Patent Description:
Diabetes can be characterized by hyperglycemia and relative insulin deficiency. There are two main types of diabetes, Type I diabetes (insulin-dependent diabetes mellitus) and Type II diabetes (non-insulin-dependent diabetes mellitus). In some instances, diabetes is also characterized by insulin resistance.

Insulin secretion functions to control the level of blood glucose to keep glucose levels at an optimum level. Healthcare may often include both establishing a therapeutic program and monitoring the progress of the afflicted person. Monitoring blood glucose levels is an important process that is used to help diabetics maintain blood glucose levels as near to normal as possible throughout the day. Monitoring can also allow successful treatment of a diabetic by altering therapy as necessary. Monitoring may allow the diabetic to follow more closely his or her condition and, in addition, can provide information of value to the healthcare provider in determining both progress of the patient and detecting any need to change the patient's therapy program.

There are two main types of blood glucose monitoring systems used by patients: single point (or non-continuous) systems and continuous systems. Non-continuous systems consist of meters and tests strips and require blood samples to be drawn from fingertips or alternate sites, such as forearms and legs. An example of a noncontinuous system may require a diabetic to apply a blood sample to a reagent-impregnated region of a test strip, and determine a blood glucose level by an electrochemical analysis method or comparing the color of the reagent-impregnated regions of the test strip with a color chart supplied by the test strip manufacturer. Alternatively, many patients use a continuous glucose monitoring (CGM) device to monitor their glucose level on an ongoing basis. In order to perform CGM, a glucose sensor may be placed under the skin such that the sensor is capable of measuring the glucose level of the person in the interstitial fluid. The glucose sensor may periodically measure the glucose level of the person and transmit the glucose measurement results at a known time interval, such as every minute, to an electronic monitor.

Individuals with diabetes are currently using CGM to calculate correction boluses using the same equations designed for self-monitoring of blood glucose levels. This can increase the risk of hypoglycemia due to the increased uncertainty of CGM.

Persons with diabetes often carry specialized electronic meters, called blood glucose meters, which allow them to periodically measure their glucose levels and assist them in taking appropriate action, such as administering insulin or ingesting carbohydrates. Some diabetics may also wear a CGM device to manage their diabetes. These CGM devices generally provide continuous glucose data values which can provide for better control of a user's blood glucose values. These persons may also carry with them a portable communication device, such as a mobile phone, a personal digital assistant, a tablet or similar device which communicates with their blood glucose meter or CGM.

Smart hearing aids, which comprise one or more sensors to collect information about a wearer's activity or health status, are known. These hearing aids are often integrated into a communication network. Hearing aids can be used to draw a wearer's attention to a status of devices of the network by playing an audio message.

In the future, more body sensors will be available to persons with diabetes where the body sensors will provide for collecting information other than blood glucose values. Since these sensors are not necessarily part of a proprietary diabetes management solution provided by a single manufacturer or company, their integration into a more capable diabetes management system may increase certain risks for the users. Minimizing these risks is one goal of the embodiments disclosed herein.

The information above recites background information related to the present disclosure and is not necessarily an admission of certain teachings as prior art.

<CIT> discloses a system and a method for determining an amount of insulin to administer to a diabetic patient. <CIT> discloses activity Sensing Techniques for an Infusion Pump System. <CIT> discloses Insulin Management.

The claimed invention is defined by the independent claims.

Embodiments described herein provide for safer methods for calculating insulin boluses, typically meal boluses and correction boluses. Embodiments disclosed herein detail calculations using an algorithm that improves the accuracy of bolus calculations by accounting for activity or health status of the user.

There exists a need in the art for diabetes management methods and systems that will provide two (or more) suggestions for a bolus, such that a patient can select the bolus which suits his/her needs best. These methods provide a patient with an alternative bolus suggestion, which is determined by taking into account additional information concerning the patient's current activity or health status. The additional information may be achieved by use of a body-worn sensor. The body-worn sensor could be arranged/integrated in a hearing aid and/or could be arranged/integrated in a smart watch, such as an Apple Watch for example, or arranged/integrated in an activity tracker, such as a Fitbit device.

Persons with diabetes often carry a handheld glucose meter as well as a portable computing device, such as a mobile phone. Given the close proximity of these two devices, the portable computing device can serve as a data collector for the glucose measurements taken by the glucose meter.

