Analyte sensor system for detecting medication administration

Abstract

Aspects of the present disclosure provide techniques for detecting medication administration by one or more health management devices in a health management system. An example method performed by an analyte sensor system in the health management system includes receiving an injection of a medication via an injection port of the analyte sensor system, delivering the medication to subcutaneous tissue of a user of the analyte sensor system via a cannula coupled with the injection port, generating, using an analyte sensor of the analyte sensor system, a signal associated with an analyte concentration level of the subcutaneous tissue of the user, processing the signal to generate processed analyte sensor data, wherein the processed analyte sensor data indicates at least the analyte concentration level of the user, and transmitting the processed analyte sensor data to a display device.

Description

Dexcom Ref. No.: 0972-PCT01ANALYTE SENSOR SYSTEM FOR DETECTING MEDICATION ADMINISTRATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 738,742, filed December 24, 2024, which is assigned to the assignee of the present application and is hereby expressly incorporated by reference in its entirety for all applicable purposes, as if fully set forth herein.INTRODUCTION

[0002] The present application relates generally to medical devices such as analyte sensors, and more particularly to systems, devices, and methods for detecting medication administration by an analyte sensor system.

[0003] Diabetes is a metabolic condition relating to the production or use of insulin by the body. Insulin is a hormone that allows the body to use glucose for energy, or store glucose as fat.

[0004] Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and / or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which causes an array of physiological derangements (kidney failure, skin ulcers, or bleeding into the vitreous of the eye) associated with the deterioration of small blood vessels. A hypoglycemic reaction (low blood sugar) may be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.

[0005] Conventionally, a diabetic patient carries a selfmonitoring blood glucose (SMBG) monitor, which may require uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a diabetic will normally only measure his or her glucose level two to four times per day. Unfortunately, these time intervals are spread so far apart that the diabetic will likely be alerted to a hyperglycemic or hypoglycemic condition too late, sometimes incurring dangerous side effects as a result. In fact, it is unlikely that a diabetic will take a timely SMBG value, and further the diabetic will not know if his blood glucose value is going up (higher) or down (lower), due to limitations of conventional methods.P+S Ref. No.: DEXC / 0972PC 1Dexcom Ref. No.: 0972-PCT01

[0006] Consequently, a variety of non-invasive, transdermal (e.g., transcutaneous) and / or implantable sensors are being developed for continuously detecting and / or quantifying blood glucose values. Generally, in a diabetes management system, a transmitter associated with the sensor wirelessly transmits raw or minimally processed data for subsequent display and / or analysis at one or more display devices, which can include a mobile device, a server, or any other type of communication devices. A display device, such as a mobile device, may then utilize a trusted software application (e.g., approved and / or provided by the manufacturer of the sensor), which takes the raw or minimally processed data and provides the user with information about the user's blood glucose levels. Because diabetes management systems using such implantable sensors can provide more up-to-date information to users, they may reduce the risk of a user failing to regulate the user's blood glucose levels.

[0007] This background is provided to introduce a brief context for the summary and detailed description that follow. This background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above.SUMMARY

[0008] Certain embodiments of the present disclosure provide an analyte sensor system configured to detect administration of a medication to a user of the analyte sensor system. The analyte sensor system includes an injection port configured to receive an injection of a medication and a cannula, coupled with the injection port, configured to deliver the medication to subcutaneous tissue of a user of the analyte sensor system. The analyte sensor system also includes an analyte sensor configured to generate a signal associated with an analyte concentration level of the subcutaneous tissue of the user and a sensor electronics module. The analyte sensor may be disposed on or embedded into a surface of the cannula. The analyte sensor system also includes a sensor electronics module configured to receive the signal from the analyte sensor, process the signal to generate processed analyte sensor data, wherein the processed analyte sensor data indicates at least the analyte concentration level of the user, and transmit the processed analyte sensor data to a display device.

[0009] Certain embodiments of the present disclosure provide a method for wirelessP+S Ref. No.: DEXC / 0972PC 2Dexcom Ref. No.: 0972-PCT01communication performed by an analyte sensor system. The method includes receiving an injection of a medication via an injection port of the analyte sensor system, delivering the medication to subcutaneous tissue of a user of the analyte sensor system via a cannula coupled with the injection port, generating, using an analyte sensor of the analyte sensor system, a signal associated with an analyte concentration level of the subcutaneous tissue of the user, wherein the analyte sensor may be disposed on or embedded into a surface of the cannula, processing the signal to generate processed analyte sensor data, wherein the processed analyte sensor data indicates at least the analyte concentration level of the user, and transmitting the processed analyte sensor data to a display device.

[0010] Certain embodiments of the present disclosure provide a method for wireless communication performed by a display device. The method includes receiving processed analyte sensor data from an analyte sensor system of a user, wherein the processed analyte sensor data includes a signal generated by an analyte sensor of the analyte sensor system that indicates at least an analyte concentration level of the user; detecting one or more electrical disturbances in the signal associated with deliverance of a medication to subcutaneous tissue of the user; and determining, based on the detected one or more electrical disturbances, a time at which the medication was delivered to the subcutaneous tissue of the user and the volume of the medication that was delivered to the subcutaneous tissue of the user; and displaying, to the user, the analyte concentration level, the time at which the medication was delivered to the subcutaneous tissue of the user, and the volume of the medication that was delivered to the subcutaneous tissue of the user.

[0011] Other aspects provide: an apparatus operable, configured, or otherwise adapted to perform the aforementioned methods as well as those described elsewhere herein; a non-transitory, computer-readable media comprising instructions that, when executed by one or more processors of an apparatus, cause the apparatus to perform the aforementioned methods as well as those described elsewhere herein; a computer program product embodied on a computer-readable storage medium comprising code for performing the aforementioned methods as well as those described elsewhere herein; and an apparatus comprising means for performing the aforementioned methods as well as those described elsewhere herein. By way of example, an apparatus may comprise a processing system, a device with a processing system, or processing systems cooperating over one or more networks.

[0012] The following description and the appended figures set forth certain featuresP+S Ref. No.: DEXC / 0972PC 3Dexcom Ref. No.: 0972-PCT01for purposes of illustration.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1A illustrates an example diabetes management system, according to some embodiments disclosed herein.

[0014] FIG. 2 illustrates a more detailed view of a health management system including a display device that is communicatively coupled to an analyte sensor system, according to some embodiments disclosed herein.

[0015] FIG. 3A is an example analyte sensor system, according to some embodiments disclosed herein.

[0016] FIG. 3B is an example analyte sensor system, according to some embodiments disclosed herein.

[0017] FIG. 3C illustrates aspects of an example analyte sensor system, according to some embodiments disclosed herein.

[0018] FIG. 4 illustrates an example analyte sensor system, according to some embodiments disclosed herein.

[0019] FIG. 5 illustrates an example analyte sensor system, according to some embodiments disclosed herein.

[0020] FIG. 6 depicts a graph illustrating an electrical signal corresponding to an analyte concentration level of a user, according to some embodiments disclosed herein.

[0021] FIG. 7 depicts a plurality of graphs illustrating a first electrical signal measured by a first electrode of an analyte sensor and a second electrical signal measured by a second electrode of the analyte sensor, according to some embodiments disclosed herein.

[0022] FIG. 8 depicts a method for wireless communication by an analyte sensor system, according to some embodiments disclosed herein.

[0023] FIG. 9 depicts a method for wireless communication by a display device, according to some embodiments disclosed herein.

[0024] FIG. 10 depicts aspects of an example a health management device, according to some embodiments disclosed herein.

[0025] FIG. 11 depicts aspects of an example a health management device,P+S Ref. No.: DEXC / 0972PC 4Dexcom Ref. No.: 0972-PCT01according to some embodiments disclosed herein.DETAILED DESCRIPTION

[0026] Aspects of the present disclosure provide techniques, including apparatuses, methods, processing systems, and computer-readable mediums, for detecting medication administration by one or more health management devices in a health management system.Introduction to Health Management Systems

[0027] FIG. 1 depicts a health management system 100 including an example continuous analyte sensor system (SS) 8 having continuous analyte sensor(s) and sensor electronics, in accordance with certain aspects of the present disclosure. For example, SS 8 may be configured to continuously monitor one or more analytes of a user 50, in accordance with certain aspects of the present disclosure.

[0028] As shown, SS 8 includes sensor electronics module 12 and one or more analyte sensor(s) 10 (individually referred to herein as analyte sensor(s) 10 and collectively referred to herein as analyte sensor(s) 10) associated with sensor electronics module 12. In some embodiments, the one or more analyte sensor(s) 10 may comprise one or more continuous analyte sensors configured to provide continuous analyte concentration level measurements. Sensor electronics module 12 may be in wireless communication (e.g., directly or indirectly) with one or more of display devices 110, 120, 130, and 140, and / or server system 134.

[0029] In certain embodiments, the analyte sensor(s) 10 may comprise one or more sensors for detecting and / or measuring analyte(s). The analyte sensor(s) 10 may be a multi-analyte sensor configured to continuously measure two or more analytes or a single analyte sensor configured to continuously measure a single analyte as a non-invasive device, a subcutaneous device, a transcutaneous device, a transdermal device, and / or an intravascular device. In certain embodiments, the analyte sensor(s) 10 may be configured to continuously measure analyte concentration levels of the user 50 using one or more techniques, such as enzymatic techniques, chemical techniques, physical techniques, electrochemical techniques, potentiostatic techniques, potentiometric techniques, impedimetric techniques, coulometric techniques, spectrophotometric techniques, polarimetric techniques, calorimetric techniques, iontophoretic techniques, radiometric techniques, immunochemical techniques, and the like. The term “continuous,” as usedP+S Ref. No.: DEXC / 0972PC 5Dexcom Ref. No.: 0972-PCT01herein, can mean fully continuous, semi-continuous, periodic, etc. In certain aspects, the analyte sensor(s) 10 provides a data stream indicative of the concentration of one or more analytes of the user 50. The data stream may include raw data signals, which are then converted into a calibrated and / or filtered data stream used to provide estimated analyte value(s) to the user 50.

[0030] In certain embodiments, the analyte sensor(s) 10 may be a multi-analyte sensor, configured to continuously measure one or more analytes in a body of the user 50. In some embodiments, the one or more analytes may include at least one of sodium ions, potassium ions, hydrogen ions, lithium ions, magnesium ions, calcium ions, chloride ions, sulfite ions, sulfate ions, phosphate ions, ammonium ions, uric acid, urea, ketones, and / or glucose.

[0031] In certain embodiments, the analyte sensor(s) 10 may comprise a percutaneous wire that has a proximal portion coupled to the sensor electronics module 12 and a distal portion with several electrodes, such as a measurement electrode and a reference electrode. The measurement (or working) electrode may be coated, covered, treated, embedded, etc., with one or more chemical molecules that react with a particular analyte, and the reference electrode may provide a reference electrical voltage. The measurement electrode may generate the analog electrical signal, which is conveyed along a conductor that extends from the measurement electrode to the proximal portion of the percutaneous wire that is coupled to the sensor electronics module 12. After the SS 8 has been applied to epidermis of the user 50, analyte sensor(s) 10 penetrates the epidermis, and the distal portion extends into the dermis and / or subcutaneous tissue under epidermis. Other configurations of analyte sensor(s) 10 may also be used, such as a multianalyte sensor that includes multiple measurement electrodes, each generating an analog electrical signal that represents the concentration levels of a particular analyte.

[0032] Generally, a single-analyte sensor generates an analog electrical signal that is proportional to the concentration level of a particular analyte. Similarly, each multianalyte sensor generates multiple analog electrical signals, and each analog electrical signal is proportional to the concentration level of a particular analyte. As an illustrative example, analyte sensor(s) 10 may include a single-analyte sensor configured to measure glucose concentration levels, and another single-analyte sensor configured to measure concentration levels of another analyte of the user 50, such as at least one of a sodium ion concentration level, a potassium ion concentration level, a hydrogen ion concentrationP+S Ref. No.: DEXC / 0972PC 6Dexcom Ref. No.: 0972-PCT01level, a lithium ion concentration level, a magnesium ion concentration level, a calcium ion concentration level, a chloride ion concentration level, a sulfite ion concentration level, a sulfate ion concentration level, a phosphate ion concentration level, an ammonium ion concentration level, a uric acid concentration level, a urea concentration level, and / or a ketone concentration level. As another illustrative example, analyte sensor(s) 10 may include a single-analyte sensor configured to measure glucose concentration levels, and one or more multi-analyte sensors configured to measure a sodium ion concentration level, a potassium ion concentration level, a hydrogen ion concentration level, a lithium ion concentration level, a magnesium ion concentration level, a calcium ion concentration level, a chloride ion concentration level, a sulfite ion concentration level, a sulfate ion concentration level, a phosphate ion concentration level, an ammonium ion concentration level, a uric acid concentration level, a urea concentration level, a ketone concentration level, a concentration of lactate, a concentration level of creatinine, etc. As yet another illustrative example, analyte sensor(s) 10 may include a multi-analyte sensor configured to measure glucose concentration levels, a sodium ion concentration level, a potassium ion concentration level, a hydrogen ion concentration level, a lithium ion concentration level, a magnesium ion concentration level, a calcium ion concentration level, a chloride ion concentration level, a sulfite ion concentration level, a sulfate ion concentration level, a phosphate ion concentration level, an ammonium ion concentration level, a uric acid concentration level, a urea concentration level, a ketone concentration level, a concentration of lactate, a concentration level of creatinine, etc.

