JP2016540564A - 糖尿病管理用ボーラス投与フィードバック - Google Patents
糖尿病管理用ボーラス投与フィードバック Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H80/00—ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16Z—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
- G16Z99/00—Subject matter not provided for in other main groups of this subclass
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3546—Range
- A61M2205/3569—Range sublocal, e.g. between console and disposable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
Abstract
Description
本国際特許出願は、2013年12月5日出願の先行出願された米国特許出願第14/098,353号のパリ条約及びアメリカ合衆国法典第35巻「特許法」第119条に基づく優先権の利益を主張するものであり、この先行出願は、参照により本明細書に組み入れられる。
米国特許第7,060,059号、
米国特許出願第2011/0313680及び同第2011/0257627号、
国際公開第2012/051344号、
Percival et al.,「Closed−Loop Control and Advisory Mode Evaluation of an Artificial Pancreatic β Cell:Use of Proportional−Integral−Derivative Equivalent Model−Based Controllers」Journal of Diabetes Science and Technology,Vol.2,Issue 4,July 2008、
Paola Soru et al..,「MPC Based Artificial Pancreas;Strategies for Individualization and Meal Compensation」Annual Reviews in Control 36,p.118〜128(2012)、
Cobelli et al.,「Artificial Pancreas:Past,Present,Future」Diabetes Vol.60,Nov.2011、
Magni et al.,「Run−to−Run Tuning of Model Predictive Control for Type 1 Diabetes Subjects:In Silico Trial」Journal of Diabetes Science and Technology,Vol.3,Issue 5,September 2009、
Lee et al.,「A Closed−Loop Artificial Pancreas Using Model Predictive Control and a Sliding Meal Size Estimator」Journal of Diabetes Science and Technology,Vol.3,Issue 5,September 2009、
Lee et al.,「A Closed−Loop Artificial Pancreas based on MPC:Human Friendly Identification and Automatic Meal Disturbance Rejection」Proceedings of the 17th World Congress,The International Federation of Automatic Control,Seoul Korea July 6〜11,2008、
Magni et al.,「Model Predictive Control of Type 1 Diabetes:An in Silico Trial」Journal of Diabetes Science and Technology,Vol.1,Issue 6,November 2007、
Wang et al.,「Automatic Bolus and Adaptive Basal Algorithm for the Artificial Pancreatic β−Cell」Diabetes Technology and Therapeutics,Vol.12,No.11,2010、及び、
Percival et al.,「Closed−Loop Control of an Artificial Pancreatic β−Cell Using Multi−Parametric Model Predictive Control」Diabetes Research 2008。
Claims (10)
- 輸液ポンプと、少なくとも1つのグルコースモニターと、マイクロコントローラとを有する糖尿病管理システムを操作する方法であって、前記方法は前記マイクロコントローラで実行される以下のステップ:
グルコースを有する流体サンプルが前記サンプルへの電気信号の印加により酵素副産物に変換されるグルコース測定を判定するステップと、
前記判定するステップにより行われた前記グルコース測定に基づいてボーラス推奨値を計算するステップと、
前記ボーラス推奨値が前記システムのユーザーにより従われたかどうか評価するステップであって、
前記ボーラス推奨値が前記ユーザーにより従われなかった場合、
前記輸液ポンプにより送達された実際のボーラスを記憶することと、
その後の流体サンプル中のグルコース値を測定することであって、経時的なグルコース値が所定の高い傾向閾値を上回る場合、推奨ボーラス及びポンプにより送達された実際のボーラスとともに高グルコース傾向を報知し、経時的なグルコース値が所定の低い傾向閾値を下回る場合、推奨ボーラス及びポンプにより送達された実際のボーラスとともに低グルコース傾向を報知する、ステップと、
を含む、方法。 - 前記コントローラにおいて前記測定するステップによって行われた前記グルコース測定を記憶するステップを更に含む、請求項1に記載の方法。
- 前記コントローラへの入力のために別のボーラス推奨値の必要性を確認するステップを更に含む、請求項1に記載の方法。
- 確認することは、前記ユーザーの流体サンプルのグルコース測定値の減少する変化率を含む、請求項1に記載の方法。
- 前記グルコースモニターは連続グルコースモニターを含み、前記マイクロコントローラは閉ループコントローラを含む、請求項1に記載の方法。
- 前記高グルコース傾向を報知することは、グルコース測定の傾向が、前記推奨ボーラス及び送達される前記実際のボーラスとともにボーラス送達後に増加しているというメッセージを表示することを含む、請求項5に記載の方法。
- 前記低グルコース傾向を報知することは、グルコース測定の傾向が、前記推奨ボーラス及び送達される前記実際のボーラスとともにボーラス送達後に減少しているというテキストメッセージを表示することを含む、請求項5に記載の方法。
- 前記低い傾向閾値は、30分毎に約20mg/dLのグルコース濃度の低下率を含み、前記高い傾向閾値は、30分毎に約20mg/dLのグルコース濃度の増加する変化率を含む、請求項1に記載の方法。
- 糖尿病管理用システムであって、
別個の不均一な時間間隔にて被検体の流体サンプル中のグルコースレベルを測定して、ボーラス計算の入力データとしてそのような一時的なグルコースレベルを提供する一時的なグルコース計と、
別個の概して均一な時間間隔にて前記被検体のグルコースレベルを連続的に測定して、ボーラス計算に使用することができるグルコース測定データの形態でそれぞれの間隔にて前記グルコースレベルを提供する連続グルコースモニターと、
インスリンを前記被検体に送達するインスリン輸液ポンプと、
