DE102014005101A1 - Portable device and method for determining an insulin-determining characteristic - Google Patents

Abstract

The invention relates to a method for determining a parameter, in particular an insulin dose-determining characteristic, and a portable device (1), comprising at least one data processing device (6) for at least electronic storage and processing of a decision matrix, wherein the decision matrix has at least one blood glucose value and at least two or all values selected from the group consisting of insulin value, HbAlc value and cortisol value, and wherein the processing of the decision matrix by the data processing device (6) leads to the determination of a parameter, in particular an insulin dose-determining parameter.

Description

The present invention relates to a portable device and a method for determining a parameter, in particular a insulin dose-determining parameter.

According to the study on adult health in Germany of the Robert Koch Institute ( DEGS1, "Prevalence and timing of known diabetes mellitus", Bundesgesundheitsblatt 56: 668-677, 2013 ), the lifetime prevalence of diabetes mellitus increased from 5.2% of the total population to 7.2% from 1998 to 2012. Diabetes is diagnosed more often in obese than in normal weight. In Germany, about 90% of diabetic patients suffer from type 2 diabetes (non-primary insulin-dependent diabetes mellitus) and only just under 5% from type 1 diabetes (primary insulin-dependent diabetes mellitus). Type 1 diabetics suffer from insulin deficiency syndrome, which can only be treated with lifelong insulin therapy. In contrast, type 2 diabetics usually suffer from a disruption of insulin action (insulin resistance), although the body produces sufficient insulin, but the body cells do not respond or insufficiently to (endogenous and injected) insulin.

People who suffer from diabetes usually need to check their blood sugar levels several times a day. Mostly the blood sugar value is determined on the basis of blood glucose meters. Such devices for indirect determination of an insulin dose to be administered are described in the prior art in a variety of embodiments. The most common devices suitable for everyday use are usually portable handsets with a slide-in device for a test strip carrying an isolated blood sample. Based on a measurement of the blood sugar value, the patient can therefore independently determine whether his blood sugar level is too high or too low.

Basically, the blood sugar level rises after the intake of carbohydrate-rich food. In healthy people, the hormone insulin, which lowers the glucose level in the blood, is produced in response to a rise in blood sugar levels by beta-cells in the pancreatic islets of Langerhans. In addition to food intake, blood sugar levels can also be increased by glucagon (the antagonist of insulin), adrenaline and / or cortisol. If necessary - namely, if the blood glucose level is too high - it is recommended in principle that diabetes patients inject an insulin dose in order to lower the blood sugar level to a standard value. This means that the determination of a necessary dose of insulin usually takes place indirectly, in that only the blood sugar value is determined. For example, symptoms that can be associated with high blood sugar levels include frequent urination as the body tries to excrete glucose through the urine, fatigue and listlessness, weight loss or dry skin. In people with type 2 diabetes, however, there are very often no clear symptoms, as the blood sugar level in the body increases only slowly, but continuously over months or years. Therefore, it is relatively difficult to diagnose type 2 diabetes, which is why this form of diabetes is discovered in many cases only by accident. However, in the case of a delayed diagnosis, there is often already a consequential health risk for the person concerned. Due to an insufficiency, for example, the binding of insulin to the insulin receptors of these patients or a reduced number of insulin receptors, the blood sugar level in these patients can sometimes not or not sufficiently lowered by the injection of insulin. In these cases, it may even be possible for the patient to suffer from hyperinsulinism - a condition in which the concentration of insulin in the blood goes far beyond normal levels.

A major disadvantage of conventional devices suitable for everyday use is therefore in particular that only the blood glucose value is determined therewith. Although blood glucose levels may sometimes be used to give an indirect indication of the need to administer an insulin dose, especially for patients suffering from insulin resistance, this results in the measurement of elevated blood sugar levels by the injection of insulin No or hardly any lowering of the blood sugar level can be achieved. Only a very high level of insulin in the blood can at least partially break through insulin resistance based on the oversupply of insulin. In the long term, however, this type of treatment can lead to serious health problems.

It is therefore the technical object to provide a portable device and / or a method that is suitable for everyday use and by which can determine whether it is appropriate that an insulin dose must be administered especially at an elevated blood sugar level.

