Methods and systems for improved blood glucose level monitoring and control

Abstract

A method for identifying a deviation of a first biomarker measurement, comprising: receiving a first biomarker measurement from a subject at a first timepoint; comparing the received first biomarker measurement to a subject-determined baseline of first biomarker measurements; determining, based on the comparison, that the first biomarker measurement is a deviation from the subject-determined baseline of first biomarker measurements; and reporting the determined deviation of the first biomarker measurement.

Description

Philips Docket: 2024PF00460METHODS AND SYSTEMS FOR IMPROVED BLOOD GLUCOSE LEVEL MONITORING AND CONTROLField of the Disclosure

[0001] The present disclosure is directed generally to improved monitoring and control of blood glucose levels, and more specifically to methods and systems for detecting deviations in blood glucose level measurements.Background

[0002] Diabetes is a chronic medical condition characterized by elevated levels of glucose in the blood, resulting from the body’s inability to properly produce or use insulin. The prevalence of diabetes, particularly type 2 diabetes, has grown at an alarming rate globally, driven by factors such as sedentary lifestyles, poor dietary habits, and increasing obesity rates. According to recent estimates by the World Health Organization (WHO), over 422 million people worldwide are living with diabetes, with projections showing a continued upward trend. Diabetes is a significant public health concern as it poses a high risk for developing severe complications such as cardiovascular disease, kidney failure, nerve damage, and retinopathy, which may result in blindness. Without effective management, diabetes can lead to a diminished quality of life and premature death.

[0003] Managing diabetes, particularly type 2 diabetes, requires a comprehensive approach involving lifestyle modifications, glucose monitoring, and in many cases, pharmacological interventions. The core of diabetes management is to maintain blood glucose levels within a target range, as defined by healthcare professionals, to prevent both short-term complications like hypoglycemia and hyperglycemia, and long-term health risks. Effective management strategies may include regular blood glucose testing, dietary adjustments focusing on carbohydrate regulation, physical activity, and the administration of medications such as insulin or oral hypoglycemics. Even people without diabetes may have an interest in monitoring their glucose levels. Emerging technologies, such as continuous glucose monitors (CGMs) and insulin pumps, have enhanced the ability of individuals to monitor and control blood sugar levels with greater precision, allowing for personalized treatment regimens that respond dynamically to fluctuations in glucose levels throughout the day.Philips Docket: 2024PF00460

[0004] While measuring blood glucose levels is beneficial to retain control in a reactive manner, it does not directly help the user understand the cause of fluctuations when they occur. Such understanding could help to take not only corrective but also preventive actions to keep blood glucose levels within a desired range.

[0005] One way to enhance insights into blood glucose levels is to compare a blood glucose level measurement to a user-specific baseline that has been established on historical data, and to alert the user to blood glucose level deviations with regard to that baseline. Such deviations give insights and could indicate a need for corrective short-term or long-term actions, or could be confirming and rewarding, such as when due to beneficial diet or lifestyle changes. However, comparing to a fixed baseline is sensitive to just small time shifts. Thus, there remains a need for improved systems and methods that simplify the management of diabetes and optimize glucose control for better health outcomes.Summary of the Disclosure

[0006] Accordingly, there is a continued need for methods and systems for improved monitoring and control of biomarkers. Various embodiments and implementations herein are directed to a biomarker monitoring system configured for identifying a deviation of a biomarker measurement. The system receives a biomarker measurement from a subject at a first timepoint and compares that to a subject-determined baseline of biomarker measurements. The comparison determines that the biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements, and reports that determined deviation.

[0007] Generally, in one aspect, a method for identifying a deviation of a first biomarker measurement is provided. The method includes: (i) receiving a first biomarker measurement from a subject at a first timepoint; (ii) comparing the received first biomarker measurement to a subject- determined baseline of first biomarker measurements; (iii) determining, based on the comparison, that the first biomarker measurement is a deviation from the subject-determined baseline of first biomarker measurements; and (iv) reporting the determined deviation of the first biomarker measurement.Philips Docket: 2024PF00460

[0008] According to an embodiment, the method further comprises determining that the determined deviation of the first biomarker measurement from the subject-determined baseline of first biomarker measurements is a time-warp deviation.

[0009] According to an embodiment, the method further comprises generating the subject- determined baseline of biomarker measurements by: (i) obtaining, for a first period of time, a plurality of biomarker measurements; and (ii) determining, from the plurality of biomarker measurements, a subject-determined baseline of biomarker measurements.

[0010] According to an embodiment, the first biomarker is a blood glucose level (BGL), and the method further comprises adjusting, based on the reporting, a blood sugar control program. According to an embodiment, adjusting a blood sugar control program comprises adjusting one or more of dietary intake, fine-tuning an insulin or oral medication schedule, and adjusting an activity level.

[0011] According to an embodiment, the subject-determined baseline of first biomarker measurements comprises an upper biomarker measurement limit, a lower biomarker measurement limit, and a biomarker measurement average for a plurality of timepoints.

[0012] According to an embodiment, determining that the biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements comprises determining an amount of the deviation, and wherein reporting the determined deviation comprises reporting the determined amount of the deviation.

[0013] According to another aspect is a method for identifying a deviation of a blood glucose level (BGL) measurement, in accordance with an embodiment. The method includes: receiving a BGL measurement from a subject at a first timepoint; comparing the received BGL measurement to a subject-determined baseline of BGL measurement measurements; determining, based on the comparison, that the BGL measurement is a deviation from the subject-determined baseline of BGL measurements; and reporting the determined deviation of the BGL measurement.

