JP6876046B2 - インスリン・デリバリ量の調節 - Google Patents
インスリン・デリバリ量の調節 Download PDFInfo
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- JP6876046B2 JP6876046B2 JP2018530882A JP2018530882A JP6876046B2 JP 6876046 B2 JP6876046 B2 JP 6876046B2 JP 2018530882 A JP2018530882 A JP 2018530882A JP 2018530882 A JP2018530882 A JP 2018530882A JP 6876046 B2 JP6876046 B2 JP 6876046B2
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- insulin
- blood glucose
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Description
35 U.S.C.§119(e)に準拠して、糖尿病管理システムにおける目標血糖値を変更するためのシステム及び方法(SYSTEMS AND METHODS FOR CHANGING TARGET GLUCOSE VALUES IN DIABETES MANAGEMENT SYSTEM)と題する米国特許仮出願第 62/278,978 号(「’978 仮出願」)の出願日である 2016 年 1 月 14 日、及びインスリン・デリバリ量を調節するためのシステムと方法(SYSTEMS AND METHODS FOR ADJUSTING INSULIN DELIVERY RATES)と題する米国特許仮出願第 62/340,470 号(「’470仮出願」)の出願日である 2016 年 5 月 23 日について、ここで優先権の利益を主張する。「’978仮出願」及び「’470仮出願」で開示された全体は、本明細書に援用される。
連続グルコース・モニタリング・データ(CGM)及び他のユーザ固有の用量パラメータ(例えば、ベースライン基礎量(BBR)、インスリン効果値(ISF)及び糖質/インスリン比(CR))、に基づいて、自動的に基礎量を調節する、閉ループ又はハイブリッド閉ループ・モード;
より長い時間期間にわたる異なる時間ブロックに対するユーザ固有の用量パラメータ(例えば、BBR、ISFs 及び CRs)を更新するために、血糖モニタ(BGM)データを使用することができるモード;
患者がインスリン・ポンプを使用する治療プログラムをマニュアルで制御することを必要とするマニュアル・モード;並びに
インスリン・ペン又は注射器を使用して PWD が注射するための用量を推奨するアドバイザリ・モード;
を含むことができる。デリバリ・モードにまたがって機能する最適化されたコントロール・パラメータを決定することにより、本明細書で提供されるシステム及び方法は、PWDが異なるデリバリ・モードに切り替える場合でも優れたアナライト・コントロールを提供することができる。例えば、本明細書で提供される方法及びシステムは、もし、連続グルコース・モニタが誤動作するか、又は前記システムが連続データへのアクセスを失う場合に、BBR から離れた基礎インスリン・デリバリを調節するハイブリッド閉ループ・デリバリ・モードから強制的に切り替えて離れるようにすることができる。ある場合では、システムがアドバイザリ又はマニュアル・モードにあるときに、データを収集して、PWDがハイブリッド閉ループ・システムに切り替えるための準備としてコントロール・パラメータを最適化することができる(たとえば、PWDが連続グルコース・モニタ(CGM)及び/又はインスリン・ポンプの使用を始める準備をする。)。
図1は、インスリン用のポンプ・アセンブリ 15 及び連続グルコース・モニタ 50 を含む、糖尿病管理システム 10 の例を示している。図示のように、連続グルコース・モニタ 50 は、ポンプ・アセンブリ 15 と無線通信している。ある場合には、連続グルコース・モニタは、ポンプ・アセンブリ 15 と有線通信することができる。図示していないある場合では、連続グルコース・モニタをインスリン・ポンプ・アセンブリに組み込むことができる。図示のように、ポンプ・アセンブリ 15 は、ポンプ・アセンブリ 15 の一部を形成する再使用可能なポンプ・コントローラ 200 を含むことができる。ある場合では、再使用可能なポンプ・コントローラ 200 は、1つ以上の基礎量を決定するように適合される。ある場合では、連続グルコース・モニタ 50 は、ポンプ・アセンブリ 15 に基礎デリバリ量を伝達するように適合されたコントローラとして機能することができる。