According to the claimed invention, a computer-implemented diabetes management method for determining an insulin bolus by a diabetes management device or component thereof comprising a processor is disclosed herein, and the method comprises:.

In an embodiment, in the first receiving step, the processor receives the glucose value from a glucose monitoring device.

The method of any one of the previous embodiments can include steps wherein the processor receives information about a carbohydrate content associated with a meal which is to be ingested prior to determining the first determined insulin bolus, and wherein the carbohydrate content is considered by the processor in determining the first determined insulin bolus.

The method of any one of the previous embodiments can include use of a body-worn sensor device which comprises a hearing aid, a smart watch, or an activity tracker, or any combination thereof.

The method of any one of the previous embodiments can include use of body parameter information that includes at least one of the user's heart beat rate, internal body temperature, respiratory rate, speed of movement or acceleration of movement.

In the method of any one of the previous embodiments, the notification can include providing an audible alarm or warning to the user by use of a hearing aid, a smart watch, or an activity tracker, or any combination thereof.

Embodiments described herein provide for a method for integrating additional sensor information into a diabetes management system wherein the additional sensor(s) may be provided by different manufacturers and/or companies. The method provides for calculating via the algorithm a standard insulin bolus dose typically utilizing an insulin sensitivity factor of a user and a pre-set target glucose level. In an embodiment, a risk of hypoglycemia can be minimized by automatically selecting the minimum value between the first calculated insulin bolus dose and the re-calculated insulin bolus dose if there is no user response within a given period of time. There is thus provided in selected embodiments a way to reduce the risk to patients in using the system in situations where the first calculated bolus deviates significantly (typically above a preset threshold) from the second calculated bolus.

Additional embodiments described herein provide for a system or method for determining an insulin amount, the system or method comprising a processor, wherein the processor is configured to:.

In the previous system or method, the body-worn sensor device comprises a hearing aid, a smart watch, or an activity tracker, or a combination thereof.

In the previous embodiments of the system or method, the body parameter information includes at least one of the user's heart beat rate, internal body temperature, respiratory rate, speed of movement or acceleration of movement.

In the previous embodiments of the system or method, the processor is configured to conduct the notification by communicating to a hearing aid, a smart watch, or an activity tracker, or any combination thereof to provide an audible alert to the user.

The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the inventions defined by the claims.

Specific embodiments of the present disclosure will now be described. The invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which embodiments of this invention belong. The terminology used herein is for describing particular embodiments only and is not intended to be limiting of the invention. As used in the specification and appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

Parts of methods described herein such as mathematical determinations, calculations, inputting of data for computations or determinations of equations or parts thereof can be performed on parts of or one or more computers or computer systems that can include one or more processors, as well as software to run or execute programs and run calculations or computations.

Methods and systems and parts thereof described herein can be combined to implement embodiments of the invention. Forms of words used herein can have variations: for example when a word such as "calculate" is used, this implies that variations such as "calculated" and "calculating" are understood and have been considered.

As used herein, "user," "patient," and "person" are used to refer to an individual interacting with the disclosed diabetes management systems to improve that individual's health via the improvements described herein.

Referring to <FIG>, there is shown a high-level drawing of one embodiment of a handheld diabetes management device <NUM> that may be used in measuring the blood glucose (bG) of a patient and implementing a bolus calculation or carbohydrate suggestion. Typically, the device <NUM> includes a housing <NUM> that may contain user unit control switches <NUM> (e.g., ON/OFF), a touchscreen display <NUM>, and a port <NUM> into which a bG test strip <NUM> may be inserted. The display <NUM> may display user selectable options for allowing the user to access a software driven menu 16a of various selections, a selection 16b for allowing the user to enter bolus information, a selection 16c for enabling the user to enter carbohydrate information for snacks or meals, and a selection 16d for allowing the user to enter information pertaining to health events (e.g., meals, exercise, periods of stress, periodic physiological events such as a menstrual cycle, etc.) that may affect the user's bG measurement being read by the device <NUM>. Although the display <NUM> will be described herein as a touchscreen display, it will be appreciated that any other suitable form of display may be incorporated (e.g., LED, etc.). If a touchscreen display is not used, the user control switches <NUM> may need to include specific buttons or controls by which the user is able to select various options and input markers needed to carry out the bolus calculation or carbohydrate suggestion. It will be appreciated that the above is a high-level description of the device <NUM>, and in practice, the device may include additional controls, input ports, output ports, etc., as may be desired to even further enhance the utility of the device <NUM> or its use with other components and devices (e.g., laptop computers, infusion pumps, etc.). Accordingly, the above description of the device <NUM> should not be taken as limiting its construction or features in any way.