The solution of this object is achieved by the present portable device according to claim 1 and in particular by providing a portable device comprising at least one data processing device for at least electronic storage and processing of a decision matrix, wherein the decision matrix at least one blood glucose value and at least two or all values selected from the group consisting of insulin value, HbAlc value and cortisol value, and wherein the processing of the decision matrix by a, for example, the already mentioned data processing device for determining a characteristic, in particular an insulin dose-determining characteristic leads.

In one embodiment of the invention, it is provided that the data processing device is set up for electronically storing a decision matrix comprising a plurality of measured values, the decision matrix having at least one blood sugar value and at least two or all values selected from the group consisting of insulin value, HbAlc value, cortisol value and optionally additionally at least one or more values, preferably all values selected from the group consisting of adrenalin value, skin resistance value and pulse rate value, and that the data processing matrix processes these measured values encompassed by the decision matrix in such a way that, for example, a parameter is determined in particular in the form of a numerical value.

The evaluation of a parameter determined using the portable device according to the invention can provide an indication and / or the basis for a judgment as to how a patient whose body parameters have been analyzed should behave in the future and / or how he should be treated in the future. It is envisaged that the evaluation of the particular characteristic will lead to the possibility of assessing whether the patient should undergo medical treatment, for example if there is a medical emergency or if the patient, for example, is practicing more endurance sports, depending on the determined value of the parameter should. It is additionally provided that the evaluation of the characteristic variable determined by means of the portable device according to the invention, in particular an insulin dose-determining characteristic, can provide an indication and / or a basis for a judgment that the patient should not be given insulin injection despite an elevated blood sugar level. Furthermore, it is conceivable that the evaluation of the parameter, in particular the insulin dose-determining characteristic, may be an indication and / or a basis for a diagnosis of long-term diabetes or newly occurring diabetes.

In order to determine the characteristic even more accurately in certain circumstances, it may be advantageous for the decision matrix of the portable device according to the invention to comprise one or more values, preferably all values selected from the group consisting of adrenalin value, skin resistance value and pulse rate value. The extension of the decision matrix by additional values - in addition to the essential values - may under certain circumstances further increase the relevance and significance of the parameter determined thereby.

In a further embodiment of the invention, the portable device according to the invention comprises at least one measuring device or devices for determining at least one or more, preferably all values selected from the group consisting of blood sugar value, insulin value, HbAlc value and cortisol value or selected from the group consisting Blood sugar value, insulin value, HbAlc value, cortisol value, adrenaline value, skin resistance value and pulse rate value.

In a further embodiment, the portable device according to the invention comprises a first measuring device for determining the blood sugar value, a second measuring device for determining the insulin value, a third measuring device for determining the HbAlc value, optionally a fourth measuring device for determining the cortisol value and optionally a fifth measuring device for determining of the adrenalin value, wherein at least one or more, preferably all measured values are measured by the measuring devices within a measuring interval or several measuring intervals. A measuring device required for the measurement or the measurements can be provided, for example, in microfluidic technology and / or using methods of dry chemistry known per se.

Preferably, the portable device according to the invention further comprises a sixth measuring device for determining the skin resistance and / or a seventh measuring device for determining the pulse frequency, wherein at least one or more, preferably all measured values are measured by the measuring device or the measuring devices within a measuring interval or several measuring intervals.

For this purpose, it is particularly expedient if the measurement interval or the measurement intervals is / are chosen to be so short that the measurement results are not or only slightly falsified by intervening metabolic conversions or reactions. Preferably, a measurement interval is shorter than a few minutes or seconds, in particular shorter than 10 minutes or even shorter than 10 seconds. However, it is particularly favorable if the measurements are carried out almost simultaneously or simultaneously, ie simultaneously.

In one embodiment of the invention, it can be provided that the data processing device is set up to record and / or process a chronological course of the at least one measured value over a control interval. It is thus possible to use one or more of them combined or separately recorded. Von Vortell is able to provide follow-up during the set control interval, such as a number of hours, days, weeks or months or more. With such a progress control, the relevance and informative value of the parameter determined thereby, in particular the insulin-determining characteristic, can be increased.

