Methods and systems for improved optical analyte measurements - Patents.com

Abstract

A method for measuring an analyte includes identifying a test strip in a video stream generated by a camera based on at least one registration mark associated with the test strip shown in the video stream, identifying an addition of a fluid dose to a deposition site formed on the test strip based on the video stream, starting a timer in response to identifying the addition of the fluid dose, generating at least one optical measurement of a reagent disposed at a measurement site on the test strip, and generating a measurement of an analyte in the fluid dose based on the at least one optical measurement of the reagent only in response to at least one optical measurement being generated after a predetermined minimum period of time has elapsed and before a predetermined maximum period of time has elapsed after starting the timer.

Description

[Technical field]

[0001] The present disclosure relates generally to the field of analyte measurement systems, and more specifically to optical measurement systems that assist a user in performing an analyte measurement process. [Background technology]

[0002] Analyte measurement systems known in the art allow for the analysis of a volume of bodily fluid provided by a user to identify the level of one or more analytes in the user's body using electronic devices and one or more electrochemical reactions. These analyte measurement systems provide significant benefits in providing accurate measurements of analytes (i.e., biological or environmental) in an individual user's fluid sample. Some analyte measurement systems use test strips having chemical reagents. Upon receiving a volume of fluid containing an analyte, the color of the reagent changes due to a chemical reaction between the reagent and the analyte, where the color change varies based on the concentration of the analyte, thus providing a measurement of the analyte. While many analytes are measured in this manner, one specific example of an analyte measured in a volume of fluid is glucose, which is measured in a volume of bodily fluid as part of the monitoring and treatment of diabetes.

[0003] Older color-changing test strip systems rely on a human observer to determine the analyte measurement by observing the color change in the reagent, often with the aid of a printed color matching guide. Such manual systems based on different human observer perceptions can present problems such as reduced accuracy and inconsistent measurements. More recently, automated analyte measurement devices have been developed that use cameras to observe the reagent to improve analyte measurement accuracy. For example, widely available smartphones contain optical sensors and digital image processing hardware that enable the smartphone to generate measurements of analytes in the test strip when the smartphone runs a specifically configured analyte measurement software application.

[0004] Although the use of specifically configured optical measurement devices improves analyte measurement, challenges remain in ensuring the accuracy of the measurement process. One such challenge is in ensuring that the optical measurement of the test strip is performed at the appropriate time after the test strip has received a dose of a given fluid. Taking the optical measurement too early can be inaccurate because the reagents have not had enough time to complete their chemical reaction with the analyte, but if the optical measurement is taken too late, the reagents may suffer drying or bleaching which affects the color of the reagent. Either situation can result in inaccurate analyte measurement results even if the test strip and analyte measurement device are fully operational. Therefore, improvements in optical analyte measurement systems that overcome these challenges would be beneficial. Summary of the Invention

[0005] In one embodiment, a method for measuring an analyte is developed, the method including: identifying a test strip in a video stream generated by a camera based on at least one registration mark associated with the test strip shown in the video stream; identifying by a processor an application of a fluid dose to a deposition site formed on the test strip based on the video stream; initiating by the processor a timer in response to identifying the application of the fluid dose; generating by an optical sensor at least one optical measurement of a reagent disposed at a measurement site on the test strip; and generating by the processor a measurement of an analyte in the fluid dose based on the at least one optical measurement of the reagent only in response to the at least one optical measurement being generated after a predetermined minimum period of time has elapsed after the timer has been started and before a predetermined maximum period of time has elapsed after the timer has been started.

[0006] In a further embodiment, the method includes identifying a vial in a video stream generated by the camera based on at least one of a contour shape of the test vial or at least one registration mark located on the vial shown in the video stream, identifying an opening of the vial in the video stream based on the at least one registration mark located on a lid of the vial by the processor, and identifying the removal of a test strip from the vial after identifying the opening of the vial in the video stream based on the at least one registration mark associated with the test strip shown in the video stream.

[0007] In a further embodiment of the method, the at least one registration mark associated with the vial further includes an indicia formed on a label of the vial.

[0008] In a further embodiment of the method, the at least one registration mark disposed on the lid of the vial further comprises a color marking formed on an inner surface of the lid.

[0009] In a further embodiment of the method, the at least one registration mark associated with the test strip further comprises a printed mark formed on one side of the test strip at a predetermined location relative to the deposition site.

[0010] In a further embodiment, the method includes identifying by the processor that the back side of the test strip is exposed in the video stream based on the absence of a printed mark formed on one side of the test strip, and generating by the processor and the output device an output message indicating that the test strip should be rotated to expose the side of the test strip having the printed mark.

[0011] In a further embodiment of the method, the at least one registration mark associated with the test strip further comprises an indicia formed on a back surface of the color card that holds the test strip.

[0012] In a further embodiment, the method of identifying adding a dose includes identifying, by a processor, a user's finger in the video stream; identifying, by the processor, contact of the finger with the deposition site in the video stream; and identifying, by the processor, adding a dose in response to a change in optical properties of the deposition site in the video stream after contact of the finger with the deposition site.

[0013] In a further embodiment, the method of identifying to add a dose further comprises identifying, by the processor, to add a dose in response to a change in an optical property of the deposition site in the video stream.

[0014] In a further embodiment, the method of identifying adding a dose further comprises identifying, by the processor, adding a dose in response to contact of a finger with the deposition site in the video stream.

[0015] Further embodiments include generating, by the processor and output device, an output message informing a user that measurement of the analyte in the fluid dose cannot be completed in response to no optical measurements of the measurement site being generated after a predetermined minimum period of time has elapsed and before a predetermined maximum period of time has elapsed.

[0016] In a further embodiment of the method, the optical sensor generating the measurements is a camera generating a video stream.

[0017] In a further embodiment of the method, the optical sensor generating the measurements is a different camera than the camera generating the video stream.

[0018] In a further embodiment of the method, the camera is integrated into the wearable electronic device and the optical sensor is integrated into the mobile electronic device.

[0019] In another embodiment, a system for measuring an analyte is developed. The system includes a wearable electronic device and a mobile electronic device. The wearable electronic device includes a camera configured to generate a video stream and a transmitter configured to transmit the video stream to the mobile electronic device. The mobile electronic device includes a receiver configured to receive the transmitted video stream from the wearable electronic device, an optical sensor configured to generate optical measurements, a memory configured to store program instructions, and a processor operatively connected to the receiver, the optical sensor, and the memory. The processor is configured to execute program instructions to: identify a test strip in the video stream based on at least one registration mark associated with the test strip shown in the video stream; identify an application of a fluid dose to a deposition site formed on the test strip based on the video stream; start a timer in response to applying the fluid dose; generate at least one optical measurement value of a reagent disposed at a measurement site on the test strip by an optical sensor; and generate a measurement value of an analyte in the fluid dose based on the at least one optical measurement value of the reagent only in response to at least one optical measurement value being generated after a predetermined minimum period of time has elapsed after the timer is started and before a predetermined maximum period of time has elapsed after the timer is started.

