Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device

Patent metadata

Field	Value
Publication number	US-9659037-B2
Application number	US-64341509-A
Country	US
Kind code	B2
Filing date	Dec 21, 2009
Priority date	Dec 23, 2008
Publication date	May 23, 2017
Grant date	May 23, 2017

Abstract

Embodiments related to a system and method managing the implementation, execution, data collection, and data analysis of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor causes the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and mark/indicate the structured collection procedure as completed if no exception occurred during performance of an event in the schedule of events.

First claim

What is claimed is:

1. A collection device for performing a structured collection procedure on a patient which addresses a medical use case or question, said device comprising:
a portable electronic device comprising a blood glucose meter configured for determining and storing a biomarker value;
a memory;
a user interface;
a processor connected to the memory and the user interface; and
program instructions which when executed by the processor cause the processor to:
receive via the user interface a defined medical use case or question,
select automatically a structured collection procedure from a plurality of structured collection procedures, each comprising at least a primary schedule of events and a secondary schedule of events, based on and matching the defined medical use case or question received via the user interface,
initiate automatically the primary schedule of events of the selected structured collection procedure upon the processor determining that one or more entry criterions have been met, in which the one or more entry criterions comprises at least one specific question to which the processor requires a specific answer to be received from the patient via input from the user interface before the primary schedule of events is started,
provide guidance to collect biomarker data according to an event scheduled in the primary schedule of events of the selected structured collection procedure,
store in the memory a use case parameter which identifies the defined medical use case or question which the selected structured collection procedure is addressing, and patient data comprising the biomarker data collected in accordance with the event in the primary schedule of events, said patient data being associated with the event and the use case parameter, wherein the event provides context to the associated patient data, thereby defining contextual data,
end automatically the selected structured collection procedure upon the processor determining that one or more context specific exit criterions have been met, in which the one or more context specific exit criterions establishes at least one requirement for exiting or completing the selected structured collection procedure such that the selected structured collection procedure has adequate contextual data to address the defined medical use case or question being addressed, wherein the processor continues automatically to a next event scheduled in the primary schedule of events by which to collect further patient data until the one or more context specific exit criterions are met,
mark the selected structured collection procedure as completed based upon no exception occurring during performance of the event in the primary schedule of events, wherein the selected structured collection procedure can be used only once, and wherein each successive download of the selected structured collection procedure requires access from an authorized user with a valid ID,
indicate non-completion of the selected structured collection procedure upon one or more exceptions occurring,
dynamically change the selected structured collection procedure by switching to the secondary schedule of events upon the one or more exceptions occurring and fill missing data caused by the one or more exceptions with at least one of historical data and an estimate from historical data, and
upon the one or more exceptions occurring:
mark the patient data comprising the biomarker data collected in accordance with the event in the primary schedule of events as invalid;
cancel all remaining events in the primary schedule of events for a current day; and
reschedule the primary schedule of events for a next day after the current day;

wherein the collection device is communicatively coupled to a computer, wherein the computer provides a graphical user interface to implement the selected structured collection procedure on the collection device.

2. A collection device according to claim 1 wherein the processor uses a state condition to indicate completion of the selected structured collection procedure.

3. A collection device according to claim 1 wherein the processor provides a completion flag in the memory to indicate completion of the selected structured collection procedure.

4. A collection device according to claim 1 wherein at time of initiation of the selected structured collection procedure, the program instructions cause the processor to create a data structure in the memory for the patient data.

5. A collection device according to claim 3 wherein the program instructions further cause the processor to mark the completion flag as completed based upon the one or more exceptions being resolved.

6. A collection device according to claim 1 wherein the program instructions further cause the processor to perform an analysis on the patient data.

7. A collection device according to claim 1 wherein the program instructions further cause the processor to provide a snooze feature to enable an allowable delay to the collection of the biomarker data when prompted.

8. A collection device according to claim 1 wherein the program instructions further cause the processor to apply one or more acceptance criterions to determine whether the patient data was collected within a specific time-window around each event provided in the schedule of events for the selected structured collection procedure.

9. A collection device according to claim 1 wherein the program instructions further cause the processor to apply one or more adherence criterions to determine whether data was successfully collected for each event provided in the schedule of events applied for the selected structured collection procedure.

10. A collection device according to claim 9 wherein the program instructions further cause the processor to associate in the patient data the data collected successfully with a date-time stamp, the event, any available contextual information, and a unique identifier.

11. A collection device according to claim 9 wherein the program instructions further cause the processor to indicate in the patient data the one or more exceptions for the event not meeting the one or more adherence criterions.

12. A collection device according to claim 1 wherein the program instructions further cause the processor to end the selected structured collection procedure when an adverse event occurs.

13. A collection device according to claim 1 , wherein:
the plurality of structured collection procedures comprises at least a first structured collection procedure and a second structured collection procedure;
the selected collection procedure is the first structured collection procedure;
the one or more context specific exit criterion for the first structured collection procedure establish one or more conditions to meet for one or more entry criterions of the second collection procedure; and
further comprising program instructions which when executed by the processor cause the processor to:
implement automatically a schedule of events of the second structured collection procedure upon meeting the one or more context specific exit criterion of the first structured collection procedure.

14. A collection device according to claim 1 , wherein:
the plurality of structured collection procedures comprises at least a first structured collection procedure and a second structured collection procedure;
the selected collection procedure is the first structured collection procedure;
the one or more context specific exit criterion for the first structured collection procedure are based on one or more contraindications;
one or more entry criterion

Assignees

• Soni Abhishek S
• Weinert Stefan
• Rasch-Menges Juergen
• Walling P Douglas
• Bousamra Steven A
• Greenburg Alan M
• Roche Diabetes Care Inc

Inventors

• Soni Abhishek S
• Weinert Stefan
• Rasch-Menges Juergen
• Walling P Douglas
• Bousamra Steven A
• Greenburg Alan M

Classifications

• G16H10/20

  for electronic clinical trials or questionnaires · CPC title

• G16H40/63 Primary

  for local operation · CPC title

• G06F16/21 Primary

  Design, administration or maintenance of databases · 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

• G01N33/66

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