JPWO2020161099A5 - - Google Patents

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JPWO2020161099A5
JPWO2020161099A5 JP2021545766A JP2021545766A JPWO2020161099A5 JP WO2020161099 A5 JPWO2020161099 A5 JP WO2020161099A5 JP 2021545766 A JP2021545766 A JP 2021545766A JP 2021545766 A JP2021545766 A JP 2021545766A JP WO2020161099 A5 JPWO2020161099 A5 JP WO2020161099A5
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連続的グルコース監視(CGM)測定中の誤差を補償する方法であって、
センサと、メモリと、プロセッサとを含むCGMデバイスを提供するステップと、
前記センサに定電圧電位を印加し、前記定電圧電位から結果として生じる一次電流信号を測定し、測定された一次電流信号を前記メモリ内に記憶するステップと、
一次電流信号の測定間で、前記センサに精査電位変調シーケンスを適用し、前記精査電位変調シーケンスから結果として生じる精査電位変調電流信号を測定し、測定された精査電位変調電流信号を前記メモリ内に記憶するステップと、
各一次電流信号について、グルコース値を決定するために、前記一次電流信号と、前記一次電流信号に関連する複数の前記測定された精査電位変調電流信号とを用いるステップと
含み、
前記グルコース値の決定が、
前記精査電位変調シーケンスの電位ステップ内の測定された第1の精査電位変調電流によって除算された、測定された終期精査電位変調電流、
前記精査電位変調シーケンスの、より前の電位ステップの測定された終期精査電位変調電流によって除算された、より後の電位ステップの測定された終期精査電位変調電流、
前記精査電位変調シーケンスの、より前の電位ステップの測定された第1の精査電位変調電流によって除算された、より後の電位ステップの測定された終期精査電位変調電流、及び
前記精査電位変調シーケンスの、より前の電位ステップの測定された終期精査電位変調電流によって除算された、より後の電位ステップの測定された第1の精査電位変調電流、
の少なくとも1つを計算することを含む、方法。
A method of compensating for errors during continuous glucose monitoring (CGM) measurements, comprising:
providing a CGM device including a sensor, a memory, and a processor;
applying a constant voltage potential to the sensor, measuring a primary current signal resulting from the constant voltage potential, and storing the measured primary current signal in the memory;
between measurements of the primary current signal, applying a probe potential modulation sequence to the sensor, measuring a probe potential modulated current signal resulting from the probe potential modulation sequence, and storing the measured probe potential modulated current signal in the memory. a step of memorizing;
using the primary current signal and a plurality of the measured probe potential modulated current signals associated with the primary current signal to determine a glucose level for each primary current signal ;
Determining the glucose level comprises:
a measured terminal probing potential-modulated current divided by a measured first probing potential-modulated current in a potential step of said probing potential-modulated sequence;
a measured end probe potential modulation current of a later potential step divided by a measured end probe potential modulation current of an earlier potential step of the probe potential modulation sequence;
a measured final probe potential modulation current of a later potential step divided by a measured first probe potential modulation current of an earlier potential step of the probe potential modulation sequence; and
a measured first probe potential modulation current of a later potential step divided by a measured terminal probe potential modulation current of an earlier potential step of said probe potential modulation sequence;
A method comprising calculating at least one of
前記一次電流信号および精査電位変調電流信号が作用電極電流信号である、請求項1に記載の方法。 2. The method of claim 1, wherein said primary current signal and probing potential modulated current signal are working electrode current signals. 一次電流信号が3分および5分ごとに測定される、請求項1に記載の方法。 2. The method of claim 1, wherein the primary current signal is measured every 3 and 5 minutes. 前記精査電位変調シーケンスが2つ以上の電圧ステップを含む、請求項1に記載の方法。 2. The method of claim 1, wherein the probing potential modulation sequence comprises two or more voltage steps. 前記精査電位変調シーケンスが4つ以上の電圧ステップを含む、請求項4に記載の方法。 5. The method of claim 4, wherein the probing potential modulation sequence comprises four or more voltage steps. 前記精査電位変調シーケンスが、前記定電圧電位よりも高い電圧における少なくとも1つの上昇と、前記定電圧電位よりも低い電圧における少なくとも1つの低下とを含む、請求項1に記載の方法。 2. The method of claim 1, wherein the probing potential modulation sequence comprises at least one rise in voltage above the constant voltage potential and at least one drop in voltage below the constant voltage potential. 各一次電流信号を、前記一次電流信号が測定される前または後に測定された複数の精査電位変調電流信号と関連付けるステップをさらに含む、請求項1に記載の方法。 2. The method of claim 1, further comprising associating each primary current signal with a plurality of probing potential-modulated current signals measured before or after said primary current signal is measured. 