It is provided that the measured values are transmitted to a preferably integrated data processing device with integrated storage unit for electronic storage and are preferably processed by one, for example the already mentioned data processing device, so that a parameter, in particular an insulin-determining characteristic, in particular in the form of a numerical value is determined ,

Different measuring devices, in particular for the in vitro measurement of various body parameters, for example with microfluidic technology and / or dry chemistry, are widely known. For example, the blood sugar level may be determined by applying an isolated blood sample to a test matrix, particularly a test strip, for example, from a variety of previously known blood glucose meters.

Furthermore, for example, already in the US Pat. No. 6,893,552 B1 described (see in particular column 1, lines 34-38, column 7, lines 50-67) that the insulin level can be measured in combination with the blood glucose value.

From the US 2006/240401 A1 (see in particular paragraphs 18 and 42) it is also known that it is possible to measure the HbAlc concentration (glycohemoglobin concentration) simultaneously with the blood glucose content by applying an isolated body fluid sample to a disposable strip placed in a device for receiving a test strip introduced into a compact, spectroscopic measuring device and then carried out a measurement of the desired parameters.

In Wang et al., On-Chip Integration of Enzyme and Immunoassays: Simultaneous Measurements of Insulin and Glucose; 125 (28): 8444-5, 2013 published in the Journal of American Chemical Society, also describes a microfluidic biochip system that allows for simultaneous, immunological and enzymatic analysis of glucose and insulin. This microfluidic technology can be advantageously used in the invention.

The relevance or informative value of the measured values can be further increased if an additional, known measuring device, which is set up for measuring a skin conductance, can be connected or integrated. An impedance and / or a resistance of the skin is / are preferably measurable with the further measuring device as a measured variable for the skin conductance, for example via contact surfaces formed laterally on the device according to the invention and / or arranged. For this purpose, the data processing device has at least one data input for the data signals or measuring device. The advantage here is that stress is recognizable, since stress causes a sweat of the subject, whereby the skin resistance is reduced. Thus, in the portable device according to the invention, the stress situation can be reproduced, and it can be taken into account that more sugar is released under stress. For example, the data processing device can be designed and set up such that the influence of stress on the measurement result can be displayed and / or compensated.

In addition, it can be provided that a further measuring device, which is set up to measure a hydrocortisol value, can be connected or integrated. For this purpose, the data processing device of the device according to the invention has at least one data input for the data signals of the measuring device. The advantage here is that the blood sugar value increasing effect of hydrocortisol is considered by distributions of hydrocortisol in the sample can be detected and included in the evaluation of the measured data. The cortisol values of an isolated body fluid sample can be determined, for example, by means of an immunoelectrochemical detection method ( Sun et al., Sensors and Actuators B 133, 533-537, 2008 ), which in particular has the advantage that it can be carried out on the basis of a very small amount of sample. The preparation of the electrochemical cell for which the sample is applied and the method for measurement of cortisol are included in the description with reference to the above-mentioned publication.

In a further embodiment of the invention, additionally or alternatively, it can be provided that a further measuring device, which is set up for measuring a pulse frequency value, can be connected or integrated. In this case, the measuring device can be set up for the simultaneous determination of the oxygen saturation. The advantage here is that a further or additional possibility is provided to recognize and detect stress situations of the examination subject in order to increase the significance of the measured values. For this purpose, the data processing device of the device according to the invention has a data input for the data signals of the measuring device.

It is particularly expedient that the at least one measuring device or the measuring devices of the portable device according to the invention is / are designed for measuring at least one isolated body fluid, in particular isolated blood or isolated saliva. It is expedient that the portable device according to the invention comprises one or more receiving devices for receiving one or more carrier matrix / carrier matrices containing one or more samples. A suitable carrier matrix may be, for example, a test strip (eg, a dry chemistry test strip), a measuring cell (eg, an electrochemical measuring cell), or a chip (eg, a bio-chip) for receiving an isolated body fluid sample, in particular an isolated blood or saliva sample be formed.