Referring to <FIG>, a high-level block diagram of the device <NUM> is shown. The device <NUM> can include a rechargeable or non-rechargeable battery <NUM> for powering the various electronic components of the device <NUM>. A processing subsystem <NUM> (e.g., a microprocessor based subsystem) is included that receives information from a bG analyzer <NUM>. The bG analyzer <NUM> can be located adjacent the port <NUM> of the housing <NUM> to permit the bG analyzer <NUM> to read the bG test strip <NUM>. The bG analyzer <NUM> can include a code key 24a that includes calibration information for the bG test strip <NUM> being read. The processing subsystem <NUM> can also be in communication with a database <NUM> that is used to store bG test values obtained from the bG analyzer <NUM> and other important health related information for the user. In particular, the database <NUM> can include a subsection 26a for storing recommended bolus and carbohydrate advice history records (hereinafter "advice history records") that are still active in their influence of current and future advice as well as historical records, and a section 26b for storing medication (insulin), health, carbohydrate and bG related variables (e.g., insulin sensitivities of the user for various time segments of the day) pertinent to the user. It will be appreciated that the database <NUM> will typically be formed by a non-volatile memory. Further, the bG related variables such as the insulin sensitivities of the user can be stored as global parameters and may not be in the advice history records.

The processing subsystem <NUM> can also be in communication with the display <NUM>, the user control switches <NUM>, and one or more interfaces <NUM> for interfacing the device <NUM> to other external devices. The processing subsystem <NUM> can also be in communication with a memory (such as a RAM) <NUM> for storing various types of information (e.g., meal and bed times) that are input by the user, as well as any other information requiring temporary or permanent storage. However, it will be appreciated that the database <NUM> and the memory <NUM> could be implemented in a single memory device (e.g., RAM) if desired, as indicated in phantom in <FIG>. The processing subsystem <NUM> can be in communication with an alarm generation subsystem <NUM> that is used to generate an alarm or warning comprising audible signals, tactile signals (e.g., a vibration signal) or possibly even visual signals serving as warnings or alarms such as illuminated lights (e.g., LEDs) on the device <NUM>. In one embodiment, the processing subsystem <NUM> can also receive inputs from a remote continuous glucose monitoring ("CGM") device <NUM> secured to the user's body such that device <NUM> is continually updated with glucose information for the user. Finally, in one embodiment, the processing subsystem <NUM> can be in communication with a remote insulin infusion pump <NUM> (herein referred to as an "insulin pump <NUM>") worn by the user so that the device <NUM> is able to communicate bolus information to the insulin pump <NUM>. By "remote" it is meant that the CGM device <NUM> and the insulin pump <NUM> are each located outside of the device <NUM> but otherwise still in communication with the device <NUM>. It should be appreciated that the device <NUM> can communicate with the insulin pump <NUM> either through a wired or wireless connection.

The device <NUM> can be used to implement a non-transitory machine-readable code, for example a diabetes management application comprising a bolus calculator software module 22a (herein referred to as "bolus calculator 22a"), that is run by the processing subsystem <NUM> which includes a processor. The bolus calculator 22a can be formed as a single module or as a collection of independent modules that run concurrently on the processing subsystem <NUM>. The processing subsystem <NUM>, working in connection with the bolus calculator 22a, receives a wide variety of user inputs applied by the user through the touchscreen display <NUM> to generate a recommended correction bolus, a recommended meal bolus, a recommended total bolus, or when appropriate a suggested carbohydrate amount. The suggested carbohydrate amount may be provided in response to the detection by the device <NUM> of a hypoglycemic bG test value. The operations and capabilities of the device <NUM> will be explained in detail in the following paragraphs. The device <NUM> significantly enhances the convenience and ease of use to the user through the implementation of a plurality of customizable inputs that enable the user to program the device <NUM> with unique health information pertinent to the user. More specifically, the device <NUM> allows the user to program the device <NUM> with health information which even more completely enables the device <NUM> to take into account unique health conditions affecting the user, as well as regular occurring and non-regular occurring health events that could otherwise have an impact on the bolus and carbohydrate calculations made by the device <NUM>.

