JP2012071177A - センサからのデータの正確性を確認する方法および装置 - Google Patents
センサからのデータの正確性を確認する方法および装置 Download PDFInfo
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Abstract
【解決手段】データ値はセンサから受け取る(2100)。データ値に関連するパラメータがしきい値と比較される(2110)。例えば、データ値の2次微分係数がしきい値と比較される。付加的なしきい値の違反はセンサから受け取った更なるデータ値に対してモニタされる(2130)。2つのパラメータがしきい値を超えるとデータの受領は終了される(2170)。センサデータから導き出される分散の限量子に基づきデータにフィルタをかけるための方法及びシステム。限量子は、センサデータにフィルタをかけるアダプティブフィルタへの入力として用いられる。センサデータの信頼性を決定することでセンサのキャリブレーションを行い、信頼性のないデータ値を破棄し、破棄されないデータ値にフィルタをかけ、及びフィルタされたデータ値を用いてセンサの出力を調節する方法及びシステム。
【選択図】図20
Description
本出願は、「リアルタイム自己調節キャリブレーションのアルゴリズム」と題され、2002年5月8日に出願された米国特許出願第10/141,375号の一部継続出願であり、その出願自体は、「ブドウ糖モニタキャリブレーション方法」と題された2000年2月23日に出願した米国特許出願第09/511,580号で、現在は米国特許第6,424,847号の一部継続出願であり、双方の全ての内容は本願に参照としてここに援用され、それらへの優先権を主張する。
26.0+26.0×0.02=26.5ナノアンペア
である。
26.0−26.0×0.02=25.5ナノアンペア
である。
SPSR=血糖の読込み参照値/有効ISIG
ここに、SPSR=単一点感受性指数
血糖レベル=有効ISIG×SPSR
SPSR=102/20.1=5.07mg/dl ナノアンペアあたり
血糖レベル=15.0×5.07=76.1mg/dl
MSPSR=血糖の読込み参照値/(有効ISIG‐オフセット)
血糖レベル=(有効ISIG‐オフセット)×MSPSR
MSPSR=102/(20.1-3)=5.96mg/dl
ナノアンペアあたり
血糖レベル=(15.0−3)×5.96=71.5mg/dl
血糖レベル=有効ISIG×MSPSR
もし、SPSR<4のときには、オフセット値は5を用い、そうでなければ、
もし、4<=SPSR<7のときには、オフセット値は3を用い、そうでなければ、
もし、SPSR>=7のときには、オフセット値は0を用いる。
Yiは、組み合わされたキャリブレーションのデータポイントのi番目の読込まれた血糖の参照値であり、
Nは、キャリブレーションに用いる組み合わされたキャリブレーションのデータポイントの総数であり、
iは、組み合わされたキャリブレーションのデータポイントの識別番号である。
血糖レベル=有効ISIG×LRSR
血糖レベル=(有効ISIG‐オフセット)×MLRSR
Abs(1−PES/CFc)×100=しきい値1、及び
Abs(CFc−PES)×Isig=しきい値2
Abs(1−CFp/CFc)×100=しきい値1、及び
Abs(CFc−CFp)×Isig=しきい値2、及び
(CFp−PES)×(CFc−CFp)=0
Abs(PES−CFc)<Abs(CFp−CFc)
Abs(1−PES/CFc)×100<しきい値3、及び
Abs(CFc−PES)×ISIG<しきい値4
Abs(PES−CFp)<Abs(CFc−CFp)
上記の記載は、好ましい実施形態での基本的なキャリブレーション技術ではあるが、上記記載されたキャリブレーション技術には多くの修正が可能である。例えば、代替の実施形態として、キャリブレーション係数は、それぞれの組み合わされたキャリブレーションのデータポイントに対してMSPSRを計算するために、最初に単一点技術を用いて計算し、次に、経過時間による時間的な順序により、重み付けされないか又は重み付けされて、それらを共に平均化しても良い。他の実施形態では、SRとして用いられる、他の直線の曲線適合技術を勾配の計算に用いても良い。付加的な代替の実施形態では、他の非回帰曲線適合技術が、有効ISIGに関連した血糖レベルを表現する式を発生するのに用いられても良い。その式は、多項式、放物線、双曲線、漸近線、対数、指数、ガウス関数、又は同様のものであっても良い。これらの実施形態では、SRは、単一の値(勾配のように)ではなく、むしろ、ブドウ糖センサ12からの有効ISIGをブドウ糖モニタ100又はポスト・プロセッサ200の血糖値を変換するのに用いられる曲線を表現する式である。付け加えて、勾配を近似するより強固な公式を用いることで、より古いISIGよりもより最新のISIGに重みをつけるために、異なる重みを有する異なるIS:Gが与えられる。例えば、連続した8つのISIG(すなわち、n=8)が利用できる場合:
SR2=(SR1+SRday1)/2
SR3=SR2+SRday2)/2
SRn=(SR(n-1)+SRday(n-1))/2