[0014] According to an embodiment, the method further comprises determining that the determined deviation of the BGL measurement from the subject-determined baseline of BLG measurements is a time-warp deviation.Philips Docket: 2024PF00460

[0015] According to an embodiment, the method further comprises adjusting, based on the reporting, a blood sugar control program. According to an embodiment, adjusting a blood sugar control program comprises adjusting one or more of dietary intake, fine-tuning an insulin or oral medication schedule, and adjusting an activity level.

[0016] According to an embodiment, the subject-determined baseline of BGL measurements comprises an upper BGL measurement limit, a lower BGL measurement limit, and a BGL measurement average for a plurality of timepoints.

[0017] According to an embodiment, determining that the BGL measurement is a deviation from the subject-determined baseline of BGL measurements comprises determining an amount of the deviation, and wherein reporting the determined deviation comprises reporting the determined amount of the deviation.

[0018] According to another aspect is a system for identifying a deviation of a blood glucose level (BGL) measurement. The system includes: a biomarker monitor configured to obtain a biomarker measurement from a subject; a processor configured to: (i) receive a biomarker measurement from the biomarker monitor; (ii) compare the biomarker measurement to a subject- determined baseline of biomarker measurements; (iii) determine, based on the comparison, that the biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements; and a user interface configured to report one or more of the biomarker measurement and the determined deviation.

[0019] According to an embodiment, determining that the that the biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements comprises determining that the deviation is a time-warp deviation.

[0020] According to an embodiment, the processor is further configured to generate the subj ectdetermined baseline of biomarker measurements by: (i) obtaining, for a first period of time, a plurality of biomarker measurements; and (ii) determining, from the plurality of biomarker measurements, a subject-determined baseline of biomarker measurements.

[0021] According to an embodiment, the biomarker is a blood glucose level (BGL), and the method further comprises adjusting, based on the reporting, a blood sugar control program. According to an embodiment, adjusting a blood sugar control program comprises adjusting one orPhilips Docket: 2024PF00460 more of dietary intake, fine-tuning an insulin or oral medication schedule, and adjusting an activity level.

[0022] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.

[0023] These and other aspects of the various embodiments will be apparent from and elucidated with reference to the embodiment s) described hereinafter.Brief Description of the Drawings

[0024] In the drawings, like reference characters generally refer to the same parts throughout the different views. The figures showing features and ways of implementing various embodiments and are not to be construed as being limiting to other possible embodiments falling within the scope of the attached claims. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the various embodiments.

[0025] FIG. 1 is a flowchart of a method for biomarker monitoring, in accordance with an embodiment.

[0026] FIG. 2 is a schematic representation of a biomarker monitoring system, in accordance with an embodiment.

[0027] FIG. 3 is a flowchart of a method for biomarker monitoring, in accordance with an embodiment.

[0028] FIG. 4 is a graph of a subject-specific biomarker baseline, in accordance with an embodiment.Philips Docket: 2024PF00460

[0029] FIG. 5 is a graph of a subject-specific biomarker baseline with biomarker measurements, in accordance with an embodiment.

[0030] FIG. 6 is a graph of a subject-specific biomarker baseline with biomarker measurements, in accordance with an embodiment.

[0031] FIG. 7 is a graph of a subject-specific biomarker baseline with biomarker measurements, in accordance with an embodiment.

[0032] FIG. 8 is a graph of a subject-specific biomarker baseline with biomarker measurements, in accordance with an embodiment.

[0033] FIG. 9 is a graph of a subject-specific biomarker baseline with biomarker measurements, in accordance with an embodiment.Detailed Description of Embodiments

[0034] The present disclosure describes various embodiments of a system and method configured for identifying a deviation of a biomarker measurement. More generally, Applicant has recognized and appreciated that it would be beneficial to provide methods and systems for improved monitoring and control of biomarkers. Accordingly, a biomarker monitoring system receives a biomarker measurement from a subject at a first timepoint and compares that to a subject-determined baseline of biomarker measurements. The comparison determines that the biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements, and reports that determined deviation.

[0035] According to an embodiment, the systems and methods described or otherwise envisioned herein can, in some non-limiting embodiments, be implemented as a component of or an extension of a biomarker monitoring or control system, as an element of a commercial product for biomarker monitoring or control, or any suitable system. However, the disclosure is not limited to these devices or systems, and thus disclosure and embodiments disclosed herein can encompass any system that may utilize or benefit from the analysis described or otherwise envisioned herein.

[0036] Referring to FIG. 1, in one embodiment is a flowchart of a method 100 for identifying a deviation of a first biomarker measurement using a biomarker monitoring system. The methods described in connection with the figures are provided as examples only, and shall be understoodPhilips Docket: 2024PF00460 to not limit the scope of the disclosure. The biomarker monitoring system can be any of the systems described or otherwise envisioned herein. The biomarker monitoring system can be a single system or multiple different systems.