[0033] Accordingly, analyte sensor(s) 10 is configured to generate at least one analog electrical signal that is proportional to the concentration level of a particular analyte, and sensor electronics module 12 is configured to convert the analog electrical signal into an analyte sensor count values, calibrate the analyte sensor count values based on the sensitivity profile of the analyte sensor(s) 10 to generate measured analyte concentration levels, and transmit the measured analyte concentration level data, including the measured analyte concentration levels, to a display device, such as display devices 210, 220, 230, and / or 240, via a wireless connection. For example, sensor electronics module 12 may be configured to sample the analog electrical signal at a particular sampling period (or rate), such as every 1 second (1 Hz), 5 seconds, 10 seconds, 30 seconds, 1 minute, 3 minutes, 5 minutes, etc., and to transmit the measured analyte concentration data to the display device at a particular transmission period (or rate), whichP+S Ref. No.: DEXC / 0972PC 7Dexcom Ref. No.: 0972-PCT01may be the same as (or longer than) the sampling period, such as every 1 minute (0.016 Hz), 5 minutes, 10 minutes, 30 minutes, at the conclusion of the wear period, etc. Depending on the sampling and transmission periods, the measured analyte concentration data transmitted to the display device include at least one measured analyte concentration level having an associated time tag, sequence number, etc. Additional details regarding analyte concentration level measurement and the configuration of the analyte sensor(s) 10 and sensor electronics module 12 may be found in U.S. patent application Ser. No.18 / 241,658 filed on September 1, 2023 and entitled, “DEVICES AND METHODS FOR MEASURING A CONCENTRATION OF A TARGET ANALYTE IN A BIOLOGICAL FLUID IN VIVO,” which is incorporated herein by reference in its entirety.

[0034] In certain embodiments, analyte sensor(s) 10 may incorporate a thermocouple within, or alongside, the percutaneous wire to provide an analog temperature signal to the sensor electronics module 12, which may be used to correct the analog electrical signal or the measured analyte data for temperature. In other embodiments, the thermocouple may be incorporated into the sensor electronics module 12 above the adhesive pad, or, alternatively, the thermocouple may contact the epidermis of the patient through openings in the adhesive pad. In some embodiments, the analyte sensor(s) 10 may incorporate a percutaneous flexible planar substrate including a plurality of electrodes, such as 2 electrodes, 3 electrodes, 4 electrodes, 5 electrodes, 6 electrodes, 7 electrodes, or 8 electrodes.

[0035] In certain embodiments, sensor electronics module 12 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data. Sensor electronics module 12 can be physically coupled to analyte sensor(s) 10 and can be integral with (non-releasably attached to) or releasably attachable to analyte sensor(s) 10. Sensor electronics module 12 may include hardware, firmware, and / or software that enable measurement of levels of analyte(s) via analyte sensor(s) 10. For example, sensor electronics module 12 can include an electrochemical analog front end (e.g., a potentiostat, galvanostat, coulostat, etc.), a power source for providing power to the sensor (including power switches and controlling logic), other components useful for signal processing and data storage, and a telemetry module for transmitting data from the sensor electronics module to, e.g., one or more display devices. Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example,P+S Ref. No.: DEXC / 0972PC 8Dexcom Ref. No.: 0972-PCT01the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), an electrochemical analog front end (AFE), a microcontroller, and / or a processor.

[0036] Display devices 110, 120, 130, and / or 140 are configured for displaying displayable sensor data, including analyte data, which may be transmitted by sensor electronics module 12. Each of display devices 110, 120, 130, and / or 140 may include a display such as a touchscreen display 112, 122, 132, and / or 142 for displaying sensor data to a patient and / or for receiving inputs from the patient. For example, a graphical user interface (GUI) may be presented to the patient for such purposes. In certain embodiments, the display devices may include other types of user interfaces such as a voice user interface instead of, or in addition to, a touchscreen display for communicating sensor data to the patient of the display device and / or for receiving patient inputs. In certain embodiments, one, some, or all of display devices 110, 120, 130, 140 may be configured to display or otherwise communicate the sensor information as it is communicated from sensor electronics module 12 (e.g., in a data package that is transmitted to respective display devices), without any additional prospective processing required for calibration and / or real-time display of the sensor data.

[0037] The plurality of display devices 110, 120, 130, 140 depicted in FIG. 1 may include a custom or proprietary display device, for example, display device 110, especially designed for displaying certain types of displayable sensor information associated with analyte data received from sensor electronics module 12 (e.g., a numerical value and / or an arrow, in certain embodiments). In certain embodiments, one of the plurality of display devices 110, 120, 130, 140 includes a smartphone, such as a mobile phone, based on an Android, iOS, or another operating system configured to display a graphical representation of the continuous sensor data (e.g., including current and / or historic data). In some embodiments, one of the plurality of display devices 110, 120, 130, 140 may include a home automation system display or speakers. In certain embodiments, health management system 100 further includes a medical delivery device (e.g., an insulin pump or pen). Sensor electronics module 12 may be configured to transmit sensor information and / or analyte data to medical delivery device. The medical delivery device (not shown) may be configured to administer a certain dosage of insulin or another medicament to the user based on the sensor information and / or analyte data (e.g., which may include a recommended insulin dosage) received from the sensorP+S Ref. No.: DEXC / 0972PC 9Dexcom Ref. No.: 0972-PCT01electronics module 12.

[0038] Server system 134 may be used to directly or indirectly collect analyte data from SS 8 and / or the plurality of display devices, for example, to perform analytics thereon, generate universal or individualized models for analyte concentration levels and profiles, provide services or feedback, including from individuals or systems remotely monitoring the analyte data, perform or assist SS 8 and the plurality of display devices with identification, authentication, etc., according to the embodiments described herein, so on. Note that, in certain embodiments, server system 134 may be representative of multiple systems or computing devices that perform the functions of server system 134 (e.g., in a distributed manner).

[0039] The term “analyte” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (e.g., blood, interstitial fluid, cerebral spinal fluid, lymph fluid, urine, sweat, saliva, etc.) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, electrolytes, ions, gasses, hormones, proteins, enzymes, neurotransmitters, infectious agents, and / or reaction products. In some examples, the analyte measured by the sensing regions, devices, and methods is glucose. However, other analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcamitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); bilirubin, biotinidase; biopterin; c-reactive protein; carnitine; camosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-P hydroxy-cholic acid; cortisol; creatine; creatine kinase; creatine kinase MM isoenzyme; creatinine; cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1 -antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, 21 -deoxycortisol); desbutylhalofantrine;P+S Ref. No.: DEXC / 0972PC 10Dexcom Ref. No.: 0972-PCT01dihydropteridine reductase; diptheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycines; free P-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose / gal-1 -phosphate; galactose- 1 -phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycerol; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; beta-hydroxybutyrate; ketones; lactate; lead; lipoproteins ((a), B / A-l, P); lysozyme; mefloquine; netilmicin; oxygen; phenobarbitone; phenytoin; phytanic / pristanic acid; potassium, sodium, and / or other blood electrolytes; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles / mumps / rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi / rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uric acid; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain examples. The analyte can be naturally present in the biological fluid, or endogenous, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternately, the analyte can be introduced into the body, or exogenous, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaineP+S Ref. No.: DEXC / 0972PC 11Dexcom Ref. No.: 0972-PCT01(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbiturates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5 -hydroxy tryptamine (5HT), 5-hydroxyindoleacetic acid (FHIAA), and histamine.

[0040] The term “ion” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an atom or molecule with a net electric charge due to the loss or gain of one or more electrons. Ions in a biological fluid is referred to as “electrolytes.” Non-limiting examples of ions in biological fluids include sodium (Na+), potassium (K+), magnesium (Mg2+), calcium (Ca2+), hydrogen (H+), lithium (Li+), chloride (Cl ), sulfide (S2), sulfite (SO32), sulfate (SO42), phosphate (PO43), and ammonium (NfLL). An ion is an example of an analyte.

[0041] FIG. 2 illustrates a more detailed view of health management system 100 including a display device 150 that is communicatively coupled to SS 8. In certain embodiments, display device 150 may be any one of display devices 110, 120, 130, and 140 of FIG. 1. In some embodiments, the display device 150 includes smartphone, such as a mobile phone, based on an Android, iOS, or another operating system configured to display a graphical representation of the continuous sensor data (e.g., including current and / or historic data). In some embodiments, the display device 150 may be a smartwatch or another type of device, such as an insulin pump or other type of pump.

[0042] The communication path between SS 8 and display device 150 is shown as communication path 180. In certain embodiments, SS 8 and display device 150 are configured to wirelessly communicate over communication path 180 using low range and / or distance wireless communication protocols. Examples of low range and / orP+S Ref. No.: DEXC / 0972PC 12Dexcom Ref. No.: 0972-PCT01distance wireless communication protocols include Bluetooth and Bluetooth Low Energy (BLE) protocols. In certain embodiments, other short range wireless communications may include Near Field Communications (NFC), radio frequency identification (RFID) communications, IR (infra-red) communications, optical communications. In certain embodiments, wireless communication protocols other than low range and / or distance wireless communication protocols may be used for communication path 180, such as WiFi Direct. Display device 150 is also configured to connect to network 190 (e.g., local area network (LAN), wide area network (WAN), the Internet, etc.). For example, display device 150 may connect to network 190 via a wired (e.g., Ethernet) or wireless (e.g., WLAN, wireless WAN, cellular, Mesh network, personal area network (PAN) etc.) interface. Display device 150 is able to communicate with server system 134 through network 190. The communication path between display device 150 and server system 134 is shown as communication path 181 via network 190.

[0043] Note that, in certain embodiments, SS 8 may be able to independently (e.g., wirelessly) communicate with server system 134 through network 190. An independent communication path between SS 8 and server system 134 is shown as communication path 182. However, in certain other embodiments, SS 8 may not be configured with the necessary hardware / software to establish, for example, an independent wireless communication path with server system 134 through network 190. In such embodiments, SS 8 may communicate with server system 134 through display device 150. An indirect or pass-through communication path between SS 8 and server system 134 is shown as communication path 183.

[0044] In embodiments where display device 150 is a proprietary display device, such as display device 110 designed specifically for the communication of analyte data, display device 150 may not be configured with the necessary hardware / software for independently connecting to network 190. Instead, in certain such embodiments, display device 150 is configured to establish a wired or wireless communication path 184 (e.g., through a Universal System Bus (USB) connection) with computer device 103, which is configured to communicate with server system 134 through network 190. For example, computer device 103 may connect to network 190 via a wired (e.g., Ethernet) or wireless (e.g., WLAN, wireless WAN, cellular, etc.) interface. In some embodiments, the display device 150 may be capable of independently communicating with server system 134 through network 190, independent of computer device 103.P+S Ref. No.: DEXC / 0972PC 13Dexcom Ref. No.: 0972-PCT01

[0045] Health management system 100 additionally includes server system 134, which in turn includes server 135 that is coupled to storage 136 (e.g., one or more computer storage systems, cloud-based storage systems and / or services, etc.). In certain embodiments, server system 134 may be located or execute in a public or private cloud. In certain embodiments, server system 134 is located or executes on-premises (“on-prem”). As discussed, server system 134 is configured to receive, collect, and / or monitor information, including analyte data and related information, as well as encryption / authentication information from SS 8 and / or display device 150. Such information may include input responsive to the analyte data or input (e.g., the user’s analyte concentration measurements and other physiological / behavioral information) received in connection with an analyte monitoring or sensor application running on SS 8 or display device 150. This information may be stored in storage 136 and may be processed, such as by an analytics engine capable of performing analytics on the information. An example of an analyte sensor application that may be executable on display device 150 is analyte sensor application 121, as further described below.

