JP6479475B2 - 薬剤投与量情報を決定するための方法及び装置 - Google Patents
薬剤投与量情報を決定するための方法及び装置 Download PDFInfo
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Description
・2mg/dL/分≦検体変化率 → 勧告投与量20%増、
・1mg/dL/分≦検体変化率<2mg/dL/分 → 勧告投与量10%増、
・−1mg/dL/分≦検体変化率<1mg/dL/分 → 勧告投与量無修正、
・−2mg/dL/分≦検体変化率<−1mg/dL/分 → 勧告投与量10%減、
・検体変化率≦−2mg/dL/分 → 勧告投与量20%減、
が適用される。
・(d/dt)g(t) = ((p1 + SI・X(t))g(t)) + (p1・Gb) - (p3・um(t)),
・(d/dt)X(t) = p2・(I(1) - Ib - X(t)),
・(d/dt)I(t) = -(p4・I) + ui(t),
と書かれる、「男性におけるブドウ糖許容量を制御する要因の生理学的評価、静脈内ブドウ糖に対する応答によるインスリン感受性及びベータ細胞ブドウ糖感受性の測定(Physiological Evaluation of Factors Controlling Glucose Tolerance in Man, Measurement of Insulin Sensitivity and Beta-cell Glucose Sensitivity from the Response to Intravenous Glucose)」,J, Clin, Invest.,The American Society for Clinical Investigation, Inc.,1981年12月,第68巻,p.1456〜1467に説明されている、バーグマンミニマルモデルの拡張である。ここで、ブドウ糖状態、有効インスリン状態及び血漿インスリン状態:g,X及びIは時間Iにかけて推定され、追跡される。時間が過ぎる内での食事及びインスリンの存在:um及びuiは系に対する未知の擾乱と見なされる。生理学的パラメータ:pl, pl, pJ, p4, SIは。また定常状態におけるブドウ糖値及びインスリン値:Gb及びIbも、以前の母集団データを用いて設定することができ、あるいは、設定し、次いで適切な適合アルゴリズムを用いて時間の経過にわたる適合を可能にすることができる。上記技術文献はその全体が本明細書に含められる。
・予測アラーム後の固定時点(例えば30分)、
・予測アラーム後のユーザ設定時点(例えば45分)、
・検体値が閾検体レベルを横切ったであろうという受信器デバイスの予測に基づく時点(例えば23分)、及び/または
・設定可能な予測アラームの所定の時間に等しい時点(例えば、10分、20分及び/または30分)、
にユーザに送られ得る。
101 センサ
102 データ処理ユニット(センサエレクトロニクス)
103 通信リンク
104 主受信器ユニット
105 データ処理端末
106 副受信器ユニット
110 一体化センサ/センサエレクトロニクスアセンブリ
210 皮膚表面
211 体表パッチ素子
220 読取器/受信器ユニット
222 ディスプレイ
240 信号
250 検体センサ
260 データ処理モジュール/端末
270 リモート端末
301 血糖検査ストリップインターフェース
302 RF受信器
303 入力
304 温度検出部
305 クロック
306 電源
307 処理/格納部
308 電力変換/監視部
309 受信器シリアル通信部
310 出力/ディスプレイ
Claims (18)
- 受信器ユニットにおいて実行される方法において、
生体内検体センサからユーザの検体レベルに関するデータを、1つ以上のプロセッサが受け取るステップ、
前記受け取られた検体データから前記ユーザの検体レベルを、前記1つ以上のプロセッサが決定するステップ、
前記受け取られた検体データ及び以前の検体データを用いて前記ユーザの前記検体レベルの変化率を、前記1つ以上のプロセッサが決定するステップ、
前記検体レベルの前記決定された変化率に対応する少なくとも1つのビンに前記ユーザの前記検体レベルに関する前記検体データを、前記1つ以上のプロセッサが分別するステップ、