[0037] At step 110 of the method, a biomarker monitoring system 200 is provided. Referring to an embodiment of a biomarker monitoring system 200 as depicted in FIG. 2, for example, the system comprises one or more of a processor 220, memory 230, user interface 240, communications interface 250, and storage 260, interconnected via one or more system buses 212. It will be understood that FIG. 2 constitutes, in some respects, an abstraction and that the actual organization of the components of the system 200 may be different and more complex than illustrated. Additionally, biomarker monitoring system 200 can be any of the systems described or otherwise envisioned herein. Other elements and components of biomarker monitoring system 200 are disclosed and / or envisioned elsewhere herein.

[0038] According to an embodiment, the biomarker monitoring system 200 is in communication with and / or comprises one or more biomarker monitors 270, as described or otherwise envisioned herein. According to an embodiment, the one or more biomarker monitors can be any sensor, invasive or non-invasive, that measures a biomarker. Examples of measurable biomarkers include, but are not limited to, heart rate, heart rate variability, respiration rate, blood pressure, a subject’s activity level or motion / movement, metabolic biomarkers such as blood glucose levels, oxygenation level, cholesterol level, and triglyceride level, among many, many other possible biomarkers.

[0039] According to an embodiment, the biomarker monitoring system 200 is in communication with and / or comprises one or more blood glucose monitors 270. According to an embodiment, the one or more blood glucose monitors 270 can comprise a fingerstick glucose monitor (i.e., a traditional blood glucose meter), a continuous glucose monitor (CGM), a flash glucose monitor, an implantable glucose monitor, anon-invasive glucose monitor, and / or any other system or method for measuring blood glucose levels.

[0040] At step 120 of the method, the biomarker monitoring system 200 generates a subject- determined baseline of biomarker measurements, which will be utilized by the system to identify biomarker measurement deviations.Philips Docket: 2024PF00460

[0041] According to an embodiment, a biomarker monitoring measurement is any measurement of a subject’s biomarker monitoring, either an actual measurement or an estimate. According to an embodiment, a biomarker monitoring measurement is obtained using any of the methods or systems described or otherwise envisioned herein. Examples of measurable biomarkers include, but are not limited to, heart rate, heart rate variability, respiration rate, blood pressure, a subject’s activity level or motion / movement, metabolic biomarkers such as blood glucose levels, oxygenation level, cholesterol level, and triglyceride level, among many, many other possible biomarkers

[0042] To generate a baseline of biomarker measurements, the system obtains a plurality of biomarker measurements over a first time period. The number of measurements comprising the plurality can depend on a variety of factors, including but not limited to the subject, the desired baseline, the availability of measurements, and many other measurements. For example, the measurements can be obtained throughout the course of the first time period, at intervals. The intervals can be minutes or hours, and can be regular or irregular. The first time period can be any period including days, weeks, or months. The first time period can be any period of time required or sufficient to generate a suitable baseline, where a suitable baseline is a baseline that is capable of being utilized to identify deviations, as described or otherwise envisioned herein. Once obtained, the plurality of measurements may be utilized immediately, or may be stored in local or remote storage for use in further steps of the method.

[0043] To further generate a baseline of biomarker measurements, the system determines a subject-determined baseline of biomarker measurements. The baseline may be generated from the measurements by averaging or percentile filtering, or according to known methods for generating a baseline of subject measurements over time. Once generated, the baseline may be utilized immediately, or may be stored in local or remote storage for use in further steps of the method.

[0044] At step 130 of the method, the biomarker monitoring system receives a biomarker measurement from the subject, and importantly this subject is the same subject for which the baseline was generated. According to an embodiment, the received biomarker measurement is any measurement of a subject biomarker, either an actual measurement or an estimate. According to an embodiment, a biomarker measurement is obtained using any of the methods or systems described or otherwise envisioned herein. Once received, the biomarker measurement may bePhilips Docket: 2024PF00460 utilized immediately, or may be stored in local or remote storage for use in further steps of the method.

[0045] According to one embodiment, the biomarker monitoring system 200 receives a BGL measurement from the subject. According to an embodiment, the received BGL measurement is any measurement of a subject’s blood glucose level, either an actual measurement or an estimate. According to an embodiment, a BGL measurement is obtained using any of the methods or systems described or otherwise envisioned herein. Once received, the blood glucose level measurement may be utilized immediately, or may be stored in local or remote storage for use in further steps of the method

[0046] At step 140 of the method, the biomarker monitoring system 200 compares the received biomarker measurement to the subject-determined baseline of biomarker measurements. According to an embodiment, comparing the biomarker measurement to the subject-determined baseline of biomarker measurements comprises comparing the biomarker measurement taken at a certain timepoint to biomarker measurement s) in the subject-determined baseline at a same or similar timepoint.

[0047] At step 150 of the method, the biomarker monitoring system 200 determines, based on the comparison in step 140, that the received biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements. In other words, the comparison reveals that biomarker measurement is not as expected for the timepoint based on the subject-determined baseline of biomarker measurements. This is a significant improvement compared to prior art methods of biomarker monitoring.

[0048] At optional step 152 of the method, the biomarker monitoring system 200 determines, based on the comparison in step 140, whether the received biomarker measurement is a time-warp deviation from the subject-determined baseline of biomarker measurements. In other words, the comparison may reveal that biomarker measurement is not as expected for the timepoint based on the subject-determined baseline of biomarker measurements, instead revealing that the biomarker measurement is only offset in time relative to the subject-determined baseline of biomarker measurements. This can be, for example, that the biomarker measurement is offset in time relative to the subject-determined baseline of biomarker measurements, but is not a deviation relative toPhilips Docket: 2024PF00460 the subject-determined baseline of biomarker measurements, i.e. is considered to be within the limits when the offset in time is taken into account.