[0046] In certain embodiments, server system 134 at least partially directs communications between SS 8 and display device 150, for example, for facilitating authentication therebetween. Such communications include messaging (e.g., advertisement, command, or other messaging), message delivery, and analyte data. For example, in certain embodiments, server system 134 may process and exchange messages between SS 8 and display device 150 related to frequency bands, timing of transmissions, security, alarms, and so on. In certain embodiments, server system 134 may also update information stored on SS 8 and / or display device 150. In certain embodiments, server system 134 may send / receive information to / from SS 8 and or display device 150 in realtime or sporadically. Further, in certain embodiments, server system 134 may implement cloud computing capabilities for SS 8 and / or display device 150.

[0047] FIG. 2 also illustrates the components of SS 8 in further detail. As shown, in certain embodiments, SS 8 includes analyte sensor(s) 10 coupled to sensor electronics module 12. As shown, the sensor electronics module 12 includes one or more hardware components, such one or more processors 11, sensor measurement circuitry 13, one or more memories 14, connectivity interface 15, and real time clock (RTC) 17. In some embodiments, the one or more hardware components of the sensor electronics module 12 may be implemented as ASIC on a printed circuit board (PCB).P+S Ref. No.: DEXC / 0972PC 14Dexcom Ref. No.: 0972-PCT01

[0048] As shown, sensor electronics module 12 includes the sensor measurement circuitry 13 that is coupled to analyte sensor(s) 10 (such as a potentiostat) for processing and managing sensor data. Sensor measurement circuitry 13 may also be coupled to the one or more processors 11 of the sensor electronics module 12. In some embodiments, the one or more processors 11 may be a general-purpose or application-specific microprocessor, an ASIC, a field programmable gate array (FPGA), etc., that executes instructions to perform control, computation, input / output, etc. functions for the sensor electronics module 12. The one or more processors 11 may include a single integrated circuit, such as a micro processing device, or multiple integrated circuit devices and / or circuit boards working in cooperation to accomplish the appropriate functionality.

[0049] In some embodiments, the one or more processors 11 may be configured to sample an analog electrical signal received from the analyte sensor(s) 10 using the analog-to-digital (A / D) signal processing circuitry, such as the sensor measurement circuitry 13, at regular intervals (such as the sampling period) to generate analyte sensor count values based on the analog electrical signals received from the analyte sensor(s) 10, calibrate the analyte sensor count values based on the sensitivity profile of the analyte sensor(s) 10 to generate measured analyte concentration levels, and generate measured analyte data from the measured analyte concentration levels, generate sensor data packages that include, inter alia, the measured analyte concentration level data. The one or more processors 11 may store the measured analyte concentration level data in the one or more memories 14, and generate the sensor data packages at regular intervals (such as the transmission period) for transmission to the display device 150. The one or more processors 11 may also add additional data to the sensor data packages, such as supplemental sensor information that includes a sensor identifier, a sensor status, temperatures that correspond to the measured analyte data, etc. The sensor data packages are then wirelessly transmitted over a wireless connection to the display device 150. In certain embodiments, the wireless connection is a Bluetooth or Bluetooth Low Energy (BLE) connection. In such embodiments, the sensor data packages are transmitted in the form of Bluetooth or BLE data packets to the display device 150.

[0050] In some embodiments, the one or more processors 11 may perform part or all of the functions of the sensor measurement circuitry 13 for obtaining and processing sensor measurement values from analyte sensor(s) 10. The one or more processors 11 may also be coupled to the one or more memories 14 and the RTC 17 for storing andP+S Ref. No.: DEXC / 0972PC 15Dexcom Ref. No.: 0972-PCT01tracking sensor data. In addition, the one or more processors 11 may be further coupled to the connectivity interface 15, which includes a radio unit or transceiver (TRX) 16 for sending sensor data (e.g., measured analyte concentration levels) and receiving requests and commands from an external device, such as display device 150. As used herein, the term transceiver generally refers to a device or a collection of devices that enable SS 8 to (e.g., wirelessly) transmit and receive data. It is contemplated that, in some embodiments, the sensor measurement circuitry 13 may carry out all the functions of the one or more processors 11 or vice versa.

[0051] Transceiver 16 may be configured with the necessary hardware and wireless communications protocols for enabling wireless communications between SS 8 and other devices, such as display device 150 and / or server system 134. For example, as described above, transceiver 16 may be configured with the necessary hardware and communication protocols to establish a Bluetooth or BLE connection with display device 150. As one of ordinary skill in the art appreciates, in such an example, the necessary hardware may include a Bluetooth or BLE security manager and / or other Bluetooth or BLE related hardware / software modules configured for Bluetooth or BLE communications standards. In some embodiments where SS 8 is configured to establish an independent communication path with server system 134, transceiver 16 may be configured with the necessary hardware and communication protocols (e.g., long range wireless cellular communication protocol, such as, GSM, CDMA, LTE, VoLTE, 3G, 4G, 5G communication protocols) for establishing a wireless connection to network 190 to connect with server system 134. As discussed elsewhere, other short range protocols, may also be used for communication between display device 150 and a SS 8 such as NFC, RFID, etc.

[0052] FIG. 2 similarly illustrates the components of display device 150 in further detail. As shown, display device 150 includes connectivity interface 128, one or more processors 126, one or more memories 127, a real time clock (RTC) 163, a display 125 for presenting a graphical user interface (GUI), and a storage 123. A bus (not shown here) may be used to interconnect the various elements of display device 150 and transfer data between these elements. Connectivity interface 128 includes a transceiver (TRX) 129 used for receiving sensor data (e.g., measured analyte concentration levels) from SS 8 and for sending requests, instructions, and / or data to SS 8 as well as server system 134. Transceiver 129 is coupled to other elements of display device 150 via connectivityP+S Ref. No.: DEXC / 0972PC 16Dexcom Ref. No.: 0972-PCT01interface 128 and / or the bus. Transceiver 129 may include multiple transceiver modules operable on different wireless standards. For example, transceiver 129 may be configured with one or more communication protocols, such as wireless communication protocol(s) for establishing a wireless communication path with network 190 and / or low range wireless communication protocol(s) (e.g., Bluetooth or BLE) for establishing a wireless communication path 180 with SS 8. Additionally, connectivity interface 128 may in some cases include additional components for controlling radio and / or wired connections, such as baseband and / or Ethernet modems, audio / video codecs, and so on.

[0053] In some embodiments, when a standardized communication protocol is used between display device 150 and SS 8, commercially available transceiver circuits may be utilized that incorporate processing circuitry to handle low level data communication functions such as the management of data encoding, transmission frequencies, handshake protocols, security, and the like. In such embodiments, the one or more processors 126 of display device 150 and / or the one or more processors 11 of SS 8 may not need to manage these activities, but instead provide desired data values for transmission, and manage high level functions such as power up or down, set a rate at which messages are transmitted, and the like. Instructions and data values for performing these high level functions can be provided to the transceiver circuits via a data bus and transfer protocol established by the manufacturer of transceivers 129 and 16. However, in embodiments where a standardized communication protocol is not used between transceivers 129 and 16 (e.g., when non- standardized or modified protocols are used), the one or more processors 126 and 11 may be configured to execute instructions associated with proprietary communications protocols (e.g., one or more of the communications protocols described herein) to control and manage their respective transceivers. In addition, when non-standardized or modified protocols are used, customized circuitries may be used to service such protocols.

[0054] The one or more processors 126 may include processor sub-modules, including, by way of example, an applications processor that interfaces with and / or controls other elements of display device 150 (e.g., connectivity interface 128, analyte sensor application 121 (hereinafter “sensor application 121”), display 125, RTC 163, one or more memories 127, storage 123, etc.). In certain embodiments, the one or more processors 126 is configured to perform functions related to device management, such as, for example, managing lists of available or previously paired devices, informationP+S Ref. No.: DEXC / 0972PC 17Dexcom Ref. No.: 0972-PCT01related to network conditions (e.g., link quality and the like), information related to the timing, type, and / or structure of messaging exchanged between SS 8 and display device 150, and so on. The one or more processors 126 may further be configured to receive and process user input, such as, for example, a user's biometric information, such as the user’s finger print (e.g., to authorize the user's access to data or to be used for authorization / encryption of data, including analyte data), as well as analyte data.

[0055] The one or more processors 126 may include and / or be coupled to circuitry such as logic circuits, memory, a battery and power circuitry, and other circuitry drivers for periphery components and audio components. The one or more processors 126 and any sub-processors thereof may include logic circuits for receiving, processing, and / or storing data received and / or input to display device 150, and data to be transmitted or delivered by display device 150. As described above, the one or more processors 126 may be coupled by a bus to display 125, connectivity interface 128, storage 123, etc. Hence, the one or more processors 126 may receive and process electrical signals generated by these respective elements and thus perform various functions. By way of example, the one or more processors 126 may access stored content from storage 123 and one or more memories 127 at the direction of analyte sensor application 121, and process the stored content to be displayed by display 125. Additionally, the one or more processors 126 may process the stored content for transmission via connectivity interface 128 to SS 8 and / or server system 134. Display device 150 may include other peripheral components not shown in detail in FIG. 2.

[0056] In certain embodiments, the one or more memories 127 may include volatile memory, such as random access memory (RAM) for storing data and / or instructions for software programs and applications, such as analyte sensor application 121. Display 125 presents a GUI associated with operating system 162 and / or analyte sensor application 121. In various embodiments, a user may interact with analyte sensor application 121 via a corresponding GUI presented on display 125. By way of example, display 125 may be a touchscreen display that accepts touch input. Analyte sensor application 121 may process and / or present analyte-related data received by display device 150 and present such data via display 125. Additionally, analyte sensor application 121 may be used to obtain, access, display, control, and / or interface with analyte data and related messaging and processes associated with SS 8 (e.g., and / or any other medical device (e.g., insulin pump or pen) that are communicatively coupled with display device 150), as is describedP+S Ref. No.: DEXC / 0972PC 18Dexcom Ref. No.: 0972-PCT01in further detail herein.

[0057] Storage 123 may be a non-volatile storage for storing software programs, instructions, data, etc. For example, storage 123 may store analyte sensor application 121 that, when executed using the one or more processors 126, for example, receives input (e.g., by a conventional hard / soft key or a touch screen, voice detection, or other input mechanism), and allows a user to interact with the analyte data and related content via display 125. In various embodiments, storage 123 may also store user input data and / or other data collected by display device 150 (e.g., input from other users gathered via analyte sensor application 121). Storage 123 may further be used to store volumes of analyte data received from SS 8 (or any other medical data received from other medical devices (e.g., insulin pump, pen, etc.) for later retrieval and use, e.g., for determining trends and triggering alerts.

[0058] As described above, SS 8, in certain embodiments, gathers analyte data (e.g., measured analyte concentration levels) from analyte sensor 10 and transmits the same or a modified version of the collected data to display device 150. Data points regarding analyte values may be gathered and transmitted over the life of analyte sensor (s) 10 (e.g., in the range of 1 to 30 days or more). New measurements may be transmitted often enough to adequately monitor analyte concentration levels. In certain embodiments, rather than having the transmission and receiving circuitry of each of SS 8 and display device 150 continuously communicate, SS 8 and display device 150 may regularly and / or periodically establish a communication channel among each other. Thus, in such embodiments, SS 8 may, for example, communicate with display device 150 at predetermined time intervals. The duration of the predetermined time interval can be selected to be long enough so that SS 8 does not consume too much power by transmitting data more frequently than needed, yet frequent enough to provide substantially real-time sensor information (e.g., measured glucose values or analyte data) to display device 150 for output (e.g., via display 125) to the user. While the predetermined time interval is every five minutes in some embodiments, it is appreciated that this time interval can be varied to be any desired length of time. In other embodiments, transceivers 129 and 16 may be continuously communicating. For example, in certain embodiments, transceivers 129 and 16 may establish a session or connection there between and continue to communicate together until the connection is lost.

[0059] Analyte sensor application 121 may be downloaded, installed, and initiallyP+S Ref. No.: DEXC / 0972PC 19Dexcom Ref. No.: 0972-PCT01configured / setup on display device 150. For example, display device 150 may obtain analyte sensor application 121 from server system 134, or from another source, such as an application store or the like, via a network, e.g., network 190. Following installation and setup, analyte sensor application 121 may be configured to access, process, and / or interface with analyte data (e.g., whether stored on server system 134, locally from storage 123, from SS 8, or any other medical device). By way of example, analyte sensor application 121 may present a menu that includes various controls or commands that may be executed in connection with the operation of SS 8, display device 150, one or more other display devices (e.g., display device 110, 130, 140, etc.), and / or one or more other partner devices, such as an insulin pump. For example, analyte sensor application 121 may be used to interface with or control other display and / or partner devices, for example, to deliver or make available thereto analyte data, including for example by receiving / sending analyte data directly to the other display and / or partner device and / or by sending an instruction for SS 8 and the other display and / or partner device to be connected.