The diabetes management application may receive one or more glucose measurements and a measurement time associated with each of the one or more glucose measurements. The diabetes management application determines a bolus calculation based on the one or more glucose measurements. Further teachings relating to bolus calculators which would be suitable for purposes of the present invention can be found in <CIT>, and <CIT>.

The diabetes management application may generate a bolus recommendation based on a bolus calculation. For example only, the bolus recommendation may include instructing the patient to take an amount of insulin or to consume carbohydrates in order to increase or decrease the patient's blood glucose. In order for the diabetes management application to provide an effective bolus recommendation, the bolus recommendation must occur within a predetermined period following the timestamp of the blood glucose measurement. For example, the predetermined period may be less than <NUM> minutes. The diabetes management application determines whether the timestamp is within the predetermined period.

The diabetes management application may generate a request for information input screen. The request for information input screen can include a display of previously received data. For example, the request for information input screen may display a previously recorded glucose measurement. The request for information input screen advises the patient to input specified information. For example, the specified information may include meal information, and the total number of carbohydrates the patient has consumed or will consume.

The diabetes management application determines a bolus calculation based on the one or more glucose measurements received from the meter <NUM> and manually recorded patient data, such as insulin values and meal information. The diabetes management application generates the bolus recommendation based on the bolus calculation. The diabetes management application also generates an alternative or re-calculated bolus recommendation which is based on (i.e., takes into account) body parameter information indicating the patient's activity or health status as further described elsewhere herein. Such activity or health status information is provided by a body-worn sensor, one example of which is a hearing aid <NUM> (see <FIG>) that includes a sensor such as a sensor that measures the wearer's internal body temperature by measuring the same within the wearer's ear. The hearing aid would typically communicate such activity or health status information with the glucose meter <NUM> using bidirectional wireless communication as shown in <FIG> via communication link <NUM>.

Referring to <FIG>, in one embodiment, an exemplary CGM system <NUM> is illustrated for monitoring the glucose level of a person having diabetes. In particular, the CGM system <NUM> is operative to collect and/or transmit measured glucose values at a predetermined, adjustable interval, such as every one minute, five minutes, or at other suitable intervals. The CGM system <NUM> illustratively includes a glucose sensor <NUM> having a sensor, needle or probe <NUM> that is inserted under a skin surface <NUM> of the person. The end of the needle <NUM> is positioned in a region containing an interstitial fluid <NUM> such that measurements taken by the glucose sensor <NUM> are based on the level of glucose in the interstitial fluid <NUM>. The needle can also be placed in a region with blood and/or other bodily fluid. The glucose sensor <NUM> is positioned adjacent the abdomen of the person or at another suitable location. The glucose sensor <NUM> may comprise other components as well, including but not limited to a wireless transmitter <NUM> and an antenna <NUM>. Note that the glucose sensor <NUM> is not drawn to scale and may in certain embodiments be mounted generally as a puck on the skin surface. The glucose sensor <NUM> may alternatively use other suitable devices for taking measurements, such as, for example, a non-invasive device (e.g., an infrared light sensor). Upon taking a measurement, the glucose sensor <NUM> transmits the measured glucose value(s) via a communication link <NUM> to a computing device <NUM> (also sometimes referred to as management device <NUM>), illustratively a blood glucose management device <NUM>, a smart phone <NUM> or a bolus calculator <NUM> (in specific embodiments the computing device <NUM> has a housing, as described herein, and is a stand-alone device, working in conjunction with a processor(s) which includes a bolus calculator module performing logic properties of, for example, the computing device).