図2は、図1に示すシステム 10 などの糖尿病管理システムの動作のための例示的な方法 202 を示す。図2に示すように、システムは、ブロック 251 及び 252 でのユーザ入力などの、ユーザ入力を受け取ることができる。そして、このユーザ入力を、ブロック 261 で使われる、若しくは決定される1つ以上の目標血糖値、及び/又はブロック 262 で使われる、若しくは決定される1つ以上のユーザ固有の用量パラメータなどの、初期設定を提供するのに使用することができる。ある場合では、ブロック 251 及び 252 におけるユーザ入力を、PWD、PWD の介護者、又は医療専門家は入力することができる。ある場合では、ブロック 251 及び 252 におけるユーザ入力を、スマートフォンのようなモバイル・コンピューティング・デバイス 60 に入力することができる。ユーザ固有の用量パラメータに基づいて、方法 202 は、ブロック 263 において、複数の基礎インスリン・デリバリ・プロファイル及び/又は量を生成することができる。ある場合では、複数の基礎インスリン・デリバリ・プロファイル及び/又は量は、1つ以上のベースライン基礎量に基づくことがある。ブロック 264 において、前記方法 202 は、ブロック 271 で生成されたような、連続グルコース・モニタ(CGM)又は血糖メータ(BGM)からの血糖データを使用して、(ブロック 261 からの目標血糖値などの)1つ以上の目標血糖値から予測される将来の血糖値の変動に基づいて、ブロック 263 で生成された各基礎デリバリ・プロファイル又は量を分析することができる。ある場合では、血糖データは図1のシステム 10 の連続グルコース・モニタ 50 からのものであってもよい。以下に説明するように、各生成された基礎デリバリ・プロファイル又は量についての予測された血糖値は、ユーザ固有の用量パラメータ(例えば、ブロック 262 で決定される、又は、決定されない場合、調節された用量パラメータ)を使用することができる。更に、予測血糖値は、以前のインスリン用量及び/又は食物摂取(例えば、摂取された糖質の推定値)に関する入力を含むことができる。ある場合では、ブロック 264 で使用される予測血糖値は、運動、病気、又はPWDの血糖値に影響を及ぼし得る他の身体的状態を示すデータを考慮することができる。ブロック 264 で実行される予測血糖レベルの変動の分析に基づいてブロック 263 で生成された基礎デリバリ・プロファイル又は量を、ブロック 265 で選択することができる。そして、ブロック 272 において、システムは、その選択された基礎デリバリ・プロファイル又は量に従って、PWD に、選択された期間の間、基礎インスリンをデリバリすることができる。ある場合では、図1のシステム 10 のポンプ・アセンブリ 15 をインスリンをデリバリするのに使用することができる。ある場合では、ブロック 263、264、265 及び 272 を、システム 10 の再使用可能なポンプ・コントローラ 200 によってそれぞれ行うことができる。ある場合では、ブロック 271、263、264 及び 265 をすべて、システム 10 の連続グルコース・モニタ 50 によって、再使用可能なポンプ・コントローラ 200 に送られた選択されたデリバリ量に関するデータを使って、実行することができる。ある場合では、ブロック 251、252、261、262、263、264 及び 265 のすべてを、モバイル・コンピューティング・デバイス 60 から再使用可能なポンプ・コントローラ 200 に送られた選択されたデリバリ量に関するデータを使って、図1のシステム 10 のモバイル・コンピューティング・デバイス 60 上で実行することができる。
本明細書で提供されるシステム及び方法は、基礎インスリン・デリバリ量及び任意選択的にボーラス・インスリン・デリバリ量を決定するために、1人の PWDについて複数のユーザ固有の用量パラメータを使用することができる。ある場合では、最初のユーザ固有の投与量パラメータを医療専門家が設定することができる。ある場合では、ユーザ(例えば、PWD、PWDの介護者、又は医療専門家)が入力したデータを使用して、1つ以上のユーザ固有の用量パラメータを推定することができる。例えば、図2は、ブロック 252 において、ユーザが少なくとも1つの用量パラメータを入力する方法を示す。
