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WO2026030213A1 - Time synchronization techniques for analyte sensor system - Google Patents

Time synchronization techniques for analyte sensor system

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Publication number
WO2026030213A1
WO2026030213A1 PCT/US2025/039475 US2025039475W WO2026030213A1 WO 2026030213 A1 WO2026030213 A1 WO 2026030213A1 US 2025039475 W US2025039475 W US 2025039475W WO 2026030213 A1 WO2026030213 A1 WO 2026030213A1
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Prior art keywords
measurements
afe
mcu
measurement interval
clock
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PCT/US2025/039475
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French (fr)
Inventor
Jeffrey Scott STANTON
David Lee Lemke
Didier Serge Sagan
Injy GADALLA
David A. DUNDOV
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Dexcom Inc
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Dexcom Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Aspects of the present disclosure provide an analyte sensor system, including a transcutaneous analyte sensor an analog front end (AFE), and a micro controller unit (MCU). The AFE may be configured to perform, using the transcutaneous analyte sensor, one or more measurements associated with a user during at least a first measurement interval and perform one or more actions to maintain time synchronization associated with the MCU retrieving the one or more measurements from the AFE. The MCU may be configured to operate in a sleep mode during the at least the first measurement interval, exit the sleep mode and retrieve the one or more measurements for the first measurement interval from the AFE based on the one or more actions, and transmit data associated with the one or more measurements to a display device for display to the user.

Description

TIME SYNCHRONIZATION TECHNIQUES FOR ANALYTE SENSOR SYSTEM
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63/678,739, filed August 2, 2024, and U.S. Provisional Patent Application No. 63/721,748, filed November 18, 2024, each of 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.
BACKGROUND
[0002] The present application relates generally to medical devices such as analyte sensors, and more particularly to systems, devices, and methods related to time synchronization techniques for analyte sensor systems.
[0003] In vivo analyte sensors can typically be configured to analyze a single analyte using an enzyme to provide specificity for the single analyte. Determining concentrations of multiple analytes of physiological relevance can be desirable in certain medical instances. For example, the concentration of an ion. such as sodium, potassium, magnesium, calcium, or ammonium, in a host’s biological fluid can provide important information about that host’s health status. Illustratively, the potassium ion (K+) is a biomarker of cardiovascular disease. In another example, the potassium ion (K+) is a biomarker of kidney disease. Indeed, in the US, about 14.8M individuals with diabetes are diagnosed with kidney disease, for example, impaired renal function; these patients may benefit from frequent measurement of blood potassium to assess kidney function and guide therapies, which may include oral medications, at one end of the spectrum, to dialysis on the other. In yet another example, the potassium ion (K+) is a biomarker of both cardiovascular disease and kidney disease.
[0004] 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 [0005] Certain embodiments of the present disclosure provide an analyte sensor system, including a transcutaneous analyte sensor an analog front end (AFE), and a micro controller unit (MCU). The AFE may be configured to perform, using the transcutaneous analyte sensor, one or more measurements associated with a user during at least a first measurement interval and perform one or more actions to maintain time synchronization associated with the MCU retrieving the one or more measurements from the AFE. The MCU may be configured to operate in a sleep mode during the at least the first measurement interval, exit the sleep mode and retrieve the one or more measurements for the first measurement interval from the AFE based on the one or more actions, and transmit data associated with the one or more measurements to a display device for display to the user.
[0006] Certain embodiments of the present disclosure provide a method for wireless communication by an analyte sensor system. The method includes performing, by an analog front end (AFE) of the analyte sensor system using a transcutaneous analyte sensor of the analyte sensor system, one or more measurements associated with a user during at least a first measurement interval, performing, by the AFE, one or more actions to maintain time synchronization associated with a microcontroller unit (MCU) of the analyte sensor system retrieving the one or more measurements from the AFE, operating, by the MCU. in a sleep mode during the at least the first measurement interval, exiting the sleep mode and retrieving, by the MCU, the one or more measurements for the first measurement interval from the AFE based on the one or more actions, and transmitting, by the MCU, data associated with the one or more measurements to a display device for display to the user.
[0007] 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 elsew here 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 sy stem, or processing systems cooperating over one or more networks.
[0008] The following description and the appended figures set forth certain features for purposes of illustration.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 illustrates an example diabetes management system, according to some embodiments disclosed herein.
[0010] 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.
[0011] FIG. 3A is an example analyte sensor system, in accordance with some embodiments.
[0012] FIG. 3B is an example analyte sensor system, in accordance with some embodiments.
[0013] FIG. 3C illustrates aspects of an example analyte sensor system, in accordance with some embodiments.
[0014] FIG. 4 illustrates a simplified block diagram of an analyte sensor system configured to measure one or more analytes of a user or patient, in accordance with some embodiments.
[0015] FIGS. 5A and 5B illustrate time synchronization issues that may occur due to timing inaccuracies of a clock of an analog front end (AFE) of an analyte sensor system, in accordance with some embodiments.
[0016] FIG. 6 includes a process flow illustrating example operations between a micro controller unit (MCU) and the AFE of the analyte sensor system, in accordance with some embodiments.
[0017] FIG. 7A illustrates an example measurement interval, in accordance with some embodiments.
[0018] FIG. 7B illustrates different manners by which the AFE may modify a measurement sequence of an example measurement interval, in accordance with some embodiments.
[0019] FIG. 8 depicts a method for wireless communication by an analyte sensor system, according to some embodiments disclosed herein.
[0020] FIG. 9 depicts aspects of an example health monitoring device, according to some embodiments disclosed herein.
DETAILED DESCRIPTION
[0021] Aspects of the present disclosure provide techniques, including apparatuses, methods, processing systems, and computer-readable mediums, for addressing timing inaccuracies associated with an analog front end (AFE) of an analyte sensor system. These techniques may improve time synchronization between the AFE and a micro controller unit (MCU) of the analyte sensor system.
Introduction to Health Management Systems
[0022] 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.
[0023] 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.
[0024] 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, spectrophotometric techniques, polarimetric techniques, calorimetric techniques, iontophoretic techniques, radiometric techniques, immunochemical techniques, and the like. The term “continuous,” as used herein, 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.
[0025] 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, manganese ions, uric acid, urea, ketones, and/or glucose.
[0026] 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.
[0027] 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 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 manganese concentration level, a phosphate ion concentration level, an ammonium ion concentration level, auric 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 manganese concentration level, a manganese 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 manganese concentration level, a manganese 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.
[0028] 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), which may 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.
[0029] 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.
[0030] 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, the electronics can take the form of an integrated circuit (IC), such as an Application- Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor. [0031] Display devices 1 10, 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 1 10, 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.
[0032] 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 sensor electronics module 12.
[0033] 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).
[0034] 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-|3 hydroxy -cholic acid; cortisol; creatine; creatine kinase; creatine kinase MM isoenzyme; creatinine; cyclosporin A; d-penicillamine; deethyl chloroquine; 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 -deoxy cortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free -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; manganese; 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 triiodothyronine (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); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbiturates, methaqualone, tranquilizers such as Valium, Librium, Mil town. 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-dihydroxy phenylacetic acid (DOPAC), homovanillic acid (HVA), 5 -hydroxy tryptamine (5HT), 5- hydroxyindoleacetic acid (FHIAA), and histamine.
[0035] 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 (FT), lithium (Li+), chloride (CT), sulfide (S2‘), sulfite (SCL2-), sulfate (SO ’), phosphate (PO ’). and ammonium (NH-i ). An ion is an example of an analyte.
[0036] 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.
[0037] The communication path between SS 8 and display device 150 is shown as wireless communication path 180. In certain embodiments, SS 8 and display device 150 are configured to wirelessly communicate over wireless communication path 180 using low range and/or distance wireless communication protocols. Examples of low range and/or distance 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. 1R (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 wireless 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.
[0038] 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.
[0039] 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 netw ork 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.
[0040] 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.
[0041] 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.
[0042] 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, memory 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).
[0043] 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.
[0044] 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 memory 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.
[0045] 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 memory 14 and the RTC 17 for storing and tracking 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.
[0046] 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.
[0047] 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)one or more sensors 163 (e.g.. an accelerometer, an inertial measurement unit (IMU), etc.), 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 connectivity interface 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.
[0048] 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 1 1 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.
[0049] 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, one or more sensors 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, information related 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.
[0050] 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.
[0051] 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 described in further detail herein. [0052] 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.
[0053] As described above, SS 8, in certain embodiments, gathers analyte data (e g., measured analyte concentration levels) from analyte sensor(s) 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 displaydevice 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.
[0054] Analyte sensor application 121 may be downloaded, installed, and initially configured/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.
[0055] 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.
[0056] 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.
[0057] 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 a pressure 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.
[0058] 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.
[0059] 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 memory 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.
[0060] Further, as shown, the analyte sensor(s) 10 includes one or more electrodes configured for sensing or measuring analyte concentration levels of a user (e.g., user 50). For example, as shown, the analyte sensor(s) 10 includes a working electrode 337 and a reference electrode 339. In some embodiments, while not shown in FIG. 3C, the working electrode 337 and reference electrode 339 may be electrically coupled to one or more other hardware components of the sensor electronics module 12 (e.g., the one or more processors 11 and/or the sensor measurement circuitry 13) via respective input pins on the PCB 304.