[0060] In certain embodiments, after downloading analyte sensor application 121, as one of the initial steps, the user may be directed by analyte sensor application 121 to establish a secure wireless connection between the display device 150 to the SS 8 of the user, which the user may have already placed on their body. A wireless communication path 180 between display device 150 and SS 8 allows SS 8 to transmit analyte measurements to display device 150 and for the two devices to engage in any of the other interactions described above.

[0061] FIG. 3A illustrates a perspective view of the SS 8 described with respect to FIGS. 1 and 2. As shown, the sensor electronics module 12 of the SS 8 may include an outer housing with a first, top portion 392 and a second, bottom portion 394. In embodiments, the outer housing may include a clamshell design.

[0062] As shown in FIG. 3A, the outer housing may feature a generally oblong shape. The outer housing may further include aperture 396 disposed substantially through a center portion of outer housing and adapted for analyte sensor(s) 10 and needle insertion through a bottom of SS 8. In embodiments, aperture 396 may be a channel or elongated slot. SS 8 may further include an adhesive patch 326 configured to secure SS 8 to epidermis of a user (e.g., user 50 described with respect to FIG. 1). In embodiments, adhesive patch 326 may include an adhesive suitable for skin adhesion, for example aP+S Ref. No.: DEXC / 0972PC 20Dexcom Ref. No.: 0972-PCT01pressure sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment, though any suitable type of adhesive is also contemplated. As shown, adhesive patch 326 may feature an aperture 398 aligned with aperture 396 such that analyte sensor(s) 10 may pass through a bottom of SS 8 and through adhesive patch 326.

[0063] FIG. 3B illustrates a bottom perspective view of SS 8 of FIG. 3A. FIG. 3B further illustrates aperture 396 disposed substantially in a center portion of a bottom of SS 8, and aperture 398, both adapted for analyte sensor(s) 10 and needle insertion.

[0064] FIG. 3C illustrates a cross-sectional view of SS 8 of FIGs. 3A and 3B. FIG.3C illustrates the first, top portion 392 and the second, bottom portion 394 of the outer housing, adhesive patch 326, aperture 396 in the center portion of SS 8, aperture 398 in the center portion of adhesive patch 326, and analyte sensor(s) 10 passing through aperture 396. As sensor electronics module 12, previously described in connection with FIGS. 1 and 2, may further include a PCB 304 for communicatively coupling one or more hardware components of the sensor electronics module 12 of the SS 8, such as the analyte sensor(s) 10, the one or more processors 11, the sensor measurement circuitry 13, the one or more memories 14, the connectivity interface 15, and the RTC 17. Additionally, as shown, the sensor electronics module 12 may include a battery 302, which may be electrically coupled to the PCB 304 and configured to provide power to the one or more hardware components of the SS.

[0065] Additionally, the analyte sensor(s) 10 may include one or more electrodes 337 configured to sense or measuring analyte concentration levels of a user (e.g., user 50), such as a glucose concentration level. For example, the one or more electrodes 337 may include a working electrode coated with an enzyme, such as glucose oxidase or glucose dehydrogenase, which facilitates a reaction with glucose. This reaction produces an electroactive compound, such as hydrogen peroxide or an electron mediator, which generates an electrical signal at the one or more electrodes 337. The signal is proportional to the glucose concentration and may be received and processed by one or more hardware components of the sensor electronics module 12 (e.g., the one or more processors 11 and / or the sensor measurement circuitry 13) via an input pin on the PCB 304. In some embodiments, the electrode may also include additional layers or coatings, such as membranes to reduce interference from other substances, to improve measurement accuracy.P+S Ref. No.: DEXC / 0972PC 21Dexcom Ref. No.: 0972-PCT01Analyte Sensor System for Detecting Medication Administration

[0066] Diabetes management often relies on consistent monitoring and accurate administration of insulin to regulate blood glucose levels effectively. Traditionally, users were required to manually log insulin dosages when using insulin pens, which is prone to human error or oversight. To address these issues, advancements in Bluetooth technology have been incorporated into insulin pens, enabling automated tracking of insulin administration events. For example, Bluetooth-enabled insulin pens are capable of recording the timing and dosage of each insulin administration, allowing users to reliably monitor their dosing, avoid missed doses, and better regulate their glucose levels. Additionally, Bluetooth-enabled pen caps have been developed to provide similar functionality across a broader range of insulin pens. These pen caps are capable of detecting when an insulin dose is administered by monitoring cap removal and replacement events, and subsequently logging these actions to support consistent tracking and analysis.

[0067] Despite advancements in Bluetooth-based insulin pens, several limitations continue to challenge their effectiveness in supporting diabetes management. One significant issue is that these insulin pens may not accurately measure the precise dosage delivered to the user. For example, if an occlusion occurs during injection of insulin, such as a clog in the needle or insulin flow restriction, the user may receive only a partial dose, or none at all, despite the pen recording a full administration. This lack of feedback on incomplete or interrupted dosing may be especially concerning for caregivers managing diabetes in children or elderly patients, where ensuring proper dosing is critical and historical reporting may not be accurate.

[0068] Additionally, these Bluetooth-enabled insulin pens may lack integration with an analyte sensor system, such as a continuous glucose monitor (CGM), which may complicate diabetes management. For example, due to the lack of integration between these Bluetooth-enabled insulin pens and analyte sensor systems, users and caregivers must separately track blood glucose levels and insulin administration without a comprehensive view of how each affects the other. Furthermore, because analyte sensor systems may be unable to interface with Bluetooth-enabled insulin pens, the analyte sensor system may not have information on whether insulin has been administered. As a result, a health monitoring application associated with the analyte sensor system may be configured to issue alerts when rising glucose levels of a user are detected, even if theP+S Ref. No.: DEXC / 0972PC 22Dexcom Ref. No.: 0972-PCT01user has already administered insulin. This limitation may be especially challenging for caregivers. For example, if a child’s analyte sensor system shows rising glucose levels while they are at school, a parent may receive an alert without knowing whether insulin has already been administered to the child, creating uncertainty in managing the child’ s diabetes remotely.

[0069] Another potential complication with insulin self-administration is the possibility that the administered insulin may be ineffective. For example, insulin that is improperly stored, expired, or otherwise degraded may fail to lower glucose levels as expected, even if the correct dosage is administered. While Bluetooth-enabled insulin pens may track and record the insulin dose administered, they may not provide any feedback on the effectiveness of the insulin itself. As a result, users may experience persistent hyperglycemia despite accurate dosing, leading to further complications in managing glucose levels.

[0070] Moreover, use of these insulin pens may still require self-administration of insulin, which may add further challenges for users. Regular injections are often painful, causing discomfort with each dose and, over time, potentially leading to injection site sensitivity or scarring. This discomfort may discourage consistent insulin administration, especially in younger patients or those with needle anxiety. As a result, the pain associated with these injections may impact both adherence to treatment regimens and overall quality of life for individuals managing diabetes.

[0071] Accordingly, aspects of the present disclosure provide techniques for integrating insulin administration tracking with continuous glucose monitoring to improve dosing accuracy and support more effective health management. For example, in some embodiments, these techniques involve equipping an analyte sensor system, such as a CGM, with an injection port through which insulin may be administered to a user. In some embodiments, the injection port of the analyte sensor system may be coupled with a cannula that may be inserted into subcutaneous tissue of the user when the analyte sensor system is deployed onto the user. Insulin or another medication may then be injected by a user into the injection port of the analyte sensor system using a syringe. Once injected, the insulin may travel down a length of the cannula before exiting into the subcutaneous tissue of the user through an egress in the cannula.

[0072] In some embodiments, the cannula may be inserted into the subcutaneousP+S Ref. No.: DEXC / 0972PC 23Dexcom Ref. No.: 0972-PCT01tissue of the user using an insertion needle of an applicator device used to deploy the analyte sensor system. For example, when the analyte sensor system is deployed, the insertion needle of the applicator device may be configured to puncture the skin of the user and insert the cannula into the subcutaneous tissue. Thereafter, the insertion needle may retract back into the applicator device, leaving behind the cannula. The cannula may then remain in the subcutaneous tissue of the user for a lifetime of the analyte sensor system, typically lasting around 7-14 days. In some embodiments, the injection port may be sealed with a membrane, allowing repeated access to the cannula for infusion / inj ection while maintaining a patent seal. As such, aside from the initial puncture to insert the cannula into the user’s subcutaneous tissue, the user may administer insulin throughout the lifetime of the analyte sensor system without needing to puncture their skin repeatedly with a syringe, reducing the pain associated with diabetes management and improving adherence to treatment regimens and overall quality of life of the user managing diabetes.

[0073] Additionally, in some embodiments, a sensor wire of the analyte sensor system (e.g., used to sense one or more analytes, such as glucose, may be embedded into or printed on a surface of the cannula. In some embodiments, the sensor wire may include one or more electrodes that may be used to perform analyte concentration level measurements (e.g., glucose concentration level measurements) of the user. Further, in some embodiments, in addition to performing the analyte concentration level measurements, the one or more electrodes may also be used to sense electrical disturbances in localized subcutaneous tissue associated with the injection of a medication, such as insulin or another medication, through the injection port of the analyte sensor. For example, when the medication is injected into the injection portion of the analyte sensor system and diffused into the subcutaneous tissue of the user through the cannula, the medication may cause an electrical disturbance in the localized subcutaneous tissue relative to a baseline electrical measurement (e.g., current) of the subcutaneous tissue, which may be sensed by the one or more electrodes. Further, in some cases, the analyte sensor system may use this electrical disturbance to detect whether the medication has been administered to the user, as well as a volume or dosage size of the medication that was administered, enabling more accurate and convenient tracking of medication administration and improving health management for both the user and caregivers. Additionally, the electrical disturbance may enable the analyte sensor system to determine the dosage size or volume based on an actual amount of medication administered in vivo,P+S Ref. No.: DEXC / 0972PC 24Dexcom Ref. No.: 0972-PCT01rather than relying on an assumed dose that could be affected by occlusions, as seen with Bluetooth-enabled insulin pens described above.

[0074] Further, in some embodiments, in addition to being able to detect whether the medication, such as insulin, has been administered based on the electrical disturbance, the analyte sensor system may also be able to determine an effectiveness of the insulin. For example, when insulin is injected into the injection port of the analyte sensor system and delivered to the subcutaneous tissue of the user, a glucose concentration level of the subcutaneous tissue near the cannula may be expected to decrease significantly for a period of time. However, when insulin is improperly stored, expired, or otherwise degraded, the insulin may fail to lower glucose concentration levels as expected. Accordingly, in some embodiments, when the analyte sensor system detects that insulin has been administered but does not detect a drop in the glucose concentration level by a threshold amount, the analyte sensor system may be configured to determine that the insulin is no longer effective and may provide a notification to the user indicating that the insulin is ineffective.

[0075] FIG. 4 illustrates an example analyte sensor system 400, in accordance with aspects presented herein. As shown, the analyte sensor system includes an injection port 402 that may be configured to receive an injection of a medication. For example, in some embodiments, the user may draw up a certain volume of the medication using a syringe 404 before puncturing a membrane 406 of the injection port 402 and injecting the medication into a medication reservoir 408 of the analyte sensor system. In some cases, the medication may comprise insulin, glucagon, growth hormone, or another injectable medication. The injection port 402 and medication reservoir 408 may be coupled with a cannula 410, which may be configured to reside within, and deliver the medication to, subcutaneous tissue 412 of a user 414 of the analyte sensor system 400. The cannula 410 may include an interior portion forming a tube-like structure that is configured to allow the medication to flow from the injection port 402 / medication reservoir 408 and through the cannula 410. Additionally, as shown, the cannula 410 includes an egress 416, which may be configured to allow the medication to flow out of the cannula 410 and into the subcutaneous tissue 412 of the user 414, as shown at 418. As depicted, the egress 416 may comprise a single aperture or hole. However, in other embodiments, the egress may be composed of a plurality of apertures, arranged in a grid structure, formed using laser puncturing.P+S Ref. No.: DEXC / 0972PC 25Dexcom Ref. No.: 0972-PCT01

[0076] Further, as shown, the analyte sensor system 400 includes a transcutaneous analyte sensor 420, which may be configured to perform one or more measurements of an analyte concentration level of the user 414. For example, as will be described in greater detail below, the analyte sensor 420 may be configured to generate one or more electrical signals proportional to the analyte concentration level of the user 414, which may be provided to a sensor electronics module 424. In some embodiments, the analyte sensor 420 and sensor electronics module 424 may be examples of the analyte sensor(s) 10 and sensor electronics module 12 depicted and described with respect to FIGS. 1 and 2. In some embodiments, one or more processors of the sensor electronics module 424 may process the signal received from the analyte sensor 420 to generate processed analyte sensor data. In some embodiments, the processed analyte sensor data may indicate at least the analyte concentration level of the user. Thereafter, the sensor electronics module 424 may be configured to transmit the processed analyte sensor data to a display device for display to the user 414.