[0020] In a further embodiment, the processor is further configured to identify a vial in the video stream generated by the camera based on at least one registration mark located on the vial shown in the video stream, identify an opening of the vial in the video stream based on at least one of a contour shape of the test vial or the at least one registration mark located on a lid of the vial, and identify the removal of a test strip from the vial after identifying the opening of the vial in the video stream based on the at least one registration mark associated with the test strip shown in the video stream.

[0021] In a further embodiment of the system, the at least one registration mark associated with the vial further includes an indicia formed on a label of the vial.

[0022] In a further embodiment of the system, the at least one registration mark disposed on the lid of the vial further comprises a color marking formed on an inner surface of the lid.

[0023] In a further embodiment of the system, the at least one registration mark associated with the test strip further includes an indicia formed on one side of the test strip at a predetermined location relative to the deposition site.

[0024] In a further embodiment, the processor is configured to identify that the back side of the test strip is exposed in the video stream based on the absence of an indicia formed on one side of the test strip, and to generate an output message via an output device indicating that the test strip should be rotated to expose the one side of the test strip having the indicia.

[0025] In a further embodiment of the system, the at least one registration mark associated with the test strip further includes an indicia formed on a back surface of the color card that holds the test strip.

[0026] In a further embodiment, the processor is configured to identify a user's finger in the video stream, identify contact of the finger with the deposition site in the video stream, and apply a dose in response to a change in optical properties of the deposition site in the video stream after contact of the finger with the deposition site.

[0027] In a further embodiment, the processor is configured to identify by the processor the application of the dose in response to a change in an optical property of the deposition site in the video stream.

[0028] In a further embodiment, the processor is configured to identify by the processor the application of the dose in response to contact of a finger with the deposition site in the video stream.

[0029] In a further embodiment, the system includes an output device in at least one of the wearable electronic device or the mobile electronic device, and the processor is operably connected to the output device and is further configured to generate an output message informing a user that measurement of the analyte in the fluid dose cannot be completed in response to no optical measurement being generated at the measurement site after a predetermined minimum period of time has elapsed and before a predetermined maximum period of time has elapsed.

[0030] Advantages, benefits, features and objects, in addition to those set forth above, will become more readily apparent from a consideration of the following detailed description, which refers to the drawings, in which: [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 illustrates components in an analyte measurement system that uses wearable and mobile electronic devices to identify when a test strip receives a dose during the analyte measurement process. [Diagram 2] FIG. 2 is a schematic diagram illustrating components of the wearable and mobile electronic devices of FIG. 1. [Diagram 3] FIG. 2 is a process block diagram for the operation of the analyte measurement system. [Figure 4] 1A-1D show a series of views of a vial holding a test strip as the vial is opened and the test strip is removed from the vial. [Diagram 5] 1A-1D show a series of views of a test strip receiving a fluid dose. [Figure 6] 1A-1C show a series of views of a test strip placed on a color card to receive a fluid dose. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] These and other benefits, advantages, features and objects will become better understood from the following description, in which reference is made to the accompanying drawings which form a part hereof and in which embodiments of the inventive concepts are shown by way of example, and not by way of limitation, and in which corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.

[0033] While the inventive concept is susceptible to various modifications and alternative forms, exemplary embodiments of the present invention are shown by way of example in the drawings and described in detail herein. However, it should be understood that the following description of exemplary embodiments is not intended to limit the inventive concept to the particular form disclosed, but rather to include all advantages, effects, and features within the spirit and scope defined by the embodiments described herein and the following embodiments. Therefore, reference should be made to the embodiments described herein and the following embodiments to interpret the scope of the inventive concept. As such, it should be noted that the embodiments described herein may have advantages, effects, and features that are useful in solving other problems.

[0034] The devices, systems, and methods will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all, embodiments of the inventive concepts are shown. Indeed, the devices, systems, and methods may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

[0035] Similarly, many modifications and other embodiments of the devices, systems, and methods described herein will come to mind to one skilled in the art to which this disclosure pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. It is therefore to be understood that the devices, systems, and methods are not limited to the particular embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of the embodiments. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

[0036] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure pertains. Although any methods and materials similar or equivalent to those described herein can be used in practicing or testing the methods, the preferred methods and materials are described herein.

[0037] Furthermore, the reference to an element by the indefinite article "a" or "an" does not exclude the possibility of the presence of a plurality of elements, unless the context clearly requires that there is one and only one element. Thus, the indefinite article "a" or "an" usually means "at least one". Similarly, the terms "have", "comprise" or "include", or any grammatical variants thereof, are used in a non-exclusive manner. Thus, these terms may refer both to the situation in which no further features are present in the entity described in this context, in addition to the features introduced by these terms, and to the situation in which one or more further features are present. For example, the expressions "A has B", "A comprises B", and "A includes B" may both refer to the situation in which, apart from B, no other elements are present in A (i.e., A consists solely and exclusively of B), or the situation in which, apart from B, one or more further elements are present in A, such as element C, elements C and D, or further elements.

[0038] As used herein, the term "mobile electronic device" refers to a portable computing device that provides a user with one or more of the following components: output devices, input devices, memory, and wireless communication devices, each controlled by one or more processors in the mobile electronic device. As used herein, the term "wearable electronic device" refers to a type of mobile electronic device that is further adapted to be worn by a human user, similar to eyeglasses, clothing, watches, or jewelry. Examples of output devices include, but are not limited to, liquid crystal display (LCD) displays, organic or inorganic light emitting diode (LED) displays, and other forms of graphic display devices, audio speakers, and haptic feedback devices. Examples of input devices include, but are not limited to, buttons, keyboards, touch screens, and audio microphones. Examples of memory include, but are not limited to, both volatile data storage devices, such as random access memory (RAM), and non-volatile data storage devices, such as magnetic disks, optical disks, and solid-state storage devices, including EEPROM, NAND flash, or other forms of solid-state data storage devices. Examples of wireless communication devices include, but are not limited to, radio transceivers that operate with Near Field Communication (NFC) protocols, the Bluetooth® protocol family including Bluetooth® Low Energy (BLE), the IEEE 802.11 protocol family ("Wi-Fi"), and cellular data transmission standards (such as "4G" or "5G"). Examples of processors include one or more central processing units (CPUs), graphic processing units (GPUs), neural network processors (NPUs), digital signal processors (DSPs), field programmable gate arrays (FPGAs), digital logic devices implementing application specific integrated circuits (ASICs), and any other suitable digital logic devices within an integrated device or as a combination of devices operating together to implement a processor. Common examples of mobile electronic devices include, but are not limited to, smartphones, tablet computing devices, and notebook computers.Common examples of wearable electronic devices include, but are not limited to, smart watches and smart glasses.