各一次電流信号を、複数の精査電位変調電流信号と関連付けるステップが、各一次電流信号を、前記一次電流信号が測定された直後に測定された複数の精査電位変調電流信号と関連付けるステップを含む、請求項7に記載の方法。 associating each primary current signal with a plurality of probing potential-modulated current signals comprises associating each primary current signal with a plurality of probing potential-modulated current signals measured immediately after said primary current signal is measured; 8. The method of claim 7. 決定されたグルコース値を前記CGMデバイスのユーザに伝達するステップをさらに含む、請求項1に記載の方法。 2. The method of claim 1, further comprising communicating the determined glucose value to a user of the CGM device. 連続的グルコース監視(CGM)デバイスを作製する方法であって、
一次電流信号が参照CGMセンサについて測定される前または後に、前記参照CGMセンサに適用される精査電位変調シーケンスに応答して前記参照CGMセンサについて測定された複数の精査電位変調電流信号に基づいて予測式を作成するステップと、
センサと、メモリと、プロセッサとを含むCGMデバイスを提供するステップと、
前記予測式を前記CGMデバイスの前記メモリ内に記憶するステップと、
前記プロセッサによって実行されると、前記CGMデバイスに、
定電圧電位を前記センサに印加させ、前記定電圧電位から結果として生じる一次電流信号を測定させ、測定された一次電流信号を前記メモリ内に記憶させることと
一次電流信号の測定間で、精査電位変調シーケンスを前記センサに適用させ、前記精査電位変調シーケンスから結果として生じる精査電位変調電流信号を測定させ、測定された精査電位変調電流信号を前記メモリ内に記憶させることと
各一次電流信号について、グルコース値を決定するために、前記一次電流信号と、前記一次電流信号に関連する複数の前記測定された精査電位変調電流信号と、前記記憶された予測式とを使用させることであって、前記グルコース値の決定が、
前記精査電位変調シーケンスの電位ステップ内の測定された第1の精査電位変調電流によって除算された、測定された終期精査電位変調電流、
前記精査電位変調シーケンスの、より前の電位ステップの測定された終期精査電位変調電流によって除算された、より後の電位ステップの測定された終期精査電位変調電流、
前記精査電位変調シーケンスの、より前の電位ステップの測定された第1の精査電位変調電流によって除算された、より後の電位ステップの測定された終期精査電位変調電流、及び
前記精査電位変調シーケンスの、より前の電位ステップの測定された終期精査電位変調電流によって除算された、より後の電位ステップの測定された第1の精査電位変調電流、
の少なくとも1つを計算することを含む、使用させることと、
決定されたグルコース値を前記CGMデバイスのユーザに伝達させることと、を行わせる
コンピュータプログラムコードを前記CGMデバイスの前記メモリ内に記憶するステップと
を含む方法。
A method of making a continuous glucose monitoring (CGM) device, comprising:
prediction based on a plurality of probe potential modulated current signals measured about the reference CGM sensor in response to a probe potential modulation sequence applied to the reference CGM sensor before or after the primary current signal is measured about the reference CGM sensor; creating an expression;
providing a CGM device including a sensor, a memory, and a processor;
storing the prediction formula in the memory of the CGM device;
When executed by the processor, the CGM device will:
applying a constant voltage potential to the sensor, measuring a primary current signal resulting from the constant voltage potential, and storing the measured primary current signal in the memory;
between measurements of the primary current signal, applying a probe potential modulation sequence to the sensor, measuring a probe potential modulated current signal resulting from the probe potential modulation sequence, and storing the measured probe potential modulated current signal in the memory. to remember and
for each primary current signal, using said primary current signal, said plurality of said measured probe potential modulated current signals associated with said primary current signal, and said stored prediction formula to determine a glucose level; wherein the determination of the glucose level comprises:
a measured terminal probing potential-modulated current divided by a measured first probing potential-modulated current in a potential step of said probing potential-modulated sequence;
a measured end probe potential modulation current of a later potential step divided by a measured end probe potential modulation current of an earlier potential step of the probe potential modulation sequence;
a measured final probe potential modulation current of a later potential step divided by a measured first probe potential modulation current of an earlier potential step of the probe potential modulation sequence; and
a measured first probe potential modulation current of a later potential step divided by a measured terminal probe potential modulation current of an earlier potential step of said probe potential modulation sequence;
causing to use, including calculating at least one of
causing the determined glucose value to be communicated to a user of the CGM device;
storing computer program code in said memory of said CGM device.
