WO2004089203A1 - Method and device for obtaining an indication of a glucose concentration value in the blood - Google Patents

Method and device for obtaining an indication of a glucose concentration value in the blood Download PDF

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Publication number
WO2004089203A1
WO2004089203A1 PCT/NL2004/000232 NL2004000232W WO2004089203A1 WO 2004089203 A1 WO2004089203 A1 WO 2004089203A1 NL 2004000232 W NL2004000232 W NL 2004000232W WO 2004089203 A1 WO2004089203 A1 WO 2004089203A1
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WIPO (PCT)
Prior art keywords
parameter values
momentary
glucose concentration
response
values
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PCT/NL2004/000232
Other languages
French (fr)
Inventor
Jelle Nanna Feitsma
Original Assignee
Fetrics Holland V.O.F.
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Publication of WO2004089203A1 publication Critical patent/WO2004089203A1/en

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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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels

Definitions

  • the present invention relates to a method for obtaining an indication of a glucose concentration value in the blood of a person.
  • the invention relates to a device for obtaining an indication of a glucose concentration value in the blood of a person.
  • WO 97/15227 states that for non-diabetic subjects there is a correlation between changes in the electrocardiogram (ECG) and glucose concentration values in the blood. These changes in the ECG are the result of changes in the insulin level in the blood which influence the plasma concentrations of potassium as a consequence of insulin-mediated cellular potassium uptake. For insulin-dependent patients (type I), wherein the insulin level is below a basal value, the glucose concentration in the plasma is hereby not correlated to the ECG.
  • the object of the invention is to provide a method with which an indication of the glucose concentration in the blood of a person can be obtained in simple and effective manner.
  • the method must be specifically suitable for obtaining an indication of a glucose concentration value in the blood of a person suffering from diabetes mellitus.
  • the person is therefore preferably a patient.
  • the invention therefore relates to a method for obtaining an indication of a glucose concentration value in the blood of a person.
  • the method according to the invention comprises the steps of:
  • the measured momentary value of a number of parameters representing the pumping power of the heart can be any momentary value of a parameter which at the very least gives an indication of the pumping power of the heart.
  • a momentary value is here understood to mean the parameter value at a given moment.
  • "a number” must be understood to mean one or more.
  • pulse pressure refers to the difference in pressure between the systolic and diastolic pressure.
  • systolic pressure (or upper pressure) is understood to mean: the pressure in the systemic part of the blood circulation during the systole of the left ventricle of the heart.
  • diastolic pressure (or lower pressure) is understood to mean: the pressure value in the systemic part of the blood circulation during diastole of the left ventricle of the heart.
  • Measuring of the value of the blood pressure parameters can take place with measuring means which make use of existing techniques.
  • a measuring method is preferably chosen which makes use of a non-invasive measuring method.
  • An example of a non-invasive method for measuring the blood pressure values is an auscultatory blood pressure measurement and/or an oscillometric blood pressure measurement. These measuring methods are known in the art.
  • non-invasive and invasive measuring methods of determining blood pressure parameters can also be applied. It is for instance also possible to arrange an implant subdermally which comprises pressure sensors for measuring blood pressure parameters. Within the scope of the invention this is also considered a non-invasive measuring method, since only the once-only introduction of the implant is invasive, whereafter the pressure measurements per se take place non-invasively.
  • the blood pressure measurement can be performed in automated manner, i.e. without the intervention of a person.
  • the method can hereby be carried out in automated manner.
  • this makes it possible to perform continuous or pseudo-continuous measurement.
  • a more precise monitoring of the glucose concentration in the blood can be obtained using a continuous measurement. This makes it more readily possible to intervene if the glucose concentration in the blood reaches or passes a predetermined reference value. This can reduce the chance of complications resulting from high or low glucose concentrations in the blood, whereby the quality of life of for instance a diabetes mellitus patient can be improved.
  • the measured momentary parameter value is converted into a response as a function of the momentary parameter value and an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration.
  • the response obtained is here an indication of the glucose concentration value in the blood.
  • the response can comprise an audio-visual signal, such as a number of light signals or a number of auditive signals or a combination thereof.
  • the audio-visual signal can also include a numerical value being shown on a display.
  • the established relation can for instance be a relation between the pulse pressure and the glucose concentration in the blood. It has been found that the relation between the pulse pressure and the glucose concentration in the blood can be described by a substantially linear relation.
  • reference parameter values can be determined which correspond to a predetermined glucose concentration in the blood.
