Sensor assembly and monitoring method

Abstract

A sensor assembly (110) comprising at least two sensors is disclosed. The at least two sensors are selected from: at least one analyte sensor configured for detecting at least one analyte in a bodily fluid of a subject, wherein the analyte sensor comprises at least two first electrodes (118, 118'); and at least one electrocardiogram sensor (114) configured for detecting at least one cardiac parameter of the subject, wherein the electrocardiogram sensor (114) comprises at least two second electrodes (124, 124'), wherein at least one of the first electrodes (118') and at least one of the second electrodes (124') constitute a shared electrode (128).

Description

Technical Field

[0001] This invention relates to a sensor assembly and a monitoring method. The sensor assembly and the monitoring method can be used to determine at least one of an analyte value in a subject's bodily fluids or the subject's risk of hypoglycemia. The sensor assembly can be applied to the continuous monitoring of at least one analyte, specifically in home care and in professional care settings such as hospitals. However, other applications are possible. Background Technology

[0002] Determining the concentration of at least one analyte, such as at least one metabolite in a subject's bodily fluids, plays an important role in the prevention and treatment of various diseases. Such analytes may include, for example, but not limited to, glucose, lactate, cholesterol, or other types of analytes and metabolites. The following description will relate to glucose monitoring without limiting other possible applications. However, it is also feasible to apply this method to other types of analytes, either additionally or alternatively.

[0003] As described in more detail in the review article "Hypoglycaemia detection and prediction techniques: A systematic review on the latest developments" by Diouri O, Cigler M, Vetteretti M, Mader JK, Choudhary P, and Renard E., Diabetes Metab Res Rev. 2021; 37(7):e3449;doi:10.1002 / dmrr.3449, various clinical studies have demonstrated a close association between cardiovascular morbidity and mortality and diabetes. Studies have shown that hypoglycemia accelerates heart rate and alters heart rate variability. Early detection of hypoglycemia can be supported using wearable medical patches that measure heart rate and stroke-by-stroke variability. Various sensors are available that are configured to measure heart rate or record electrocardiograms (ECGs), and the data obtained in this way can be used for hypoglycemia detection or prediction.

[0004] US 2009 / 0299155 A1 relates to a method for determining cardiac health by continuously, persistently, and / or intermittently detecting the concentration of a cardiac marker in vivo using a sensor. The sensor system may be partially inserted into the circulatory system of a subject, for example, subcutaneously, percutaneously, or intervascularly, or noninvasively positioned in an extracorporeal blood circulation device. The sensor may be an enzyme sensor and may include a detection electrode and at least one reference electrode, as well as a third electrode configured to measure at least one additional signal. To determine the at least one additional signal, the sensor is configured to continuously, persistently, and / or intermittently measure a second substance, such as glucose, in vivo. A communication device is configured to receive and process at least one additional signal from an assistive medical device, such as an ECG sensor.

[0005] WO 2022 / 104997 A1 discloses an ECG sensor that fuses BCG (cardiovascular glucose) signals by using a dual-signal collection electrode patch (i.e., skin-only electrode) for collecting electrical signals, wherein the patch includes two BCG sensing electrodes and one ECG electrode in a flat, layered structure.

[0006] US 2023 / 028745 A1 discloses an optical physiological sensor comprising an LED and multiple detectors integrated into a wearable device configured to measure at least one physiological parameter of a subject, such as heart rate or glucose. The sensor may optionally include an ECG sensor having at least two electrodes positioned on the housing of the wearable device.

[0007] US 2023 / 078426 A1 and US 8,718,742 B2 relate to sensor systems having multiple skin-attached electrodes configured to monitor voltages generated by a person.

[0008] Problems to be solved Therefore, it is desirable to provide a sensor assembly and method for determining the value of at least one analyte in a subject's bodily fluids, which at least partially addresses the technical challenges mentioned above. Specifically, it is desirable to reduce the complexity of the sensor assembly so that the device is simpler, cheaper, and smaller. Summary of the Invention

[0009] This problem is solved by sensor components and monitoring methods having the features of the independent claims. Advantageous embodiments, which can be implemented independently or in any arbitrary combination, are listed in the dependent claims and throughout the specification.

[0010] As used below, the terms “have,” “contain,” or “include,” or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms can refer either to a situation where no further features exist in the entity described in this context besides the features introduced by these terms, or to a situation where one or more further features exist. For example, the statements “A has B,” “A includes B,” and “A contains B” can refer to a situation where no other elements exist in A besides B (i.e., where A is solely and uniquely composed of B); or to a situation where, besides B, entity A contains one or more further elements, such as element C, element D, or even further elements.

[0011] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may exist once or more are generally used only once when introducing the corresponding feature or element. In the following text, in most cases, when referring to the corresponding feature or element, the expressions "at least one" or "one or more" will not be used repeatedly, even though the corresponding feature or element may exist once or more.

[0012] Furthermore, as used below, the terms “preferredly,” “more preferably,” “particularly,” “more particularly,” “specifically,” “more specifically,” or similar terms are used in combination with optional features without limiting the possibility of alternatives. Therefore, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As those skilled in the art will recognize, the invention can be carried out by using alternative features. Similarly, features introduced by phrases such as “in one embodiment of the invention” are intended to be optional features without limiting alternative embodiments of the invention, without limiting the scope of the invention, and without limiting the possibility of combining features introduced in this way with other optional or non-optional features of the invention.

[0013] This problem is addressed by a sensor assembly and monitoring method for predicting hypoglycemia, wherein an analyte sensor is combined with an electrocardiogram sensor, particularly with at least one shared electrode.

[0014] In a first aspect, a sensor assembly comprising at least two sensors is disclosed.

[0015] The sensor assembly includes at least one analyte sensor configured to detect at least one analyte in a subject's bodily fluids. The analyte sensor includes at least two first electrodes. These at least two first electrodes may be at least two electrodes selected from subcutaneous electrodes or minimally invasive electrodes, or at least one skin-attached electrode and at least one electrode selected from subcutaneous electrodes or minimally invasive electrodes.

[0016] The sensor assembly includes at least one electrocardiogram (ECG) sensor configured to detect at least one cardiac parameter of a subject. The ECG sensor includes at least two second electrodes. These at least two second electrodes may be at least two skin-contact electrodes, or at least one skin-contact electrode and at least one electrode selected from subcutaneous or minimally invasive electrodes.

[0017] The analyte sensor and the electrocardiogram sensor have at least one shared electrode. The shared electrode can be a skin-tight electrode or an electrode selected from subcutaneous electrodes or minimally invasive electrodes.

[0018] Additionally, the sensor assembly may include at least one other type of sensor as disclosed below.

[0019] As used herein, the term "sensor assembly" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, systems comprising at least two individual sensors. As used herein, the term "sensor" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, any element or device configured to detect at least one condition or measure at least one measured variable.

