JP5037128B2 - センサアナライトデータの臨床的受容性評価 - Google Patents

センサアナライトデータの臨床的受容性評価 Download PDF

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Publication number
JP5037128B2
JP5037128B2 JP2006522016A JP2006522016A JP5037128B2 JP 5037128 B2 JP5037128 B2 JP 5037128B2 JP 2006522016 A JP2006522016 A JP 2006522016A JP 2006522016 A JP2006522016 A JP 2006522016A JP 5037128 B2 JP5037128 B2 JP 5037128B2
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data
sensor
analyte
module
reference data
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Expired - Lifetime
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Japanese (ja)
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JP2007501028A (ja
JP2007501028A5 (https=
Inventor
ポール・ブイ・グッド・ジュニア
ジェイムズ・エイチ・ブローカー
アパーブ・ユー・カマス
ヴィクトリア・カール−ブレンデル
ジェイムズ・ピー・スロワー
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Dexcom Inc
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Dexcom Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/14Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405Devices for taking blood samples
    • A61B5/1433Devices for taking blood samples provided with locking means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031Implanted circuitry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1486Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
    • A61B5/14865Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1495Calibrating or testing of in-vivo probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0223Operational features of calibration, e.g. protocols for calibrating sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08Sensors provided with means for identification, e.g. barcodes or memory chips
    • A61B2562/085Sensors provided with means for identification, e.g. barcodes or memory chips combined with means for recording calibration data
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient; User input means
    • A61B5/742Details of notification to user or communication with user or patient; User input means using visual displays
    • A61B5/743Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/48707Physical analysis of biological material of liquid biological material by electrical means
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Ophthalmology & Optometry (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Medical Treatment And Welfare Office Work (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
JP2006522016A 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 Expired - Lifetime JP5037128B2 (ja)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US10/633,404 US7276029B2 (en) 2003-08-01 2003-08-01 System and methods for processing analyte sensor data
US10/633,404 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 2003-08-01
US10/633,329 US8060173B2 (en) 2003-08-01 2003-08-01 System and methods for processing analyte sensor data
US10/633,367 2003-08-01
US10/632,537 US6931327B2 (en) 2003-08-01 2003-08-01 System and methods for processing analyte sensor data
US10/633,329 2003-08-01
PCT/US2004/024263 WO2005011489A1 (en) 2003-08-01 2004-07-27 Processing analyte sensor data

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2007294586A Division JP2008096448A (ja) 2003-08-01 2007-11-13 アナライトセンサデータの処理

Publications (3)

Publication Number Publication Date
JP2007501028A JP2007501028A (ja) 2007-01-25
JP2007501028A5 JP2007501028A5 (https=) 2011-01-20
JP5037128B2 true JP5037128B2 (ja) 2012-09-26

Family

ID=34120054

Family Applications (6)

Application Number Title Priority Date Filing Date
JP2006522016A Expired - Lifetime 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 Expired - Lifetime 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

Family Applications After (5)

Application Number Title Priority Date Filing Date
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 Expired - Lifetime 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

Country Status (4)

Country Link
US (22) US8060173B2 (https=)
EP (7) EP2494922B1 (https=)
JP (6) JP5037128B2 (https=)
WO (1) WO2005011489A1 (https=)

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