[0039] 1 illustrates an analyte measurement system 100 that includes a wearable electronic device 104 and a mobile electronic device 140. During operation, the wearable electronic device 104 generates a video stream that enables the mobile electronic device 140 to track a vial 160 holding one or more test strips 170 to identify when the test strip 170 receives a fluid dose, such as a blood dose from a subject's finger 190. As described in more detail below, the system 100 initiates a timer upon detecting the application of a fluid dose to a deposition site 172 on one side of the test strip 170 to enable an optical sensor 142 on the mobile electronic device 140 to measure an optical measurement of a measurement site 178 on a backside 170' of the test strip after a predetermined minimum time has elapsed and before a predetermined maximum time has elapsed.

[0040] In FIG. 1, the test strip 170 includes a deposition site 172 where a user provides a liquid blood sample. The test strip 170 also includes a registration mark 174, shown as a printed mark in the form of an index arrow on the surface of the test strip 170 at a predetermined position relative to the deposition site 172. Aperture 176 is formed at one end of the test strip 170. The registration mark 174 allows for efficient identification and tracking of the test strip 170, including identification of which side of the test strip 170 faces the camera in the video stream. In the example of FIG. 1, only one side of the test strip 170 is configured to receive a blood sample and the registration mark 174 is formed only on this side of the test strip 170, but in alternative embodiments the test strip may be configured to receive a blood dose on either side of the test strip. The back side 170' of the test strip refers to the same test strip 170, but the back side of the test strip that is visible includes a measurement site 178 and aperture 176. When the backside 170' of the test strip is in view, neither the registration mark arrow indicator 174 nor the deposition site 172 are visible to the camera 108. In some embodiments, the system 100 can detect when the backside 170' of the test strip is exposed to the camera 108. In the test strip 170, the deposition site 172 provides a fluid inlet that allows a fluid dose to permeate one or more internal layers in the test strip to allow a chemical reaction with one or more reagents in the test strip. Examples of internal layers include, for example, filters and different layers of chemical reagents that are responsive to one or more analytes in the fluid dose. The measurement site 178 is an optically exposed area formed on the backside 170' of the test strip that changes color in response to the level of analyte in the fluid dose that permeates the test strip from the deposition site 172. In one configuration, the reagent is directly exposed at the measurement site 178, while in another configuration, an optically clear layer, such as a thin film, covers the reagent while providing an optical aperture. Both configurations allow for the generation of an optical measurement of the reagent to detect a color change of the reagent upon reaction with an analyte in the fluid volume.

[0041] With reference to the schematic diagrams in FIG. 1 and FIG. 2, in one embodiment of the system 100, the wearable electronic device 104 is embodied as glasses, also referred to as "smart glasses," although other forms of wearable electronic devices, including smart watches, may be used in alternative configurations. The wearable electronic device 104 includes a frame and optical lenses similar to traditional glasses. The wearable electronic device 104 further includes a camera 108, a position sensor 112, and a head-up display (HUD) 116, each of which is operatively connected to an electronic control unit 120. The camera 108 is, for example, a CMOS or other suitable digital imaging device that generates images and video streams of an area in front of the wearable electronic device 104 that corresponds to the field of view of a person wearing the wearable electronic device 104. In some embodiments, a single black and white or color camera generates the video stream as a two-dimensional video stream. In other embodiments, the camera 108 is further configured to generate a video stream that provides three-dimensional object data. In one configuration, the camera 108 further incorporates two or more cameras that provide stereoscopic video, while in another configuration, the camera 108 includes a depth sensor that provides three-dimensional depth information corresponding to objects in the video stream. The position sensor 112 includes, for example, a microelectromechanical (MEM) three-axis gyroscope and one or more accelerators that provide data to identify the spatial orientation of the wearable electronic device 104 during operation. The HUD 116 provides visual output to the wearer without the wearer having to change his or her line of sight to a particular display device. Although FIG. 1 shows the HUD 116 separate from a glass lens in the wearable electronic device 104, alternative configurations provide one or more visual display devices that are integrated into the lens or that project a graphic output onto the lens. Although not shown in further detail, the wearable electronic device 104 also optionally includes an audio output device.

[0042] The electronic control unit 120 houses at least one wearable electronic device processor 204 operatively connected to the camera 108, the position sensor 112, and the HUD 116. The electronic control unit 120 further houses a memory 208 and a communication transceiver 228 operatively connected to the wearable electronic device processor 204. In the embodiment of FIG. 2, the memory 208 stores firmware instructions 212 that control the operation of the wearable electronic device 104. The communication transceiver 228 includes a transmitter that enables transmission of data, including a video stream, to a corresponding communication transceiver 258 in the mobile electronic device 140. The communication transceiver 228 further includes a receiver that enables the wearable electronic device 104 to receive data from the mobile electronic device 140, among other things, to receive messages from the mobile electronic device 140 for display to the user via the HUD 116. In the example of FIG. 2, the communications transceiver 228 is a Bluetooth® or Bluetooth® Low Energy wireless data communications transceiver, although alternative configurations may use a different wireless communication standard or may employ a wired connection interface such as Universal Serial Bus (USB).

[0043] 1 and the schematic diagram in FIG. 2, in one embodiment of the system 100, the mobile electronic device 140 further includes a mobile electronic device processor 224 operably connected to a timer 226, a memory 232, a communications transceiver 258, an optical sensor 142, and one or more display and user input / output (I / O) devices 146. The mobile electronic device 140 is operably connected to the wearable electronic device 104 using the transceiver 258 to communicate with a corresponding transceiver 228 in the wearable electronic device 104.