[0020] A sensor may include at least one electrode. As used herein, the term "electrode" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, an electrical conductor that is generally of any shape. The term may specifically refer to, but is not limited to, a conductor that remains in contact with the ionic portion of a circuit. A sensor assembly includes at least one shared electrode. As used herein, the term "shared" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, at least one electrode used by two different sensors. While sensors including a "sensor assembly" may share one or more electrodes, they may still be considered individual. As used herein, the term "individual" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, at least two sensors, wherein any synergy between the sensors is excluded except for the use of at least one shared electrode.

[0021] As used herein, the term "analyte sensor" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, a sensor configured for the qualitative or quantitative detection of at least one of the presence, quantity, or concentration of at least one analyte. As used herein, the term "detection" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, the process of determining at least one value, particularly selected from the presence, quantity, or concentration of at least one analyte. Detection may be or may include at least one of qualitative or quantitative detection, wherein qualitative detection includes determining the presence or absence of at least one analyte, and wherein quantitative detection includes determining at least one of the quantity or concentration of at least one analyte.

[0022] As used herein, the term "analyte" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, at least one of a chemical substance or a biological substance that participates in the metabolism of a subject's body. An analyte can be any electrochemically detectable species, including simple ions such as potassium, but can also be much more complex structures such as creatinine. Exemplarily, an analyte can be a metabolite or a combination of at least two metabolites. For example, an analyte may be selected from the group consisting of: glucose, ascorbate, ketones, lactate, triglycerides, and cholesterol. Glucose is preferred as the analyte; however, another analyte or a combination of at least two analytes may be detected.

[0023] As used herein, the term "subject" is a broad term and will be given the common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. The term specifically refers to humans or animals, whether actually humans or animals, in a healthy state or potentially suffering from one or more diseases. A subject can be a patient. As an example, a subject can be a human or animal suffering from diabetes. A subject can be a user who wants to monitor analyte values ​​(such as glucose levels) in a user's body tissues and / or deliver medications (such as insulin) to a user's body tissues, such as a patient. However, in one embodiment, the user of the sensor assembly may be different from the subject. Additionally or alternatively, the invention can be applied to other types of users or patients.

[0024] As used further herein, the term "body fluid" generally refers to a fluid, particularly a liquid, which is generally present in the body or body tissues of the subject and / or can be produced by the subject's body. Body fluids may be selected from the group consisting of blood and tissue fluid. However, additionally or alternatively, at least one other type of body fluid may be used, wherein such other type of body fluid may preferably be selected from saliva, tears, or urine.

[0025] The analyte sensor may be at least one of a subcutaneous analyte sensor or a minimally invasive sensor. As used herein, the term "subcutaneous" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, an arrangement of the analyte sensor that is wholly or at least partially located beneath the skin tissue within the body tissue of a subject. As used herein, the term "minimally invasive" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, an arrangement of the analyte sensor that is wholly or at least partially located within the skin tissue of a subject. The analyte sensor may be a fully or partially implanted analyte sensor. The analyte sensor may be an in vivo sensor. The analyte sensor is adapted to detect analytes in the body fluids of a subject in at least one of the subject's subcutaneous tissue or skin tissue.

[0026] An analyte sensor may include an insertable portion. As used herein, the term "insertable portion" is a broad term and will be given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, elements configured to be inserted into any body tissue, particularly a portion or component of at least one detection electrode. Other portions or components of the analyte sensor, particularly at least one of a counter electrode, reference electrode, or combined counter / reference electrode, may remain outside the body. The insertable portion may be wholly or partially covered with at least one diffusion-limiting membrane, such as at least one polymer membrane or gel membrane, which, on the one hand, restricts the diffusion of the analyte toward the detection electrode, and on the other hand, retains sensor material, such as one or more test chemicals, within the analyte sensor, thereby preventing the chemicals from migrating into body tissue. The insertable portion may include, wholly or partially, a biocompatible surface that has the least possible adverse effect on the user or body tissue. The insertable portion may be completely or partially covered with at least one biocompatible membrane layer, such as at least one polymer membrane or gel membrane, wherein the at least one biocompatible membrane layer may be permeable to body fluids or at least to analytes contained therein.

[0027] An analyte sensor can be inserted into at least one of a subject's skin tissue or body tissue using at least one insertion device (also referred to as an inserter). The sensor assembly may additionally include the insertion device. The sensor assembly can be configured to insert the analyte sensor into the subject's body tissue. Insertion can be performed such that the analyte sensor is positioned completely or partially in or beneath the skin after insertion. Insertion can be performed such that a portion of the analyte sensor protrudes through the skin from the body tissue to make contact with the exterior of the body (e.g., electrically). A puncture site can be used to place a corresponding electrode in at least one of the subject's skin tissue or body tissue. After the analyte sensor is inserted into at least one of the skin tissue or body tissue, the sensor assembly can be disassembled into a disposable component, such as including an inserter in use and an analyte sensor with a body mount that can be attached to the subject's skin, and wherein the analyte sensor can protrude into at least one of the skin tissue or body tissue.

[0028] An analyte sensor is an electrochemical sensor. As used herein, the term "electrochemical sensor" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, an analyte sensor configured to detect the electrochemically detectable properties of an analyte, such as an electrochemical detection reaction. For example, an electrochemical detection reaction can be detected by applying and comparing at least one electrode potential or current. Specifically, the analyte sensor is configured to generate at least one analyte sensor signal that can directly or indirectly indicate at least one of the presence or extent of an electrochemical detection reaction. The analyte sensor signal can be at least one of a qualitative signal or a quantitative signal. Other embodiments are also possible. As a result of detection, at least one analyte sensor signal characterizing the result of the detection can be generated. The at least one analyte sensor signal can specifically be or may include at least one electronic signal, particularly at least one of a voltage or a current. The at least one analyte sensor signal can be or may include at least one of an analog signal or a digital signal.

[0029] The analyte sensor includes at least two first electrodes. Embodiments are feasible in which the analyte sensor may include three or more first electrodes. As used herein, the terms “first,” “second,” and “third” are broad terms and are given common and customary meanings to those skilled in the art, and are not limited to specific or customary meanings. The term is specifically considered, but not limited to, a description that does not specify an order and does not exclude the possibility of other elements of this kind being present. At least one first electrode of the analyte sensor is a subcutaneous electrode or a minimally invasive electrode. The use of one or more skin-attached electrodes including the analyte sensor is also feasible. As used herein, the term “skin-attached” is broad and is given common and customary meanings to those skilled in the art, and is not limited to specific or customary meanings. The term may specifically refer to, but is not limited to, an arrangement of electrodes attached from outside the subject’s body to body tissue. In a preferred embodiment, the skin-attached electrode may be an adhesive electrode attached to body tissue using at least one adhesive.