In some embodiments, the CGM system <NUM> can further include a therapy delivery device <NUM>, illustratively an insulin infusion pump <NUM>, for delivering therapy (e.g., insulin) to the person. The pump <NUM> can have a single housing or can have a two-part housing where one part is reusable and the other disposable, where the disposable part can include a power source such as a battery. The insulin pump <NUM> is in communication with the management device <NUM> via a bidirectional communication link <NUM>, and the management device <NUM> is able to communicate bolus and basal rate information to the insulin pump <NUM>. The insulin pump <NUM> can include a cannula or catheter <NUM> having a needle that is inserted through the skin <NUM> of the person for infusing insulin. Insulin pump <NUM> is illustratively positioned adjacent the abdomen of the person or at another suitable location. Similar to the glucose sensor <NUM>, the infusion pump <NUM> also typically includes a wireless transmitter and an antenna for communication with management device <NUM>. The insulin pump <NUM> is operative to deliver basal insulin (e.g., small doses of insulin continuously or repeatedly released at a basal rate) and bolus insulin (e.g., a surge dose of insulin, such as around a meal event, for example). The bolus insulin may be delivered in response to a user input triggered by the user, or in response to a command from the management device <NUM>. Similarly, the basal rate of the basal insulin is set based on user input or in response to a command from management device <NUM>. Infusion pump <NUM> may optionally include a display for displaying pump data and a user interface providing user controls. In an alternative embodiment, insulin pump <NUM> and the glucose sensor <NUM> may be provided as a single device worn by the patient, and at least a portion of logic run by a processor may reside on this single device. Bolus insulin may also be injected by other means, such as manually by the user via an insulin pen or a needle.

Similar to the embodiment shown and described earlier, the CGM system includes an additional body-worn sensor. One embodiment of such a body-worn sensor is the hearing aid <NUM> which can communicate body parameter information such as the above-referenced activity or health status information with the management device <NUM> via the communication link <NUM> and optionally communicating in a bidirectional wireless manner.

Referring to <FIG> and <FIG>, communication links <NUM>, <NUM> and <NUM> are illustratively wireless, such as a radio frequency ("RF") or other suitable wireless frequency, in which data and controls are transmitted via electromagnetic waves between the sensor <NUM>, the therapy delivery device <NUM>, the body-worn sensor <NUM>, and the management device <NUM>. Bluetooth® is one exemplary type of wireless RF communication system that can use a frequency of approximately <NUM> Gigahertz (GHz). Another exemplary type of wireless communication scheme uses infrared light, such as the systems supported by the Infrared Data Association® (IrDAO). Other suitable types of wireless communication may be provided. Furthermore, each communication link <NUM>, <NUM> and <NUM> may facilitate communication between multiple devices, such as between the glucose sensor <NUM>, the management device <NUM>, the insulin pump <NUM>, the body-worn sensor <NUM>, and other suitable devices or systems. In another embodiment, the glucose sensor <NUM> could communicate with the management device <NUM> via communicating with the insulin pump <NUM>. Wired links may alternatively be provided between devices of the system <NUM>, such as, for example, a wired Ethernet link. Other suitable public or proprietary wired or wireless links may also be used.

<FIG> illustrates an exemplary embodiment of the management device <NUM> of the CGM system <NUM> of <FIG>. The management device <NUM> includes at least one processing device <NUM> that executes software and/or firmware code stored in a memory <NUM> of management device <NUM>. The software/firmware code contains instructions that, when executed by the processor <NUM> of the management device <NUM>, causes the management device <NUM> to perform the functions described herein. The management device <NUM> may alternatively include one or more application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), digital signal processors (DSPs), hardwired logic, or combinations thereof. While the management device <NUM> is illustratively a glucose monitor <NUM>, other suitable management devices <NUM> may be provided, such as, for example, desktop computers, laptop computers, computer servers, personal data assistants ("PDA"), smart phones, cellular devices, tablet computers, infusion pumps, an integrated device including a glucose measurement engine and a PDA or cell phone, etc. Although the management device <NUM> is illustrated as a single management device <NUM>, multiple computing devices may be used together to perform the functions of the management device <NUM> described herein. <FIG> also illustrates that the system can include a bolus calculator module <NUM>, a hazard analysis logic component <NUM> (such as for accounting for time / rates of change of glucose levels in calculations), a recursive filter <NUM> (such as for removing noise in calculations or adjusting for the probability of glucose sensor accuracy), and / or a basal rate adjustment logic component <NUM> (such as for adjusting for the effect of the user activities on rates in calculations).

