JP2000503556A - 患者の血液サンプルの血糖値測定と予測による患者の健康状態のモニター方法 - Google Patents

患者の血液サンプルの血糖値測定と予測による患者の健康状態のモニター方法

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JP2000503556A
JP2000503556A JP9518419A JP51841997A JP2000503556A JP 2000503556 A JP2000503556 A JP 2000503556A JP 9518419 A JP9518419 A JP 9518419A JP 51841997 A JP51841997 A JP 51841997A JP 2000503556 A JP2000503556 A JP 2000503556A
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ヘイノネン,ペッカ
オッコネン,ハリ
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Abstract

(57)【要約】 本発明は、患者の治療を改善し楽にするために、患者の血糖値を示す測定結果を受信し、第1のメモリー手段(10)にその測定結果を格納するための手段(15)を有するモニター装置(9)に関する。該モニター装置は、患者の食餌療法、薬物療法及び運動療法に関するデータを受信し、第1のメモリー手段(10)にそのデータを格納するための手段(15)、第1のメモリー手段(10)に格納された該データに基づいて予測値を計算するためのデータ処理手段(11,12)、及び前記計算された予測値と患者の実際の血糖値との差を計算し、予測値の後続の計算で前述の差を考慮に入れるために前記予測値の計算に利用される数理モデルを補正するための補正手段(13)を有する。

Description

【発明の詳細な説明】 患者の血液サンプルの血糖値測定と予測による患者の健康状態のモニター方法 発明の技術分野 本発明は、患者の血液サンプルの血糖値を測定することによって患者の健康状 態をモニターする方法に関する。本発明はさらに患者の健康状態をモニターする ためのモニター装置に関するものであり、該装置には、患者の血液サンプル中の 血糖値を示す測定結果を受信するための手段及び測定時刻を示すデータと共に第 1のメモリー手段中に該測定結果を格納するための手段が含まれる。 先行技術の記載 周知のように、糖尿病患者の健康状態のモニターは主として患者の血糖値の定 期的な測定に基づいている。患者の血糖値が明確に許容範囲内にあり、患者の薬 物療法が最適であることを確かめるために糖尿病治療には定期的な測定と測定結 果の定期的なモニターが必要とされる。 現在のヘルスケア・システムでは、糖尿病治療を専門とする人が直接継続的に 患者の健康状態をモニターすることは財政的並びに実際的理由のために不可能で あり、患者の健康状態のモニターは患者自身に依存する部分が大きい。したがっ て患者自身が定期的に、すなわち一日に6回から8回もの頻度で測定を行わなけ ればならない。患者を治療する医師が患者の健康状態の進展についてのデータを 長期間にわたって入手することができるように、患者は測定結果の記録をつけ、 医師が後でそれを調べることができるようにしなけれ ばならない。 比較的多数の糖尿病患者が例えば心臓血管疾患、神経障害あるいは失明などの 2次疾患(これらの疾患も少なからぬ社会的コストを生み出す原因となるもので あるが)も患っているという事実によっても、現在医師たちが糖尿病患者を十分 に効果的に治療できないこと、あるいは、患者がセルフケアを行うのを助けるこ とができないことが明らかに示されている。その1つの理由として、一人の各医 師が非常に多数の患者を治療する場合が多く、そのため、一人一人の患者個人と 医師との触れ合いが不十分となって、医師が一人一人の患者の健康状態の進展を 十分効果的にモニターすることができないということが挙げられる。 発明の概要 本発明の目的は糖尿病患者の治療を促進し改善することであり、以前より効果 的に患者が自身をケアできる方法を提供することである。