  • These reference parameter values can for instance be related to physiologically relevant glucose concentration values, such as for instance an upper limit, a lower limit, an ideally desired value and optionally intermediate or surrounding values.
  • the response can therefore also be brought about as a function of a number of momentary parameter values and a number of established reference parameter values. This provides the advantage that, once the reference parameter values have been established, the conversion step becomes simpler since the momentary parameter values no longer have to be processed on the basis of the relation between parameters representing the pumping power of the heart and the glucose concentration in the blood.
  • the invention relates to a device for obtaining an indication of a glucose concentration value in the blood of a person, comprising:
  • - input means for inputting a number of momentary values of a number of parameters representing the pumping power of the heart
  • the momentary value of a number of parameters representing the pumping power of the heart can be any momentary value of a parameter which at the very least gives an indication of the pumping power of the heart.
  • the momentary value is here understood to mean the parameter value at a given moment.
  • the input of the momentary parameter values can be carried out manually by a person.
  • the input means can therefore comprise means suitable for inputting data by a person, such as for instance a keyboard.
  • the input may originate from an electronic measuring apparatus.
  • the input means can therefore comprise means suitable for receiving data from an electronic measuring apparatus, such as for instance an interface.
  • the memory means for storing a number of predetermined parameter values which can be connected to the input means can be existing memory means suitable for this purpose.
  • the measured momentary parameter value is converted into a response as a function of a number of momentary parameter values and a number of predetermined parameter values.
  • the predetermined parameter values can herein be parameter values corresponding to predetermined glucose concentration values.
  • the relation between predetermined parameter values and glucose concentration values is within the relation found between a number of parameters representing the pumping power of the heart and the glucose concentration in the blood. It is not therefore necessary for the response as a function of the momentary parameter values to comprise a conversion of the momentary parameter values on the basis of an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration in the blood.
  • the response means can be a means which is suitable for giving a signal comprising an audio-visual signal, such as a number of light signals or a number of auditive signals or a combination thereof.
  • the response can also comprise an electrical signal for an apparatus.
  • the function on the basis of which the momentary parameter value and an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration is converted into a response can be any suitable switching function.
  • the function can thus be based on a number of threshold values on the basis of which a switching action takes place, for instance when a threshold value is reached or exceeded.
  • the function can for instance be based on one switching moment with which two different switching actions can be generated. A plurality of switching moments can be applied to generate a plurality of switching actions.
  • the function can be based on the absolute value of the result from the established relation.
  • a response can also be provided as a function of momentary parameter values and an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration.
  • the device according to the invention can therefore have the feature that:
  • the at least one memory means is replaced by at least one memory means adapted to store an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration, and the device comprises:
  • At least one conversion means which can be connected to the memory means for converting the number of momentary parameter values into a glucose concentration value on the basis of the established relation, and - the at least one response means is replaced by at least one response means for providing a response as a function of the momentary parameter values and the established relation.
  • the response hereby depends on the established relation, whereby it can be made dependent on a glucose concentration value. It hereby becomes possible, among other things, that the audio-visual signal can also comprise a numerical value, of for instance a glucose concentration value, being shown on a display.
  • the memory means can be existing memory means suitable for storing an established relation between parameters and/or parameter values.
  • the conversion means can be a means suitable for converting data, such as a data-processing means comprising a microprocessor.
  • Parameters representing the pumping power of the heart can comprise a blood pressure parameter. It has been found that a good correlation exists between the pulse pressure value and the glucose concentration in the blood.
  • the pulse pressure is therefore preferably chosen as parameters representing the pumping power of the heart.
  • pulse pressure refers to the difference in pressure between the systolic and diastolic pressure.
  • systolic pressure or upper pressure
  • diastolic pressure or lower pressure
  • the established relation between a number of parameters representing the pumping power of the heart and the glucose concentration in the blood can for instance be a relation between the pulse pressure and the glucose concentration in the blood. It has been found that the relation between the pulse pressure and the glucose concentration in the blood can be described by a substantially linear relation.
  • a particular embodiment of the device according to the invention has the feature that the input means comprise measuring means, which measuring means are provided with sensors for measuring parameters representing the pumping power of the heart.
  • the measuring means for measuring the momentary parameter values can hereby be integrated into the device according to the invention.
  • the measurement can herein be performed with little or no intervention by a person, whereby measurement can be performed automatically or pseudo-automatically.
  • the advantage of an automatic measurement is that an autonomously functioning system can hereby be obtained.
