Continuous analyte monitoring system time-in-range notifications

Abstract

In certain embodiments, a method for providing notifications on a display device is provided. Measured analyte data are received, at a current time, from a continuous analyte monitoring (CAM) system worn by a user. In response to receiving the measured analyte data, a time-in-range (TIR) tally count is determined based on the current time and the measured analyte data, and a TIR tally goal is determined based on the current time and a TIR daily goal. A TIR tally notification is generated, and then presented to the user in a graphical user interface (GUI). The TIR tally notification includes the TIR tally count, the TIR tally goal, and a TIR tally goal progress bar. The measured analyte data are periodically received based on a measurement time period, and the TIR tally notification is periodically generated based on a TIR tally time period.

Description

Att’y Dkt: 0986-PCT01 PATENTCONTINUOUS ANALYTE MONITORING SYSTEM TIME-IN-RANGE NOTIFICATIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 725,919 (filed on November 27, 2024), the content of which is incorporated by reference herein in its entirety.INTRODUCTION

[0002] Many diseases or conditions are dependent upon maintaining analyte levels within an acceptable range. As one example, diabetes is a metabolic condition affecting hundreds of millions of people. For these people, monitoring blood glucose levels and regulating those levels to be within an acceptable range is important not only to mitigate long-term issues such as heart disease and vision loss, but also to avoid the effects of hyperglycemia and hypoglycemia. Maintaining blood glucose levels within an acceptable range can be challenging, as glucose levels are almost constantly changing over time and in response to everyday events, such as eating or exercising.

[0003] Advances in medical technologies have enabled development of various systems for monitoring analytes such as blood glucose, including continuous analyte monitoring (CAM) systems such as continuous glucose monitoring (CGM) systems, which measure and record glucose concentrations in substantially real-time. CAM systems are important tools for users of these systems to ensure that measured analyte values are within the acceptable range.SUMMARY

[0004] In certain embodiments, a system comprises a display device that includes a wireless transceiver configured to receive measured analyte data from a continuous analyte monitoring (CAM) system worn by a user, a display, a memory, and a processor coupled to the wireless transceiver, the display, and the memory. In response to receiving the measured analyte data at a first time (e.g., the current time), the processor is configured to determine a time-in-range (TIR) tally count based on the first time and the measured analyte data, and determine a TIR tally goal based on the first time and a TIR daily goal. The processor is further configured to generate a TIR tally notification, and then present the TIR tally notification to the user in a graphical user interfaceAtt’y Dkt: 0986-PCT01 PATENT(GUT) on the display. The TIR tally notification includes at least one of the TIR tally count, the TIR tally goal, and a TIR tally goal progress bar. The measured analyte data are periodically received based on a measurement time period, and the TIR tally notification is periodically generated based on a TIR tally time period.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] So that the manner in which the above-recited features of the present disclosure can be understood in detail, a more particular description, briefly summarized above, may be had by reference to aspects, some of which are illustrated in the drawings. It is to be noted, however, that the appended drawings illustrate only certain typical aspects of this disclosure and are therefore not to be considered limiting of its scope, for the description may admit to other equally effective aspects.

[0006] FIG. 1 illustrates aspects of an example health management system, in accordance with embodiments of the present disclosure.

[0007] FIGS. 2A, 2B, and 2C illustrate aspects of an example continuous analyte monitoring (CAM) system, in accordance with embodiments of the present disclosure.

[0008] FIG. 3 illustrates example inputs and metrics for use by the health management system of FIG. 1, in accordance with embodiments of the present disclosure.

[0009] FIG. 4 depicts a data flow diagram for providing TIR tally notifications on a display device, in accordance with certain embodiments of the present disclosure.

[0010] FIG. 5 depicts a flow diagram describing functionality for providing notifications on a display device, in accordance with certain embodiments of the present disclosure.

[0011] FIGS. 6A, 6B, 6C depict example TIR tally notifications, in accordance with certain embodiments of the present disclosure.

[0012] FIG. 7 depicts a block diagram of an example computer device, in accordance with embodiments of the present disclosure.

[0013] To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. It is contemplated that elements disclosed in one aspect may be beneficially utilized on other aspects without specific recitation.Att’y Dkt: 0986-PCT01 PATENTDETAILED DESCRIPTION

[0014] A CAM system periodically measures the user’s analyte concentration levels, generates measured analyte data, and periodically transmits the measured analyte data (e.g., measured analyte concentration levels) to a display device for presentation to the user in a graphical user interface (GUI). The GUI may present the most recently received measured analyte data in a graph format, along with lower and upper limits (or thresholds) for the normal (or target) range of analyte concentration level for the user, such as glucose concentration level.

[0015] During the day, the user may visually inspect the graph to get a feel for the number of measured analyte concentration levels that are “in-range,” i.e., the number of measured analyte concentration levels that are located in the region of the graph that is between the lower threshold and the upper threshold, as well as the number of measured analyte concentration levels that are “out-of-range,” i.e., the number of measured analyte concentration levels that are located below the lower threshold or above upper threshold.

[0016] A TIR for the day (or daily TIR) defines the percentage of time that a user’s measured analyte concentration levels fall between a lower in-range threshold and an upper in-range threshold over a TIR cycle, such as 24 hours. Similarly, a TIR goal for the day (or TIR daily goal) defines the percentage of time that a user’s measured analyte concentration levels should fall between a lower in-range threshold and an upper in-range threshold over the TIR cycle. Certain existing display devices determine a user’ s daily TIR, which indicates whether a user has met their TIR daily goal, after all of the measured analyte data have been received for the day. Unfortunately, these display devices do not allow the user to track their progress toward meeting their TIR daily goal in real-time during the day.

[0017] Some existing display devices may calculate a “current” TIR that is based on the measured analyte concentration levels that have been received from the beginning of the TIR cycle to the current time. Unfortunately, a current TIR, as provided by some existing display device, does not account for the effect of measured analyte data dropouts on the accuracy of the TIR calculation as fewer measured analyte data may produce artificially high or low TIR values, or provide a level of confidence that the user is actually on track to meet their TIR daily goal. This lack of real-time accountability reduces motivation, limits opportunities for positive behavior reinforcement, and reinforces sub-optimal behaviors throughout the day.Att’y Dkt: 0986-PCT01 PATENT

[0018] Embodiments of the present disclosure advantageously provide a display device that is configured to provide CAM system users with real-time feedback about how their analyte (e.g., glucose) is tracking toward their TIR daily goal in order to improve motivation, reinforce positive behaviors, and highlight sub-optimal behaviors throughout the day.

[0019] Rather than simply calculate and present a daily TIR or a current TIR to the user, in certain embodiments, the display device described herein determines a TIR tally count and a TIR tally goal every time new measured analyte data are received. The TIR tally count is an accumulation of the number of TIR tally points that are earned throughout the day. The TIR tally goal is the realtime equivalent of the TIR daily goal during the day. The TIR tally count and the TIR tally goal convert the prior TIR calculations into a real-time metric, and the TIR tally count builds up throughput the day to provide accurate, real-time progress tracking of the user’s TIR throughput the day. In other words, the TIR tally count and the TIR tally goal indicate how far the user is from meeting their TIR daily goal throughput the day.

[0020] In certain embodiments, the user earns TIR tally points throughout the day, such as one TIR tally point for every, e.g., 15 minutes that the measured analyte concentration levels falls inside the TIR range thresholds. However, the user does not earn a TIR tally point if the measured analyte concentration levels falls outside the TIR range thresholds. The TIR tally points are accumulated into the TIR tally count, which is presented to the user in TIR tally notifications throughout the day. Advantageously, the TIR tally count and the TIR tally goal account for dropouts (or gaps) in the measured analyte data, and, at the end of each TIR cycle, the TIR tally count equals the TIR for the day, and the TIR tally goal equals the TIR daily goal.

[0021] The display device may also determine a TIR tally status that is based on the TIR tally count and the TIR tally goal. The TIR tally status indicates whether the user has reached their TIR daily goal, whether the user is “on track” to meet their TIR daily goal, or whether the user is “offtrack” and will not meet their TIR daily goal.

[0022] The display device also generates a TIR tally notification for presentation to the user that includes the TIR tally count, the TIR tally goal, and a TIR tally goal progress bar. The TIR tally notification may also include the TIR tally status. The TIR tally goal progress bar incrementally fills up during the day by adding a segment or a “slice” for each TIR tally point that is earned or missed. Watching the TIR tally goal progress bar build during the day creates a motivation for theAtt’y Dkt: 0986-PCT01 PATENT user to earn TTR tally points to receive new “in-range” progress bar segments towards maximizing their TIR, to celebrate reaching the TIR daily goal while letting the user continue to optimize their day, and to allow the user to view missed opportunities to increase their TIR without focusing on the negative, such as “out-of-range” progress bar segments from missed TIR tally points.

[0023] Embodiments of the present disclosure are broadly applicable to continuous analyte monitoring (CAM) systems that monitor analytes that are amenable to time in-range analysis, such as glucose, lactate, potassium, troponin, creatinine, ketone, etc.

[0024] FIG. 1 illustrates aspects of health management system 100, in accordance with embodiments of the present disclosure.

[0025] Generally, health management system 100 provides therapy management guidance (e.g., notifications, alerts, alarms, insights, therapy management support recommendations or guidance, etc.) to each user 102 based on measured analyte data acquired by CAM system 200 worn by each user 102.

[0026] In certain embodiments, health management system 100 includes, inter alia, user database 110, mobile computing devices (or display devices) 150 connected to network(s) 180, and CAM systems 200. Network(s) 180 may include one or more local area networks (LANs), wireless LANs (WLANs), low power wide area networks (LPWANs), wide area networks (WANs), cellular networks (such as 3G, 4G, LTE, 5G, 6G, etc ), the Internet, etc., employing various network topologies and protocols (hereinafter “network 180”). For example, network 180 may also include various combinations of wired and / or wireless physical layers, such as, for example, copper wire or coaxial cable networks, fiber optic networks, WiFi networks, Bluetooth mesh networks, CDMA, FDMA and TDMA cellular networks, etc.

[0027] User database 110 may be hosted by a network database server connected to network 180. User database 110 may store user profile 118 for each user 102 which may include, inter alia, demographic data 120, physiological data 122, disease data 124, medication data 126, application data 128 including inputs 130 (such as measured analyte data) and metrics 132, and output data 144 (such as a disease prediction).

[0028] CAM systems 200 are configured to operate continuously to monitor one or more analytes for users 102. Each CAM system 200 is worn by a user 102, and may be coupled to a displayAtt’y Dkt: 0986-PCT01 PATENT device 150 via wireless connection 170 to transfer measured analyte data (and other data) to display device 150. Wireless connection 170 may be a Bluetooth connection, a Bluetooth Low Energy (BLE) connection, an RFID or NFC connection, an IEEE 802.11 connection (Wi-Fi), etc. CAM system 200 is described in more detail with respect to FIGS. 2A, 2B, 2C.

