System and method for automated optical analyte measurements via wearable smart devices

Patent metadata

Field	Value
Publication number	US-12450901-B2
Application number	US-202418640369-A
Country	US
Kind code	B2
Filing date	Apr 19, 2024
Priority date	Oct 22, 2021
Publication date	Oct 21, 2025
Grant date	Oct 21, 2025

Abstract

Systems and methods for measuring an analyte include devices configured to perform an analyte testing operation. The devices include a wearable electronic device and a remote device operatively connected to each other and each having a processor, the processors cooperating with each other in the execution of program instructions to measure an analyte. The wearable electronic device includes a camera configured to generate a video stream, which is analyzed to identify missing test components, to identify the application of a body fluid on a test strip where the sample undergoes changes in one or more optical properties, the image of which is analyzed to determine a level of the analyte. The wearable electronic device further includes a head-up display (HUD) for providing output messages to the user relating to the performance and status of the analyte testing operation.

First claim

The invention claimed is:

1. A system for measurement of an analyte comprising:
a wearable electronic device and a remote device, the wearable electronic device comprising:
a camera configured to generate a video stream;
a first communication transceiver configured to transmit and receive communications to and from a second communication transceiver at the remote device;
a head-up display (HUD);
a first memory configured to store program instructions; and
a first processor operatively connected to the first communication transceiver, the camera, and the first memory, the first processor being configured to execute the program instructions;

the remote device further comprising:
a second memory configured to store program instructions; and
a second processor operatively connected to the second transceiver and the second memory, the second transceiver configured to transmit and receive communications to and from the first communication transceiver;

the wearable electronic device and the remote device being operatively connected to each other, wherein the first processor and second processor cooperate to execute the program instructions to:
identify test components in the video stream and provide guidance to the user via the HUD of required test components not detected in the video stream;
identify the application of a bodily fluid sample to a deposit site on a test strip based on the video stream;
activate a timer in response to confirmation of the application of the bodily fluid sample;
after a minimum period of time and before a maximum period of time from the activation of the timer, generating via the camera at least one image of the test strip including at least a portion of a measurement site, the at least one image being captured after guidance to the user via the HUD for positioning the test strip a predetermined distance and angular orientation relative to the camera;
analyze optical properties of at least a portion of the measurement site within the image to determine a level of an analyte; and
display the level of the analyte on the HUD.

2. The system of claim 1 , wherein the program instructions proceed based on one or more inputs from the user upon completion of at least one of the steps of application of the bodily fluid sample to a deposit site of the test strip and generating the at least one image.

3. The system of claim 1 , wherein the program instructions proceed based on an automatic tracking of user activities and automatic identification of components required for the analyte testing operation, at least one of the first processor and second processor being configured for performing the automatic tracking and automatic identification via a video stream generated by the camera.

4. The system of claim 3 , wherein at least one of the first and second processors 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 depicted in the video stream;
identify an opening of the vial in the video stream based on at least one registration mark located on a lid of the vial; and
identify extraction of the test strip from the vial after the identification of the opening of the vial in the video stream based on at least one registration mark associated with the test strip depicted in the video stream.

5. The system of claim 4 , wherein the at least one registration mark associated with the vial further comprises an indicator formed on a label of the vial.

6. The system of claim 4 , wherein the at least one registration mark associated with the test strip further comprises an indicator formed on a surface of the test strip at a predetermined position relative to the deposit site.

7. The system of claim 6 , wherein at least one of the first and second processors is further configured to:
identify that a reverse side of the test strip is exposed in the video stream based on an absence of the indicator formed on the surface of the test strip; and
generate on the HUD an output message indicating that the test strip should be rotated to expose the surface of the test strip bearing the indicator.

8. The system of claim 3 , where at least one of the first and second processors is further configured to identify errors in extraction and handling of the test strip depicted in the video stream and provide guidance to the user via the HUD based on the errors.

9. The system of claim 3 , wherein at least one of the first and second processors is further configured to:
identify a finger of a user in the video stream;
generating guidance on the HUD for producing a bodily fluid sample following identification of the finger in the video stream;
identify contact between the finger and the deposit site in the video stream; and
identify the application of the fluid sample in response to a change in an optical property of the deposit site in the video stream after the contact between the finger and the deposit site.

10. The system of claim 3 , wherein at least one of the first and second processors is further configured to identify the application of the fluid sample in response to a change in an optical property of the deposit site in the video stream.

11. The system of claim 3 , wherein at least one of the first and second processors is further configured to generate on the HUD an output message informing the user that the 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 time period has elapsed and prior to the predetermined maximum time period elapsing.

12. The system of claim 1 , wherein the step of identifying the application of a bodily fluid sample occurs following guidance to the user via the HUD for correct application of the bodily fluid to the test strip.

13. The system of claim 1 , the remote device further comprising a display operatively connected to the second processor, and wherein the operation further comprises displaying the level of the analyte on the display.

14. The system of claim 13 , wherein the remote device comprises a mobile electronic device.

15. The system of claim 14 , wherein the mobile electronic device comprises a smartphone where the program instructions comprise a software application stored on the second memory and executed by the second processor in communication with the first processor for directing the wearable electronic device in the performance of the analyte testing operation.

16. A method for measuring an analyte using a wearable electronic device and a remote device, the wearable electronic device having a camera and a head-up display (HUD), wherein the wearable electronic device and the remote device are operatively connected to each other and having processors configured to cooperate to execute program instructions to:
identify test components in a video stream;
provide guidance to the user via the HUD of required test components not detected in the video stream;
identify the application of a bodily fluid sample to a deposit site on a test strip based on the video stream; activate a timer in response to confirmation of the application of the bodily fluid sample;
after a minimum period of time and before a maximum period of time from the activation of the timer, generate via the camera at least one image of the test strip including at least a portion of a measurement site, the at least one image being captured after guidance to the user via the HUD for positioning the test strip a predetermined distance and angular orientati

Assignees

• Roche Diabetes Care Inc

Inventors

• Steck Alexander
• Limburg Bernhard
• Hailer Fredrik
• Berg Max

Classifications

• G06T2207/30204

  Marker · CPC title

• G06T2207/30196

  Human being; Person · CPC title

• G06T2207/30004

  Biomedical image processing · CPC title

• G06T2207/10024

  Color image · CPC title

• G06T2207/10016

  Video; Image sequence · CPC title