少なくとも患者の食餌 療法、薬物療法及び運動療法を考慮に入れる、患者の血糖値の振る舞い(behavio ur)に関する適応型数理モデルを定式化し、このモデルが与える予測値を測定さ れた血糖値と比較することを含み、この比較の結果に基づいて数理モデルを補正 し、患者が自分で自分の血糖値の振る舞いに基づいて理解すべき治療効果をモニ ターし予測できるように、該数理モデルを利用するための手段を患者に与えるこ とを特徴とする本発明の方法によって本目的は達成される。 本発明のもう一つの目的は患者の治療を促進し改善するモニター装置を提供す ることである。この目的は、該モニター装置が、少なくとも患者の食餌療法、薬 物療法及び運動療法に関するデータを受信し、第1のメモリー手段に該データを 格納する手段と、該第1の メモリー手段に格納されたデータに基づいて、所定の時刻の患者の予測可能な血 糖値を示す予測値を計算するためのデータ処理手段と、計算された予測値と前記 所定の時刻に計算された患者の実際の血糖値との差を計算し、予測値のその後の 計算で前記差を考慮に入れるために、前記データ処理手段が予測値を計算するた めに利用する数理モデルを補正するための補正手段とを有することを特徴とする 本発明のモニター装置によって達成される。 本発明の基礎となる考えは、適応型数理モデルが患者の血糖値の振る舞いに関 して定式化されたとき、そして、該装置に入力されたデータに基づいて、患者の 血糖値を説明する予測値を計算するためのデータ処理手段、及び前回の予測値と 実際の測定結果との間の差に基づいて予測値を計算するために用いられる該モデ ルを補正するための補正手段を有するモニター装置を患者が与えられたとき、患 者は以前よりよく自分のケアができ、自分自身の健康状態の進展をモニターし予 測できるという考えである。なぜなら、患者は、このモニター装置によって、予 測可能な薬物療法、食餌療法及び運動療法に基づいて自分の血糖値がどのように 変化しそうであるかをよりよく評価することができるからである。換言すれば、 もし予測値が悪くなった場合、患者は例えば自分の医師に連絡し薬物療法の変更 の可能性について話し合ったり、あるいは例えば自分の食餌療法の変更などを行 うことができる。 この補正手段のおかげで、該モニター装置は適応性のあるものになる。すなわ ち、データ処理手段によって利用される数理モデルの中に問題の患者の特性を考 慮することにより、前回の予測値と実際の測定結果との間の差を長期的に利用し て問題の患者のための数理モデルを展開することができる。予測値を計算するた めに利用されるこの数理モデルがこの補正手段の働きのおかげで長期的に非常に 正確であるということが判明すれば、すなわち予測値と後で測定される実際の値 との間の差がゼロに近づけば、患者は、本発明のモニター装置によるいくつかの 測定値をスキップすることさえできる。なぜなら、期待される食餌療法、薬物療 法及び運動療法によって血糖値の進展を該装置で正確に予測することができるか らである。血糖値の測定はかなり複雑なものなので、このことによって患者の状 況は相当楽になる。 したがって、本発明の方法及びモニター装置は以下の主要な利点を有するもの である。すなわち、本方法及びモニター装置によって患者は自分の血糖値の進展 を以前よりよく評価することができるので、患者のセルフケアは格段に改善し楽 になる。例えばトレンド分析などのために後日医師が利用できるデータを該モニ ター装置のメモリから読むことができるので医師は、患者の健康状態についての より詳細でより正確なデータを入手できる。このモニター装置のおかげで、毎日 の血糖値測定の回数を長期的に減らすことができる。 本発明のモニター装置の1つの好適な実施例では、該モニター装置は無線デー タ伝送を利用する通信装置を介して患者が通信する病院などのデータ処理装置か ら成る。本発明のこの実施例では、患者は、自分が現在いる場所に拘らずモニタ ー装置へ必要なデータを伝送することが可能となる。この実施例ではまた、医師 は、患者と医師との間での診察のアポイントメントや電話さえも必要とせず、所 望に応じて患者の健康状態に関する直近のデータをモニターすることができる。 