ここに、SRnは、時間間隔(n−1)からのデータを用い、リアルタイムなブドウ糖モニタ100より用いられ、有効ISIGsを時間間隔nに亘って血糖の読込み値に変換する、時間間隔nの開始時に計算された新たな感受性指数である。
Rk=c×δk+b
ここに、c及びbは定数であり、Rkは生の信号のk番目の分離した時間のインターバルにおけるノイズの分散の評価値である。定数c及びbは、生の信号を平滑にし、遅れを最小限とするために最適に調整できる。項δkは、下記のように計算しても良い:
Rk=c×δk+b
ここに、項δkは下記のように計算しても良い:
Claims (61)
- センサのデータの正確性を確認する方法であって、
当該センサから第1データ値を受け取ること、
当該第1データ値に関連する第1パラメータを第1しきい値と比較すること、
当該センサから第2データ値を受け取ること、
当該第2データ値に関連する第1パラメータを当該第1しきい値と比較すること、
当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えないときには、当該センサからのデータの受け取りを継続すること、
当該第1データ値に関連する当該第1パラメータ、及び当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えるときには、当該センサからのデータの受け取りを終了すること、
を備えることを特徴とする方法。 - 請求項1に記載の方法において、当該センサは、ブドウ糖センサであることを特徴とする方法。
- 請求項2に記載の方法において、当該データ値は、血糖濃度であることを特徴とする方法。
- 請求項1に記載の方法において、当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えないときには、当該第1データ値を破棄すること、をさらに備えることを特徴とする方法。
- 請求項1に記載の方法において、当該第1データ値に関連する当該第1パラメータは、当該第1データの2次微分係数であり、当該第2データ値に関連する当該第1パラメータは、当該第2データの2次微分係数であることを特徴とする方法。
- 請求項1に記載の方法において、当該第1データ値に関連する当該第1パラメータは、当該第1データの1次微分係数であり、当該第2データ値に関連する当該第1パラメータは、当該第2データの1次微分係数であることを特徴とする方法。
- 請求項1に記載の方法において、当該第1データ値に関連する第2パラメータを第2しきい値と比較すること、
当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第1データ値に関連する当該第2パラメータが、当該第2しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えないとき、当該センサからのデータの受け取りを継続すること、
当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第1データ値に関連する当該第2パラメータが、当該第2しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えるとき、当該センサからのデータの受け取りを終了すること、
をさらに備えること特徴とする方法。 - 請求項7に記載の方法において、当該センサは、ブドウ糖センサであることを特徴とする方法。
- 請求項7に記載の方法において、当該データ値は、血糖濃度であることを特徴とする方法。
- 請求項7に記載の方法において、当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第1データ値に関連する当該第2パラメータが、当該第2しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えないとき、当該第1データ値を破棄すること、
をさらに備えることを特徴とする方法。 - 請求項7に記載の方法において、当該第1データ値に関連する当該第1パラメータは、当該第1データの2次微分係数であり、当該第2データ値に関連する当該第1パラメータは、当該第2データの2次微分係数であり、当該第1データ値に関連する当該第2パラメータは、1次微分係数であることを特徴とする方法。
- 請求項1に記載の方法において、予め決められた時間の期間内に、当該第2データ値に関連する第1パラメータが、当該第1しきい値を超えるときに、当該センサからのデータの受け取りを終了することを特徴とする方法。
- 請求項7に記載の方法において、予め決められた時間の期間内に、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えたときに、当該センサからのデータの受け取りを終了することを特徴とする方法。
- 請求項3に記載の方法において、当該第1しきい値は、当該血糖濃度により変化することを特徴とする方法。
- 請求項8に記載の方法において、当該第2しきい値は、当該血糖濃度により変化することを特徴とする方法。
- 請求項7に記載の方法において、当該第2しきい値は、当該血糖濃度により変化することを特徴とする方法。
