JP2007501028A - アナライトセンサデータの処理 - Google Patents
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Abstract
Description
Clarke他、「Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose」、Diabetes Care、Volume 10、Number 5、September-October 1987 Parkes他、「A New Consensus Error Grid to Evaluate the Clinical Significance of Inaccuracies in the Measurement of Blood Glucose」、Diabetes Care、Volume 23、Number 8、August 2000 「Biosensors and the Body」、D. M. Fraser、ed.、1997、pp.1-56 John Wiley and Sons、New YorkのFraser, D. M.「An Introduction to In vivo Biosensing: Progress and problems」
好ましいいくつかの実施形態を理解しやすくするために、いくつかの用語を以下で定義する。
GOX+グルコース+O2→グルコン酸+H202+還元されたGOX
好ましいいくつかの実施形態は、注目するアナライト、またはアナライトの濃度または存在を示す物質の濃度を測定するアナライトセンサの使用に関する。いくつかの実施形態では、センサは、連続的デバイス、例えば、皮下、経皮、または血管内デバイスである。いくつかの実施形態では、デバイスは、複数の間欠的血液試料を分析することができる。アナライトセンサは、酵素測定、化学的測定、物理的測定、電気化学的測定、分光測定、旋光測定、熱量測定、放射性測定などのアナライト感知の任意の方法を使用できる。
好ましいいくつかの実施形態において有用なアナライトセンサは、注目するアナライトの濃度を測定することができるデバイスであればどのようなものでもよい。例示的な一実施形態は以下で説明されるが、これは、埋め込み型グルコースセンサを使用する。しかし、本明細書で説明されているデバイスおよび方法は、アナライトの濃度を検出し、アナライトの濃度を表す出力信号を供給することができるデバイスであればどのようなデバイスにも適用可能であることは理解されるであろう。
GOX+グルコース+O2→グルコン酸+H202+還元されたGOX
通常、アナライトセンサは、上記の図1および2を参照しつつ詳しく説明されているように、ユーザのアナライト濃度を示す生データ信号を発生する。しかし、上述のグルコースセンサは、注目するアナライトの濃度を示す生データ信号出力を供給することができる多数のアナライトセンサの一例にすぎないことはよく知られている。そのため、データ平滑化、較正、評価、およびその他のデータ処理を含む、好ましい実施形態のデバイスおよび方法を、出力信号を発生することができるアナライトセンサから得られる生データに適用することができることは理解されるであろう。
図4Aから図4Dは、第1、第2、第3、および第4の実施形態の受信機の概略図である。受信機(40)は、本明細書の別のところで説明されているように、アナライトセンサからのセンサデータを受信し、処理し、表示するために必要なシステムを備える。特に、受信機(40)は、例えば、ページャサイズのデバイスとすることができ、複数のボタン(42)およびバックライトを備えることができる液晶ディスプレイ(LCD)画面(44)を持ちユーザインターフェイスを備える。いくつかの実施形態では、ユーザインターフェイスは、図5を参照しつつ説明されているようなキーボード、スピーカ、およびバイブレータも備えることができる。
次に、一実施形態のセンサデータ(60)の初期較正およびデータ出力を例示する流れ図である、図6を参照する。
12 本体
14 ヘッド
16 電極
17 感知膜
18 バイオインターフェイス膜
19 クリップ
20 ポテンショスタット
21 A/Dコンバータ
22 マイクロプロセッサ
23 EEPROM
24 SRAM
25 電池
26 水晶振動子
27 RFトランシーバ
28 水晶振動子
40 受信機
42 ボタン
44 液晶ディスプレイ(LCD)画面
50 水晶振動子
51 RFトランシーバ
52 マイクロプロセッサ
53 EEPROM
54 SRAM
55 電池
56 水晶振動子
57 ユーザインターフェイス
58 パーソナルコンピュータ(PC)comポート
59 基準アナライトモニタcomポート
60 センサデータ
72 勾配
74 オフセット
76、92、94 マッチする対
80 センサデータ
82 臨床的受容性評価モジュール
100 データ対
110 較正
Claims (23)
- 実質的に連続的なアナライトセンサを初期化する方法であって、
実質的に連続的なアナライトセンサから、少なくとも1つのセンサデータ点を含むデータストリームを受信するステップと、
基準アナライトモニタから、少なくとも1つの基準データ点を含む基準データを受信するステップと、