本発明のモニター装置のもう一つの好適な実施例では、モニター装置と血糖値 の測定に適した測定装置とが一体化して通信装置、好適には無線データ伝送を利 用する移動電話となっている。本発明のこの実施例によって、たった一つの装置 で十分なので、患者はいく つかのばらばらの人目につく装置を携帯することから解放される。また、この実 施例では、患者は、自分のいる場所に拘らず治療してくれている医師に自分の健 康状態に関するデータを通信装置を介して継続的に伝送することができ、また、 医師は患者の健康状態の進展をモニターすることができ、必要な場合には移動電 話によって直接患者に連絡をとることさえできる。この実施例では、予測値の計 算は、患者が現在移動電話システムのシャドウエリアにいるかどうかには当然左 右されない。なぜなら、予測値の計算は患者が携帯しているモニター装置内です べて行われるからである。患者が計算の時点でシャドウエリアにいる場合には、 患者は後で、そう望む場合には、自分を治療してくれている医師が利用できるデ ータ処理システムへ、患者がモニター装置に入力しそのメモリに格納されたデー タを伝送することができる。 本発明のモニター装置の好適な実施例は従属請求の範囲第3項乃至第7項に開 示されている。 図面の簡単な説明 以下に、添付図面で例示する本発明のいくつかの好適な実施例を用いてより詳 細に、例を挙げて本発明を説明する。 図1は本発明のモニター装置の第1の好適な実施例を例示する。 図2及び3は本発明のモニター装置の第2の好適な実施例を例示する。 図4は予測値の計算を例示する。 好適な実施例の説明 図1は、本発明のモニター装置の第1の好適な実施例を例示する。図1に示す ケースでは、該モニター装置は病院のデータ処理シス テム9及びそこで使われるアプリケーション・ソフトウェアから成る。 図1に示す状況で、患者は、データをモニター装置9へ入力することができる 手段として移動電話1を利用することができる。ある時刻、例えば5時間後の可 能な血糖値を出すために患者がモニター装置9に予測値を計算させたいとき、患 者は、少なくとも最近(最新)の測定結果と測定時刻(測定結果に関するデータ が以前にモニター装置に入力されていなかった場合)、予測値を計算するための 、期待される薬物療法、食餌療法、運動療法及び時刻(すなわちこの例では5時 間後)に関するデータを移動電話1のキーボードを介してモニター装置9へ入力 する。もし移動電話が一体化した血糖値測定用の測定装置を有していれば、測定 結果や測定時刻は移動電話1のメモリ内に格納できるので入力する必要はない。 例によって、GSM移動電話システム(Groupe Special Mobile)の移動電話であると 仮定されている移動電話1は、この入力されたデータをショートメッセージ3の 形で基地局4へ伝送する。基地局4は、基地局コントローラ5、移動サービス交 換センター(MSC)6及びゲートウェイセンター7を介してこのメッセージを移動 システムのショートメッセージサービスセンター(SMSC)8へ発信する。GSMシス テム及びそのショートメッセージサービスについては、例えば、M.Mouly and M .-B.Pautet,Palaiseau著「移動通信のためのGSMシステム」(France 、 1992 、ISBN: 2-9507190-0-7)により詳細に説明されている。したがってこれに関連し てはこれ以上詳細には説明しない。 ショートメッセージサービスセンター8は、患者の移動電話1から直接病院の データ処理システム9へ受信されたショートメッセージを伝送するようにプログ ラムされている。したがって患者を治療する医師は、患者の現在いる位置に拘ら ず、いつでも患者に関する 直近のデータにアクセスすることができる。 モニター装置9は、そのトランシーバーユニット15を介して患者から送られて きたデータを受信すると、コンピュータのハードディスク内のファイルなどから 成る第1のメモリー手段10にそのデータを格納する。それから計算器12は、該第 1のメモリー手段に格納されたデータに基づいて予測値の計算を開始する。この 計算中、計算器12は第2のメモリー手段11に格納された補正係数をも考慮に入れ る。