[0061] In some embodiments, the working electrode 337 may be coated, covered, treated, embedded, etc., with one or more chemical molecules that react with a particular analyte of a user and produce a measurable electrical analog signal proportional to a concentration of that particular analyte. The reference electrode 339 may be used to provide a stable, known potential or voltage, against which a potential of the working electrode 337 may be measured, ensuring precise control and accurate measurement of the concentration level of the analyte within the user.
Aspects Related to Time Synchronization Techniques for Analyte Sensor Systems
[0062] The real-time measurement of analytes (e.g., sodium, potassium, chloride, glucose, etc.) in patients can significantly improve medical outcomes for individuals with both acute and chronic conditions across various medical fields, including nephrology, hepatology, and cardiology. This continuous monitoring can be achieved through a wearable device, such as an analyte sensor system, designed to be worn by the patient and continuously measure these circulating analytes.
[0063] FIG. 4 illustrates a simplified block diagram of an analyte sensor system 400 configured to measure one or more analytes of a user or patient. In some cases, the analyte sensor system 400 may be an example of the SS 8 described with respect to FIGS. 1, 2, 3A. 3B, and 3C.
[0064] As shown, the analyte sensor system 400 includes a micro controller unit (MCU) 402, an analog front end (AFE) 404, a transcutaneous analyte sensor 406, and a battery 408. In some embodiments, the MCU 402. the AFE 404, and the battery 408 may be part of a sensor electronics module of the analyte sensor system 400, such as the sensor electronic module 12 of the SS 8 described with respect to FIGS. 1 and 2. In some embodiments, the battery 408 may be configured to supply power to the MCU 402, the AFE 404, and the analyte sensor 406.
[0065] As shown, the AFE 404 includes sensor measurement circuitry 412 configured to use the analyte sensor 406 to perform one or more measurements associated with a user of the analyte sensor system 400. After performing the one or more measurements, the one or more measurements may be provided by the AFE 404 to the MCU 402 for further processing. For example, as shown, the MCU 402 may include one or more processors 414 that may be configured to convert the one or more measurements received from the AFE 404 to an estimated analyte value, representing the analyte concentration level of the user. This estimated analyte value may then be transmitted by a transceiver 416 of the MCU 402 to display device, such as the display device 150 depicted and described with respect to FIG. 2, for display to the user. In some embodiments, the transceiver 416 may transmit the estimated analyte value using a wireless technology, such as Bluetooth, Bluetooth Low Energy (BLE), WiFi, etc. [0066] In some embodiments, the MCU 402 may be configured to instruct the AFE 404 to perform the one or more measurements according to a particular measurement sequence. For example, the MCU 402 may instruct the AFE 404 to perform a first measurement of a glucose concentration level of the user, followed by a second measurement of the potassium concentration level. However, directing the AFE 404 to perform measurements according to the particular measurement sequence may require substantial signaling between the MCU 402 and AFE 404, leading to significant battery consumption. Moreover, this process requires the MCU 402 to remain continuously powered, further increasing power usage.
[0067] Accordingly, in some embodiments, to reduce power consumption, the AFE 404 may include a sequencer 418 that may configure the AFE 404 to perform the one or more measurements according to the particular measurement sequence. For example, the sequencer 418 may be a hardware device that includes a plurality of registers, which may be programmed to define the measurement sequence by which the AFE 404 performs the one or more measurements.
[0068] For example, in some embodiments, the sequencer 418 may be programmed such that the AFE 404 performs the one or more measurements in the following sequence: (1) measurements for a first analyte (e.g., glucose), (2) measurements for a second analyte (e.g., potassium), (3) impedance measurements associated with the first analyte, (4) impedance measurements for the second analyte, (5) temperature measurements, and (6) oxygen measurements. It should be appreciated that this measurement sequence is just one example and the measurements may be performed in a different sequence or order. Additionally, it should be appreciated that different types of measurements than those listed above may also be performed, such as measurements for third analyte (e.g., sodium), measurements for a fourth analyte (e.g., magnesium), etc.
[0069] In some embodiments, the sequencer 418 may configure additional parameters associated with performing the one or more measurements, such as a frequency of each measurement, a duration or gap of time between each measurement, a duration of one or more measurement intervals, etc. In some embodiments, upon completion of each of the different measurements, the AFE 404 may be configured to store each of the measurements as a data set within a buffer 420, according to a specific data structure. [0070] In some embodiments, the AFE 404 may be configured to perform the one or more measurements during pre-defined measurement intervals. For example, during a first measurement interval, the AFE 404 may be configured to perform a first set of measurements based on the measurement sequence described above and store the first set of measurements in the buffer 420 according to the defined data structure. After the first set of measurements are complete, the MCU 402 may be configured to retrieve the first set of measurements from the AFE 404 and to perform additional processing on the first set of measurements, such as converting the first set of measurements to a first estimated analyte value. Thereafter, the AFE 404 may begin performing a second set of measurements for a second measurement interval based on the measurement sequence and may store the second set of measurements in the buffer 420 according to the defined data structure. After the second set of measurements are complete, the MCU 402 may again be configured to retrieve the second set of measurements from the AFE 404 and to perform the additional processing on the second set of measurements, such as converting the second set of measurements to a second estimated analyte value or second analyte value.
[0071] As noted above, the analyte sensor system 400 may be powered using the battery 408, which only includes a finite amount of stored energy. As such, because the MCU 402 may consume a significant amount of energy while operating, it may be advantageous to place the MCU 402 into a sleep mode during the measurement intervals in which the AFE 404 is performing the one or more measurements to conserv e the stored energy of the battery 408. For example, while operating in the sleep mode, one or more components of the MCU 402 (e.g., the one or more processors 414, the transceiver 416, etc.) may be powered down or may operate in a low-power state. Thereafter, once a particular measurement interval is complete, the MCU 402 may be configured to wake up from the sleep mode, power on the one or more components, and retrieve the one or more measurements from the AFE 404.
[0072] However, while operating in sleep mode may help to conserve energy, these techniques may introduce certain challenges regarding when the MCU 402 should wake up from the sleep mode and when the MCU 402 should attempt to retrieve the one or more measurements from the AFE 404. For example, a time at which the MCU 402 is configured to wake up and retrieve the one or more measurements from the AFE 404 may be controlled based on a crystal-based clock 422 of the MCU 402, which is highly accurate. However, a length of the measurement interval during which the AFE 404 completes the one or more measurements may may depend on a non-crystal-based clock 424 of the AFE 404, which may not be as accurate as the clock 422 of the MCU 402. For example, in some cases, the clock 424 of the AFE 404 may have a timing inaccuracy of up to 2 percent, which may cause the measurement interval to last longer than expected by the MCU 402. This may cause a timing mismatch between the clock 422 and the clock 424, leading to the MCU 402 and AFE 404 becoming out of sync with one another. For example, for a five-minute measurement interval, this 2 percent timing inaccuracy of the clock 424 of the AFE 404 may cause the five-minute measurement interval to last anywhere between 4 minutes and 54 seconds to 5 minutes and 6 seconds.
[0073] As a result, there may be some scenarios in which, due to the timing inaccuracy of the clock 424 of the AFE 404, the MCU 402 may wake up from the sleep mode relatively early and try to retrieve the one or more measurements from the AFE 404 before the AFE 404 has completed the one or more measurements. For example, in the scenario in which the timing inaccuracy of the clock 424 causes the measurement interval to extend to 5 minutes and 6 seconds, the crystal-based clock 422 may cause the MCU 402 to wake up at 5 minutes and attempt to retrieve the one or more measurements even though the one or more measurements will not be completed by the AFE 404 until 5 minutes and 6 seconds. Waking up from the sleep mode and attempting to retrieve the one or more measurements prior to the one or more measurements being completed by the AFE 404 may cause the MCU 402 to receive an incomplete data set or a corrupted data set from the AFE 404, which may, in turn, prevent the user of the analyte sensor system 400 from receiving their estimated analyte values or may cause the user to receive inaccurate estimated analyte values.
[0074] Additionally, in some scenarios, the timing inaccuracy of the clock 424 of the
AFE 404, may cause the AFE 404 to complete the one or more measurements before a time at which the MCU 402 expects the one or more measurements to be completed. For example, in the scenario in which the timing inaccuracy of the clock 424 causes a first measurement interval to be shortened to 4 minutes and 54 seconds, the MCU 402 may still wake up at 5 minutes and attempt to retrieve the one or more measurements for the first measurement interval, 6 seconds after the AFE 404 completed the one or more measurements. However, in this scenario, because the MCU 402 wakes up 6 seconds late, the AFE 404 may have already started performing the one or more measurements for a second measurement interval, potentially overwriting one or more measurements from the first measurement interval. This may again result in the MCU 402 receiving an incomplete or corrupted data set from the AFE 404. For example, if the AFE 404 overwrites the data associated with one or more measurements of the first measurement interval with the data from the one or more measurements of the second measurement interval, the MCU 402 may be unable to retrieve the data associated with one or more measurements of the first measurement interval, ultimately preventing the user of the analyte sensor system 400 from receiving their estimated analyte values.
