NL2034198B1 - System for regulating the concentration of glucose in the blood of a person - Google Patents

System for regulating the concentration of glucose in the blood of a person Download PDF

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Publication number
NL2034198B1
NL2034198B1 NL2034198A NL2034198A NL2034198B1 NL 2034198 B1 NL2034198 B1 NL 2034198B1 NL 2034198 A NL2034198 A NL 2034198A NL 2034198 A NL2034198 A NL 2034198A NL 2034198 B1 NL2034198 B1 NL 2034198B1
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NL
Netherlands
Prior art keywords
slope
person
glucose concentration
supplied
certain amount
Prior art date
Application number
NL2034198A
Other languages
Dutch (nl)
Inventor
Koops Robin
Original Assignee
Inreda Diabetic B V
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Inreda Diabetic B V filed Critical Inreda Diabetic B V
Priority to NL2034198A priority Critical patent/NL2034198B1/en
Priority to PCT/EP2024/054376 priority patent/WO2024175636A1/en
Application granted granted Critical
Publication of NL2034198B1 publication Critical patent/NL2034198B1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • A61M5/172Means 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
    • A61M5/1723Means 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • A61M5/16804Flow controllers
    • A61M5/16827Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M2005/14208Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • A61M5/172Means 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
    • A61M5/1723Means 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
    • A61M2005/1726Means 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

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Diabetes (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)

Abstract

The invention relates to a system for regulating the concentration of glucose in the blood of a person, comprising: 5 - a device for selectively supplying at least one and preferably two substances, - at least one and preferably two infusion sets connectable to said device for infusing a said substance to said person; - at least one sensor for measuring a glucose concentration in the blood of said person; - a controller for controlling said device such that a certain amount of a said substance is 10 supplied per time unit and thereby infused into the body of the person via said or a respective infusion set, wherein said certain amount is chosen in accordance with the measured glucose concentration, wherein said controller is arranged to determine a slope of the measured glucose concentration, and wherein the time unit per which the certain amount is supplied is dependent on said slope.

