DK2174128T3 - Fremgangsmåde og anordning til evaluering af carbohydrat-til-insulin-forhold - Google Patents

Fremgangsmåde og anordning til evaluering af carbohydrat-til-insulin-forhold Download PDF

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DK2174128T3
DK2174128T3 DK08826517.8T DK08826517T DK2174128T3 DK 2174128 T3 DK2174128 T3 DK 2174128T3 DK 08826517 T DK08826517 T DK 08826517T DK 2174128 T3 DK2174128 T3 DK 2174128T3
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patient
insulin
carbohydrate
glucose level
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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
    • A61B5/14503—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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • 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
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • 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
    • 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
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • 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
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • 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
    • 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
    • A61M2005/1726—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 the body parameters being measured at, or proximate to, the infusion site
    • 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
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission

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Claims (14)

1. System til bestemmelse af et evalueret carbohydrat-til-insulin-forhold (CIRnew) for en patient, hvilket system omfatter: en hukommelseskomponent, der er tilpasset til at lagre et initialt sæt af værdier omfattende mindst et normoglykæmi-glucoseniveau (BGo), et målglucoseniveau (TBG), en insulinsensitivitet (IS) og et estimeret carbohydrat-til-insulin-forhold (CIRoid); en bolusudvælgelseskomponent, der er tilpasset til udvælgelse af en testbolus svarende til det lagrede initiale sæt af værdier og et planlagt måltid; en brugergrænsefladekomponent, der er tilpasset til udvælgelse af et måltid med et kendt indhold af kendt carbohydratladning (Carbs); en glucoseregistreringskomponent, der er tilpasset til periodisk bestemmelse af et postprandialt glucoseniveau (CBG) for patienten efter administration af testbolussen og indtagelse af det planlagte måltid; og en CIR-evalueringskomponent, der er tilpasset til bestemmelse af det evaluerede carbohydrat-til-insulin-forhold (CIRnew) for patienten baseret på det initiale sæt af værdier og værdien for det postprandiale glucoseniveau (CBG), hvor bestemmelsen af det postprandiale glucoseniveau (CBG) gentages, indtil: enten et i alt væsentligt konstant glucoseniveau (BGi) er opnået, i hvilket tilfælde det evaluerede carbohydrat-til-insulin-forhold (CIRnew) beregnes som:
når forskellen (ABG) mellem BGi og BGo er større end en forhåndsbestemt værdi (Y), og
når forskellen (ABG) mellem BGi og BGo er mindre end den forhåndsdefinerede værdi (Y); eller et normalt postprandialt glucoseniveau er opnået, i hvilket tilfælde det evaluerede carbohydrat-til-insulin-forhold (CIRnew) beregnes som:
hvor η = antal perioder anvendt til bestemmelse af det evaluerede carbohydrat-til-insulin-forhold (CIRnew) i = en tæller, der kendetegner hver periode CBi = en nødvendig korrektionsbolus, når CBG er over TBG CGi = en nødvendig glucosekorrektion, når CBG er under TBG
2. System ifølge krav 1, hvor, hvis en forskel mellem værdien for normoglykæmi-glucoseniveauet (BGo) og værdien for det postprandiale glucoseniveau ligger inden for et forhåndsdefineret interval, det evaluerede carbohydrat-til-insulin-forhold (CIRnew) bestemmes til at være i alt væsentligt det samme som patientens initiale carbohydrat-til-insulin-forhold (CIR0id).
3. System ifølge krav 1, hvor, hvis en forskel mellem værdien for normoglykæmi-glucoseniveauet (BGo) og værdien for det postprandiale glucoseniveau ikke ligger inden for et forhåndsbestemt interval, carbohydrat-til-insulin-forholdet evalueres igen.