[0049] According to an embodiment, therefore, a deviation of the received biomarker measurement(s) is a deviation other than a time-warp deviation (where a time-warp deviation is an offset in time of the received biomarker measurement s) relative to the subject-determined baseline of biomarker measurements). This deviation other than a time-warp deviation can be, for example, a deviation in amplitude or degree of the received biomarker measurement(s) relative to the subject-determined baseline of biomarker measurements. As one example, the deviation other than a time-warp deviation is an elevated peak or other measurement of the received biomarker measurement s) relative to the subject-determined baseline of biomarker measurements. As another example, the deviation other than a time-warp deviation is a depressed peak or other measurement of the received biomarker measurement(s) relative to the subject-determined baseline of biomarker measurements.

[0050] According to an embodiment, at step 152 of the method, the system determines - based on the comparison in step 140 - that the received biomarker measurement is indeed a time-warp deviation from the subject-determined baseline of biomarker measurements. In other words, the comparison reveals that biomarker measurement is not as expected for the timepoint based on the subject-determined baseline of biomarker measurements, but reveals that the biomarker measurement is only offset in time relative to the subject-determined baseline of biomarker measurements. According to one embodiment, the identification of a time-warp means that the biomarker monitoring system 200 does not progress to step 160 of the method (namely, the system does not report), as the time-warp does not trigger the reporting methods. According to another embodiment, the identification of a time-warp means that the biomarker monitoring system does progress to step 160 of the method (namely, the system does report), as the time-warp does indeed trigger the reporting methods. For example, after taking into consideration the time warp, limits based on the subject-determined baseline of biomarker measurements can still be exceeded, warranting the progression to step 160, whereas if the limits based on the subject-determined baseline of biomarker measurements are not exceeded the method does not progress to step 160. On the other hand, exceeding the limits based on the subject-determined baseline of biomarker measurements can cause the method to progress to step 160 in spite of the observation of a time warp with respect to the subject-determined baseline of biomarker measurements if the magnitudePhilips Docket: 2024PF00460 of the time warp exceeds a user based limit. Whether a time-warp triggers or does not trigger reporting may be based on design choice, user settings, or other factors for instance lowering thresholds for users with an elevated health risk.

[0051] According to another embodiment, at step 152 of the method, the system determines - based on the comparison in step 140 - that the received biomarker measurement is indeed a timewarp deviation from the subject-determined baseline of biomarker measurements, but also determines that the received biomarker measurement comprises a deviation in addition to the timewarp deviation. For example, the system determines that while the received biomarker measurements are offset in time relative to the subject-determined baseline of biomarker measurements, the received biomarker measurements are also offset in amplitude or degree (i.e., a deviation other than just a time-warp) relative to the subject-determined baseline of biomarker measurements. According to an embodiment, the system can be designed such that the identification of the deviation other than just a time-warp triggers reporting (and thus the system progresses to step 160) even if there is an identified time-warp deviation.

[0052] At step 160 of the method, the biomarker monitoring system 200 reports one or more of the received biomarker measurement and the determined deviation to a medical professional, the subject, and / or another person via a user interface of the system. The information may be provided to a user via any mechanism for display, visualization, or otherwise providing information via a user interface. According to an embodiment, the information may be communicated by wired and / or wireless communication to a user interface and / or to another device. For example, the system may communicate the information to a mobile phone, computer, laptop, wearable device, and / or any other device configured to allow display and / or other communication of the report. The user interface can be any device or system that allows information to be conveyed and / or received, and may include a display, a mouse, and / or a keyboard for receiving user commands. As just one non-limiting example, the user interface may be a component of a biomarker monitoring system, or any other system.

[0053] According to an embodiment, reporting the one or more of the received biomarker measurement and / or the determined deviation by the biomarker monitoring system 200 comprises communicating the information to another system, device, or component. For example, the system may report the one or more of the received biomarker measurement and / or the determinedPhilips Docket: 2024PF00460 deviation (e.g., a time-warp deviation and / or a deviation other than a time-warp) to an insulin pump or other device.

[0054] At step 170 of the method, a biomarker control program being implemented by the subject is adjusted based on the information provided in the report via the user interface, including one or more of the received biomarker measurement and / or the determined deviation. For example, the determined deviation may identify that an adjustment of the subject’s biomarker control program is necessary. The adjustment can be a change in one or more factors related to the subject’s biomarker control program, including but not limited to adjusting one or more of dietary intake, fine-tuning an oral medication amount or schedule, adjusting an activity level, and much more. For example, the adjustment may comprise raising or lowering an amount of oral medication to be taken by the subject, based on the target biomarker and the determined deviation.

[0055] For example, according to an embodiment, a blood sugar control program being implemented by the subject is adjusted based on the information provided in the report via the user interface, including one or more of the received BGL measurement and / or the determined deviation. For example, the determined deviation may identify that an adjustment of the subject’s blood sugar control program is necessary. The adjustment can be a change in one or more factors related to the subject’s blood sugar control program, including but not limited to adjusting one or more of dietary intake, fine-tuning an insulin or oral medication schedule, and adjusting an activity level. For example, the adjustment may comprise raising or lowering an amount of insulin to be taken by the subject, based on the determined deviation.