[0075] FIGS. 5A and 5B illustrate the time synchronization issues described above that may occur due to the timing inaccuracies of the clock 424 of the AFE 404. For example. FIG. 5A includes a plurality of timelines that illustrate a scenario in which the MCU 402 wakes up from the sleep mode before the one or more measurements are completed by the AFE 404. As shown, the plurality of timelines include a first timeline 502 A illustrating a plurality of measurement intervals in which the AFE 404 is configured to perform the one or more measurements. Additionally, as shown, the plurality’ of timelines includes a second timeline 504A illustrating a plurality of ON durations during which the MCU 402 is configured to wake up from the sleep mode and receive the one or more measurements from the AFE 404. It should be appreciated that during the periods of time between the ON durations, the MCU 402 may be configured to operate in a sleep mode, as described above.
[0076] As illustrated on the first timeline 502A, a first measurement interval 506A begins, according to the clock 424 of the AFE 404, at time WA during which the AFE 404 performs the one or more measurements and during which the MCU 402 is configured to operate in the sleep mode. Thereafter, based on the cry stal-based clock 422 of the MCU 402, the MCU 402 may be configured to wake up from the sleep mode during a first ON duration 508A beginning at time tl (e.g., 5 minutes). However, as shown, due to the inaccuracies of the clock 424 of the AFE 404, the one or more measurements may not be completed by the AFE 404 until time I2A (e.g., 5 minutes and 6 seconds). In this scenario, the MCU 402 may wake up at time HA before the one or more measurements are fully completed by the AFE 404 at time 12 . potentially resulting in the MCU 402 receiving an incomplete or corrupted data set of the one or more measurements from the AFE 404.
[0077] FIG. 5B includes a plurality of timelines that illustrate a scenario in which the one or more measurements are completed by the AFE 404 prior to a time at which the MCU 402 expects the one or more measurements to be completed. As shown, the plurality of timelines include a first timeline 502B illustrating a plurality of measurement intervals in which the AFE 404 is configured to perform the one or more measurements. Additionally, as shown, the plurality of timelines includes a second timeline 504B illustrating a plurality of ON durations during which the MCU 402 is configured to wake up from the sleep mode and receive the one or more measurements from the AFE 404. It should be appreciated that during the periods of time between the ON durations, the MCU 402 may be configured to operate in a sleep mode, as described above.
[0078] As illustrated on the first timeline 502B, a first measurement interval 506B begins, according to the clock 424 of the AFE 404, at time t0.\ during which the AFE 404 performs the one or more measurements and during which the MCU 402 is configured to operate in the sleep mode. Thereafter, due to the inaccuracies of the clock 424 of the AFE 404, the AFE 404 may complete the one or more measurements before a time at which the MCU 402 expects the one or more measurements to be completed. For example, as shown, the one or more measurements may be completed by the AFE 404 at time HB (e.g., 4 minutes and 54 seconds). However, the MCU 402 may not wake up until the first ON duration 508B, which starts at time I2B after time tlB. In this scenario, because the MCU 402 has woken up from the sleep mode relatively late at time t2s, the AFE 404 has have already started performing the one or more measurements for a second measurement interval 510B, causing the one or more measurements of the first measurement interval 506B to at least be partially overwritten in the buffer 420 of the AFE 404. This again may cause the MCU 402 to receive an incomplete or corrupted data set of the one or more measurements from the AFE 404
[0079] As can be seen, time synchronization between the AFE 404 and MCU 402 is crucial for the MCU 402 to accurately receive the one or more measurements from the AFE 404. Accordingly, aspects of the present disclosure provide techniques for addressing the timing inaccuracy associated with the clock 424 of the AFE 404, enabling the AFE 404 and the MCU 402 to remain synchronized in time. Further, by maintaining time synchronization between the AFE 404 and the MCU 402, the MCU 402 may be able to reliably wake from the sleep mode to retrieve, from the AFE 404, a data set including one or more precisely when the one or more measurements have been completed by the AFE 404. As a result, these techniques may help prevent the scenarios described above with respect to FIGS. 5A and 5B, in which the MCU 402 retrieves an incomplete or corrupted data set.
[0080] FIG. 6 includes a process flow illustrating example operations 600 between the MCU 402 and the AFE 404 of the analyte sensor system 400 for performing one or more measurements associated with a user of the analyte sensor system 400, and for providing data associated with the one or more measurements to a display device 602 for display to the user.
[0081] As shown, operations 600 begin at 610 with the AFE 404 performing one or more measurements associated with a user of the analyte sensor system 400, for example, using sensor measurement circuitry 412 and the analyte sensor 406 illustrated in FIG. 4. In some embodiments, the one or more measurements may be performed during at least a first measurement interval. Additionally, in some embodiments, the AFE 404 may be configured to perform the one or more measurements during the first measurement interval according to a particular measurement sequence. In some embodiments, the measurement sequence may be programmed or set by the sequencer 418 shown in FIG. 4.
[0082] In some embodiments, during the first measurement interval in which the AFE 404 performs the one or more measurements, the MCU 402 may be configured to operate in a sleep mode, as shown at 612. As discussed above, while operating in the sleep mode, one or more components of the MCU 402 (e.g., the one or more processors 414, the transceiver 416, etc.) may be powered down or operate according to a low-power state to conserve energy' of the battery' 408 of FIG. 4.
[0083] As discussed above, due to inaccuracies associated with the clock 424 of the AFE 404, the one or more measurements for the first measurement interval may be completed by the AFE 404 before or after a time at which the MCU 402 is configured to exit/wake up from the sleep mode, which may cause the MCU 402 to receive an incomplete or corrupted data set of the one or more measurements from the AFE 404.
[0084] In some embodiments, the AFE 404 may be configured to perform one or more actions to help account for the timing inaccuracy of the clock 424 of the AFE 404 and maintain time synchronization associated with the MCU 402 retrieving the one or more measurements from the AFE 404. For example, in some embodiments, the techniques presented herein may include the use of an interrupt signal that may be sent by the AFE 404 to the MCU 402 to cause the MCU 402 to wake up from the sleep mode and to retrieve the one or more measurements for the first measurement interval. For example, as shown at 614, once the AFE 404 has completed the one or more measurements for the first measurement interval (e.g., as governed by the clock 424 of the AFE 404), the AFE 404 may send an interrupt signal to the MCU 402. In some embodiments, the interrupt signal may be sent by the AFE 404 to the MCU 402 on the signal line 410 between the AFE 404 and the MCU 402.
[0085] As shown, at 616, upon receiving the interrupt signal, the interrupt signal may cause the MCU 402 to exit (e.g., wake up from) the sleep mode by powering on the one or more components of the MCU 402. Thereafter, as shown at 618, the MCU 402 may retrieve a data set including the one or more measurements for the first measurement interval from the AFE 404. Accordingly, even when the particular measurement interval is shortened or extended by the 2 percent error or inaccuracy associated the clock 424 of the AFE 404, the intermpt signal may allow the MCU 402 to wake up and retrieve precisely when the one or more measurements for the first measurement interval have been completed, avoiding the potential of the MCU 402 retrieving an incomplete or corrupted data set.
[0086] After retrieving the one or more measurements from the AFE 404, the MCU 402 may be configured to process the one or more measurements for the first measurement internal, for example, using the one or more processors 414. In some embodiments, processing the one or more measurements may include generating one or more estimated analyte concentration values for the first measurement interval, as shown at 620. Thereafter, as shown at 622, the MCU 402 may be configured to transmit (e.g., using the transceiver 416) the one or more estimated analyte concentration values for the first measurement interval to the display device 602 for display to the user.
[0087] As noted above, the AFE 404 may perform one or more actions to maintain time synchronization associated with the MCU 402 retrieving the one or more measurements from the AFE 404. For example, in some embodiments, another manner for helping to account for the timing inaccuracy associated with the clock 424 of the AFE 404 and to maintain the time synchronization may be to adjust the measurement sequence by which the AFE 404 performs the one or more measurements during a measurement interval. For example, in some embodiments, the AFE 404 may be configured to perform the one or more measurements for the first measurement interval according to a first measurement sequence configured by the sequencer 418. Thereafter, as shown at 624, the AFE 404 may determine a difference between an actual duration of the first measurement interval and an expected duration of the first measurement interval. For example, in some cases, the AFE 404 may determine that the actual duration of the first measurement interval is longer or shorter than an expected duration of the first measurement interval. In one scenario, the AFE 404 may determine that the first measurement interval has lasted 5 minutes and 6 seconds - 6 seconds longer than an expected duration of 5 minutes.
[0088] In response, as shown at 626, the AFE 404 may modify the measurement sequence configured in the sequencer 418 to shorten or lengthen a duration of a subsequent second measurement interval. For example, in the scenario described above in which the first measurement interval lasted 5 minutes and 6 seconds, the AFE 404 may modify the measurement sequence to shorten a duration of the second measurement interval by 6 seconds.
[0089] Thereafter, as shown at 630, the AFE 404 may then perform the one or more measurements for the second measurement interval according to the modified measurement sequence. The MCU 402 may operate in the sleep mode during the second measurement interval, as shown at 632. Thereafter, the MCU 402 may be configured to exit the sleep mode, as shown at 634.