[0030] Specifically, the analyte sensor may include at least one detection electrode selected from subcutaneous or minimally invasive detection electrodes, also referred to as a "working electrode," and at least one additional electrode, wherein the additional electrode may preferably be selected from a counter electrode, a reference electrode, or a combination of counter / reference electrodes, and may also be a subcutaneous or skin-attached electrode. As used herein, the term "detection electrode" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, an electrode configured to perform at least one electrochemical detection reaction to detect at least one analyte. The detection electrode may have an analyte detector sensitive to the analyte to be detected. As used herein, the term "analyte detector" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, any material or material composition suitable for altering a detectable property in the presence of an analyte. This property may be an electrochemically detectable property. Specifically, the analyte detection reagent can be a highly selective analyte detection reagent, which changes its property only in the presence of the analyte in the body fluid, and remains unchanged in the absence of the analyte. The extent or change of this property depends on the concentration of the analyte in the body fluid to allow for quantitative detection of the analyte. For example, the analyte detection reagent may contain enzymes such as glucose oxidase and / or glucose dehydrogenase. For potential analyte detection reagents, refer to WO 2007 / 071562 A1 and the prior art documents disclosed therein. However, other embodiments are feasible.

[0031] As used herein, the term "counter electrode" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, an electrode configured to perform at least one electrochemical counter reaction adapted to balance the current flow required for a detection reaction at the detection electrode. As used herein, the term "reference electrode" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, an electrode adapted to provide a constant electrode potential as a reference potential, particularly at least within tolerances, such as by providing a redox system with a constant electrode potential. The counter electrode and reference electrode may be two separate electrodes or a shared electrode as indicated herein by the term "combined counter / reference electrode." For potential materials that can be used for the counter electrode and / or reference electrode, reference can be made to WO 2007 / 071562 A1 and the prior art documents disclosed therein. However, other embodiments are possible. The detection electrode is sensitive to the target analyte under a polarization voltage applied between the working electrode and the reference electrode and controlled by a potentiometer. The sensor signal can be provided as a current between the counter electrode and the detection electrode.

[0032] The analyte sensor can be configured to determine conductivity using at least one of DC or AC measurements, particularly at least one of resistance or impedance measurements. Impedance can be the ratio of AC voltage to AC current induced by that AC voltage at different frequencies. The DC and AC measurements mentioned for determining conductivity can preferably operate independently. At least two electrodes can be used for at least one of ampere or potential measurements. Potential measurements can include: measuring potential in a constant-current manner, wherein the current remains constant over a time period; or measuring potential in a kinetic-current manner, wherein the current is intentionally changed over that time period. Ampere measurements can include: measuring current in a constant-potential manner, wherein the potential remains constant over a time period; or measuring current in a kinetic-current manner, wherein the potential is intentionally changed over that time period. Impedance measurements can be performed as a constant-potential method or a constant-current method. Alternatively or additionally, the open-circuit potential method (OCP) can be used, wherein no current can be intentionally sensed by the measuring electronics. These types of measurements are generally known to those skilled in the art of analyte detection, such as from WO 2007 / 071562 A1 and the prior art documents disclosed therein. For potential setups of electrodes, electrode materials, or measurement configurations, refer to this document. Analyte sensors are generally known in the art and include continuous glucose sensor systems or, for example, continuous ketone measurements.

[0033] As used herein, the term "electrocardiogram sensor" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, a sensor configured for qualitative or quantitative detection of at least one cardiac parameter of a subject. Typically, an electrocardiogram sensor is configured to detect at least one cardiac parameter by measuring the electrical activity of a subject's heart. As used herein, the term "detection" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, the process of determining at least one of at least one cardiac parameter of a subject.

[0034] As used herein, the term "cardiac parameter" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or custom-defined meaning. The term may specifically refer to, but is not limited to, quantitative values ​​related to the heart of a subject. In a preferred embodiment, the cardiac parameter may be the subject's heart rate; however, it is also possible to use different quantitative values ​​related to the subject's heart. As used herein, the term "heart rate" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or custom-defined meaning. The term may specifically refer to, but is not limited to, the reciprocal of a time interval between consecutive heartbeats of a subject. Alternatively or additionally, the term may refer to, but is not limited to, at least one other parameter detected using an electrocardiogram sensor.

[0035] The electrocardiogram (ECG) sensor includes at least two second electrodes. Embodiments in which the ECG sensor may include three or more second electrodes are feasible. As indicated above, the terms “first,” “second,” and “third” are considered, but not limited to, descriptions that do not specify an order and do not exclude the possibility of other elements of this kind. As further indicated above, the term “electrode” specifically refers to, but is not limited to, an electrical conductor of any shape. The minimum distance between the second electrodes is used to generate a measurable voltage, particularly because the measurable voltage is proportional to the distance between the electrodes. Surprisingly, it has been found that a detectable level can be achieved at a smaller distance when measuring voltage between a subcutaneous electrode and a skin-attached electrode compared to two skin-attached electrodes. The at least two second electrodes of the ECG sensor are preferably skin-attached electrodes; however, the use of one or more skin-attached electrodes, subcutaneous electrodes, or minimally invasive electrodes is also feasible. As further indicated above, as used herein, the term “skin-attached” refers to, but is not limited to, an arrangement of electrodes that are attached entirely to body tissue from outside the subject's body. The ECG sensor is adapted to perform at least one measurement for detecting at least one cardiac parameter of a subject.

[0036] Specifically, at least two second electrodes of the electrocardiogram (ECG) sensor can be configured to generate at least one ECG sensor signal. In a preferred embodiment, at least one ECG sensor signal is generated by performing at least one microvoltage measurement. As used herein, the term "microvoltage measurement" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a measurement in which a small-amplitude voltage is measured by at least one particular electronic component having high input impedance and configured to amplify the measurement signal, thereby preferably suppressing noise in a highly efficient manner.

[0037] At least one first electrode of the first electrode of the analyte sensor and at least one second electrode of the second electrode of the electrocardiogram sensor constitute a shared electrode. As used herein, the term "shared electrode" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, a shared electrode used jointly by at least two individual sensors for detecting signals from at least one sensor. The shared electrode is configured for dual-use, triple-use, or multiple-use purposes, depending on the number of sensors included in the sensor assembly. The shared electrode may be or include electrodes containing Ag / AgCl; however, the use of different electrode materials may also be feasible. As indicated above, as used herein, the term "individual" may refer to, but is not limited to, at least two sensors, wherein any synergy between the sensors is excluded except for the use of at least one shared electrode. As used herein, the term "configuration" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, the resulting state in which a particular type of element arrangement is formed in the assembly. The shared electrode may preferably be selected from subcutaneous electrodes, skin-attached electrodes, or minimally invasive electrodes. As indicated above, and as used herein, the terms “subcutaneous,” “skin-attached,” and “minimally invasive” may refer, but are not limited to, an arrangement in which the shared electrode is wholly or at least partially embedded in at least one of the subject’s skin or body tissues, or is attached entirely to body tissues from outside the subject’s body.