[0029] The term “analyte” as used herein is a broad term used in its ordinary sense, including, without limitation, to refer to a chemical substance, compound, molecule, element, etc., in a biological fluid (such as blood, interstitial fluid, cerebral spinal fluid, lymph fluid, urine, etc.) that may be identified or measured, and analyzed.

[0030] Analytes may include naturally occurring substances, artificial substances, pharmacologic agents, metabolites, ions, blood gasses, hormones, neurotransmitters, vitamins, minerals, peptides, pathogens, toxins, and / or reaction products. Analytes for measurement by the devices and methods of the present disclosure may include (but may not be limited to) glucose; lactate; potassium; troponin; creatinine; ketone; acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan); androstenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-P hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; creatinine phosphokinase (CPK); cyclosporin A; cystatin C; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1 -antitrypsin, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, hepatitis B virus, HCMV, HIV-1, HTLV-1, MCAD, RNA, PKU, Plasmodium vivax, 21 -deoxy cortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycines; free P-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; gal actose / gal-1 -phosphate; galactose- 1 -phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha- hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lead;Att’y Dkt: 0986-PCT01 PATENT lipoproteins ((a), B / A-l, P); lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin; phytanic / pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sisomicin; somatomedin C; specific antibodies recognizing any one or more of the following that may include (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; 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 may also constitute analytes in certain implementations. Ions are a charged atoms or compounds that may include the following (sodium, potassium, calcium, chloride, nitrogen, or bicarbonate, for example). The analyte may be naturally present in the biological fluid, for example, a metabolic product, a hormone, an antigen, an antibody, an ion etc. Alternatively, the analyte may be introduced into the body or exogenous, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, a challenge agent analyte (such as introduced for the purpose of measuring the increase and or decrease in rate of change in concentration of the challenge agent analyte or other analytes in response to the introduced challenge agent analyte), or a drug or pharmaceutical composition, including but not limited to exogenous insulin; glucagon, 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, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin);Att’y Dkt: 0986-PCT01 PATENT 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 may also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3 -methoxy tyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC), Homovanillic acid (HVA), 5 -Hydroxy tryptamine (5HT), and 5-Hydroxyindoleacetic acid (FHIAA), and intermediaries in the Citric Acid Cycle.

[0031] In certain embodiments, CAM system 200 is configured to continuously measure one or more analytes and transmit the measured analyte data to an electric medical records (EMR) system (not shown in FIG. 1). An EMR system includes one or more network computing devices that host a software platform that is configured to receive, store and manage medical data. An EMR system is generally used throughout hospitals and / or other caregiver facilities to document clinical information on patients over long periods. EMR systems organize and present data in ways that assist clinicians with, for example, interpreting health conditions and providing ongoing care, scheduling, billing, and follow up. Data contained in an EMR system may also be used to create reports for clinical care and / or disease management for a patient. In other embodiments, an EMR system may provide access to population-level health statistics, health economics, and the generation of clinical evidence or assessment of healthcare outcomes. In particular, as described herein, TME 114 may access the EMR system to obtain data associated with a user 102, such as measured analyte data, for disease prediction purposes. In some cases, TME 114 may provide the disease prediction to the EMR system.

[0032] CAM system 200 is configured to continuously measure one or more analyte concentration levels, and then transmit measured analyte data to display device 150 over wireless connection 170. In certain embodiments, a single-analyte sensor may be configured to generate an analog sensor signal that is proportional to the concentration level of a respective analyte, and a sensor electronics module may be configured to sample the analog sensor signal, generate measured analyte data, and transmit the measured analyte data to a display device 150. In certain embodiments, CAM system 200 periodically transmits the measured analyte data to display device 150 during the wear session. In other embodiments, CAM system 200 stores the measured analyteAtfy Dkt: 0986-PCT01 PATENT data in a memory, and transmits the measured analyte data to display device 150 at the conclusion of the wear session.

[0033] In certain embodiments, CAM system 200 may include multiple single-analyte sensors, and each single-analyte sensor generates an analog sensor signal that is proportional to the concentration level of a particular analyte. In other embodiments, CAM system 200 may include a multi-analyte sensor that generates multiple analog sensor signals, and each analog sensor signal is proportional to the concentration level of a particular analyte. In further embodiments, CAM system 200 may include multiple multi-analyte sensors, a combination of single-analyte sensors and multi-analyte sensors, etc.

[0034] Display devices 150 may be mobile computing devices that are wirelessly connected to network 180, using a WLAN, a cellular network, etc. In certain embodiments, display devices 150 may include a CAM data receiver, a smartphone, a tablet computer, a smartwatch, a laptop computer, etc. In some embodiments, display device 150 may transmit the measured analyte data to one or more other individuals having an interest in the health of the patient (such as a family member or physician for real-time treatment and care of the patient).

[0035] Generally, display device 150 is configured to receive and process measured analyte data from CAM system 200, and may store and execute one or more applications, such as a mobile health application, etc. In particular, display device 150 may store information about a user, including the user’s measured analyte data, in a user profile 118 that is associated with the user. These data may be stored by display device 150 as well as user database 110.

[0036] Generally, therapy management engine TME 114 may include one or more software modules, such as DAM 116, etc., for providing therapy management guidance (e.g., alerts, alarms, notification, insights, etc.) to each user based on information stored in the user’s user profile 118. In certain embodiments, the software modules (or relevant functionality) may be distributed across multiple devices, and a portion of TME 114 may be stored and executed by display device 150 and / or CAM system 200, while the remaining portion of TME 114 may be stored and executed by a network computing device. In some other embodiments, TME 114 may be stored and executed by display device 150 and / or CAM system 200. In yet some other embodiments, TME 114 may be stored and executed by a network computing device (e.g., server), in which case the output of TME 114 may be provided by display on display device 150, for example.Att’y Dkt: 0986-PCT01 PATENT

[0037] User profile 118 may include information collected about the user. For example, display device 150 may collect and store inputs 130, including the measured analyte data received from CAM system 200, in user profile 118. In certain embodiments, inputs 130 may include other data in addition to measured analyte data received from CAM system 200. For example, additional inputs 130 may be acquired through manual user input, one or more other non-analyte sensors or devices, various processes executing on display device 150, etc. Inputs 130 of user profile 118 are described in further detail below with respect to FIG. 3.

[0038] DAM 116 may be configured to generate metrics 132 based on inputs 130. Metrics 132, discussed in more detail below with respect to FIG. 3, are generally indicative of the health or state of a user, such as one or more of the user’s physiological state, trends associated with the health or state of a user, analyte features, etc. In certain embodiments, TME 114 may provide therapy management guidance to a user based on metrics 132 and / or inputs 130. As shown, metrics 132 are also stored in user profile 118.

[0039] User profile 118 also includes demographic data 120, disease data 124, and / or medication data 126 (such as type of medication, brand of medication, dosage, frequency of administration). In certain embodiments, such information may be provided through user input or obtained from certain data sources (such as electronic medical records, EMR systems, etc.). In certain embodiments, demographic data 120 may include one or more of the user’s age, body mass index (BMI), ethnicity, gender, etc. In certain embodiments, disease data 124 may include information about a condition of a user, such as whether the user has been previously diagnosed with or experienced various diseases, such as diabetes, liver disease, kidney disease, heart disease, hyperglycemia, hypoglycemia, co-morbidities, etc. In certain embodiments, information about a user’s condition may also include the length of time since diagnosis, the level of control, level of compliance with condition management therapy, other types of diagnosis (such as heart disease, obesity) or measures of health (such as heart rate, exercise, stress, sleep, etc.), and / or the like.

[0040] In certain embodiments, medication data 126 may include information about the amount, frequency, and type of a medication taken by a user. In certain embodiments, the amount, frequency, and type of a medication taken by a user is time-stamped and correlated with the user’s analyte levels, thereby, indicating the impact the amount, frequency, and type of the medication had on the user’s analyte levels.Att’y Dkt: 0986-PCT01 PATENT

[0041] In certain embodiments, user profile 1 18 may be dynamic because at least part of the information that is stored in user profile 118 may be revised over time and / or new information may be added to user profile 118 by TME 114, display device 150, etc. Accordingly, information in user profile 118 stored in user database 110 may provide an up-to-date repository of information related to a user.

[0042] User database 110 may be implemented as any type of data store, such as relational databases, non-relational databases, key-value data stores, file systems including hierarchical file systems, etc. In some embodiments, user database 110 may be distributed. For example, user database 110 may comprise persistent storage devices, which are distributed. Furthermore, user database 110 may be replicated so that the storage devices are geographically dispersed.

[0043] FIG. 2A depicts a diagram of CAM system 200 and display devices 150, in accordance with embodiments of the present disclosure.

[0044] In certain embodiments, CAM system 200 includes, inter alia, continuous analyte sensor (CAS) 210, sensor electronic module (SEM) 220, and a power source, such as a battery. One or more non-analyte sensors (NAS) 230 or other devices may also be coupled to SEM 220.

[0045] Generally, CAS 210 may include one or more single-analyte sensors, one or more multi analyte sensors, a combination of single analyte sensors and multi-analyte sensors, etc. Each single-analyte sensor generates an analog sensor signal that is proportional to the concentration level of a particular analyte. Similarly, each multi-analyte sensor generates multiple analog sensor signals, and each analog signal is proportional to the concentration level of a particular analyte. As an illustrative example, CAS 210 may include a single-analyte sensor configured to measure glucose concentration levels, and one or more multi-analyte sensors configured to measure lactate concentration levels, potassium concentration levels, troponin concentration levels, creatinine concentration levels, etc. As another illustrative example, CAS 210 may include a multi-analyte sensor configured to measure glucose concentration levels, lactate concentration levels, potassium concentration levels, troponin concentration levels, creatinine concentration levels, etc.

[0046] Accordingly, CAS 210 is configured to generate at least one analog sensor signal that is proportional to the concentration level of particular analyte, and SEM 220 is configured to sample the analog sensor signal, generate measured analyte data, and transmit the measured analyte data to display device 150 via wireless connection 170. SEM 220 is configured to sample the analogAtt’y Dkt: 0986-PCT01 PATENT sensor 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 data to display device 150 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 data transmitted to display device 150 include at least one analyte concentration level measurement having an associated time tag, sequence number, etc.