The memory <NUM> is any suitable computer readable medium that is accessible by the processor <NUM>. The memory <NUM> may be a single storage device or multiple storage devices, may be located internally or externally to the management device <NUM>, and may include both volatile and non-volatile media. Further, the memory <NUM> may include one or both of removable and non-removable media. Exemplary memory <NUM> includes random-access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, CD-ROM, Digital Versatile Disk (DVD) or other optical disk storage, a magnetic storage device, or any other suitable medium which is configured to store data and which is accessible by the management device <NUM>.

The management device <NUM> further includes a communication device <NUM> operatively coupled to processor <NUM>. The communication device <NUM> includes any suitable wireless and/or wired communication module operative to transmit and receive data and controls over the communication links <NUM>, <NUM> and <NUM> between the device <NUM>, the glucose sensor <NUM>, the body-worn sensor <NUM>, and the insulin pump <NUM>. In one embodiment, the communication device <NUM> includes an antenna <NUM> (<FIG>) for receiving and / or transmitting data wirelessly over the communication links <NUM>, <NUM> and <NUM>. The management device <NUM> stores in the memory <NUM> measured glucose results and other data received from the glucose sensor <NUM>, the body-worn sensor <NUM>, and/or the insulin pump <NUM> via the communication device <NUM>.

The management device <NUM> includes one or more user input devices <NUM> for receiving user input. The input devices <NUM> may include pushbuttons, switches, a mouse pointer, keyboard, touch screen, or any other suitable input device. The display <NUM> is operatively coupled to the processor <NUM>. The display <NUM> may comprise any suitable display or monitor technology (e.g., liquid crystal display, etc.) configured to display information provided by the processor <NUM> to the user. Processor <NUM> is configured to transmit to the display <NUM> information related to the basal rate and bolus information. Moreover, the displayed information may include warnings and / or alarms, etc. regarding whether the estimated or predicted glucose level of the person is hypoglycemic or hyperglycemic. For example, a warning may be issued if the person's glucose level falls below (or is predicted to fall below) a predetermined hypoglycemic threshold, such as from about <NUM> to about <NUM>/dL of glucose in blood. Management device <NUM> may also be configured to communicate information or warnings to the person via a sense of touch, for example, by vibrating, or by sending information or warnings to the body-worn sensor (such as the hearing aid <NUM>) for the body-worn sensor to provide the information or warnings to the user.

For a further description of additional features that may be provided by the bolus calculator module, see <CIT> and <CIT>.

In specific embodiments, methods comprise removing the corresponding meal bolus when the selected insulin dose is negative. Methods can also include a carbohydrate suggestion when the selected insulin dose is negative.

Methods and devices described herein can be used instead of or with a system in conjunction with methods described in <CIT>.

Specific embodiments herein comprise an alarm or warning, sometimes referred to as an alert. More specifically, the alert is customizable and can be a visual alert, such as a displayed icon or message, or light, an audible alert, such as a beep or music, or a vibrational alert, or a combination thereof. The alert can have single and/or multiple modes of notification. For example, the alert can simultaneously include an audible, visual, and vibrational notification. When an event triggers the alert notification, the user may be notified of the event or condition by feeling the vibration, hearing the audible alert, and/or seeing the visual alert.

In one example, an event or a pattern can trigger an alarm or warning, or a combination of the two (i.e., an alert) that can be used to alert the patient to take specific actions whenever a particular event occurs. For example, the pattern can be a post-prandial event, hypoglycemic event, exercise, meals, etc. or any other problematic event or pattern that has occurred in the patient's past physiological data. Thus, when the event is detected again on a real-time basis, the system <NUM> will alert the patient to that fact such as via the display <NUM> and / or vibration and / or noise. The bolus calculator can have the processor <NUM> or multiple processors <NUM> (including the bolus calculator module <NUM>) interacting with various hardware and / or software to send the alert to a clinician if the person's glucose level falls below (or is predicted to fall below) a predetermined hypoglycemic threshold; an alert can also be sent if the measure of uncertainty is above a certain point. The bolus calculator can be configured to transmit the alert wirelessly and activate an application on the clinician's computer when the computer comes online and/or is otherwise turned on/activated.

In an embodiment, the first determined insulin bolus related to the received blood glucose value is calculated by utilizing one of the traditional bolus calculators described above.