[0038] The shared electrode can be configured for simultaneous use, i.e., it can be used simultaneously by at least two individual sensors, each of the two or more individual sensors using the shared electrode for a specific purpose during a time interval. In a preferred embodiment, the shared electrode can be used by an analyte sensor as at least one of a counter electrode, a reference electrode, or a combined counter / reference electrode for detecting the analyte sensor signal, and as one of the second electrodes of an electrocardiogram (ECG) sensor for detecting the ECG sensor signal during the same time interval. In this embodiment, the shared electrode can preferably be a skin-contact electrode. Alternatively or additionally, the shared electrode can be used continuously by at least two individual sensors.

[0039] In a preferred embodiment, the shared electrode may be used by the analyte sensor as at least one of a detection electrode, counter electrode, reference electrode, or a combination of counter / reference electrodes to detect the analyte sensor signal, and after a time interval during which the analyte sensor signal has been detected, it may be used as a second electrode of the second electrode of the electrocardiogram (ECG) sensor to detect the ECG sensor signal. In this embodiment, the shared electrode may preferably be a subcutaneous electrode. However, combinations of these and other embodiments are also possible.

[0040] Using a shared electrode for both the analyte sensor and the electrocardiogram (ECG) sensor reduces the complexity of the sensor assembly, particularly because it allows for the use of at least one fewer electrode compared to existing combinations of analyte and ECG sensors. For example, concurrently using a skin-tight second electrode designed for the ECG sensor as a counter-reference electrode for the analyte sensor simplifies the analyte sensor and additionally improves its biocompatibility, especially due to the reduced number of electrodes that can be subcutaneously inserted into the subject's skin. As another example, concurrently using a skin-tight first electrode designed for the analyte sensor as an additional second electrode for the ECG sensor introduces an additional second electrode for the ECG sensor, or alternatively, reduces the number of leads for the second electrode used in the ECG sensor. In this way, the overall size of the ECG sensor can be reduced without compromising the amplitude of the ECG sensor signal.

[0041] In a particularly preferred embodiment, the sensor assembly may further include at least one additional sensor. Preferably, the at least one additional sensor may be selected from a temperature sensor configured to determine at least one temperature value of the subject; however, the use of different types of sensors is also feasible. As used herein, the term "temperature sensor" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a sensor comprising at least one electronic component configured to generate at least one temperature sensor signal. The temperature sensor signal may be selected from a voltage signal or a current signal, thereby determining a resistance value. The temperature sensor signal may be used to compensate for at least one adverse temperature effect, particularly by using a corresponding algorithm; however, other uses are also contemplated.

[0042] At least one additional sensor may include at least two third electrodes. As indicated above, the terms "first," "second," and "third" are considered, but not limited to, descriptions that do not specify an order and do not exclude the possibility of other elements of this kind. Preferably, the at least two third electrodes may be selected from subcutaneous electrodes, minimally invasive electrodes, or skin-attached electrodes. Preferably, at least one temperature sensor signal generated by a temperature sensor may be correlated with the subject's temperature, particularly a temperature selected from the subject's skin or internal environment. At least one temperature sensor signal may be generated by performing at least one of voltage measurements across at least two third electrodes or current measurements across at least two third electrodes. For example, a voltage across at least two third electrodes may be used to determine at least one temperature value at the subject's skin or internal environment.

[0043] In a preferred embodiment, the shared electrode may additionally serve as one of the third electrodes. The shared electrode may be used simultaneously or continuously by a temperature sensor other than the analyte sensor and the electrocardiogram sensor, as described in more detail elsewhere herein. For example, the shared electrode may be a skin-tight electrode, serving as a counter electrode, reference electrode, or combined counter / reference electrode of the analyte sensor, and serving as one of the second electrodes of the electrocardiogram sensor during the same time interval, and further serving as one of the third electrodes of the temperature sensor during the same time interval. As another example, the shared electrode may be a subcutaneous electrode or a minimally invasive electrode, serving as a detection electrode, counter electrode, reference electrode, or combined counter / reference electrode of the analyte sensor, and subsequently serving as one of the second electrodes of the electrocardiogram sensor, and subsequently serving as one of the third electrodes of the temperature sensor. However, combinations of these and other embodiments are also feasible.

[0044] In a preferred embodiment, the sensor assembly may include at least one electronic unit configured to connect to at least two sensors. Alternatively or additionally, a separate electronic unit not included in the sensor assembly may be configured to connect to at least two sensors. The at least two sensors included in the sensor assembly are operatively connected to the electronic unit. As used herein, the term "electronic unit" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. The term may specifically refer to, but is not limited to, any unit, such as a unit that can be held in monolithic form, configured to perform at least one electronic function. For example, the electronic unit may have at least one interface for connecting to at least two sensors. Each sensor may include one or more leads for electrical contact electrodes. The leads may be connected to one or more electronic components at any point before using the sensor assembly, such as during application or at a later point. For example, the leads may have been connected to the electronic unit before the sensor assembly is applied to the subject. The electronic unit may provide at least one electronic function that interacts with each sensor, such as at least one measurement function. For example, the electronic unit may be a single device comprising at least one analog front-end, preferably a combination of two parts, wherein the sensor signal can be digitized and processed using an algorithm. The electronic unit may be configured to determine or control at least one sensor signal or to transmit such at least one sensor signal to at least one of another components. The electronic unit may include at least one microcontroller unit configured to control the operation of the sensor.

[0045] Specifically, the electronic unit may be configured to perform at least one measurement using at least two sensors, particularly at least one selected from voltage or current measurements, record at least one sensor signal, store the at least one sensor signal, and transmit the at least one sensor signal to another component. Therefore, the electronic unit may specifically include at least one of the following: a voltmeter, an ammeter, a potentiometer, a voltage source, a current source, a signal receiver, a signal transmitter, an analog-to-digital converter, an electronic filter, a data storage device, or an energy storage device. For example, the electronic unit may be implemented as a transmitter or may include at least one transmitter configured to transmit data to a remote computer or a remote device. The sensor assembly may further include at least one electronic remote device configured to communicate with and / or control the sensor assembly. The electronic remote device may be selected from a personal computer, wearable device, smartphone, proprietary remote control, tablet computer, or server.

[0046] To perform at least one measurement using at least two sensors, an electronic unit may be configured to measure corresponding sensor signals from at least two sensors in at least one manner, either concurrently or continuously. As used herein, the term "concurrent" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a manner in which sensor signals from at least two sensors are recorded simultaneously during equal time intervals. For example, a shared electrode may be used to provide a common potential that can be shared by at least two sensors. As used herein, the term "continuous" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, alternative manner in which sensor signals from at least two sensors are subsequently recorded during continuous time intervals. For example, a shared electrode may be used to provide different potentials during continuous time intervals, which can then be used by at least two sensors. In this manner, interleaving between sensor signals from at least two sensors can be controlled. For example, at least one interference signal may be generated between at least one analyte sensor signal and at least one electrocardiogram sensor signal. As another example, the DC voltage applied between the subcutaneous working electrode and, for example, the combined counter / reference electrode can be adjusted during the regulation of the polarization potential of the subcutaneous working electrode relative to the combined counter / reference electrode. This voltage shift may affect the ECG signal when the combined counter / reference electrode is shared with one of the two ECG electrodes. ECG signal acquisition can preferably be decoupled in time from the regulation of the polarization potential.