Description

SYSTEM FOR REGULATING THE CONCENTRATION OF GLUCOSE IN THE BLOOD OF
A PERSON
The invention relates to a system for regulating the concentration of glucose in the blood of a person, comprising: - a device for selectively supplying at least one and preferably two substances, - at least one and preferably two infusion sets connectable to said device for infusing a said substance to said person; - at least one sensor for measuring a glucose concentration in the blood of said person: - a controller for controlling said device such that a certain amount of a said substance is supplied per time unit and thereby infused into the body of the person via said or a respective infusion set, wherein said certain amount is chosen in accordance with the measured glucose concentration.
Such a system is known from for example the international patent application with number
WO2007/049961 in the name of the same applicant. WO2007/049961 in particular teaches a program which incorporates an adjustable glucagon injection curve represented by a first formula (mI(E)/ fall mmol/l / unit of time) and an adjustable insulin injection curve represented by a second formula (ml(E)/ rise mmol/l / unit of time) corresponding to an amount of glucagon or insulin respectively introduced into the body of the patient. and the nominal concentration of the glucose in the blood of the patient as a reaction thereto.
It is an object of the invention to improve the system described in WO2007/049961 and in particular the program thereof.
This object is achieved by providing a system according to the preamble, wherein the controller is arranged to determine a slope of the measured glucose concentration, and wherein the time unit per which the certain amount is supplied is dependent on said slope. Alternatively formulated, the frequency with which the certain amount is supplied, for example expressed in number of dosages or units per minute, is dependent on said slope.
The slope of the measured glucose concentration is defined by the change of measured glucose concentration in time, i.e. the fall or rise of the measured glucose concentration in time. By adjusting or changing the time unit per which the certain amount is supplied in dependence on said slope, a said substance is supplied more or less frequently in dependence of said slope. This is an improvement with respect to the system described in WO2007/049961, wherein the time unit per which the certain amount is supplied is a fixed time unit and therefore independent of the slope of the measured glucose concentration, because this allows the system to better and/or quicker correct for changes in the glucose concentration in the blood of the person.
Said slope of the measured glucose concentration may for example be defined in mmol/liter/hour, 1.¢. the change of measured glucose concentration in mmol/Liter per hour.
Said at least one and preferably two substances may for example be insulin and glucagon.
Said controller may comprise a program comprising the above described adjustable glucagon injection curve represented by a first formula (ml(E)/ fall mmol/l / unit of time) and the above described adjustable insulin injection curve represented by a second formula (ml(E)/ rise mmol/l / unit of time), wherein said unit of time per which the glucagon or insulin is injected is adjusted in dependence of said slope.
Said program may be stored in a memory of said controller.
The controller may receive the measured glucose concentration from the sensor, wherein the sensor is able to communicate with the controller. Communication preferably takes place wirelessly, for example via a transmitter, but may alternatively take place via a wire.
In an embodiment of the system according to the invention the time unit per which the certain amount is supplied is decreased in case of a steeper slope, such that in case of a steeper slope the at least one substance is supplied more frequently, and vice versa.
An advantage of an increase in the frequency of the supply of said substance in case of a steeper slope is that the response of the glucose values to the supply of substance may be quicker. This may prevent excessive glucose values, both at the upper and lower level. A less steep or flat slope implies that the glucose concentration in the blood of the person does not change very quickly such that it is possible to less frequently supply the substance, which may also help keeping the slope flat and thereby the glucose concentration in the blood stable.
The slope for insulin is in particular a positive slope and the slope for glucagon is in particular anegative slope.
It is noted that a steeper slope may alternatively be defined as a slope having a higher value for insulin and a slope having a lower value for glucagon, as compared to a more flat slope. For example, the slope for insulin may lie between approximately 0 — 15 mmol/l/h and at a slope of about 5 mmol/l/h the time unit per which the certain amount is supplied is shorter, i.e. the frequency of supply is higher, than at a slope of about 0 mmol/l/h and at a slope of about 10 mmol/l/h the time unit per which the certain amount is supplied is shorter than at a slope of about 5 mmol/lI/h and so forth. For example, the slope for glucagon may lie between approximately 0 — -15 mmol/l/h and at a slope of about -5 mmol/l/h the time unit per which the certain amount is supplied is shorter, 1.e. the frequency of supply is higher, than at a slope of about 0 mmol/I'h and at a slope of about -10 mmol/l/h the time unit per which the certain amount is supplied is shorter than at a slope of about -5 mmol/l/h and so forth.