[0090] In the scenario described above in which the first measurement interval lasted 5 minutes and 6 seconds, modifying the measurement sequence to shorten the duration of the second measurement interval (e.g., by 6 seconds) may advantageously cause the AFE 404 to complete the one or more measurements for the second measurement interval approximately when (e.g., just prior to a point in time at which) the MCU 402 is configured to exit the sleep mode at 634 to retrieve the one or more measurements form the AFE 404.
[0091] As shown at 633, although the measurement sequence may be modified to correct the duration of the second measurement interval such that the AFE 404 and MCU 402 are synchronized in time, in some embodiments, the AFE 404 may still be configured to send an interrupt signal to the MCU 402 to wake the MCU 402 up from the sleep mode and instruct the MCU 402 to retrieve the one or more measurements from the AFE 404. In some embodiments, rather than having the AFE 404 send the interrupt signal to the MCU 402 at 433, the MCU 402 may autonomously exit the sleep mode at 634 to retrieve the one or more measurements for the second measurement interval at a point in time at which it expects the one or more measurements to be completed (e.g., 5 minutes, in one example).
[0092] After exiting the sleep mode, the MCU 402 may retrieve a data set including the one or more measurements for the second measurement interval from the AFE 404, as shown at 636. The MCU 402 may then be configured to process the one or more measurements for the second measurement interval, for example, using the one or more processors 414. In some embodiments, processing the one or more measurements may include generating one or more estimated analyte concentration values for the first measurement interval, as shown at 638. Thereafter, at shown at 640, the MCU 402 may be configured to transmit (e.g., using the transceiver 416) the one or more estimated analyte concentration values for the second measurement interval to the display device 602 for display to the user.
[0093] In some embodiments, the AFE 404 may be configured to modify the measurement sequence at 626 in different manners. For example, FIG. 7A illustrates an example measurement interval 702. In some cases, the measurement interval may be an example of the first measurement interval described above with respect to FIG. 6. During the first measurement interval, the AFE 404 may perform one or more measurements according to a measurement sequence. For example, as shown, the AFE 404 may be configured to perform a first measurement (e.g., for a first analyte), a second measurement (e.g., for a second analyte), a third measurement (e.g., impedance measurements associated with the first analyte), a fourth measurement (e.g., impedance measurements associated with the second analyte), a fifth measurement (e.g., a temperature measurement), and a sixth measurement (e.g., an oxygen measurement).
[0094] Further, as shown, the AFE 404 may be configured to perform each measurement of the one or more measurements for a particular duration 704. In some embodiments, the duration 704 may be the same or different for different measurements. Additionally, in some embodiments, each measurement may be followed by a gap 706 to allow the AFE 404 a certain amount of time to prepare to perform the next measurement.
[0095] FIG. 7B illustrates different manners by which the AFE 404 may modify a measurement sequence (e g., at 626 in FIG. 6) of an example measurement interval 710. In some cases, the measurement interval 710 may be an example of the second measurement interval described above with respect to FIG. 6. [0096] In some embodiments, modifying the measurement sequence at 626 in FIG. 6 may include adjusting a duration of at least one of the measurements that are performed during the second measurement interval. For example, as shown in FIG. 7B, a duration 708 of at least the second measurement may be shortened relative to the duration 704 of the second measurement shown in FIG. 7A.
[0097] Further, in some embodiments, modifying the measurement sequence at 626 in FIG. 6 may include adjusting gaps between different measurements performed during the second measurement interval. For example, as shown at 710 in FIG. 7B, the gaps between the fourth, fifth, and sixth measurements may be shortened relative to the gaps (e.g., 706) betw een the fourth, fifth, and sixth measurements shown in FIG. 7A.
[0098] In some embodiments, shortening the gaps between the measurements and/or shortening the duration of the one or more measurements may result in a period of time 712 at the end of the second measurement interval in which no measurements are being performed, resulting in the one or more measurements being completed prior to the end of the second measurement interval and allow ing the MCU 402 to safely retrieve the data set including the one or more measurements for the second measurement interval.
[0099] In some embodiments, modifying the measurement sequence at 626 in FIG. 6 may include adjusting a frequency of the measurements performed during the second measurement interval. In some embodiments, modifying the measurement sequence at 626 in FIG. 6 may include adjusting which or how' many measurements are performed during the second measurement interv al. For example, in some embodiments, the AFE 404 may adjust the measurement sequence such that one or more of the measurements, such as the fifth and sixth measurements of FIG. 7B, are dropped or not performed. In some embodiments, modifying the measurement sequence at 626 in FIG. 6 may include other adjusting other parameters to adjust (e.g., shorten or lengthen) a total duration of the one or more measurements performed during the second measurement interval.
[0100] It should be appreciated that, while the techniques described above relate to shortening certain parameters (e.g., measurement duration, gaps, etc.), the AFE 404 may also be configured to modify the measurement sequence by lengthening these parameters. For example, in some embodiments, modifying the measurement sequence at 626 in FIG. 6 may include at least one of lengthening a duration of the one or more of the measurements that are performed during the second measurement interval, lengthening the gaps between measurements performed during the second measurement interval, or adjusting other parameters to lengthen a total duration of the one or more measurements performed during the second measurement interval.
[0101] In some embodiments, to account for future drift (e.g., timing inaccuracies) associated with the clock 424 of the AFE 404, the AFE 404 may be configured to periodically monitor the expected duration and actual duration of subsequent measurement intervals and periodically adjust the measurement sequence configured in the sequencer 418 to ensure that a duration of the subsequent measurement intervals is equal to the expected duration for these subsequent measurement intervals.
[0102] As discussed above, at 624 in FIG. 6, the AFE 404 may be configured to determine a difference between an actual duration of the first measurement interval and an expected duration of the first measurement interval. In some embodiments, the AFE 404 may determine the difference between the actual duration of the first measurement interval and an expected duration of the first measurement interval based on a difference between a clock speed of the clock 424 of the AFE 404 and a clock speed of the clock 422 of the MCU 402.
[0103] For example, in some embodiments, the MCU 402 may have an SPI interface 426 shown in FIG. 4 that is configured to output, to the AFE 404 at 623 in FIG. 6, one or more clock signals indicating a clock speed of the clock of the MCU 402. Accordingly, to determine the difference betw een the clock speed of the clock 424 of the AFE 404 and the clock speed of the MCU 402, the AFE 404 may be configured to count a number of clock cycles or signals that are received from the MCU 402 on the SPI interface 426 within a clock window associated with the clock 424 of the AFE 404. As an example, the AFE 404 may determine, for a clock window including 1000 clock cycles of the clock 424 of the AFE 404, that only 980 clock signals associated with the clock 422 of the MCU 402 have been received, indicating that the clock speed of the clock 424 of the AFE 404 is too fast. In other examples, the AFE 404 may determine, for a clock window including 1000 clock cycles of the clock 424 of the AFE 404, that 1020 clock signals associated with the clock 422 of the MCU 402 have been received, indicating that the clock speed of the clock 424 of the AFE 404 is too slow.
[0104] Accordingly, the AFE 404 may be configured to determine the difference between the actual duration of the first measurement interval and the expected duration of the first measurement interval at 624 based on the determined difference between the clock speed of the clock 424 of the AFE 404 and the clock speed of the MCU 402. The AFE 404 may then be configured to modify the measurement sequence configured in the sequencer 418, based on the determined difference, such that a duration of at least the second measurement interval is as close as possible to duration for the second measurement interval as expected by the MCU 402 based on the clock 422 of the MCU 402. As an example, at 626 in FIG. 6, the AFE 404 may modify the measurement sequence configured in the sequencer 418 such that a duration of at least the second measurement interval is as close as possible to a 5-minute measurement interval expected by the MCU 402.
[0105] In some embodiments, while the difference between the clock speed of the clock 424 of the AFE 404 and the clock speed of the MCU 402 may be used to modify the measurement sequence configured in the sequencer 418 to ensure that measurement inter als in which the AFE 404 performs the one or more measurements comply with the timing of the clock 422 of the MCU 402 which governs when the MCU 402 wakes up and retrieves the one or more measurements, the difference between the clock speed of the clock 424 of the AFE 404 and the clock speed of the MCU 402 may also be used for other purposes. For example, in some embodiments, the difference between the clock speed of the clock 424 of the AFE 404 and the clock speed of the MCU 402 may be used to correct for timing errors included within the one or more measurements performed by the AFE 404.
[0106] For example, as noted above, in addition to performing measurements for various analytes, the AFE 404 may also be configured to perform impedance measurements associated with each of these analytes, which may require accurate timing. For example, when performing these impedance measurements, the AFE 404 may be configured to perform multiple impedance samples which are associated with an exponential decay. As a result, when the clock 424 of the AFE 404 has a certain amount of timing inaccuracy, these timing inaccuracies may be introduced into each of these impedance samples, causing the impedance samples, themselves, to be inaccurate.
[0107] Accordingly, the AFE 404 may determine the difference between the clock speed of the clock 424 of the AFE 404 and the clock speed of the MCU 402, representing a timing error betw een the clock 424 of the AFE 404 and the clock of the MCU 402. In some embodiments, the timing error may be based on the clock 424 of the AFE 404 being less accurate than the clock 422 of the MCU 402. Thereafter, at 630, the AFE 404 may be configured to subtract or otherwise remove this timing error from the measured impedance samples to improve the accuracy of the measured impedance samples.