[0077] In some embodiments, as illustrated in FIG. 4, the analyte sensor 420 may be coupled to the cannula 410 and both may protrude together from a bottom side 422 of the analyte sensor system 400 that is configured to face in a direction towards the subcutaneous tissue 412 of the user 414 when the analyte sensor system 400 is attached to the user 414. In some embodiments, the analyte sensor 420 may be disposed on an exterior surface of the cannula 410, embedded into the exterior surface of the cannula 410, or a combination thereof. In some embodiments, the analyte sensor 420 may be disposed on an interior surface of the cannula 410 in the tube-like structure through which the medication flows.

[0078] In some embodiments, as illustrated in FIG. 5, the cannula 410 and the analyte sensor 420 may independently protrude from the bottom side 422 of the analyte sensor system 400, forming a "snake-bite" configuration. For example, as shown at 424 in FIG. 5, the cannula 410 and analyte sensor 420 are decoupled from each other, as compared to their configuration in FIG. 4, and are positioned with a specific distance between them while separately extending from the bottom side 422 of the analyte sensor system 400.

[0079] As noted above, the analyte sensor 420 may be used to measure an analyte concentration level of the user 414. For example, when measuring a glucose concentration level, the analyte sensor 420 may measure the glucose concentration level through anP+S Ref. No.: DEXC / 0972PC 26Dexcom Ref. No.: 0972-PCT01enzymatic reaction with glucose in interstitial fluid of the subcutaneous tissue 412, producing hydrogen peroxide as a byproduct. This byproduct may undergo oxidation at one or more electrodes of the analyte sensor 420, generating one or more electrical signals in the form of an electrical current. A magnitude of this electrical current may be proportional to the glucose concentration level of the user 414. In some embodiments, the one or more electrical signals may be provided to the sensor electronics module 424 of the analyte sensor system 400. Using one or more processors, the sensor electronics module 424 may be configured to process the one or more electrical signals to generate processed analyte sensor data, indicating at least the analyte concentration level of the user. The processed analyte sensor data may then may transmitted to a display device for display to the user.

[0080] In some embodiments, the analyte sensor system 400 may be configured to keep track of whether the user 414 has administered their medication and, in some embodiments, inform the user 414 when a missed dose of medication is detected. In some embodiments, the analyte sensor system 400 may be configured to detect whether the medication has been administered using the one or more electrodes of the analyte sensor. For example, as shown in FIGS. 4 and 5, the analyte sensor 420 may include a first electrode 426, which may be disposed on a first side (e.g., above) the egress of the cannula. Additionally, the analyte sensor 420 may include a second electrode 428, which may be disposed on a second side (e.g., below) the egress of the cannula opposite the first side. In some embodiments, the first electrode 426 and the second electrode 428 may comprise glucose oxidase sensors.

[0081] In some embodiments, the first electrode 426 and the second electrode 428 may be configured to detect one or more electrical disturbances in the signal generated by the analyte sensor 420, which may be associated with the administration / deliverance of the medication to the subcutaneous tissue 412 of the user 414. For example, when insulin is delivered to the subcutaneous tissue 412 via the egress 416, phenol and cresol, which are preservatives commonly found in insulin formulations, may cause an electrical disturbance to occur within the signal generated by the analyte sensor 420 by interfering with the enzymatic reaction sensed by the analyte sensor 420. Accordingly, when the user 414 injects the medication (e.g., insulin) into the injection port 402 and the medication is delivered to the subcutaneous tissue 412 of the user 414, one or more processors of the sensor electronics module 424 may be configured detect, based on the one or moreP+S Ref. No.: DEXC / 0972PC 27Dexcom Ref. No.: 0972-PCT01electrodes (e.g., including the first electrode 426 and the second electrode 428), one or more electrical disturbances in the signal received from the analyte sensor 420. In some embodiments, the one or more electrical disturbances may comprise a spike in an electrical current measurement relative to a baseline electrical current measurement associated with the analyte concentration level of the user 414.

[0082] For example, FIG. 6 depicts a graph illustrating an electrical signal 600, represented as current over time, which corresponds to the analyte concentration level of the user 414. In some embodiments, the electrical signal 600 may be an example of the one or more electrical signals measured by the analyte sensor 420 and provided to the sensor electronics module 424. As illustrated, the analyte sensor 420 may measure a baseline current measurement 602 between time to and ti, indicative of a baseline analyte concentration level of the user 414. Subsequently, at time ti, the analyte sensor 420 may measure an electrical disturbance, appearing as a current spike 604 relative to the baseline current measurement. In some cases, the current spike 604 may be associated with the medication being delivered to the subcutaneous tissue 412.

[0083] For example, when the medication is delivered to the subcutaneous tis sue 412 of the user 414 at time ti, the medication may cause the baseline current measurement 602 to spike, resulting in the current spike 604, which may be included within the electrical signal 600 and detected by the sensor electronics module 424. As shown, after the initial spike at time ti, the electrical disturbance or current spike 604 may dissipate over a period of time (e.g., between time ti and t2) before returning to the baseline current measurement 602 at time t2. While FIG. 6 illustrates the current spike 604 as being positive, it should be appreciated that the current spike 604 may instead be represented as a negative equivalent (e.g., a negative deflection in the electrical signal 600).

[0084] In some embodiments, the sensor electronics module 424 may be configured to determine, based on the detected one or more electrical disturbances (e.g., current spike 604), a time at which the medication is delivered to the subcutaneous tissue 412 of the user 414 (e.g., ti) and a volume of the medication that is delivered to the subcutaneous tissue 412 of the user 414. In some embodiments, the processed analyte sensor data may further indicate the time at which the medication is delivered to the subcutaneous tissue 412 and the volume of the medication that is delivered to the subcutaneous tissue 412. In some embodiments, the processed analyte sensor data may include or indicate the one or more electrical disturbances detected by the sensor electronics module 424.P+S Ref. No.: DEXC / 0972PC 28Dexcom Ref. No.: 0972-PCT01

[0085] To determine the time at which the medication is delivered to the subcutaneous tissue 412, the sensor electronics module 424 may first receive the electrical signal 600 from the analyte sensor 420 and may detect the one or more electrical disturbances within the electrical signal 600, such as the current spike 604. In some embodiments, the sensor electronics module 424 may detect the one or more electrical disturbances based on a current of the electrical signal 600 rising above or falling below the baseline current measurement 602 by a threshold amount.

[0086] Accordingly, when the sensor electronics module 424 detects the one or more electrical disturbances in the electrical signal 600, the sensor electronics module may record the time at which the one or more electrical disturbances occurred. For example, with reference to FIG. 6, the sensor electronics module 424 may record the one or more electrical disturbances have occurred at time ti associated with the current spike 604. The sensor electronics module may then determine the time at which medication was delivered to the subcutaneous tissue 412 based on the time at which the one or more electrical disturbances occurred. In other words, the sensor electronics module may determine that the medication was delivered to the subcutaneous tissue 412 at time ti when the one or more electrical disturbances occurred in the electrical signal 600.

[0087] As noted above, in some cases, the one or more electrodes may include the first electrode 426 and the second electrode 428. In some embodiments, the sensor electronics module 424 may be configured to determine the time at which the medication is administered based on the one or more electrical disturbances detected using both the first electrode 426 and second electrode 428.

[0088] For example, FIG.7 depicts a plurality of graphs illustrating a first electrical signal 700A measured by the first electrode 426 and a second electrical signal 700B measured by the second electrode 428. In some embodiments, the first electrical signal 700A and the second electrical signal 700B may be examples of the one or more electrical signals provided to the sensor electronics module 424 by the analyte sensor 420. As shown, the sensor electronics module 424 may detect a first electrical disturbance 702 based on the first electrode 426 and a second electrical disturbance 704 based on the second electrode 428.

[0089] Further, as shown, the sensor electronics module 424 may detect that the first electrical disturbance 702 occurs at a first time tiA and may also detect that the secondP+S Ref. No.: DEXC / 0972PC 29Dexcom Ref. No.: 0972-PCT01electrical disturbance 704 occurs at a second time tiB. In some embodiments, the sensor electronics module 424 may then determine the time at which the medication is delivered based on the first time at which the first electrical disturbance is detected and the second time at which the second electrical disturbance is detected. In some embodiments, if the first time and the second time are different, the sensor electronics module 424 may be configured to determine the time at which the medication is delivered as the earlier or the later of the first time or the second time. In some embodiments, if the first time and the second time are different, the sensor electronics module 424 may be configured to determine the time at which the medication is delivered by averaging the first time and the second time.

[0090] In some embodiments, detecting the time at which the medication is delivered based on the first time tiA and the second time tiB may introduce redundancy and reduce false detection in scenarios in which an electrical disturbance is only detected based on one of the first electrode 426 or the second electrode 428. For example, in some embodiments, to avoid false detection of medication administration, the sensor electronics module 424 may be configured to only determine the time at which the medication has been delivered or administered to the subcutaneous tissue 412 when both the first electrical disturbance 702 associated with the first electrode 426 is detected at the first time tiA and the second electrical disturbance 704 associated with the second electrode 428 is detected at the second time tiB. In some embodiments, when only one of the first electrical disturbance 702 associated with the first electrode 426 is detected or the second electrical disturbance 704 associated with the second electrode 428 is detected, the sensor electronics module 424 may be configured to ignore the one detected electrical disturbance and not determine that the medication has been delivered or administered to the subcutaneous tissue 412. While the techniques presented above involve detecting the time at which the medication is delivered based on the first time and the second time, in some embodiments, the sensor electronics module 424 may be configured to detect the time at which the medication is delivered based only on one of the first time tiA or the second time tiB.

[0091] In some embodiments, the sensor electronics module 424 may be configured to determine the volume of the medication that is delivered based on at least one of a difference between magnitudes of the first electrical disturbance and second electrical disturbance or a difference between durations that it takes for the first electricalP+S Ref. No.: DEXC / 0972PC 30Dexcom Ref. No.: 0972-PCT01disturbance and second electrical disturbance to dissipate, or a combination thereof. For example, in some cases, the first electrical disturbance 702 detected based on the first electrode 426 may have a first magnitude Mi, representing a difference in current between a baseline current measurement 706 of the first electrical signal 700 A and a peak of the first electrical disturbance 702. Similarly, the second electrical disturbance 704 detected based on the second electrode 428 may have a second magnitude M2, representing a difference in current between a baseline current measurement 708 of the second electrical signal 700B and a peak of the second electrical disturbance 704.

[0092] In some embodiments, the sensor electronics module 424 may be configured to determine the volume of the medication that is delivered to the subcutaneous tissue 412 based on a difference between the first magnitude Mi of the first electrical disturbance 702 and the second magnitude M2 of the second electrical disturbance 704. For example, in some embodiments, calibration or correlation data may be stored in memory of the sensor electronics module 424 that associates known delivered medication volumes with corresponding differences between electrical disturbance magnitudes detected at the first and second electrodes. Accordingly, in some cases, the sensor electronics module 424 may compare the measured difference between the first magnitude Mi of the first electrical disturbance 702 and the second magnitude M2 of the second electrical disturbance 704 to the stored calibration or correlation data to estimate the volume of the medication delivered to the subcutaneous tissue 412.

[0093] Further, in some cases, after the medication is delivered to the subcutaneous tissue 412, resulting in the first electrical disturbance 702 and the second electrical disturbance 704, the first electrical disturbance 702 and the second electrical disturbance 704 may each dissipate over a period of time, with the first electrical signal 700A returning to the baseline current measurement 706 and the second electrical signal 700B returning to the baseline current measurement 708, respectively. For example, as shown, after the medication is administered and the first electrical disturbance 702 occurs at time tiA in the first electrical signal 700A, the first electrical disturbance 702 may dissipate over a first duration between time tiA and t2A before the first electrical signal 700A returns to the baseline current measurement 706. Similarly, after the medication is administered and the second electrical disturbance 704 occurs at time tiB in the second electrical signal 700B, the second electrical disturbance 704 may dissipate over a second duration between time tiB and t2B before the second electrical signal 700B returns to the baseline currentP+S Ref. No.: DEXC / 0972PC 31Dexcom Ref. No.: 0972-PCT01measurement 708.

[0094] In some embodiments, the sensor electronics module 424 may be configured to determine the volume of the medication that is delivered based on the first duration and the second duration. For example, in some embodiments, the sensor electronics module 424 may be configured to determine the volume of the medication that is delivered based a difference between the first duration and the second duration. In some embodiments, the sensor electronics module 424 may be configured to determine the volume of the medication that is delivered based an average of the first duration and the second duration. For example, in some cases, calibration or correlation data may be stored in memory of the sensor electronics module 424 that associates known delivered medication volumes with corresponding relationships between the first duration and the second duration, such as the difference or the average of the first duration and the second duration. Accordingly, in some embodiments, the sensor electronics module 424 may compare the measured duration-based value (e.g., the difference between or the average of the first duration and the second duration) to the stored calibration or correlation data to estimate the delivered volume.