In order to make the individual measuring devices as space-saving as possible and thus to create a particularly compact device, it is provided that at least two or more, preferably all measuring devices of the portable device according to the invention are combined in an integral measuring device. In particular, the first measuring device for determining the blood sugar value, the second measuring device for determining the insulin value, the third measuring device for determining HbAlc value, optionally the fourth measuring device for determining the cortisol value and optionally the fifth measuring device for determining the adrenaline value can be combined in an integral measuring device be, with which preferably by means of a measurement with this integral measuring device, the three or four or five parameters can be measured. By designing a compact portable device according to the invention, it is thus possible to determine the values encompassed by the decision matrix without the use of further laboratory measuring devices. This has the particular advantage that the user anywhere and at any time can perform a measurement of the desired parameters, where he can lead the device due to its compact design at any time.

It is particularly expedient that the portable device according to the invention has laterally, preferably on opposite sides formed and / or arranged contact surfaces which are connected to one or the measuring device for measuring a skin resistance.

The portable device according to the invention can have a display, which is preferably integrated, and which is set up to display the measurement results and / or the parameter, in particular the insulin dose-determining parameter.

It can also be provided that means for establishing a preferably wireless data connection with a control center and / or with a PC and / or with a suitable terminal are formed. For example, such a data connection can be set up via a mobile radio connection. It is particularly advantageous if the specific parameter can be transmitted to a diabetes monitoring center, which can be set up, for example, in a control center or in a PC. In this way, on the basis of the transmitted characteristic, the necessary insulin dose and / or drugs for lowering the blood sugar level, for example sulfonylurea, Glucophage or metformin, can be precisely defined, either as a software program of the portable device according to the invention itself or from the control center, for example a diabetes center, out. The advantage here is that the insulin dose and / or the aforementioned drugs is completely tunable to the patient / are.

As a power supply of the portable device according to the invention it is provided that the device for a network-independent operation comprises at least one battery and / or a connection for a power supply for network-dependent operation of the portable device and / or for charging the at least one battery.

The stated object can moreover be achieved by the non-invasive method according to the invention for determining a parameter, in particular an insulin dose-determining parameter, wherein at least one isolated body fluid measures at least the blood sugar value and at least two or all values from the group consisting of insulin value, HbA1c value and cortisol value and / or from one or the determined blood sugar value and at least two or all values from the group consisting of one or the determined insulin value, one or the determined HbAlc value and one or the determined cortisol value, a decision matrix is created or provided, and wherein Processing of the decision matrix, the characteristic, in particular the insulin dose determinant characteristic is determined.

It is envisaged that in the noninvasive method according to the invention at least one or more, preferably all measurements are made on at least one isolated body fluid, preferably on an isolated blood sample and / or isolated saliva sample.

In order to improve the informative value of the parameter, in particular the insulin dose-determining parameter, it is expedient that a value be used in the preparation of the decision matrix of the non-invasive method according to the invention the pulse rate and / or a value of the skin resistance are taken into account.

It is particularly advantageous if a portable device according to the invention is used in the noninvasive method according to the invention. The advantage here is that a meaningful assessment of the body metabolism and in particular a dietary adjustment or a determination of a necessary insulin dose within a short period of time is feasible laboratory-independent / are.

An embodiment of possibly independent significance can provide in the noninvasive method according to the invention that the values mentioned above are first recorded, after which a food intake occurs, after which a new measurement of the values takes place.

In this way, individual nutritional profiles can be created.

In this case, it is particularly favorable to wait at least half an hour between the intake of food and the measurement.

For refinement, several measurements can be taken after ingestion in order to record a course group. This course group can be stored for evaluation and / or archiving in, for example, the already mentioned data processing device and / or transmitted via a preferably wireless data connection.

In this case, it makes sense to carry out the several measurements in the period of the first two hours after the food intake, since a subsequent measurement no longer has any effect with regard to food intake.

The invention will now be described in detail with reference to an embodiment, but is not limited to this embodiment. Further exemplary embodiments result from the combination of the features of individual or several protection claims with one another and / or with one or more features of the exemplary embodiment.