前記CGMデバイスが、前記センサと、トランスミッタ回路と、前記メモリと、前記プロセッサとを有するウェアラブル部分を含み、前記ウェアラブル部分が、前記グルコース値を計算し、ポータブルユーザデバイスに伝達するように構成された、請求項10に記載の方法。 The CGM device includes a wearable portion having the sensor, transmitter circuitry, the memory, and the processor, the wearable portion configured to calculate and communicate the glucose value to a portable user device. 11. The method of claim 10 . 前記CGMデバイスが、前記センサおよびトランスミッタ回路を有するウェアラブル部分と、前記メモリ、前記プロセッサ、およびレシーバ回路を有するポータブルユーザデバイスとを含み、前記ウェアラブル部分が、電流信号を測定して前記ポータブルユーザデバイスに伝達するように構成され、前記ポータブルユーザデバイスが、前記ウェアラブル部分から受信した電流信号からグルコース値を計算するように構成される、請求項10に記載の方法。 The CGM device includes a wearable portion having the sensor and transmitter circuitry and a portable user device having the memory, the processor, and receiver circuitry, the wearable portion measuring a current signal to the portable user device. 11. The method of claim 10 , wherein the portable user device is configured to communicate and the portable user device is configured to calculate a glucose value from a current signal received from the wearable portion. 連続的グルコース監視(CGM)デバイスであって、
間質液から電流信号を生成するように構成されたセンサと、
プロセッサと、
前記プロセッサに結合されたメモリと、
前記プロセッサに結合されたトランスミッタ回路と
を有するウェアラブル部分を備え、
前記メモリが、参照センサに印加された定電圧電位の印加によって生成された一次電流信号と、一次電流信号測定間で適用された精査電位変調シーケンスの適用によって生成された複数の精査電位変調電流信号とに基づく予測式を含み、
前記メモリが、前記プロセッサによって実行されると、前記CGMデバイスに、
前記センサと前記ウェアラブル部分のメモリとを使用して一次電流信号を測定および記憶させることと
前記一次電流信号に関連する複数の精査電位変調電流信号を測定および記憶させることと
グルコース値を計算するために、前記一次電流信号と、前記複数の精査電位変調電流信号と、前記記憶された予測式とを使用させることであって、前記グルコース値の計算が、
前記精査電位変調シーケンスの電位ステップ内の測定された第1の精査電位変調電流によって除算された、測定された終期精査電位変調電流、
前記精査電位変調シーケンスの、より前の電位ステップの測定された終期精査電位変調電流によって除算された、より後の電位ステップの測定された終期精査電位変調電流、
前記精査電位変調シーケンスの、より前の電位ステップの測定された第1の精査電位変調電流によって除算された、より後の電位ステップの測定された終期精査電位変調電流、及び
前記精査電位変調シーケンスの、より前の電位ステップの測定された終期精査電位変調電流によって除算された、より後の電位ステップの測定された第1の精査電位変調電流、
の少なくとも1つを計算することを含む、使用させることと、
前記グルコース値を前記CGMデバイスのユーザに伝達させることと、を行わせる
その中に記憶されたコンピュータプログラムコードを含む、
CGMデバイス。
A continuous glucose monitoring (CGM) device comprising:
a sensor configured to generate a current signal from interstitial fluid;
a processor;
a memory coupled to the processor;
a transmitter circuit coupled to the processor; and a wearable portion having:
The memory stores a primary current signal generated by application of a constant voltage potential applied to a reference sensor and a plurality of probe potential modulated current signals produced by application of a probe potential modulation sequence applied between primary current signal measurements. contains a prediction formula based on and
When the memory is executed by the processor, the CGM device:
measuring and storing a primary current signal using the sensor and memory of the wearable portion;
measuring and storing a plurality of probing potential modulated current signals associated with the primary current signal;
using the primary current signal, the plurality of probing potential-modulated current signals, and the stored prediction formula to calculate a glucose level, wherein the calculation of the glucose level comprises:
a measured terminal probing potential-modulated current divided by a measured first probing potential-modulated current in a potential step of said probing potential-modulated sequence;
a measured end probe potential modulation current of a later potential step divided by a measured end probe potential modulation current of an earlier potential step of the probe potential modulation sequence;
a measured final probe potential modulation current of a later potential step divided by a measured first probe potential modulation current of an earlier potential step of the probe potential modulation sequence; and
a measured first probe potential modulation current of a later potential step divided by a measured terminal probe potential modulation current of an earlier potential step of said probe potential modulation sequence;
causing to use, including calculating at least one of
causing the glucose value to be communicated to a user of the CGM device;
including computer program code stored therein,
CGM device.
前記ウェアラブル部分が、
前記センサに結合され、前記センサによって生成された電流信号を測定するように構成された電流感知回路と、
前記電流感知回路に結合され、前記測定された電流信号からデジタル化された電流信号を生成するように構成されたサンプリング回路と
を含む、請求項13に記載のCGMデバイス。
The wearable portion is
a current sensing circuit coupled to the sensor and configured to measure a current signal produced by the sensor;
and a sampling circuit coupled to the current sensing circuit and configured to generate a digitized current signal from the measured current signal.
ポータブルユーザデバイスをさらに備え、前記ポータブルユーザデバイスが、レシーバ回路とディスプレイとを含み、前記ウェアラブル部分の前記トランスミッタ回路が、前記CGMデバイスの前記ユーザへの提示のために、グルコース値を前記ポータブルユーザデバイスの前記レシーバ回路に伝達するように構成された、請求項13に記載のCGMデバイス。 Further comprising a portable user device, said portable user device including a receiver circuit and a display, said transmitter circuit of said wearable portion transmitting glucose values to said portable user device for presentation to said user of said CGM device. 14. The CGM device of claim 13 , configured to transmit to said receiver circuit of a.
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