HK1144366B - Method and apparatus for trend alert calculation and display - Google Patents

Description

Method and apparatus for trend alert calculation and display

RELATED APPLICATIONS

Priority is claimed FOR U.S. non-provisional application No. 12/120,400 filed on 14.5.2008 AND U.S. provisional application No. 60/938,621 filed on 17.5.2007 entitled "METHOD AND APPARATUS FOR tree extension CALCULATION AND DISPLAY". The entire contents of the above application specification, except for portions that are inconsistent with this specification, if any, are hereby fully incorporated by reference.

Technical Field

Embodiments of the present invention relate generally to the field of medical devices, and more particularly to methods, apparatus and systems associated with detecting, monitoring, analyzing and/or displaying trends in the level of an analyte in a body.

Background

Hypoglycemia (hypoglycemia) can be a serious event for diabetics who take insulin or oral medications. In some cases, hypoglycemia can result in loss of cognitive ability, spasticity, paralysis, or coma. Adverse effects from hypoglycemia range from embarrassment (loss of thinking in a meeting) to more serious consequences such as an automobile accident. For these reasons, hypoglycemia detection is one of the most important benefits of continuous blood glucose monitoring. Hyperglycemia (hyperglycemia) can also cause problems, such as damage to nerves, blood vessels, and tissues, and can lead to more serious conditions such as ketoacidosis or hypertonic condition syndrome.

It would therefore be beneficial to provide a user with a simple and effective mechanism for monitoring a user's glucose values and glucose level trends in order to assist the user in managing and controlling glucose levels. Monitoring, detecting, analyzing, and/or displaying the levels or trends of other analytes may also provide benefits.

Drawings

Embodiments of the present invention will be readily understood by the following detailed description in conjunction with the accompanying drawings. Embodiments of the invention are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings.

FIG. 1 illustrates a display for an electronic monitoring unit according to an embodiment of the invention;

FIG. 2 illustrates an exemplary electronic monitoring unit showing various display feature items according to various embodiments of the present invention;

FIG. 3 illustrates an exemplary display element showing a change interval of a change rate option according to embodiments of the invention; and

FIG. 4 illustrates an exemplary analyte sensing system for implementing various embodiments of the present invention.

Detailed Description

In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of embodiments in accordance with the present invention is defined by the appended claims and their equivalents.

Various operations may be described as multiple discrete operations in turn, in a manner that is helpful in understanding various embodiments of the invention; however, the order of description should not be construed as to imply that these operations are order dependent.

The description may use perspective-based descriptions such as up/down, back/front, and top/bottom. This description is merely for convenience in discussion and is not intended to limit the application of embodiments of the present invention.

The terms "coupled" and "connected," along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Rather, in particular embodiments, "connected" may be used to indicate that two or more elements are in direct physical or electrical contact with each other. Coupled may mean that two or more elements are in direct physical or electrical contact with each other. However, "coupled" may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other.

For the purposes of this description, a phrase in the form "A/B" or "A and/or B" means "(A), (B), or (A and B)". For the purposes of this description, a phrase in the form of "at least one of A, B and C" means "(A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C)". For the purposes of this description, a phrase in the form of "(A) B" means "(B) or (AB)", i.e., A is an optional element.

The description may use the phrases "in one embodiment," or "in an embodiment," which may each refer to one or more of the same or different embodiments. In addition, the terms "comprising", "including", "having", and the like are used as synonyms for embodiments of the present invention.

In various embodiments of the present invention, methods, devices, and systems are provided for detecting, analyzing, and/or displaying trends in analyte levels in a body. In an exemplary embodiment of the invention, one or more components of the disclosed apparatus and/or system may be assigned to a computing system, and one or more methods described herein may be performed with the computing system.

Embodiments of the present invention provide methods, devices and systems associated with detecting, monitoring, analyzing and/or displaying trends in the levels of analytes in a body. Embodiments of the present invention provide a display mechanism that indicates trends in the levels of analytes in the body.

In one embodiment, a method is provided that includes obtaining a plurality of analyte metrics from a body using an analyte sensing device, and selecting two or more metrics of the plurality of metrics for calculating and displaying a rate of change of an analyte over a time period spanning the two or more metrics on a device associated with the analyte sensing device.

In another embodiment, a method is provided that includes measuring a plurality of analyte values of an individual at a plurality of time points over a defined time period with an analyte sensing device, determining a rate of change of the plurality of analyte values at the plurality of time points over the defined time period, and displaying a graphical representation of the rate of change, wherein the determined rate of change is represented as a best-fit rate of change in a plurality of predefined options indicative of relative rates of change, and wherein the best-fit rate of change is highlighted.