- センサからのデータにフィルタをかける方法であって、
当該センサから複数のデータ値を受け取ること、
当該複数のデータ値と関連する測定エラーの分散の限量子を獲得すること、及び
アダプティブフィルタにより当該複数のデータ値にフィルタをかること、を備え、
当該限量子は、当該アダプティブフィルタへの入力であることを特徴とする方法。 - 請求項17に記載の方法において、当該センサは、ブドウ糖センサであることを特徴とする方法。
- 請求項18に記載の方法において、当該データ値は、血糖濃度であることを特徴とする方法。
- 請求項17に記載の方法において、限量子を獲得することは、連続する当該複数のデータポイントの絶対値の標準偏差を公式化すること、を備えることを特徴とする方法。
- 請求項20に記載の方法において、当該標準偏差を公式化することは、期間が定められ、重み付けされない標準偏差を公式化すること、を備えることを特徴とする方法。
- 請求項20に記載の方法において、当該標準偏差を公式化することは、繰り返され、重み付けされた標準偏差を公式化すること、を備えることを特徴とする方法。
- 請求項17に記載の方法において、当該アダプティブフィルタは、カルマンフィルタであることを特徴とする方法。
- センサをキャリブレーションする方法であって、
当該センサから複数のデータ値を受け取ること、
当該複数のデータ値のそれぞれのデータ値の当該信頼性を決定すること、
信頼性のない、当該複数のデータ値のデータ値を破棄すること、
破棄されない当該複数のデータの当該データ値にフィルタをかけること、及び
当該フィルタをかけたデータ値を用いて、当該センサの出力を調整すること、
を備えることを特徴とする方法。 - 請求項26に記載の方法において、当該センサは、ブドウ糖センサであることを特徴とする方法。
- 請求項26に記載の方法において、当該複数のデータ値は、血糖濃度であることを特徴とする方法。
- 請求項26に記載の方法において、各データ値の当該信頼性の決定は、各データ値を予め決定されたしきい値と比較すること、を備えることを特徴とする方法。
- 請求項26に記載の方法において、各データ値の当該信頼性の決定は、各データ値に関連するパラメータを予め決定されたしきい値と比較すること、を備えることを特徴とする方法。
- 請求項30に記載の方法において、当該パラメータは、2次微分係数であることを特徴とする方法。
- 請求項30に記載の方法において、当該パラメータは、1次微分係数であることを特徴とする方法。
- 請求項30に記載の方法において、当該予め決定されたしきい値は、最新の複数のデータ値により変化することを特徴とする方法。
- 請求項30に記載の方法において、当該最新の複数のデータ値は、血糖濃度であることを特徴とする方法。
- 請求項30に記載の方法において、破棄されたデータ値は、当該予め決定されたしきい値に関係する予め確立されたクライテリアに合致しない破棄されたデータ値、を備えることを特徴とする方法。
- 請求項26に記載の方法において、当該データ値にフィルタをかけることは、アダプティブフィルタにより当該データ値にフィルタをかけること、を備えることを特徴とする方法。
- 請求項26に記載の方法において、当該アダプティブフィルタは、カルマンフィルタであることを特徴とする方法。
- 請求項36に記載の方法において、アダプティブフィルタにより当該データ値にフィルタをかけることは、破棄されない当該複数のデータの当該データ値に基づくパラメータにより当該アダプティブフィルタを用いること、を備えることを特徴とする方法。
- 請求項38に記載の方法において、当該パラメータは、破棄されない当該複数のデータの当該データ値の標準偏差であることを特徴とする方法。
- 請求項38に記載の方法において、当該パラメータは、破棄されない当該複数のデータの当該データ値の絶対値の標準偏差であることを特徴とする方法。
- 請求項39に記載の方法において、当該標準偏差は、期間が定められ、重み付けされない標準偏差であることを特徴とする方法。
- 請求項39に記載の方法において、当該標準偏差は、繰り返され、重み付けされた標準偏差であることを特徴とする方法。
- センサのデータの正確性を確認する装置であって、
当該センサから第1データ値を受け取る手段と、
当該第1データ値に関連する第1パラメータを第1しきい値と比較する手段と、
当該センサから第2データ値を受け取る手段と、
当該第2データ値に関連する第1パラメータを第1しきい値と比較する手段と、
当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えないときには、当該センサからのデータの受け取りを継続する手段と、
当該第1データ値に関連する当該第1パラメータ、及び当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えるときには、当該センサからのデータの受け取りを終了する手段と、
を備えることを特徴とする装置。 - 請求項43に記載の装置において、当該センサは、ブドウ糖センサであることを特徴とする装置。
- 請求項44に記載の装置において、当該データ値は、血糖濃度であることを特徴とする装置。