[0108] In some embodiments, in addition to or instead of using an interrupt signal and/or adjusting the measurement sequence, the MCU 402 may be configured to autonomously wake up or exit the sleep mode at 634 by a threshold amount of time prior to when the MCU 402 expects the one or more measurements for the second measurement interval to be completed by the AFE 404. In some embodiments, the MCU 402 may then send a polling message to the AFE 404 inquiring whether the one or more measurements have been completed. If the one or more measurements have been completed, the AFE 404 may send the one or more measurements to the MCU 402 at 636 in response to receiving the polling message. If, however, the one or more measurements have not been completed, the AFE 404 may send a polling response message to the MCU 402 that indicates that the one or more measurements have not been completed.
[0109] In some embodiments, the MCU 402 may be configured to re-enter the sleep mode for a period of time and wake up again after a period of time to transmit another polling message inquiring whether the one or more measurements have been completed. The MCU 402 may be configured to continually re-enter the sleep mode, autonomously wake up, and transmit polling messages until the one or more measurements are completed by the AFE 404 and the AFE 404 sends the one or more measurements to the MCU 402. In some embodiments, rather than re-entering the sleep mode in response to receiving an indication that the one or more measurements have not been completed, the MCU 402 may be configured to stay awake and periodically transmit the polling messages until the until the one or more measurements are completed by the AFE 404 and the AFE 404 sends the one or more measurements to the MCU 402 at 636.
[0110] In some embodiments, the MCU 402 may be configured to adjust a time at which it wakes up or exits from the sleep mode and attempts to retrieve the one or more measurements from the AFE 404. For example, in some embodiments, the MCU 402 may be configured to estimate a difference between an actual duration of a measurement interval during which the AFE 404 performs the one or more measurements and an expected duration of the measurement interval. The MCU 402 may then use the estimated time difference to adjust the time at which it wakes up from the sleep mode. [0111] In some embodiments, the MCU 402 may estimate the difference based on an interrupt signal received from the AFE 404. For example, in some embodiments, the MCU 402 may first determine a time at which the AFE 404 starts performing the one or more measurements. The MCU 402 may then receive the interrupt signal from the AFE 404 and determine a time at which the interrupt signal is received. The MCU 402 may then determine the duration between the start of the one or more measurements and the time at which the interrupt signal is received, indicating an actual duration of the measurement interval during which the AFE 404 performed the one or more measurements. The MCU 402 may then determine the difference between the actual duration of the measurement interval and the expected duration of the measurement interval and adjust the time at which it wakes up from the sleep mode based on the determined difference. In some embodiments, the MCU 402 may be configured to use the determined difference to correct for any timing errors associated with the impedance measurements included within the one or more measurements received from the AFE 404.
[0112] Another manner for helping to account for the timing inaccuracy associated with the clock 424 of the AFE 404 may be equip the AFE 404 with a crystal-based clock. However, crystal-based clocks are relatively expensive. Additionally, there may be space restrictions within the analyte sensor system that may prevent equipping the AFE 404 with the crystal-based clock.
Example Operations of a Display Device
[0113] FIG. 8 shows an example of a method 800 of communication by an analyte sensor system in an analyte monitoring system, such as the analyte sensor system 8 described with respect to FIGS. 1, 2, 3A, 3B, or 3C and/or the analyte sensor system 400 described with respect to FIGS. 4, 5A, 5B, 6, 7A, or 7B.
[0114] Method 800 begins at 802 with performing, by an analog front end (AFE) of the analyte sensor system using a transcutaneous analyte sensor of the analyte sensor system, one or more measurements associated with a user during at least a first measurement interval.
[0115] At 804. the AFE performs one or more actions to maintain time synchronization associated with a microcontroller unit (MCU) of the analyte sensor system retrieving the one or more measurements from the AFE. [0116] At 806, the MCU operates a sleep mode during the at least the first measurement interval.
[0117] At 808, the MCU exits the sleep mode and retrieves the one or more measurements for the first measurement interval from the AFE based on the one or more actions.
[0118] At 810, the MCU transmits data associated with the one or more measurements to a display device for display to the user.
[0119] In some embodiments, performing, by the AFE, the one or more actions to maintain the time synchronization comprises sending, by the AFE, an interrupt signal to the MCU after completing the one or more measurements for the first measurement interval.
[0120] In some embodiments, exiting the sleep mode and retrieving the one or more measurements, by the MCU, comprises exiting the sleep mode and retrieving the one or more measurements upon receiving the interrupt signal from the AFE.
[0121] In some embodiments, method 800 further includes determining, by the AFE after performing the one or more measurements for at least the first measurement interval, a difference between an actual duration of the first measurement interval and an expected duration of the first measurement interval
[0122] In some embodiments, determining, by the AFE. the difference between the actual duration of the first measurement interval and the expected duration of the first measurement interval comprises determining, by the AFE, a difference between a clock speed of a clock of the AFE and a clock speed of a clock of the MCU.
[0123] In some embodiments, method 800 further includes receiving, by the AFE, one or more clock signals from the MCU associated with the clock of the MCU, wherein determining, by the AFE, the difference between the clock speed of a clock of the AFE and the clock speed of the clock of the MCU is based on the one or more clock signals received from the MCU.
[0124] In some embodiments, receiving, by the AFE, the one or more clock signals from the MCU comprises receiving, by the AFE, the one or more clock signals from the MCU using a serial peripheral interface (SPI).
[0125] In some embodiments, determining, by the AFE, the difference betw een the clock speed of the clock of the AFE and the clock speed of a clock of the MCU comprises: counting, by the AFE, a number of the one or more clock signals received from the MCU in a clock window; and determining, by the AFE, a timing difference between the clock of the AFE and the clock of the MCU based on a difference between the number of the one or more clock signals received from the MCU during the clock window and a number of clock cycles associated with the clock of the AFE occurring during the clock window.
[0126] In some embodiments, the one or more measurements includes at least an impedance measurement associated with a first analyte, In some embodiments, method 800 further includes removing, by the AFE, a timing error from the impedance measurement associated with the first analyte based on the determined timing difference. In some embodiments, the timing error is based on the clock of the AFE being less accurate than the clock of the MCU.
[0127] In some embodiments, the actual duration of the first measurement interval is based on the clock of the AFE.
[0128] In some embodiments, the clock of the AFE is less accurate than a clock of the MCU.
[0129] In some embodiments, performing, by the AFE, the one or more actions to maintain the time synchronization is based on the clock of the AFE being less accurate than the clock of the MCU.
[0130] In some embodiments, performing, by the AFE, the one or more measurements comprises performing, by the AFE, the one or more measurements according to a measurement sequence. In some embodiments, performing the one or more actions to maintain the time synchronization comprises modifying, by the AFE, the measurement sequence for a second measurement interval based on the determined difference between the actual duration of the first measurement interval and the expected duration of the first measurement interval.
[0131] In some embodiments, modifying, by the AFE, the measurement sequence for the second measurement interval comprises at least one of: adjusting, by the AFE, a duration of at least one of the measurements of the one or more measurements to be performed during the second measurement interval; adjusting, by the AFE, gaps between different measurements of the one or more measurements to be performed during the second measurement interval; adjusting, by the AFE, a frequency of measurements of the one or more measurements to be performed during the second measurement interval; adjusting, by the AFE, which or how many measurements of the one or more measurements are to be performed during the second measurement interval; or adjusting, by the AFE, other parameters to adjust a total duration of the one or more measurements to be performed during the second measurement interval.
[0132] In some embodiments, method 800 further includes performing, by the AFE, the one or more measurements associated with the user during the second measurement interval according to the modified measurement sequence. In some embodiments, method 800 further includes operating, by the MCU, in the sleep mode during the second measurement interval; and exiting the sleep mode and retrieving, by the MCU, the one or more measurements for the second measurement interval.
[0133] In some embodiments,, based on the modified measurement sequence, the one or more measurements for the second measurement interval are completed when the MCU exits the sleep mode and retrieves the one or more measurements.
[0134] In some embodiments, performing the one or more actions to maintain the time synchronization comprises sending, by the AFE, an intermpt signal to the MCU after completing the one or more measurements for the second measurement interval. In some embodiments, exiting the sleep mode and retrieving, by the MCU, the one or more measurements for the second measurement interval comprises exiting the sleep mode and retrieving, by the MCU, the one or more measurements for the second measurement interval upon receiving the interrupt signal from the AFE.
[0135] In some embodiments, the one or more measurements comprise at least one of: a first measurement for a first analyte; a second measurement for a second analyte; an impedance measurement associated with the first analyte; an impedance measurement associated with the second analyte; an oxygen measurement; or a temperature measurement.
[0136] In some embodiments, exiting the sleep mode, by the MCU, comprises autonomously exiting the sleep mode.
[0137] In some embodiments, method 800 further includes, after autonomously exiting the sleep mode, sending, by the MCU, a polling message to the AFE inquiring whether the one or more measurements for at least the first measurement interval have been completed. [0138] In some embodiments, retrieving, by the MCU. the one or more measurements for at least the first measurement interval is based on the polling message.