[0047] Sensor assemblies may include electrical energy storage devices, such as at least one battery. As used herein, the term "battery" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term refers to any power source comprising at least one electrochemical cell having at least one external connection for powering an electrical device. When the battery supplies power, its positive terminal may be referred to as the cathode, and its negative terminal may be referred to as the anode. Specifically, the battery may be a primary battery. A primary battery may be configured for single use or as a disposable battery. Sensor assemblies may include at least one connector element configured to establish electrical contact between the electrical energy storage device of the sensor assembly and electronic components.

[0048] The electronic unit may preferably be configured to determine at least one of the analyte value in a subject's body fluids or the subject's risk of hypoglycemia by combining at least one analyte sensor signal with at least one electrocardiogram sensor signal. In a particular embodiment, at least one temperature sensor signal may be further used for this purpose. As used herein, the term "combination" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, the process of determining at least one value by considering at least two individual values ​​that can be detected at the same time point, during the same time interval, or in consecutive time intervals. For example, in addition to recording at least one analyte sensor signal, the accompanying observation of at least one cardiac parameter of the subject, particularly heart rate, may aid in the early detection of hypoglycemia. Further details in this regard can be found in methods such as those disclosed by Diouri O et al., see above.

[0049] As used herein, the term "hypoglycemia" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, the observation of blood glucose levels below a critical concentration (typically 70 mg / dL); however, it may be feasible to use different thresholds. As used herein, the term "risk" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, the prediction of an expected observation, such as the prediction that blood glucose levels will reach a critical concentration that will lead to hypoglycemia.

[0050] Specifically, a sensor assembly can be an integrated system that can be treated as a single unit before use. For example, the elements of a sensor assembly, such as at least two sensors, an insertion cannula, electronic units, housing, and connector elements, can form a pre-assembled single unit. As used herein, the term "pre-assembled" is a broad term and will be given a meaning common and customary to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, the fact that an assembly process has already occurred. The components of the sensor assembly can be assembled, for example, by mechanical interconnection, and thus mechanically ready for use, such as ready to be inserted into a subject's body tissue to detect an analyte. Pre-assembly can be performed in a factory, thus making the sensor assembly a functional module assembled in a factory.

[0051] In another aspect of the invention, a monitoring method is disclosed, which may preferably use a sensor assembly as described elsewhere herein. The monitoring method includes continuously receiving at least two sensor signals from at least two associated individual sensors having shared electrodes, wherein the at least two sensor signals are correlated in time. For definitions and embodiments of the monitoring method, refer to the description of the sensor assembly as described elsewhere herein.

[0052] Specifically, the monitoring method includes the following steps: a) Continuously receiving at least one analyte sensor signal from at least one analyte sensor, wherein the analyte sensor includes at least two first electrodes configured to generate at least one analyte sensor signal; and b) Continuously receiving at least one electrocardiogram (ECG) sensor signal from at least one ECG sensor, wherein the ECG sensor includes at least two second electrodes configured to generate at least one ECG sensor signal. Wherein at least one of the first electrodes and at least one of the second electrodes constitute a shared electrode, and wherein the at least one analyte sensor signal is temporally correlated with the at least one electrocardiogram sensor signal.

[0053] These method steps can be performed in a given order. Alternatively, one or more of these method steps can be performed in parallel and / or with overlapping time. Furthermore, one or more of these method steps can be performed discontinuously or alternately. Additionally, one or more of these method steps can be performed repeatedly. Additionally, there may be additional method steps not mentioned herein.

[0054] As used herein, the term "receive" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, the process of obtaining at least one measurement result, particularly from at least one sensor signal of one of at least two individual sensors. As used herein, the term "continuously" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, a repetitive process of receiving multiple sensor signals of the same kind, particularly continuously, from associated sensors.

[0055] By continuously receiving multiple sensor signals from each associated sensor, wherein the sensor signals from different sensors are preferably correlated in time using at least one timestamp, and by subsequently combining the time-correlated sensor signals from different sensors, at least one of the following further steps can preferably be performed: c) Determine the value of at least one analyte in the subject's bodily fluids; or d) Determine the risk of hypoglycemia in the subjects.

[0056] As used herein, the term "correlated" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, a fixed relationship between two individual items, wherein, as used herein, the relationship specifically refers to a temporal relationship in which sensor signals originating from different sensors refer to a common time parameter. For example, sensor signals may be generated by different sensors at the same point in time. As another example, each sensor signal from a particular sensor may have a timestamp indicating the time value at which it was generated. In this way, when combining time-related sensor signals from different sensors, the time difference between the two sensor signals generated by the two different sensors can be considered. As used herein, the term "timestamp" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to, but is not limited to, a time value associated with an item, and thus can provide a pair of values. In particular, a timestamp can be a pair of values, which on one hand includes the value of a particular sensor signal generated by a particular sensor, and on the other hand includes the point in time associated with, as in the case of the particular sensor signal generated by the particular sensor. However, it is also possible to use different kinds of correlation between a specific sensor signal and a specific sensor that has generated that specific sensor signal.

[0057] In a particularly preferred embodiment, the monitoring method may include at least one further step. This at least one further step may preferably be selected from… – Receive at least one additional value from the subject continuously or intermittently from at least one additional sensor; – Use at least one additional value of the subject in either step c) or d).

[0058] Specifically, at least one additional sensor may be selected from at least one temperature sensor as described in more detail elsewhere herein. In this embodiment, this at least one further step may preferably be selected from... e) Receive at least one temperature value of the subject continuously or intermittently from at least one temperature sensor; f) Use the subject's at least one temperature value in either c) or d).

[0059] As indicated above, and as used herein, the term "continuously" can refer to, but is not limited to, a repetitive process of receiving multiple sensor signals from associated sensors continuously within consecutive time intervals. As used herein, the term "intermittently" is a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term can refer to, but is not limited to, a repetitive process of receiving a single sensor signal from associated sensors continuously within consecutive time intervals. Intermittently receiving at least one temperature sensor signal from a temperature sensor saves measurement time, and, on the other hand, allows the temperature value of the subject determined thereby to remain constant compared to the analyte value in the subject's bodily fluids over a considerably long time interval.

[0060] The monitoring method can be computer-implemented. As used herein, the term "computer-implemented method" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term can refer to, but is not limited to, methods involving at least one computer and / or at least one computer network. The computer and / or computer network may include at least one processor configured to perform at least one method step in the method according to the invention. Specifically, each of the method steps can be performed by the computer and / or computer network. The method can be performed completely automatically (specifically, without user interaction).