TDD [u/日] = 2×TDB [u/日] = 1800 / ISF [mg/dL/u又は[mmol/u] = 400 / CR [g/u] = 48時間/日×BBR [u/時間]。
ある場合では、ISF、CR及びBBRを推定するために使用される数式は、BBR、ISF及びCR間の非線形関係を使用できる。
初期目標血糖値を、任意の適切な技術を用いて設定又は決定することができる。ある場合では、目標血糖値を、本明細書で提供されるシステム又はデバイス内のメモリ上に予めプログラムすることができる。ある場合では、変更しないシステムに予めプログラムされた単一の目標血糖値が存在することがある。ある場合では、昼間時間セグメントは、それぞれ予めプログラムされた目標血糖値を有することができる。ある場合では、ユーザは、1つ以上の目標血糖値をプログラムすることができ、目標血糖値を異なる時間期間について異なるように設定することができる。ある場合では、ユーザは、PWDの典型的な睡眠スケジュール、運動スケジュール及び/又は食事スケジュールをプログラムすることができる。本明細書で提供される方法及びシステムは、睡眠時間に対してはより低い目標血糖値を、及び食事時間及び/又は運動時間の辺りではより高い目標血糖値を選択することができる。ある場合では、前記システムを使用する PWD の前の PWD に関する過去の連続グルコース・モニタ・データを使用して(特定の昼間時間期間又は 1 日全体のいずれかの)初期目標血糖値を設定することができる。ある場合では、本明細書で提供される方法は、本明細書で提供される方法及びシステムが、BBR 以外の量でインスリンをデリバリすることから、PWDの血糖変動データを検出して、1つ以上の初期目標血糖値を設定することが可能になるのに先立つ準備的な時間期間(例えば、少なくとも 24 時間、少なくとも 48 時間、少なくとも 5 日間又は少なくとも 10 日間)に、PWD に CGM を装着させることができる。
本明細書で提供される方法及びシステムは、ある場合では、複数のデリバリ・モードを含むことができる。ある場合では、本明細書で提供される方法及びシステムは、1つ以上の血糖測定デバイス又は方法を使用して血糖の存在をモニタし、インスリンの投与をコントロール又はモニタし、動作モードに関わらずユーザ固有の用量パラメータを決定及び/又は更新することができる。例えば、可能な動作モードは:
・連続グルコース・モニタリング・データ(CGM)及び他のユーザ固有の用量パラメータ(例えば、BBR、ISF 及び CR)に基づいて、自動的に基礎量を調節する、閉ループ又はハイブリッド閉ループ・モード;
・より長い時間期間にわたる異なる時間ブロックに対するユーザ固有の用量パラメータ(例えば、BBR、ISFs 及び CR)を更新するために、血糖モニタ(BGM)データを使用することができるモード;
・患者がインスリン・ポンプを使用する治療プログラムをマニュアルで制御することを必要とするマニュアル・モード;並びに
・インスリン・ペン又は注射器を使用してユーザが注射するための用量を推奨するアドバイザリ・モード;
を含むことができる。デリバリ・モードにまたがって機能する最適化されたコントロール・パラメータを決定することにより、本明細書で提供されるシステム及び方法は、PWDが異なるデリバリ・モードに切り替える場合でも優れた血糖コントロールを提供することができる。例えば、本明細書で提供される方法及びシステムは、もし、連続グルコース・モニタが誤動作するか、又は前記システムが連続データへのアクセスを失う場合に、BBR から離れた基礎インスリン・デリバリを調節するハイブリッド閉ループ・デリバリ・モードから強制的に切り替えて離れるようにすることができるが、依然として個別化した ISF 及び CR を補正及び/又は食事ボーラス量を計算するのに使用することができる。ある場合では、システムがアドバイザリ又はマニュアル・モードにあるときに、データを収集して、PWDがハイブリッド閉ループ・システムに切り替えるための準備として(たとえば、PWDが連続グルコース・モニタ(CGM)及び/又はインスリン・ポンプの使用を始める準備をする)、コントロール・パラメータを最適化することができる。ある場合では、BBR から離れた基礎インスリン・デリバリを調節する閉ループ・デリバリ・モードを、十分な量の現在の血糖データが利用可能になるまで使用することができないことがある(例えば、図2のブロック 263、264、265 及び 272 で発生することがある複数のプロファイルに従う、インスリン・デリバリは、図2のブロック 271 で十分な CGM 及び/又はBGM データが収集されるまでは発生することがない)。ある場合では、本明細書で提供されるシステム及び方法は、十分な血糖データが利用可能でないときに、各昼間時間期間のBBR量でインスリンをデリバリすることができる。ある場合では、本明細書で提供される方法及びシステムは、所定の時間期間内に連続グルコース・モニタから所定の数の認証された血糖測定値が存在するかどうか(例えば、直近の 20 分内に、少なくとも2つの認証された血糖データ・ポイント)に基づいて、開ループ・モードと閉ループ・モードとの間で切り替わることができる。