- 請求項43に記載の装置において、当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えないときには、当該第1データを破棄する手段を、さらに備えることを特徴とする装置。
- 請求項43に記載の装置において、当該第1データ値に関連する当該第1パラメータは、当該第1データの2次微分係数であり、当該第2データ値に関連する当該第1パラメータは、当該第2データの2次微分係数であることを特徴とする装置。
- 請求項43に記載の装置において、当該第1データ値に関連する当該第1パラメータは、当該第1データの1次微分係数であり、当該第2データ値に関連する当該第1パラメータは、当該第2データの1次微分係数であることを特徴とする装置。
- 請求項43に記載の装置において、当該第1データ値に関連する第2パラメータを第2しきい値と比較する手段と、
当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第1データ値に関連する当該第2パラメータが、当該第2しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えないとき、当該センサからのデータの受け取りを継続する手段と、
当該第1データ値に関連する当該第1パラメータが、当該第1しきい値を超え、当該第1データ値に関連する当該第2パラメータが、当該第2しきい値を超え、当該第2データ値に関連する当該第1パラメータが、当該第1しきい値を超えるとき、当該センサからのデータの受け取りを終了する手段と、
を、さらに備えることを特徴とする装置。 - センサからのデータにフィルタをかける装置であって、
当該センサから複数のデータ値を受け取る手段と、
当該複数のデータ値と関連する測定エラーの分散の限量子を獲得する手段と、及び
アダプティブフィルタにより当該複数のデータ値にフィルタをかける手段と、を備え、
当該限量子は、当該アダプティブフィルタへの入力であることを特徴とする装置。 - 請求項50に記載の装置において、当該センサは、ブドウ糖センサであることを特徴とする装置。
- 請求項51に記載の装置において、当該複数のデータ値は、血糖濃度であることを特徴とする装置。
- 請求項50に記載の装置において、限量子を獲得する手段は、連続する当該複数のデータポイントの絶対値の標準偏差を公式化する手段を備えることを特徴とする装置。
- 請求項53に記載の装置において、当該標準偏差を公式化する手段は、期間が定められ、重み付けされない標準偏差を公式化する手段を備えることを特徴とする装置。
- 請求項53に記載の装置において、当該標準偏差を公式化する手段は、繰り返され、重み付けされた標準偏差を公式化する手段を備えることを特徴とする装置。
- 請求項50に記載の装置において、当該アダプティブフィルタは、カルマンフィルタであることを特徴とする装置。
- センサをキャリブレーションする装置であって、
当該センサから複数のデータ値を受け取る手段と、
当該複数のデータ値のそれぞれのデータ値の当該信頼性を決定する手段と、
信頼性のない当該複数のデータ値のデータ値を破棄する手段と、
破棄されない当該複数のデータの当該データ値にフィルタをかけ、及び当該フィルタをかけたデータ値を用いて当該センサの出力を調整する手段と、
を備えることを特徴とする装置。 - 請求項57に記載の装置において、当該センサは、ブドウ糖センサであることを特徴とする装置。
- 請求項57に記載の装置において、当該複数のデータ値は、血糖濃度であることを特徴とする装置。
- 請求項57に記載の装置において、各データ値の当該信頼性を決定する手段は、各データ値を予め決定されたしきい値と比較する手段を備えることを特徴とする装置。
- 請求項57に記載の装置において、各データ値の当該信頼性を決定する手段は、各データ値に関連するパラメータを予め決定されたしきい値と比較する手段を備えることを特徴とする装置。
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CA2548286C (en) | 2017-07-11 |
CA2548286A1 (en) | 2005-07-21 |
JP2007516814A (ja) | 2007-06-28 |
WO2005065542A2 (en) | 2005-07-21 |
DK1699352T3 (da) | 2013-05-27 |
US9204840B2 (en) | 2015-12-08 |
US20090005666A1 (en) | 2009-01-01 |
US20050004439A1 (en) | 2005-01-06 |
JP5283764B2 (ja) | 2013-09-04 |
EP1699352B1 (en) | 2013-02-13 |
EP1699352A2 (en) | 2006-09-13 |
US7890295B2 (en) | 2011-02-15 |
WO2005065542A3 (en) | 2005-12-29 |
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