It shows

1 a portable device according to the invention in a highly simplified representation for explaining the functional components,

2 a diagram of an exemplary decision matrix for determining a characteristic.

A whole with 1 designated portable device has at least one receiving device 2 for at least one test strip and / or a measuring cell and / or a chip. The device additionally comprises at least one data processing device for at least electronic storage and processing of a decision matrix, wherein the decision matrix comprises at least one blood sugar value and at least two or all values selected from the group consisting of insulin value, HbAlc value and cortisol value, and wherein the processing of the decision matrix by the data processing device leads to the determination of a parameter, in particular an insulin dose-determining parameter. Optionally, the decision matrix may further comprise at least one or more values, preferably all values selected from the group consisting of adrenalin value, skin resistance value and pulse rate value.

In the embodiment, the recording device 2 formed with a slot-shaped receiving opening into which the evaluated test strips are inserted or retracted.

The test strips were previously contacted with a liquid sample, the substance to be examined.

The liquid sample is a body fluid, for example a drop of blood or saliva drops.

The portable device 1 has in its interior a not shown first measuring device 3 which is set up in a manner known per se for measuring a blood glucose value of the sample on the test strip.

The portable device 2 has a second measuring device 4 also in the portable device 1 is integrated.

The second measuring device 4 is preferably set up on the test strip to measure an insulin value of the sample.

In the portable device 1 is finally a third measuring device 5 integrated, which is adapted for measuring a value of components from the HbA group to the sample preferably on the test strip. In the embodiment, the third measuring device 5 set up to measure a HbAlc value.

In the portable device 1 is also a fourth measuring device 17 designed to measure a Hydrocortisolwertes in a body fluid sample, which is preferably applied to an electrochemical measuring cell. Measuring methods for measuring the hydrocortisol value are known per se and in the measuring device 17 realized.

In the portable device 1 is a data processing device 6 formed, which for data evaluation and storage of a decision matrix to the first measuring device 3 , the second measuring device 4 and the third measuring device 5 connected.

The fourth measuring device 17 is to the data processing device 6 connected to provide a numerical value which depends on the measured hydrocortisol value and which characterizes the stress state of the person from whom the liquid sample was taken on the test strip.

The first measuring device 3 , the second measuring device 4 and the third measuring device 5 and preferably the fourth measuring device 17 are here for simultaneous measurement or for sequential measurement of the by the recording device 2 supplied test strip and preferably an electrochemical measuring cell.

The data processing device 6 is by appropriate programming for the electronic processing of the output signals of the first measuring device 3 , the second measuring device 4 , the third measuring device 5 and the fourth measuring device 17 set up.

With the data processing device 6 Processing results and a resulting decision matrix are stored electronically. Are the first measuring device 3 , the second measuring device 4 and the third measuring device 5 set up and arranged for the sequential measurement of the test strip, the arrangement allows obtaining measurement results 7 within a given measurement interval. This measurement interval is designed so that there are no significant changes in the chemical composition of the sample on the test strip between the individual measurements.

The data processing device 6 is programmed so that the combination of the measuring signals of the first measuring device 3 , the second measuring device 4 , the third measuring device 5 and the fourth measuring device 17 a decision matrix for determining a characteristic variable can be generated, wherein the decision matrix at least one blood sugar value and at least two or all values selected from the group consisting of insulin value, HbAlc value and cortisol value and preferably also at least one or more values, preferably all values selected from the Group consisting of adrenalin value, skin resistance value and pulse rate value. Based on this characteristic, it is possible to determine a necessary insulin dose based on the laws of biological metabolism.

The data processing device 6 is for recording the measurement results 7 and / or the mentioned parameter in an integrated memory unit 8th set up.

In this way, the data processing device 6 a time course of an element or a plurality of elements selected from the group consisting of blood glucose value, insulin value, HbA group value, cortisol value and preferably one or more elements selected from the group consisting of adrenalin value, skin resistance value and pulse rate value and a characteristic, which one to administered insulin dose, evaluated over a temporal control interval.

In the embodiment shown, the first measuring device 3 , the second measuring device 4 and the third measuring device 5 integrated into a common measuring device. In this way, a simultaneous measurement of the sample on the test strip is particularly easy.