本明細書で提供されるシステム及び方法は、1つ以上の保存されたユーザ固有の用量パラメータ(例えば、BBR、ISF、CR)、1つ以上の目標血糖、及び/又は血糖データに基づいて基礎インスリン・デリバリを自動化することができる。図2に示された例示的な方法は、基礎インスリン・デリバリを自動化する例示的なプロセスをブロック 263、264、265 及び 272 として示す。本明細書で提供される方法及びシステムは、将来の時間期間にわたる複数の可能性のある基礎インスリン・デリバリ・プロファイル及び/又は量について、その将来の時間期間についての複数の将来の血糖レベルを予測し、並びに複数の可能性のある基礎インスリン・デリバリ・プロファイル及び/又は量のうちのどれが1つ以上の目標血糖値に近似する将来の血糖値を生成するかを決定する、モデル予測コントロール・システムを使用することができる。複数の可能性のある基礎インスリン・デリバリ・プロファイル又は量を評価しないで基礎インスリン・デリバリを調節するだけのコントロール・アルゴリズムと比較して、本明細書で提供される方法及びシステムは、改善されたコントロールを生みだすことができる。ある場合では、本明細書で提供される方法及びシステムは、将来の血糖値を、将来に向かって少なくとも2時間、少なくとも3時間、少なくとも4時間、又は少なくとも5時間予測することができ、BBR と比べて基礎インスリン・デリバリを増加又は減少させることの長期的な影響を適切に考慮することができる。量又はプロファイルが選択された後、その量又はプロファイルが、新しい基礎インスリン・デリバリ・プロファイル又は量を選択するプロセスにおいて1つ以上の工程を繰り返す前に、所定のデリバリ時間期間、デリバリされることがある(例えば、図2のブロック 272)。ある場合では、この所定のデリバリ時間期間は、生成された基礎インスリン・デリバリ・プロファイル及び/又は量の時間の長さよりも短く、将来の血糖値を推定する時間よりも短くてもよい。したがって、本明細書で提供される方法及びシステムは、最近の血糖データに基づいて基礎インスリン・デリバリを動的に変更することができる。例えば、ブロック 263 で基礎デリバリ・プロファイルを生成することが 15 分毎に繰り返されてもよく、ブロック 264 で評価される時間期間は 4 時間のウィンドウであってもよく、基礎デリバリ・プロファイルについて解析する新しい 4 時間のウィンドウは 15 分毎に生成される。このように、各デリバリ動作は、その動作だけではなく、将来の 4 時間についての血糖レベルに影響を与えるために、どのようにして先のデリバリ動作が決定されるかについての予測にも基づいている。
可能性のある基礎インスリン・デリバリ・プロファイル及び/又は量を、任意の適切な技術を用いて生成することができる。ある場合では、生成されたプロファイル又は量のそれぞれは、ユーザ固有の用量パラメータに基づくことがある。ある場合では、生成されたプロファイル又は量のそれぞれは、特定の昼間時間期間に特有の1つ以上のユーザ固有の用量パラメータに基づくことがある。ある場合では、生成されたプロファイル又は量のそれぞれは、図2のブロック 263 に示すように、保存されたベースライン基礎量(BBR)との所定の関係に基づいている。ある場合では、生成された分析のためにプロファイル及び/又は量は、少なくとも 2 時間、少なくとも 3 時間、又は少なくとも 4 時間にわたってある。ある場合では、生成されたプロファイルは、1 日(例えば、24 時間)以下にわたってある場合もある。ある場合では、生成されたプロファイル又は量のそれぞれは、1つ以上の保存された BBR の所定の倍数又は分数に基づく基礎インスリン・デリバリ量を含む。ある場合では、複数のインスリン・デリバリ・プロファイル及び/又は量は、複数の昼間時間ブロック固有の BBR に基づく。