[0061] This document further discloses and proposes a computer program comprising computer-executable instructions for performing the monitoring methods disclosed herein when the instructions are executed on a computer or computer network. Specifically, the computer program may be stored on a computer-readable data carrier and / or a computer-readable storage medium. As used herein, each of the terms "computer-readable data carrier" and "computer-readable storage medium" specifically refers to a non-transitory data storage tool, such as a hardware storage medium on which computer-executable instructions are stored. The computer-readable data carrier or storage medium may specifically be or may include at least one of random access memory (RAM) or read-only memory (ROM). Therefore, specifically, one, more than one, or even all of the method steps disclosed herein can be performed by using a computer or computer network, preferably by using a computer program.

[0062] This document further discloses and proposes a computer program product with program code tools to perform the methods disclosed herein when the program is executed on a computer or computer network. Specifically, the program code tools may be stored on a computer-readable data carrier and / or a computer-readable storage medium.

[0063] This paper further discloses and proposes a data carrier on which data structures are stored, which, after being loaded into a computer or computer network, such as into the working memory or main memory of the computer or computer network, can execute the methods disclosed herein.

[0064] This document further discloses and proposes a non-transitory computer-readable medium including instructions that, when executed by one or more processors, cause the one or more processors to perform the methods disclosed herein.

[0065] This document further discloses and proposes a computer program product having program code tools stored on a machine-readable medium, so that when the program is executed on a computer or computer network, the methods disclosed herein can be performed. As used herein, a computer program product refers to a program that is a tradable product. The product can generally exist in any format (such as in paper format) or reside on a computer-readable data carrier and / or a computer-readable storage medium. Specifically, the computer program product can be distributed on a data network.

[0066] This document further discloses and proposes a modulated data signal containing instructions readable by a computer system or computer network for performing a method according to one or more embodiments disclosed herein.

[0067] Referring to the computer implementation aspects of the present invention, one or more, or even all, of the method steps disclosed herein can be performed using a computer or computer network. Therefore, in general, any method step, including providing and / or manipulating data, can be performed using a computer or computer network. Generally, these method steps can include any method steps other than those typically requiring manual work, such as providing samples and / or performing actual measurements.

[0068] The sensor components and monitoring methods disclosed herein are preferably applied to the continuous monitoring of at least one analyte, such as for continuous glucose monitoring (CGM), specifically in home care and professional care settings such as hospitals. However, other applications are possible.

[0069] In summary, and without excluding further possible embodiments, the following embodiments are conceivable: Example 1. A sensor assembly comprising at least two sensors selected from: – At least one analyte sensor configured to detect at least one analyte in a subject's bodily fluids, wherein the analyte sensor includes at least two first electrodes; and – At least one electrocardiogram (ECG) sensor configured to detect at least one cardiac parameter of the subject, wherein the ECG sensor includes at least two second electrodes; Wherein at least one of the first electrodes and at least one of the second electrodes constitute a shared electrode.

[0070] Example 2. The sensor assembly according to the foregoing embodiments, wherein the shared electrode is configured to be used simultaneously by the at least one analyte sensor and the at least one electrocardiogram sensor.

[0071] Example 3. The sensor assembly according to the foregoing embodiments, wherein the analyte sensor is at least one of a subcutaneous analyte sensor or a minimally invasive sensor.

[0072] Example 4. The sensor assembly according to any one of the foregoing embodiments, wherein the shared electrode is selected from skin-attached electrodes, subcutaneous electrodes, or minimally invasive electrodes.

[0073] Example 5. The sensor assembly according to any one of the foregoing embodiments, wherein one of the first electrodes of the analyte sensor is a detection electrode.

[0074] Example 6. The sensor assembly according to the foregoing embodiments, wherein the detection electrode is at least one of a subcutaneous electrode or a minimally invasive electrode.

[0075] Example 7. A sensor assembly according to any one of the two foregoing embodiments, wherein another first electrode of the first electrode of the analyte sensor is selected from a reference electrode, a counter electrode, or a counter / reference electrode.

[0076] Example 8. The sensor assembly according to the foregoing embodiments, wherein at least one of the reference electrode, the pair electrode, or the pair / reference electrode is a skin-contact electrode.

[0077] Example 9. A sensor assembly according to any of the preceding embodiments, wherein the at least two first electrodes of the analyte sensor are configured to generate at least one analyte sensor signal.

[0078] Example 10. The sensor assembly according to the foregoing embodiments, wherein the at least one analyte sensor signal is generated by performing a constant potential measurement.

[0079] Example 11. A sensor assembly according to any of the preceding embodiments, wherein the at least two second electrodes of the electrocardiogram sensor are configured to generate at least one electrocardiogram sensor signal.

[0080] Example 12. The sensor assembly according to the foregoing embodiments, wherein at least one of the at least two second electrodes of the electrocardiogram sensor is a skin-contact electrode.

[0081] Example 13. A sensor assembly according to any one of the two foregoing embodiments, wherein the at least one electrocardiogram sensor signal is generated by performing micro-voltage measurements.

[0082] Example 14. The sensor assembly according to any one of the foregoing embodiments, wherein the at least one cardiac parameter of the subject is the subject's heart rate.

[0083] Example 15. The sensor assembly according to any one of the foregoing embodiments further includes at least one additional sensor, wherein the additional sensor includes at least two third electrodes.

[0084] Example 16. The sensor assembly according to the foregoing embodiments, wherein the at least two third electrodes of the temperature sensor are configured to generate at least one additional sensor signal.

[0085] Example 17. The sensor assembly according to the foregoing embodiments, wherein the shared electrode is used as one of the third electrodes.

[0086] Example 18. A sensor assembly according to the three foregoing embodiments, wherein the at least one additional sensor is: – A temperature sensor configured to determine at least one temperature value of the subject.

[0087] Example 19. The sensor assembly according to any one of the foregoing embodiments further comprises: – At least one electronic unit configured to be connected to the at least two sensors.

[0088] Example 20. The sensor assembly according to the foregoing embodiments, wherein the electronic unit includes at least one microcontroller unit configured to control the operation of the at least two sensors.

[0089] Example 21. A sensor assembly according to any one of the foregoing embodiments, wherein the electronic unit is configured to determine at least one of the following: – The analyte value in the subject's bodily fluid; – Risk of hypoglycemia in this subject This determination is made by combining the signals from the at least one analyte sensor and the at least one electrocardiogram sensor.

[0090] Example 22. A monitoring method comprising the following steps: a) Continuously receiving at least one analyte sensor signal from at least one analyte sensor, wherein the analyte sensor includes at least two first electrodes configured to generate at least one analyte sensor signal; and b) Continuously receiving at least one electrocardiogram (ECG) sensor signal from at least one ECG sensor, wherein the ECG sensor includes at least two second electrodes configured to generate at least one ECG sensor signal. Wherein at least one of the first electrodes and at least one of the second electrodes constitute a shared electrode, and wherein the at least one analyte sensor signal is temporally correlated with the at least one electrocardiogram sensor signal.

[0091] Example 23. The method according to the foregoing embodiments, wherein the method is performed by using a sensor component according to any one of the foregoing sensor component embodiments.

[0092] Example 24. The method according to any one of the foregoing method embodiments, wherein temporal correlation includes using at least one timestamp.