[0047] CAS 210 may be a non-invasive device, a subcutaneous device, a transcutaneous device, a transdermal device, a dermal device, an intradermal device, a subdermal device, an intravascular device, etc. Tn certain embodiments, CAS 210 may be configured to continuously measure analyte concentration levels using one or more measurement techniques, such as enzymatic, immunometric, aptameric, amperometric, voltametric, potentiometric, impedimetric, conductimetric, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, iontophoretic, radiometric, immunochemical, optical, ion-selective, etc.

[0048] Display devices 150 may be mobile computing devices that are connected network 180. In certain embodiments, display devices 150 may include CAM data receiver 152, smartphone 154, tablet computer 156, smartwatch 158, laptop computer (not shown), etc. In some embodiments, display devices 150 may be non-mobile computing devices (such as a desktop computer, etc.) that are connected to network 180.

[0049] In certain embodiments, display devices 150 are configured for displaying data, including measured analyte data, which may be transmitted by SEM 220. Display devices 150 may include a touchscreen display for displaying data to a user and receiving inputs from the user. For example, the GUI may be presented to the user for such purposes. In some embodiments, display devices 150 may include other types of user interfaces such as a voice user interface instead of, or in addition to, a touchscreen display for communicating data to the user of display device 150 and receiving user inputs.

[0050] In some embodiments, one, some, or all of display devices 150 are configured to display or otherwise communicate the data as it is communicated from SEM 220 (such as in a data package that is transmitted to respective display devices 150), without any additional prospective processing required for calibration and real-time display of the data. In certain embodiments, theAtt’y Dkt: 0986-PCT01 PATENT display devices 150 may be configured for providing alerts / alarms / notifications based on the displayable data.

[0051] For example, CAM data receiver 152 may be a custom display device specially designed for displaying certain types of data associated with measured analyte data received from SEM 220. For another example, smartphone 154 may use a commercially available operating system (OS), and may be configured to display a graphical representation of the continuous measured analyte data (such as including current and historic data) using the GUI.

[0052] Because different display devices 150 provide different user interfaces, the content of the data packages (such as amount, format, and / or type of data to be displayed, alarms, etc.) may be customized (such as programmed differently by the manufacture and / or by an end user) for each particular display device 150. Accordingly, in certain embodiments, a number of different display devices 150 may be in direct wireless communication with a SEM 220 of a CAM system 200 worn by a user 102 during a wear session to enable a number of different types and / or levels of display and / or functionality associated with the displayable data. In certain embodiments, the type of alarms customized for each particular display device 150, the number of alarms customized for each particular display device 150, the timing of alarms customized for each particular display device 150, and / or the threshold levels configured for each of the alarms (such as for triggering) are based on output data 144.

[0053] Non-analyte sensors 230 may include a temperature sensor, an altimeter sensor, an accelerometer sensor, a respiration rate sensor, a sweat sensor, a heart rate sensor, an electrocardiogram (ECG) sensor, a blood pressure sensor, a respiratory sensor, an oxygenated hemoglobin sensor (spO2), etc. Other devices may be coupled to SEM 220, such as an insulin pump, a peritoneal dialysis machine, a hemodialysis machine, etc.

[0054] FIGS. 2B, 2C depict top and side views of CAM system 200, respectively, in accordance with embodiments of the present disclosure.

[0055] CAM system 200 includes housing 202 enclosing SEM 220, and adhesive pad 204 disposed on the bottom surface of housing 202. CAS 210 protrudes from the bottom surface of housing 202 and adhesive pad 204. CAM system 200 is configured to be worn on epidermis 104 of user 102 at a convenient location, such as the back of the upper arm, the abdomen, etc.Att’y Dkt: 0986-PCT01 PATENT

[0056] CAM system 200 may be battery powered, and, in certain embodiments, the battery may be replaced or recharged if necessary. SEM 220 is coupled to CAS 210, and includes electronic circuitry configured to acquire, process, store and transmit measured analyte data, as well as other information, to display devices 150 for presentation to user 102.

[0057] In certain embodiments, CAS 210 may be a single-analyte sensor that includes a percutaneous wire that has a proximal portion coupled to SEM 220 and a distal portion with several electrodes. A measurement (or working) electrode may be coated, covered, treated, embedded, etc., with one or more chemical molecules that react with a particular analyte, and a reference electrode may provide a reference electrical voltage. The measurement electrode may generate the analog sensor 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 SEM 220. After CAM system 200 has been applied to epidermis 104 of user 102, CAS 210 penetrates epidermis 104, and the distal portion extends into the dermis and / or subcutaneous tissue 106 under epidermis 104 (as depicted in FIG. 2B). Other configurations of CAS 210 may also be used, such as a multi-analyte sensor that includes multiple measurement electrodes, each generating an analog sensor signal that represents the concentration levels of a particular analyte.

[0058] In certain embodiments, CAS 210 may incorporate a thermocouple within, or alongside, the percutaneous wire to provide an analog temperature signal to SEM 220, which may be used to correct the analog sensor signal or the measured analyte data for temperature. In other embodiments, the thermocouple may be incorporated into SEM 220 above adhesive pad 204, or, alternatively, the thermocouple may contact epidermis 104 of user 102 through openings in adhesive pad 204.

[0059] In certain embodiments, SEM 220 includes, inter alia, processor (P) 222, memory (M) 224, transceiver or transmitter / receiver (T / R) 226, one or more antennae (A) 228 coupled to transceiver 226, analog signal processing circuitry, analog to-digital (A / D) signal processing circuitry, digital signal processing circuitry, a power source for CAS 210 (such as a potentiostat), etc.

[0060] Processor 222 may be a general-purpose or application-specific microprocessor, an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), etc., that executes instructions to perform control, computation, input / output, etc. functions for CAM systemAtt’y Dkt: 0986-PCT01 PATENT200. Processor 222 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. In certain embodiments, processor 222, memory 224, transmitter / receiver 226, the A / D signal processing circuitry, and the digital signal processing circuitry may be combined into a system-on-chip (SoC).

[0061] In operation, CAS 210 and adhesive pad 204 may be assembled to form an application assembly, where the application assembly is configured to be applied to the user’s epidermis 104 so that CAS 210 is subcutaneously inserted as depicted. In such scenarios, SEM 220 may be attached to the assembly after application to the user’s epidermis 104 via an attachment mechanism (not shown). Alternatively, SEM 220 may be incorporated as part of the application assembly, such that CAS 210, adhesive pad 204 and SEM 220 can all be applied at once to the user’s epidermis 104. In one or more embodiments, this application assembly is applied to the user’s epidermis 104 using a separate sensor applicator (not shown).

[0062] Unlike the fmgersticks required by certain conventional analyte measurement techniques, for example, user-initiated application of CAM system 200 with a sensor applicator is nearly painless and does not require the withdrawal of blood. Moreover, the automatic sensor applicator generally enables the user to embed CAS 210 subcutaneously into the user’s epidermis 104 without the assistance of a clinician or health care provider.

[0063] CAM system 200 may be removed by peeling adhesive pad 204 from the user’s epidermis 104. It is to be appreciated that CAM system 200 and its various components are illustrated as one example form factor, and CAM system 200 and its components may have different form factors without departing from the spirit or scope of the described techniques.

[0064] Generally, processor 222 is configured to sample the analog sensor signal using the A / D signal processing circuitry at regular intervals (such as the sampling period), generate measured analyte data from the sampled analog sensor signal, and generate sensor data packages that include, inter alia, the measured analyte data. Processor 222 may store the measured analyte data in memory 224, and generate the sensor data packages at regular intervals (such as the transmission period) for transmission by T / R 226 to display device 150. Processor 222 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.Att’y Dkt: 0986-PCT01 PATENT

[0065] With respect to the supplemental sensor information, the sensor identifier represents information that uniquely identifies CAS 210 from other sensors, such as other sensors of other analyte monitoring devices, other sensors implanted previously or subsequently in the user’s epidermis 104, and so on. By uniquely identifying CAS 210, the sensor identifier may also be used to identify other aspects about CAS 210, such as a manufacturing lot of CAS 210, packaging details of CAS 210, shipping details of CAS 210, and so on. In this way, various issues detected for sensors manufactured, packaged, and / or shipped in a similar manner as CAS 210 may be identified and used in different ways in order to calibrate the measured analyte data, to notify users of defective sensors, to notify manufacturing facilities of machining issues, and so forth.

[0066] The sensor status of the supplemental sensor information represents a state of CAS 210 at a given time, such as a state of the sensor at a same time one of the measured analyte data is produced. To this end, the sensor status may include an entry for each of the measured analyte data, such that there is a one-to-one relationship between the measured analyte data and statuses captured in the supplemental sensor information. For example, the sensor status may describe an operational state of CAS 210. In certain embodiments, processor 222 may identify one of a number of predetermined operational states for a given measurement. The identified operational state may be based on the communications from CAS 210 and / or characteristics of those communications.

[0067] In certain embodiments, a lookup table, stored in memory 224, may include the predetermined number of operational states and bases for selecting one state from another. For example, the predetermined states may include a “normal” operation state where the bases for selecting this state may include an analog sensor signal from CAS 210 that falls within thresholds indicative of normal operation, an analog temperature signal that is within a threshold of suitable temperatures to continue operation as expected, etc. The predetermined states may also include operational states that indicate that one or more characteristics of the analog sensor signal from CAS 210 are outside of normal activity and may result in potential errors in the measured analyte data, such as an analog sensor signal from CAS 210 that is outside a threshold of expected signal strength, an environmental temperature that is outside suitable temperatures to continue operation as expected, detecting that the user 102 has physically rolled onto CAM system 200, etc.Att’y Dkt: 0986-PCT01 PATENT

[0068] FIG. 3 illustrates inputs 130 and metrics 132 for use by health management system 100, in accordance with embodiments of the present disclosure. In particular, FIG. 3 provides a more detailed illustration of example inputs 130 and example metrics 132 introduced in FIG. 1.

[0069] FIG. 3 illustrates example inputs 130 on the left, the application 160 and the DAM 116 in the middle, and the metrics 132 on the right. In certain embodiments, each one of the metrics 132 may correspond to one or more values, e.g., discrete numerical values, ranges, or qualitative values (high / medium / low, stable / unstable, etc.). The application 160 obtains inputs 130 through one or more channels (e.g., manual user input, sensors, other applications executing on display device 150, an EMR system, etc.). As mentioned previously, in certain embodiments, the inputs 130 may be processed by the DAM 1 16 to output a plurality of metrics, such as the metrics 132. The inputs 130 and the metrics 132 may be used by the TME 114 to provide therapy management guidance or treatment, and other functionalities described herein.