ある場合では、生成された基礎インスリン・デリバリ・プロファイルのそれぞれは、1つ以上の保存された BBR の整数倍のような(例えば、0xBBR、1xBBR、2xBBR 及び 3xBBR)BBRの比率でインスリンをデリバリする。ある場合では、インスリン・デリバリ・プロファイルは、1つ以上の保存された BBRの分数及び倍数の両方を含み得る比率でインスリンをデリバリすることができる(例えば、0xBBR、0.5xBBR、1xBBR、1.5xBBR 及び 2xBBR)。ある場合では、生成された基礎インスリン・デリバリ・プロファイルのそれぞれは、0 から 3 の倍数又は分数のみでインスリンをデリバリする。ある場合では、生成された基礎インスリン・デリバリ・プロファイルのそれぞれは、0 から 2 の倍数又は分数のみでインスリンをデリバリする。ある場合では、複数の生成された基礎デリバリ・プロファイルは、BBR の 0%、BBR の 100%、又は BBR の 200% における基礎インスリンのデリバリのみを含み得る。ある場合では、各生成された基礎デリバリ・プロファイルのパーミュテイションは、固定した将来の時間期間を有する。ある場合では、パーミュテイションについての異なる将来の時間期間は、異なる長さを有することがある。ある場合では、生成される評価のための基礎デリバリ・プロファイル又は量の数は、100 未満、50 未満、30 未満、25 未満、又は20 未満である。保存された BBR に基づいて評価されたプリセット・パーミュテイションの数を制限することによって、本明細書で提供される方法及びシステムは、基礎デリバリ量を決定するコントローラを作動させるために使用されるエネルギー消費を制限することができる。
再び図2について述べると、複数の生成された基礎インスリン・デリバリ・プロファイル及び/又は量の評価は、将来の血糖レベルを予測し、それらを目標血糖値と比較することを含む。ある場合では、複数のパーミュテイションを生成して分析することができる。
本明細書で提供されるシステム及び方法は、任意の適切な生理モデルを使用して、将来の血糖値を予測することができる。ある場合では、本明細書で提供される方法及びシステムは、過去及び現在の糖質、インスリン及び血糖値を使用して将来の血糖値を予測することができる。
B は後方シフト演算子であり、
ts はサンプリング時間(例えば、GCM は 5 分毎のサンプリング時間間隔を使うことができる)である。
上記の式から、第2項は、インスリンによる血糖値への影響を表すことができる:
上記の式から、第3項は、撹乱による血糖値への影響を表すことができる(例えば、AR2 撹乱モデル):
よって、
ある実施形態では、時刻 (t) (IOB_Dt) での決定 IOB を以下の数学的過程に従って計算することができる:
についての式に代入すると以下となる。
ある実施形態では、時刻 (t) (IOB_At) での作用 IOB を以下の数学的過程に従って計算することができる:
以下のように表わすことができる。
図1について戻って述べると、連続グルコース・モニタ 50 及び血糖メータ 70 は、共にシステム 10 に血糖データを提供することができる。しかしながら、血糖データは不正確のこともある。ある場合では、連続グルコース・モニタ 50 を、規則的又は不規則な間隔(例えば、3 日毎、5 日毎、7 日毎又は 10 日毎)で、交換することができる(又はセンサ・シャフト 56 を交換することができる)。ある場合では、血糖メータ 70 からのデータを、規則的又は不規則な間隔(例えば、3 時間毎、6 時間毎、12 時間毎、毎日など)で、連続グルコース・モニタ 50 を校正するために使用することができる。ある場合では、本明細書で提供されるシステム及び方法は、連続グルコース・モニタ 50 からのデータに基づいて、及び/又は定期的に、連続グルコース・モニタ 50 を変更すること、又は血糖メータ 70 を使用する連続グルコース・モニタ 50 を校正することをユーザに思い出させることができる。例えば、インスリン・デリバリのパターンが、以前に予測されたインスリン・デリバリのパターンから大きく変化する場合、連続グルコース・モニタ 50 をメンテナンスし及び/又は交換する必要があることを示すことがある。