In further embodiments, for example, only the first measuring device 3 and the second measuring device 4 or the first measuring device 3 and the third measuring device 4 or the second measuring device 4 and the third measuring device 5 integrated into a common measuring device, while the remaining measuring devices 3 . 4 . 5 is formed separately. Finally, in another embodiment, the measuring devices 3 . 4 . 5 formed separately from each other.

In the embodiment according to 1 can the cradle 2 in a variant, also for simultaneous recording of a plurality of test strips and / or one or more electrochemical measuring cells and / or one or more chips (in particular one or more biochips), so that the measuring devices 3 . 4 . 5 and 17 be able to perform the respective measurements independently.

In the portable device 1 is another measuring device 9 designed to measure a skin conductance.

For this purpose, the portable device according to the invention 1 on two opposite sides 10 . 11 of the housing 12 of the portable device 1 one contact surface each 13 . 14 on.

These contact surfaces 13 . 14 are in this embodiment and in other embodiments generally so on the housing 12 arranged that the contact surfaces 13 . 14 in use with different skin areas of a hand, which is the portable device 1 keeps in touch.

In this way, with the other measuring device 9 for measurement on the contact surfaces 13 . 14 connected, the skin resistance of the portable device 1 holding hand between these points of contact measurable.

With the portable device 1 and more specifically with the other measuring device 9 For measuring the skin conductance, therefore, a measured variable is measurable, with which a stress state of the operator can be characterized.

The data processing device 6 is set up so that the specific skin resistance in the evaluation of the first measuring device 3 , the second measuring device 4 , the third measuring device 5 and the fourth measuring device 17 and in the determination of a parameter, in particular an insulin-determining characteristic or in the case of medication.

The portable device 1 further has a measuring device 15 for measuring a pulse rate.

For this purpose is on the housing 12 a signal input 16 designed for a pulse sensor. The signal input 16 is for measuring the pulse rate with the measuring device 15 connected.

The data processing device 6 is for receiving and for further processing an output signal of the measuring device 15 set up. Thus, the pulse rate, which also provides information about a stress state of the operator, in the processing of the measurement signals from the measuring devices 3 . 4 . 5 be taken into account. This is established by programming the data processing device.

In the embodiment according to 1 a preferred embodiment is realized in which the measured value for the positive frequency can be combined with a measured value for the oxygen saturation of the blood. These combined readings are taken through the shared signal input 16 the measuring device 15 and thus the data processing device 6 fed.

On the portable device according to the invention 1 is a display 18 training, on which the measurement results 7 and further information can be displayed. In particular, the time course of the measurement results 7 displayable. The derived therefrom characteristic in the data processing device 6 was determined, for example, based on a time interval is with the display 18 displayable.

An example for the creation of a decision matrix for the determination of a preferably insulin-determining parameter is shown in FIG 2 shown. In the illustrated starting situation, the determined or provided blood glucose value of the isolated body fluid sample is increased, that is it is above the standard value of 100 mg%. In order to be able to determine a parameter by means of which an assessment of the state of health and / or the need for insulin administration can be assessed, an insulin value, a HbA1c value and a cortisol value of the body fluid sample are additionally taken into account. The body parameters are each compared with known norm values and on the basis of this a characteristic is created. Depending on this, an assessment of the condition of the person from whom the isolated sample originates can be made. The relevance and significance of such a parameter can be improved by including further parameters such as the skin resistance, the pulse rate and the adrenaline level of the person from whom the body fluid sample originates.

For example, if the blood sugar level in a sample is increased (normal value up to 100 mg%) and at the same time there is an increase in the HbAlc value (standard value to 6 mg%) and the insulin value (standard range between 7-28 mg%), the cortisol value ( Normal range up to 8 mg%) and the adrenalin value (normal range 28-54 mg%) are within the normal range and the pulse rate only slightly increased (standard value approx. 72) and the skin resistance is also normal, the evaluation of the parameter would be: An insulin dose not necessary. The subject should move immediately, especially endurance sports.