[0093] Example 25. The method according to any one of the foregoing method embodiments, wherein the at least one analyte sensor signal and the at least one electrocardiogram sensor signal have been recorded in at least one manner, either concurrently or continuously.

[0094] Example 26. The method according to any one of the foregoing method embodiments further includes at least one of the following further steps: c) Determine the value of at least one analyte in the subject's bodily fluids; d) Determine the subject's risk of hypoglycemia. This determination is made by combining the signals from the at least one analyte sensor and the at least one electrocardiogram sensor.

[0095] Example 27. The method according to any one of the foregoing method embodiments further includes at least one of the following further steps: e) Receive at least one temperature value of the subject continuously or intermittently from at least one temperature sensor; and f) Use the subject's at least one temperature value in either c) or d).

[0096] Example 28. A computer or computer network including at least one processor, wherein the processor is configured to perform the method according to any one of the foregoing method embodiments.

[0097] Example 29. A computer-loadable data structure adapted to perform the method according to any one of the foregoing method embodiments when the data structure is executed on a computer.

[0098] Example 30. A computer program, wherein the computer program is adapted to perform the method according to any one of the foregoing method embodiments when executed on a computer.

[0099] Example 31. A computer program comprising program tools for performing the method according to any one of the foregoing method embodiments when the computer program is executed on a computer or on a computer network.

[0100] Example 32. A computer program comprising a program tool for performing the method according to any one of the foregoing method embodiments, wherein the program tool is stored on a computer-readable storage medium.

[0101] Example 33. A storage medium on which a data structure is stored, and wherein the data structure is adapted to be used, after being loaded into at least one of the main memory or working memory of a computer or computer network, according to any one of the foregoing method embodiments.

[0102] Example 34. A computer program product having a program code tool, wherein the program code tool may be stored or stored on a storage medium for performing the method according to any one of the foregoing method embodiments when the program code tool is executed on a computer or on a computer network. Attached Figure Description

[0103] Preferably, in conjunction with the dependent claims, further optional features and embodiments are disclosed in more detail in the description of the following embodiments. As those skilled in the art will recognize, each optional feature can be implemented individually and in any feasible combination. The scope of the invention is not limited to the preferred embodiments. Embodiments are schematically depicted in the accompanying drawings. In these drawings, the same reference numerals refer to the same or functionally equivalent elements.

[0104] In the attached diagram: Figure 1 schematically illustrates an exemplary embodiment of the sensor assembly; and Figure 2 schematically illustrates an exemplary embodiment of the monitoring method. Detailed Implementation

[0105] Figure 1 schematically illustrates an exemplary embodiment of a sensor assembly 110, which is preferably configured to perform the monitoring method 210 shown in more detail in Figure 2. The exemplary sensor assembly 110 schematically depicted in Figure 1 includes the following three sensors: – A subcutaneous analyte sensor 112, configured to detect at least one analyte in the body fluids of a subject; – An electrocardiogram sensor 114, configured to detect at least one cardiac parameter of a subject, particularly heart rate; and – An optional temperature sensor 116 is configured to determine at least one temperature value of the subject.

[0106] Alternatively, the analyte sensor may be a minimally invasive analyte sensor. As another alternative, or in addition to the optional temperature sensor 116, the sensor assembly 110 may include one or more optional additional sensors (not depicted here).

[0107] As shown in Figure 1, the subcutaneous analyte sensor 112 includes two first electrodes 118 and 118', wherein the first electrode 118 is a detection electrode 120, and the other first electrode 118' is a counter / reference electrode 122. As an alternative to or supplement to the counter / reference electrode 122, the subcutaneous analyte sensor 112 may include one or more optional additional electrodes selected from the reference electrode or counter electrode (not depicted here). Further as shown in Figure 1, the electrocardiogram sensor 114 includes two second electrodes 124 and 124'. Further as shown in Figure 1, an optional temperature sensor 116 includes two optional third electrodes 126 and 126'.

[0108] As schematically illustrated in Figure 1, the additional first electrode 118', second electrode 124', and optional third electrode 126' of the counter / reference electrode 122 constitute a shared electrode 128. As a result, the exemplary sensor assembly 110 depicted in Figure 1 uses only three electrodes 118, 124, 128 for the subcutaneous analyte sensor 112 and the electrocardiogram sensor 114, and four electrodes 118, 124, 126, 128 for the subcutaneous analyte sensor 112, the electrocardiogram sensor 114, and the optional temperature sensor 116.

[0109] Sensor assembly 110 can be attached to the skin 130 of a subject. In the exemplary sensor assembly 110 of FIG1, each of the shared electrode 128, the second electrode 124, and the optional third electrode 126 is preferably a skin-adhesive electrode 132 placed on the surface 134 of the skin 130 outside the subject's body 136 using an adhesive, while the first electrode 118 implemented as a detection electrode 120 is preferably a subcutaneous electrode 138 placed below the surface 134 of the skin 130 outside the subject's body 136 using an inserter. In an alternative arrangement of sensor assembly 110 (not depicted here), the two first electrodes 118, 118' of the subcutaneous analyte sensor 112 may be subcutaneous electrodes, while the two second electrodes 124, 124' of the electrocardiogram sensor 114 may include both skin-adhesive and subcutaneous electrodes. In this example, the shared electrode 128 may be a subcutaneous electrode shared by both the subcutaneous analyte sensor 112 and the electrocardiogram sensor 114. However, various alternative arrangements (not depicted here) are feasible, wherein the electrodes are implemented in a manner different from those on or under the skin 130 surface 134. In this way, the exemplary sensor assembly 110 depicted in FIG1 may exhibit improved biocompatibility, particularly due to the feature of having one less electrode subcutaneously inserted into the subject's skin 130 compared to prior art sensor assemblies.

[0110] The two first electrodes 118, 118' of the subcutaneous analyte sensor 112, wherein the additional first electrode 118' corresponds to a shared electrode 128, are configured to generate at least one analyte sensor signal. According to the exemplary arrangement of the sensor assembly 110 depicted in FIG1, at least one analyte sensor signal can be generated by performing a potentiostat measurement using the two first electrodes 118, 118', wherein the first electrode 118 here serves as a detection electrode 120, and the additional first electrode 118 here serves as a counter / reference electrode 122.

[0111] Similarly, the two second electrodes 124, 124' of the electrocardiogram sensor 114, wherein the additional second electrode 124' corresponds to the shared electrode 128, are configured to generate at least one electrocardiogram sensor signal. According to... Figure 1 An exemplary arrangement of the depicted sensor assembly 110 is provided, in which at least one electrocardiogram sensor signal can be generated by microvoltage measurement using two second electrodes 124, 124'.

[0112] Furthermore, still in a similar manner, the two third electrodes 126, 126' of the optional temperature sensor 116, wherein the additional third electrode 126' corresponds to the shared electrode 128, are configured to generate at least one temperature sensor signal. According to the exemplary arrangement of the sensor assembly 110 depicted in FIG1, at least one temperature sensor signal can be generated by voltage and / or current measurement using the two third electrodes 126, 126'.