[0044] In the mobile electronic device 140, the optical sensor 142 is, for example, a digital camera that generates still images or videos of the test strip 170, including the measurement site 178 located on the backside 170' of the test strip and optionally the color card 180, to generate at least one optical measurement for analysis to measure the analyte level in the fluid dose applied to the test strip. The optical sensor 142 and camera 108 in the wearable electronic device 104 may be configured with similar hardware in some embodiments, but in the configuration of FIG. 1, the camera 108 is configured to generate a video stream that captures the entire scene including the vial 160, the test strip 170, and the deposition site 172, optionally the color card 180, and a finger 190 to identify when the test strip 170 receives the fluid dose. The optical sensor 142 is configured to generate one or more optical measurements of the measurement site 178 on the backside 170' of the test strip at an appropriate time after the fluid dose is applied to provide an input to the analyte measurement process. The optical measurement is, for example, a digital photograph including the measurement site 178 on the backside 170' of the test strip. As such, the camera 108 provides a broader view of the elements used in the analyte testing process, while the optical sensor 142 provides a more detailed digital image or video of the reagents on the test strip 170, and optionally, calibration data provided on the color card 180. In an alternative configuration, a single camera performs the functions of both the camera 108 in the wearable electronic device 104 and the optical sensor 142 in the mobile electronic device 140. For example, the single camera may be reconfigured to generate a lower resolution video stream for identification and tracking of the vial 160, test strip 170, color card 180, and finger 190 to enable the mobile electronic device 140 to identify when the test strip 170 receives a fluid dose. The single camera can then operate at a higher resolution to capture one or more high fidelity images of the back side 170' of the test strip alone or together with the color card 180 to provide input for the analyte measurement process.

[0045] In the mobile electronic device 140, user input / output (I / O) devices 146 include a touchscreen display that provides graphical output to the user and receives touch input to control the operation of the mobile electronic device 140, and more particularly, to provide input to the analyte measurement process. Other examples of I / O devices include a microphone for speech input, a speaker for audio output, mechanical buttons, and the like. In some configurations, the wearable electronic device 104 implements user I / O devices such as a voice input device or a gesture tracking input device that uses the camera 108 to record input from the user that the camera 108 transmits to the mobile electronic device 140. The wearable electronic device 104 may further receive output data from the mobile electronic device 140 for display to the user via the HUD 116.

[0046] In the mobile electronic device 140, the timer 226 enables the mobile electronic device processor 224 to maintain an elapsed time count during operation, including counting the elapsed time beginning when the test strip 170 receives a fluid dose to ensure that an optical measurement of the reagent for analyte measurement occurs after a predetermined minimum time has elapsed and before a predetermined maximum time has elapsed. Although the timer 226 is shown as a separate component for illustrative purposes, in many practical embodiments the timer 226 will be integrated into the mobile electronic device processor 224 as a timer circuit or implemented as a software timer.

[0047] In the mobile electronic device 140, the memory 232 includes one or more non-volatile and volatile data storage devices. In the configuration of FIG. 2, the memory 232 stores application software 250 and operating system software 254, both of which contain instructions executed by the mobile electronic device processor 144. The application software 250 includes instructions implementing a user interface and an analyte analysis program to perform an analyte measurement process based on image analysis of one or more optical measurements of a reagent on the test strip 170. The application software 250 also stores a predetermined minimum elapsed time threshold and a predetermined maximum elapsed time threshold to ensure that an optical measurement is generated after the fluid dose has had sufficient time to react with the reagent in the test strip 170, but before the maximum useful life for measuring the analyte has elapsed. As described in more detail below, part of the analyte measurement process includes identifying the vial 160, removing the test strip 170, and identifying contact of the finger 190 with the test strip 170 to apply a fluid dose to the deposition site 172. The application software 250 further includes object recognition data 252 that enables the mobile electronic device processor 224 to perform automatic object identification and tracking of the vial 160 and test strip 170 in the video stream received from the wearable electronic device 104. The object recognition data 252 is generated through a training process that occurs prior to distribution of the application software 250. Among other things, the training process utilizes predetermined shapes, colors, and patterns of registration marks formed on the vial 160, test strip 170, back side 170' of the test strip, and color card 180 to enable automatic identification and tracking of these components in the video stream. Examples of object recognition data 252 include image classifiers such as neural networks, among other things, convolutional neural networks, support vector machines, hidden Markov models, and one-dimensional and two-dimensional barcode scanning engines.Additionally, object recognition data 252 may include filters for color detection and edge detection along with other image processing data necessary for tasks such as object detection and image segmentation to enable tracking of objects such as vials 160, test strips 170, and color cards 180 in the video stream. Operating system (OS) software 254 includes a software kernel, drivers, libraries, and other system software associated with a standard commercially available operating system. The OS software 254 provides standardized services such as network and graphics stacks, a file system for data storage and management, software access to optical sensors 142, displays, and I / O devices 146, timers 226, communications transceivers 258, and other components in the mobile electronic device 140.

[0048] In the mobile electronic device 140, the communications transceiver 258 includes a transmitter that enables transmission of data, including command data and output message data, to a corresponding transceiver 228 in the wearable electronic device 104. The communications transceiver 258 further includes a receiver that enables the mobile electronic device 140 to receive data from the mobile electronic device 140, among other things, to receive a video stream from the camera 108 in the wearable electronic device 104. In the example of FIG. 2, the communications transceiver 258 is a Bluetooth® or Bluetooth® low energy wireless data communications transceiver, although alternative configurations may use a different wireless communication standard or may employ a wired connection interface, such as USB.

[0049] FIG. 1 further shows a vial 160 and a color card 180. The vial 160 stores one or more of the test strips 170. In addition to providing storage, the vial 160 protects the test strips from contamination in the environment, including preventing the reagents in the test strip 170 from absorbing excessive amounts of moisture and light from the surrounding environment. The vial 160 further includes a printed label 162 having one or more registration marks, shown as dashed indicator registration marks 163 printed along one or more edges of the label 162 in FIG. 1, or another suitable surface of the vial 160 in another embodiment. The outline shape of the vial 160 and the registration marks 163 form a simple visual indicator that allows efficient identification and tracking of the vial 160 in the video stream generated and transmitted by the wearable electronic device 104 to the mobile electronic device 140. The registration marks 163 are widely distributed on the exterior of the vial 160 to allow identification and tracking of the vial 160 from a wide range of viewing angles and when a user's hand holds the vial 160. Alternative embodiments of the registration marks of the vial 160 include printed pattern indicia including, for example, a bar code, or engraved or embossed geometric shapes formed on the exterior of the vial 160 that aid in automatic identification and tracking of the vial 160. In the embodiment of FIG. 1, the lid 164 provides access to the interior of the vial 160. The lid 164 may be fully removable or may remain attached to the body of the vial 160 while open. In either configuration, a second registration mark 168 is formed on the interior surface of the vial lid 164. The second registration mark 168 is, for example, a circle or other geometric shape formed in a predetermined color that contrasts with the color of the vial 160 to provide a clear indication that the vial 160 is open in the video stream that the wearable electronic device 104 generates during use of the vial 160.In an alternative embodiment, registration mark 168 is a one- or two-dimensional bar code or other registration mark that is identifiable to an automated vision algorithm. Registration marks 163 and 168 allow for both accurate identification of vial 160 and determination when vial 160 is closed or open.