前記ユーザの前記決定された検体レベルに基づいて、ボーラスである勧告インスリン投与量を、前記1つ以上のプロセッサが決定するステップ、
前記少なくとも1つのビンへの前記検体データの前記分別に基づいて、前記勧告インスリン投与量を、前記1つ以上のプロセッサが修正するステップ、並びに
間質液中検体レベルと血中検体レベルの間の時間差に基づいて前記勧告インスリン投与量を、前記1つ以上のプロセッサが修正するステップ、
を含むことを特徴とする方法。 - 前記勧告インスリン投与量及び前記修正勧告インスリン投与量の一方または両方を前記ユーザに、前記1つ以上のプロセッサが提示するステップ、
をさらに含むことを特徴とする請求項1に記載の方法。 - 2mg/dL/分≦[前記検体レベルの前記変化率]であれば、前記修正勧告インスリン投与量が前記勧告インスリン投与量の少なくとも20%の増加を含むことを特徴とする請求項1または2に記載の方法。
- 1mg/dL/分≦[前記検体レベルの前記変化率]<2mg/dL/分であると決定されれば、前記修正勧告インスリン投与量が勧告インスリン投与量の少なくとも10%の増加を含むことを特徴とする請求項1または2に記載の方法。
- −1mg/dL/分≦[前記検体レベルの前記変化率]<1mg/dL/分であると決定されれば、または前記検体レベル変化率が決定され得なければ、前記修正勧告インスリン投与量が無修正の前記勧告インスリン投与量を含むことを特徴とする請求項1または2に記載の方法。
- −2mg/dL/分≦[前記検体レベルの前記変化率]<−1mg/dL/分であると決定されれば、前記修正勧告インスリン投与量が前記勧告インスリン投与量の少なくとも10%の減少を含むことを特徴とする請求項1または2に記載の方法。
- [前記検体レベルの前記決定された変化率]≧−2mg/dL/分であれば、前記修正勧告インスリン投与量が、前記勧告インスリン投与量の少なくとも20%の減少を含むことを特徴とする請求項1または2に記載の方法。
- 前記決定された変化率及び以前の変化率の少なくとも一方を用いて所定の将来時点に対する検体レベル変移を、前記1つ以上のプロセッサが決定するステップ、
前記所定の将来時点に対する前記決定された検体レベル変移に基づいて前記勧告インスリン投与量を、前記1つ以上のプロセッサが修正するステップ、及び
前記ユーザに前記修正勧告インスリン投与量を、前記1つ以上のプロセッサが提示するステップ、
をさらに含むことを特徴とする請求項1から7のいずれか1項に記載の方法。 - 前記受け取られた検体データ、前記決定された変化率、ユーザのインスリン感受性及び検体レベル目標値の内の少なくとも1つを用いて所定の将来時点に対する検体レベル変移を、前記1つ以上のプロセッサが決定するステップ、
前記所定の将来時点に対する前記決定された検体レベル変移に基づいて前記勧告インスリン投与量を、前記1つ以上のプロセッサが修正するステップ、及び
前記ユーザに前記修正勧告インスリン投与量を、前記1つ以上のプロセッサが提示するステップ、
をさらに含むことを特徴とする請求項1から7のいずれか1項に記載の方法。 - 薬物投与デバイスに前記修正勧告インスリン投与量を、前記1つ以上のプロセッサから、前記1つ以上のプロセッサが送信するステップ、
をさらに含むことを特徴とする請求項1から9のいずれか1項に記載の方法。 - 前記時間差が検体センサにともなう較正係数に基づいて決定されることを特徴とする請求項1から10のいずれか1項に記載の方法。
- 傾向感度に基づいて前記勧告インスリン投与量を前記1つ以上のプロセッサが修正するステップをさらに含むことを特徴とする請求項1から11のいずれか1項に記載の方法。
- 受信器ユニット装置において、
ユーザインターフェース、
1つ以上のプロセッサ、及び
前記1つ以上のプロセッサによって実行されると、生体内検体センサからのユーザの検体レベルに関する検体データの受取り、前記受け取られた検体データからの前記ユーザの検体レベルの決定、前記受け取られた検体データ及び以前の検体データを用いる前記ユーザの前記検体レベルの変化率の決定、前記検体レベルの前記決定された変化率に対応する少なくとも1つのビンへの前記ユーザの前記検体レベルに関する前記検体データの分別、前記ユーザの前記決定された検体レベルに基づく、ボーラスである勧告インスリン投与量の決定、前記少なくとも1つのビンへの前記検体データの前記分別に基づく前記勧告インスリン投与量の修正、並びに、間質液中検体レベルと血中検体レベルの間の時間差に基づく前記勧告インスリン投与量の修正、を前記1つ以上のプロセッサに行わせる、命令を格納しているメモリ、