前記基準データ点と実質的に時間に対応するセンサデータ点とのマッチングを行うことにより少なくとも1つのマッチするデータ対を提供するステップと、
前記実質的に連続的なアナライトセンサの安定性を判定するステップとを含む方法。 - 前記実質的に連続的なアナライトセンサの前記安定性を判定する前記ステップは、約1分から約6週間までの範囲の一定期間にわたって前記実質的に連続的なアナライトセンサがホストの組織と平衡状態になるようにするステップを含む請求項1に記載の方法。
- 前記実質的に連続的なアナライトセンサの安定性を判定する前記ステップは、少なくとも1つのマッチするデータ対を評価することを含む請求項1または2に記載の方法。
- 前記実質的に連続的なアナライトセンサの安定性を判定する前記ステップは、pH、酸素、次亜塩素酸塩、干渉種、マッチした対の相関、R値、ベースラインドリフト、ベースラインオフセット、および振幅からなるグループから選択された少なくとも1つの特性を評価することを含む請求項1から3のいずれか一項に記載の方法。
- さらに、前記実質的に連続的なアナライトセンサの前記安定性に基づいて聴覚的出力、視覚的出力、および触覚的出力からなるグループから選択された少なくとも1つの出力をユーザに供給するステップを含む請求項1から4のいずれか一項に記載の方法。
- 少なくとも1つの出力を供給する前記ステップは、推定アナライト数値、アナライト濃度の方向トレンド、および推定アナライト値のグラフ表現のうちの少なくとも1つを示すことを含む請求項5に記載の方法。
- 前記出力は、ユーザインターフェイス上に表示される請求項5または6に記載の方法。
- 実質的に連続的なアナライトセンサからデータストリームを受信する前記ステップは、実質的に連続的なグルコースセンサからセンサデータを受信することを含む請求項1から7のいずれか一項に記載の方法。
- 基準データを受信する前記ステップは、自己血糖測定検査から基準データを受信することを含む請求項1から8のいずれか一項に記載の方法。
- 連続的なアナライトセンサを初期化するシステムであって、
前記アナライトセンサから複数の一定時間間隔のセンサデータ点を含むデータストリームを受信する連続的なアナライトセンサに動作するように接続されたセンサデータモジュールと、
少なくとも1つの基準データ点を含む基準データを基準アナライトモニタから取得するように適合された基準入力モジュールと、
基準データ点と実質的に時間に対応するセンサデータ点とのマッチングを行うことにより少なくとも1つのマッチするデータ対を形成するプロセッサモジュールと、
前記連続的アナライトセンサの安定性を判定するようにプログラムされる前記プロセッサモジュールに関連付けられたスタートアップモジュールとを備えるシステム。 - 前記スタートアップモジュールは、前記連続的アナライトセンサがホストの組織内に挿入されてから前記連続的アナライトセンサの安定性を判定するまでの約6時間から約6週間までの範囲の期間待つようにプログラムされる請求項10に記載のシステム。
- 前記スタートアップモジュールは、少なくとも1つのマッチするデータ対を評価するようにプログラムされる請求項10または11に記載のシステム。
- 前記スタートアップモジュールは、pH、酸素、次亜塩素酸塩、干渉種、マッチした対の相関、R値、ベースラインドリフト、ベースラインオフセット、および振幅からなるグループから選択された少なくとも1つの特性を評価するようにプログラムされる請求項10から12のいずれか一項に記載のシステム。
- さらに、前記プロセッサモジュールに関連付けられ、センサデータの出力を制御するようにプログラムされた出力制御モジュールを備える請求項9から12のいずれか一項に記載のシステム。
- 前記出力制御モジュールは、推定アナライト数値、アナライト濃度の方向トレンド、および推定アナライト値のグラフ表現のうちの少なくとも1つを示す請求項14に記載のシステム。
- 前記出力制御モジュールは、ユーザインターフェイスに情報を出力する請求項14または15に記載のシステム。
- 前記センサデータモジュールは、前記実質的に連続的なグルコースセンサからセンサデータを受信するように構成されている請求項10から16のいずれか一項に記載のシステム。
- 前記基準入力モジュールは、自己血糖測定検査から基準データを受信するように構成される請求項10から17のいずれか一項に記載のシステム。
- 前記スタートアップモジュールは、安定性の判定後に、アナライトセンサデータの表示を初期化するように構成されている請求項10から18のいずれか一項に記載のシステム。
- 請求項1から9のいずれか一項に記載の初期化の方法を使用するグルコースセンサ。
- 請求項10から19のいずれか一項に記載のシステムを含むグルコースセンサ。
- 図1から12Bのいずれか1つ、または複数の実施例のうちのいずれか1つを参照しつつ本明細書で実質的に説明されているようなバイオセンサ。
- 図1から12Bのいずれか1つ、または複数の実施例のうちのいずれか1つを参照しつつ本明細書で実質的に説明されているようなグルコースセンサ。
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US10/633,367 | 2003-08-01 | ||