[0139] In some embodiments, method 800 further includes sending, by the AFE to the MCU based on the polling message from the MCU, a polling response message indicating that the one or more measurements for at least the first measurement interval have not been completed.
[0140] In some embodiments, method 800 further includes re-entering, by the MCU, the sleep mode in response to receiving the polling response message. In some embodiments, method 800 further includes autonomously exiting, by the MCU, the sleep mode after a period of time. In some embodiments, method 800 further includes transmitting, by the MCU, a second polling message inquiring whether the one or more measurements for at least the first measurement interval have been completed. In some embodiments, method 800 further includes retrieving, by the MCU, the one or more measurements for the first measurement interval based on the second polling message.
[0141] In some embodiments, method 800 further includes transmitting, by the MCU after a period of time after receiving the polling response message, a second polling message inquiring whether the one or more measurements for at least the first measurement interval have been completed. In some embodiments, method 800 further includes retrieving, by the MCU, the one or more measurements for the first measurement interval based on the second polling message.
[0142] In some embodiments, method 800 further includes determining, by the MCU, an actual duration of the first measurement interval based on a time at which the AFE starts performing the one or more measurements and a time at which the interrupt signal is received. In some embodiments, method 800 further includes determining, by the MCU, a different between the actual duration of the first measurement interval and an expected duration of the first measurement interval. In some embodiments, method 800 further includes adjusting, by the MCU, a time at which the MCU is configured to exit the sleep mode and retrieve the one or more measurements for a second measurement interval based on the different between the actual duration of the first measurement interval and the expected duration of the first measurement interval.
Example Health Monitoring Device(s)
[0143] FIG. 9 depicts aspects of an example health monitoring device 900. In some aspects, health monitoring device 900 is an analyte sensor system, such as the analyte sensor system 8 described with respect to FIGS. 1, 2, 3A, 3B, or 3C and/or the analyte sensor system 400 described with respect to FIGS. 4, 5A, 5B, 6, 7A, or 7B.
[0144] The health monitoring device 900 includes a processing system 905 coupled to the transceiver 975 (e.g., a transmitter and/or a receiver). The transceiver 975 is configured to transmit and receive signals for the health monitoring device 900 via the first antenna system 980, such as the various signals as described herein. The processing system 905 may be configured to perform processing functions for the health monitoring device 900, including processing signals received and/or to be transmitted by the health monitoring device 900.
[0145] The processing system 905 includes one or more processors 910. In various aspects, the one or more processors 1310 may be representative of the one or more processors 11, as described with respect to FIG. 2. The one or more processors 910 are coupled to a computer-readable medium/memory 940 via a bus 970. In some aspects, the computer-readable medi um/memory 1345 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 940 is configured to store instructions (e.g., computerexecutable code) that when executed by the one or more processors 910, cause the one or more processors 910 to perform the method 800 described with respect to FIG. 8, or any aspects related to this methods. Note that reference to a processor performing a function of health monitoring device 900 may include one or more processors 910 performing that function of health monitoring device 900.
[0146] In the depicted example, computer-readable medium/memory 940 stores code (e.g., executable instructions), such as code for performing 941 , code for operating 942, code for exiting 943, code for retrieving 944, code for transmitting 945, code for sending 946, code for determining 947, code for receiving 948, code for counting 949, code for removing 950, code for modifying 951, code for adjusting 952, and code for reentering 953. Processing of the code for code for performing 941, code for operating 942, code for exiting 943, code for retrieving 944, code for transmitting 945, code for sending 946, code for determining 947, code for receiving 948, code for counting 949, code for removing 950, code for modifying 951, code for adjusting 952. and code for re-entering 953 may cause the health monitoring device 900 to perform the method 800 described with respect to FIG. 8, or any aspects related to this methods. [0147] The one or more processors 910 include circuitry configured to implement (e.g., execute) the code stored in the computer-readable medium/memory 940, including circuitry such as circuitry for performing 920, circuitry for operating 921, circuitry for exiting 922, circuitry for retrieving 923, circuitry for transmitting 924, circuitry for sending 925. circuitry for determining 926, circuitry for receiving 927. circuitry for counting 928, circuitry for removing 929, circuitry for modifying 930, circuitry for adjusting 931, and circuitry for re-entering 932. Processing with circuitry for circuitry for performing 920, circuitry for operating 921, circuitry for exiting 922, circuitry for retrieving 923. circuitry for transmitting 924, circuitry for sending 925. circuitry for determining 926, circuitry for receiving 927, circuitry for counting 928, circuitry for removing 929, circuitry for modifying 930, circuitry for adjusting 931, and circuitry' for re-entering 932 may cause the health monitoring device 900 to perform the method 800 described with respect to FIG. 8, or any aspects related to this methods.
Example Clauses
[0148] Implementation examples are described in the following numbered clauses:
[0149] Clause 1 : An analyte sensor system, comprising: a transcutaneous analyte sensor; an analog front end (AFE); and a micro controller unit (MCU), wherein: the AFE is configured to: perform, using the transcutaneous analyte sensor, one or more measurements associated with a user during at least a first measurement interval; and perform one or more actions to maintain time synchronization associated with the MCU retrieving the one or more measurements from the AFE; and the MCU is configured to: operate in a sleep mode during the at least the first measurement interval; exit the sleep mode and retrieve the one or more measurements for the first measurement interval from the AFE based on the one or more actions; and transmit data associated with the one or more measurements to a display device for display to the user.
[0150] Clause 2: The analyte sensor system of Clause 1 , wherein, in order to perform the one or more actions to maintain the time synchronization, the AFE is configured to send an interrupt signal to the MCU after completing the one or more measurements for the first measurement interval.
[0151] Clause 3: The analyte sensor system of Clause 2, wherein MCU is configured to exit the sleep mode and retrieve the one or more measurements from the AFE upon receiving the interrupt signal from the AFE. [0152] Clause 4: The analyte sensor system of any of Clauses 1-3, wherein, after performing the one or more measurements for at least the first measurement interval, the AFE is further configured to determine a difference between an actual duration of the first measurement interval and an expected duration of the first measurement interval.
[0153] Clause 5: The analyte sensor system of Clause 4, wherein the AFE is configured to determine the difference between the actual duration of the first measurement interval and the expected duration of the first measurement interval based on a difference between a clock speed of a clock of the AFE and a clock speed of a clock of the MCU.
[0154] Clause 6: The analyte sensor system of Clause 5, wherein, in order to determine the difference between the clock speed of a clock of the AFE and the clock speed of the clock of the MCU. the AFE is configured to receive one or more clock signals from the MCU associated with the clock of the MCU.
[0155] Clause 7: The analyte sensor system of Clause 6, wherein the AFE is configured to receive the one or more clock signals from the MCU using a serial peripheral interface (SPI).
[0156] Clause 8: The analyte sensor system of any of Clauses 6-7, wherein, in order to determine the difference between the clock speed of the clock of the AFE and the clock speed of a clock of the MCU, the AFE is configured to: count a number of the one or more clock signals received from the MCU in a clock window; and determine a timing difference between the clock of the AFE and the clock of the MCU based on a difference between the number of the one or more clock signals received from the MCU during the clock window and a number of clock cycles associated with the clock of the AFE occurring during the clock window.
[0157] Clause 9: The analyte sensor system of Clause 8, wherein: the one or more measurements includes at least an impedance measurement associated with a first analyte; and the AFE is further configured to remove a timing error from the impedance measurement associated with the first analyte based on the determined timing difference, wherein the timing error is based on the clock of the AFE being less accurate than the clock of the MCU.
[0158] Clause 10: The analyte sensor system of any of Clauses 5-9, wherein the actual duration of the first measurement interval is based on the clock of the AFE. [0159] Clause 11 : The analyte sensor system of claim 10. wherein the clock of the AFE is less accurate than a clock of the MCU.
[0160] Clause 12: The analyte sensor system of Clause 11, wherein the AFE is configured to perform the one or more actions to maintain the time synchronization based on the clock of the AFE being less accurate than the clock of the MCU.
[0161] Clause 13: The analyte sensor system of any of Clauses 4-12, wherein: the AFE is configured to perform the one or more measurements according to a measurement sequence; and in order to perform the one or more actions to maintain the time synchronization, the AFE is configured to modify the measurement sequence for a second measurement interval based on the determined difference between the actual duration of the first measurement interval and the expected duration of the first measurement interval.
[0162] Clause 14: The analyte sensor system of Clause 13, wherein, in order to modify the measurement sequence for the second measurement interval, the AFE is further configured to at least one of: adjust a duration of at least one of the measurements of the one or more measurements to be performed during the second measurement interval; adjust gaps between different measurements of the one or more measurements to be performed during the second measurement interval; adjust a frequency of measurements of the one or more measurements to be performed during the second measurement interval; adjust which or how many measurements of the one or more measurements are to be performed during the second measurement interval; or adjust other parameters to adjust a total duration of the one or more measurements to be performed during the second measurement interval.
