Structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof

• US 10,565,170 B2
• Filed: 12/21/2009
• Issued: 02/18/2020
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Walling, P. Douglas, Rasch-Menges, Juergen, Weinert, Stefan, Bousamra, Steven, Soni, Abhishek S., Eisenhardt, Christoph
• Primary Examiner(s): Nguyen, Hiep V
• Application Number:
  US12/643,338
• Publication Number:
  US 20100212675A1
• Time in Patent Office: 3,711 Days
• Field of Search: 600300, 600365, 707744, 707803
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G06F 16/21 Design, administration or maintenance of databases
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof are disclosed which implement a structured collection procedure based on a medical use case and/or question which provides at least one or more parameters defining entry criterion, a schedule of events, adherence criterion, and exit criterion. The entry criterion establish conditions needed to be met prior to obtaining biomarker data from the patient. Each event can include one or more of a performance time, patient guidance to perform the event, a request for information from the patient a request for patient action, and a request for collection of biomarker data from the patient. The adherence criterion can be used to assess whether an event performed is acceptable to addressing the medical use case and/or question, and the exit criterion establishes conditions needed to be met prior to exiting the collection procedure.

Claims

1. A hand-held device having an improved user interface for diagnostic or therapy support of a patient and for improving compliancy with a structured collection procedure with a chronic disease, comprising:

a display;

a user interface; and

a processor coupled to the display and the user interface; and

program instructions that when executed by the processor causes the processor to;

prompt a plurality of medical use cases or questions related to the chronic disease for selection on the display,

receive a selected medical use case or question via the user interface,

select automatically the structured collection procedure for the diagnostic or therapy support of the patient with the chronic disease based on the selected medical use case or question from a plurality of structured collection procedures stored in a memory, and

implement the selected structured collection procedure,

said selected structured collection procedure having parameters defining a schedule of events, each of said events comprising a request for collection of at least one type of biomarker data, wherein the at least one type of biomarker data comprises a biomarker measurement and wherein when the biomarker measurement is below or at a prescheduled time when compared to a data event request as determined by the processor through a comparison of a time of the biomarker measurement to a time of the data event request, the processor will give the biomarker measurement a unique identifier in a data file, and when the time of the biomarker measurement compared to the time of the data event request is above the prescheduled time, the processor will not give the unique identifier; and

when the unique identifier is provided by the processor, a user is prompted by the processor to provide context for the biomarker measurement;

when the unique identifier is provided, the processor is caused to generate and display a prompt for the user via the display to provide the context by providing a rating related to the biomarker measurement to be stored by the processor, and upon cancelation of the structured collection procedure, the processor nulls the unique identifier to improve compliancy with the collection procedure; and

the prompt requesting the rating comprises prompting the user to input a rating selection via the display of the rating generated by the processor, the rating selection comprising an energy level rating from 1 to 5, where 1 is indicative of a low energy level of the user and 5 is indicative of a high energy level of the user, and a meal size rating from 1 to 5, where 1 is indicative of a small meal and 5is indicative of a large meal, and when input of the rating selection is confirmed by the processor to be input within an exit time threshold, the processor is configured to determine at least one exit criterion is met to exit from the selected structured collection procedure, to generate a notification of the exit from the selected structured collection procedure, and to display on the display the biomarker measurement and the context for the biomarker measurement including the rating selection; and

an indicator connected to the processor and which operates under the control of the processor to emit at least one of audible, tactile, and visual alerts through the user interface at least one of as reminders regarding the request for collection of at least one type of biomarker data for each of said events of said schedule of events of said selected structured collection procedure or as the notification of the exit from the selected structured collection procedure; and

the program instructions lead to at least one of a sending of a report generated based on data collected from the selected structured collection procedure from the device to a physician and a displaying of the report on the user interface, wherein a communication link between a computer of the physician and the device is established on connection via a web server.

2. A device for diagnostic or therapy support according to claim 1 wherein the parameters of the structured collection procedure further define at least one entry criterion which establishes one or more conditions needed to be met in order for a processor to perform the schedule of events.

3. A device for diagnostic or therapy support according to claim 2 wherein the entry criterion is defined as a particular medical question so that the structured collection procedure is automatically selected and the schedule of events started upon meeting the entry criterion.

4. A device for diagnostic or therapy support according to claim 1 wherein the parameters of the structured collection procedure further define at least one adherence criterion which establishes one or more conditions used to qualitatively assess whether an event performed according to the schedule of events provided data which is acceptable to addressing the selected medical use case or question.