4. System ifølge krav 1, hvor indholdet af det kendte måltid omfatter carbohydrater med et relativt højt glykæmisk indeks.
5. System ifølge krav 1, hvor, hvis en forskel i glucoseniveaueme beregnet ved fratrækning af værdien for normoglykæmi-glucoseniveauet (BGo) fra værdien for det postprandiale glucoseniveau er større end en forhåndsbestemt værdi, brugerinterfacekomponenten endvidere er tilpasset til at råde patienten til at administrere en korrektionsbolus.
6. System ifølge krav 1, hvor, hvis en forskel i glucoseniveaueme beregnet ved fratrækning af værdien for det postprandiale glucoseniveau ffa værdien for normoglykæmi-glucoseniveauet (BGo) er større end en forhåndsbestemt værdi, brugerinterfacekomponenten endvidere er tilpasset til at råde patienten til at indtage en mængde carbohydrater for at opnå målglucoseniveauet.
7. System ifølge krav 1, hvor brugerinterfacekomponenten er tilpasset til at råde patienten til at faste i et tidsrum før bestemmelse af det initiale sæt af værdier.
8. System ifølge krav 1, hvor brugerinterfacekomponenten endvidere er tilpasset til at råde patienten til at opnå normoglykæmi før bestemmelse af det initiale sæt af værdier.
9. System ifølge krav 1, hvor det evaluerede carbohydrat-til-insulin-forhold (CIRnew) bestemmes baseret på mindst én af en korrektionsbolus og en korrektionsglucose.
10. System ifølge krav 1, hvor glucoseregistreringskomponenten omfatter en CGM.
11. System ifølge krav 1, hvilket system endvidere omfatter en insulininfusionskomponent koblet til glucoseregistreringskomponenten.
12. System ifølge krav 11, hvor insulininfusionskomponenten er konfigureret som en patchenhed, der kan klæbe til patientens hud, og systemet endvidere omfatter en ή emstyringsenhed, der er konfigureret til at kommunikere med patchenheden og endvidere konfigureret til at tillade programmering og dataregistrering.
13. System ifølge krav 1, hvor korrektionsbolussen (CB,), der er nødvendig, når det postprandiale glucoseniveau (CBG) er over målglucoseniveauet (TBG), beregnes på følgende måde:
14. Fremgangsmåde til bestemmelse af et evalueret carbohydrat-til-insulin-forhold (CIR„ew) for en patient, hvilken fremgangsmåde omfatter: bestemmelse (50, 51) af et initialt sæt af værdier omfattende mindst et normoglykæmi-glucoseniveau (BGo), et målglucoseniveau (TBG), en insulinsensitivitet (IS), og et estimeret carbohydrat-til-insulin-forhold (CIRoid); udvælgelse (52) af et planlagt måltid med et kendt indhold af kendt carbohydratladning (Carbs); udvælgelse (53) af en testbolus svarende til det bestemte initiale sæt af værdier og det planlagte måltid; bestemmelse (55) af patientens postprandiale glucoseniveau (CBG) efter administration af testbolussen og indtagelse af det planlagte måltid; bestemmelse (57), (58), (80) af det evaluerede carbohydrat-til-insulin-forhold (CIRnew) for patienten baseret på det initiale sæt af værdier og det postprandiale glucoseniveau (CBG) for patienten, hvor bestemmelsen af det postprandiale glucoseniveau (CBG) gentages, indtil: enten et i alt væsentligt konstant glucoseniveau (BGi) er opnået, i hvilket tilfælde det evaluerede carbohydrat-til-insulin-forhold (CIRnew) beregnes som:
når forskellen (ABG) mellem BGi og BGo er større end en forhåndsbestemt værdi (Y) og
når forskellen (ΔΒΟ) mellem BGi og BGo er mindre end den forhåndsdefinerede værdi (Y); eller et normalt postprandialt glucoseniveau er opnået, i hvilket tilfælde det evaluerede carbohydrat-til-insulin-forhold (CIRnew) beregnes som:
hvor n = antal af perioder anvendt til bestemmelse af det evaluerede carbohydrat-til-insulin-forhold (CIRnew) i = en tæller, der kendetegner hver periode CBi = en nødvendig korrektionsbolus, når CBG er over TBG CG, = en nødvendig glucosekorrektion, når CBG er under TBG.
DK08826517.8T 2007-06-20 2008-06-20 Fremgangsmåde og anordning til evaluering af carbohydrat-til-insulin-forhold DK2174128T3 (da)

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US93669007P 2007-06-20 2007-06-20
PCT/IB2008/003185 WO2009013637A2 (en) 2007-06-20 2008-06-20 Method and device for assessing carbohydrate-to-insulin ratio

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