[0163] Clause 15: The analyte sensor system of any of Clauses 13-14. wherein: the AFE is further configured to perform the one or more measurements associated with the user during the second measurement interval according to the modified measurement sequence; and the MCU is further configured to: operate in the sleep mode during the second measurement interval; and exit the sleep mode and retrieve the one or more measurements for the second measurement interval.
[0164] Clause 16: The analyte sensor system of claim 15, wherein, based on the modified measurement sequence, the one or more measurements for the second measurement interval are completed when the MCU exits the sleep mode and retrieves the one or more measurements. [0165] Clause 17: The analyte sensor system of Clause 15, wherein: in order to perform the one or more actions to maintain the time synchronization, the AFE is further configured to send an interrupt signal to the MCU after completing the one or more measurements for the second measurement interval; and the MCU is configured to exit the sleep mode and retrieve the one or more measurements for the second measurement interval upon receiving the interrupt signal from the AFE.
[0166] Clause 18: The analyte sensor system of any of Clauses 1-17, wherein the one or more measurements comprise at least one of: a first measurement for a first analyte; a second measurement for a second analyte; an impedance measurement associated with the first analyte; an impedance measurement associated with the second analyte; an oxygen measurement; or a temperature measurement.
[0167] Clause 19: The analyte sensor system of any of Clauses 1-18, wherein the MCU is configured to autonomously exit the sleep mode.
[0168] Clause 20: The analyte sensor system of Clause 19, wherein, after autonomously exiting the sleep mode, the MCU is further configured to send a polling message to the AFE inquiring whether the one or more measurements for at least the first measurement interval have been completed.
[0169] Clause 21 : The analyte sensor system of Clause 20, wherein the MCU is configured to retrieve the one or more measurements for at least the first measurement interval based on the polling message.
[0170] Clause 22: The analyte sensor system of any of Clauses 20-21, wherein the AFE is further configured to send, to the MCU based on the polling message from the MCU, a polling response message indicating that the one or more measurements for at least the first measurement interval have not been completed.
[0171] Clause 23: The analyte sensor system of Clause 22, wherein the MCU is further configured to: re-enter the sleep mode in response to receiving the polling response message; autonomously exit the sleep mode after a period of time; transmit a second polling message inquiring whether the one or more measurements for at least the first measurement interval have been completed; and retrieve the one or more measurements for the first measurement interval based on the second polling message.
[0172] Clause 24: The analyte sensor system of any of Clauses 22-23, wherein the MCU is further configured to: transmit, after a period of time after receiving the polling response message, a second polling message inquiring whether the one or more measurements for at least the first measurement interval have been completed; and retrieve the one or more measurements for the first measurement interval based on the second polling message.
[0173] Clause 25: The analyte sensor system of any of Clauses 1-24, wherein the MCU is further configured to: determine an actual duration of the first measurement interval based on a time at which the AFE starts performing the one or more measurements and a time at which an interrupt signal is received from the AFE; and determine a different between the actual duration of the first measurement interval and an expected duration of the first measurement interval; and adjust a time at which the MCU is configured to exit the sleep mode and retrieve the one or more measurements for a second measurement interval based on the different between the actual duration of the first measurement interval and the expected duration of the first measurement interval.
[0174] Clause 26: A method for wireless communication by an analyte sensor system, comprising: performing, by an analog front end (AFE) of the analyte sensor system using a transcutaneous analyte sensor of the analyte sensor system, one or more measurements associated with a user during at least a first measurement interval; and performing, by the AFE, one or more actions to maintain time synchronization associated with a microcontroller unit (MCU) of the analyte sensor system retrieving the one or more measurements from the AFE; operating, by the MCU, in a sleep mode during the at least the first measurement interval; exiting the sleep mode and retrieving, by the MCU. the one or more measurements for the first measurement interval from the AFE based on the one or more actions; and transmitting, by the MCU, data associated with the one or more measurements to a display device for display to the user.
[0175] Clause 27: The method of Clause 26, wherein performing, by the AFE, the one or more actions to maintain the time synchronization comprises sending, by the AFE, an interrupt signal to the MCU after completing the one or more measurements for the first measurement interval.
[0176] Clause 28: The method of Clause 27, wherein exiting the sleep mode and retrieving the one or more measurements, by the MCU, comprises exiting the sleep mode and retrieving the one or more measurements upon receiving the interrupt signal from the AFE. [0177] Clause 29: The method of any of Clauses 26-28. further comprising determining, by the AFE after performing the one or more measurements for at least the first measurement interval, a difference between an actual duration of the first measurement interval and an expected duration of the first measurement interval
[0178] Clause 30: The method of Clause 29, wherein determining, by the AFE, the difference between the actual duration of the first measurement interval and the expected duration of the first measurement interval comprises determining, by the AFE, a difference between a clock speed of a clock of the AFE and a clock speed of a clock of the MCU.
[0179] Clause 31 : The method of Clause 30, further comprising receiving, by the AFE, one or more clock signals from the MCU associated with the clock of the MCU, wherein determining, by the AFE. the difference between the clock speed of a clock of the AFE and the clock speed of the clock of the MCU is based on the one or more clock signals received from the MCU.
[0180] Clause 32: The method of Clause 31, wherein receiving, by the AFE, the one or more clock signals from the MCU comprises receiving, by the AFE, the one or more clock signals from the MCU using a serial peripheral interface (SPI).
[0181] Clause 33: The method of any of Clauses 31-32, wherein determining, by the AFE, the difference between the clock speed of the clock of the AFE and the clock speed of a clock of the MCU comprises: counting, by the AFE, a number of the one or more clock signals received from the MCU in a clock window; and determining, by the AFE, a timing difference between the clock of the AFE and the clock of the MCU based on a difference between the number of the one or more clock signals received from the MCU during the clock window and a number of clock cycles associated with the clock of the AFE occurring during the clock window.
[0182] Clause 34: The method of Clause 33, wherein: the one or more measurements includes at least an impedance measurement associated with a first analyte; the method further comprises removing, by the AFE, a timing error from the impedance measurement associated with the first analyte based on the determined timing difference; and the timing error is based on the clock of the AFE being less accurate than the clock of the MCU.
[0183] Clause 35: The method of any of Clauses 30-34, wherein the actual duration of the first measurement interval is based on the clock of the AFE. [0184] Clause 36: The method of Clause 35, wherein the clock of the AFE is less accurate than a clock of the MCU.
[0185] Clause 37: The method of Clause 36, wherein performing, by the AFE, the one or more actions to maintain the time synchronization is based on the clock of the AFE being less accurate than the clock of the MCU.
[0186] Clause 38: The method of any of Clauses 29-37, wherein: performing, by the AFE, the one or more measurements comprises performing, by the AFE, the one or more measurements according to a measurement sequence; and performing the one or more actions to maintain the time synchronization comprises modifying, by the AFE, the measurement sequence for a second measurement interval based on the determined difference between the actual duration of the first measurement interval and the expected duration of the first measurement interval.
[0187] Clause 39: The method of Clause 38, wherein modifying, by the AFE, the measurement sequence for the second measurement interval comprises at least one of: adjusting, by the AFE, a duration of at least one of the measurements of the one or more measurements to be performed during the second measurement interval; adjusting, by the AFE, gaps between different measurements of the one or more measurements to be performed during the second measurement interval; adjusting, by the AFE, a frequency of measurements of the one or more measurements to be performed during the second measurement interval; adjusting, by the AFE, which or how many measurements of the one or more measurements are to be performed during the second measurement interval; or adjusting, by the AFE, other parameters to adjust a total duration of the one or more measurements to be performed during the second measurement interval.
[0188] Clause 40: The method of any of Clauses 38-39, further comprising: performing, by the AFE, the one or more measurements associated with the user during the second measurement interval according to the modified measurement sequence; and operating, by the MCU, in the sleep mode during the second measurement interval; and exiting the sleep mode and retrieving, by the MCU, the one or more measurements for the second measurement interval.
[0189] Clause 41: The method of Clause 40, wherein, based on the modified measurement sequence, the one or more measurements for the second measurement interval are completed when the MCU exits the sleep mode and retrieves the one or more measurements.
[0190] Clause 42: The method of any of Clauses 40-41. wherein: performing the one or more actions to maintain the time synchronization comprises sending, by the AFE, an intermpt signal to the MCU after completing the one or more measurements for the second measurement interval; and exiting the sleep mode and retrieving, by the MCU, the one or more measurements for the second measurement interval comprises exiting the sleep mode and retrieving, by the MCU, the one or more measurements for the second measurement interval upon receiving the interrupt signal from the AFE.
[0191] Clause 43: The method of any of Clauses 26-42, wherein the one or more measurements comprise at least one of: a first measurement for a first analyte; a second measurement for a second analyte; an impedance measurement associated with the first analyte; an impedance measurement associated with the second analyte; an oxygen measurement; or a temperature measurement.
[0192] Clause 44: The method of any of Clauses 26-43, wherein exiting the sleep mode, by the MCU, comprises autonomously exiting the sleep mode.
[0193] Clause 45: The method of Clause 44, further comprising, after autonomously exiting the sleep mode, sending, by the MCU, a polling message to the AFE inquiring whether the one or more measurements for at least the first measurement interval have been completed.
[0194] Clause 46: The method of Clause 45, wherein retrieving, by the MCU, the one or more measurements for at least the first measurement interval is based on the polling message.
