JP5037496B2 - 1型糖尿病用の完全自動制御システム - Google Patents
1型糖尿病用の完全自動制御システム Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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
- A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
Description
に包含させ(pack in)、予想ωt :=yt −ψt T θt をψt 中で用いた状態で、既知の再帰的予測の手法の一つは、拡張最小二乗[13,14]であり、以下に示される式に従うものである。
ここで、Nd及びNmは、それぞれ、最小及び最大(出力)予測費用ホライゾンリミットであり、Nuは制御ホライゾン境界、δmは予測エラーのウェイト、λnは制御信号のウェイトである。GPCの実行におけるいくつかの基本ガイドラインは、(1)早期の出力は現在の入力信号の影響を受けないので、Nd≧dであること、(2)U(t|t)による反応立ち上がり時間の実質的な部分をカバーする出力ホライゾンNy:=Nm-Ndであること、及び(3)Ny≧NuでNu=0または平方(square)ホライゾンであること、すなわち、Ny=Nuであって、一般に実行されたものであることである。
z-1+・・・+eK-1 z-(K-1)である。最適な予測判断材料
・・・Cγt+N+d-1]Tである。式(14)をさらに解くと、下記の式を導出することができる。
A(z-1)、B(z-1)、C(z-1)は、それぞれ、下記の式で表される。
ここで、簡単にするため、式(1)の同一のシステム遅延dをqkとukとの間であると仮定する。同一の入力信号を介した2つのシステムの間の接続が、最適化された制御信号について解く際に重要性を有し[5]、これによって行列Gを、新たなシステム用の、下記の式によって表される類似の行列Geに拡張することができる。
14 供給装置
16 血糖値センサ
18 制御部
Claims (32)
- 被験者の血糖値を自動的に制御するためのシステムであって、
前記被験者の血糖値を継続的に検知し、それに対応する血糖値信号を生成するように動作する血糖値センサと、
インスリンドース制御信号に応じたドースで、前記被験者にインスリンを供給するように動作する供給装置と、
前記被験者の体重及び時間とともに前記血糖値信号により示される経時変化する前記被験者の血糖値の関数として前記インスリンドース制御信号を生成するように動作する制御部と、
を備え、
前記制御部は、
前記インスリンドース制御信号を、
(a)前記血糖値信号及び
(b)以前に供給されたインスリンの効果を示す、所定のサンプリング期間ごとに得られた値の全てに基づいて計算された、前記被験者内のインスリンの蓄積
に基づいて生成する制御アルゴリズムを備え、
前記供給装置による供給は、前記被験者の皮下空間に対するものであり、前記被験者内のインスリンの蓄積に基づいて前記インスリンドース制御信号を生成することは、前記被験者のプラズマ中に蓄積されたインスリンと、前記インスリンの前記皮下空間から前記プラズマへの吸収とに基づいて行われることを特徴とするシステム。 - (1)前記制御アルゴリズムが、インスリンの供給ドースに対する前記被験者の反応を明確にモデル化し、前記血糖値信号及びインスリンドース制御信号の経時変化する値に基づいて、前記被験者の予測される血糖値を示す予測血糖値信号を生成する被験者モデルを含み、
(2)前記インスリンドース制御信号が、前記予測血糖値信号と、前記被験者の好適な血糖値を示す設定点信号との差に基づいて生成されることを特徴とする請求項1に記載のシステム。 - 前記制御部が、前記インスリンドース制御信号を、
(a)期間に渡る前記予測血糖値信号及び前記設定点信号の差についての加重積分、及び
(b)前記期間に渡る前記インスリンドース制御信号の加重積分、
を対象とする目的関数を最適化することによって生成するモデル予測制御アルゴリズムを備えることを特徴とする請求項1に記載のシステム。 - 前記モデル予測制御アルゴリズムが、モデルパラメータを再帰的かつ継続的にアップデートして、前記被験者モデルを、インスリンの供給ドースに対する前記被験者の反応の変化に動的に適合させる適合モデル予測制御アルゴリズムであることを特徴とする請求項3に記載のシステム。
- 前記目的関数が、(c)前記被験者中の利用の有限比率によるインスリンの蓄積を最小限にする目的にも拡張して適用されることを特徴とする請求項3に記載のシステム。
- 前記被験者モデルが、経験的被験者モデルであることを特徴とする請求項2に記載のシステム。