[0095] In some embodiments, the one or more electrical disturbances within the one or more electrical signals provided by the analyte sensor 420 to the sensor electronics module 424 may be unique to the type of medication that is injected and delivered to the subcutaneous tissue 412 of the user 414. For example, when the medication is delivered to the subcutaneous tissue 412, an electrical disturbance may be generated, which may form a type of unique signature associated with that type of medication. As such, different types of medications may have different signature electrical disturbances. For example, in some cases, a first insulin may be associated with a first signature electrical disturbance while a second insulin may be associated with a second signature electrical disturbance.

[0096] In some cases, the differences between the different signature electrical disturbances may be based on different amounts of phenol and cresol used in each of the first insulin and second insulin. Moreover, another medication, such as growth hormone or glucagon may have a different signature electrical disturbance relative to insulin. Accordingly, in some embodiments, in addition to being able to determine the time at which the medication is delivered and the volume of the medication that is delivered, the sensor electronics module 424 may be configured to determine what medication is delivered to the subcutaneous tissue 412 based on the one or more electrical disturbances.P+S Ref. No.: DEXC / 0972PC 32Dexcom Ref. No.: 0972-PCT01For example, to determine the medication that is delivered, the sensor electronics module 424 may detect the one or more electrical disturbances and correlate the one or more electrical disturbances to a particular signature electrical disturbance associated with a particular medication.

[0097] In some embodiments, an electrical disturbance in current may be characterized by various parameters that define its signature. In some embodiments, these parameters may include at least a magnitude of the electrical disturbance relative to a baseline current measurement and a duration of the disturbance from onset to dissipation.

[0098] In some embodiments, by way of its capability to determine when a user has administered their medication, the analyte sensor system 400 may also be configured to determine that the user has missed a dose of the medication and may provide a notification to the user of the missed dose of medication. For example, in some embodiments, the sensor electronics module 424 may be configured to detect an absence of one or more electrical disturbances in the electrical signal provided by the analyte sensor 420 to the sensor electronics module 424 that extends for a threshold period of time. In other words, the sensor electronics module 424 may detect that there have not been any electrical disturbances in the electrical signal for the threshold period of time. When no electrical disturbances are detected for the threshold period of time, the sensor electronics module 424 may deduce that the user 414 has forgotten to administer the medication. In some embodiments, the threshold period of time may correspond to a period of time between when doses of the medication are expected to be administered. In some embodiments, the sensor electronics module may be configured to determine the threshold period of time based on a previous determination of what medication is delivered, as discussed above.

[0099] For example, in some embodiments, when the medication is first delivered to the subcutaneous tissue of the user 414, the sensor electronics module 424 may be configured to determine what medication has been administered / delivered, for example, based on a signature electrical disturbance associated with the medication. The sensor electronics module 424 may then determine the period of time based on the determined medication. For example, in some cases, different types of insulin may be associated with different periods of time between doses. For example, insulin glargine may be associated with a 12-hour to 24-hour period of time while insulin aspart may be associated with a 3-hour to 5-hour period of time. Accordingly, in some embodiments, when the sensor electronics module 424 determines that the medication that is delivered comprises insulinP+S Ref. No.: DEXC / 0972PC 33Dexcom Ref. No.: 0972-PCT01glargine, the sensor electronics module 424 may determine the threshold period of time to be 12 hours or 24 hours.

[0100] Accordingly, if the sensor electronics module 424 detects an absence of one or more electrical disturbances in the signal for longer than a 12-hour or 24-hour period, the sensor electronics module 424 may determine that the user 414 may have missed a dose of their insulin. Further, in such cases, the sensor electronics module 424 may be configured to provide a notification (e.g., a haptic alert, an auditory alert, an instruction sent to a display device to display an alert to the user 414 of the missed dose, or another type of alert) to the user 414 indicating a missed dose of medication based on the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0101] In some embodiments, the sensor electronics module 424 may determine the threshold period of time based on a pattern of electrical disturbances that are detected. For example, in some embodiments, the sensor electronics module 424 may determine that it detects an electrical disturbance in the electrical signal received from the analyte sensor 420 every 12 hours. In such cases, based on this 12-hour electrical disturbance pattern, the sensor electronics module 424 may conclude that the medication should be administered every 12 hours and may, therefore, determine the threshold period of time to be 12 hours.

[0102] In some embodiments, the sensor electronics module 424 of the analyte sensor system 400 may be configured to determine that the user 414 may have missed a dose of their medication based on an increase in the analyte concentration level of the user 414. For example, in some embodiments, the sensor electronics module 424 may detect, based on the processed analyte sensor data, an increase in the analyte concentration level of the user 414. Further, in such cases, when the sensor electronics module 424 also detects an absence of one or more electrical disturbances in the electrical signal for longer than the threshold period of time, the sensor electronics module 424 may determine that the user 414 missed a dose of the medication. In such cases, the sensor electronics module 424 may then be configured to provide a notification to the user 414 indicating the missed dose of medication based on the detected increase in the analyte concentration level of the user and the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.P+S Ref. No.: DEXC / 0972PC 34Dexcom Ref. No.: 0972-PCT01

[0103] It should be appreciated that, while the techniques presented above are described primarily with respect to actions performed by the analyte sensor system 400, these techniques may also be performed by a display device based on the processed analyte sensor data, such as the display device 150 depicted and described with respect to FIGS. 1 and 2. For example, as noted above, the processed analyte sensor data may include or indicate the one or more electrical disturbances detected by the sensor electronics module 424 in the one or more signal received from the analyte sensor 420. Accordingly, in some embodiments, using the techniques described above and the processed analyte sensor data (e.g., one or more electrical disturbances), the display device may also be configured to perform the techniques associated with determining a time at which the medication is delivered to the subcutaneous tissue 412, determining a volume of the medication that was delivered, determining what medication was delivered or administered, determining whether the user 414 missed a dose of their medication, providing the user 414 with a notification or alert of a missed does, etc. In some embodiments, the display device may be configured to display, to the user 414, the analyte concentration level, the time at which the medication was delivered, and the volume of the medication that was delivered.Example Operations of an Analyte Sensor System

[0104] FIG. 8 shows an example of a method 800 for wireless communication by an analyte sensor system, such as the analyte sensor system 400 depicted and described with respect to FIGS. 4-7. In some embodiments, one or more operations of the method 800 may be performed by one or more processors of the analyte sensor system, such as the one or more processors 11, based on instructions stored in one or more memories. For example, in some embodiments, the analyte sensor system may include one or more memories, such as the one or more memories 14, including instructions that, when executed by the one or more processors, cause the analyte sensor system to perform one or more operations of the method 800.

[0105] As shown, method 800 begins at 802 with the analyte sensor system receiving an injection of a medication via an injection port (e.g., injection port 402) of the analyte sensor system.

[0106] At 804, the analyte sensor system delivers the medication to subcutaneous tissue of a user (e.g., subcutaneous tissue 412 of the user 414) of the analyte sensor systemP+S Ref. No.: DEXC / 0972PC 35Dexcom Ref. No.: 0972-PCT01via a cannula (e.g., cannula 410) coupled with the injection port.

[0107] At 806, the analyte sensor system generates, using an analyte sensor (e.g., analyte sensor 420) of the analyte sensor system, a signal associated with an analyte concentration level of the subcutaneous tissue of the user.

[0108] At 808, the analyte sensor system processes the signal to generate processed analyte sensor data, wherein the processed analyte sensor data indicates at least the analyte concentration level of the user.

[0109] At 810, the analyte sensor system transmits the processed analyte sensor data to a display device

[0110] In some embodiments, the analyte sensor may be disposed on or embedded into a surface of the cannula. In some embodiments, the surface of the cannula comprises at least one of an exterior surface or an interior surface.

[0111] In some embodiments, the cannula and the analyte sensor separately protrude from a bottom side of the analyte sensor system forming a snake-bite configuration. In some embodiments, the bottom side of the analyte sensor system is configured to face in a direction towards the subcutaneous tissue of the user when the analyte sensor system is attached to the user.

[0112] In some embodiments, the cannula comprises an interior portion configured to allow the medication to flow through the cannula. In some embodiments, the cannula comprises an egress configured to allow the medication to flow out of the cannula and into the subcutaneous tissue of the user.

[0113] In some embodiments, the egress comprises a single aperture. In some embodiments, the egress comprise a plurality of apertures.

[0114] In some embodiments, the analyte sensor includes a plurality of electrodes.

[0115] In some embodiments, the plurality of electrodes comprises a first electrode disposed on a first side of the egress of the cannula and a second electrode disposed on a second side of the egress of the cannula opposite the first side.

[0116] In some embodiments, the method 800 further comprises detecting one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user. In some embodiments, the method 800 further comprises determining, based on the detected one or more electrical disturbances, a timeP+S Ref. No.: DEXC / 0972PC 36Dexcom Ref. No.: 0972-PCT01at which the medication is delivered to the subcutaneous tissue of the user and a volume of the medication that is delivered to the subcutaneous tissue of the user.

[0117] In some embodiments, the processed analyte sensor data further indicates the time at which the medication is delivered to the subcutaneous tissue and the volume of the medication that is delivered to the subcutaneous tissue.

[0118] In some embodiments, the one or more electrical disturbances comprise a first electrical disturbance detected based on the first electrode and a second electrical disturbance detected based on the second electrode.

[0119] In some embodiments, determining the time at which the medication is delivered is based on a first time at which the first electrical disturbance is detected and a second time at which the second electrical disturbance is detected.

[0120] In some embodiments, determining the volume of the medication that is delivered is based on a first magnitude of the first electrical disturbance, a second magnitude of the second electrical disturbance, a first duration that it takes for the first electrical disturbance to dissipate after the first time at which the first electrical disturbance is detected, and a second duration that it takes for the second electrical disturbance to dissipate after the second time at which the second electrical disturbance is detected.

[0121] In some embodiments, the method 800 further includes detecting an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time. In some embodiments, the method 800 further includes providing a notification to the user indicating a missed dose of medication based on the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0122] In some embodiments, the method 800 further includes detecting, based on the processed analyte sensor data, an increase in the analyte concentration level of the user. In some embodiments, the method 800 further includes detecting an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time. In some embodiments, the method 800 further includes providing a notification to the user indicating a missed dose of medication based on the detected increase in the analyte concentration level of the user and the detected absence of the one or more electricalP+S Ref. No.: DEXC / 0972PC 37Dexcom Ref. No.: 0972-PCT01disturbances in the signal for the threshold period of time.

[0123] In some embodiments, the medication comprises insulin.Example Operations of an a Display Device

[0124] FIG. 9 shows an example of a method 900 for wireless communication by a display device, such as the display device 150 depicted and described with respect to FIGS. 1 and 2. In some embodiments, one or more operations of the method 900 may be performed by one or more processors of the display device, such as the one or more processors 126, based on instructions stored in one or more memories. For example, in some embodiments, the display device may include one or more memories, such as the one or more memories 127, including instructions that, when executed by the one or more processors, cause the display device to perform one or more operations of the method 900.

[0125] As shown, method 900 begins at 902 with the display device receiving processed analyte sensor data from an analyte sensor system of a user. In some embodiments, the processed analyte sensor data includes a signal generated by an analyte sensor of the analyte sensor system that indicates at least an analyte concentration level of the user.

[0126] At 904, the display device detects one or more electrical disturbances in the signal associated with deliverance of a medication to subcutaneous tissue of the user.

[0127] At 906, the display device determines, based on the detected one or more electrical disturbances, a time at which the medication was delivered to the subcutaneous tissue of the user and the volume of the medication that was delivered to the subcutaneous tissue of the user.

[0128] At 908, the display device displays, to the user, the analyte concentration level, the time at which the medication was delivered to the subcutaneous tissue of the user, and the volume of the medication that was delivered to the subcutaneous tissue of the user.

[0129] In some embodiments, the one or more electrical disturbances comprise a first electrical disturbance associated with a first electrode of the analyte sensor of the analyte sensor system and a second electrical disturbance associated with a second electrode of the analyte sensor of the analyte sensor system.P+S Ref. No.: DEXC / 0972PC 38Dexcom Ref. No.: 0972-PCT01

[0130] In some embodiments, determining the time at which the medication is delivered is based on a first time at which the first electrical disturbance associated with the first electrode is detected and a second time at which the second electrical disturbance associated with the second electrode is detected.