[0113] As further illustrated in Figure 1, the leads are 140, 140', 140", and 140". Electronic unit 142 is used to transmit signals from various sensors (i.e., at least one analyte sensor signal, at least one electrocardiogram sensor signal, and optionally at least one temperature sensor signal) to electronic unit 142. Electronic unit 142 is configured to connect to various sensors, namely, subcutaneous analyte sensor 112, electrocardiogram sensor 114, and optionally temperature sensor 116. Electronic unit 142 includes at least one microcontroller unit (not depicted here) configured to control the operation of the various sensors. Electronic unit 142 may be included by sensor assembly 110; alternatively or additionally, electronic unit 142 may be an external unit not included by sensor assembly 110, as schematically depicted in FIG. 1. Electronic unit 142 may provide at least one electronic function, such as at least one measurement function, that interacts with each sensor 112, 114, and optionally 116.

[0114] Electronic unit 142 can be configured to determine and / or control at least one sensor signal and / or transmit the at least one sensor signal. Electronic unit 142 can be configured to determine... – The analyte value in the subject's bodily fluid; and / or – Risk of hypoglycemia in subjects.

[0115] For this purpose, electronic unit 142 can be configured to combine at least one analyte sensor signal with at least one electrocardiogram sensor signal and optionally at least one temperature signal, as described in more detail elsewhere herein.

[0116] Figure 2 schematically illustrates an exemplary embodiment of the monitoring method 210, which is exemplarily performed herein using the sensor assembly 110 of Figure 1. As shown above, the first electrode 118', the second electrode 124', and the optional third electrode 126' constitute a shared electrode 128. For further details regarding the monitoring method 210, refer to the description of the exemplary embodiment of the sensor assembly 110 depicted in Figure 1.

[0117] In the first receiving step 212 according to method step a), at least one analyte sensor signal is continuously received from the subcutaneous analyte sensor 112.

[0118] In the second receiving step 214 according to method step b), at least one electrocardiogram sensor signal is continuously received from electrocardiogram sensor 114.

[0119] In an optional third receiving step 216 according to method step e), at least one temperature signal may be received continuously or intermittently from temperature sensor 116.

[0120] As schematically indicated by arrows 218, 218', at least one sensor signal from each associated sensor 112, 114 and optionally 116 is preferably correlated in time using timestamp 220.

[0121] Continuously received sensor signals from each associated sensor 112, 114 and optionally 116, wherein the sensor signals from different sensors are preferably correlated in time using timestamp 220, and can subsequently be combined during further steps as follows: – In the first determining step 222 according to step c), at least one analyte value in the subject's body fluids can be determined.

[0122] – In the second determination step 224 according to step d), the subject’s risk of hypoglycemia can be determined.

[0123] Optionally, at least one temperature value of the subject determined based on at least one temperature signal received from temperature sensor 116 may be further used in the first determination step 222 and / or the second determination step 224 according to step f).

[0124] List of reference numerals

Claims

1. A sensor assembly (110) comprising at least two sensors selected from: – At least one analyte sensor configured to detect at least one analyte in a subject's bodily fluids, said analyte sensor comprising at least two first electrodes (118, 118'); and – At least one electrocardiogram (ECG) sensor (114) configured to detect at least one cardiac parameter of the subject, wherein the ECG sensor (114) includes at least two second electrodes (124, 124'). At least one of the first electrodes (118') and at least one of the second electrodes (124') constitute a shared electrode (128).

2. The sensor assembly (110) according to the preceding claim, wherein the shared electrode (128) is selected from skin-adhesive electrodes (132), subcutaneous electrodes (138), or minimally invasive electrodes.

3. The sensor assembly (110) according to any one of the preceding claims, wherein one (118) of the first electrode of the analyte sensor is a detection electrode (120), and wherein the other (118') of the first electrode of the analyte sensor is selected from a reference electrode, a counter electrode, or a counter / reference electrode (122).

4. The sensor assembly (110) according to any one of the preceding claims, wherein the at least two first electrodes (118, 118') of the analyte sensor are configured to generate at least one analyte sensor signal.

5. The sensor assembly (110) according to the preceding claim, wherein the at least one analyte sensor signal is generated by performing a constant potential measurement.

6. The sensor assembly (110) according to any one of the preceding claims, wherein the at least two second electrodes (124, 124') of the electrocardiogram sensor (114) are configured to generate at least one electrocardiogram sensor signal.

7. The sensor assembly (110) according to the preceding claim, wherein the at least one electrocardiogram sensor signal is generated by performing microvoltage measurement.

8. The sensor assembly (110) according to any one of the preceding claims, further comprising: – At least one temperature sensor (116) configured to determine at least one temperature value of the subject, wherein the temperature sensor (116) includes at least two third electrodes (126, 126'), wherein the at least two third electrodes (126, 126') of the temperature sensor (116) are configured to generate at least one temperature sensor signal.

9. The sensor assembly (110) according to the preceding claim, wherein the shared electrode (128) is further used as one of the third electrodes (126').

10. The sensor assembly (110) according to any one of the preceding claims, further comprising: – At least one electronic unit (142) configured to be connected to the at least two sensors, wherein the electronic unit (142) includes at least one microcontroller unit configured to control the operation of the at least two sensors.

11. The sensor assembly (110) according to the preceding claim, wherein the electronic unit (142) is configured to determine at least one of the following: – The analyte values ​​in the subject's bodily fluids; – Risk of hypoglycemia in the subjects The determination is made by combining the signals from the at least one analyte sensor and the at least one electrocardiogram sensor.

12. A monitoring method (210) comprising the following steps: a) Continuously receiving at least one analyte sensor signal from at least one analyte sensor, wherein the analyte sensor includes at least two first electrodes (118, 118') configured to generate at least one analyte sensor signal; and b) Continuously receiving at least one electrocardiogram (ECG) sensor signal from at least one ECG sensor (114), wherein the ECG sensor (114) includes at least two second electrodes (124, 124') configured to generate at least one ECG sensor signal. At least one of the first electrodes (118') and at least one of the second electrodes (124') constitute a shared electrode (128), and wherein the at least one analyte sensor signal is temporally correlated with the at least one electrocardiogram sensor signal.

13. The method (210) according to the preceding claim, wherein correlation in time includes using at least one timestamp.

14. The method (210) according to any one of the preceding method claims, further comprising at least one of the following further steps: c) Determine the value of at least one analyte in the subject's bodily fluids; d) Determine the risk of hypoglycemia in the subject. The determination is made by combining the signals from the at least one analyte sensor and the at least one electrocardiogram sensor.

15. The method (210) according to any one of the preceding method claims, further comprising at least one of the following further steps: e) Continuously or intermittently receiving at least one temperature value of the subject from at least one temperature sensor (116); and f) Using the subject's at least one temperature value in either c) or d).

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