[0070] Starting with the inputs 130, user statistics, such as one or more of age, height, weight, BMI, body composition (e.g., % body fat or % muscle from a computed tomography (CT) scan, a magnetic resonance imaging (MRI) scan, dual-energy X-ray absorptiometry (DEXA) scan, etc.), stature, build, or other information may also be provided as an input. In certain embodiments, the user statistics are provided through a user interface, by interfacing with an electronic source such as an electronic medical record, and / or from measurement devices. In certain embodiments, the measurement devices include one or more wireless devices, e.g., Bluetooth-enabled, weight scale and / or camera, which may, for example, communicate with the display device 150 to provide the user data.

[0071] The medication / treatment information may also be provided as an input. Medication information may include information about the type, dose, and / or timing of when one or more medications are to be taken by the user. As mentioned elsewhere herein, the medication information may include information about one or more medications prescribed to the user for treating one or more symptoms of cardiovascular disease (e.g., HF), kidney disease, diabetes, and / or other conditions. In certain embodiments, the medication information includes information about administration of insulin, dextrose, and / or glucose, and / or other drugs prescribed for treatment of acute hyper- and / or hypokalemia or other acute conditions. Treatment information may further include information regarding different lifestyle habits, surgical procedures, dialysis,Att’y Dkt: 0986-PCT01 PATENT and / or other invasive or non-invasive procedures recommended by the user’s physician. For example, the user’s physician may recommend a user increase / decrease their potassium intake, or exercise for a minimum of thirty minutes a day, to reduce hyper- and / or hypokalemic episodes, etc. The medication / treatment information may be provided through manual user input.

[0072] In certain embodiments, the analyte sensor data may also be provided as input, for example, through the CAM system 200. The analyte sensor data may include analyte data measured by at least an analyte sensor (or multi-analyte sensor). For example, the analyte sensor data may include glucose data measured by at least a glucose sensor (or multi-analyte sensor) in the CAM system 200. For users undergoing intensive insulin therapy, glucose data can be used as a predictor of how and when the user would be dosing insulin, and such data may then also be used as an input 130 to forecast other metrics. In certain embodiments, the analyte sensor data may include lactate data measured by at least a lactate sensor (or multi-analyte sensor) in the CAM system 200. The analyte sensor data may include other analyte data, such as potassium data, calcium data, creatinine data, BUN data, ammonia data, C-peptide data, or cystatin C-data, or any other analytes described herein and measured by a sensor (or multi-analyte sensor) in the CAM system 200.

[0073] The input may also be received from one or more non-analyte sensors, such as non-analyte sensors 230 described with respect to FIG. 2. Input from such non-analyte sensors 230 may include information related to heart rate, heart rate variability, electrocardiogram (ECG) data, respiration rate, oxygen saturation, blood pressure, blood volume, blood volume / user weight, accelerometer data, urine output, or a body temperature (e.g., to detect illness, physical activity, etc.) of a user. In certain embodiments, electromagnetic sensors may also detect low-power radio frequency (RF) fields emitted from objects or tools touching or near the object, which may provide information about user activity or location.

[0074] The input received from non-analyte sensors 230 may include input relating to a user’s medication administration / delivery. In particular, input related to the user’s medication administration may be received, via a wireless connection on a smart pen, via user input, and / or from a medication pump or other device. Medication administration information may include one or more of medication volume, time of delivery, etc. Other parameters, such as medication action time or duration of medication action, may also be received as inputs.Att’y Dkt: 0986-PCT01 PATENT

[0075] The inputs 130 may also include food consumption information, including information about one or more of meals, snacks, and / or beverages, such as one or more of the size, content (carbohydrate, fat, protein, etc.), sequence of consumption, and time of consumption. The food consumption information may be provided by a user through manual entry, by providing a photograph through an application that is configured to recognize food types and quantities, and / or by scanning a bar code or menu. In various examples, meal size may be manually entered as one or more of calories, quantity (“three cookies”), menu items (“Royale with Cheese”), and / or food exchanges (1 fruit, 1 dairy). In some examples, meal information may be received via a convenient user interface provided by the application 160.

[0076] The food consumption information (the type of food (e.g., liquid or solid, snack or meal, etc.) and / or the composition of the food (e.g., carbohydrate, fat, protein, etc.)) may be determined automatically based on information provided by one or more sensors. Some example sensors may include body sound sensors (e.g., abdominal sounds may be used to detect the types of meal, e.g., liquid / solid food, snack / meal, etc ), radio-frequency sensors, cameras, hyperspectral cameras, and / or analyte (e.g., potassium, insulin, glucose, lactate, calcium, creatinine, etc.) sensors to determine the type and / or composition of the food.

[0077] Medical history and / or disease diagnoses (e.g., cardiovascular disease, kidney disease, diabetes, liver disease, hypertension, etc.) may be provided as an input. For example, the user may have an existing diagnosis of diabetes and this diagnosis may be provided through manual user input. In certain embodiments, disease diagnoses are also provided by interfacing with an electronic source such as an EMR.

[0078] Exercise / activity information may also be provided as an input. Exercise information may be any information surrounding activities requiring physical exertion by the user.

[0079] Date / time information may also be provided as an input. The date and / or time information may be processed by the DAM 116 independently of other inputs 130, or may be dependent upon (e.g., associated with) another input 130. Time information may include time of day or time from a real-time clock. For example, in certain embodiments, input analyte data may be timestamped to indicate a date and time when the analyte measurement was taken for the user.

[0080] User input of any of the above-mentioned inputs 130 may be provided through CAM system 200, non-analyte sensors 230, and / or a user interface, such a user interface of display deviceAtfy Dkt: 0986-PCT01 PATENT150 of FIG. 1 . As described above, in certain embodiments, the DAM 116 determines or computes the user’s metrics 132 based on inputs 130. An example list of metrics 132 is shown in FIG. 3.

[0081] In certain embodiments, analyte metrics (e.g., glucose metrics) may be calculated by the DAM 116 based on the inputs 130. Analyte metrics may include analyte levels, analyte baselines, maximum and minimum analyte levels, analyte rates of change, and / or analyte baseline rates of change.

[0082] In certain embodiments, analyte levels may be determined from sensor data (e.g., glucose measurements obtained from CAM system 200). For example, analyte levels refer to time-stamped analyte measurements or values that are continuously generated and stored over time.

[0083] In certain embodiments, an analyte baseline may be determined from sensor data (e.g., analyte measurements obtained from the CAM system 200). An analyte baseline represents a user’s normal analyte levels during periods where significant fluctuations in analyte levels are typically not expected. A user’s analyte baseline is generally expected to remain constant or within a narrow “normal range” over time, unless challenged through an action such as by the consumption of foods (e.g., diet), performance of exercise, or administration of a medicament (e.g., insulin). Generally, increasing fluctuation from the user’s analyte baseline may indicate a loss of analyte regulation (e.g., glycemic control), which may put the user at an increased risk.

[0084] In certain embodiments, an absolute maximum analyte level may be determined from sensor data (e.g., analyte measurements obtained from CAM system 200), health / sickness metrics (e.g., described in more detail below), and / or disease stage metrics (e.g., described in more detail below). The absolute maximum analyte level represents a user’s maximum analyte level determined to be safe over a period of time (e.g., hourly, weekly, daily, etc.). In certain embodiments, the absolute maximum analyte level may be consistent across all users (e.g., based on current medical guidelines). In certain other embodiments, each user may have a different absolute maximum analyte level. In certain embodiments, the absolute maximum analyte level per user may change over time. For example, a user may be initially assigned an absolute maximum analyte level based on clinical input. This assigned absolute maximum analyte level may be adjusted over time based on other sensor data, disease stages, comorbidities, etc. for the user.

[0085] For example, a user’s absolute maximum analyte level may vary over time as a user’s disease progresses and / or improves. In certain embodiments, a first absolute maximum analyteAtt’y Dkt: 0986-PCT01 PATENT level may be determined for periods of time where no external conditions exist that would affect the analyte level, and a second absolute maximum analyte level may be determined for periods of time where external conditions do exist that would affect the analyte level (e.g., during periods of time when the user is eating, exercising, taking medication that affects analyte levels, etc.).

[0086] In certain embodiments, an absolute minimum analyte level may be determined from sensor data (e.g., analyte measurements obtained from CAM system 200), medication / treatment metrics, and / or medical history / disease diagnosis metrics. The absolute minimum analyte level represents a user’s minimum analyte level determined to be safe over a period of time (e.g., hourly, weekly, daily, etc.). In certain embodiments, the absolute minimum analyte level may be consistent across all users (e g., set based on current medical guidelines). In certain other embodiments, each user may have a different absolute minimum analyte level. In certain embodiments, the absolute minimum analyte level per user may change over time. For example, a user may be initially assigned an absolute minimum analyte level based on clinical input. This assigned absolute minimum analyte level may be adjusted over time based on other sensor data, disease stages, comorbidities, etc. for the user.

[0087] For example, a user’s absolute minimum analyte level may vary over time as a user’s diseases progress and / or improves. In certain embodiments, a first absolute minimum analyte level may be determined for periods of time where no external conditions exist that would affect the analyte level, and a second absolute minimum analyte level may be determined for periods of time where external conditions do exist that would affect the analyte level (e.g., during periods of time when the user is eating, exercising, taking medication that affects analyte levels, etc.).

[0088] In certain embodiments, analyte level rates of change may be determined from sensor data (e.g., analyte measurements obtained from CAM system 200 over time). For example, an analyte level rate of change refers to a rate that indicates how one or more time-stamped analyte measurements or values change in relation to one or more other time-stamped analyte measurements or values. Analyte level rates of change may be determined over one or more seconds, minutes, hours, days, etc.

[0089] In certain embodiments, determined analyte level rates of change may be marked as “increasing rapidly” or “decreasing rapidly.” As used herein, “rapidly” may describe analyte level rates of change that are clinically significant and pointing towards a trend of the analyte level ofAtt’y Dkt: 0986-PCT01 PATENT the patient likely breaching the absolute maximum analyte level or the absolute minimum analyte level within a next period of defined time. In other words, a predictive trend (e.g., produced by the TME 114 using one or more trained models) may, in some cases, indicate that a user is likely to hit, for example, the absolute maximum analyte level within a specified time period (e.g., one or two hours) based on the determined analyte level rate of change. Accordingly, such an analyte level rate of change may be marked as “increasing rapidly.” Similarly, a predictive trend (e.g., produced by the TME 114 using one or more trained models) may, in some cases, indicate that a user is likely to hit the absolute minimum analyte level within a specified time period (e.g., one or two hours) based on the analyte level rate of change determined. Accordingly, such an analyte level rate of change may be marked as “decreasing rapidly.”