第1のメモリー手段10と第2のメモリー手段11とは例えば、同じメモリー・ チップ中に物理的に位置する別々の記憶場所から成るものであってもよいし、あ るいは、同じコンピュータハードディスク中に場所を占める別々のファイルから 成るものであってもよい。図3と関連させながらより詳細に予測値の計算につい て説明する。 予測値が計算されたとき、モニター装置9は、ショートメッセージの形で患者 の移動電話1へ予測値を伝送し、患者はその予測値によって自分の血糖値が次の 5時間の間許容範囲内に留まることを確信することができる。これに反して、そ の予測値によって血糖値が例えば次の5時間の間不都合に変化しそうなことが示 された場合には、患者は自分の食餌療法、運動療法あるいは薬物療法さえも変更 することを検討することもできるし、また、新しい変更データをモニター装置へ 入力し、その変更が血糖値に及ぼす影響を示す新しい予測値を入手することがで きる。 次に患者が血糖値を測定し、測定値と測定時刻に関するデータをモニター装置 9へ入力すると、該装置はこのデータを第1のメモリー手段10の中へ格納し、ま た、予測値を計算するために用いられる数理モデルを補正するためにこのデータ を利用する。 直近の測定時刻が計算器12がすでに以前に予測値を計算した時刻に対応してい る場合には計算器12はメモリ10からこの予測値を検索 し、それを補正器13へ送る。次いで補正器13は予測値とその測定値との差を計算 する。この差に基づいて、補正器13は、予測値を計算するために用いられる補正 係数を変更し、もし計算器がメモリー手段10に格納された同じ初期値とこの新し い補正係数とを用いて新しい予測値を計算した場合に予測値と測定値との差が前 よりも小さくなるようにする。この新しい補正係数は第2のメモリー手段11に格 納され、そこから計算器12は予測値の次の計算のためにこの新しい補正係数を検 索する。 直近の測定時刻が計算器12がすでに以前に予測値を計算した時刻に対応してい ない場合には、メモリー手段10に格納されたデータに基づいて計算器12はまずこ の測定時刻に対する新しい予測値を計算する。次いで、補正器13は予測値と測定 値との差及び新しい補正係数を上記の方法で計算する。 例えば一日のある時刻に対して計算された測定値と予測値との差が長期的に( 数週間の間)繰り返しゼロに非常に近づいている場合、モニター装置9による、 一日のその時刻に対する予測値は十分に正確であると考えることができる。この ような場合、モニター装置9は、前述の時刻にその血糖値を測定する必要はない ことを例えばショートメッセージなどで患者に示唆することができる。したがっ て、毎日の必要な測定が一日に1、2回位までに僅かになるまで数理モデルが十 分に正確であることが証明されると患者は毎日の測定回数を一度に1回に減らす ことができる。これによって、バランスをとるために現在必要とされる一日に6 〜8回の測定に比べると患者の毎日の生活は格段に楽になる。 図2と3に、本発明のモニター装置の第2の好適な実施例を例示する。図2と 3に示すケースでは、モニター装置9'は移動電話に接続されている。 移動電話MSは例えば従来のGSM移動電話などでもよく、その電池収納スペース には、電池及び予測値の計算に必要な構成部品の双方が一体化して含まれている ユニット14’が従来の電池の代わりに含まれる。これらの構成部品には例えば計 算器12’、補正器13’及びメモリー手段10’と11’などが含まれる。ユニット14 ’は移動電話MSの通信バスに接続されているので移動電話のキーボード15’を用 いて予測値の計算に必要なデータを計算器12’に入力することができる。それに 応じて、計算器12’は移動電話のディスプレイ16’を介して計算された予測値を ユーザーに送ることができる。したがって、予測値の計算には別個のデータ処理 装置との通信を必要とせず、モニター装置9'は、モニター装置に入力されたデ ータに基づいて独立して予測値を計算することができる。しかし、患者が希望す れば、患者は最新の測定結果を含む自分がモニター装置へ入力したデータをショ ートメッセージを用いて自分を治療してくれている医師が利用できるデータ処理 システムへ伝送することもできる。 