  • An autonomously operating system is not only very convenient to use, but also makes it possible to use the device as or in a monitoring system, since the system can continue to monitor the condition of the person to whom it is coupled, irrespective of whether the person is conscious or not. In addition, this makes it possible to perform continuous or pseudo- continuous measurement.
  • a more precise monitoring of the glucose concentration in the blood can be obtained using a continuous measurement. This makes it more readily possible to intervene if the glucose concentration in the blood or a parameter representing the pumping power of the heart reaches or passes a determined reference value. This can reduce the chance of complications resulting from high or low glucose concentrations in the blood, whereby the quality of life of diabetes mellitus patients can be improved.
  • Measurement of the value of blood pressure parameters can take place with sensors which make use of existing techniques. Suitable sensors are for instance pressure sensors.
  • a measuring method is preferably chosen which makes use of a non-invasive measuring method.
  • An example of a non-invasive method for measuring the blood pressure values is an auscultatory blood pressure measurement and/or an oscillometric blood pressure measurement. These measuring methods are known in the professional field.
  • Other non-invasive and invasive measuring methods for determining blood pressure parameters can also be applied. It is for instance possible to arrange an implant subdermally which comprises pressure sensors for measuring blood pressure parameters. Within the scope of the invention this is also considered a non-invasive measuring method, since only the once-only introduction of the implant is invasive, whereafter the pressure measurements per se take place non-invasively.
  • the response means comprises at least one display means for displaying at least one glucose concentration value and/or a number of parameters representing the pumping power of the heart.
  • the display means can be an alphanumeric display on which the glucose concentration value and/or a number of parameters representing the pumping power of the heart are displayed numerically.
  • the glucose concentration and/or a number of parameters representing the pumping power of the heart can be displayed graphically.
  • the glucose concentration value can also be displayed as a function of time if the measurement takes place continuously or pseudo-continuously.
  • the device according to the invention is preferably portable. It is particularly advantageous when the device comprises a housing which can be worn round the wrist of the person. This has the advantage that the device can be permanently connected to the person for some time, thereby enabling a continuous or pseudo- continuous measurement. Attachment round the wrist herein also makes possible an auscultatory and/or an oscillometric blood pressure measurement.
  • auscultatory and oscillometric blood pressure measurements is that they are completely non-invasive.
  • the correlations found between parameters representing the pumping power of the heart and the glucose concentration in the blood are sufficiently general to have a predictive value for a large population of subjects. It will nevertheless be the case that there is some variation present per person in the correlations found.
  • a number of glucose concentration values of the blood which are determined by means of another measuring method, can therefore be inputted as calibration values.
  • a correlation can be established for a specific person, or an already established correlation can be modified for a specific person.
  • the device according to the invention therefore comprises input means for inputting a number of calibration values of the glucose concentration
  • This response can be a signal which is an indication of a glucose concentration value in the blood or a physiological condition associated with a glucose concentration in the blood.
  • the signal can comprise a number of auditive and/or visual signals.
  • Visual signals can for instance comprise light signals and/or a numerical value being shown on a display.
  • the person or a physician can determine whether a glucose concentration in the blood is too high or too low, or lies within a good range. Intervention is possible on the basis hereof, for instance by glucose intake or administering insulin.
  • the device according to the invention can generate a signal if a number of the parameter values, or a value which is a function of a number of the parameter values, reaches or exceeds a threshold value.
  • a signal can be an audio-visual signal which in such a case will warn the person or his vicinity.
  • the signal can comprise a radio signal.
  • Such a radio signal can be coupled to a monitoring system as described in EP 0 880 936.
  • the device according to the invention comprises as response means pump means for introducing a quantity of insulin into a person.
  • the pump means can be arranged externally on the body of the person with a connection to the vascular system of the person. It is however also possible to implant the pump means and/or other elements of the device according to the invention in the body of the person.
  • the invention is further elucidated by way of illustration on the basis of the following, non-limitative example making use of the figures 1-5.
  • the figures show graphically the progression in time of the glucose concentration in the blood of 5 test subjects. Shown is the glucose concentration in the blood as determined using a digital blood sugar monitor (X) and as determined with the method according to the invention ( ⁇ ).