[0090] In certain embodiments, analyte baseline rates of change may be determined from analyte baselines determined for a user over time. For example, an analyte baseline rate of change refers to a rate that indicates how one or more time-stamped analyte baselines for a user change in relation to one or more other time-stamped analyte baselines for the same user. Analyte baseline rates of change may be determined over one or more seconds, minutes, hours, days, etc.

[0091] The user’s metrics 132 may further include metrics for other analytes. For example, in certain embodiments, metrics 132 may include lactate levels, lactate baselines, maximum and minimum lactate levels, lactate rates of change, lactate baseline rates of change, lactate clearance rates, lactate trends, calcium levels, calcium baselines, maximum and minimum calcium levels, calcium rates of change, calcium baseline rates of change, calcium clearance rates, calcium trends, ketone levels, ketone baselines, maximum and minimum ketone levels, ketone rates of change, ketone baseline rates of change, ketone clearance rates, ketone trends, creatinine levels, creatinine baselines, maximum and minimum creatinine levels, creatinine rates of change, creatinine baseline rates of change, creatinine clearance rates, creatinine trends, and / or levels, baselines, maximum and minimum levels, rates of change, baseline rates of change, clearance rates, and / or trends of one or more other analytes of the user.

[0092] As shown, DAM 116 further includes TIR tally module 310, which determines real time TIR metrics. For example, TIR tally module 310 may determine a TIR tally count and a TIR tally goal every time new measured analyte data are received. The TIR tally count and the TIR tally goal provide real time TIR metrics, and the TIR tally count builds up throughout the day to provideAtt’y Dkt: 0986-PCT01 PATENT accurate, real time progress tracking of the user’s TIR throughput the day. In other words, the TIR tally count and the TIR tally goal indicate how far the user is from meeting their TIR daily goal throughput the day.

[0093] As described above, the user earns TIR tally points throughout the day, such as one TIR tally point for every, e.g., 15 minutes that the measured analyte concentration levels falls inside TIR range thresholds. However, the user does not earn a TIR tally point if the measured analyte concentration levels falls outside the TIR range thresholds. The TIR tally points are accumulated into the TIR tally count, which is presented to the user in TIR tally notifications throughout the day. The TIR tally count and the TIR tally goal account for dropouts (or gaps) in the measured analyte data, and, at the end of each TIR cycle, the TIR tally count equals the TIR for the day, and the TIR tally goal equals the TIR daily goal.

[0094] TIR tally module 310 may also determine a TIR tally status that is based on the TIR tally count and the TIR tally goal. The TIR tally status is another TIR metric that indicates whether the user has reached their TIR daily goal, whether the user is “on track” to meet their TIR daily goal, or whether the user is “off-track” and will not meet their TIR daily goal. The TIR tally status may also be presented in the TIR tally notification.

[0095] TIR tally module 310 may also determine data for a TIR tally goal progress bar displayed in the TIR tally notification. The TIR tally goal progress bar is another TIR metric that has a number of segments that is equal to the maximum number of measured analyte concentration levels that may be received during each TIR cycle. In other words, each segment represents a measured analyte concentration level for a particular time period, such as 15 minutes. The TIR tally progress bar incrementally fills up during the day by adding an earned TIR segment for each TIR tally point that is earned, a missed TIR segment for each TIR tally point that is missed, and a no data / invalid TIR segment for each measured analyte concentration level that is invalid or not received (e.g., no data).

[0096] More particularly, TIR tally module 310 may receive input data (such as the current time, the measured analyte data for the particular time period, and the TIR daily goal), generate output data (such as the TIR tally count, the TIR tally goal, the TIR tally status, and the TIR tally goal progress bar data), and generate a TIR tally notification based on the output data. TIR tally module 310 may then present the TIR tally notification (e.g., TIR tally notification 450 shown in FIG. 4)Att’y Dkt: 0986-PCT01 PATENT on the display of the display device 150, such as the display 736 of the computing device 700 depicted in FIG. 7.

[0097] FIG. 4 depicts a data flow diagram 400 for providing TIR tally notifications 600 on a display device 150, in accordance with certain embodiments of the present disclosure. In the embodiments of FIG. 4, the TIR tally module 310 is executed by the processor of the display device 150 (such as processor 705 in FIG. 7)). However, as described above, the TIR tally module 310 (e.g., as part of TME 114) may be additionally or alternatively executed one or more other entities in the health management system 100 of FIG. 1. In such embodiments, the output (e.g., output data 430) of the TIR tally module 310 may be provided for display (such as the display 736 in FIG. 7) on the display device 150. In certain embodiments, TIR tally module 310 may also be executed separately and not as a part of TME 114.

[0098] As shown in FIG. 4, in certain embodiments, the processor of the display device 150 (such as processor 705) executes a TIR tally module 310 that receives input data 420, generates output data 430, and accesses TIR tally module data 440 stored in the memory of the display device 150 (such as memory 710). The TIR tally module data 440 includes TIR tally parameters and a TIR tally state.

[0099] The TIR tally parameters include a TIR daily goal, a TIR tally cycle start time, a TIR tally cycle time period, a TIR tally cycle end time, a TIR tally time period, and a measurement time period. The TIR daily goal defines the percentage of time that a user’s measured analyte concentration levels should fall between a lower in-range threshold and an upper in-range threshold over a TIR cycle. The TIR tally cycle start time defines the beginning of the TIR cycle. The TIR tally cycle time period defines the length of the TIR cycle, such as 24 hours, etc. The TIR tally cycle end time defines the end of the TIR cycle, and is equal to the TIR tally cycle start time plus the TIR tally cycle time period. The TIR tally time period defines the rate at which the TIR tally notification is generated. The measurement time period defines the rate at which the measured analyte data are received at the display device, such as 5 minutes, 15 minutes, etc.

[0100] To provide a more customized experience for the user, certain TIR tally module parameters may be adjustable by the user, such as the TIR daily goal and the TIR tally start time. Adjusting the TIR daily goal allows the user to decrease the daily TIR goal to increase positive feedback by attaining the TIR daily goal more often. Conversely, the user may increase the TIR daily goal toAtt’y Dkt: 0986-PCT01 PATENT encourage improved daily TTR performance. Adjusting the TIR tally start time allows the user to achieve their TIR daily goal earlier in the day (such as at 6 pm rather than midnight), and avoids the delay should the user go to sleep before achieving their TIR daily goal. In certain embodiments, other TIR tally module parameters may not be adjustable by the user, such as the measurement time period, the TIR tally time period and the TIR tally cycle time period. In such embodiments, the measurement time period is typically governed by the CAM system 200, which is not usually adjustable by the user. The TIR tally time period and the TIR tally cycle time period are also not amenable to customization by the user. However, in some other embodiments, measurement time period, the TIR tally time period and the TIR tally cycle time period may be adjustable by the user.

[0101] The TIR tally state includes data that generally characterize the progress of the user towards meeting their TIR daily goal. The TIR tally state includes the TIR tally count, the TIR tally goal, the TIR tally status, and data for the TIR tally goal progress bar. When new measured analyte data are received from the CAM system 200, the TIR tally module 310 updates the TIR tally state. Generally, the new measured analyte data are received at a current time, which may also be described as the display time of the new measured analyte data, or the record-time of the new measured analyte data.

[0102] The current time, the measured analyte data, and the TIR daily goal are provided as input data 420 to the TIR tally module 310. The TIR tally module 310 then determines the TIR tally count, the TIR tally goal, the TIR tally status, and TIR tally goal progress bar data, and provides these data as output data 430.

[0103] The TIR tally module 310 periodically generates a TIR tally notification 450 based on the output data 430, and then provides the TIR tally notification 450 for presentation to the user in the GUI. The TIR tally notification 450 may include the TIR tally count 460, the TIR tally goal 470, the TIR tally status 480, and the TIR tally goal progress bar 490.

[0104] In certain embodiments, each new measured analyte data may include a measured analyte concentration level (ACL), and the number of segments in the TIR tally goal progress bar 640 may be equal to the maximum number of ACLs that may be received during the TIR tally cycle time period. In other words, each segment may be associated with a particular measured ACL that is expected to arrive during the TIR tally cycle time period. For example, if the measurement time period is 5 minutes and the TIR tally cycle time period is 24 hours, the maximum number of ACLsAtt’y Dkt: 0986-PCT01 PATENT in the TTR tally cycle time period is 288, and the TIR tally goal progress bar 640 includes 288 segments.

[0105] As discussed above, the segment types for the TIR tally goal progress bar 490 may include earned TIR segments 492, missed TIR segments 494, and invalid / no data segments 496 (or an invalid segments). Each earned TIR segment 492 represents a TIR tally point that was earned, each missed TIR segment 494 represents a TIR tally point that was missed, and each invalid / no data segment 496 represents a measured analyte concentration level that was invalid or not received (e.g., no data). Each segment in the TIR tally goal progress bar 490 may be coded with a particular color, pattern, etc., that is associated with the segment type, such as green for earned TIR segments 492, dark grey for missed TIR segments 494, light grey for invalid / no data segments 496, etc.

[0106] In the example TIR tally notification 450 depicted in FIG. 4, the TIR tally count 460 is 57, the TIR tally goal 470 is 70, and the TIR tally status 48 is “On track.” The TIR tally goal progress bar 490 includes earned TIR segments 492, missed TIR segments 494, and invalid / no data segments 496.

[0107] At the start of the TIR tally cycle, the TIR tally goal progress bar 490 may include all of the segments as “invalid / no data” segments 496, and then change each segment to the appropriate type when the measured ACL associated with that segment is processed. Alternatively, the TIR tally goal progress bar 490 may not present any segments at all, and simply add segments when the measured ACLs are received and processed.

[0108] FIG. 5 depicts a flow diagram 500 describing functionality for providing a TIR tally notification (e.g., TIR tally notification 450) on a display device 150, in accordance with certain embodiments of the present disclosure. Flow diagram 500 is described with reference to TIR tally module 310 being executed by the processor of the display device 150 (such as processor 705). However, as described above, TIR tally module 310 (which may be part of TME 114 or a separate application) may be executed by one or more other components in the health management system 100 of FIG. 1.

[0109] At the beginning of a TIR tally cycle time period, the TIR tally module 310 may initialize certain data. In certain embodiments, the TIR tally module 310 may set a TIR tally cycle end time to a TIR tally cycle start time plus the TIR tally cycle time period. For example, the TIR tally cycleAtt’y Dkt: 0986-PCT01 PATENT time period may be set to 24 hours, and the TIR tally cycle start time may be set to 12 am (00:00:00), 6 am (06:00:00), noon (12:00:00), 6 pm or 18:00:00, or any other time.

[0110] The TIR tally module 310 may also set a maximum number of measured ACLs in the TIR tally cycle time period to the TIR tally cycle time period divided by the measurement time period. For example, for a TIR tally cycle time period of 24 hours and a measurement time period of 5 minutes, the maximum number of measured ACLs in the TIR tally cycle time period is 288.