In an embodiment, there is also provided an apparatus/system for performing the methods described herein.

In one embodiment, the phrase "relative rates of change" refers to various rates of change whose rate differences are distinguished from one another, whether or not the differences are determined by numerical values.

In one embodiment, the phrase "best-fit rate of change" refers to the identified and/or highlighted rate of change(s) selected from a set of predefined options for respective rates of change that is closest to the calculated/determined rate of change, or meets a selection rule indicating selection, identification, display, and/or highlighting of a particular predefined option.

In one embodiment, any suitable analyte may be measured, such as glucose or lactate, and the associated values may be displayed as described herein.

Embodiments of the present invention provide a mechanism to calculate the rate of change of glucose levels in the body and display the rate of change or a reasonable substitute in graphical form for viewing by a user, health professional or other individual. The rate of change may be calculated from the slope of a line between two or more points, or a best fit to a plurality of points. Thus, in one embodiment, glucose values may be plotted over time, the values may be adapted with a straight line, and a slope of the straight line indicative of the change in glucose values over the analyzed time period may be provided. In one embodiment, the slope of the line may be displayed to the user, health professional, or other individual in various ways to provide information about the trend and/or rate of change of the user's glucose value.

In one embodiment, the rate of change (slope) may be determined for two or more data values within a time period. In one embodiment, a suitable time period may be less than 10 minutes, or may be, for example, from 5 minutes to 30 minutes or more. Any suitable number of data values, such as 1 per second, 1 per minute, may be obtained within the defined time period, whether or not the incremental rules between metrics are regular. In one embodiment, data values may be generated continuously, and two or more data values may be selected that represent analyte values at selected times or times that are potentially somewhat drifting due to the occurrence of sensor delays.

In one embodiment, the calculated rate of change may be displayed directly to the user. For example, if the calculated rate of change is 2mg/dl/min, the device may display text that reads "2 mg/dl/min," where the reading is somehow associated with an indication of a display value representing the rate of change. In one embodiment, positive rates of change may be shown with or without a "+" sign, and negative rates of change may be shown with or without a "-" sign, although in various embodiments, some indicator, whether textual, symbolic, graphical, colored, or otherwise, may be used that distinguishes between positive and negative rates of change.

In one embodiment, the calculated rate of change may be displayed to the user by displaying a graphic representing the rate of change, whether representing an accurately calculated rate or a best fit. For example, in one embodiment, a line may be displayed whose slope matches the slope of the fitted line from which the analyte value was obtained. In a related embodiment, instead of simply using a straight line, an arrow pointing in the direction of the slope may be used. In embodiments, other objects or indicators may be used.

In other embodiments, predefined options may be provided that represent various rates of change, and a particular calculated/determined rate of change may be represented by the option that most closely matches the calculated/determined rate of change ("best-fit rate of change"), although it is not necessarily an exact match. In one embodiment, to avoid underestimating the degree of hypoglycemic or hyperglycemic tendency, the value that is the farthest from the stable value (no current change) may be selected when the calculated/determined rate of change falls between the two values. Such embodiments relate to including one or more selection rules that indicate selection, identification, display and/or highlighting of a particular option of a plurality of predefined options. For example, if the selectable options include "0" or "no change rate", "2 mg/dl/min", and "4 mg/dl/min", and the calculated change rate is 3mg/dl/min, then in one embodiment, the "4 mg/dl/min" option may be selected. A downside of this approach is that it may increase the number of situations (such as so-called "false alarms") that a user appears to be in a state of concern or danger. Alternative methods may also be used (i.e. selecting a value closer to "0" or "no change rate" when the calculated value lies between two defined options). Such a system would reduce the number of "false alarms," but may also underemphasize actual conditions or concerns. The above-described case illustrates an exemplary selection rule, and other rules indicating the selection process may be implemented according to an embodiment of the present invention.

FIG. 1 illustrates an example display for an electronic monitoring unit in accordance with an embodiment of the invention. FIG. 1 shows a current glucose value 102 displayed in mg/dl according to a highlighted selected display type 104 (pressing the option "Menu" for options). The current glucose value 102 is also shown with a directional arrow 106 to indicate the current glucose trend of the individual. In addition, the display includes a signal indicator 108, a battery power indicator 110, and a current date/time indication 112(1 month 31, three weeks, three afternoons 5:54(5:54PM Wed, Jan 31)).

In one embodiment, the directional arrow 106 may have a slope that exactly or substantially matches the slope of the rate of change of the glucose value over a defined period of time.