[0195] Clause 47: The method of any of Clauses 45-46, further comprising sending, by the AFE to the MCU based on the polling message from the MCU, a polling response message indicating that the one or more measurements for at least the first measurement interval have not been completed.
[0196] Clause 48: The method of Clause 47, further comprising: re-entering, by the MCU, the sleep mode in response to receiving the polling response message; autonomously exiting, by the MCU. the sleep mode after a period of time; transmitting, by the MCU, a second polling message inquiring whether the one or more measurements for at least the first measurement interval have been completed; and retrieving, by the MCU, the one or more measurements for the first measurement interval based on the second polling message.
[0197] Clause 49: The method of any of Clauses 47-48, further comprising: transmitting, by the MCU after a period of time after receiving the polling response message, a second polling message inquiring whether the one or more measurements for at least the first measurement interval have been completed; and retrieving, by the MCU, the one or more measurements for the first measurement interval based on the second polling message.
[0198] Clause 50: The method of any of Clauses 26-49, further comprising: determining, by the MCU, an actual duration of the first measurement interval based on a time at which the AFE starts performing the one or more measurements and a time at which an interrupt signal is received from the AFE; and determining, by the MCU, a different between the actual duration of the first measurement interval and an expected duration of the first measurement interval; and adjusting, by the MCU, a time at which the MCU is configured to exit the sleep mode and retrieve the one or more measurements for a second measurement interval based on the different between the actual duration of the first measurement interval and the expected duration of the first measurement interval.
[0199] Clause 51: An analyte sensor system configured to perform a method in accordance with any of Clauses 26-50.
[0200] Clause 52: An analyte monitoring system, comprising: an analyte sensor system and a display device configured to perform a method in accordance with any of Clauses 26-50.
[0201] Clause 53: A processing system of an apparatus, comprising: one or more processors individually or collectively configured to execute instructions stored on one or more memories and to cause the apparatus to perform a method in accordance with any one of Clauses 26-50.
[0202] Clause 54: An apparatus, comprising means for performing a method in accordance with any one of Clauses 26-50.
[0203] Clause 55: 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 one of Clauses 26-50.
[0204] Clause 56: A computer program product embodied on a computer-readable storage medium comprising code for performing a method in accordance with any one of Clauses 26-50.
Additional Considerations
[0205] In this document, the terms "computer program medium7’ 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, 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.
[0206] 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 spint 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 distributed amongst 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.
[0207] 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.
[0208] 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 ty pe 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.
[0209] 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 functionality7 described or claimed as part of the module are all configured in a common package. 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.
[0210] 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 constmed 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.
[0211] 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.
[0212] It should be appreciated that all methods and processes disclosed herein may be 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. [0213] 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.

Claims

1. An analyte sensor system, comprising: a transcutaneous analyte sensor; an analog front end (AFE); and a micro controller unit (MCU), wherein: the AFE is configured to: perform, using the transcutaneous analyte sensor, one or more measurements associated with a user during at least a first measurement interval; and perform one or more actions to maintain time synchronization associated with the MCU retrieving the one or more measurements from the AFE; and the MCU is configured to: operate in a sleep mode during the at least the first measurement interval; exit the sleep mode and retrieve the one or more measurements for the first measurement interval from the AFE based on the one or more actions; and transmit data associated with the one or more measurements to a display device for display to the user.
2. The analyte sensor system of claim 1, wherein: in order to perform the one or more actions to maintain the time synchronization, the AFE is configured to send an interrupt signal to the MCU after completing the one or more measurements for the first measurement interval; and the MCU is configured to exit the sleep mode and retrieve the one or more measurements from the AFE upon receiving the interrupt signal from the AFE.
3. The analy te sensor system of claim 1, wherein the AFE is further configured to: receive one or more clock signals from the MCU associated with a clock of the
MCU; determine a difference between a clock speed of a clock of the AFE and a clock speed of a clock of the MCU based on the one or more clock signals received from the MCU; and after performing the one or more measurements for at least the first measurement interval, determine a difference between an actual duration of the first measurement interval and an expected duration of the first measurement interval based on the determined difference between the clock speed of the clock of the AFE and the clock speed of the clock of the MCU.
4. The analyte sensor system of claim 3, wherein, in order to determine the difference between the clock speed of the clock of the AFE and the clock speed of a clock of the MCU, the AFE is configured to: count a number of the one or more clock signals received from the MCU in a clock window; and determine a timing difference between the clock of the AFE and the clock of the MCU based on a difference between the number of the one or more clock signals received from the MCU during the clock window and a number of clock cycles associated with the clock of the AFE occurring during the clock window.
5. The analyte sensor system of claim 4, wherein: the one or more measurements includes at least an impedance measurement associated with a first analyte; and the AFE is further configured to remove a timing error from the impedance measurement associated with the first analyte based on the determined timing difference, wherein the timing error is based on the clock of the AFE being less accurate than the clock of the MCU.
6. The analyte sensor system of claim 3, wherein: the AFE is configured to perform the one or more measurements according to a measurement sequence; and in order to perform the one or more actions to maintain the time synchronization, the AFE is configured to modify the measurement sequence for a second measurement interval based on the determined difference between the actual duration of the first measurement interval and the expected duration of the first measurement interval.
7. The analyte sensor system of claim 6, wherein, in order to modify the measurement sequence for the second measurement interval, the AFE is further configured to at least one of: adjust a duration of at least one of the measurements of the one or more measurements to be performed during the second measurement interval; adjust gaps between different measurements of the one or more measurements to be performed during the second measurement interval; adjust a frequency of measurements of the one or more measurements to be performed during the second measurement interval; adjust which or how many measurements of the one or more measurements are to be performed during the second measurement interval; or adjust other parameters to adjust a total duration of the one or more measurements to be performed during the second measurement interval.
8. The analyte sensor system of claim 7, wherein: the AFE is further configured to perform the one or more measurements associated with the user during the second measurement interval according to the modified measurement sequence; and the MCU is further configured to: operate in the sleep mode during the second measurement interval; and exit the sleep mode and retrieve the one or more measurements for the second measurement interval.
9. The analyte sensor system of claim 8, wherein, based on the modified measurement sequence, the one or more measurements for the second measurement interval are completed when the MCU exits the sleep mode and retrieves the one or more measurements.
10. The analy te sensor sy stem of claim 8, wherein: in order to perform the one or more actions to maintain the time synchronization, the AFE is further configured to send an interrupt signal to the MCU after completing the one or more measurements for the second measurement interval; and the MCU is configured to exit the sleep mode and retrieve the one or more measurements for the second measurement interval upon receiving the interrupt signal from the AFE.
11. The analyte sensor system of claim 1, wherein the MCU is further configured to: autonomously exit the sleep mode; send, after autonomously exiting the sleep mode, a polling message to the AFE inquiring whether the one or more measurements for at least the first measurement interval have been completed; and retrieve the one or more measurements for at least the first measurement interval based on the polling message.
12. The analyte sensor system of claim 11, wherein: the AFE is further configured to send, to the MCU based on the polling message from the MCU, a polling response message indicating that the one or more measurements for at least the first measurement interval have not been completed; and the MCU is further configured to: re-enter the sleep mode in response to receiving the polling response message; autonomously exit the sleep mode after a period of time; transmit a second polling message inquiring whether the one or more measurements for at least the first measurement interval have been completed; and retrieve the one or more measurements for the first measurement interval based on the second polling message.
13. The analyte sensor system of claim 11, wherein: the AFE is further configured to send, to the MCU based on the polling message from the MCU, a polling response message indicating that the one or more measurements for at least the first measurement interval have not been completed; and the MCU is further configured to: transmit, after a period of time after receiving the polling response message, a second polling message inquiring whether the one or more measurements for at least the first measurement interval have been completed; and retrieve the one or more measurements for the first measurement interval based on the second polling message.
14. The analyte sensor system of claim 1, wherein the MCU is further configured to: determine an actual duration of the first measurement interval based on a time at which the AFE starts performing the one or more measurements and a time at which an interrupt signal is received from the AFE; determine a different between the actual duration of the first measurement interval and an expected duration of the first measurement interval; and adjust a time at which the MCU is configured to exit the sleep mode and retrieve the one or more measurements for a second measurement interval based on the different between the actual duration of the first measurement interval and the expected duration of the first measurement interv al.
15. A method for wireless communication by an analy te sensor system, comprising: performing, by an analog front end (AFE) of the analyte sensor system using a transcutaneous analyte sensor of the analyte sensor system, one or more measurements associated with a user during at least a first measurement interval; and performing, by the AFE, one or more actions to maintain time sy nchronization associated with a microcontroller unit (MCU) of the analyte sensor system retrieving the one or more measurements from the AFE; operating, by the MCU, in a sleep mode during the at least the first measurement interval; exiting the sleep mode and retrieving, by the MCU. the one or more measurements for the first measurement interval from the AFE based on the one or more actions; and transmitting, by the MCU, data associated with the one or more measurements to a display device for display to the user.
PCT/US2025/039475 2024-08-02 2025-07-28 Time synchronization techniques for analyte sensor system Pending WO2026030213A1 (en)

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