JP6803945B2 - 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 - Google Patents
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 Download PDFInfo
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- HKZLPVFGJNLROG-UHFFFAOYSA-M silver monochloride Chemical compound [Cl-].[Ag+] HKZLPVFGJNLROG-UHFFFAOYSA-M 0.000 description 1
- BSWGGJHLVUUXTL-UHFFFAOYSA-N silver zinc Chemical compound [Zn].[Ag] BSWGGJHLVUUXTL-UHFFFAOYSA-N 0.000 description 1
- URWAJWIAIPFPJE-YFMIWBNJSA-N sisomycin Chemical compound O1C[C@@](O)(C)[C@H](NC)[C@@H](O)[C@H]1O[C@@H]1[C@@H](O)[C@H](O[C@@H]2[C@@H](CC=C(CN)O2)N)[C@@H](N)C[C@H]1N URWAJWIAIPFPJE-YFMIWBNJSA-N 0.000 description 1
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- 239000011573 trace mineral Substances 0.000 description 1
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- 239000003204 tranquilizing agent Substances 0.000 description 1
- 230000002936 tranquilizing effect Effects 0.000 description 1
- LOIYMIARKYCTBW-OWOJBTEDSA-N trans-urocanic acid Chemical compound OC(=O)\C=C\C1=CNC=N1 LOIYMIARKYCTBW-OWOJBTEDSA-N 0.000 description 1
- LOIYMIARKYCTBW-UHFFFAOYSA-N trans-urocanic acid Natural products OC(=O)C=CC1=CNC=N1 LOIYMIARKYCTBW-UHFFFAOYSA-N 0.000 description 1
- 238000000844 transformation Methods 0.000 description 1
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- 241000701161 unidentified adenovirus Species 0.000 description 1
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- 229940116269 uric acid Drugs 0.000 description 1
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- 235000019155 vitamin A Nutrition 0.000 description 1
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- 229910052725 zinc Inorganic materials 0.000 description 1
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- FUTVBRXUIKZACV-UHFFFAOYSA-J zinc;3-[18-(2-carboxylatoethyl)-8,13-bis(ethenyl)-3,7,12,17-tetramethylporphyrin-21,24-diid-2-yl]propanoate Chemical compound [Zn+2].[N-]1C2=C(C)C(CCC([O-])=O)=C1C=C([N-]1)C(CCC([O-])=O)=C(C)C1=CC(C(C)=C1C=C)=NC1=CC(C(C)=C1C=C)=NC1=C2 FUTVBRXUIKZACV-UHFFFAOYSA-J 0.000 description 1
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Description
従来、糖尿病患者は、通常自己血糖測定(SMBG)モニタを携行するが、通常、指が針で刺されたようにちくちく痛む不快な方法を含む。不快であるし、面倒でもあるため、糖尿病患者は、通常、血糖値を1日に2回から4回しか測定しない。不幸にも、これらの時間間隔はバラバラに広がっているため、糖尿病患者は気づくのが遅すぎる可能性があり、血糖上昇または血糖降下状態の危険な副作用を招くこともときにはある。実際、糖尿病患者がタイムリーなSMBG値を取得することがありそうもないだけでなく、糖尿病患者は従来の方法に基づいて自分の血糖値が上昇(より高く)または降下(より低く)しているかを知ることもなく、知識に基づいてインスリン療法の決定を下すことができない。
同様に、さまざまな知られているアナライト(例えば、酸素、塩、タンパク質、およびビタミン)に対する実質的に連続的な推定アナライト測定を正確に実施し、先を見越した、および/または遡及的なデータ解析および出力をユーザに提供するシステムおよび方法が必要である。
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が実現される。
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 (18)
- 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において、
実質的に連続的なグルコースセンサから1つ以上のセンサデータ点を含むセンサデータを受信するように構成されているセンサデータ受信モジュールと、
センサデータの安定性のレベルに応じてユーザインターフェイス上にセンサデータを表示するように構成されているインターフェイス制御モジュールとを備えていて、
前記安定性のレベルは、少なくとも実質的に連続的なグルコースセンサと関連する感度変化の徴候についてチェックするためのセンサデータの評価に少なくとも部分的に基づいていることを特徴とするシステム。 - 前記インターフェイス制御モジュールは、予め定められた安定性のレベルが判定された後にセンサデータを表示するように構成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。