  • the blood sugar value measurement was performed as quickly as possible using a digital blood sugar monitor (accu-check compact; roche; article number 2248832001, serial number: GF00046924). This value was also carefully noted. The measurement procedure was repeated as carefully as possible every half-hour (or at another determined interval) for a continuous period of several hours. After the data had been obtained, the data were processed by plotting the measured glucose concentrations in the blood against the pulse pressure (systolic pressure - diastolic pressure). Using regression analysis of the collected data, a clear relation could be established between the pulse pressure and the glucose concentration in the blood. For the measurement data obtained from the measurements on the 15 test subjects, the best correlation was found for the relation:
  • A is the glucose concentration in the blood in mmol/1
  • B is a constant with the value 0.6
  • X is the measured pulse pressure value (systolic - diastolic) in mm Hg
  • C is a constant with the value 38.6.
  • Figures 1-5 show the results of 5 test subjects. It is apparent that a good prediction of the value of the glucose concentration in the blood can be given with the found relation.

Abstract

The present invention relates to a device for obtaining an indication of a glucose concentration value in the blood of a person, comprising: -input means for inputting a number of momentary values of a number of parameters representing the pumping power of the heart, -at least one memory means which can be connected to the input means and which is adapted to store a number of predetermined parameters values, -at least one response means for providing a response as a function of the momentary parameter values and predetermined parameter values. The momentary value of a number of parameters representing the pumping power of the heart can be any momentary value of a parameter which at the very least gives an indication of the pumping power (blood pressure) of the heart.

Description

METHOD AND DEVICE FOR OBTAINING AN INDICATION OF A GLUCOSE CONCENTRATION VALUE IN THE BLOOD
The present invention relates to a method for obtaining an indication of a glucose concentration value in the blood of a person. In a further aspect the invention relates to a device for obtaining an indication of a glucose concentration value in the blood of a person. WO 97/15227 states that for non-diabetic subjects there is a correlation between changes in the electrocardiogram (ECG) and glucose concentration values in the blood. These changes in the ECG are the result of changes in the insulin level in the blood which influence the plasma concentrations of potassium as a consequence of insulin-mediated cellular potassium uptake. For insulin-dependent patients (type I), wherein the insulin level is below a basal value, the glucose concentration in the plasma is hereby not correlated to the ECG.
The object of the invention is to provide a method with which an indication of the glucose concentration in the blood of a person can be obtained in simple and effective manner. The method must be specifically suitable for obtaining an indication of a glucose concentration value in the blood of a person suffering from diabetes mellitus. The person is therefore preferably a patient.
It has been found that there is a correlation between the pulse pressure and the glucose concentration in the blood. This correlation is also present in diabetes patients. Although the background to this correlation is not yet proven, applicants believe that the power generated by the heart muscle is correlated to the amount of energy (glucose) available to the heart muscle. This correlation is found at the level of the pulse pressure. It is however anticipated that this correlation can also be found for other parameters representing the pumping power of the heart.
In a first aspect the invention therefore relates to a method for obtaining an indication of a glucose concentration value in the blood of a person. The method according to the invention comprises the steps of:
- providing at least one measuring means for measuring a number of parameters representing the pumping power of the heart,
- measuring momentary values of the number of parameters using the measuring means,
- providing a conversion means for converting momentary parameter values into a response as a function of parameter values and an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration,
- converting measured momentary parameter values into a response using the conversion means. The measured momentary value of a number of parameters representing the pumping power of the heart can be any momentary value of a parameter which at the very least gives an indication of the pumping power of the heart. A momentary value is here understood to mean the parameter value at a given moment. Within the context of the invention "a number" must be understood to mean one or more. As already noted, there is good correlation between the pulse pressure value and the glucose concentration in the blood. The pulse pressure is therefore preferably chosen as the parameter representing the pumping power of the heart. Within the context of the present invention the term pulse pressure refers to the difference in pressure between the systolic and diastolic pressure. Within the context of this invention systolic pressure (or upper pressure) is understood to mean: the pressure in the systemic part of the blood circulation during the systole of the left ventricle of the heart. Within the context of this invention the diastolic pressure (or lower pressure) is understood to mean: the pressure value in the systemic part of the blood circulation during diastole of the left ventricle of the heart. Measuring of the value of the blood pressure parameters can take place with measuring means which make use of existing techniques. A measuring method is preferably chosen which makes use of a non-invasive measuring method. An example of a non-invasive method for measuring the blood pressure values is an auscultatory blood pressure measurement and/or an oscillometric blood pressure measurement. These measuring methods are known in the art. Other non-invasive and invasive measuring methods of determining blood pressure parameters can also be applied. It is for instance also possible to arrange an implant subdermally which comprises pressure sensors for measuring blood pressure parameters. Within the scope of the invention this is also considered a non-invasive measuring method, since only the once-only introduction of the implant is invasive, whereafter the pressure measurements per se take place non-invasively.