According to the invention, the diabetes management application determines whether no user input is received in the given timeframe, and if so, can instruct a connected insulin therapy device to administer to the patient the lesser value of either the first calculated insulin bolus or the re-calculated insulin bolus. In another embodiment, if no such user input is received in the given timeframe, the system can utilize the first calculated insulin bolus as the amount to be administered to the patient or the system can be configurable by the patient to utilize either the first calculated insulin bolus or the re-calculated insulin bolus.

Regarding the re-calculated insulin bolus determination step, the bolus calculator (or bolus calculation method) can include a correction term within the bolus calculator which takes into account the body-worn sensor information. The correction term may be a factor applied to the first bolus calculated and/or a bolus shift value to add or subtract, respectively, to the first bolus calculated. The correction term will depend on the body parameter sensed by the additional sensor (different body parameters would call for the application of different correction terms). The relationship between the originally calculated bolus and the re-calculated bolus may in some embodiments be linear. In an embodiment, the re-calculated insulin bolus could for example be calculated using an algorithm as follows: <MAT>.

In embodiments where there is more than one body parameter considered for the calculation, the algorithm would include an analogous calculation in the same fashion for the additional body parameter.

The respective parameters an and bn described above can be stored in the system's firmware and in exemplary embodiments be activated and adjusted by health care practitioners and/or the user.

In another embodiment, the re-calculated insulin bolus could be calculated in the same way as the first calculated bolus, but the carbohydrate to insulin ratio, insulin sensitivity factor, and an offset compensating the activity-based basal need could be adjusted either singly or in combination to re-calculate the bolus.

In embodiments described herein, a carbohydrate input would be optional, since carbohydrate input information is needed only for meal bolus corrections.

In use, a patient would typically test their implemented algorithm in consultation with their health care practitioner to see if it suits his or her needs. If the deviation between the B1 and B2 values is too large, it may indicate some miscalculation. Thus, typically, a patient would have the opportunity through testing to find out which calculated bolus tends to be optimal for them. It is envisioned that after some amount of testing, a patient may be more comfortable with the performance of the algorithm and decide that he or she no longer needs to decide whether to accept the B1 or B2 value, but just accept the B2 value on an ongoing basis.

In embodiments herein, a significant deviation or a significant deviation threshold can be understood to constitute a difference in calculated bolus values of <NUM>% or greater. In particular, in one aspect, the significant deviation threshold could be set at <NUM>%. In another aspect, the user could adjust the amount of the significant deviation threshold number to be higher or lower, provided the significant deviation threshold could only be set at a value of <NUM>% or greater. In another embodiment, the significant deviation threshold could be a selectable threshold value using either a percentage or an absolute value in insulin units.

Typically, for risk minimization purposes, the insulin administration described here could be automatically carried out by the system. However, it is also envisioned in alternative aspects that the user could turn such an automatic insulin delivery feature off.

In the above-described method, the diabetes management application can optionally receive information about a carbohydrate content associated with a meal which is to be or was recently ingested prior to calculating the first determined insulin bolus, and the carbohydrate content information can be considered by the diabetes management application in determining the first calculated insulin bolus.

In selected embodiments, the body-worn sensor device can comprise a hearing aid and/or can comprise a smart watch or activity tracker, or alternatively, a combination of these devices.

The body parameter information could include at least one of the user's heart beat rate, internal body temperature, heart rate (pulse), respiratory rate, speed of movement or acceleration of movement. In one aspect, the user's body temperature would be measured by the body-worn sensor (e.g., in one aspect, a hearing aid such as the hearing aid <NUM> could be utilized which would measure the user's internal body temperature by utilizing a thermometer within the ear).

The informing step can optionally include providing an audible alert to the user by use of a hearing aid such as the hearing aid <NUM>.

In another embodiment, a diabetes management system for a continuous glucose monitoring (CGM) device is provided herein wherein the system is configured to:.

In this embodiment, the re-calculated insulin bolus would be computed in the same fashion as set forth above with respect to the previous embodiment.

The body-worn sensor device of this embodiment can include a hearing aid and/or a smart watch or activity tracker.

The body parameter information of this embodiment can include at least one of the user's heart beat rate, internal body temperature, respiratory rate, speed or acceleration.

The informing aspect of this embodiment can include providing an audible alert to the user by use of a hearing aid.