を備えることを特徴とする装置。 - 前記メモリが、前記1つ以上のプロセッサによって実行されると、前記勧告インスリン投与量及び前記修正勧告インスリン投与量の一方または両方の前記ユーザインテーフェース上の提示を前記1つ以上のプロセッサに行わせる、命令を格納していることを特徴とする請求項13に記載の装置。
- 前記メモリが、前記1つ以上のプロセッサによって実行されると、前記決定された変化率及び以前の変化率の少なくとも一方を用いる所定の将来時点に対する検体レベル変移の決定、前記所定の将来時点に対する前記決定された検体レベル変移に基づく前記勧告インスリン投与量の修正、及び前記修正勧告インスリン投与量の前記ユーザインターフェース上の提示、を前記1つ以上のプロセッサに行わせる、命令を格納していることを特徴とする請求項13または14のいずれか1項に記載の装置。
- 前記メモリが、前記1つ以上のプロセッサによって実行されると、前記受け取られた検体データ、前記決定された変化率、ユーザのインスリン感受性及び検体レベル目標値の内の少なくとも1つを用いる所定の将来時点に対する検体レベル変移の決定、前記所定の将来時点に対する前記決定された検体レベル変移に基づく前記勧告インスリン投与量の修正、及び前記ユーザインターフェース上の前記修正勧告インスリン投与量の提示、を前記1つ以上のプロセッサに行わせる、命令を格納していることを特徴とする請求項13または14に記載の装置。
- 前記メモリが、前記1つ以上のプロセッサによって実行されると、検体センサにともなう較正係数に基づく前記時間差の決定を前記1つ以上のプロセッサに行わせる、命令を格納していることを特徴とする請求項13から16のいずれか1項に記載の装置。
- 前記メモリが、前記1つ以上のプロセッサによって実行されると、傾向感度に基づく前記勧告インスリン投与量の修正を前記1つ以上のプロセッサに行わせる、命令を格納していることを特徴とする請求項13から17のいずれか1項に記載の装置。
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- 2012-12-29 EP EP19200742.5A patent/EP3662965B1/en active Active
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EP2797660B1 (en) | 2019-10-02 |
US20130184547A1 (en) | 2013-07-18 |
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EP4249034A2 (en) | 2023-09-27 |
AU2012362155A1 (en) | 2014-01-23 |
EP2797660A1 (en) | 2014-11-05 |
AU2021266271A1 (en) | 2021-12-09 |
US20190192071A1 (en) | 2019-06-27 |
WO2013102158A1 (en) | 2013-07-04 |
AU2019201453B2 (en) | 2021-08-12 |
AU2019201453A1 (en) | 2019-03-21 |
EP2797660A4 (en) | 2015-08-19 |
EP4249034A3 (en) | 2023-11-15 |
CA2840644A1 (en) | 2013-07-04 |
JP2015505264A (ja) | 2015-02-19 |
EP3662965A1 (en) | 2020-06-10 |
AU2021266271B2 (en) | 2024-01-11 |
AU2024202384A1 (en) | 2024-05-02 |
DK3662965T3 (da) | 2024-07-22 |
AU2017228654A1 (en) | 2017-10-05 |
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