[0111] The TIR tally module 310 may also set the number of measured ACLs from the TIR tally cycle start time to the current time to zero, the number of in-range ACLs from the TIR tally cycle start time to the current time to zero, and the number of invalid ACLs from the TIR tally cycle start time to the current time to zero.

[0112] At 510, measured analyte data from a CAM system 200 worn by a user are received over a wireless connection (such as wireless connection 170) at a current time. The wireless transceiver in the display device 150 is configured to receive the measured analyte data from the CAM system 200, and provide the measured analyte data as input data to the TIR tally module 310.

[0113] The measured analyte data may be periodically received based on the measurement time period (such as every 1 minute, 5 minutes, 10 minutes, 15 minutes, etc.). In some examples, the measurement time period may be between 5 minutes and 15 minutes. In some other examples, the measurement time period may be 5 minutes.

[0114] In response to receiving the measured analyte data, the TIR tally module 310 performs the functionality at 520, which includes the functionality at 522 and 524. The TIR tally module 310 may perform the functionality at 522 before, simultaneously with, or after the functionality at 524.

[0115] At 522, the TIR tally module 310 determines a TIR tally count based on the current time and the measured analyte data. In certain embodiments, the TIR tally module 310 may perform the following operations to determine the TIR tally count.

[0116] First, the appropriate ACL counter is incremented based on the measured ACL. For example, when the measured ACL is less than a minimum ACL or greater than a maximum ACL, one is added to the number of invalid ACLs. When the measured ACL is between the minimum ACL and the maximum ACL, one is added to the number of measured ACLs. A TIR tally point isAtt’y Dkt: 0986-PCT01 PATENT earned when the measured ACL is between a lower in-range threshold and an upper in-range threshold, and one is added to the number of in-range ACLs.

[0117] Then, a TIR tally divisor is set to the maximum number of measured ACLs (Nmax) minus the number of invalid ACLs (Ninvaiid), a TIR tally multiplier is set to 100 divided by the TIR tally divisor, and the TIR tally count (TIRtc) is set to the number of in-range ACLs (Nin-range) multiplied by the TIR tally multiplier, as given by Equation 1 :TIRtc = Nin -range * (100 / (N max—Ninvaiid)) Eq . 1

[0118] In certain embodiments, the minimum ACL is equal to 40, the maximum ACL is equal to 320, the lower in-range threshold is equal to 70, and the upper in-range threshold is between 140 and 180, such as 140, 160, 180, etc. Other minimum, maximum, and threshold values are also supported. In one example, the lower in-range threshold and the upper in-range threshold may depend upon the user’s demographic data 120, such as an age between 50 and 60, etc. Similarly, other examples, the lower in-range threshold and the upper in-range threshold may depend upon other data in user profde 118, such as physiological data 122, disease data 124, and / or medication data 126. In a further example, the lower in-range threshold and the upper in-range threshold may be provided as user-adjustable TIR tally parameters to provide a more customized experience for the user, as described above for the TIR daily goal.

[0119] At 524, a TIR tally goal is determined based on the current time and a TIR daily goal. In certain embodiments, the TIR tally module 310 may perform the following operations to determine the TIR tally goal.

[0120] A time from TIR start (tfrom start) is set to the current time (Current) minus the TIR tally cycle start time (ttc start) .

[0121] A time to TIR end (tto end) is set to the TIR tally cycle end time (ttc end) minus the current time (t current) .

[0122] A TIR goal sum is set to the time from TIR start (tfrom start) plus the time to TIR end (tto end).

[0123] A TIR tally goal quotient is set to the time from TIR start (tfrom start) divided by the TIR goal sum.Att’y Dkt: 0986-PCT01 PATENT

[0124] The TTR tally goal is set to the TIR daily goal (TIRdg) multiplied by the TTR tally goal quotient, as given by Equations 2, 3 and 4: tfrom start tcurrent ttc start Eq. 2 tto end ttc end tcurrent Eq. JTIRtg = TIRdg • ( tfrom start / (tfrom start + tto en d)) Eq. 4

[0125] As discussed above, the TIR daily goal is a time-in-range percent value for the TIR tally cycle time period. In certain embodiments, the TIR daily goal is between 50 and 100. For example, the TIR daily goal may be 70. In another example, the TIR daily goal may be 96. Other values are also supported.

[0126] At 526, the TIR tally status is determined. In certain embodiments, the TIR tally module 310 may perform the following operations to determine the TIR tally status.

[0127] When the TIR tally goal is equal to or greater than the TIR daily goal, the TIR tally status is set to a reached status. When the TIR tally goal is less than or equal to the TIR tally count, the TIR tally status is set to an on-track status. And, when the TTR tally goal is greater than the TIR tally count, the TIR tally status is set to an off-track status.

[0128] At 530, a TIR tally notification (e g., TIR tally notification 450) is generated by the TIR tally module 310.

[0129] In the example of FIG. 4, the TIR tally notification 450 includes the TIR tally count 460, the TIR tally goal 470, and the TIR tally goal progress bar 490. The TIR tally notification 450 typically includes the TIR tally status 480 as well.

[0130] The TIR tally goal progress bar 490 includes earned TIR segments 492, missed TIR segments 494, and invalid / no data segments 496, as depicted in FIGS. 4, 6A, 6B, 6C. The invalid / no data segments 496 are associated with the number of invalid ACLs, the earned TIR segments 492 are associated with the number of in-range ACLs, and the missed TIR segments 494 are associated with a number of missed ACLs.

[0131] In certain embodiments, the TIR tally module 310 may perform the following operations to determine the number of missed ACLs.Atfy Dkt: 0986-PCT01 PATENT

[0132] The number of missed ACLs (Nmissed) may be determined by subtracting a sum of the number of invalid ACLs (Ninvaiid) and the number of in-range ACLs (Nin-range) from the maximum number of measured ACLs (Nmax), as given by Equation 5:Nmissed—Nmax—(Ninvaiid + Nin-range) Eq. 5

[0133] In certain embodiments, the TIR tally goal progress bar includes invalid / no data segments extending from the current time to the TIR tally cycle end time.

[0134] The TIR tally notification (e.g., TIR tally notification 450) may be periodically generated based on the TIR tally time period (such as every 5 minutes, 10 minutes, 15 minutes, etc.). In one example, the TIR tally time period may be between the measurement time period and 60 minutes. In another example, the TIR tally time period may be 15 minutes. In a further example, the TIR tally time period may be the same as the measurement time period.

[0135] At 540, the TIR tally notification 450 (e.g., TIR tally notification 450) is provided to the display of the display device 150 for presentation to the user in the GUI.

[0136] In certain embodiments, after the TIR tally status is set to the reached status, the color of the earned TIR segments 492, the missed TIR segments 494, and the invalid / no data segments 496 may be changed to a different color (such as blue, etc.).

[0137] In certain embodiments, other data may be added to the TIR tally goal progress bar 490, such as events, spikes, etc.

[0138] FIGS. 6A, 6B, 6C depict example TIR tally notifications 600a-c, in accordance with certain embodiments of the present disclosure.

[0139] FIG 6A depicts an example TIR tally notification 600a (i.e., TIR tally notification 450 in which the TIR tally count 460 is 57, the TIR tally goal 470 is 70, and the TIR tally status 480 is “On track.” The TIR tally goal progress bar 490 includes earned TIR segments 492, missed TIR segments 494, and invalid / no data segments 496.

[0140] FIG 6B depicts an example, TIR tally notification 600b in which the TIR tally count 460 is 70, the TIR tally goal 470 is 70, and the TIR tally status 480 is “Reached.” The TIR tally goal progress bar 490 includes earned TIR segments 492, missed TIR segments 494, and invalid / no data segments 496.Att’y Dkt: 0986-PCT01 PATENT

[0141] FIG 6C depicts an example, TIR tally notification 600c in which the TTR tally count 460 is 40, the TIR tally goal 470 is 70, and the TIR tally status 480 is “Off track.” The TIR tally goal progress bar 490 includes earned TIR segments 492, missed TIR segments 494, and invalid / no data segments 496.

[0142] FIG. 7 depicts a block diagram of computing device 700, in accordance with embodiments of the present disclosure.

[0143] In certain embodiments, computing device 700 may be configured as display device 150. In these embodiments, computing device 700 may be coupled to network 180 via a wireless connection. Certain display devices 150, such as laptop computers, may include one or more VO devices 735, such as a keyboard, a mouse, display 736, touch screen 737, etc. Other display devices 150, such as handheld health monitors, smartphones, smartwatches, tablet computers, etc., may include touch screen 737, which is a combination of an I / O device and a display. Other display devices 150, such as wearable health monitors, etc., may include one or more VO devices 735 (such as buttons, a touchpad, etc.), and display 736 or touch screen 737. Generally, display devices 150 may be battery powered, and the battery may be periodically recharged or replaced as needed.

[0144] Computing device 700 includes interconnect (or bus) 730 coupled to one or more processors 705, storage element or memory 710, one or more network interfaces 725, and one or more I / O interfaces 720, which may include a display interface (such as HDMI, etc.), a keyboard interface (such as USB, etc.), a local wireless communications interface (such as a wireless transceiver for Bluetooth, BLE, RFID, NFC, etc ), a touch screen interface, etc. In certain embodiments, processor 705 may be a central processing unit (CPU), and computing device 700 may include one or more specialized processors, such as a graphics processing unit (GPU), a neural processing unit (NPU), etc. Generally, network interfaces 725 are coupled to network 180 using a wired or wireless connection(s), and VO interfaces 720 are coupled to VO device(s) 735, such as display 736, etc., using wired or wireless connections.

[0145] Bus 730 is a communication system that transfers data between processor 705, memory 710, network interfaces 725, and I / O interfaces 720. In certain embodiments, bus 730 transfers data between these components and one or more specialized processors, such as GPLs, NPUs, etc.

[0146] Processor 705 includes one or more general-purpose or application-specific microprocessors with one or more processing cores that execute instructions to perform variousAtt’y Dkt: 0986-PCT01 PATENT functions for computing device 700, such as control, computation, input / output, etc. Processor 705 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. Additionally, processor 705 may execute software applications and software modules stored within memory 710, such as an operating system, TME 114, etc. For example, TME 114 may include rule-based models, machine learning models including LR models, ANNs, recurrent neural networks (RNNs), long short-term memory (LSTM) networks, convolutional neural networks (CNNs), etc., DAM 116, as well as other software modules.