本明細書で提供される方法及びシステムは、基礎デリバリ・プロファイルについて血糖を予測することによって、及び目標血糖値から予測血糖値の変動指数を計算することによって、将来の各基礎デリバリ・プロファイルを評価することができる。それから、本明細書で提供される方法及びシステムは、最も低い変動指数に対応する基礎量デリバリ動作のプロファイルを選択することができる。変動指数は、異なるタイプの変動を重み付けするために、さまざまな異なる数式を使用することができる。変動指数はコスト関数とすることができる。ある場合では、本明細書で提供される方法及びシステムは、複数の昼間時間セグメントの目標血糖値からの予測血糖値の差の二乗を合計するコスト関数を使用することができる。本明細書で提供される方法及びシステムは、任意の適切なコスト関数を使用することができる。ある場合では、コスト関数は、各予測血糖値と各目標血糖値との間の差の絶対値を合計することができる。ある場合では、本明細書で提供される方法及びシステムで使用されるコスト関数は、その差の二乗を使用することができる。ある場合では、本明細書で提供される方法及びシステムで使用されるコスト関数は、各予測血糖レベルの対数と目標血糖の対数との間の差の二乗を使用することができる。ある場合では、本明細書で提供される方法及びシステムで使用されるコスト関数は、低血糖イベントのリスクを低減するために、目標血糖よりも低い血糖値により高いコストを割り当てることができる。ある場合では、損失について最も低い値を有するプロファイルを選択することができる。ある場合では、本明細書で提供されるコスト関数は、以前に投与された基礎量を維持する、及び/又はベースライン基礎量をデリバリするプロファイルの方へ、選択されたプロファイルを追加的にバイアスをかける要素を含むことができ、このことによって、システムが基礎デリバリ・プロファイル又は量がブロック 265 で選択されるたびに、デリバリ量を変えることを防ぐことができる。ある場合では、コスト関数は、予測された高値よりも予測された低値に対してより高いコストを提供するために、値の対数の間の差を二乗することができる。
本明細書で提供される方法及びシステムは、それから、最低コスト関数値を生成する基礎プロファイル又は量を選択することができる。次に図2を参照すると、ブロック 272 において、インスリンは、ある時間量について選択されたプロファイルに従ってデリバリされ得る。ある場合では、前記時間量は所定の時間量である。ある場合では、所定の時間量は、推定された将来の血糖値についての時間範囲、及び選択された基礎デリバリ・プロファイルの時間の長さよりも短い。ある場合では、所定の時間量は、90 分以下、60 分以下、45 分以下、30 分以下、20 分以下、15 分以下、10 分以下又は 5 分以下である。前記時間期間の後、システムはブロック 263、264,265 及び 272 での動作を再び繰り返して、後の時間期間について基礎インスリンを選択してデリバリすることができる。
本明細書で提供される方法及びシステムは、ユーザ固有の用量パラメータを調節することができる。例えば、図2は、デリバリされた基礎インスリン量が BBR とは異なっている時間期間を検出するためのブロック 281 を含み、ブロック 262 において、ユーザ固有の用量パラメータを調節するために使うことができる。これらの更新されたユーザ固有の用量パラメータは、ブロック 263 で新しい基礎デリバリ・プロファイルを生成し、異なる基礎デリバリ・プロファイルを評価するためにブロック 264 で使用される。例えば、1.46U/時間のBBR(35U/日のTDBに結び付く)に対して、もし、検討中の昼間時間期間が 1 時間であり、最初の 45 分間に、インスリンが 2.92U/時間の量でデリバリされ(例えば、2xBBR)であり、最後の 15 分間のみが 1.46U/時間の量でデリバリされた(例えば、1xBBR)場合、関連する昼間時間期間(例えば、将来別の日の同じ時間、又は将来ある日の先行する昼間時間期間)についてのユーザ固有の用量パラメータを調節することができる。
本明細書で提供される方法及びシステムは、目標血糖値を調節することができる。例えば、図2に示されているシステムは、CGM 及び/又は BGM データ(例えば、図1の CGM50 及び/又は BGM 70 からのデータ)の変動を解析するためのブロック 283 を含むが、その後、ブロック 261 で目標血糖値を調節するために使用することができる。ある場合では、目標血糖値が昼間時間期間について設定される。ある場合では、目標血糖値の昼間時間期間は、少なくとも 15 分、少なくとも 30 分、少なくとも 1 時間又は少なくとも 2 時間である。ある場合では、目標血糖値を制限された範囲にすることができる。ある場合では、目標血糖値は、少なくとも 80mg/dL、少なくとも 90mg/dL、少なくとも 100mg/dL、少なくとも 110mg/dL、又は少なくとも 120mg/dLでなければならない。ある場合では、血糖目標は、200mg/dL 以下、180mg/dL 以下、160mg/dL 以下、140mg/dL 以下又は 125mg/dL 以下でなければならない。ある場合では、制限範囲は 100mg/dL と 160mg/dL との間である。次いで、これらの更新された目標血糖値をブロック 264 で使用して、異なる基礎デリバリ・プロファイルを評価することができる。