5. A device for diagnostic or therapy support according to claim 4 wherein the adherence criterion is assessed and the structured collection procedure is dynamically adapted based on the assessment.

6. A device for diagnostic or therapy support according to claim 1 wherein the parameters of the structured collection procedure further define the at least one exit criterion which establishes one or more conditions needed to be met prior to exiting the structured collection procedure.

7. A device for diagnostic or therapy support according to claim 1 wherein the processor implements the selected structure collection procedure as output.

8. A device for diagnostic or therapy support according to claim 7 wherein the output of the selected structured collection procedure is provided to a blood glucose meter.

9. A device for diagnostic or therapy support according to claim 7 wherein the output is one of a printed paper tool, software to be operated by a collection device, software sent to a collection device, software download from the server by a collection device, a display of a clinician computer, and a display of a collection device.

10. A device for diagnostic or therapy support according to claim 1 wherein the memory is one of provided to the device, provided with the device, and remotely accessed by the device.

11. A device for diagnostic or therapy support according to claim 1 wherein the plurality of medical use cases or questions comprises optimizing an insulin-to-carbohydrate ratio, determining bolus timing in regard to a meal start, and determining an exercise equivalent.

12. A device for diagnostic or therapy support according to claim 1 wherein the plurality of medical use cases or questions include one or more questions concerning controlling the biomarker in a predefined context, therapy onset, type of therapy, oral mono-therapy, oral combination therapy, insulin therapy, lifestyle therapy, adherence to therapy, and therapy efficacy.

13. A device for diagnostic or therapy support according to claim 12 wherein the oral mono-therapy is selected from the group consisting of, sulfonylureas, biguanides, thiazolidine-diones, alpha-glucosidase inhibitors, meglitinides, dipeptidyl peptidase IV inhibitors, GLP-1analogs, taspoglutide, PPAR dual alpha/gamma agonists, and aleglitazar.

14. A device for diagnostic or therapy support according to claim 12 wherein the oral combination therapy is one or more selected from the group consisting of, sulfonylureas, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, dipeptidyl peptidase IV inhibitors, GLP-1 analogs, taspoglutide, PPAR dual alpha/gamma agonists, and aleglitazar.

15. A device for diagnostic or therapy support according to claim 12 wherein the insulin therapy is one or more selected from the group consisting of, insulin injection or inhalation, type of insulin, and split of insulin in basal and bolus.

16. A hand-held device for diagnostic or therapy support of a patient with a chronic disease and for improving compliancy with a structured collection procedure, comprising:

a processor; and

program instructions that when executed by the processor causes the processor to;

retrieve automatically from memory the structured collection procedure, said structured collection procedure being based on a medical use case or question of and having parameters defining;

entry criterion which establishes conditions needed to be met prior to obtaining biomarker data, and a schedule of events, each of said events comprising a request for collection of at least one type of biomarker data,

implement automatically the schedule of events of the structured collection procedure upon the entry criterion being met at some unknown time, wherein the at least one type of biomarker data comprises a biomarker measurement and wherein when the biomarker measurement is below or at a prescheduled time when compared to a data event request as determined by the processor through a comparison of a time of the biomarker measurement to a time of the data event request, the biomarker measurement will be given, by the processor, a unique identifier in a data file, and when the time of the biomarker measurement compared to the time of the data event request is above the prescheduled time, the processor will not give the unique identifier; and

when the unique identifier is provided, a user is prompted by the processor to provide context for the biomarker measurement; and

when the unique identifier is provided, the processor is caused to generate and display a prompt for the user via a user interface display to provide the context by providing a rating related to the biomarker measurement to be stored by the processor, and upon cancelation of the structured collection procedure, the processor nulls the unique identifier to improve compliancy with the collection procedure; and

the prompt requesting the rating comprises prompting the user to input a rating selection via the user interface display of the rating generated by the processor, the rating selection comprising an energy level rating from 1 to 5, where 1 is indicative of a low energy level of the user and 5 is indicative of a high energy level of the user, and a meal size rating from 1 to 5, where 1 is indicative of a small meal and 5 is indicative of a large meal, and when input of the rating selection is confirmed by the processor to be input within an exit time threshold, the processor is configured to determine at least one exit criterion is met to exit from the structured collection procedure, to generate a notification of the exit from the structured collection procedure, and to display on the user interface display the biomarker measurement and the context for the biomarker measurement including the rating selection; and

an indicator connected to the processor and which operates under the control of the processor to emit at least one of audible, tactile, and visual alerts at least one of as reminders regarding the request for collection of at least one type of biomarker data for each of said events of said schedule of events of the structured collection procedure or as the notification of the exit from the structured collection procedure; and

the program instructions lead to a sending of a report generated based on data collected from the structured collection procedure from the device to a physician, wherein a communication link between a computer of the physician and the device is established on connection via a web server.