[0056] Referring to FIG. 3, in one embodiment, is a flowchart of a method 300 for identifying a deviation of a first biomarker measurement using a biomarker monitoring system. The methods described in connection with the figures are provided as examples only, and shall be understood to not limit the scope of the disclosure. The biomarker monitoring system can be any of the systems described or otherwise envisioned herein. The biomarker monitoring system can be a single system or multiple different systems.

[0057] At step 310 of the method, a biomarker monitoring system 200 obtains one or more biomarker measurements from the subject, such as using the biomarker monitor or sensor 270. According to an embodiment, the biomarker measurement is any measurement of the subject’s biomarker, either an actual measurement or an estimate. According to an embodiment, a biomarkerPhilips Docket: 2024PF00460 measurement is obtained using any of the methods or systems described or otherwise envisioned herein. The biomarker measurement can typically be the output of a biomarker monitor which measures the subject’s biomarker, but could also be a value estimated from other invasive or non- invasive sources such as an optical sensor, sweat measurement, urine analyzer, and more. Once received, the biomarker measurement may be utilized immediately, or may be stored in local or remote storage for use in further steps of the method.

[0058] At step 320 of the method, which can occur before or after step 310, the biomarker monitoring system 200 determines a subject-specific baseline for biomarker measurements from the subject. The subject-specific baseline can be determined by, for example, averaging or percentile filtering, among other methods, and can be determined over multiple periods of a certain recurring nature (e.g., day, week, year, etc.).

[0059] For example, according to an embodiment, the subject-specific biomarker baseline can be one of many forms, for example capturing stereotypical recurring life patterns of general population, representing: (1) one day of 24 hours, capturing daytime and nighttime variations; (2) 7 days in a week, capturing weekdays and weekend days variations; and / or (3) 365 / 366 days in a year, capturing seasonal and holiday variations, among many other possibilities.

[0060] According to an embodiment, the subject-specific biomarker baseline may be represented as a vector of typical biomarker values, one per sample period (e.g., 1 per minute, 1 per hour, etc.). These typical values can be determined as the mean or median over multiple life pattern periods, as mentioned, and can be determined once or can be continually maintained and adapted over time. The baseline could also capture subject-specific biomarker ranges, such as confidence intervals, standard deviation, or any other form of minimum / maximum representation. Optionally, each baseline entry could capture a histogram of the subject-specific biomarker values seen for that time point entry.

[0061] At the end of step 320, the biomarker monitoring system 200 comprises a subjectspecific biomarker baseline 330. The subject-specific biomarker baseline 330 may be utilized immediately, or may be stored in local or remote storage for use in further steps of the method.

[0062] At step 340 of the method, the biomarker monitoring system 200 compares the one or more received biomarker measurements obtained from the subject to the determined subjectspecific baseline.Philips Docket: 2024PF00460

[0063] At step 350 of the method, based on the comparison at step 340 of the method, the biomarker monitoring system 200 determines that the received biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements. In other words, the comparison reveals that biomarker measurement is not as expected for the timepoint based on the subject-determined baseline of biomarker measurements. According to an embodiment, the comparison operation takes a threshold or margin into account. For example, the system or operation can apply a fixed margin, for example a margin of ‘x %’. It might also use biomarker ranges or even a histogram per baseline entry, when those are implemented. Many other options for identifying a deviation are possible.

[0064] According to an embodiment, the biomarker monitoring system 200 reports the identified deviation (and / or the received biomarker measurement(s)) to a user. The user can be the subject, a clinician, or any other user. The information may be provided to a user via any mechanism for display, visualization, or otherwise providing information via a user interface. According to an embodiment, the information may be communicated by wired and / or wireless communication to a user interface and / or to another device. For example, the system may communicate the information to a mobile phone, computer, laptop, wearable device, and / or any other device configured to allow display and / or other communication of the report. The user interface can be any device or system that allows information to be conveyed and / or received, and may include a display, a mouse, and / or a keyboard for receiving user commands. As just one nonlimiting example, the user interface may be a component of a biomarker monitoring system, or any other system.

[0065] According to an embodiment, a deviation could be reported as a real-time alert (e.g., notification) providing the received biomarker measurement and the baseline biomarker information optionally including ranges, and a time stamp. The user can thus notice in real-time that their biomarker deviates from the baseline, and by how much. Alternatively, the received biomarker measurement and baseline the biomarker measurement may be plotted a graph, readable by the user, and optionally highlighting or otherwise identifying the deviation(s).

[0066] For example, referring to FIG. 4 is a graph of a subject-specific biomarker baseline 400 generated by the biomarker monitoring system 200 for a subject. The subject-specific biomarker baseline 400 is generated for a time period (“time (t)”) which can be any time period such as a day, a week, a month, a year, or any other time period. According to an embodiment (not shown in FIG.Philips Docket: 2024PF004604), the subject-specific biomarker baseline 400 comprises a plurality of these graphs, such as a unique or linked graph for each hour of the day, a unique or linked graph for each day of the week, a unique or linked graph for each week of the month, a unique or linked graph for each month, and more. The subject-specific biomarker baseline 400 is generated for the time period using a plurality of subject-specific biomarker measurements received from the subject for the time period (e.g., a day, a week, a month, a year, etc.). The graph shows variation of the biomarker measurements over the time period. In this example, the graph comprises a baseline 430, which may be a median or other conglomeration of the biomarker measurements for the time period. The graph also comprises an upper limit 410 of the biomarker measurement range and a lower limit 420 of the biomarker measurement range.