- 前記経験的被験者モデルが、前記被験者の開ループ血糖制御によって得られる入出力データに対して行われるシステム同定処理に基づいて初期的に構築されるタイプのものであることを特徴とする請求項6に記載のシステム。
- 前記制御部は、さらに、前記制御アルゴリズムが、供給の基本比率を超えるドースのインスリンが不要である旨を示した場合、前記インスリンドース制御信号を生成してインスリンの供給の基本比率を提供することを特徴とする請求項1に記載のシステム。
- 前記基本比率がユーザによって提供される基本比率値に基づいて決定されることを特徴とする請求項8に記載のシステム。
- 前記制御部が、ユーザによって提供される基本比率値が無い、または所定の最大許容値よりも大きい場合に、前記被験者の体重に基づいたデフォルトの基本比率値を採用することを特徴とする請求項9に記載のシステム。
- 前記制御部が、経時的な前記血糖値信号に基づいてオンラインで前記基本比率を適応することを特徴とする請求項10に記載のシステム。
- 前記制御部が、インスリンの最大許容ドースに対応する制限を前記インスリンドース制御信号に自動的に課すように動作することを特徴とする請求項11に記載のシステム。
- 前記血糖値センサが、前記供給装置と一体化されていることを特徴とする請求項1に記載のシステム。
- 前記供給装置が、機械駆動式の注入機構と、インスリンのカートリッジとを備えることを特徴とする請求項13に記載のシステム。
- 前記供給装置が、逆調節作用薬ドース制御信号に応じて、前記被験者に逆調節作用薬のドースを供給するようにさらに動作し、
前記制御部が、前記被験者の体重と、時間とともに前記血糖値信号により示される経時変化する前記被験者の血糖値との関数として、前記逆調節作用薬ドース制御信号を生成するようにさらに動作することを特徴とする請求項1に記載のシステム。 - 前記逆調節作用薬が、グルカゴンを含むことを特徴とする請求項15に記載のシステム。
- 被験者の血糖値を自動的に制御するためのシステムを制御する方法であって、
血糖値センサが、継続的に前記被験者の血糖値を検知してそれに対応する血糖値信号を生成し、
供給装置が、インスリンドース制御信号に応じたドースのインスリンを前記被験者に供給し、
制御部が、前記被験者の体重及び時間とともに前記血糖値信号によって示される前記被験者の経時変化する血糖値の関数として前記インスリンドース制御信号を制御アルゴリズムにより生成し、
前記制御アルゴリズムは、
前記インスリンドース制御信号を、
(a)前記血糖値信号及び
(b)以前に供給されたインスリンの効果を示す、所定のサンプリング期間ごとに得られた値の全てに基づいて計算された、前記被験者内のインスリンの蓄積
に基づいて生成することを含み、
前記供給装置による供給は、前記被験者の皮下空間に対するものであり、前記被験者内のインスリンの蓄積に基づいて前記インスリンドース制御信号を生成することは、前記被験者のプラズマ中に蓄積されたインスリンと、前記インスリンの前記皮下空間から前記プラズマへの吸収とに基づいて行われることを特徴とする方法。 - (1)前記制御アルゴリズムが、インスリンの供給ドースに対する前記被験者の反応を明確にモデル化し、前記血糖値信号及びインスリンドース制御信号の経時変化する値に基づいて、前記被験者の予測される血糖値を示す予測血糖値信号を生成する被験者モデルを利用し、
(2)前記インスリンドース制御信号が、前記予測血糖値信号と、前記被験者の好適な血糖値を示す設定点信号との差に基づいて生成されることを特徴とする請求項17に記載の方法。 - 前記制御アルゴリズムが、前記インスリンドース制御信号を、
(a)期間に渡る前記血糖値信号及び前記設定点信号の差についての加重積分、及び
(b)前記期間に渡る前記インスリンドース制御信号の加重積分、
を対象とする目的関数を最適化することによって生成するモデル予測制御アルゴリズムを備えることを特徴とする請求項17に記載の方法。 - 前記モデル予測制御アルゴリズムが、モデルパラメータを再帰的かつ継続的にアップデートして、前記被験者モデルを、インスリンの供給ドースに対する前記被験者の反応の変化に動的に適合させる適合モデル予測制御アルゴリズムであることを特徴とする請求項19に記載の方法。
- 前記目的関数が、(c)前記被験者中の利用の有限比率によるインスリンの蓄積を最小限にする目的にも拡張して適用されることを特徴とする請求項19に記載の方法。
- 前記被験者モデルが、経験的被験者モデルであることを特徴とする請求項18に記載の方法。
- 前記経験的被験者モデルが、前記被験者の開ループ血糖制御によって得られる入出力データに対して行われるシステム同定処理に基づいて初期的に構築されることを特徴とする請求項22に記載の方法。