ユニット14'には血液サンプルの血糖値を測定するためそれ自体周知の一体化 した測定装置(図示せず)も含まれることが望ましい。それによって患者はいくつ かの別々の器具を持ち運ぶ必要がなくなり、移動電話/モニター装置だけで十分 となる。 図4に予測値の計算を例示する。本発明によって、予測値の計算はそれ自体周 知のどんな適応型数理モデルでも利用することができ、計算された予測値と実際 の測定結果との差をこの数理モデルの補正のために利用することが可能となり、 計算された予測値と実際の測定結果との差が長期的に最小になるようにすること ができる。換言すれば、この数理モデルは、ある一定の初期値が変化したとき患 者の系、すなわち血糖値がどのように変動するかを”学習する”ことができる。 本発明のモニター装置で利用可能なそれ自体周知の数 理モデルの一例としていわゆるWidrowの適応型LMS(最小平均二乗(Least Means S quare))アルゴリズムがある。 図4で、予測値を計算すべき時刻ti、最新の測定結果、測定時刻、並びに患者 の評価された薬物療法、食餌療法及び運動療法についてのデータを含む基礎デー タXが数理モデルHへ入力されている。図4の数理モデルは、糖尿病の人の血糖値 は通常ある一定の正確さをもつ一定の毎日のパターンに従う、すなわち該血糖値 は糖尿病患者の毎日のルーチンにほぼ同じように日々従うという事実を利用する ものである。したがって、初期値と実際の測定値の記録をつけることによって異 なる初期値が血糖値に及ぼす影響を長期間モニターすることができる。したがっ てこの数理モデルはこのモデルがより正確な予測値を提供するように修正するこ とができる。実際、この修正は、例えば毎日のルーチンのそれぞれの時刻に対し て別個の補正テーブルを設け、それぞれの初期値にはそれ自身の補正係数、すな わち例えば、予測値を計算するときに利用される重み係数を設け、計算された予 測値と実際の測定値との間の実際の差が判明するとその重み係数の値を変更する という方法によって行われる。 i)=H * X から計算することができる。次いでこの計算された予測値は、患者 の時刻tiにおける実際の測定値が入手されるまでメモリに格納される。実際の 測定値g(ti)がわかると、予測値と測の差は数理モデルHを補正するために利用され、例えば、このモデルで使われる 補正係数は公式 hik+1 = hik + 2 *μ*e(ti )* xi(ti)によって補正される。こ こで、hikは時刻tiでの計算に用いられる初期値xiの重み係数であり、μは、た だ一回だけの計算に基づいてこのモデルが根本的に変化するものではなく、この 係数 が最適値へ向かって比較的小さなステップ幅で変化することを保証する小さな正 の定数である。 上記の説明及び関連図は単に本発明を例示することを意図したものにすぎない と理解されるべきである。本請求の範囲に開示した本発明の範囲と精神から逸脱 せず、本発明の異なる変形と改変を行えることは当業者には明らかであろう。
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Claims (1)

  1. 【特許請求の範囲】 1.患者の血液サンプル中の血糖値g(ti )を測定し、患者の健康状態をモニ ターする方法において、 患者の血糖値の振る舞いに関する適応型数理モデル(H)を定式化し、該モデル が少なくとも患者の食餌療法、薬物療法及び運動療法を考慮し、測定された前記 血糖値g(ti )と該モデルによって与え て該数理モデル(H)を補正することとを含み、 患者に前記数理モデル(H)を利用するための手段(1,9')を提供して、自分の血 糖値の振る舞いに基づいて患者が自身で理解すべき治療効果をモニターし、予測 できるようにすることを特徴とする方法。 2.