前記ポンプ、グルコース計、及び前記グルコースモニターと連通したマイクロコントローラであって、前記マイクロコントローラが前記被検体にボーラス推奨値を提供し、前記ポンプにより送達された実際のボーラスが前記ボーラス推奨値以外であるかどうか評価し、送達された前記実際のボーラスが前記ボーラス推奨値以外である場合、一定期間にわたってグルコース値の傾向を判定して、送達された実際のボーラス及びボーラス推奨値とともにユーザーに低い傾向又は高い傾向のうちの1つを報知するように構成されている、マイクロコントローラと、
を備える、システム。 - 前記低い傾向閾値は、30分毎に約20mg/dLのグルコース濃度の低下率を含み、前記高い傾向閾値は、30分毎に約20mg/dLのグルコース濃度の増加する変化率を含む、請求項8に記載のシステム。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/098,353 US9861747B2 (en) | 2013-12-05 | 2013-12-05 | Method and system for management of diabetes with a glucose monitor and infusion pump to provide feedback on bolus dosing |
US14/098,353 | 2013-12-05 | ||
PCT/US2014/066095 WO2015084581A1 (en) | 2013-12-05 | 2014-11-18 | Bolus dosing feedback for the management of diabetes |
Publications (2)
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JP2016540564A true JP2016540564A (ja) | 2016-12-28 |
JP6549577B2 JP6549577B2 (ja) | 2019-07-24 |
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JP2016534654A Active JP6549577B2 (ja) | 2013-12-05 | 2014-11-18 | 糖尿病管理用ボーラス投与フィードバック |
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US (2) | US9861747B2 (ja) |
EP (1) | EP3077023B1 (ja) |
JP (1) | JP6549577B2 (ja) |
KR (1) | KR20160094391A (ja) |
CN (1) | CN105813668B (ja) |
AU (1) | AU2014357567B2 (ja) |
CA (1) | CA2932263C (ja) |
ES (1) | ES2759110T3 (ja) |
RU (1) | RU2687572C1 (ja) |
TW (2) | TWI639131B (ja) |
WO (1) | WO2015084581A1 (ja) |
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JP6874155B2 (ja) | 2017-05-05 | 2021-05-19 | イーライ リリー アンド カンパニー | 生理的グルコースの閉ループ制御 |
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2013
- 2013-12-05 US US14/098,353 patent/US9861747B2/en active Active
-
2014
- 2014-11-18 CN CN201480066343.6A patent/CN105813668B/zh not_active Expired - Fee Related
- 2014-11-18 EP EP14867860.0A patent/EP3077023B1/en active Active
- 2014-11-18 ES ES14867860T patent/ES2759110T3/es active Active
- 2014-11-18 CA CA2932263A patent/CA2932263C/en active Active
- 2014-11-18 WO PCT/US2014/066095 patent/WO2015084581A1/en active Application Filing
- 2014-11-18 AU AU2014357567A patent/AU2014357567B2/en not_active Ceased
- 2014-11-18 KR KR1020167017385A patent/KR20160094391A/ko not_active Application Discontinuation
- 2014-11-18 JP JP2016534654A patent/JP6549577B2/ja active Active
- 2014-11-18 RU RU2016126607A patent/RU2687572C1/ru not_active IP Right Cessation
- 2014-12-03 TW TW103141893A patent/TWI639131B/zh not_active IP Right Cessation
- 2014-12-03 TW TW107129096A patent/TWI667629B/zh not_active IP Right Cessation
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2017
- 2017-12-11 US US15/837,358 patent/US10188796B2/en active Active
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Also Published As
Publication number | Publication date |
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CA2932263C (en) | 2021-11-23 |
CN105813668A (zh) | 2016-07-27 |
US9861747B2 (en) | 2018-01-09 |
ES2759110T3 (es) | 2020-05-07 |
US10188796B2 (en) | 2019-01-29 |
WO2015084581A1 (en) | 2015-06-11 |
AU2014357567A1 (en) | 2016-06-09 |
EP3077023B1 (en) | 2019-09-18 |
TW201843646A (zh) | 2018-12-16 |
TWI639131B (zh) | 2018-10-21 |
AU2014357567B2 (en) | 2019-03-28 |
RU2687572C1 (ru) | 2019-05-15 |
KR20160094391A (ko) | 2016-08-09 |
CA2932263A1 (en) | 2015-06-11 |
EP3077023A1 (en) | 2016-10-12 |
JP6549577B2 (ja) | 2019-07-24 |
EP3077023A4 (en) | 2017-08-16 |
US20150157792A1 (en) | 2015-06-11 |
CN105813668B (zh) | 2019-11-15 |
US20180104411A1 (en) | 2018-04-19 |
TW201535305A (zh) | 2015-09-16 |
TWI667629B (zh) | 2019-08-01 |
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