As described above, the certain amount of said substance supplied per time unit is chosen in accordance with the measured glucose concentration. If the certain amount is decreased when the frequency of supply is increased, i.e. smaller dosages are supplied more often, the total amount of substance supplied in a certain time frame may remain the same. If the certain amount is not decreased when the frequency of supply is increased, 1.e. same size dosages are supplied more often, the total amount of substance supplied in a certain time frame may increase. The average infusion rate in a certain time frame is calculated by multiplying the number of dosages supplied in that time frame by the dosage size. As described above, the average infusion rate may either increase or remain the same if the frequency of supply is increased and may either decrease or remain the same if the frequency of supply is decreased, dependent on the dosage size.
In order to measure the glucose concentration frequently enough to be able to determine the slope thereof, it is advantageous if said sensor substantially continuous measures said glucose concentration. Said sensor may in particular be a so called Continuous Glucose Monitoring (CMG) sensor for substantially continuously measuring the glucose concentration. Such sensor may for example measure the glucose concentration every few seconds, such as every 5, 10, 15, 20, 25, 30, 40, 45,50, or 55 seconds, or every few minutes, such as every 1, 2, 3, 4, 5 minutes. It is preferred to measure the glucose concentration at least every 5 or 10 seconds.
The invention will be further explained with respect to figures in which:
Figure 1 schematically shows the system according to an embodiment of the invention;
Figures 2a and 2b show the average infusion rate of two substances respectively in units per minute, and
Figure 3 shows the infusion rates of figures 2a and 2b in a combined figure.
Figure 1 shows a system for regulating the concentration of glucose in the blood of a person.
The system comprises in this exemplary embodiment a device 1 for selectively supplying in this embodiment two substances contained in respective reservoirs 2, 3, which reservoirs 2, 3 can be received in respective receiving spaces of the device 1. In this embodiment the two substances are insulin and glucagon, respectively. Respective two infusion sets 4, 5 are connected to said device 1 in a fluid communicating manner with the respective reservoirs 2, 3 for infusing a said substance to said person. In this embodiment the infusion sets 4,5 each comprise a respective hose or tube 8.9 for transporting a respective substance to an infusion element 10, 11 of that infusion set 4,5. The infusion elements 10, 11 each comprise a canula 12, 13 which may be inserted into the body of the person for infusing the substance into the body of the person. In this embodiment one sensor 6 for measuring a glucose concentration in the blood of said person is provided. In this embodiment the sensor 6 is shown to be a separate sensor but alternatively the sensor may be combined with one of the infusion sets 4, 5, in particular with the infusion element 10, 11 thereof. It may be preferred to provide two glucose sensors 6, wherein optionally each sensor 6 is combined with a respective infusion set. A controller 7 is provided, in this embodiment as part of the device 1, for controlling said device 1 such that a certain amount of any one of the two substances is supplied per time unit and thereby infused into the body of the person via said or a respective infusion set 4. 5, wherein said certain amount is chosen in accordance with the measured glucose concentration. In accordance with the invention said controller 7 1s arranged to determine a slope of the measured glucose concentration, wherein the time unit per which the certain amount is supplied is dependent on said slope, which will be explained with respect to figures 2a. 2b and 3.
Figure 2a and 2b respectively show the amount of insulin and glucagon to be injected in dosages or Units (U)/minute into the body of a person in dependence of the measured glucose concentration in mmol/Liter and in dependence of the slope of the measured glucose concentration in mmol/Liter/hour. The slope of the measured glucose concentration is defined by the change of measured glucose concentration in time, i.e. the rise or fall of the measured glucose concentration in time. Figure 2a shows that the number of units per minute supplied to said person increases with increasing positive slope for insulin, and increases with decreasing negative slope for glucagon, as seen at a certain measured glucose concentration. In other words, the steeper the positive or negative slope becomes, the more frequently insulin and glucagon are supplied, respectively. Figures 2a and 2b show that the slope for insulin lies approximately between 0 and 15 mmol/L/H and that the slope for glucagon lies approximately between 0 and -15 mmol/L/H. Figures 2a and 2b further show that the measured glucose concentration range in which insulin is supplied lies between approximately 6 and 20 mmol/L and for glucagon this range lies between approximately 2 and 5.5 mmol/L. The number of dosages in units per minute supplied to said person is here both dependent on the measured glucose concentration, i.e. at higher glucose concentration values for insulin and at lower glucose concentration values for glucagon more units per minute are supplied, and on the slope of the measured glucose concentration, 1.e. at any given glucose concentration value more units per minute are supplied at positive higher number slopes for insulin and at negative lower number slopes for glucagon.
Figure 3 shows the curves of figures 2a and 2b in a combined curve.
It is noted that the invention is not limited to the shown embodiments but also extends to variants within the scope of the appended claims.