17. A device for diagnostic or therapy support according to claim 16 wherein the parameters of the structured collection procedure further define adherence criterion which establishes one or more conditions used to qualitatively assess whether an event performed according to the schedule of events provided data which is acceptable to addressing a medical use case or question upon which the structured collection procedure is based.

18. A device for diagnostic or therapy support according to claim 17 wherein the adherence criterion is assessed and the structured collection procedure is dynamically adapted based on the assessment.

19. A device for diagnostic or therapy support according to claim 17 wherein the adherence criterion is defined as the at least one exit criterion.

20. A device for diagnostic or therapy support according to claim 17 wherein the adherence criterion is assessed based on a group of data collected during the collection procedure.

21. A device for diagnostic or therapy support according to claim 16 wherein the structured collection procedure is authorized for retrieval by a clinician.

22. A device for diagnostic or therapy support according to claim 21 wherein the structured collection procedure until authorized remains hidden from viewing on a display of the device.

23. A device for diagnostic or therapy support according to claim 16 wherein the processor implements automatically a schedule of events of a second structured collection procedure upon entry criterion of the second structured collection procedure being met at some unknown time.

24. A device for diagnostic or therapy support according to claim 16 wherein the retrieved structured collection procedure further includes the at least one exit criterion which establishes the conditions needed to be met prior to exiting the structured collection procedure, and the processor ends the structured collection procedure automatically upon the at least one exit criterion being met at some unknown time.

25. A device for diagnostic or therapy support according to claim 24 wherein the at least one exit criterion of the retrieved structured collection procedure meets entry criterion of a second structured collection procedure such that the processor implements automatically a schedule of events of the second structured collection procedure upon meeting the at least one exit criterion of the retrieved structured collection procedure at some unknown time.

26. A device for diagnostic or therapy support according to claim 24 wherein the at least one exit criterion of the retrieved structured collection procedure and the entry criterion of the second structured collection procedure are based on one or more contraindications.

27. A device for diagnostic or therapy support according to claim 24 wherein the retrieved structured collection procedure further includes a check provided between the entry and exit criterions and which the processor runs after a predetermined sampling grouping of the schedule of events, said check is run by the processor to determine one or more of whether a parameter needs adjustment and whether to re-run the sampling grouping.

28. A device for diagnostic or therapy support according to claim 16 wherein the program instructions further causes the processor to permit adjustment of the parameters of the structured collection procedure.

29. A hand-held device for diagnostic or therapy support of a patient with a chronic disease and for improving compliancy with a structured collection procedure, comprising:

a processor; and

program instructions that when executed by the processor causes the processor to;

retrieve automatically from memory the structured collection procedure, said structured collection procedure being based on a medical use case or question of and having parameters defining;

a schedule of events, each of said events comprising a request for collection of at least one type of biomarker data, and

adherence criterion which is used to assess whether an event is performed according to the schedule of events such that data provided according to the event is determined acceptable to addressing the medical use case by fulfilling the adherence criterion, and

implement automatically the schedule of events of the structured collection procedure, and

take one or more additional actions upon the adherence criterion not being met, wherein at least one of the additional actions is to reject the data provided according to the event as unacceptable such that such rejected data is not used for further calculations by the processor; and

wherein the at least one type of biomarker data comprises a biomarker measurement and wherein when the biomarker measurement is below or at a prescheduled time when compared to a data event request as determined by the processor through a comparison of a time of the biomarker measurement to a time of the data event request, the processor will give the biomarker measurement a unique identifier in a data file, and when the time of the biomarker measurement compared to the time of the data event request is above the prescheduled time, the processor will not give the unique identifier; and

when the unique identifier is provided, a user is prompted by the processor to provide context for the biomarker measurement; and

when the unique identifier is provided, the processor is caused to generate and display a prompt for the user via a user interface display to provide the context by providing a rating related to the biomarker measurement to be stored by the processor, and upon cancelation of the structured collection procedure, the processor nulls the unique identifier to improve compliancy with the collection procedure; and