In addition, it is advantageous if the blood pressure measurement can be performed in automated manner, i.e. without the intervention of a person. The method can hereby be carried out in automated manner. In addition, this makes it possible to perform continuous or pseudo-continuous measurement. A more precise monitoring of the glucose concentration in the blood can be obtained using a continuous measurement. This makes it more readily possible to intervene if the glucose concentration in the blood reaches or passes a predetermined reference value. This can reduce the chance of complications resulting from high or low glucose concentrations in the blood, whereby the quality of life of for instance a diabetes mellitus patient can be improved.
In the method according to the invention the measured momentary parameter value is converted into a response as a function of the momentary parameter value and an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration. The response obtained is here an indication of the glucose concentration value in the blood. The response can comprise an audio-visual signal, such as a number of light signals or a number of auditive signals or a combination thereof. The audio-visual signal can also include a numerical value being shown on a display. The established relation can for instance be a relation between the pulse pressure and the glucose concentration in the blood. It has been found that the relation between the pulse pressure and the glucose concentration in the blood can be described by a substantially linear relation. A substantially linear relation is understood to mean a mathematical relation or function which, at least in a certain interval, is substantially defined by a relation which can be described with a first degree equation of the general type y=Ax±B. It may however be the case that for particular individuals the relation between the pulse pressure and the glucose concentration in the blood can be better described by another relation. It must therefore be understood that the invention is not limited to linear relations between the pulse pressure and the glucose concentration in the blood.
Once the relation between parameters representing the pumping power of the heart and the glucose concentration in the blood has been established, reference parameter values can be determined which correspond to a predetermined glucose concentration in the blood. These reference parameter values can for instance be related to physiologically relevant glucose concentration values, such as for instance an upper limit, a lower limit, an ideally desired value and optionally intermediate or surrounding values. The response can therefore also be brought about as a function of a number of momentary parameter values and a number of established reference parameter values. This provides the advantage that, once the reference parameter values have been established, the conversion step becomes simpler since the momentary parameter values no longer have to be processed on the basis of the relation between parameters representing the pumping power of the heart and the glucose concentration in the blood. hi a subsequent aspect the invention relates to a device for obtaining an indication of a glucose concentration value in the blood of a person, comprising:
- input means for inputting a number of momentary values of a number of parameters representing the pumping power of the heart,
- at least one memory means which can be connected to the input means and which is adapted to store a number of predetermined parameter values, - at least one response means for providing a response as a function of the momentary parameter values and predetermined parameter values. The momentary value of a number of parameters representing the pumping power of the heart can be any momentary value of a parameter which at the very least gives an indication of the pumping power of the heart. The momentary value is here understood to mean the parameter value at a given moment.
The input of the momentary parameter values can be carried out manually by a person. The input means can therefore comprise means suitable for inputting data by a person, such as for instance a keyboard. In addition, the input may originate from an electronic measuring apparatus. The input means can therefore comprise means suitable for receiving data from an electronic measuring apparatus, such as for instance an interface.
The memory means for storing a number of predetermined parameter values which can be connected to the input means can be existing memory means suitable for this purpose. In the device according to the invention the measured momentary parameter value is converted into a response as a function of a number of momentary parameter values and a number of predetermined parameter values. The predetermined parameter values can herein be parameter values corresponding to predetermined glucose concentration values. The relation between predetermined parameter values and glucose concentration values is within the relation found between a number of parameters representing the pumping power of the heart and the glucose concentration in the blood. It is not therefore necessary for the response as a function of the momentary parameter values to comprise a conversion of the momentary parameter values on the basis of an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration in the blood. This relation can also be established by determining parameter values which are known to correspond to predetermined glucose concentration values, for instance physiologically relevant glucose concentration values. The response means can be a means which is suitable for giving a signal comprising an audio-visual signal, such as a number of light signals or a number of auditive signals or a combination thereof. The response can also comprise an electrical signal for an apparatus.
The function on the basis of which the momentary parameter value and an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration is converted into a response can be any suitable switching function. The function can thus be based on a number of threshold values on the basis of which a switching action takes place, for instance when a threshold value is reached or exceeded. The function can for instance be based on one switching moment with which two different switching actions can be generated. A plurality of switching moments can be applied to generate a plurality of switching actions. In addition, the function can be based on the absolute value of the result from the established relation.
