値との差を求めることと、
パーソナライズされたインシュリン値を提供するために求めた前記差に対してインシュリン感度因子を適用することと、
前記パーソナライズされたインシュリン値に対してインシュリン調整因子を適用することと、
を行うよう動作可能である、構成8に記載の装置。
[構成14]
前記プロセッサは、前記改定ボーラス投与量の計算時に、
時間パラメータの表にアクセスすることと、
前記最新の血糖測定値に対する予測されたユーザ応答時間に基づいて時間パラメータを選択することと、
前記時間パラメータを求めた前記変化率に適用することと、
を行うよう動作可能である、構成8に記載の装置。
[構成15]
前記プロセッサは、前記改定ボーラス投与量の計算時に、
前記最新の血糖測定値を取得することと、
求めた変化率因子を使用して前記最新の血糖測定値を修正し、求めた前記変化率因子は求めた前記変化率及び時間パラメータから生成されることと、
修正された前記最新の血糖測定値と目標血糖値との差を求めることと、
前記改定ボーラス投与量を提供するために求めた前記差に対してインシュリン感度因子を適用することと、
を行うよう動作可能である、構成8に記載の装置。
[構成16]
前記プロセッサは、前記人工膵臓アプリケーションの実行時に、
食事ボーラスの指示が出力されるか、又は修正ボーラスの指示が出力されるかを決定することと、
食事ボーラスが送出されることに応じて、炭水化物の量を取得することと、
炭水化物のグラム数に対するインシュリンの単位数を示すインシュリン/カーボ比値を取得することと、
取得された前記炭水化物の量及び前記インシュリン/カーボ比値を使用して食事パラメータを生成することと、
前記食事パラメータを前記修正ボーラス投与量に加算することにより食事修正ボーラス投与量を生成することと、
前記食事パラメータを前記改定ボーラス投与量に加算することにより食事改定ボーラス投与量を生成することと、
前記関数を適用する前に、食事ボーラス投与量を前記修正ボーラス投与量で置き換え、前記食事改定ボーラス投与量を前記改定ボーラス投与量に置き換えることと、
前記関数の前記出力に基づいて前記インシュリンボーラス投与量として前記食事ボーラス投与量を設定することと、
を行うよう動作可能である、構成8に記載の装置。
[構成17]
幾つかの血糖測定値をある期間に渡り受信することと、
プロセッサによりユーザに要求されたインシュリンの修正ボーラス投与量を前記幾つかの血糖測定値の評価に基づいて決定することと、
関数の出力に基づいて修正ボーラス投与量の最終インシュリン値を取得し、前記関数は、前記関数の前記出力を生成するために、前記幾つかの血糖測定値のうち選択された血糖測定値、前記ユーザの目標血糖値、及びインシュリン調整因子を利用することと、
取得された前記最終インシュリン値に基づいてインシュリンボーラス投与量を設定することと、
設定された前記インシュリンボーラス投与量に従ってインシュリンの送出を実行することと、
を含む、方法。
[構成18]
選択された前記血糖測定値と前記ユーザの前記目標血糖値との差を計算することと、
計算された前記差、又は最大修正血糖値のどちらがより低い血糖値であるかを求めることと、
前記より低い血糖値に対してインシュリン調整因子を適用することと、
前記より低い血糖値に対する前記インシュリン調整因子の前記適用結果を出力し、前記結果は前記最終インシュリン値であることと、
を更に含む関数を適用することと、
を更に含む、構成17に記載の方法。
[構成19]
前記関数の前記出力の生成は、
選択された前記血糖測定値と前記ユーザの前記目標血糖値との差を計算することと、
計算された前記差、又は最大修正血糖値のどちらがより低い血糖値であるかを求めることと、
前記より低い血糖値に対してインシュリン調整因子を適用することにより調整因子適用後のボーラス投与量を決定することと、
前記幾つかの血糖測定値から血糖測定値を選択することと、
前記期間中に受信された前記幾つかの血糖測定値から前記血糖測定値の変化率を求めることと、
前記変化率に時間パラメータを乗算することにより変化率修正因子を求めることと、
選択された前記血糖測定値に前記変化率修正因子を加算することにより修正血糖測定値を生成することと、
前記修正血糖測定値と目標血糖値との差を求めることと、
前記修正血糖測定値と目標血糖値との求めた前記差と前記調整因子適用後のボーラス投与量とのどちらが各最小値であるかを求めることと、
前記各最小値を、ボーラス投与指示として、薬品送出装置へ、第一のインシュリン修正値として出力することと、
を含む、構成17に記載の方法。
[構成20]
前記関数の前記出力は、
血糖値における測定値と目標値の差を求めるために選択された前記血糖測定値と前記ユーザの前記目標血糖値との差を計算することと、
選択された前記血糖測定値が計測された時間に相当する特定の時間における血糖値を予測することと、
血糖値における予測値と目標値の差を求めるために予測された前記血糖値と前記ユーザの前記目標血糖値との差を計算することと、