In another example, the blood glucose level, insulin level, and cortisol level are each greatly increased, with skin resistance and adrenaline level being normal and pulse rate only slightly elevated. In this case, the evaluation of the parameter determined using the decision matrix is: Insulin administration is not required. The subject should move immediately, especially endurance sports.

In another example, the blood glucose level is high, the cortisol level is high, and the HbAlc level is slightly elevated. The adrenaline and insulin levels are within the respective normal range. The pulse rate is normal and skin resistance is increased. In this case, the evaluation of the parameter determined using the decision matrix is: Insulin administration is not required. The subject should move more frequently in the future, especially endurance sports.

In order to generate a parameter, in particular an insulin-determining parameter, it is possible, for example, to assign different parameters to the individual groups (groups A to C). By comparing the determined or provided measured values (body parameters) with a standard value serving as a reference, the individual body parameters can be assigned to one of the three groups and therefore preferably receive a characteristic number (of the respective group). It can be provided that a parameter is determined by the sum of all key figures, on the basis of which an assessment can be made. For example, this judgment could be that the subject requires an insulin dose, or the subject does not require an insulin dose but immediate exercise, particularly endurance sports, or the subject does not need an insulin dose, but should move more in the future, especially exercise more endurance sports.

Based on the example values in 2 a division into one of the three groups can be made. The blood glucose value (especially after eating) is considered increased if it has a value of BZ pp 180 mg%, in particular 200 mg%, preferably 220 mg%, particularly preferably 240 mg%. A markedly elevated blood glucose level BZ pp is present at values above 280 mg%. The respective measured values can also vary depending on a specific time of day or on the time interval to the last food intake. The cortisol value is highly dependent on the respective time of day, so the morning standard in the blood is 25 mg / dl and the nocturnal value is 5 mg / dl. It is therefore advantageous if the device according to the invention adapts the standard value of cortisol to the respective time of day. The determination of the insulin value, HbAlc value and adrenaline value is preferably carried out by measuring it in an isolated blood sample. The value of the skin resistance usually depends on the respective measuring device such. B. from the size of the series resistor. It can therefore be provided that, before the device is put into operation, a self-calibration is carried out by the corresponding person, in particular in order to be able to determine deviations of the skin resistance. However, it is equally conceivable that the limit values for the division into one of the three groups 2 are set differently. It can be provided that an assessment is made by means of the frequency of the division of the respective measured values into one of the three groups.

On the basis of the selected examples, it becomes clear that a significant advantage of the portable device according to the invention over previously known blood glucose monitoring devices is, in particular, that not only the blood sugar content is determined in order to assess the need for insulin administration. This makes it possible for the first time by determining and assessing the insulin dose-determining parameter, in diabetes patients (eg with a type 1 or type 2 diabetic) for which a diabetic diagnosis already exists, an individually adapted recommendation for the patient Need to create an insulin dose. By determining the characteristic, it is therefore possible in particular to detect blood sugar derailments, such as, for example, hyper- or hypoglycaemia. By taking into account further body parameters, however, it is possible to put them in relation to other metabolic processes in the body of the subject and to create an improved, individual behavior recommendation for the subject by creating the characteristic. Especially in diabetic patients suffering from insulin resistance, the blood sugar level can be lowered by the administration of insulin barely or only by the administration of a high dose of insulin. However, only by measuring the blood sugar level using the commonly used blood glucose monitors would these patients assume that there is a need to administer insulin. In particular, there is the danger that diabetics in particular with insulin resistance by the use of conventional measuring instruments, which only serve to determine the blood sugar level, but do not allow detection of other body parameters, receive a false assessment of their blood sugar derailment. In particular, this can lead to long-term doses of unnecessary insulin, which in the worst case can lead to consequential health damage.