A response can also be provided as a function of momentary parameter values and an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration. The device according to the invention can therefore have the feature that:
- the at least one memory means is replaced by at least one memory means adapted to store an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration, and the device comprises:
- at least one conversion means which can be connected to the memory means for converting the number of momentary parameter values into a glucose concentration value on the basis of the established relation, and - the at least one response means is replaced by at least one response means for providing a response as a function of the momentary parameter values and the established relation.
The response hereby depends on the established relation, whereby it can be made dependent on a glucose concentration value. It hereby becomes possible, among other things, that the audio-visual signal can also comprise a numerical value, of for instance a glucose concentration value, being shown on a display.
The memory means can be existing memory means suitable for storing an established relation between parameters and/or parameter values. The conversion means can be a means suitable for converting data, such as a data-processing means comprising a microprocessor.
Parameters representing the pumping power of the heart can comprise a blood pressure parameter. It has been found that a good correlation exists between the pulse pressure value and the glucose concentration in the blood. The pulse pressure is therefore preferably chosen as parameters representing the pumping power of the heart. Within the context of the present invention the term pulse pressure refers to the difference in pressure between the systolic and diastolic pressure. Within the context of this invention systolic pressure (or upper pressure) is understood to mean: the pressure in the systemic part of the blood circulation during the systole of the left ventricle of the heart. Within the context of this invention the diastolic pressure (or lower pressure) is understood to mean: the pressure value in the systemic part of the blood circulation during diastole of the left ventricle of the heart.
The established relation between a number of parameters representing the pumping power of the heart and the glucose concentration in the blood can for instance be a relation between the pulse pressure and the glucose concentration in the blood. It has been found that the relation between the pulse pressure and the glucose concentration in the blood can be described by a substantially linear relation. A substantially linear relation is understood to mean a mathematical relation or function which, at least in a determined interval, is substantially defined by a relation which can be described with a first degree equation of the general type y=Ax±B. It may however be the case that for particular individuals the relation between the pulse pressure and the glucose concentration in the blood can be better described by another relation. It must therefore be understood that the invention is not limited to linear relations between the pulse pressure and the glucose concentration in the blood.
A particular embodiment of the device according to the invention has the feature that the input means comprise measuring means, which measuring means are provided with sensors for measuring parameters representing the pumping power of the heart. The measuring means for measuring the momentary parameter values can hereby be integrated into the device according to the invention. The measurement can herein be performed with little or no intervention by a person, whereby measurement can be performed automatically or pseudo-automatically. The advantage of an automatic measurement is that an autonomously functioning system can hereby be obtained. An autonomously operating system is not only very convenient to use, but also makes it possible to use the device as or in a monitoring system, since the system can continue to monitor the condition of the person to whom it is coupled, irrespective of whether the person is conscious or not. In addition, this makes it possible to perform continuous or pseudo- continuous measurement. A more precise monitoring of the glucose concentration in the blood can be obtained using a continuous measurement. This makes it more readily possible to intervene if the glucose concentration in the blood or a parameter representing the pumping power of the heart reaches or passes a determined reference value. This can reduce the chance of complications resulting from high or low glucose concentrations in the blood, whereby the quality of life of diabetes mellitus patients can be improved.
Measurement of the value of blood pressure parameters can take place with sensors which make use of existing techniques. Suitable sensors are for instance pressure sensors. A measuring method is preferably chosen which makes use of a non-invasive measuring method. An example of a non-invasive method for measuring the blood pressure values is an auscultatory blood pressure measurement and/or an oscillometric blood pressure measurement. These measuring methods are known in the professional field. Other non-invasive and invasive measuring methods for determining blood pressure parameters can also be applied. It is for instance possible to arrange an implant subdermally which comprises pressure sensors for measuring blood pressure parameters. Within the scope of the invention this is also considered a non-invasive measuring method, since only the once-only introduction of the implant is invasive, whereafter the pressure measurements per se take place non-invasively. hi a further embodiment the response means comprises at least one display means for displaying at least one glucose concentration value and/or a number of parameters representing the pumping power of the heart. The display means can be an alphanumeric display on which the glucose concentration value and/or a number of parameters representing the pumping power of the heart are displayed numerically. In addition, it is possible for the glucose concentration and/or a number of parameters representing the pumping power of the heart to be displayed graphically. The glucose concentration value can also be displayed as a function of time if the measurement takes place continuously or pseudo-continuously.