本明細書で提供される方法及びシステムは、経時的に基礎インスリン・デリバリを制御し、経時的にユーザ固有の用量パラメータを個別化するために、複数の昼間時間期間の基礎量のユーザ固有の用量パラメータ及び目標血糖値を調節することができる。例えば、図4は、本発明の様々な態様を表示するユーザ・インタフェースの様々な例(例えば、400、410、420 及び 430)を示す。
図5A及び図5Bは、図1に関して上述した例示的なポンプ・アセンブリ 15 についての追加的な詳細を提供する。図5Bは、例示的な再使用可能なポンプ・コントローラ 200 の詳細を示す。
・1日総インスリン基礎量の限度(例えば、最大単位数/日);
・様々な他の時間期間での基礎量の限度(例えば、最大基礎量/時、最大基礎量/6時間);
・インスリン効果値(例えば、mg/dL/インスリン単位の単位による);
・糖質比(例えば、g/インスリン単位の単位による);
・インスリン開始時間(例えば、分及び/又は秒の単位による);
・インスリン・オン・ボード継続時間(例えば、分及び/又は秒の単位による);
・基礎量プロファイル(例えば、インスリン単位/時間の単位で表わされる、平均基礎量又は1つ以上のセグメントでの基礎量プロファイル)
しかしながら、これらに限定されない。また、コントロール回路 240 は、ポンプ使用の履歴情報から導かれる以下のパラメータ:
・用量の記録;
・1日総1回用量の平均;
・1日総基礎1回用量の平均;
・1日総ボーラス1回用量の平均;
・1日食事ボーラス量に対する1日補正ボーラス量の比率;
・1日補正ボーラス量;
・1日総1回用量の平均に対する1日補正ボーラス量の比率;
・総ボーラス1回用量の平均に対する総基礎1回用量の平均の比率;
・1日最大ボーラス量の平均;及び
・1日あたりのカニューレ及びチューブ・プライム(tube prime)の頻度;
のいずれかをメモリ・デバイス 242 に保存させることができる(及び再使用可能なポンプ・コントローラ 200 をモバイル・コンピューティング・デバイス 60 に定期的に通信させることができる)。これらの前述の用量パラメータ又は履歴パラメータがメモリ・デバイス 242 に保存されない範囲で、コントロール回路 240 を、メモリ・デバイス 242 に保存された他のデータから、又はモバイル・コンピューティング・デバイス 60との通信を介した入力から、これらの前述の用量パラメータ又は履歴パラメータのいずれをも計算するように構成することができる。
Claims (12)
- インスリンポンプと通信するとともに、前記インスリンポンプの動作方法を制御するように構成されるポンプコントローラであり、前記動作方法は、
前記ポンプコントローラが、第1の複数のインスリン・デリバリ・プロファイルを生成する、第1生成ステップであり、前記第1の複数のインスリン・デリバリ・プロファイルのそれぞれが、第1の時間間隔にわたる第1の一連のインスリン・デリバリ動作を含む、第1生成ステップと、
前記ポンプコントローラが、前記第1の複数のインスリン・デリバリ・プロファイルのうちの各インスリン・デリバリ・プロファイルについて、前記第1の時間間隔にわたる複数の時間に関する第1の複数の将来の血糖レベルを予測する、第1予測ステップであり、予測される将来の血糖レベルのそれぞれは、糖尿病を抱える人の少なくとも1つの最新の血糖レベルを用いて予測される、第1予測ステップと、
前記ポンプコントローラが、各インスリン・デリバリ・プロファイルについての前記第1の複数の将来の血糖レベルと少なくとも1つの目標血糖レベルとを比較することに少なくとも部分的に基づいて、前記第1の複数のインスリン・デリバリ・プロファイルの第1のプロファイルを選択する、第1選択ステップと、
インスリンの1回用量をデリバリした後、前記第1の時間間隔よりも短い第2の時間間隔について、前記インスリン・ポンプを用いてインスリンの第1の1回用量をデリバリする、第1デリバリステップであり、インスリンの前記第1の1回用量は前記第1のプロファイルの第1の動作又は第1の一連の動作に相当する、第1デリバリステップと、