[0050] During operation, the optical sensor 142 detects a color change in a reagent visible at a measurement site 178 on the backside 170' of the test strip in response to one or more chemical reactions with an analyte in the fluid dose. In the example of FIG. 1, the color change in the reagent disposed at the measurement site 178 indicates the level of glucose analyte in the blood sample. As described above, the system 100 identifies when the deposition site 172 has received a fluid dose and uses a timer to determine when the optical sensor should generate a subsequent optical measurement of the measurement site 178 to ensure an accurate measurement of the blood glucose level. While the system 100 shows a test strip including separate deposition sites 172 and measurement sites 178 for illustrative purposes, one skilled in the art will recognize that alternative test strips provide a single deposition site and measurement site with the reagent disposed in the same location on the same area of ​​the test strip. As such, in some embodiments, the deposition site and the reagent occupy separate locations on the test strip, while in other embodiments, the deposition site and the reagent refer to one location on the test strip.

[0051] In FIG. 1, color card 180 is an optional component with a back side shown in FIG. 1 that holds test strip 170 in place prior to administration. Color card 180 also has a front side (not shown) that includes a predetermined array of colors and other reference markings that aid in calibrating the image from optical sensor 142 for accurate color measurement of exposed measurement site 178. Apertures 186 in color card 180 allow measurement sites 178 on back side 170' of the test strip to be measured by the optical sensor within the color pattern of color card 180. The back side of color card 180 includes registration marks 182 and 184, which are shown as arrow indicia printed on the back side of color card 108 in the exemplary embodiment of FIG. 1. Registration marks 182 and 184 are associated with test strip 170 and further aid in identifying and tracking test strip 170 in the video stream to detect when test strip 170 receives a fluid dose. Color card 180 is optional, and system 100 is configured to use test strip backside 170' separately or in conjunction with color card 180 to generate optical measurements of reagent at measurement site 178 on test strip backside 170' to measure glucose analyte in a blood sample.

[0052] 3 illustrates a process 300 for operation of system 100 to perform an analyte testing operation with automatic detection of when a fluid dose is applied to a deposition site of a test strip and automatic timing of when system 100 should generate one or more optical measurements of a measurement site to measure the level of analyte in the fluid dose. In describing process 300, references to a process that performs a function or action refer to the operation of one or more digital processors, such as the processors in wearable electronic device 104 and mobile electronic device 140, to execute stored program instructions to perform the function or action in conjunction with other components in system 100.

[0053] The process 300 begins with the activation of a camera, such as the camera 108 in the wearable electronic device 104, to generate a video stream of a scene in front of the user at the start of the analyte testing process (block 304). In the system 100, the user begins execution of the application software 250, and the mobile electronic device 140 sends a command to the wearable electronic device 104 to activate the camera 108. In the embodiment of FIG. 1, the wearable electronic device processor 204 activates the camera 108 and transmits a video stream from the camera 108 to the mobile electronic device 140 using a transceiver 228, so that the mobile electronic device processor 224 can receive the video stream for further processing using a corresponding transceiver 258. As is commonly known in the art, the video stream includes a series of frames of image data indicative of a view from the camera 108 over time during the analyte testing process.

[0054] The process 300 continues with the mobile electronic device processor 224 identifying the vial 160 in the video stream generated by the wearable electronic device 104 (block 308). Numerous digital image processing techniques may be used to identify an object, such as the vial 160 or other object detected in the video stream during the process 300, although non-limiting examples of preferred techniques are described in further detail herein. The identification process for the vial 160 further includes an object tracking operation that segments different portions of frames in the video stream that contain the object, and an object identification operation that uses an image classifier to identify the tracked object.

[0055] In an object tracking operation, the mobile electronic device processor 224 in the mobile electronic device 140 identifies and tracks one or more objects shown in the video stream. To track the objects, the mobile electronic device processor 224 performs a contour detection operation that identifies boundaries of various objects in the video stream that have similar image intensity values, including the boundaries of the vial 160. In particular, each frame of the video stream is formed as a two-dimensional array of pixels, and the mobile electronic device processor 224 identifies contours based on adjacent pixel regions that have the same or similar number of pixel values ​​in either color data (e.g., red / green / blue) or monochromatic image data (e.g., grayscale values). In some configurations, the mobile electronic device processor 224 performs image pre-processing operations, such as converting the color video stream to grayscale, binarizing the grayscale pixels, and performing edge detection processing to improve the accuracy of the contour detection process. The mobile electronic device processor 224 segments the original image using, for example, a rectangular bounding box that encircles the detected contour region, and the mobile electronic device processor 224 performs a contour detection process across a series of video frames to track the movement of the object, such as as the user moves the vial 160. For example, as shown in view 404 of Figure 4, the video stream shows the vial 160, and the mobile electronic device processor 224 generates a segment of a rectangular bounding box 406 in frames of the video stream that contain the detected contour of the vial 160. Although view 404 shows the vial 160 separately, some frames in the video stream contain multiple objects, and the contour detection process described above enables tracking of multiple objects in the video stream.