[0147] Generally, memory 710 stores instructions for execution by processor 705 as well as data. Memory 710 may include a variety of non-transitory computer-readable medium that may be accessed by processor 705 as well as other components. In various embodiments, memory 710 may include volatile and nonvolatile medium, non-removable medium and / or removable medium. For example, memory 710 may include combinations of random access memory (RAM), dynamic RAM (DRAM), static RAM (SRAM), read only memory (ROM), flash memory, cache memory, and / or any other type of non-transitory computer-readable medium.

[0148] Memory 710 comprises various components for retrieving, presenting, modifying, and storing user profde 118 as well as other data 712. For example, memory 710 stores software applications and modules that provide functionality when executed by processor 705, such as TME 114, DAM 1 16, etc. The operating system provides operating system functionality for computing device 700. Data 712 may include data associated with the operating system, the software applications and modules, TME 114, DAM 116, etc.

[0149] Network interfaces 725 are configured to transmit data to and from network 180 using one or more wired and / or wireless connections. As discussed above, network 180 may include one or more LANs, WLANs, LPWANs, WANs, cellular networks (such as 3G, 4G, LTE, 5G, 6G, etc.), the Internet, etc., employing various network topologies and protocols. For example, network 180 may also include various combinations of wired and / or wireless physical layers, such as, for example, copper wire or coaxial cable networks, fiber optic networks, WiFi networks, Bluetooth mesh networks, CDMA, FDMA and TDMA cellular networks, etc.

[0150] I / O interfaces 720 are configured to transmit and / or receive data from I / O devices 735. I / O interfaces 720 enable connectivity between processor 705, memory 710 and I / O device(s) 735 byAtfy Dkt: 0986-PCT01 PATENT encoding data to be sent from processor 705 or memory 710 to I / O devices 735, and decoding data received from I / O devices 735 for processor 705 or memory 710. Generally, data may be sent over wired and / or wireless connections. For example, VO interfaces 720 may include one or more wired communications interfaces, such as USB, Ethernet, etc., and / or one or more wireless communications interfaces, coupled to one or more antennas, such as WiFi, Bluetooth, cellular, etc. Importantly, CAM system 200 may communicate with VO interfaces 720 via Bluetooth, BLE, RFID, NFC, etc.

[0151] Generally, I / O devices 735 provide data to and from computing device 700. As discussed above, VO devices 735 are operably connected to computing device 700 using a wired and / or wireless connection. I / O devices 735 may include a local processor coupled to a communication interface that is configured to communicate with computing device 700 using the wired and / or wireless connection. For example, VO devices 735 may include display 736, touch screen 737, a keyboard, a mouse, a touch pad, etc.

[0152] Generally, TME 114 may generate notifications based on metrics 132, which includes measured analyte data provided by the CAM system 200 worn by the user (such as measured glucose data). In certain embodiments, TME 114 may be stored on and executed by display device 150, which may also store at least a relevant portion of metrics 132. Accordingly, display device 150 may generate and present the notifications to the user. In other embodiments, TME 114 may be stored on and executed by a network computing device 142, which may generate the notifications based on metrics 132, and then transmit the notifications to display device 150 for presentation to the user. The notifications help the user determine why analyte level fluctuations may be contemporaneously occurring, such as how the user’s recent meals, activities, etc., may have impacted the user’s measured glucose concentration levels, etc.Example Embodiments

[0153] Implementation examples are described in the following numbered clauses.

[0154] Clause 1: A system comprises a display device, comprising a wireless transceiver configured to receive measured analyte data from a continuous analyte monitoring (CAM) system worn by a user; a display; a memory; and a processor, coupled to the wireless transceiver, the display, and the memory, the processor configured to: in response to receiving the measured analyte data at a first time: determine a time-in-range (TIR) tally count based on the first time andAtfy Dkt: 0986-PCT01 PATENT the measured analyte data, and determine a TIR tally goal based on the first time and a TIR daily goal; generate a TIR tally notification comprising at least one of the TIR tally count, the TIR tally goal, and a TIR tally goal progress bar; and present, on the display, the TIR tally notification to the user in a graphical user interface (GUI), wherein the measured analyte data are periodically received based on a measurement time period, and wherein the TIR tally notification is periodically generated based on a TIR tally time period.

[0155] Clause 2: The system of clause 1, wherein the first time is a current time; the measurement time period is between 5 minutes and 15 minutes; and the TIR tally time period is between the measurement time period and 60 minutes.

[0156] Clause 3: The system of clause 2, wherein the measurement time period is 5 minutes; and the TIR tally time period is 15 minutes.

[0157] Clause 4: The system of clause 1, wherein the measured analyte data comprise a measured analyte concentration level (ACL); and wherein to determine the TIR tally count is further based on at least one of a TIR tally cycle time period, a TIR tally cycle start time, a TIR tally cycle end time, a maximum number of measured ACLs in the TIR tally cycle time period, a number of measured ACLs from the TIR tally cycle start time to the first time, a number of in range ACLs from the TIR tally cycle start time to the first time, and a number of invalid ACLs from the TIR tally cycle start time to the first time.

[0158] Clause 5: The system of clause 4, wherein the TIR tally cycle time period is 24 hours; and the TIR tally cycle start time is 00:00:00, 06:00:00, 12:00:00, or 18:00:00.

[0159] Clause 6: The system of clause 4, further comprising at the TIR tally cycle start time: set the TIR tally cycle end time to the TIR tally cycle start time plus the TIR tally cycle time period; set the maximum number of measured ACLs in the TIR tally cycle time period to the TIR tally cycle time period divided by the measurement time period; set the number of measured ACLs from the TIR tally cycle start time to the first time to zero; set the number of in range ACLs from the TIR tally cycle start time to the first time to zero; and set the number of invalid ACLs from the TIR tally cycle start time to the first time to zero.

[0160] Clause 7: The system of clause 6, wherein to determine the TIR tally count further comprises when the measured ACL is less than a minimum ACL or greater than a maximum ACL,Att’y Dkt: 0986-PCT01 PATENT add one to the number of invalid ACLs; when the measured ACL is between the minimum ACL and the maximum ACL, add one to the number of measured ACLs; when the measured ACL is between a lower in-range threshold and an upper in-range threshold, add one to the number of in range ACLs; set a TIR tally divisor to the maximum number of measured ACLs minus the number of invalid ACLs; set a TIR tally multiplier to 100 divided by the TIR tally divisor; and set the TIR tally count to the number of in range ACLs multiplied by the TIR tally multiplier.

[0161] Clause 8: The system of clause 7, wherein the minimum ACL is equal to 40; the maximum ACL is equal to 320; the lower in-range threshold is equal to 70; and the upper in-range threshold is between 140 and 180.

[0162] Clause 9: The system of clause 7, wherein to determine the TIR tally goal comprises set a time from TIR start to the first time minus the TIR tally cycle start time, set a time to TIR end to the TIR tally cycle end time minus the first time, set a TIR goal sum to the time from TIR start plus the time to TIR end, set a TIR tally goal quotient to the time from TIR start divided by the TIR goal sum, and set the TIR tally goal to the TIR daily goal multiplied by the TIR tally goal quotient; and the TIR daily goal is a time-in-range percent value for the TIR tally cycle time period.

[0163] Clause 10: The system of clause 9, wherein the TIR daily goal is between 50 and 100.

[0164] Clause 11 : The system of clause 10, wherein the TIR daily goal is 70 or 96

[0165] Clause 12: The system of clause 9, wherein the processor of the display device is further configured to determine a TIR tally status, comprising: when the TIR tally goal is equal to or greater than the TIR daily goal, set the TIR tally status to a reached status; when the TIR tally goal is less than or equal to the TIR tally count, set the TIR tally status to an on-track status; and when the TIR tally goal is greater than the TIR tally count, set the TIR tally status to an off-track status.

[0166] Clause 13: The system of clause 12, wherein the TIR tally notification further comprises the TIR tally status; the TIR tally goal progress bar comprises earned TIR segments, missed TIR segments, and invalid / no data TIR segments; the invalid / no data TIR segments are associated with the number of invalid ACLs; the earned TIR segments are associated with the number of in range ACLs; the missed TIR segments are associated with a number of missed ACLs; and the number of missed ACLs is a difference between the measured ACLs and a sum of the number of invalid ACLs and the number of in-range ACLs.Att’y Dkt: 0986-PCT01 PATENT

[0167] Clause 14: The system of clause 13, wherein the TIR tally goal progress bar further comprises invalid / no data segments extending from the first time to the TIR tally cycle end time.

[0168] Clause 15: The system of clause 1, wherein the measured analyte data are measured glucose concentration levels.

[0169] Clause 16: A method for providing notifications on a display device comprises receiving, at a first time, measured analyte data from a continuous analyte monitoring (CAM) system worn by a user; in response to receiving the measured analyte data: determining a time-in-range (TIR) tally count based on the first time and the measured analyte data, and determining a TIR tally goal based on the first time and a TIR daily goal; generating a TIR tally notification comprising at least one of the TIR tally count, the TIR tally goal, and a TIR tally goal progress bar; and presenting the TIR tally notification to the user in a graphical user interface (GUI), wherein the measured analyte data are periodically received based on a measurement time period, and wherein the TIR tally notification is periodically generated based on a TIR tally time period.

[0170] Clause 17: The method of clause 16, wherein the first time is a current time; the measurement time period is between 5 minutes and 15 minutes; and the TIR tally time period is between the measurement time period and 60 minutes.

[0171] Clause 18: The method of clause 17, wherein the measurement time period is 5 minutes; and the TIR tally time period is 15 minutes.

[0172] Clause 19: The method of clause 16, wherein the measured analyte data comprise a measured analyte concentration level (ACL); and determining the TIR tally count is further based on at least one of: a TIR tally cycle time period, a TIR tally cycle start time, a TIR tally cycle end time, a maximum number of measured ACLs in the TIR tally cycle time period, a number of measured ACLs from the TIR tally cycle start time to the first time, a number of in range ACLs from the TIR tally cycle start time to the first time, and a number of invalid ACLs from the TIR tally cycle start time to the first time.

[0173] Clause 20: The method of clause 19, wherein the TIR tally cycle time period is 24 hours; and the TIR tally cycle start time is 00:00:00, 06:00:00, 12:00:00, or 18:00:00.

[0174] Clause 21 : The method of clause 19, further comprising at the TIR tally cycle start time: setting the TIR tally cycle end time to the TIR tally cycle start time plus the TIR tally cycle timeAtt’y Dkt: 0986-PCT01 PATENT period; setting the maximum number of measured ACLs in the TIR tally cycle time period to the TIR tally cycle time period divided by the measurement time period; setting the number of measured ACLs from the TIR tally cycle start time to the first time to zero; setting the number of in range ACLs from the TIR tally cycle start time to the first time to zero; and setting the number of invalid ACLs from the TIR tally cycle start time to the first time to zero.