[0067] Referring to FIG. 5, in one embodiment, is a graph 500 of a subject-specific biomarker baseline (410, 420, 430) generated by the biomarker monitoring system 200 for a subject, together with a plot of received biomarker measurements 440. In this embodiment, received biomarker measurements 440 are received frequently or continuously, and the system graphs the measurements or otherwise compares the measurements to the subject-specific biomarker baseline (410, 420, 430).

[0068] In comparison, referring to FIG. 6, in one embodiment, is a graph 600 of a subjectspecific biomarker baseline (410, 420, 430) generated by the biomarker monitoring system 200 for a subject, together with a plot of received biomarker measurements 440a, 440b, 440c, and 440d. In this embodiment, received biomarker measurements 440a, 440b, 440c, and 440d are received intermittently or periodically, and thus the system graphs the measurements or otherwise compares the measurements to the subject-specific biomarker baseline as periodic measurements. For example, biomarker measurements 440a and 440b are outside the upper limit 410 of the baseline, biomarker measurement 440d is outside the lower limit 420 of the baseline, and biomarker measurement 440c is within the upper and lower limit, intersecting the baseline 430.

[0069] Referring to FIG. 7, in one embodiment, is a graph 500 of a subject-specific biomarker baseline (410, 420, 430) generated by the biomarker monitoring system 200 for a subject, together with a plot of received biomarker measurements 440, and identification of deviations 450 and 460. In this example, received biomarker measurements 440 fall outside the subject-specific biomarker baseline (410, 420, 430) at two locations, 450 and 460. At the other locations of the plot of receivedPhilips Docket: 2024PF00460 biomarker measurements 440, the measurements fall within the subject-specific biomarker baseline.

[0070] Notably, according to an embodiment, a deviation need not fall completely outside an upper or lower limit or threshold of a subject-specific biomarker baseline to be reported as a deviation. Rather, the deviation could simply be a variation from the average 430 of the biomarker baseline, where the variation may be identified as an amount by which the deviation varies from the baseline average 430. For example, referring to FIG. 8, in one embodiment, the deviation is 470 where the received biomarker measurement 440a is not outside the upper or lower limit or threshold of the subject-specific biomarker baseline, but is instead a significant variation from the baseline average 430.

[0071] According to an embodiment, the biomarker monitoring system 200 determines whether the received biomarker measurement is a time-warp deviation from the subject-determined baseline of biomarker measurements. In other words, the comparison may reveal that the biomarker measurement is not as expected for the timepoint based on the subject-determined baseline of biomarker measurements, instead revealing that the biomarker measurement is only offset in time relative to the subject-determined baseline of biomarker measurements. This can be, for example, that the biomarker measurement is offset in time relative to the subject-determined baseline of biomarker measurements, but is not a deviation relative to the subject-determined baseline of biomarker measurements, after taking into consideration the time warp, limits based on the subject-determined baseline of biomarker measurements can still be exceeded, warranting the system to take action, whereas if the limits based on the subject-determined baseline of biomarker measurements are not exceeded the system can refrain from taking action.

[0072] For example, referring to FIG. 9 in one embodiment, is a graph 900 of a subject-specific biomarker baseline (410, 420, 430) generated by the biomarker monitoring system 200 for a subject, together with a plot of received biomarker measurements 440. In this embodiment, received biomarker measurements 440 are received continuously or periodically, and thus the system graphs the measurements or otherwise compares the measurements to the subject-specific biomarker baseline as continuous or periodic measurements. For example, biomarker measurements 440 appear to be outside the upper limit 410 of the baseline at location 910. However, the biomarker monitoring system 200 determines that the received biomarker measurement is only a time-warp deviation from the subject-determined baseline of biomarkerPhilips Docket: 2024PF00460 measurements. However, even when taking the time warp into consideration in FIG. 9, the limits are still exceeded and consequentially the system will take action, for instance in the form of an alert to the user or an adjustment of a blood sugar control program by for example adjusting one or more of dietary intake, adjusting an insulin or oral medication schedule, and adjusting an activity level.

[0073] Referring to FIG. 2 is a schematic representation of a biomarker monitoring system 200. System 200 may be any of the systems described or otherwise envisioned herein, and may comprise any of the components described or otherwise envisioned herein. It will be understood that FIG. 2 constitutes, in some respects, an abstraction and that the actual organization of the components of the system 200 may be different and more complex than illustrated.

[0074] According to an embodiment, system 200 comprises a processor 220 capable of executing instructions stored in memory 230 or storage 260 or otherwise processing data to, for example, perform one or more steps of the method. Processor 220 may be formed of one or multiple modules. Processor 220 may take any suitable form, including but not limited to a microprocessor, microcontroller, multiple microcontrollers, circuitry, field programmable gate array (FPGA), application-specific integrated circuit (ASIC), a single processor, or plural processors.

[0075] Memory 230 can take any suitable form, including a non-volatile memory and / or RAM. The memory 230 may include various memories such as, for example LI, L2, or L3 cache or system memory. As such, the memory 230 may include static random access memory (SRAM), dynamic RAM (DRAM), flash memory, read only memory (ROM), or other similar memory devices. The memory can store, among other things, an operating system. The RAM is used by the processor for the temporary storage of data. According to an embodiment, an operating system may contain code which, when executed by the processor, controls operation of one or more components of system 200. It will be apparent that, in embodiments where the processor implements one or more of the functions described herein in hardware, the software described as corresponding to such functionality in other embodiments may be omitted.