- 前記制御アルゴリズムが供給の基本比率を超えるドースのインスリンが不要である旨を示した場合、さらに、前記インスリンドース制御信号を生成してインスリンの供給の基本比率を提供することを特徴とする請求項17に記載の方法。
- 前記基本比率がユーザによって提供される基本比率値に基づいて決定されることを特徴とする請求項24に記載の方法。
- ユーザによって提供される基本比率値が無い、または所定の最大許容値よりも大きい場合に、前記被験者の体重に基づいたデフォルトの基本比率値を採用することを特徴とする請求項25に記載の方法。
- 経時的な前記血糖値信号に基づいて、オンラインで前記基本比率を適応することを特徴とする請求項26に記載の方法。
- さらに、インスリンの最大許容ドースに対応する制限を前記インスリンドース制御信号に自動的に課すことを特徴とする請求項27に記載の方法。
- 逆調節作用薬ドース制御信号に応じて、前記被験者に逆調節作用薬のドースを供給するように供給装置を動作させることと、
前記被験者の体重と、時間とともに前記血糖値信号により示される経時変化する前記被験者の血糖値との関数として、前記逆調節作用薬ドース制御信号を生成することと、
をさらに含むことを特徴とする請求項17に記載の方法。 - 前記逆調節作用薬が、グルカゴンを含むことを特徴とする請求項29に記載の方法。
- 被験者の血糖値を自動的に制御するシステムに用いられる制御部であって、前記制御部は、インスリンドース制御信号を、前記被験者の体重及び時間の経過とともに血糖値信号によって示される前記被験者の経時変化する血糖値の関数として生成するように動作し、前記血糖値信号は、継続的に前記被験者の血糖値を検知する血糖値センサによって生成され、前記インスリンドース制御信号は、供給装置によるインスリンの前記被験者への供給ドースを制御し、前記制御部は、
前記インスリンドース制御信号を、
(a)前記血糖値信号及び
(b)以前に供給されたインスリンの効果を示す、所定のサンプリング期間ごとに得られた値の全てに基づいて計算された、前記被験者内のインスリンの蓄積
に基づいて生成する制御アルゴリズムを備え、
前記供給装置による供給は、前記被験者の皮下空間に対するものであり、前記被験者内のインスリンの蓄積に基づいて前記インスリンドース制御信号を生成することは、前記被験者のプラズマ中に蓄積されたインスリンと、前記インスリンの前記皮下空間から前記プラズマへの吸収とに基づいて行われることを特徴とする制御部。 - 前記供給装置によって前記被験者に供給する逆調節作用薬ドースを制御するための逆調節作用薬ドース制御信号を生成するようにさらに動作し、前記逆調節作用薬ドース制御信号は、前記被験者の体重及び時間と共に前記血糖値信号によって示される前記被験者の経時変化する血糖値の関数として生成されることを特徴とする請求項31に記載の制御部。
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US68112805P | 2005-05-13 | 2005-05-13 | |
US60/681,128 | 2005-05-13 | ||
US73556805P | 2005-11-10 | 2005-11-10 | |
US60/735,568 | 2005-11-10 | ||
PCT/US2006/018620 WO2006124716A2 (en) | 2005-05-13 | 2006-05-15 | Fully automated control system for type 1 diabetes |
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JP2008545454A JP2008545454A (ja) | 2008-12-18 |
JP2008545454A5 JP2008545454A5 (ja) | 2009-09-03 |
JP5037496B2 true JP5037496B2 (ja) | 2012-09-26 |
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US (2) | US7806854B2 (ja) |
EP (1) | EP1881786B1 (ja) |
JP (2) | JP5037496B2 (ja) |
CA (1) | CA2612714C (ja) |
WO (1) | WO2006124716A2 (ja) |
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CA2612714A1 (en) | 2006-11-23 |
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