In alternative embodiments, the display may provide a straight line, a bar graph, or a curve such as a semicircle (such as the right semicircle of a circle), for example, along which one or more rates of change may be indicated. For example, the rate of change may be calculated and the point at which it lies along a line, histogram, or curve representing the calculated rate of change may be highlighted in some manner. For example, a point, arrow, or tick mark may be presented, illuminated, and/or flashed at a location that indicates the calculated rate of change.

For purposes of various embodiments of the present invention, the term "highlighting" broadly refers to graphically distinguishing one element from another, whether using light, color, hue, brightness, shape, or the like.

In one embodiment, the rate of change of the indicia (e.g., illumination) may be dynamic. In other words, a graphical or textual form may be presented that provides a representation showing the calculated rate of change. In other embodiments, the identified (e.g., illuminated) rate of change may be one option in a set of predefined options, where each option is associated with a defined rate of change. In such embodiments, the calculated rate of change may be compared to the predefined options to determine the best fit among the predefined options, and the best fit option may be highlighted. In one embodiment, for example, more than one option (object, etc.) may be illuminated to show the rate of change that falls between two illuminated predefined options. As mentioned above, in one embodiment, a selection rule may be implemented that provides that the selected best fit option is always a higher option or a lower option, or the selection of the best fit may depend on a particular metric (the steepness/slope of the hypoglycemic trend relative to the hyperglycemic trend, or the rate of change).

In one embodiment, a straight line, histogram, or curve may be provided with a number of predefined options for the represented rate of change. In other words, a series of options may be predefined, such as "no change", "+ 2 mg/dl/min", "-2 mg/dl/min", and so on. In one embodiment, the calculated rate of change may be displayed by highlighting a predefined option that is closest to the calculated rate of change.

In one example embodiment, a curve illustrating half a clock face from a 12 o 'clock position to a 6 o' clock position may be used. In such an embodiment, every minute and/or a set thereof (such as every 5 minutes, etc.) over the sweep area along 180 degrees (30 minutes) may be used as a predefined option to represent the rate of change. In one embodiment, a tick mark or other graphic, text, and/or number at each minute or defined location may be highlighted in some manner to indicate that particular location as a representation of the current rate of change of glucose value. In one embodiment, a clock hand, with or without an arrow, may be used to indicate a particular minute or defined location along the curve as represented by the current rate of change to the glucose value.

In the embodiment of the invention shown in fig. 2, the exemplary electronic monitoring unit 202 provides various notification and display feature items (features). FIG. 2 illustrates a display 204 according to an embodiment of the invention. The display 204 has a time/date characteristic item 206 shown in exemplary form and may include a date, time, and/or other elements, if present. In one embodiment, the display 204 may also show various text messages, instructions, notifications, and the like, such as an instruction 208 (press wheel for options) is pressed). In one embodiment, display 204 shows measuring a current glucose value 210, displayed in mg/dl, from an individual using an electronic monitoring unit and associated glucose sensor. In addition, the display 204 includes a curve 212, such as a semi-circular curve having 5 triangular objects 214. In one embodiment, subject 214 may be used to identify a rate of change of a glucose level/value within an individual. Thus, in one embodiment, the object 214 may be predefined as relating to a particular rate of change. As an example, the highest object (appearing as an arrow pointing upward) may be associated with a glucose rate of change of +10mg/dl/min (or greater), while the lowest object (appearing as an arrow pointing downward) may be associated with a glucose rate of change of-10 mg/dl/min (or greater). As another example, the next object 214 along the curve may be associated with +/-5mg/dl/min, and so on.

In one embodiment, the opposite or mirrored graphical indicators may have the same or different absolute differences relative to the "no change" value. As noted above, in one exemplary case, the relative indicators may be, for example, +10mg/dl/min and-10 mg/dl/min. In an alternative embodiment, relative indicators may be used to indicate that there may be different relative levels of interest in a hypoglycemic region relative to a hyperglycemic region. In such an embodiment, a rate of change of-10 mg/dl/min may be of serious concern, and an arrow pointing straight down or other indicator may be used, while the opposite arrow may be a reflection of a rate of change of +15mg/dl/min, as opposed to the hypoglycemic region, to reflect a different level of concern in the hyperglycemic region.

In FIG. 2, although the objects 214 are shown as 5 triangular objects, any number of arbitrarily shaped objects may be used, whether the objects are all the same or different. For example, in one embodiment, there may be 3, 5, 7, 9, 11 or more predefined options for subjects or glucose trends. An even number of objects may also be used; however, for symmetry and ease purposes, using an odd number allows for a balanced number of objects around the center object that indicates a stable glucose value (i.e., no change).