The device according to the invention is preferably portable. It is particularly advantageous when the device comprises a housing which can be worn round the wrist of the person. This has the advantage that the device can be permanently connected to the person for some time, thereby enabling a continuous or pseudo- continuous measurement. Attachment round the wrist herein also makes possible an auscultatory and/or an oscillometric blood pressure measurement. The advantage of auscultatory and oscillometric blood pressure measurements is that they are completely non-invasive. The correlations found between parameters representing the pumping power of the heart and the glucose concentration in the blood are sufficiently general to have a predictive value for a large population of subjects. It will nevertheless be the case that there is some variation present per person in the correlations found. In a particular embodiment of the device according to the invention a number of glucose concentration values of the blood, which are determined by means of another measuring method, can therefore be inputted as calibration values. On the basis of the inputted calibration values and the measured parameter values of the number of parameters representing the pumping power of the heart, a correlation can be established for a specific person, or an already established correlation can be modified for a specific person. In a particular embodiment the device according to the invention therefore comprises input means for inputting a number of calibration values of the glucose concentration,
- memory means for storing the inputted calibration values and a number of momentary parameter values,
- analysing means for determining a relation between stored calibration values and momentary parameter values.
Using the device according to the invention a response is obtained as a function of momentary parameter values and predetermined parameter values. This response can be a signal which is an indication of a glucose concentration value in the blood or a physiological condition associated with a glucose concentration in the blood. The signal can comprise a number of auditive and/or visual signals. Visual signals can for instance comprise light signals and/or a numerical value being shown on a display. On the basis of the auditive or visual signals the person or a physician can determine whether a glucose concentration in the blood is too high or too low, or lies within a good range. Intervention is possible on the basis hereof, for instance by glucose intake or administering insulin.
In addition, the device according to the invention can generate a signal if a number of the parameter values, or a value which is a function of a number of the parameter values, reaches or exceeds a threshold value. Such a signal can be an audio-visual signal which in such a case will warn the person or his vicinity. It is also possible for the signal to comprise a radio signal. Such a radio signal can be coupled to a monitoring system as described in EP 0 880 936.
It is also possible to connect the device according to the invention to means which can provide for the introduction of insulin into the person. These means can be activated if the parameter values reach or pass a predetermined threshold value. It is hereby possible to achieve that the device according to the invention intervenes autonomously by injecting insulin if the glucose concentration in the blood becomes too high. It is also possible to link the introduction of the quantity of insulin to the rate of the fall in the glucose concentration. The amount administered and/or speed of administering can hereby be modified on the basis of the change in glucose concentration through time. In a particular embodiment the device according to the invention therefore comprises as response means pump means for introducing a quantity of insulin into a person. The pump means can be arranged externally on the body of the person with a connection to the vascular system of the person. It is however also possible to implant the pump means and/or other elements of the device according to the invention in the body of the person.
The invention is further elucidated by way of illustration on the basis of the following, non-limitative example making use of the figures 1-5. The figures show graphically the progression in time of the glucose concentration in the blood of 5 test subjects. Shown is the glucose concentration in the blood as determined using a digital blood sugar monitor (X) and as determined with the method according to the invention (□).
Figure 1 shows the determined glucose concentrations in test subject 1, wherein t=0 corresponds to 14.00 hours.
Figure 2 shows the determined glucose concentrations in test subject 2, wherein t=0 corresponds to 14.12 hours.
Figure 3 shows the deteπnined glucose concentrations in test subject 3, wherein t=0 corresponds to 14.18 hours. Figure 4 shows the determined glucose concentrations in test subject 4, wherein t=0 corresponds to 7.45 hours.
Figure 5 shows the determined glucose concentrations in test subject 5, wherein t=0 corresponds to 14.18 hours.
Example
For purposes of comparison two independent blood glucose determinations were carried out on 15 diabetes patients. These were the blood glucose determination according to the invention and a measurement with a digital blood sugar monitor (accu-check compact; roche; article number 2248832001, serial number GF00046924). Systolic and diastolic blood pressure values were first determined by inflating an inflatable cuff at biceps height to beyond an anticipated systolic blood pressure. The cuff was then deflated steadily by allowing it to empty slowly, wherein an electronic stethoscope (littman model 4000) provided the auditive signal to enable measuring of systolic and diastolic blood pressure. The measured values were carefully noted. After noting of these pressure values, the pulse frequency (heart rate) was likewise measured. This was within a range of 50 to 150 pulses per minute for all patients.