In general, bolus calculations carried out in the above embodiments are done in two parallel paths: path <NUM> is a standard or traditional bolus calculation (BC1) carried out in accordance with the prior art; and path <NUM> is a re-calculated computation (BC2) taking information of at least one additional body sensor into account. In selected embodiments, the two bolus calculation amounts are shown to the user.

A risk is probably established if these two paths lead to different (correction or meal) bolus values. This is where the above-mentioned significant deviation comes into play. Only in the event where there is a deviation above a preset threshold (the significant deviation amount) is there an impact on the diabetes management system which would require attention by the user.

According to the invention, if the user does not react within a given timeframe, the diabetes management system will automatically choose the lower calculated bolus to avoid a hypoglycemic condition for the user (even if the higher value would be correct).

After some time (for example, a period of weeks or months), the user supported by a health care practitioner may decide he or she is comfortable with the algorithm provided above. Together, they can fine-tune some correction factors (make adjustments) and test the algorithm under various daily conditions. At the end of this process, the optimized bolus calculation algorithm should deliver the right amount of insulin without user input (thus, the shut-off function could be utilized).

In certain embodiments, a diabetes management system can include a handheld medical device, a mobile computing device, and a diabetes management application. The handheld medical device can include a port configured to receive a test strip having a reaction site for receiving a sample of fluid from a patient, an optional real-time clock (RTC), and a blood glucose (bG) measurement system, cooperatively operable with a test strip inserted in the port, configured to measure glucose in a sample of fluid residing in the test strip and associate a first measurement time with the glucose measurement.

In selected embodiments, a computer-implemented diabetes management method is provided, comprising:.

In yet another embodiment, the diabetes management application receives information about a carbohydrate content associated with a meal which is to be ingested prior to determining the first determined insulin bolus, and wherein the carbohydrate content is considered by the diabetes management application in determining the first determined insulin bolus.

In yet another embodiment, the body-worn sensor device comprises a hearing aid.

In yet another embodiment, the body-worn sensor device comprises a smart watch or activity tracker.

In yet another embodiment, the body parameter information includes at least one of the user's heart beat rate, internal body temperature, respiratory rate, speed or acceleration.

In yet another embodiment, the informing step includes providing an audible alert to the user by use of a hearing aid.

In an arrangement useful for understanding the invention, a diabetes management method is provided and comprises the following steps:.

While several devices and components thereof have been discussed in detail above, it should be understood that the components, features, configurations, and methods of using the devices discussed are not limited to the contexts provided above. In particular, components, features, configurations, and methods of use described in the context of one of the devices may be incorporated into any of the other devices. Furthermore, not limited to the further description provided below, additional and alternative suitable components, features, configurations, and methods of using the devices, as well as various ways in which the teachings herein may be combined and interchanged, will be apparent to those of ordinary skill in the art in view of the teachings herein.

Having shown and described various versions in the present disclosure, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art.

The techniques described herein may be implemented by one or more computer programs executed by one or more processors. The computer programs include processor-executable instructions that are stored on a non-transitory tangible computer readable medium. The computer programs may also include stored data. Non-limiting examples of the non-transitory tangible computer readable medium are nonvolatile memory, magnetic storage, and optical storage.

Certain aspects of the described techniques include process steps and instructions described herein in the form of an algorithm. It should be noted that the described process steps and instructions could be embodied in software, firmware or hardware, and when embodied in software, could be downloaded to reside on and be operated from different platforms used by real time network operating systems.

Claim 1:
A computer-implemented diabetes management method for determining an insulin bolus by a diabetes management device (<NUM>) or component thereof comprising a processor (<NUM>), the method comprising:
receiving by the processor, a glucose value;
calculating by the processor a first calculated insulin bolus based on the received glucose value;
receiving by the processor body parameter information from at least one body-worn sensor device (<NUM>);
determining by the processor a re-calculated insulin bolus based on the body parameter information;
notifying by a first user interface (<NUM>) the user if there is a significant deviation between the amount of the first determined insulin bolus and the amount of the re-calculated insulin bolus;
receiving by the first user interface or by a second user interface (<NUM>) within a given timeframe a user input whether the calculated insulin bolus or the re-calculated insulin bolus is selected for bolus administration; and
determining by the processor a final insulin bolus if no user input was received within the given timeframe,
wherein the final insulin bolus is the lesser value of either the first calculated insulin bolus or the re-calculated insulin bolus.