前記ポンプコントローラが、第3の時間間隔についての前記第2の時間間隔の終わりから延びる時間期間についての第2の複数のインスリン・デリバリ・プロファイルを生成する、第2生成ステップと、
前記ポンプコントローラが、前記第2の複数のインスリン・デリバリ・プロファイルのうちの各インスリン・デリバリ・プロファイルについて、前記第3の時間間隔にわたる複数の時間に関する第2の複数の将来の血糖レベルを予測する、第2予測ステップと、
前記ポンプコントローラが、各インスリン・デリバリ・プロファイルについての前記第2の複数の将来の血糖レベルと少なくとも一つの目標血糖レベルとを比較することに少なくとも部分的に基づいて、前記第2の複数のインスリン・デリバリ・プロファイルの第2のプロファイルを選択する、第2選択ステップと、
前記第2の時間間隔の終わりの後、前記第3の時間間隔よりも短い第4の時間間隔について、前記インスリン・ポンプを用いて第2のインスリンの1回用量をデリバリする、第2デリバリステップと、
を含み、
前記第1及び第2の複数のインスリン・デリバリ・プロファイルの各プロファイルが、ベースライン基礎インスリン量の1つ以上の倍数又は割って得られる比率でインスリンをデリバリする一連のインスリン・デリバリ動作を含む、ポンプコントローラ。 - 前記第1及び第2の複数のインスリン・デリバリ・プロファイルの各プロファイルが、前記ベースライン基礎インスリン量の0倍及び3倍を含む、前記ベースライン基礎インスリン量の 0 倍から 3 倍の間のインスリン・デリバリ量を含む、請求項1に記載のポンプコントローラ。
- 前記第1の複数のインスリン・デリバリ・プロファイルが、5 つと 100 つとの間の数のプロファイルを含み、少なくとも1つのプロファイルが、少なくとも前記第2の時間間隔についてベースライン基礎インスリン量の0倍でインスリンをデリバリし、少なくとも1つのプロファイルが、少なくとも前記第2の時間間隔について前記ベースライン基礎インスリン量でインスリンをデリバリし、少なくとも1つのプロファイルが、少なくとも前記第2の時間間隔について前記ベースライン基礎インスリン量の2倍でインスリンをデリバリする、請求項1に記載のポンプコントローラ。
- 前記第1の複数のインスリン・デリバリ・プロファイルのうちの少なくとも1つが、前記第1の一連のインスリン・デリバリ動作の第1の部分についての第1インスリン・デリ
バリ量と前記第1の一連のインスリン・デリバリ動作の第2の部分についての第2インスリン・デリバリ量との間に変曲点を含む、請求項1に記載のポンプコントローラ。 - 前記第1の時間間隔が少なくとも2時間であり、及び前記第2の時間間隔が少なくとも5分で90分以下である、請求項1に記載のポンプコントローラ。
- 前記第1の時間間隔が少なくとも3時間であり、前記第2の時間間隔が少なくとも10分で30分以下である、請求項5に記載のポンプコントローラ。
- 前記第1の複数のインスリン・デリバリ・プロファイルの前記第1のプロファイルを、前記第1の複数のインスリン・デリバリ・プロファイルのそれぞれについて計算されたコスト関数に基づいて選択する、請求項1に記載のポンプコントローラ。
- 前記第1のプロファイルを、最も低いコスト関数を有することに基づいて選択し、各予測される将来の血糖レベルと1つ以上の目標血糖レベルとの間の差が、各インスリン・デリバリ・プロファイルについて計算されたコスト関数値を増加させる、請求項7に記載のポンプコントローラ。
- 前記予測される血糖レベルが前記目標血糖レベルよりも高い場合での違いの大きさと比較して、同じ違いの大きさで前記予測される血糖レベルが前記目標血糖レベルよりも低い場合に対して、前記コスト関数値の差に関する増加がより大きくなる、請求項8に記載のポンプコントローラ。
- 前記コスト関数が、以前にデリバリされた量に等しい量でのインスリンのデリバリを維持するか、又はベースライン基礎インスリン量でインスリンをデリバリするインスリン・デリバリ・プロファイルに対するバイアスを含む、請求項9に記載のポンプコントローラ。
- 将来の血糖を予測することが、
糖質による血糖レベルに対する影響を決定することと、
インスリンによる血糖レベルに対する影響を決定することと、
を含む、請求項10に記載のポンプコントローラ。 - 将来の血糖を予測することが、インスリン・オン・ボード及び糖質オン・ボードの影響を決定することを含む、請求項10に記載のポンプコントローラ。
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