the prompt requesting the rating comprises prompting the user to input a rating selection via the user interface display of the rating generated by the processor, the rating selection comprising an energy level rating from 1 to 5, where 1 is indicative of a low energy level of the user and 5 is indicative of a high energy level of the user, and a meal size rating from 1 to 5, where 1 is indicative of a small meal and 5 is indicative of a large meal, and when input of the rating selection is confirmed by the processor to be input within an exit time threshold, the processor is configured to determine at least one exit criterion is met to exit from the structured collection procedure, to generate a notification of the exit from the structured collection procedure, and to display on the user interface display the biomarker measurement and the context for the biomarker measurement including the rating selection; and

an indicator connected to the processor and which operates under the control of the processor to emit at least one of audible, tactile, and visual alerts at least one of as reminders regarding the request for collection of at least one type of biomarker data for each of said events of said schedule of events of the structured collection procedure or as the notification of the exit from the structured collection procedure; and

the program instructions lead to a sending of a report generated based on data collected from the structured collection procedure from the device to a physician, wherein a communication link between a computer of the physician and the device is established on connection via a web server.

30. A device for diagnostic or therapy support according to claim 29 wherein the processor provides on a display information about the one or more additional actions.

31. A device for diagnostic or therapy support according to claim 29 wherein the program instructions further causes the processor to delay the schedule of event upon not meeting the adherence criterion.

32. A device for diagnostic or therapy support according to claim 29 wherein the structured collection procedure further includes the at least one exit criterion which establishes the conditions needed to be met prior to exiting the structured collection procedure, wherein the processor ends the structured collection procedure automatically upon the at least one exit criterion being met at some unknown time, and wherein the at least one exit criterion is one or more of a particular value, a mean average, a particular event, a condition which has occurred, a condition which has not occurred, and expiration of a predetermined timeout.

33. A device for diagnostic or therapy support according to claim 29 wherein the processor ends the structured collection procedure automatically when the event is not performed according to the schedule of events, or when the data provided according to the event is not acceptable to addressing the medical use case.

34. A hand-held device for diagnostic or therapy support of a patient with a chronic disease and for improving compliancy with the structured collection procedure, comprising:

a processor; and

program instructions that when executed by the processor causes the processor to;

retrieve automatically from memory the structured collection procedure, said structured collection procedure being based on a medical use case or question of and having parameters defining a schedule of events, each of said events comprising a request for collection of at least one type of biomarker data,

receive biomarker data according to the structured collection procedure,

store the biomarker data together with data of the schedule of events as contextualized biomarker data such that conditions under which a specific biomarker measurement was collected for an associated event in the schedule of events is linked to a measured value for the specific biomarker measurement,

calculate measured noise from the contextualized biomarker data by applying a noise function, wherein the noise function comprises one or more of measured noise, procedure noise, and system noise; and

wherein the at least one type of biomarker data comprises a biomarker measurement and wherein when the biomarker measurement is below or at a prescheduled time when compared to a data event request as determined by the processor through a comparison of a time of the biomarker measurement to a time of the data event request, the processor will give the biomarker measurement a unique identifier in a data file, and when the time of the biomarker measurement compared to the time of the data event request is above the prescheduled time, the processor will not give the unique identifier; and

when the unique identifier is provided, a user is prompted by the processor to provide context for the biomarker measurement; and

wherein when the unique identifier is provided, the processor is caused to generate and display a prompt for the user via a user interface display to provide the context by providing a rating related to the biomarker measurement to be stored by the processor, and upon cancelation of the structured collection procedure, the processor nulls the unique identifier to improve compliancy with the collection procedure; and

the prompt requesting the rating comprises prompting the user to input a rating selection via the user interface display of the rating generated by the processor, the rating selection comprising an energy level rating from 1 to 5, where 1 is indicative of a low energy level of the user and 5 is indicative of a high energy level of the user, and a meal size rating from 1 to 5, where 1 is indicative of a small meal and 5 is indicative of a large meal, and when input of the rating selection is confirmed by the processor to be input within an exit time threshold, the processor is configured to determine at least one exit criterion is met to exit from the structured collection procedure, to generate a notification of the exit from the structured collection procedure, and to display on the user interface display the biomarker measurement and the context for the biomarker measurement including the rating selection; and

an indicator connected to the processor and which operates under the control of the processor to emit at least one of audible, tactile, and visual alerts through the user interface at least one of as reminders regarding the request for collection of at least one type of biomarker data for each of said events of said schedule of events of said structured collection procedure or as the notification of the exit from the structured collection procedure; and

the program instructions lead to at least one of a sending of a report generated based on data collected from the structured collection procedure from the device to a physician and a displaying of the report on the user interface, wherein a communication link between a computer of the physician and the device is established on connection via a web server.

