DK2525863T3 - Fremgangsmåde og anordning til forbedring af glykæmisk styring - Google Patents

Fremgangsmåde og anordning til forbedring af glykæmisk styring Download PDF

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Publication number
DK2525863T3
DK2525863T3 DK11734450.7T DK11734450T DK2525863T3 DK 2525863 T3 DK2525863 T3 DK 2525863T3 DK 11734450 T DK11734450 T DK 11734450T DK 2525863 T3 DK2525863 T3 DK 2525863T3
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Denmark
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insulin
data
dose
value
values
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DK11734450.7T
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English (en)
Inventor
Ofer Yodfat
Gali Shapira
Iddo M Gescheit
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Hoffmann La Roche
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • 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
    • A61M5/1413—Modular systems comprising interconnecting elements
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • 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
    • 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
    • A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • 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
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Optics & Photonics (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (18)

1. Fremgangsmåde til anbefaling af en insulindosis tilpasset til anvendelse med en insulinindgivelsesanordning, hvilken fremgangsmåde omfatter: modtagelse af blodglucose- (BG) data, der indbefatter et koncentrationsniveau for kropsglucose; bestemmelse af en insulinsensitivitets- (IS) værdi svarende til BG-dataene; og bestemmelse af en insulindosis baseret på den bestemte IS-værdi, hvor insulindosen bestemmes ud fra følgende ligning: Anbefalet bolus = (Carbs/CIR) + (CBG-TBG)/IS - RI hvor: Carbs er mængden af carbohydrater, der skal indtages; CIR er forholdet mellem carbohydrat og insulin; CBG er det aktuelle blodgluc o seniveau; TBG er målblodglucoseniveauet; IS insulinsensitivitetsværdien bestemt svarende til BG-dataene; og RI er det resterende insulin, der er tilbage i en patients krop, kendetegnet ved, at: insulinsensitivitets- (IS) værdibestemmelsen indbefatter valg af IS-værdien fra en tabel/skema, hvori IS-værdier svarer til koncentrationsniveauerne for kropsglucose.
2. Fremgangsmåde ifølge krav 1, hvor BG-dataene omfatter BG-niveau.
3. Fremgangsmåde ifølge krav 2, hvor BG-dataene endvidere omfatter BG-tendens.
4. Fremgangsmåde ifølge krav 1, hvor modtagelse af BG-data indbefatter mindst én af: modtagelse af en indlæsning fra en bruger og modtagelse af et signal fra en glucosemonitor.
5. Fremgangsmåde ifølge krav 1, der endvidere omfatter visuel visning af IS-værdier som en funktion af BG-data.
6. Fremgangsmåde ifølge krav 5, hvor visuel visning indbefatter visning af en graf eller en tabel, der viser match mellem IS-værdier og BG-dataene.
7. Fremgangsmåde ifølge krav 1, der endvidere omfatter visuel visning af IS-værdier i form af et interval.
8. Fremgangsmåde ifølge krav 1, der endvidere omfatter hentning fra en hukommelse af IS-værdien svarende til BG-dataene.
9. Fremgangsmåde ifølge krav 1, hvor insulindosen indbefatter mindst én af en boluskomponent og en basal komponent.
10. Fremgangsmåde ifølge krav 1, der endvidere omfatter tilvejebringelse af en insulinpumpe med en processor, der har en dosisvejlederapplikation, der fungerer derpå, hvilken dosisvejleder er konfigureret til at bestemme IS-værdien og insulindosen.
11. Computerprogram, der omfatter instruktioner til udførelse af fremgangsmådens trin ifølge et hvilket som helst af krav 1 til 10, når computerprogrammet udføres på en egnet computerenhed.
12. Computerlæsbart medium, hvorpå der er kodet et computerprogram ifølge krav 11.
13. Lægemiddelindgivelsesanordning, der omfatter midler tilpasset til at udføre fremgangsmådens trin ifølge et hvilket som helst af kravene 1 til 10.
14. Lægemiddelindgivelsesanordning ifølge krav 13, der omfatter: en pumpe til indgivelse af lægemidlet i en brugers krop; indlæsningsmidler til modtagelse af mindst én af blodglucose- (BG) data og insulinsensitivitets- (IS) værdier; en processor med en dosisvejlederapplikation, der fungerer derpå, konfigureret til at bestemme IS-værdien baseret på BG-dataene; en hukommelse til lagring af BG-dataene og IS-værdien; og et display til visning af udlæsning forbundet med IS-værdien.
15. Anordning ifølge krav 14, hvor BG-dataene modtages fra en kontinuerlig glucosemonitor (CGM).
16. Anordning ifølge krav 14, hvor dosisvejlederen genererer en anbefalet insulindosis forbundet med IS-værdien.
17. Anordning ifølge krav 14, hvor indlæsningsmidlerne indbefatter én eller flere af: mindst én knap/kontakt, et tastatur, en berørings skærm, en stemmekommando, et glucometer og en CGM.
18. Anordning ifølge krav 14, der endvidere indbefatter mindst én kanyle, der kan indføres subkutant for indgivelse af den anbefalede insulindosis.
DK11734450.7T 2010-01-20 2011-01-20 Fremgangsmåde og anordning til forbedring af glykæmisk styring DK2525863T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US29654010P 2010-01-20 2010-01-20
PCT/IL2011/000061 WO2011089600A1 (en) 2010-01-20 2011-01-20 A method and device for improving glycemic control

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DK2525863T3 true DK2525863T3 (da) 2019-01-21

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US (1) US9457145B2 (da)
EP (1) EP2525863B1 (da)
DK (1) DK2525863T3 (da)
ES (1) ES2704845T3 (da)
WO (1) WO2011089600A1 (da)

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EP2525863A1 (en) 2012-11-28
EP2525863B1 (en) 2018-12-05
ES2704845T3 (es) 2019-03-20
US9457145B2 (en) 2016-10-04
EP2525863A4 (en) 2014-08-13
WO2011089600A1 (en) 2011-07-28
US20130030358A1 (en) 2013-01-31

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