- 前記インターフェイス制御モジュールは、予め定められた安定性のレベルが判定された後にのみセンサデータを表示するように構成されていることを特徴とする請求項2に記載のシステム。
- 前記インターフェイス制御モジュールは、グルコース数値、グルコースデータの方向トレンド、および/またはグルコースデータのグラフ表現を含む表示フォーマットでセンサデータを表示するように構成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。
- 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の作動方法において、
センサデータ受信モジュールが、実質的に連続的なグルコースセンサから1つ以上のセンサデータ点を含むセンサデータを受信するステップと、
インターフェイス制御モジュールが、センサデータの安定性のレベルに応じてユーザインターフェイス上にセンサデータを表示するステップとを有していて、
前記安定性のレベルは、プロセッサモジュールを用いて、少なくとも実質的に連続的なグルコースセンサと関連する感度変化の徴候についてチェックするためのセンサデータの評価に少なくとも部分的に基づいて判定されることを特徴とする方法。 - 実質的に連続的なグルコースセンサシステムにおいて、
ホストにおけるグルコースの濃度を実質的に連続的に測定するように構成されている実質的に連続的なグルコースセンサと、
ホストにおけるグルコースの濃度に関連したセンサデータを受信するように構成され、かつ前記センサデータを処理して表示可能なセンサデータを提供するように構成されているコンピュータシステムとを備えていて、
前記コンピュータシステムは、前記センサデータの安定性のレベルに応じてユーザインターフェイス上にセンサデータを表示するように構成されていて、
前記安定性のレベルは、少なくとも実質的に連続的なグルコースセンサと関連する感度変化の徴候についてチェックするためのセンサデータの評価に少なくとも部分的に基づいていることを特徴とする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において、
1つ以上のセンサデータ点を含む、実質的に連続的なグルコースセンサからのセンサデータを受信するように構成されているセンサデータ受信モジュールと、
リアルタイムで連続的なグルコースセンサの安定性を判定するように構成されているスタートアップ判定モジュールとを備えていて、
前記スタートアップ判定モジュールは、実質的に連続的なグルコースセンサに関連した感度を評価し、かつ予め定められた安定性のレベルに応じて較正を初期化し、前記安定性のレベルは、感度の評価に少なくとも部分的に基づいていることを特徴とするコンピュータシステム。 - 前記センサの安定性に基づいてユーザに出力を供給するインターフェイス制御モジュールを更に備えていて、
前記インターフェイス制御モジュールからの前記出力は、推定グルコース数値、グルコース濃度の方向トレンドの徴候、または推定グルコース値のグラフ表現のうちの少なくとも1つを含むことを特徴とする請求項7に記載のコンピュータシステム。 - ユーザに現在および/または来たるべき低血糖および/または高血糖の発生を警告するように構成された警報を有するインターフェイス制御モジュールを更に備えていることを特徴とする請求項7に記載の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において、
センサデータ受信モジュールが、1つ以上のセンサデータ点を含む、実質的に連続的なグルコースセンサからのセンサデータを受信するステップと、
スタートアップ判定モジュールが、電子システムを用いて、連続的なグルコースセンサと関連した感度を評価することによって、実質的に連続的なグルコースセンサの安定性を判定するステップと、
前記スタートアップ判定モジュールが、予め定められた安定性のレベルに応じてセンサデータの較正を初期化するステップとを有していて、前記安定性のレベルは、感度の評価に少なくとも部分的に基づいていることを特徴とする方法。 - インターフェイス制御モジュールが、予め定められた安定性のレベルが判定された後に、前記センサデータを反映する出力を供給するステップを更に有していることを特徴とする請求項10に記載の方法。
- 出力を供給するステップは、推定数値、グルコース濃度の方向トレンド、または推定グルコース値のグラフ表現のうちの少なくとも1つをディスプレイ上に表示するステップを有していることを特徴とする請求項11に記載の方法。
- 出力を供給するステップは、ユーザに現在および/または来たるべき低血糖および/または高血糖の発生を警告するステップを有していることを特徴とする請求項11に記載の方法。
- 出力を供給するステップは、センサデータをインスリンポンプに送信するステップを有していることを特徴とする請求項11に記載の方法。
- 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において、
連続的なグルコースセンサに動作するようにリンクされ、前記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センサデータモジュールと、
前記センサデータモジュールと関連し、かつ連続的なグルコースセンサの安定性を評価するようにプログラムされているプロセッサモジュールとを備えていて、
前記プロセッサモジュールは、予め定められた安定性のレベルに応じて、前記センサデータのスタートアップ較正を開始するように更にプログラムされていて、
前記プロセッサモジュールは、安定性を判定するために、連続的なグルコースセンサと関連した感度を評価するようにプログラムされていて、前記安定性のレベルは、感度の評価に少なくとも部分的に基づいていることを特徴とするシステム。 - 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において、
実質的に連続的なグルコースセンサから1つ以上のセンサデータ点を含むセンサデータを受信するように構成されているセンサデータ受信モジュールと、
センサデータの安定性のレベルに応じてセンサデータをユーザインターフェイス上に表示するように構成されているインターフェイス制御モジュールとを備えていて、
前記安定性のレベルは、実質的に連続的なグルコースセンサと関連した感度の評価に少なくとも部分的に基づいていることを特徴とするシステム。 - 前記インターフェイス制御モジュールは、予め定められた安定性のレベルが判定された後にのみセンサデータを表示するように構成されていることを特徴とする請求項16に記載のシステム。
- 前記インターフェイス制御モジュールは、グルコース数値、グルコースデータの方向トレンド、および/またはグルコースデータのグラフ表現を含む表示フォーマットでセンサデータを表示するように構成されていることを特徴とする請求項16に記載のシステム。
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