[0076] User interface 240 may include one or more devices for enabling communication with a user. The user interface can be any device or system that allows information to be conveyed and / or received, and may include a display, a mouse, and / or a keyboard for receiving userPhilips Docket: 2024PF00460 commands. In some embodiments, user interface 240 may include a command line interface or graphical user interface that may be presented to a remote terminal via communication interface 250. The user interface may be located with one or more other components of the system, or may located remote from the system and in communication via a wired and / or wireless communications network.

[0077] Communication interface 250 may include one or more devices for enabling communication with other hardware devices. For example, communication interface 250 may include a network interface card (NIC) configured to communicate according to the Ethernet protocol. Additionally, communication interface 250 may implement a TCP / IP stack for communication according to the TCP / IP protocols. Various alternative or additional hardware or configurations for communication interface 250 will be apparent.

[0078] Storage 260 may include one or more machine-readable storage media such as readonly memory (ROM), random-access memory (RAM), magnetic disk storage media, optical storage media, flash-memory devices, or similar storage media. In various embodiments, storage 260 may store instructions for execution by processor 220 or data upon which processor 220 may operate. For example, storage 260 may store an operating system 261 for controlling various operations of system 200.

[0079] It will be apparent that various information described as stored in storage 260 may be additionally or alternatively stored in memory 230. In this respect, memory 230 may also be considered to constitute a storage device and storage 260 may be considered a memory. Various other arrangements will be apparent. Further, memory 230 and storage 260 may both be considered to be non-transitory machine-readable media. As used herein, the term non-transitory will be understood to exclude transitory signals but to include all forms of storage, including both volatile and non-volatile memories.

[0080] While system 200 is shown as including one of each described component, the various components may be duplicated in various embodiments. For example, processor 220 may include multiple microprocessors that are configured to independently execute the methods described herein or are configured to perform steps or subroutines of the methods described herein such that the multiple processors cooperate to achieve the functionality described herein. Further, where one or more components of system 200 is implemented in a cloud computing system, the variousPhilips Docket: 2024PF00460 hardware components may belong to separate physical systems. For example, processor 220 may include a first processor in a first server and a second processor in a second server. Many other variations and configurations are possible.

[0081] According to an embodiment, the system comprises one or more biomarker monitors 270, as described or otherwise envisioned herein. According to an embodiment, the one or more biomarker monitors can be any sensor, invasive or non-invasive, that measures a biomarker. Examples of measurable biomarkers include, but are not limited to, heart rate, heart rate variability, respiration rate, blood pressure, a subject’s activity level or motion / movement, metabolic biomarkers such as blood glucose levels, oxygenation level, cholesterol level, and triglyceride level, among many, many other possible biomarkers.

[0082] According to an embodiment, storage 260 of system 200 may store one or more algorithms, modules, and / or instructions to carry out one or more functions or steps of the methods described or otherwise envisioned herein. For example, the system may comprise, among other instructions or data, a subject-specific baseline 262, comparison and identification instructions 263, and / or reporting instructions 264, among other possible instructions.

[0083] According to an embodiment, the subject-specific baseline 262 is a determined baseline of biomarker measurements, which will be utilized by the system for identifying biomarker deviations. To generate a baseline of biomarker measurements, the system obtains a plurality of biomarker measurements over a first time period. The number of measurements comprising the plurality can depend on a variety of factors, including but not limited to the subject, the desired baseline, the availability of measurements, and many other measurements. For example, the measurements can be obtained throughout the course of the first time period, at intervals. The intervals can be minutes or hours, and can be regular or irregular. The first time period can be any period including days, weeks, or months. The first time period can be any period of time required or sufficient to generate a suitable baseline, where a suitable baseline is a baseline that is capable of being utilized for identifying deviations, as described or otherwise envisioned herein. Once obtained, the plurality of measurements may be utilized immediately, or may be stored in local or remote storage for use in further steps of the method. Once generated, the baseline may be utilized immediately, or may be stored in local or remote storage for use in further steps of the method.Philips Docket: 2024PF00460

[0084] According to an embodiment, comparison and identification instructions 263 direct the system to compare a received biomarker measurement s) to the subject-determined baseline of biomarker measurements. According to an embodiment, comparing the biomarker measurement to the subject-determined baseline of biomarker measurements comprises comparing the biomarker measurement taken at a certain timepoint to biomarker measurements in the subject- determined baseline at a same or similar timepoint. By comparing, the biomarker monitoring system 200 determines that the received biomarker measurement(s) is a deviation relative to the subject-determined baseline of biomarker measurements.

[0085] According to an embodiment, reporting instructions 265 direct the system to report one or more of the received biomarker measurement and the identified deviation to a medical professional, the subject, and / or another person via a user interface of the system. The information may be provided to a user via any mechanism for display, visualization, or otherwise providing information via a user interface. According to an embodiment, the information may be communicated by wired and / or wireless communication to a user interface and / or to another device. For example, the system may communicate the information to a mobile phone, computer, laptop, wearable device, and / or any other device configured to allow display and / or other communication of the report. The user interface can be any device or system that allows information to be conveyed and / or received, and may include a display, a mouse, and / or a keyboard for receiving user commands. As just one non-limiting example, the user interface may be a component of a biomarker monitoring system, or any other system.