[0131] In some embodiments, determining the volume of the medication that is delivered is based on a first magnitude of the first electrical disturbance, a second magnitude of the second electrical disturbance, a first duration that it takes for the first electrical disturbance to dissipate after the first time at which the first electrical disturbance is detected, and a second duration that it takes for the second electrical disturbance to dissipate after the second time at which the second electrical disturbance is detected.

[0132] In some embodiments, method 900 further includes detecting an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time. In some embodiments, method 900 further includes providing a notification to the user indicating a missed dose of medication based on the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0133] In some embodiments, method 900 further includes detecting, based on the processed analyte sensor data, an increase in the analyte concentration level of the user. In some embodiments, method 900 further includes detecting an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time, In some embodiments, method 900 further includes providing a notification to the user indicating a missed dose of medication based on the detected increase in the analyte concentration level of the user and the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0134] In some embodiments, the medication comprises insulin.Example Health Monitoring Devices

[0135] FIG. 10 depicts aspects of an example health management device 1000. In some aspects, health management device 1000 is an analyte sensor system, such as the SS 8 described with respect to FIGS. 1, 2, 3A, 3B, and 3C and / or the analyte sensor system 400 described with respect to FIGS. 4-7.P+S Ref. No.: DEXC / 0972PC 39Dexcom Ref. No.: 0972-PCT01

[0136] The health management device 1000 includes a processing system 1005 coupled to the transceiver 1055 (e.g., a transmitter and / or a receiver). The transceiver 1055 is configured to transmit and receive signals for the health management device 1000 via the antenna 1060, such as the various signals and messages as described herein. The processing system 1005 may be configured to perform processing functions for the health management device 1000, including processing signals received and / or to be transmitted by the health management device 1000.

[0137] The processing system 1005 includes one or more processors 1010. In various aspects, the one or more processors 1010 may be representative of the one or more processors 11, as described with respect to FIG. 2. The one or more processors 1010 are coupled to a computer-readable medium / memory 1030 via a bus 1050. In some aspects, the computer-readable medium / memory 1030 may be representative of the one or more memories 14, as described with respect to FIG. 2. In certain aspects, the computer-readable medium / memory 1030 is configured to store instructions (e.g., computerexecutable code) that when executed by the one or more processors 1010, cause the one or more processors 1010 to perform the method 800 described with respect to FIG. 8, or any aspect related to this method. Note that reference to a processor performing a function of health management device 1000 may include one or more processors 1010 performing that function of health management device 1000.

[0138] In the depicted example, computer-readable medium / memory 1030 stores code (e.g., executable instructions), such as code for receiving 1035, code for generating 1036, code for processing 1037, code for transmitting 1038, code for detecting 1039, code for determining 1040, and code for providing 1041. Processing of the code for receiving 1035, code for generating 1036, code for processing 1037, code for transmitting 1038, code for detecting 1039, code for determining 1040, and code for providing 1041 may cause the health management device 1000 to perform the method 800 described with respect to FIG. 8, or any aspect related to these methods.

[0139] The one or more processors 1010 include circuitry configured to implement (e.g., execute) the code stored in the computer-readable medium / memory 1030, including circuitry for receiving 1015, circuitry for generating 1016, circuitry for processing 1017, circuitry for transmitting 1018, circuitry for detecting 1019, circuitry for determining 1020, and circuitry for providing 1021. Processing with circuitry for receiving 1015, circuitry for generating 1016, circuitry for processing 1017, circuitry for transmittingP+S Ref. No.: DEXC / 0972PC 40Dexcom Ref. No.: 0972-PCT011018, circuitry for detecting 1019, circuitry for determining 1020, and circuitry for providing 1021 may cause the health management device 1000 to perform the method 800 described with respect to FIG. 8, or any aspect related to these methods.

[0140] FIG. 11 depicts aspects of an example health management device 1100. In some aspects, health management device 1100 is a display device, such as the display device 150 described with respect to FIGS. 1, 2, 3A, 3B, 3C, 4-7.

[0141] The health management device 1100 includes a processing system 1105 coupled to the transceiver 1155 (e.g., a transmitter and / or a receiver). The transceiver 1155 is configured to transmit and receive signals for the health management device 1100 via the antenna 1160, such as the various signals and messages as described herein. The processing system 1105 may be configured to perform processing functions for the health management device 1100, including processing signals received and / or to be transmitted by the health management device 1100.

[0142] The processing system 1105 includes one or more processors 1110. In various aspects, the one or more processors 1110 may be representative of the one or more processors 126, as described with respect to FIG.2. The one or more processors 1110 are coupled to a computer-readable medium / memory 1130 via a bus 1150. In some aspects, the computer-readable medium / memory 1130 may be representative of the one or more memories 127, as described with respect to FIG. 2. In certain aspects, the computer-readable medium / memory 1130 is configured to store instructions (e.g., computerexecutable code) that when executed by the one or more processors 1110, cause the one or more processors 1110 to perform the method 900 described with respect to FIG. 9, or any aspect related to this method. Note that reference to a processor performing a function of health management device 1100 may include one or more processors 1110 performing that function of health management device 1100.

[0143] In the depicted example, computer-readable medium / memory 1130 stores code (e.g., executable instructions), such as code for receiving 1135, code for detecting 1136, code for determining 1137, code for displaying 1138, and code for providing 1139. Processing of the code for receiving 1135, code for detecting 1136, code for determining 1137, code for displaying 1138, and code for providing 1139 may cause the health management device 1100 to perform the method 900 described with respect to FIG.9, or any aspect related to these methods.P+S Ref. No.: DEXC / 0972PC 41Dexcom Ref. No.: 0972-PCT01

[0144] The one or more processors 1110 include circuitry configured to implement (e.g., execute) the code stored in the computer-readable medium / memory 1130, including code for receiving 1115, code for detecting 1116, code for determining 1117, code for displaying 1118, and code for providing 1119. Processing with code for receiving 1115, code for detecting 1116, code for determining 1117, code for displaying 1118, and code for providing 1119 may cause the health management device 1100 to perform the method 900 described with respect to FIG. 9, or any aspect related to these methods.Example Clauses

[0145] Implementation examples are described in the following numbered clauses:

[0146] Clause 1: An analyte sensor system, comprising: an injection port configured to receive an injection of a medication; a cannula, coupled with the injection port, configured to deliver the medication to subcutaneous tissue of a user of the analyte sensor system; an analyte sensor configured to generate a signal associated with an analyte concentration level of the subcutaneous tissue of the user; and a sensor electronics module configured to: receive the signal from the analyte sensor; process the signal to generate processed analyte sensor data, wherein the processed analyte sensor data indicates at least the analyte concentration level of the user; and transmit the processed analyte sensor data to a display device.

[0147] Clause 2: The analyte sensor system of Clause 1, wherein: the analyte sensor is disposed on or embedded into a surface of the cannula; and the surface of the cannula comprises at least one of: an exterior surface; or an interior surface.

[0148] Clause 3: The analyte sensor system of Clause 1, wherein: the cannula and the analyte sensor separately protrude from a bottom side of the analyte sensor system forming a snake-bite configuration; and the bottom side of the analyte sensor system is configured to face in a direction towards the subcutaneous tissue of the user when the analyte sensor system is attached to the user.

[0149] Clause 4: The analyte sensor system of any one of Clauses 1-3, wherein the cannula comprises: an interior portion configured to allow the medication to flow through the cannula; and an egress configured to allow the medication to flow out of the cannula and into the subcutaneous tissue of the user.

[0150] Clause 5: The analyte sensor system of Clause 4, wherein the egressP+S Ref. No.: DEXC / 0972PC 42Dexcom Ref. No.: 0972-PCT01comprises: a single aperture; or a plurality of apertures.

[0151] Clause 6: The analyte sensor system of any one of Clauses 4-5, wherein the analyte sensor includes a plurality of electrodes.

[0152] Clause 7: The analyte sensor system of Clause 6, wherein the plurality of electrodes comprises: a first electrode disposed on a first side of the egress of the cannula; and a second electrode disposed on a second side of the egress of the cannula opposite the first side.

[0153] Clause 8: The analyte sensor system of Clause 7, wherein the sensor electronics module is further configured to: detect one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user; and determine, based on the detected one or more electrical disturbances, a time at which the medication is delivered to the subcutaneous tissue of the user and a volume of the medication that is delivered to the subcutaneous tissue of the user.

[0154] Clause 9: The analyte sensor system of Clause 8, wherein the processed analyte sensor data further indicates the time at which the medication is delivered to the subcutaneous tissue and the volume of the medication that is delivered to the subcutaneous tissue.

[0155] Clause 10: The analyte sensor system of any one of Clauses 8-9, wherein the one or more electrical disturbances comprise: a first electrical disturbance detected based on the first electrode; and a second electrical disturbance detected based on the second electrode.

[0156] Clause 11: The analyte sensor system of Clause 10, wherein the sensor electronics module is configured to determine the time at which the medication is delivered based on a first time at which the first electrical disturbance is detected and a second time at which the second electrical disturbance is detected.

[0157] Clause 12: The analyte sensor system of Clause 11, wherein the sensor electronics module is configured to determine the volume of the medication that is delivered based on: a first magnitude of the first electrical disturbance; a second magnitude of the second electrical disturbance; a first duration that it takes for the first electrical disturbance to dissipate after the first time at which the first electrical disturbance is detected; and a second duration that it takes for the second electrical disturbance to dissipate after the second time at which the second electrical disturbanceP+S Ref. No.: DEXC / 0972PC 43Dexcom Ref. No.: 0972-PCT01is detected.

[0158] Clause 13: The analyte sensor system of any one of Clauses 1-12, wherein the sensor electronics module is further configured to: detect an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time; and provide a notification to the user indicating a missed dose of medication based on the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0159] Clause 14: The analyte sensor system of any one of Clauses 1-13, wherein the sensor electronics module is further configured to: detect, based on the processed analyte sensor data, an increase in the analyte concentration level of the user; detect an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time; and provide a notification to the user indicating a missed dose of medication based on the detected increase in the analyte concentration level of the user and the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0160] Clause 15: The analyte sensor system of any one of Clauses 1-14, wherein the medication comprises insulin.

[0161] Clause 16: A method for wireless communication by an analyte sensor system, comprising: receiving an injection of a medication via an injection port of the analyte sensor system; delivering the medication to subcutaneous tissue of a user of the analyte sensor system via a cannula coupled with the injection port; generating, using an analyte sensor of the analyte sensor system, a signal associated with an analyte concentration level of the subcutaneous tissue of the user; processing the signal to generate processed analyte sensor data, wherein the processed analyte sensor data indicates at least the analyte concentration level of the user; and transmitting the processed analyte sensor data to a display device.

[0162] Clause 16: The method of Clause 15, wherein: the analyte sensor is disposed on or embedded into a surface of the cannula; and the surface of the cannula comprises at least one of: an exterior surface; or an interior surface.

[0163] Clause 17: The method of any one of Clauses 15-16, wherein the cannula comprises: an interior portion configured to allow the medication to flow through the cannula; and an egress configured to allow the medication to flow out of the cannula andP+S Ref. No.: DEXC / 0972PC 44Dexcom Ref. No.: 0972-PCT01into the subcutaneous tissue of the user.

[0164] Clause 18: The method of Clause 17, wherein the egress comprises: a single aperture; or a plurality of apertures.

[0165] Clause 19: The method of any one of Clauses 17-18, wherein the analyte sensor includes a plurality of electrodes.

[0166] Clause 20: The method of Clause 19, wherein the plurality of electrodes comprises: a first electrode disposed on a first side of the egress of the cannula; and a second electrode disposed on a second side of the egress of the cannula opposite the first side.

[0167] Clause 21: The method of Clause 20, further comprising: detecting one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user; and determining, based on the detected one or more electrical disturbances, a time at which the medication is delivered to the subcutaneous tissue of the user and a volume of the medication that is delivered to the subcutaneous tissue of the user.

[0168] Clause 22: The method of Clause 21, wherein the processed analyte sensor data further indicates the time at which the medication is delivered to the subcutaneous tissue and the volume of the medication that is delivered to the subcutaneous tissue.

[0169] Clause 23: The method of any one of Clauses 21-22, wherein the one or more electrical disturbances comprise: a first electrical disturbance detected based on the first electrode; and a second electrical disturbance detected based on the second electrode.

[0170] Clause 24: The method of Clause 23, wherein determining the time at which the medication is delivered is based on a first time at which the first electrical disturbance is detected and a second time at which the second electrical disturbance is detected.