[0056] Once the tracking operation is complete, the mobile electronic device processor 224 has access to one or more image segments that contain the object, but has not yet determined the identity of the particular object. For example, the mobile electronic device processor 224 has tracked an object in image segment 406, but has not yet identified whether the object is a vial 160 or some other object. The object tracking process results in multiple image segments that can improve the accuracy of an image classifier for detection of multiple objects of interest that may occupy different portions of a frame in a video stream. To complete the object identification process, the mobile electronic device processor 224 provides the segmented portion of the image containing the tracked object as an input to a trained image classifier having object recognition data 252 stored in memory 232. The image classifier is, for example, a trained convolutional neural network (CNN) or other suitable image classifier that is trained to identify a predetermined set of objects, such as the inside of a vial 160 and a vial lid 164, either side 170 / 170' of a test strip, a color card 180, or a finger 190. The training process of the image classifier occurs prior to process 300 and uses a set of training images that include multiple examples of objects to be identified in various expected situations that will occur during the analyte testing process. The image classifier is trained, for example, using a gradient descent training process that is otherwise known in the art. The image classifier is trained to either explicitly or implicitly recognize some or all of the outline shape of the vial 160, the registration mark features 163 formed on the vial 160, the inside of the vial lid 164, on either side 170 / 170' of the test strip, on the color card 180, to improve accuracy in identifying a given object. Additionally, the training process can include training examples that occur when the registration marks are only partially visible to the camera 108, such as when a user holds the vial 160 in a hand that may obscure some of the registration marks 163.The mobile electronic device processor 224 optionally performs additional pre-processing of the image data, which may include resizing the image data to a predetermined resolution or performing a rotational transformation of the image based on metadata received from a position sensor 112 in the wearable electronic device 104 that identifies the angular orientation of the camera 108 when each frame of the video stream is generated to improve the accuracy of the image classifier. In some configurations, the image classifier is trained using monochromatic image data, while in other configurations, color images are preferred, including configurations in which registration marks are formed using predetermined colors that aid the image classifier in identifying objects. The classifier also rejects unrelated objects that may be present in the video stream as unrelated. Furthermore, because the video stream includes a series of frames, the mobile electronic device 140 can recognize the vial 160 in one or more frames of the video stream even if the tracking or identification process is not successful in a portion of the video stream frames. One example of a software framework that enables the image processing operations described above in the application software 250 is the Open Computer Vision (OpenCV) project, available at https: / / opencv.org / . The process described above for identification of vial 160 is substantially the same as the process described below for identification of other objects in the video stream during process 300.

[0057] During the vial identification process, the mobile electronic device 140 optionally sends graphics, such as icons or animations, to the wearable electronic device 104 to assist the user in identifying the next step in the process for performing the test analysis. For example, the mobile electronic device 140 sends a graphic icon corresponding to the shape of the vial 160 to the wearable electronic device 104, and the wearable electronic device processor 204 generates a graphical display of the icon using the HUD 116 to alert the user to remove the vial 160 and place it in the field of view of the camera 108 until successful identification of the vial 160 in the video stream. In FIG. 4, view 404 shows an icon 408 that the HUD 116 overlays on the view recorded by the camera 108 to prompt the user to remove the vial 160.

[0058] Referring again to Figure 3, the process 300 continues with the mobile electronic device processor 224 identifying the vial 160 to be opened (block 312) in response to detecting the formed registration mark 168 formed on the inside of the lid 164 on the vial 160. Referring to Figure 4, the view 412 shows the lid 164 removed from the vial 160 with the registration mark 168 visible on the inside of the lid 164. The mobile electronic device processor 224 tracks and identifies the lid 164 in the image segment 416 in the same manner as described above with respect to the vial 160. Additionally, the mobile electronic device 140 optionally sends an icon of the lid to the wearable electronic device 104, which displays the icon 420 on the HUD 116 to guide the user.

[0059] 3 and 4, the process 300 continues with the mobile electronic device processor 224 identifying that the test strip 170 has been removed from the opened vial 160 (block 316). The mobile electronic device processor 224 tracks and identifies the test strip 170 within the image segment 428 in the same manner as described above with respect to the vial 160 and lid 164, as shown in view 424. Additionally, the mobile electronic device 140 optionally transmits an icon of the test strip to the wearable electronic device 104, which displays an icon 432 in the HUD 116 to guide the user. As shown in FIG. 4, in some instances, the user removes the test strip with the backside 170′ visible to the camera 108. The mobile electronic device processor 224 tracks and identifies the back side 170' of the test strip in region 430 and optionally generates an output message to the user via the HUD 116 or another output device 146 to rotate the test strip so that the side 170 of the test strip with the registration mark 174 and the deposition site 172 are visible in the video stream. The absence of the registration mark 174 on the back side 170' of the test strip, and optionally other distinct features of the back side 170', provide sufficient differentiation for the image classifier to distinguish between the sides 170 / 170' of the test strip. If the test strip 170 is flipped over to expose the back side 170' prior to receiving the fluid dose, this operation is performed at a subsequent stage of the process 300. Although view 424 shows vial 160, inside lid 164, and test strip 170 simultaneously for illustrative purposes, detection of the removal of test strip 170 from vial 160 only requires sequential detection of vial 160, inside lid 164, and test strip 170 in the same video stream within a relatively short period of time, such as a 10, 30, or 60 second time window. As such, vial 160, lid 164, and test strip 170 do not need to be identified simultaneously in the video stream for process 300 to identify that test strip 170 has been removed from vial 160.

[0060] During process 300, if the mobile electronic device processor 224 does not identify the vial 160, the inside of the lid 164 indicating the vial 160 is open, or the sequence of removal of the test strip 170 within the predetermined period of time (block 320), the process 300 returns to the processing described above with respect to block 308 so that the user can repeat the process. Upon successfully identifying that the test strip 170 has been removed from the vial 160 (block 320), the process 300 proceeds with the mobile electronic device processor 224 continuing to track the identified test strip 170 in the video stream (block 328). In one configuration, the mobile electronic device processor 224 tracks the test strip 170 separately as shown in view 504 of FIG. 5. In another configuration utilizing a color card 180, the mobile electronic device processor 224 identifies the color card 180 based at least in part on the registration mark arrows 182 and 184 and tracks the insertion of the test strip 170 into the color card 180, as shown in view 604 of FIG. 6. After identifying the test strip 170 and before the test strip 170 receives a fluid dose, the mobile electronic device processor 224 stores in memory 232 at least one image of the test strip, including the deposition site 172. As described in more detail below, at least one optical property of the deposition site 172 changes after the deposition site 172 receives a fluid dose, and the change in the optical property enables detection of when the test strip 170 receives a fluid dose.