血糖値における前記測定値と目標値の差及び血糖値における前記予測値と目標値の差のどちらがより低い血糖値であるかを求めることと、
最終血糖値を提供するために前記より低い血糖値に対してインシュリン調整因子を適用することと、
ボーラス投与量を送出するための前記最終血糖値の指示を薬品送出装置へ出力することと、
を含む、構成17に記載の方法。
Claims (16)
- プロセッサにより実行可能なプログラムコードを具現化した非一時的なコンピュータ可読媒体であって、前記プロセッサは前記プログラムコードの実行時に機能を実行するよう動作可能であり、前記機能は、
幾つかの血糖測定値をある期間に渡り受信することと、
前記幾つかの血糖測定値中の最新の血糖測定値に基づいて修正ボーラス投与量を計算することと、
前記期間中の前記幾つかの血糖測定値から血糖値の変化率を求めることと、
求めた前記変化率及び前記最新の血糖測定値を使用して改定ボーラス投与量を計算することと、
前記修正ボーラス投与量及び前記改定ボーラス投与量に対して関数を適用することと、
前記関数の出力に基づいて最終インシュリン値を決定すること、
決定された前記最終インシュリン値を使用してインシュリンボーラス投与量を設定することと、
設定された前記インシュリンボーラス投与量に従ってインシュリンの送出を実行することと、
を含む、非一時的なコンピュータ可読媒体。 - 前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に、
前記最新の血糖測定値と目標血糖値との差を求めることと、
パーソナライズされたインシュリン値を提供するために求めた前記差に対してインシュリン感度因子を適用することと、
前記パーソナライズされたインシュリン値に対してインシュリン調整因子を適用することと、
を含む機能を実行することにより前記修正ボーラス投与量を計算するよう動作可能である、請求項1に記載の非一時的なコンピュータ可読媒体。 - 前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に、
時間パラメータの表にアクセスすることと、
前記最新の血糖測定値をユーザ応答時間の予測に使用して、インシュリン投与に対する前記ユーザ応答時間の前記予測に基づいて時間パラメータを選択することと、
前記時間パラメータを求めた前記変化率に適用することと、
を含む機能を実行することにより前記改定ボーラス投与量を計算するよう動作可能である、請求項1に記載の非一時的なコンピュータ可読媒体。 - 前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に
前記最新の血糖測定値を取得することと、
変化率に時間パラメータを乗算することにより変化率修正因子を求めることと、
求めた前記変化率修正因子を使用して前記最新の血糖測定値を修正することと、
修正された前記最新の血糖測定値と目標血糖値との差を求めることと、
前記改定ボーラス投与量を提供するために求めた前記差に対してインシュリン感度因子を適用することと、
を含む機能を実行することにより前記改定ボーラス投与量を計算するよう動作可能である、請求項1に記載の非一時的なコンピュータ可読媒体。 - 前記プロセッサは前記プログラムコードの実行時に、
食事ボーラスの指示が出力されるか、又は修正ボーラスの指示が出力されるかを決定する機能を含む更なる機能を実行するよう動作可能である、請求項1に記載の非一時的なコンピュータ可読媒体。 - 前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に
食事ボーラスの前記指示が送出されることに応じて、炭水化物の量を取得することと、
炭水化物のグラム数に対するインシュリンの単位数を示すインシュリン/カーボ比値を取得することと、
取得された前記炭水化物の量及び前記インシュリン/カーボ比値を使用して食事パラメータを生成することと、
前記食事パラメータを前記修正ボーラス投与量に加算することにより食事修正ボーラス投与量を生成することと、
前記食事パラメータを前記改定ボーラス投与量に加算することにより食事改定ボーラス投与量を生成することと、
前記関数中の食事ボーラス投与量を前記修正ボーラス投与量で置き換え、前記食事改定ボーラス投与量を前記改定ボーラス投与量に置き換えることと、
前記食事修正ボーラス投与量及び前記食事改定ボーラス投与量を使用した前記関数の前記出力に基づいて、前記インシュリンボーラス投与量として前記食事ボーラス投与量を設定することと、
を行う機能を含む機能を実行するよう動作可能である、請求項5に記載の非一時的なコンピュータ可読媒体。 - 前記プロセッサにより実行可能なプログラムコードを更に具現化し、前記プロセッサは前記プログラムコードの実行時に
修正ボーラスが送出される前記指示を決定することに応じて、前記インシュリンボーラス投与量に基づいてボーラスの送出を実行することと、
を行う機能を含む機能を実行するよう動作可能である、請求項5に記載の非一時的なコンピュータ可読媒体。 - プロセッサと、