[0171] Clause 25: The method of Clause 24, wherein determining the volume of the medication that is delivered is based on: a first magnitude of the first electrical disturbance; a second magnitude of the second electrical disturbance; a first duration that it takes for the first electrical disturbance to dissipate after the first time at which the first electrical disturbance is detected; and a second duration that it takes for the second electrical disturbance to dissipate after the second time at which the second electrical disturbance is detected.P+S Ref. No.: DEXC / 0972PC 45Dexcom Ref. No.: 0972-PCT01

[0172] Clause 26: The method of any one of Clauses 15-25, further comprising: detecting an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time; and providing a notification to the user indicating a missed dose of medication based on the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0173] Clause 27: The method of any one of Clauses 15-26, further comprising: detecting, based on the processed analyte sensor data, an increase in the analyte concentration level of the user; detecting an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time; and providing a notification to the user indicating a missed dose of medication based on the detected increase in the analyte concentration level of the user and the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0174] Clause 28: The method of any one of Clauses 15-27, wherein the medication comprises insulin.

[0175] Clause 29: A method for wireless communication by a display device, comprising: receiving processed analyte sensor data from an analyte sensor system of a user, wherein the processed analyte sensor data includes a signal generated by an analyte sensor of the analyte sensor system that indicates at least an analyte concentration level of the user; detecting one or more electrical disturbances in the signal associated with deliverance of a medication to subcutaneous tissue of the user; and determining, based on the detected one or more electrical disturbances, a time at which the medication was delivered to the subcutaneous tissue of the user and the volume of the medication that was delivered to the subcutaneous tissue of the user; and displaying, to the user, the analyte concentration level, the time at which the medication was delivered to the subcutaneous tissue of the user, and the volume of the medication that was delivered to the subcutaneous tissue of the user.

[0176] Clause 30: The method of Clause 29, wherein the one or more electrical disturbances comprise: a first electrical disturbance associated with a first electrode of the analyte sensor of the analyte sensor system; and a second electrical disturbance associated with a second electrode of the analyte sensor of the analyte sensor system.P+S Ref. No.: DEXC / 0972PC 46Dexcom Ref. No.: 0972-PCT01

[0177] Clause 31: The method of Clause 30, wherein determining the time at which the medication is delivered is based on a first time at which the first electrical disturbance associated with the first electrode is detected and a second time at which the second electrical disturbance associated with the second electrode is detected.

[0178] Clause 32: The method of Clause 31, wherein determining the volume of the medication that is delivered is based on: a first magnitude of the first electrical disturbance; a second magnitude of the second electrical disturbance; a first duration that it takes for the first electrical disturbance to dissipate after the first time at which the first electrical disturbance is detected; and a second duration that it takes for the second electrical disturbance to dissipate after the second time at which the second electrical disturbance is detected.

[0179] Clause 33: The method of any one of Clauses 29-32, further comprising: detecting an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time; and providing a notification to the user indicating a missed dose of medication based on the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0180] Clause 34: The method of any one of Clauses 29-33, further comprising: detecting, based on the processed analyte sensor data, an increase in the analyte concentration level of the user; detecting an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time; and providing a notification to the user indicating a missed dose of medication based on the detected increase in the analyte concentration level of the user and the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

[0181] Clause 35: The method of any one of Clauses 29-34, wherein the medication comprises insulin.

[0182] Clause 36: An apparatus, comprising: one or more processors configured to execute instructions stored on one or more memories and to cause the apparatus to perform a method in accordance with any combination of Clauses 15-34.

[0183] Clause 37: An apparatus, comprising means for performing a method in accordance with any combination of Clauses 15-34.P+S Ref. No.: DEXC / 0972PC 47Dexcom Ref. No.: 0972-PCT01

[0184] Clause 38: A non-transitory computer-readable medium comprising executable instructions that, when executed by one or more processors of an apparatus, cause the apparatus to perform a method in accordance with any combination of Clauses 15-34.

[0185] Clause 39: A computer program product embodied on a computer-readable storage medium comprising code for performing a method in accordance with any combination of Clauses 15-34.Additional Considerations

[0186] In this document, the terms “computer program medium” and “computer usable medium” and “computer readable medium”, as well as variations thereof, are used to generally refer to transitory or non-transitory media. These and other various forms of computer program media or computer usable / readable media may be involved in carrying one or more sequences of one or more instructions to a processing device for execution. Such instructions embodied on the medium, may generally be referred to as “computer program code” or a “computer program product” or “instructions” (which may be grouped in the form of computer programs or other groupings). When executed, such instructions may enable a computing module, such as the SS 8, the analyte sensor system 400, display device 150, circuitry related thereto, and / or a processor thereof or connected thereto to perform features or functions of the present disclosure as discussed herein (for example, in connection with methods described above and / or in the claims), including for example when the same is / are incorporated into a system, apparatus, device and / or the like.

[0187] Various embodiments have been described with reference to specific example features thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the various embodiments as set forth in the appended claims. The specification and figures are, accordingly, to be regarded in an illustrative rather than a restrictive sense. It will be appreciated that, for clarity purposes, the above description has described embodiments with reference to different functional units. However, it will be apparent that any suitable distribution of functionality between different functional units may be used without detracting from the invention. For example, functionality illustrated to be performed by separate computing devices may be performed by the same computing device. Likewise, functionality illustrated to be performed by a single computing device may be distributedP+S Ref. No.: DEXC / 0972PC 48Dexcom Ref. No.: 0972-PCT01amongst several computing devices. Hence, references to specific functional units are only to be seen as references to suitable means for providing the described functionality, rather than indicative of a strict logical or physical structure or organization.

[0188] Although described above in terms of various example embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead may be applied, alone or in various combinations, to one or more of the other embodiments of the present application, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus, the breadth and scope of the present application should not be limited by any of the above-described example embodiments.

[0189] Terms and phrases used in the present application, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide illustrative instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; the term “set” should be read to include one or more objects of the type included in the set; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Similarly, the plural may in some cases be recognized as applicable to the singular and vice versa. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future.

[0190] The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. The use of the term “module” does not imply that the components or functionality described or claimed as part of the module are all configured in a commonP+S Ref. No.: DEXC / 0972PC 49Dexcom Ref. No.: 0972-PCT01package. Indeed, any or all of the various components of a module, whether control logic, circuitry, or other components, may be combined in a single package or separately maintained and may further be distributed in multiple groupings or packages or across multiple locations.

[0191] Additionally, the various embodiments set forth herein are described in terms of example block diagrams, flow charts, and other illustrations. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives may be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration. Moreover, the operations and sub-operations of various methods described herein are not necessarily limited to the order described or shown in the figures, and one of skill in the art will appreciate, upon studying the present disclosure, variations of the order of the operations described herein that are within the spirit and scope of the disclosure.

[0192] It will be understood that each block of the flowchart illustrations, and combinations of blocks in the flowchart illustrations, can be implemented by execution of computer program instructions. These computer program instructions may be loaded onto a computer or other programmable data processing apparatus (such as a controller, microcontroller, microprocessor or the like) in a sensor electronics system to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create instructions for implementing the functions specified in the flowchart block or blocks. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instructions which implement the function specified in the flowchart block or blocks. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block or blocks presented herein.

[0193] It should be appreciated that all methods and processes disclosed herein mayP+S Ref. No.: DEXC / 0972PC 50Dexcom Ref. No.: 0972-PCT01be used in any glucose or other analyte monitoring system, continuous or intermittent. It should further be appreciated that the implementation and / or execution of all methods and processes may be performed by any suitable devices or systems, whether local or remote. Further, any combination of devices or systems may be used to implement the present methods and processes.

[0194] In addition, the operations and sub-operations of methods described herein may be carried out or implemented, in some cases, by one or more of the components, elements, devices, modules, circuitry, processors, etc. of systems, apparatuses, devices, environments, and / or computing modules described herein and referenced in various of figures of the present disclosure, as well as one or more sub- components, elements, devices, modules, processors, circuitry, and the like depicted therein and / or described with respect thereto. In such instances, the description of the methods or aspects thereof may refer to a corresponding component, element, etc., but regardless of whether an explicit reference is made, one of skill in the art will recognize upon studying the present disclosure when the corresponding component, element, etc. may be used. Further, it will be appreciated that such references do not necessarily limit the described methods to the particular component, element, etc. referred to. Thus, it will be appreciated by one of skill in the art that aspects and features described above in connection with (sub-) components, elements, devices, modules, and circuitry, etc., including variations thereof, may be applied to the various operations described in connection with methods described herein, and vice versa, without departing from the scope of the present disclosure.P+S Ref. No.: DEXC / 0972PC 51

Claims

1. Dexcom Ref. No.: 0972-PCT01CLAIMS1. An analyte sensor system, comprising:an injection port configured to receive an injection of a medication;a cannula, coupled with the injection port, configured to deliver the medication to subcutaneous tissue of a user of the analyte sensor system;an analyte sensor configured to generate a signal associated with an analyte concentration level of the subcutaneous tissue of the user, wherein the analyte sensor is disposed on or embedded into a surface of the cannula; anda sensor electronics module configured to:receive the signal from the analyte sensor;process the signal to generate processed analyte sensor data, wherein the processed analyte sensor data indicates at least the analyte concentration level of the user; andtransmit the processed analyte sensor data to a display device.

2. The analyte sensor system of claim 1, wherein the surface of the cannula comprises at least one of:an exterior surface; oran interior surface.

3. The analyte sensor system of claim 1, wherein the cannula comprises:an interior portion configured to allow the medication to flow through the cannula; andan egress configured to allow the medication to flow out of the cannula and into the subcutaneous tissue of the user.

4. The analyte sensor system of claim 3, wherein the egress comprises:a single aperture; ora plurality of apertures.

5. The analyte sensor system of claim 4, wherein the analyte sensor includes a plurality of electrodes.P+S Ref. No.: DEXC / 0972PC 52Dexcom Ref. No.: 0972-PCT016. The analyte sensor system of claim 5, wherein the plurality of electrodes comprises:a first electrode disposed on a first side of the egress of the cannula; and a second electrode disposed on a second side of the egress of the cannula opposite the first side.

7. The analyte sensor system of claim 6, wherein the sensor electronics module is further configured to:detect one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user; anddetermine, based on the detected one or more electrical disturbances, a time at which the medication is delivered to the subcutaneous tissue of the user and a volume of the medication that is delivered to the subcutaneous tissue of the user.

8. The analyte sensor system of claim 7, wherein the processed analyte sensor data further indicates the time at which the medication is delivered to the subcutaneous tissue and the volume of the medication that is delivered to the subcutaneous tissue.

9. The analyte sensor system of claim 7, wherein the one or more electrical disturbances comprise:a first electrical disturbance detected based on the first electrode; anda second electrical disturbance detected based on the second electrode.

10. The analyte sensor system of claim 9, wherein the sensor electronics module is configured to determine the time at which the medication is delivered based on a first time at which the first electrical disturbance is detected and a second time at which the second electrical disturbance is detected.

11. The analyte sensor system of claim 10, wherein the sensor electronics module is configured to determine the volume of the medication that is delivered based on:a first magnitude of the first electrical disturbance;a second magnitude of the second electrical disturbance;a first duration that it takes for the first electrical disturbance to dissipate after the first time at which the first electrical disturbance is detected; andP+S Ref. No.: DEXC / 0972PC 53Dexcom Ref. No.: 0972-PCT01a second duration that it takes for the second electrical disturbance to dissipate after the second time at which the second electrical disturbance is detected.

12. The analyte sensor system of claim 1, wherein the sensor electronics module is further configured to:detect an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time; andprovide a notification to the user indicating a missed dose of medication based on the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

13. The analyte sensor system of claim 1, wherein the sensor electronics module is further configured to:detect, based on the processed analyte sensor data, an increase in the analyte concentration level of the user;detect an absence of one or more electrical disturbances in the signal associated with deliverance of the medication to the subcutaneous tissue of the user for a threshold period of time; andprovide a notification to the user indicating a missed dose of medication based on the detected increase in the analyte concentration level of the user and the detected absence of the one or more electrical disturbances in the signal for the threshold period of time.

14. The analyte sensor system of claim 1, wherein the medication comprises insulin.

15. A method for wireless communication by an analyte sensor system, comprising:receiving an injection of a medication via an injection port of the analyte sensor system;delivering the medication to subcutaneous tissue of a user of the analyte sensor system via a cannula coupled with the injection port;generating, using an analyte sensor of the analyte sensor system, a signal associated with an analyte concentration level of the subcutaneous tissue of the user, wherein the analyte sensor is disposed on or embedded into a surface of the cannula;P+S Ref. No.: DEXC / 0972PC 54Dexcom Ref. No.: 0972-PCT01processing the signal to generate processed analyte sensor data, wherein the processed analyte sensor data indicates at least the analyte concentration level of the user; andtransmitting the processed analyte sensor data to a display device.P+S Ref. No.: DEXC / 0972PC 55

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