[0061] The process 300 continues with the mobile electronic device processor 224 identifying the addition of a fluid dose to the deposition site 172 on the test strip 170 based on the video stream and starting the timer 226 upon identifying the addition of the fluid dose (block 332). In one configuration, the mobile electronic device processor 224 identifies the user's finger 190 in the video stream using the same procedures described above for identifying the vial 160, lid 164, test strip 170, and color card 180. The mobile electronic device processor 224 further identifies contact between the finger and the deposition site 172 in the video stream. For example, contact is identified in response to the finger 190 obscuring the test strip 170 in the video stream, as shown in view 508 of FIG. 5 and view 608 of FIG. 6. After identifying the contact, the mobile electronic device processor 224 identifies that a fluid dose has been applied to the deposition site 172 based on a change in at least one optical property of the deposition site 172 in the video stream relative to a previously recorded image of the deposition site 172, as shown in view 512 of FIG. 5 and view 612 of FIG. 6. Examples of optical properties of the deposition site 172 that change after the deposition site 172 receives a fluid dose include a change in one or more of color, contrast, and brightness of the deposition site 172 caused by the application of the fluid dose. In another configuration, the mobile electronic device processor 224 omits identifying the finger 190 and the contact of the finger 190 with the test strip 170 in the video stream. In this simplified configuration, the mobile electronic device processor 224 continues to track the test strip 170 until it detects a change in at least one optical property of the deposition site 172 to identify that the test strip 170 has received a fluid dose. In yet another configuration, the mobile electronic device processor 224 omits identifying changes in the optical properties of the deposition site 172 and instead detects administration of the test strip 170 based on detecting contact between the finger 190 and the test strip 170 in the video stream.In this simplified configuration, the mobile electronic device processor 224 identifies contact based on the finger 190 obscuring the test strip 170 in the video stream or close proximity of the finger 190 to the test strip 170, such as in views 508 and 608. This configuration allows detection of administration of the test strip in situations where poor ambient lighting conditions make detection of changes in optical properties at the administration site 172 difficult to detect. In all three configurations, the mobile electronic device processor 224 starts the timer 226 upon detecting the application of a fluid dose to the deposition site 172 on the test strip 170.

[0062] The process 300 proceeds when the timer 226 reaches a predetermined minimum time, and the mobile electronic device processor 224 optionally generates an output signal to a user that the optical sensor 142 should be used to generate one or more optical measurements of the measurement site 178 on the backside 170' of the test strip (block 336). The mobile electronic device processor 224 generates an output on the display touch screen 146 of the mobile electronic device 140 or via the HUD 116 of the wearable electronic device 104 to indicate that the optical sensor 142 should proceed to optically measure the test strip and generate one or more optical measurements of the measurement site 178 (block 340). The mobile electronic device processor 224 optionally generates an output including a countdown timer to indicate the time remaining in a predetermined time window after the expiration of the minimum period and before the expiration of the predetermined maximum period for generating optical measurements. In one configuration, the mobile electronic device processor 224 activates the optical sensor 142 only after the timer 226 indicates that a predetermined minimum period of time has expired, and in another configuration, the mobile electronic device processor 224 only accepts optical measurements from the optical sensor 142 that have a timestamp that falls within a predetermined time window. While the exact predetermined minimum and maximum periods for generating optical measurements may vary between embodiments, in one configuration, the minimum period of time after fluid dose administration is 13 seconds and the maximum period of time is 45 seconds. This results in a 32 second time window for the optical sensor 142 to produce one or more optical measurements of the measurement site 178.

[0063] After the timer 226 reaches the expiration of the predetermined maximum period, the mobile electronic device 224 generates an output to indicate that the maximum period has expired (block 344). If a sufficient number of optical measurements are generated before the expiration of the predetermined maximum period (block 348), the mobile electronic device processor 224 proceeds with the analyte measurement process based on the optical measurements (block 352). In another configuration, if the optical sensor 142 generates a sufficient number of optical measurements before the expiration of the predetermined maximum period, the mobile electronic device processor 224 optionally initiates the measurement process of block 352 without waiting for the expiration of the timer 226. Although not described in further detail herein, the analyte measurement process analyzes the color, and optionally other optical properties, of the reagent at the measurement site 178 on the test strip to determine the level of an analyte in the fluid sample, such as the level of glucose in the blood sample. In a configuration using a color card 180, the mobile electronic device processor 224 uses additional optical data from the color card 180 to assist in the analyte measurement process. The mobile electronic device 140 displays the analyte level measurements to the user via the display device 146, the HUD 116 in the wearable electronic device 104, or another output device. In the system 100 and process 300, the reliability of the analyte measurement process is increased because all of the optical measurements are generated during a predetermined window of time to ensure that the reagents in the test strip 170 not only have enough time to complete their chemical reactions prior to the generation of the optical measurements, but also do not suffer from dehydration or bleaching prior to the completion of the optical measurement process.

[0064] During process 300, if the predetermined maximum period of time expires before a sufficient number of optical measurements are generated (block 348), the mobile electronic device processor 224 does not proceed with the analyte measurement process and the mobile electronic device 140 generates an output message indicating that the analyte measurement cannot be completed and instructing the user, using the display device 146, the HUD 116 on the wearable electronic device 104, or via another output device, to start the analyte testing process again (block 356).

[0065] As described above, process 300 performs object identification that initiates identification of the test strip vial 160 and the opening of the lid 164 in the video stream, which allows system 100 to verify that the test strip 170 has been removed from the vial 160, rather than the test strip being unattached because it may have been outside the vial 160 for an extended period of time. Some test strips may have become contaminated if left outside the vial for an extended period of time. However, in a simplified configuration of process 300, system 100 omits identification of the test strip vial 160, the lid 164, and the removal of the test strip 170 from the vial 160. In the simplified configuration, it initiates generation of the video stream and tracking and identification of the test strip 170 in the same manner as described above. In this configuration, process 300 does not verify that the test strip 170 has been removed from the vial, which may not be necessary for some analyte testing systems. This simplified implementation of process 300 is otherwise identical to the process described above.

[0066] Although the embodiments disclosed herein use separate wearable electronic device 104 and mobile electronic device 140 for illustrative purposes, one skilled in the art will recognize that a single electronic device can be configured to perform the operations described herein. Notably, state of the art wearable electronic devices typically interface with a mobile electronic device for complex operations, whereas a better wearable electronic device can perform all of the functions described herein. Alternatively, the mobile electronic device 140 can be configured to perform all of the functions described herein using the optical sensor 142 as a camera to generate a video stream, and to perform other processing as described above. As such, specific references to processor operations in both the wearable electronic device processor 204 and the mobile electronic device processor 224 in the above description refer individually, in combination, and alternatively to the operation of a single processor in a configuration using a single electronic device.

[0067] The present disclosure has been described in connection with what are considered to be the most practical and preferred embodiments. However, these embodiments are presented by way of example and are not intended to be limited to the disclosed embodiments. Accordingly, those skilled in the art will recognize that the present disclosure encompasses all modifications and alternative arrangements, as set forth in the following claims, that are within the spirit and scope of the present disclosure.