35. A device for diagnostic or therapy support according to claim 34 wherein the program instructions further causes the processor to permit adjustment of the parameters of the structured collection procedure to adjust for the noise.

36. A device for diagnostic or therapy support according to claim 34 wherein the program instructions further causes the processor to use the noise function to adjust the structure collection protocol.

37. A device for diagnostic or therapy support according to claim 34 wherein the program instructions further causes the processor to validate the noise function by calculating total noise using a quantity of contextualized biomarker data points and the noise function, and to compare a calculated noise estimate against a measured noise of the contextualized biomarker data to determine whether the calculated noise estimate and measured noise are equal within a given confidence interval.

38. A device for diagnostic or therapy support according to claim 34 wherein the program instructions further causes the processor to use the noise function to identify non-conformance of contextualized biomarker values.

39. A device for diagnostic or therapy support according to claim 34 wherein the program instructions further causes the processor to contextualize biomarker data by associating each date event request with an associated data event value;

evaluating the contextualized biomarker data with adherence criterion; and

accepting contextualized biomarker data that meets the adherence criterion.

40. A hand-held collection device having an improved user interface for performing a prescribed structured collection procedure and for improving compliancy with the structured collection procedure with a chronic disease, said device comprising:

a memory storing the structured collection procedure and for storing patient data, said patient data comprising collected biomarker data and other data associated with each instance of the collected biomarker data, said other data comprising contextualized data which characterizes the associated collected biomarker, and said structured collection procedure comprising entry criterion to begin the structured collection procedure and which establishes conditions needed to be met prior to starting a schedule of events, at least one exit criterion to end the structured collection procedure, the schedule of events in which each of said events comprising at least one or more of guidance to perform the collection event, a request for information, a request for patient action, a request for at least one type of biomarker data, and adherence criterion to qualitatively assess whether an event performed according to the schedule of events provided data which is acceptable to addressing the medical use case;

a user interface for selecting the structured collection procedure and comprising a display;

at least one biomarker reader to provide the at least one type of biomarker data specified in the structured collection procedure;

a processor coupled to the memory, the display, the user interface, and the biomarker reader; and

a program having instructions that when executed by the processor causes the processor to;

receive input from the user interface indicating selection of the structured collection procedure, implement automatically the schedule of events after the selection upon the conditions of the entry criterion being met,

store in memory the patient data resulting from each of the events when performed,

associate automatically a unique identifier for the collected biomarker data comprising a biomarker measurement and wherein when the biomarker measurement is below or at a prescheduled time when compared to a data event request as determined by the processor through a comparison of a time of the biomarker measurement to a time of the data event request, the processor will give the biomarker measurement a unique identifier in a data file, and when the time of the biomarker measurement compared to the time of the data event request is above the prescheduled time, the processor will not give the unique identifier; and

when the unique identifier is provided, a user is prompted by the processor to provide context for the biomarker data;

end automatically the selected structured collection procedure when the at least one exit criterion is met; and

when the unique identifier is provided, the processor is caused to generate and display a prompt for the user via the display to provide the context by providing a rating related to the biomarker measurement to be stored by the processor, and upon cancelation of the structured collection procedure, the processor nulls the unique identifier; and

the prompt requesting the rating comprises prompting the user to input a rating selection via the display of the rating generated by the processor, the rating selection comprising an energy level rating from 1 to 5, where 1 is indicative of a low energy level of the user and 5 is indicative of a high energy level of the user, and a meal size rating from 1 to 5, where 1 is indicative of a small meal and 5 is indicative of a large meal, and when input of the rating selection is confirmed by the processor to be input within an exit time threshold, the processor is configured to determine the at least one exit criterion is met to exit from the selected structured collection procedure, to generate a notification of the exit from the selected structured collection procedure, and to display on the display the biomarker measurement and the context for the biomarker measurement including the rating selection; and

an indicator connected to the processor and which operates under the control of the processor to emit at least one of audible, tactile, and visual alerts through the user interface at least one of as reminders regarding the request for collection of at least one type of biomarker data for each of said events of said schedule of events of said selected structured collection procedure or as the notification of the exit from the selected structured collection procedure; and

the program instructions lead to at least one of a sending of a report generated based on data collected from the selected structured collection procedure from the device to a physician and a displaying of the report on the user interface, wherein a communication link between a computer of the physician and the device is established on connection via a web server.