After measuring of the blood pressure values, the blood sugar value measurement was performed as quickly as possible using a digital blood sugar monitor (accu-check compact; roche; article number 2248832001, serial number: GF00046924). This value was also carefully noted. The measurement procedure was repeated as carefully as possible every half-hour (or at another determined interval) for a continuous period of several hours. After the data had been obtained, the data were processed by plotting the measured glucose concentrations in the blood against the pulse pressure (systolic pressure - diastolic pressure). Using regression analysis of the collected data, a clear relation could be established between the pulse pressure and the glucose concentration in the blood. For the measurement data obtained from the measurements on the 15 test subjects, the best correlation was found for the relation:
A = B (X-C), wherein
A is the glucose concentration in the blood in mmol/1 B is a constant with the value 0.6 X is the measured pulse pressure value (systolic - diastolic) in mm Hg C is a constant with the value 38.6.
Figures 1-5 show the results of 5 test subjects. It is apparent that a good prediction of the value of the glucose concentration in the blood can be given with the found relation.

Claims

1. Method for obtaining an indication of a glucose concentration value in the blood of a person, comprising of: - providing at least one measuring means for measuring a number of parameters representing the pumping power of the heart,
- measuring momentary values of the number of parameters using the measuring means,
- providing a conversion means for converting momentary parameter values into a response as a function of parameter values and an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration,
- converting measured momentary parameter values into a response using the conversion means.
2. Method as claimed in claim 1, characterized in that on the basis of the established relation a number of reference parameter values is predetermined and the conversion of momentary parameter values into a response takes place as a function of momentary parameter values and the predetermined reference parameter values.
3. Method as claimed in claims 1-2, characterized in that the number of parameters representing the pumping power of the heart comprises a blood pressure parameter.
4. Method as claimed in any of the claims 1-3, characterized in that the number is one and that the blood pressure parameter is the pulse pressure.
5. Device for obtaining an indication of a glucose concentration value in the blood of a person, comprising:
- input means for inputting a number of momentary values of a number of parameters representing the pumping power of the heart,
- at least one memory means which can be connected to the input means and which is adapted to store a number of predetermined parameter values, - at least one response means for providing a response as a function of the momentary parameter values and predetermined parameter values.
6. Device as claimed in claim 5, characterized in that
- the at least one memory means is replaced by at least one memory means adapted to store an established relation between a number of parameters representing the pumping power of the heart and the glucose concentration, and the device comprises:
- at least one conversion means which can be comiected to the memory means for converting the number of momentary parameter values into a glucose concentration value on the basis of the established relation, and
- the at least one response means is replaced by at least one response means for providing a response as a function of the momentary parameter values and the established relation.
7. Device as claimed in claims 5-6, characterized in that the number is one and the blood pressure parameter is the pulse pressure.
8. Device as claimed in claims 5-6, characterized in that the input means comprise measuring means, which measuring means are provided with sensors for measuring parameters representing the pumping power of the heart.
9. Device as claimed in claim 8, characterized in that the sensors comprise pressure sensors.
10. Device as claimed in claim 9, characterized in that the pressure sensors are suitable for measuring systolic and diastolic blood pressure values.
11. Device as claimed in any of the claims 5-10, characterized in that the at least one response means comprises at least one display means for displaying an indication of at least one of a momentary parameter value and a glucose concentration value.
12. Device as claimed in any of the claims 5-11, characterized in that it further comprises a housing which can be worn round the wrist of the person.
13. Device as claimed in any of the claims 5-12, characterized in that it comprises:
- input means for inputting a number of calibration values of the glucose concentration,
- memory means for storing inputted calibration values and a number of momentary parameter values, - analysing means for determining a relation between stored calibration values and momentary parameter values.
14. Device as claimed in any of the claims 5, 7-13, characterized in that the at least one response means comprises means for giving a signal as a function of a number of momentary parameter values and predetermined parameter values.
15. Device as claimed in any of the claims 6-13, characterized in that the at least one response means comprises means for giving a signal as a function of a number of momentary parameter values and the established relation.
16. Device as claimed in any of the claims 5, 7-14, characterized in that the at least one response means comprises pump means for introducing a quantity of insulin into the person as a function of a number of momentary parameter values and predetermined parameter values.
17. Device as claimed in any of the claims 6-13, 15, characterized in that the at least one response means comprises pump means for introducing a quantity of insulin into the person as a function of a number of momentary parameter values and the established relation.
PCT/NL2004/000232 2003-04-11 2004-04-08 Method and device for obtaining an indication of a glucose concentration value in the blood WO2004089203A1 (en)

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Citations (3)

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WO1997015227A1 (en) * 1995-10-26 1997-05-01 Medtronic, Inc. Continuous monitoring of diabetes-related blood constituents
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