Claims (4)

ConclusiesConclusions 1. Systeem voor het reguleren van de concentratie van glucose in het bloed van een persoon, omvattende: 5 - een inrichting voor het selectief toevoeren van ten minste één en bij voorkeur twee substanties: - ten minste één en bij voorkeur twee infusiesets die met de inrichting verbonden kunnen worden voor het infuseren van een genoemde substantie in de persoon; - ten minste één sensor voor het meten van een glucoseconcentratie in het bloed van de persoon; - cen aanstuurinrichting voor het zodanig aansturen van de inrichting, dat per tijdseenheid cen bepaalde hoeveelheid van een genoemde subsantie wordt toegevoerd en daarmee via een genoemde of een respectieve infusieset in het lichaam van de persoon wordt geinfuseerd, waarbij de bepaalde hoeveelheid wordt gekozen in overeenstemming met de gemeten glucoseconcentratie; met het kenmerk, dat de aanstuurinrichting is ingericht voor het bepalen van een helling van de gemeten glucoseconcentratie, en waarbij de tijdseenheid per waarmee de bepaalde hoeveelheid wordt toegevoerd afhankelijk is van de helling.1. A system for regulating the concentration of glucose in the blood of a person, comprising: 5 - a device for selectively supplying at least one and preferably two substances: - at least one and preferably two infusion sets connectable to the device for infusing a said substance into the person; - at least one sensor for measuring a glucose concentration in the blood of the person; - a control device for controlling the device in such a way that a certain amount of a said substance is supplied per unit of time and is thereby infused into the body of the person via a said or a respective infusion set, the certain amount being selected in accordance with the measured glucose concentration; characterised in that the control device is adapted to determine a slope of the measured glucose concentration, and the unit of time per which the certain amount is supplied is dependent on the slope. 2. Svsteem volgens conclusie 1, waarbij de tijdseenheid per waarmee de bepaalde hoeveelheid wordt toegevoerd wordt verlaagd in geval van een steilere helling, zodanig, dat in het geval van een steilere helling de ten minste ene substantie vaker wordt toegevoerd, en omgekeerd.2. System according to claim 1, wherein the time unit at which the determined quantity is supplied is reduced in the case of a steeper slope, such that in the case of a steeper slope the at least one substance is supplied more often, and vice versa. 3. Systeem volgens conclusie 1 of 2. waarbij de ten minste ene substantie insuline of glucagon is en indien de inrichting is ingericht voor het selectief toevoeren van twee substanties deze twee substanties insuline en glucagon zijn.3. A system according to claim 1 or 2, wherein the at least one substance is insulin or glucagon and if the device is adapted to selectively supply two substances, these two substances are insulin and glucagon. 4. Systeem volgens conclusie 3. waarbij de helling voor insuline een positieve helling is en waarbij de helling voor glucagon een negatieve helling is.4. The system of claim 3, wherein the slope for insulin is a positive slope and the slope for glucagon is a negative slope.
NL2034198A 2023-02-21 2023-02-21 System for regulating the concentration of glucose in the blood of a person NL2034198B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
NL2034198A NL2034198B1 (en) 2023-02-21 2023-02-21 System for regulating the concentration of glucose in the blood of a person
PCT/EP2024/054376 WO2024175636A1 (en) 2023-02-21 2024-02-21 System for regulating the concentration of glucose in the blood of a person

Applications Claiming Priority (1)

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NL2034198A NL2034198B1 (en) 2023-02-21 2023-02-21 System for regulating the concentration of glucose in the blood of a person

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NL2034198B1 true NL2034198B1 (en) 2024-09-03

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4151845A (en) * 1977-11-25 1979-05-01 Miles Laboratories, Inc. Blood glucose control apparatus
WO2007049961A2 (en) 2005-10-26 2007-05-03 Inreda Diabetic B.V. Device for automatic regulation of the concentration of glucose in the blood of a diabetes patient
WO2010142734A1 (en) * 2009-06-10 2010-12-16 Imperial Innovations Limited A glucagon pump controller
US20110054391A1 (en) * 2006-07-28 2011-03-03 Ward W Kenneth Analyte sensing and response system
US8226556B2 (en) * 2005-02-01 2012-07-24 Medtronic Minimed, Inc. Algorithm sensor augmented bolus estimator for semi-closed loop infusion system

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4151845A (en) * 1977-11-25 1979-05-01 Miles Laboratories, Inc. Blood glucose control apparatus
US8226556B2 (en) * 2005-02-01 2012-07-24 Medtronic Minimed, Inc. Algorithm sensor augmented bolus estimator for semi-closed loop infusion system
WO2007049961A2 (en) 2005-10-26 2007-05-03 Inreda Diabetic B.V. Device for automatic regulation of the concentration of glucose in the blood of a diabetes patient
US20110054391A1 (en) * 2006-07-28 2011-03-03 Ward W Kenneth Analyte sensing and response system
WO2010142734A1 (en) * 2009-06-10 2010-12-16 Imperial Innovations Limited A glucagon pump controller

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WO2024175636A1 (en) 2024-08-29

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