Claims

1. 1. A method for measuring an analyte, comprising: identifying, by a processor, a test specimen in a video stream generated by a camera based on at least one registration mark associated with the test specimen shown in the video stream; identifying, by the processor, a fluid dose to be applied to a deposition site formed on the test strip based on the video stream; initiating a timer by the processor in response to the identifying the adding of the fluid dose; generating at least one optical measurement of a reagent disposed at a measurement site on the test strip with an optical sensor; generating, by the processor, a measurement value of the analyte in the fluid dose based on the at least one optical measurement value of the reagent only in response to the at least one optical measurement value being generated after a predetermined minimum period of time has elapsed after the activation of the timer and before a predetermined maximum period of time has elapsed after the activation of the timer.

2. identifying, by the processor, a vial in a video stream generated by a camera based on at least one of a contour shape of a test vial or at least one registration mark disposed on the vial shown in the video stream; identifying, by the processor, an opening of the vial in the video stream based on at least one registration mark located on a lid of the vial; 10. The method of claim 1, further comprising: identifying, by a processor, the removal of the test strip from the vial after identifying the opening of the vial in the video stream based on the at least one registration mark associated with the test strip shown in the video stream.

3. The method of claim 2 , wherein the at least one registration mark associated with the vial further comprises an indicia formed on a label of the vial.

4. 3. The method of claim 2, wherein the at least one registration mark disposed on the lid of the vial further comprises a color marking formed on an inner surface of the lid.

5. The method of claim 1 , wherein the at least one registration mark associated with the test strip further comprises a printed mark formed on one side of the test strip at a predetermined location relative to the deposition site.

6. identifying, by the processor, that a backside of the test strip is exposed in the video stream based on the absence of the printed mark formed on the one side of the test strip; 6. The method of claim 5, further comprising generating, by the processor and an output device, an output message indicating that the test strip should be rotated to expose the side of the test strip having the printed mark.

7. The method of claim 1 , wherein the at least one registration mark associated with the test strip further comprises an indicia formed on a back surface of a color card that holds the test strip.

8. Identifying the adding of the dose comprises: identifying, by the processor, a user's finger in the video stream; identifying, by the processor, contact between the finger and the deposition site in the video stream; 10. The method of claim 1, further comprising identifying, by the processor, administering the dose in response to a change in optical properties of the deposition site in the video stream after the contact of the finger with the deposition site.

9. 10. The method of claim 1, wherein identifying the administering of the dose further comprises identifying, by the processor, the administering of the dose in response to a change in optical properties of the deposition site in the video stream.

10. 10. The method of claim 1, wherein identifying the applying of the dose further comprises identifying, by the processor, the applying of the dose in response to contact of the finger with the deposition site in the video stream.

11. 10. The method of claim 1, further comprising generating, by the processor and output device, an output message informing the user that measurement of the analyte in the fluid dose cannot be completed in response to no optical measurements of the measurement site being generated after the predetermined minimum period of time has elapsed and before the predetermined maximum period of time has elapsed.

12. The method of claim 1 , wherein the optical sensor that generates the measurements is the camera that generates the video stream.

13. The method of claim 1 , wherein the optical sensor that generates the measurements is a different camera than the camera that generates the video stream.

14. The method of claim 13 , wherein the camera is integrated into a wearable electronic device and the optical sensor is integrated into a mobile electronic device.

15. 1. A system for the measurement of an analyte, comprising: A wearable electronic device and a mobile electronic device, wherein the wearable electronic device comprises: a camera configured to generate a video stream; a transmitter configured to transmit the video stream to the mobile electronic device; The mobile electronic device a receiver configured to receive the video stream transmitted from the wearable electronic device; an optical sensor configured to generate optical measurements; a memory configured to store program instructions; a processor operatively connected to the receiver, the optical sensor, and the memory, the processor executing the program instructions to: identifying a test specimen in the video stream based on at least one registration mark associated with the test specimen shown in the video stream; identifying, based on the video stream, to apply a fluid dose to a deposition site formed on the test strip; and initiating a timer in response to said adding said fluid dose; generating at least one optical measurement of a reagent disposed at a measurement site on the test strip with the optical sensor; generating a measurement value of the analyte in the fluid dose based on the at least one optical measurement value of the reagent only in response to the at least one optical measurement value being generated after a predetermined minimum period of time has elapsed after starting the timer and before a predetermined maximum period of time has elapsed after starting the timer.

16. The processor: identifying a vial in the video stream generated by a camera based on at least one registration mark disposed on the vial shown in the video stream; identifying an opening of the vial in the video stream based on at least one of a contour shape of a test vial or at least one registration mark disposed on a lid of the vial; 16. The system of claim 15, further configured to: identify removal of the test strip from the vial after identifying the opening of the vial in the video stream based on the at least one registration mark associated with the test strip shown in the video stream.

17. 17. The system of claim 16, wherein the at least one registration mark associated with the vial further comprises an indicia formed on a label of the vial.

18. 17. The system of claim 16, wherein the at least one registration mark disposed on the lid of the vial further comprises a color marking formed on an inner surface of the lid.

19. 16. The system of claim 15, wherein the at least one registration mark associated with the test strip further comprises an indicia formed on one side of the test strip at a predetermined position relative to the deposition site.

20. The processor: identifying a backside of the test specimen as exposed in the video stream based on the absence of the indicia formed on the one side of the test specimen; 20. The system of claim 19, further configured to: generate, by an output device, an output message indicating that the test strip should be rotated to expose the side of the test strip having the indicia.

21. 16. The system of claim 15, wherein the at least one registration mark associated with the test strip further comprises an indicia formed on a back surface of a color card that holds the test strip.

22. The processor: identifying a user's finger in the video stream; identifying contact between the finger and the deposition site in the video stream; and identifying the administering of the dose in response to a change in optical properties of the deposition site in the video stream after the contact of the finger with the deposition site.

23. 16. The system of claim 15, wherein the processor is further configured to identify the administering of the dose in response to a change in an optical property of the deposition site in the video stream.

24. 16. The system of claim 15, wherein the processor is further configured to identify the application of the dose in response to contact of the finger with the deposition site in the video stream.

25. further comprising an output device in at least one of the wearable electronic device or the mobile electronic device; 25. The system of claim 15, wherein the processor is operably connected to the output device and is further configured to generate an output message informing the user that measurement of the analyte in the fluid dose cannot be completed in response to no optical measurement of the measurement site being generated after the predetermined minimum period of time has elapsed and before the predetermined maximum period of time has elapsed.

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