In one example embodiment, objects related to glucose change rates of 0, +/-2, +/-4, +/-6, +/-8, +/-10mg/dl/min may be provided at 0, +/-18, +/-36, +/-54, +/-72, +/-90 degrees. Other angles may be used in other embodiments.

In one embodiment, one of the objects 214 is highlighted, such as illuminated, colored, flashing, etc., to indicate a current trend, such as illustrated by object 216. In one embodiment, the objects 214 that are not highlighted may not be displayed, or shown in a light color, a different color, faded out, in dashed lines, etc., in order to ensure that the current trend is clearly discernable, such as with the highlighted object 216.

In one embodiment, the degree of glucose rise/fall may change the manner in which a selected object (such as object 216 in FIG. 2) is highlighted or shown. For example, an object indicating a steady rate of glucose change may show a green object and/or steady light, an object indicating a medium rate of glucose change may show a yellow object and/or pulsating light, and another object indicating a fast rate of glucose change may show a red object and/or rapidly pulsating light. In one embodiment, the highlighted one of the predefined options described above may also be displayed in conjunction with text stating the current state or trend (such as "slow down" or "fast up," etc.).

In one embodiment, the options may be separated at equal intervals (such as in 2mg/dl/min increments), or may have varying intervals. For example, in one embodiment, as the rate of change of the various values increases (more positive or negative rate), the interval between options may decrease to provide a more accurate report/display to the user as the level of attention increases. Fig. 3 illustrates an exemplary display element 302 showing the interval of change of the rate of change option at a particular value (rate of change) highlighted 304.

In one embodiment, various audible or visual displays of various degrees of attention may be provided by an electronic monitoring unit or other associated device. For example, the electronic monitoring unit 202 may provide an indication of the activity to be taken based on the state or extent of interest using various suggestion buttons or lights 218 that provide exemplary suggestion options for injections, snacks (symbolized as apples), or workouts. In one embodiment, an additional advice button may provide an indication to contact the medical professional.

Embodiments of the present invention may be used with a variety of known or later developed glucose sensors or monitors. For example, in one embodiment, the glucose sensor may be a small diameter lead-based device that may be inserted into the skin for 3-7 days. In another embodiment, a suitable sensor may be provided in a device that is fully implanted subcutaneously and remains inserted for 3-12 months. The biosensor(s) may be coupled in various ways to implantable or transcutaneous electrical components and/or to an external monitoring unit capable of performing various calculations and analyses as well as data display. In one embodiment, the various graphics described herein may be displayed on the screen of an electronic monitoring unit, which may be worn on a belt or belt, for example, or located within a desktop unit, to which data may be sent via a wired or wireless connection. In one embodiment, the display may provide text or numerical readings, and/or may show various graphical representations. In one embodiment, the various graphics described herein may be displayed on a patient's personal computer or other computing device.

FIG. 4 illustrates an exemplary analyte sensing system for implementing various embodiments of the present invention. In fig. 4, the on-skin unit 402 contains various electrical components such as a transmitter 404. An analyte sensor 406 inserted into the skin 408 of the individual extends outward and is electrically coupled to the on-skin unit 402. The analyte sensor 406 obtains an analyte value or a value representative thereof, and this information may be communicated to the on-skin unit 402 and transmitted by the transmitter 404 to the receiver 412 in the electronic monitoring unit 414. Various information regarding the obtained values or calculations associated therewith may be displayed on the display 416 of the electronic monitoring unit 414.

In these embodiments, various types of notifications, such as warnings or alerts, may be used to indicate a current status, particularly a status of interest, such as audible (warning or electronic voice prompt), visual (e.g., colored or flashing lights or symbols on a display), and/or vibratory notifications. In one embodiment, the notification may provide an indication of the degree of risk or the state of interest. In one embodiment, the notification may also provide an indication or suggestion of activity to take as a result of the focus state.

In one embodiment, the sensing system may provide a recommendation to eat a snack in the next 30-60 minutes, for example, if it is determined that there is a moderate risk of developing hypoglycemia in the monitored individual, or if the data indicates a critical hypoglycemic trend and/or a rapid decrease in glucose levels. In one embodiment, these recommendations may be customized based on the individual's specific medical, athletic, and dietary parameters. In another embodiment, if an extreme state of hyperglycemia is identified, a notification may be provided to contact a health care professional to resolve the situation.

In one embodiment, the status of interest may also be communicated to the medical professional directly from the sensing device or from a separate monitoring unit, whether manually or automatically, on demand or programmed into the system.