[0175] Clause 22: The method of clause 21, wherein determining the TIR tally count further comprises when the measured ACL is less than a minimum ACL or greater than a maximum ACL, adding one to the number of invalid ACLs; when the measured ACL is between the minimum ACL and the maximum ACL, adding one to the number of measured ACLs; when the measured ACL is between a lower in-range threshold and an upper in-range threshold, adding one to the number of in range ACLs; setting a TIR tally divisor to the maximum number of measured ACLs minus the number of invalid ACLs; setting a TIR tally multiplier to 100 divided by the TIR tally divisor; and setting the TIR tally count to the number of in range ACLs multiplied by the TIR tally multiplier.

[0176] Clause 23: The method of clause 22, wherein the minimum ACL is equal to 40; the maximum ACL is equal to 320; the lower in-range threshold is equal to 70; and the upper in-range threshold is between 140 and 180.

[0177] Clause 24: The method of clause 22, wherein determining the TIR tally goal comprises setting a time from TIR start to the first time minus the TIR tally cycle start time, setting a time to TIR end to the TIR tally cycle end time minus the first time, setting a TIR goal sum to the time from TIR start plus the time to TIR end, setting a TIR tally goal quotient to the time from TIR start divided by the TIR goal sum, and setting the TIR tally goal to the TIR daily goal multiplied by the TIR tally goal quotient; and wherein the TIR daily goal is a time-in-range percent value for the TIR tally cycle time period.

[0178] Clause 25: The method of clause 24, wherein the TIR daily goal is between 50 and 100.

[0179] Clause 26: The method of clause 25, wherein the TIR daily goal is 70 or 96.

[0180] Clause 27: The method of clause 24, further comprising determining a TIR tally status, comprising when the TIR tally goal is equal to or greater than the TIR daily goal, setting the TIR tally status to a reached status; when the TIR tally goal is less than or equal to the TIR tally count,Atfy Dkt: 0986-PCT01 PATENT setting the TIR tally status to an on-track status; and when the TIR tally goal is greater than the TIR tally count, setting the TIR tally status to an off-track status.

[0181] Clause 28: The method of clause 27, wherein the TIR tally notification further comprises the TIR tally status; the TIR tally goal progress bar comprises earned TIR segments, missed TIR segments, and invalid / no data TIR segments; the invalid / no data TIR segments are associated with the number of invalid ACLs; the earned TIR segments are associated with the number of in range ACLs; the missed TIR segments are associated with a number of missed ACLs; and the number of missed ACLs is a difference between the measured ACLs and a sum of the number of invalid ACLs and the number of in-range ACLs.

[0182] Clause 29: The method of clause 28, wherein the TIR tally goal progress bar further comprises invalid / no data segments extending from the first time to the TIR tally cycle end time.

[0183] Clause 30: The method of clause 16, wherein the measured analyte data are measured glucose concentration levels.Additional Considerations

[0184] In this document, the terms “computer program medium” and “computer usable medium” and “computer readable medium”, as well as variations thereof, are used to generally refer to transitory or non-transitory media. These and other various forms of computer program media or computer usable / readable media may be involved in carrying one or more sequences of one or more instructions to a processing device for execution. Such instructions embodied on the medium, may generally be referred to as “computer program code” or a “computer program product” or “instructions” (which may be grouped in the form of computer programs or other groupings). When executed, such instructions may enable a computing module, such as the SS 8, 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.

[0185] Various embodiments have been described with reference to specific example features thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the various embodiments as set forth in theAtt’y Dkt: 0986-PCT01 PATENT 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.

[0186] 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.

[0187] Terms and phrases used in the present application, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide illustrative instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; the term “set” should be read to include one or more objects of the type included in the set; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Similarly, the plural may in some cases be recognized as applicable to the singular and vice versa. Likewise, where this document refers to technologiesAtfy Dkt: 0986-PCT01 PATENT 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.

[0188] The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. The use of the term “module” does not imply that the components or functionality described or claimed as part of the module are all configured in a 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.

[0189] Additionally, the various embodiments set forth herein are described in terms of example block diagrams, flow charts, and other illustrations. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives may be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration. Moreover, the operations and sub-operations of various methods described herein are not necessarily limited to the order described or shown in the figures, and one of skill in the art will appreciate, upon studying the present disclosure, variations of the order of the operations described herein that are within the spirit and scope of the disclosure.

[0190] 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. TheAtt’y Dkt: 0986-PCT01 PATENT 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.

[0191] 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.

[0192] 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

Atfy Dkt: 0986-PCT01 PATENTWHAT TS CLAIMED IS:

1. A system, comprising: a display device, comprising: a wireless transceiver configured to receive measured analyte data from a continuous analyte monitoring (CAM) system worn by a user; a display; a memory; and a processor, coupled to the wireless transceiver, the display, and the memory, the processor configured to: in response to receiving the measured analyte data at a first time: determine a time-in-range (TIR) tally count based on the first time and the measured analyte data, and determine a TIR tally goal based on the first time and a TIR daily goal; generate a TIR tally notification comprising at least one of the TIR tally count, the TIR tally goal, and a TIR tally goal progress bar; and present, on the display, the TIR tally notification to the user in a graphical user interface (GUI), wherein the measured analyte data are periodically received based on a measurement time period, and wherein the TIR tally notification is periodically generated based on a TIR tally time period.

2. The system of claim 1, wherein: the first time is a current time; the measurement time period is between 5 minutes and 15 minutes; and the TIR tally time period is between the measurement time period and 60 minutes.

3. The system of claim 2, wherein: the measurement time period is 5 minutes; andAtt’y Dkt: 0986-PCT01 PATENT the TIR tally time period is 15 minutes.

4. The system of claim 1, wherein: the measured analyte data comprise a measured analyte concentration level (ACL); and to determine the TIR tally count is further based on at least one of: a TIR tally cycle time period, a TIR tally cycle start time, a TIR tally cycle end time, a maximum number of measured ACLs in the TIR tally cycle time period, a number of measured ACLs from the TIR tally cycle start time to the first time, a number of in-range ACLs from the TIR tally cycle start time to the first time, and a number of invalid ACLs from the TIR tally cycle start time to the first time.

5. The system of claim 4, wherein: the TIR tally cycle time period is 24 hours; and the TIR tally cycle start time is 00:00:00, 06:00:00, 12:00:00, or 18:00:00.

6. The system of claim 4, further comprising: at the TIR tally cycle start time: set the TIR tally cycle end time to the TIR tally cycle start time plus the TIR tally cycle time period; set the maximum number of measured ACLs in the TIR tally cycle time period to the TIR tally cycle time period divided by the measurement time period; set the number of measured ACLs from the TIR tally cycle start time to the first time to zero; set the number of in-range ACLs from the TIR tally cycle start time to the first time to zero; and set the number of invalid ACLs from the TIR tally cycle start time to the first time to zero.Att’y Dkt: 0986-PCT01 PATENT7. The system of claim 6, wherein to determine the TIR tally count further comprises: when the measured ACL is less than a minimum ACL or greater than a maximum ACL, add one to the number of invalid ACLs; when the measured ACL is between the minimum ACL and the maximum ACL, add one to the number of measured ACLs; when the measured ACL is between a lower in-range threshold and an upper in-range threshold, add one to the number of in-range ACLs; set a TIR tally divisor to the maximum number of measured ACLs minus the number of invalid ACLs; set a TIR tally multiplier to 100 divided by the TIR tally divisor; and set the TIR tally count to the number of in-range ACLs multiplied by the TIR tally multiplier.

8. The system of claim 7, wherein: the minimum ACL is equal to 40; the maximum ACL is equal to 320; the lower in-range threshold is equal to 70; and the upper in-range threshold is between 140 and 180.

9. A method for providing notifications on a display device, the method comprising: receiving, at a first time, measured analyte data from a continuous analyte monitoring (CAM) system worn by a user; in response to receiving the measured analyte data: determining a time-in-range (TIR) tally count based on the first time and the measured analyte data; and determining a TIR tally goal based on the first time and a TIR daily goal; generating a TIR tally notification comprising at least one of the TIR tally count, the TIR tally goal, and a TIR tally goal progress bar; and presenting the TIR tally notification to the user in a graphical user interface (GUI),Atfy Dkt: 0986-PCT01 PATENT wherein the measured analyte data are periodically received based on a measurement time period, and wherein the TIR tally notification is periodically generated based on a TIR tally time period.

10. The method of claim 9, wherein: the first time is a current time; the measurement time period is between 5 minutes and 15 minutes; and the TIR tally time period is between the measurement time period and 60 minutes.

11. The method of claim 10, wherein: the measurement time period is 5 minutes; and the TIR tally time period is 15 minutes.

12. The method of claim 9, wherein: the measured analyte data comprise a measured analyte concentration level (ACL); and determining the TIR tally count is further based on at least one of: a TIR tally cycle time period, a TIR tally cycle start time, a TIR tally cycle end time, a maximum number of measured ACLs in the TIR tally cycle time period, a number of measured ACLs from the TIR tally cycle start time to the first time, a number of in-range ACLs from the TIR tally cycle start time to the first time, and a number of invalid ACLs from the TIR tally cycle start time to the first time.

13. The method of claim 12, wherein: the TIR tally cycle time period is 24 hours; and the TIR tally cycle start time is 00:00:00, 06:00:00, 12:00:00, or 18:00:00.

14. The method of claim 12, further comprising: at the TIR tally cycle start time:Att’y Dkt: 0986-PCT01 PATENT setting the TIR tally cycle end time to the TIR tally cycle start time plus the TIR tally cycle time period; setting the maximum number of measured ACLs in the TIR tally cycle time period to the TIR tally cycle time period divided by the measurement time period; setting the number of measured ACLs from the TIR tally cycle start time to the first time to zero; setting the number of in-range ACLs from the TIR tally cycle start time to the first time to zero; and setting the number of invalid ACLs from the TIR tally cycle start time to the first time to zero.

15. The method of claim 14, wherein determining the TIR tally count further comprises: when the measured ACL is less than a minimum ACL or greater than a maximum ACL, adding one to the number of invalid ACLs; when the measured ACL is between the minimum ACL and the maximum ACL, adding one to the number of measured ACLs; when the measured ACL is between a lower in-range threshold and an upper in-range threshold, adding one to the number of in-range ACLs; setting a TIR tally divisor to the maximum number of measured ACLs minus the number of invalid ACLs; setting a TIR tally multiplier to 100 divided by the TIR tally divisor; and setting the TIR tally count to the number of in-range ACLs multiplied by the TIR tally multiplier.

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