患者の血液サンプル中の血糖値を示す測定結果を受信し、第1のメモリー 手段(10,10')中に測定時刻を示すデータと一緒に前記測定結果を格納するための 手段(15,15')を有する、患者の健康状態をモニターするためのモニター装置(9,9 ')において、 前記モニター装置が、 少なくとも患者の食餌療法、薬物療法及び運動療法に関するデータを受信し、 前記第1のメモリー手段(10,10')に前記データを格納するための手段(15,15')と 、 前記第1のメモリー手段(10,10')に格納された前記データに基づ 2')であって、前記予測値が所定の時刻における患者の予測可能な血糖値を示す ものと、 実際の血糖値g(ti )との差を計算し、予測値のその後の計算にお いて前記差を考慮に入れるために、予測値を計算する前記データ処理手段(11,12 ,11',12')が利用する数理モデルを補正するための補正手段(13,13')とを有する ことを特徴とするモニター装置。 3.前記データ処理手段が予測値の計算において利用される補正係数を保持す るための第2のメモリー手段(11,11')を有し、前記データ処理手段(12,12')は、 前記第1のメモリー手段(10,10')中に格納された前記データに対応する前記補正 係数を前記第2のメモリー手段(11,11')から検索し、予測値の計算において前記 補正係数を利用するようにされており、 に測定された前記血糖値g(ti )との差を最小にするために前記計算で利用され る前記補正係数の値を変更し、前記第2のメモリー手段(11,11')に前記変更され た補正係数を格納するようにされていることを特徴とする請求の範囲2に記載の モニター装置。 4.前記モニター装置(9)が病院やヘルスケアセンターなどのデータ処理シス テムから成り、前記測定結果、測定時刻、食餌療法、薬物療法及び運動療法に関 するデータを受信するための前記手段(15)が、患者が利用でき、好ましくは無線 データ伝送リンクを利用する通信装置(1)から前記データを受信するための手段 を有し、 前記モニター装置(9)が、患者が利用できる前記通信装置(1)へ 有することを特徴とする請求の範囲2又は3に記載のモニター装置。 5.前記モニター装置(9')が、患者の血液サンプルの血糖値を測定し、前記 第1のメモリー手段(10')中に前記測定結果及び測定時刻を示す前記データを格 納するための測定ユニットを有することを特徴とする請求の範囲2又は3に記載 のモニター装置。 6.前記モニター装置と前記測定ユニットとが無線データ伝送リンクを利用す る通信装置、好適にはセルラー無線システムの移動電話(MS)または双方向ページ ャーに接続され、前記モニター装置(9')が、患者を治療する人が利用できるデ ータ処理システムへ前記データ伝送リンクを介して前記第1のメモリー手段(10' )に格納された前記データを伝送するための手段を有することを特徴とする請求 の範囲5に記載のモニター装置。 7.前記モニター装置(9')、前記測定ユニット及び前記移動電話の電池が、 前記移動電話(MS)の電池収納スペースの中にぴったりと収まる1つの構成部品(1 4')として一体化されていることを特徴とする請求の範囲6に記載のモニター装 置。
JP51841997A 1996-02-12 1997-02-11 患者の血液サンプルの血糖値測定と予測による患者の健康状態のモニター方法 Expired - Fee Related JP3735660B2 (ja)

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FI960637A (fi) 1997-08-13
ES2163734T5 (es) 2014-06-18
DE69707266D1 (de) 2001-11-15
KR100434823B1 (ko) 2004-09-08
FI118509B (fi) 2007-12-14
EP0883371B2 (en) 2014-05-07
EP0883371A1 (en) 1998-12-16
US5840020A (en) 1998-11-24
WO1997028737A1 (en) 1997-08-14
KR19990082004A (ko) 1999-11-15
EP0883371B1 (en) 2001-10-10
DK0883371T4 (da) 2014-07-21
DE69707266T2 (de) 2002-07-04
JP3735660B2 (ja) 2006-01-18

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