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

Patent metadata

Field	Value
Publication number	US-10565170-B2
Application number	US-64333809-A
Country	US
Kind code	B2
Filing date	Dec 21, 2009
Priority date	Dec 23, 2008
Publication date	Feb 18, 2020
Grant date	Feb 18, 2020

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.

First claim

What is claimed is:

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.

Assignees

• Walling P Douglas
• Rasch Menges Juergen
• Weinert Stefan
• Bousamra Steven
• Soni Abhishek S
• Eisenhardt Christoph
• Roche Diabetes Care Inc

Inventors

• Walling P Douglas
• Rasch-Menges Juergen
• Weinert Stefan
• Bousamra Steven
• Soni Abhishek S
• Eisenhardt Christoph

Classifications

• G01N33/66

  involving blood sugars, e.g. galactose · CPC title

• G16H40/63 Primary

  for local operation · CPC title

• G16H10/20

  for electronic clinical trials or questionnaires · CPC title

• G01N33/49 Primary

  Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)} · CPC title

• G06F16/21 Primary

  Design, administration or maintenance of databases · CPC title