In one embodiment, an audible warning may be provided to indicate a significant abnormality in glucose, such as a glucose value above or below a given threshold. In one embodiment, an audible alarm may be provided to indicate the rate of change of glucose values that, if continued, may result in a warning condition. In embodiments, various sounds may be used for alarms and/or warnings. In one embodiment, the sound used for the warning may be different from the sound used for the alarm. For example, a ring tone may be used for the alert, and a short tweet or ring tone may be used for the warning. In one embodiment, multiple tones and/or volume adjustments may be used to represent the level of interest.

Although certain embodiments have been illustrated and described herein for purposes of description of the preferred embodiment, it will be appreciated by those of ordinary skill in the art that a wide variety of alternate and/or equivalent embodiments or implementations calculated to achieve the same purposes may be substituted for the embodiments shown and described without departing from the scope of the present invention. Those with skill in the art will readily appreciate that embodiments in accordance with the present invention may be implemented in a very wide variety of ways. This application is intended to cover any adaptations or variations of the embodiments discussed herein. Therefore, it is manifestly intended that embodiments in accordance with the present invention be limited only by the claims and the equivalents thereof.

Claims (14)

1. A method for trend alert calculation and display, comprising:

measuring a plurality of analyte values of an individual at a plurality of time points within a defined time period using an analyte sensing device;

determining a rate of change of the plurality of analyte values at a plurality of time points within a defined time period; and

displaying a graphical representation of the rate of change, wherein the determined rate of change is represented as a best-fit rate of change in a plurality of predefined options indicative of relative rates of change, wherein the best-fit rate of change is highlighted, and wherein the best-fit rate of change is determined according to a selection rule that selects one rate of change as a best-fit change as opposed to another rate of change in conjunction with one or more factors.

2. The method of claim 1, wherein the graphical representation is displayed on an electronic monitoring unit or on a personal computer.

3. The method of claim 1, wherein the graphical representation depicts a plurality of predefined options indicating relative rates of change.

4. The method of claim 1, further comprising indicating a second notification of a current or future state based on the determined rate of change.

5. The method of claim 4, wherein the second notification is displayed as a textual description of a current state or a future state.

6. The method of claim 4, wherein the second notification comprises an audible alarm or warning.

7. The method of claim 1, wherein highlighting the best-fit rate of change comprises highlighting more than one rate of change when the determined rate of change is not an exact match of a single predefined best-fit rate of change.

8. A method for trend alert calculation and display, comprising:

obtaining a plurality of analyte metrics from a body using an analyte sensing device; and

selecting two or more analyte metrics of a plurality of analyte metrics for calculating and displaying, on a device associated with an analyte sensing device, a rate of change of the analyte over a period of time spanning the two or more analyte metrics, wherein the rate of change is a best-fit rate of change selected from a plurality of predefined options indicative of relative rates of change, and wherein the best-fit rate of change is determined according to a selection rule that selects one rate of change as a best-fit change as opposed to another rate of change in conjunction with one or more factors.

9. The method of claim 8, wherein the displayed rate of change is a representation of the calculated rate of change.

10. The method of claim 8, further comprising indicating a second notification of a current or future state based on the determined rate of change.

11. The method of claim 10, wherein the second notification is displayed as a textual description of a current state or a future state.

12. The method of claim 10, wherein the second notification comprises an audible alarm or warning.

13. An apparatus for trend alarm calculation and display, comprising:

an analyte sensing device coupled to an electronic monitoring unit, the electronic monitoring unit comprising a storage medium and a plurality of programming instructions stored in the storage medium, the programming instructions adapted to program a device to enable the device to perform the following:

measuring a plurality of analyte values of an individual at a plurality of time points within a defined time period using an analyte sensing device;

determining a rate of change of the plurality of analyte values at a plurality of time points within a defined time period; and

displaying a graphical representation of the rate of change, wherein the determined rate of change matches a best-fit rate of change in a plurality of predefined options indicative of relative rates of change, wherein the best-fit rate of change is highlighted, and wherein the best-fit rate of change is determined according to a selection rule that selects one rate of change as a best-fit change as opposed to another rate of change in conjunction with one or more factors.

14. A method for trend alert calculation and display, comprising:

measuring a plurality of analyte values of an individual at a plurality of time points within a defined time period using an analyte sensing device;

determining a rate of change of the plurality of analyte values at a plurality of time points within a defined time period; and

displaying a graphical representation of the rate of change, wherein the determined rate of change is represented as a best-fit rate of change in a plurality of predefined options indicative of relative rates of change, wherein the best-fit rate of change is highlighted, and wherein highlighting a best-fit rate of change comprises highlighting more than one rate of change when the determined rate of change is not an exact match of a single predefined best-fit rate of change.