US10/633,329 | 2003-08-01 | ||
US10/633,367 US7778680B2 (en) | 2003-08-01 | 2003-08-01 | System and methods for processing analyte sensor data |
US10/632,537 US6931327B2 (en) | 2003-08-01 | 2003-08-01 | System and methods for processing analyte sensor data |
US10/633,404 | 2003-08-01 | ||
US10/632,537 | 2003-08-01 | ||
US10/633,329 US8060173B2 (en) | 2003-08-01 | 2003-08-01 | System and methods for processing analyte sensor data |
US10/633,404 US7276029B2 (en) | 2003-08-01 | 2003-08-01 | System and methods for processing analyte sensor data |
PCT/US2004/024263 WO2005011489A1 (en) | 2003-08-01 | 2004-07-27 | Processing analyte sensor data |
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JP2007501028A5 JP2007501028A5 (ja) | 2011-01-20 |
JP5037128B2 JP5037128B2 (ja) | 2012-09-26 |
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JP2006522016A Active JP5037128B2 (ja) | 2003-08-01 | 2004-07-27 | センサアナライトデータの臨床的受容性評価 |
JP2007294586A Pending JP2008096448A (ja) | 2003-08-01 | 2007-11-13 | アナライトセンサデータの処理 |
JP2011177557A Pending JP2012016597A (ja) | 2003-08-01 | 2011-08-15 | アナライトセンサデータの処理 |
JP2014245879A Pending JP2015061662A (ja) | 2003-08-01 | 2014-12-04 | 連続的グルコースセンサからのセンサデータを処理するためのコンピュータシステムおよび方法、および連続的グルコースセンサシステム |
JP2017017366A Pending JP2017074483A (ja) | 2003-08-01 | 2017-02-02 | 連続的グルコースセンサからのセンサデータを処理するためのコンピュータシステムおよびコンピュータシステムの作動方法、および連続的グルコースセンサシステム |
JP2019087838A Active JP6803945B2 (ja) | 2003-08-01 | 2019-05-07 | 実質的に連続的なグルコースセンサからのデータを表示するシステムおよびシステムの作動方法、実質的に連続的なグルコースセンサシステム、連続的なグルコースセンサを初期化するコンピュータシステム、実質的に連続的なグルコースセンサを初期化するコンピュータシステムの作動方法、ならびに連続的なグルコースセンサからのデータを処理するシステム |
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JP2014245879A Pending JP2015061662A (ja) | 2003-08-01 | 2014-12-04 | 連続的グルコースセンサからのセンサデータを処理するためのコンピュータシステムおよび方法、および連続的グルコースセンサシステム |
JP2017017366A Pending JP2017074483A (ja) | 2003-08-01 | 2017-02-02 | 連続的グルコースセンサからのセンサデータを処理するためのコンピュータシステムおよびコンピュータシステムの作動方法、および連続的グルコースセンサシステム |
JP2019087838A Active JP6803945B2 (ja) | 2003-08-01 | 2019-05-07 | 実質的に連続的なグルコースセンサからのデータを表示するシステムおよびシステムの作動方法、実質的に連続的なグルコースセンサシステム、連続的なグルコースセンサを初期化するコンピュータシステム、実質的に連続的なグルコースセンサを初期化するコンピュータシステムの作動方法、ならびに連続的なグルコースセンサからのデータを処理するシステム |
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