プログラムコードと、人工膵臓アプリケーションを記憶し、前記人工膵臓アプリケーションに関連したデータを記憶するように動作可能であり、前記プログラムコード及び前記人工膵臓アプリケーションは前記プロセッサにより実行可能であるメモリと、
前記人工膵臓アプリケーションにより使用可能な、又は前記人工膵臓アプリケーションにより生成される情報を含んだ信号を受信し送信するように動作可能である送受信器と、
を備え、
前記プロセッサは前記人工膵臓アプリケーションの実行時にインシュリンの送出を制御するよう動作可能であり、また、
幾つかの血糖測定値を取得することと、
前記幾つかの血糖測定値中の最新の血糖測定値に基づいて修正ボーラス投与量を計算することと、
ある期間中の前記幾つかの血糖測定値から血糖値の変化率を求めること、
求めた前記変化率及び前記最新の血糖測定値を使用して改定ボーラス投与量を計算することと、
前記修正ボーラス投与量及び前記改定ボーラス投与量に対して関数を適用することと、
前記関数の出力に基づいて最終インシュリン値を求めることと、
求めた前記最終インシュリン値を使用してインシュリンボーラス投与量を設定することと、
設定された前記インシュリンボーラス投与量に従ってインシュリンの送出を実行することと、
を行う機能を含む機能を実行するよう動作可能である、装置。 - ユーザへ取り外し可能なように装着可能なポンプ機構と、
インシュリンを収容するよう動作可能であり、前記ポンプ機構に流動的に接続されたリザーバと、
を更に備え、
前記ポンプ機構は前記プロセッサに通信可能に接続され、
前記プロセッサからの実行信号に応答して前記設定されたインシュリンボーラス投与量に従ってインシュリンを前記リザーバから排出するよう動作可能である、
請求項8に記載の装置。 - 前記プロセッサは前記幾つかの血糖測定値を取得する際に、
前記送受信器から前記幾つかの血糖測定値中のそれぞれの血糖測定値を含む信号を受信することと、
前記各血糖測定値を前記メモリに記憶することと、
を行うよう動作可能である、請求項8に記載の装置。 - 前記プロセッサは、設定された前記インシュリンボーラス投与量に従ったインシュリン送出の実行時に、
医療機器による受信のために前記送受信器を介して制御信号を送信し、前記制御信号は医療機器により排出されるべきインシュリンの量を示すよう動作可能である、
請求項8に記載の装置。 - 前記プロセッサへ通信可能に接続され、予め定義した時間間隔にて血糖値を測定するように動作可能である血糖センサを更に備え、前記血糖センサは前記幾つかの血糖測定値を提供する、請求項8に記載の装置。
- 前記プロセッサは前記修正ボーラス投与量の計算時に、
前記最新の血糖測定値と目標血糖値との差を求めることと、
パーソナライズされたインシュリン値を提供するために求めた前記差に対してインシュリン感度因子を適用することと、
前記パーソナライズされたインシュリン値に対してインシュリン調整因子を適用することと、
を行うよう動作可能である、請求項8に記載の装置。 - 前記プロセッサは、前記改定ボーラス投与量の計算時に、
時間パラメータの表にアクセスすることと、
前記最新の血糖測定値に対する予測されたユーザ応答時間に基づいて時間パラメータを選択することと、
前記時間パラメータを求めた前記変化率に適用することと、
を行うよう動作可能である、請求項8に記載の装置。 - 前記プロセッサは、前記改定ボーラス投与量の計算時に、
前記最新の血糖測定値を取得することと、
求めた変化率因子を使用して前記最新の血糖測定値を修正し、求めた前記変化率因子は求めた前記変化率及び時間パラメータから生成されることと、
修正された前記最新の血糖測定値と目標血糖値との差を求めることと、
前記改定ボーラス投与量を提供するために求めた前記差に対してインシュリン感度因子を適用することと、
を行うよう動作可能である、請求項8に記載の装置。 - 前記プロセッサは、前記人工膵臓アプリケーションの実行時に、
食事ボーラスの指示が出力されるか、又は修正ボーラスの指示が出力されるかを決定することと、
食事ボーラスが送出されることに応じて、炭水化物の量を取得することと、
炭水化物のグラム数に対するインシュリンの単位数を示すインシュリン/カーボ比値を取得することと、
取得された前記炭水化物の量及び前記インシュリン/カーボ比値を使用して食事パラメータを生成することと、
前記食事パラメータを前記修正ボーラス投与量に加算することにより食事修正ボーラス投与量を生成することと、
前記食事パラメータを前記改定ボーラス投与量に加算することにより食事改定ボーラス投与量を生成することと、
前記関数を適用する前に、食事ボーラス投与量を前記修正ボーラス投与量で置き換え、前記食事改定ボーラス投与量を前記改定ボーラス投与量に置き換えることと、
前記関数の前記出力に基づいて前記インシュリンボーラス投与量として前記食事ボーラス投与量を設定することと、
を行うよう動作可能である、請求項8に記載の装置。
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