It is also conceivable that, for example, an emergency situation in the case of a blood sugar derailment can be detected more quickly on the basis of the portable device according to the invention, since in addition to the blood sugar value, further metabolic parameters (body parameters) are taken into account. In the case of a blood sugar derailment, where the person being tested suffers from high levels of stress, it is recommended that the subject undergo immediate medical treatment.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 6893552 B1 [0018]
• US 2006/240401 A1 [0019]

Cited non-patent literature

• DEGS1, "Prevalence and timing of known diabetes mellitus", Bundesgesundheitsblatt 56: 668-677, 2013 [0002]
• Wang et al., On-Chip Integration of Enzyme and Immunoassays: Simultaneous Measurements of Insulin and Glucose; 125 (28): 8444-5, 2013 [0020]
• Sun et al., Sensors and Actuators B 133, 533-537, 2008 [0022]

Claims (15)

Portable device ( 1 ) comprising at least one data processing device ( 6 at least for electronically storing and processing a decision matrix, wherein the decision matrix comprises at least one blood sugar value and at least two or all values selected from the group consisting of insulin value, HbAlc value and cortisol value, and wherein the processing of the decision matrix by the data processing device ( 6 ) for determining a parameter, in particular an insulin dose-determining characteristic. Portable device ( 1 ) according to claim 1, wherein the decision matrix further comprises at least one or more values, preferably all values selected from the group consisting of adrenalin value, skin resistance value and pulse rate value. Portable device ( 1 ) according to claim 1 or 2, wherein the portable device ( 1 ) at least one measuring device or measuring devices for determining at least one or more, preferably all values selected from the group consisting of blood sugar value, insulin value, HbAlc value and cortisol value or of at least one or more, preferably all values selected from the group consisting of blood glucose value , Insulin value, HbAlc value, cortisol value, adrenalin value, skin resistance value and pulse rate value. Portable device ( 1 ) according to one of claims 1 to 3, wherein the portable device ( 1 ) comprises a first measuring device for determining the blood sugar value, a second measuring device for determining the insulin value, a third measuring device for determining HbAlc value, a fourth measuring device for determining the cortisol value and a fifth measuring device for determining the adrenaline value, and wherein at least one or more preferably all measured values are measured by the measuring devices within a measuring interval or several measuring intervals. Portable device ( 1 ) according to one of claims 3 or 4, wherein the portable device further comprises a sixth measuring device for determining the skin resistance and / or a seventh measuring device for determining the pulse rate, and wherein at least one or more, preferably all measured values by the measuring device or the measuring devices within one measurement interval or several measurement intervals are measured. Portable device ( 1 ) according to one of claims 3 to 5, wherein the at least one measuring device or the measuring devices for the measurement of at least one isolated body fluid, in particular isolated blood, is / are formed. Portable device ( 1 ) according to one of claims 3 to 6, wherein at least two or more, preferably all measuring devices are combined in an integral measuring device. Portable device ( 1 ) according to one of claims 3 to 7, which laterally, preferably on opposite sides, formed on the portable device and / or arranged contact surfaces ( 13 . 14 ), which are connected to one or more measuring devices ( 17 ) are connected to measure a skin resistance. Portable device ( 1 ) according to one of claims 1 to 8, wherein a display ( 18 ), which is used to display the measurement results ( 7 ) and / or the insulin dose determinant parameter. Portable device ( 1 ) according to one of claims 1 to 9, which means ( 19 ) for establishing a preferably wireless data connection with a control center and / or with a PC and / or with a suitable terminal. Portable device ( 1 ) according to one of claims 1 to 10, which includes a battery and / or a connection for a power supply for operating the portable device. A non-invasive method of determining an insulin dose-determining characteristic, wherein at least one or more of at least one isolated body fluid has at least two or all values selected from the group consisting of insulin value, HbA1c and cortisol and / or from one or more of the determined blood glucose values and at least two or all Values from the group consisting of one or the determined insulin value, one or the determined HbAlc value and one or the determined cortisol value, a decision matrix is created or kept, and wherein the insulin dose determinant parameter is determined by the processing of the decision matrix. Non-invasive method according to claim 12, wherein at least one or more, preferably all, measurements are made on at least one isolated body fluid, preferably on isolated blood. Non-invasive method according to claim 12 or 13, wherein in the preparation of the decision matrix, a value of the pulse rate and / or a value of the skin resistance are taken into account. The non-invasive method of any one of claims 12 to 14, wherein the determination of an insulin dose determinant characteristic is performed on the portable device of claims 1 to 11.

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