[0086] By providing the novel and non-obvious biomarker monitoring system described or otherwise envisioned herein, the system has an enormous positive effect on patient care - specifically biomarker monitoring (such as BGL monitoring) - compared to prior art systems. As just one example, by providing a system that can improve biomarker monitoring, the system can facilitate early and expeditious monitoring and correction of biomarkers in a subject, thereby leading to improved and potentially saved lives.

[0087] The present invention may be a system, a method, and / or a computer program product. The computer program product may include a non-transitory computer readable storage medium (or media) having computer readable program instructions thereon for causing a system or processor to carry out aspects of the present invention. The computer readable storage medium canPhilips Docket: 2024PF00460 be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any combination of the foregoing, among other possibilities. Computer readable program instructions described herein can be downloaded to respective computing / processing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the internet, a local area network, and / or a wireless network. Aspects of the present invention are described herein with reference to flowchart illustrations and / or block diagrams of methods, apparatus, systems, and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer readable program instructions.

[0088] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0089] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

[0090] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified.

[0091] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, whenPhilips Docket: 2024PF00460 used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.”

[0092] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified.

[0093] It should also be understood that, unless clearly indicated to the contrary, in any methods claimed herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.

[0094] In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively.

[0095] While several inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the inventive teachings is / are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is,Philips Docket: 2024PF00460 therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.

Claims

Philips Docket: 2024PF00460ClaimsWhat is claimed is:

1. A method for identifying a deviation of a first biomarker measurement, comprising: receiving a first biomarker measurement from a subject at a first timepoint; comparing the received first biomarker measurement to a subject-determined baseline of first biomarker measurements; determining, based on the comparison, that the first biomarker measurement is a deviation from the subject-determined baseline of first biomarker measurements; and reporting the determined deviation of the first biomarker measurement.

2. The method of claim 1, further comprising the step of determining that the determined deviation of the first biomarker measurement from the subject-determined baseline of first biomarker measurements is a time-warp deviation.

3. The method of claim 1, further comprising the step of generating the subject- determined baseline of biomarker measurements by: (i) obtaining, for a first period of time, a plurality of biomarker measurements; and (ii) determining, from the plurality of biomarker measurements, a subject-determined baseline of biomarker measurements.

4. The method of claim 1, wherein the first biomarker is a blood glucose level (BGL), and the method further comprises adjusting, based on the reporting, a blood sugar control program, wherein adjusting a blood sugar control program comprises adjusting one or more of dietary intake, adjusting an insulin or oral medication schedule, and adjusting an activity level.

5. The method of claim 1, wherein the subject-determined baseline of first biomarker measurements comprises an upper biomarker measurement limit, a lower biomarker measurement limit, and a biomarker measurement average for a plurality of timepoints.

6. The method of claim 1, wherein determining that the biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements comprisesPhilips Docket: 2024PF00460 determining an amount of the deviation, and wherein reporting the determined deviation comprises reporting the determined amount of the deviation.

7. A method for identifying a deviation of a blood glucose level (BGL) measurement, comprising: receiving a BGL measurement from a subject at a first timepoint; comparing the received BGL measurement to a subject-determined baseline of BGL measurement measurements; determining, based on the comparison, that the BGL measurement is a deviation from the subject-determined baseline of BGL measurements; and reporting the determined deviation of the BGL measurement.

8. The method of claim 7, further comprising the step of determining that the determined deviation of the BGL measurement from the subject-determined baseline of BGL measurements is a time-warp deviation.

9. The method of claim 7, wherein the method further comprises adjusting, based on the reporting, a blood sugar control program, wherein adjusting a blood sugar control program comprises adjusting one or more of dietary intake, adjusting an insulin or oral medication schedule, and adjusting an activity level.

10. The method of claim 7, wherein the subject-determined baseline of BGL measurements comprises an upper BGL measurement limit, a lower BGL measurement limit, and a BGL measurement average for a plurality of timepoints.

11. The method of claim 7, wherein determining that the BGL measurement is a deviation from the subject-determined baseline of BGL measurements comprises determining an amount of the deviation, and wherein reporting the determined deviation comprises reporting the determined amount of the deviation.Philips Docket: 2024PF0046012. A system for identifying a deviation of a blood glucose level (BGL) measurement, comprising: a biomarker monitor configured to obtain a biomarker measurement from a subject; a processor configured to: (i) receive a biomarker measurement from the biomarker monitor; (ii) compare the biomarker measurement to a subject-determined baseline of biomarker measurements; (iii) determine, based on the comparison, that the biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements; and a user interface configured to report one or more of the biomarker measurement and the determined deviation.

13. The system of claim 12, wherein determining that the that the biomarker measurement is a deviation from the subject-determined baseline of biomarker measurements comprises determining that the deviation is a time-warp deviation.

14. The system of claim 12, wherein the processor is further configured to generate the subject-determined baseline of biomarker measurements by: (i) obtaining, for a first period of time, a plurality of biomarker measurements; and (ii) determining, from the plurality of biomarker measurements, a subject-determined baseline of biomarker measurements.

15. The system of claim 12, wherein the biomarker is a blood glucose level (BGL), and the method further comprises adjusting, based on the reporting, a blood sugar control program, wherein adjusting a blood sugar control program comprises adjusting one or more of dietary intake, adjusting an insulin or oral medication schedule, and adjusting an activity level.

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