Status reporting of a structured collection procedure

• US 10,437,962 B2
• Filed: 06/18/2010
• Issued: 10/08/2019
• 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: Soni, Abhishek S., Galley, Paul J., Greenburg, Alan, Bousamra, Steven, Weinert, Stefan, Diebold, Eric
• Primary Examiner(s): Holcomb, Mark
• Application Number:
  US12/818,894
• Publication Number:
  US 20110178820A1
• Time in Patent Office: 3,399 Days
• Field of Search: 705 2, 705 3
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

Embodiments related to a system and method managing the implementation, execution, data collection, data analysis and status reporting 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 cause the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criteria 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 criteria being met at some unknown time. Status reporting can be provided throughout the execution of the collection procedure.

Claims

1. A portable, hand-held collection device which addresses a medical question and improves compliancy with a structured collection procedure, said device comprising:

a glucose meter configured to perform a blood glucose measurement on a test strip read by a measurement engine comprising;

the measurement engine for reading the test strip;

a display;

a memory;

a processor connected to the memory and the display;

wherein the glucose meter comprises a housing containing therein the measurement engine, the display is exhibited on one face of the housing, and the housing has at one end a port for receiving the test strip; and

program instructions which when executed by the processor cause the processor to;

initiate a schedule of events of the structured collection procedure upon one or more entry criteria being met,

collect patient data for the structured collection procedure by monitoring blood glucose levels and when entered in response to a request in accordance with an event provided in the schedule of events after initiation,

store automatically in the memory the collected patient data,

assess automatically whether the collected patient data in response to the request meets one or more adherence and/or acceptance criteria, wherein the one or more adherence and/or acceptance criteria is a different criteria from the entry criteria, wherein the one or more adherence and/or acceptance criteria comprises a defined range of values, and if the patient data does not fall within the range, the processor is configured to prompt for additional patient data and automatically extend the events in the schedule of events if an assessment provided by the processor is that steps leading up to taking of the patient data were not accomplished;

associate automatically with the stored collected patient data a unique identifier in the memory if satisfying the one or more adherence and/or acceptance criteria,

provide automatically a status report when the one or more adherence and/or acceptance criteria are not met during the structured collection procedure, and

end automatically the structured collection procedure upon one or more exit criteria being met, wherein the exit criteria establishes requirements which need to be met for exiting or completing the structured collection procedure such that adequate contextual data is collected to answer the medical question addressed by the structured collection procedure and wherein the schedule of events of the structured collection procedure continues onto a next event by which to collect further patient data until the requirements for the exit criteria are met;

wherein when executed by the processor, the program instructions further cause the processor to;

check whether the patient data collected in response to the request which do not meet the one or more adherence criteria causes an adherence violation, to count the number of adherence violations, and end automatically the structured collection procedure when the number of adherence violations exceeds an acceptable number of adherence violations for a particular type of violation, wherein the type of violation is indicated by the processor, which is configured to provide type codes for what caused the violation, and the processor is configured to provide the type codes of;

a measurement taken before a window, the measurement taken after the window, the measurement skipped, incorrect amount of a medication taken, the medication is not taken, and the medication is taken at an incorrect time; and

wherein the processor sets, for each type code, the number of adherence violations for the automatic ending of the procedure to address the medical question and improve the compliancy with the structured collection procedure; and

wherein the glucose meter comprises a microprocessor, a power source, and an indicator, the indicator connected to the processor and which operates under the control of the processor to emit audible, tactile, and/or visual alerts to the individual of daily times for the blood glucose measurement; and

the glucose meter sends a message to a physician when the individual fails to complete one of the one or more adherence criteria, wherein a communication link between a computer of the physician and the blood glucose meter is established upon connection via a web server.

2. A collection device according to claim 1 further comprising a communication interface and wherein the program instructions, which when executed by the processor, further cause the processor to send a message via the communication interface to a clinician if the adherence and/or acceptance criteria are not met.

3. A collection device according to claim 1 wherein when the one or more adherence and/or acceptance criteria are not met during the structured collection procedure the program instructions further cause the processor to present on the display questions and answers to determine why the adherence and/or acceptance criteria were not met.

4. A collection device according to claim 1 wherein the program instructions, which when executed by the processor, further cause the processor to display a message on the display to contact a clinician if the adherence criteria are met but not the acceptance criteria.

5. A collection device according to claim 1 wherein when the one or more adherence criteria are not met during the structured collection procedure the program instructions further cause the processor to present on the display a prediction as to what is likely to happen if the patient continues not to meet the one or more adherence criteria.

6. A collection device according to claim 1 wherein the processor provides a status indicator on the display showing progress of completing the structured collection procedure.

7. A collection device according to claim 6 wherein progress of the status indicator is based in part on the number of unique identifiers associated with the stored collected patient data.

8. A collection device according to claim 6 wherein progress of the status indicator is based on the number of unique identifiers associated with the stored collected patient data and a total number of the requests in the schedule of events which need to meet the one or more adherence criteria in order for the one or more exit criteria to be met at some unknown time.

9. A collection device according to claim 6 wherein progress of the status indicator is based the number of unique identifiers associated with the stored collected patient data divided by a total number of the requests in the schedule of events which need to meet the one or more adherence criteria in order for the one or more exit criteria to be met at some unknown time, and provided on the display as either a fraction or as a percentage.

10. A collection device according to claim 6 wherein the status indicator represents one of a gas gage and a progress bar.

11. A collection device according to claim 1 wherein the program instructions, which when executed by the processor, further cause the processor to provide a failure message on the display and end automatically the structured collection procedure when the number of adherence violations exceeds an acceptable number of adherence violations.

12. A collection device according to claim 1 wherein the program instructions, which when executed by the processor, further cause the processor to check whether the number of adherence violations exceeds an acceptable number of adherence violations.

13. A collection device according to claim 12 wherein the program instructions, which when executed by the processor, further cause the processor to provide a triage message that indicates a risk of not completing the structured collection procedure if the number of adherence violations has not exceeded the acceptable number of adherence violations.

14. A collection device according to claim 12 wherein the program instructions, which when executed by the processor, further cause the processor to provide on the display a help message if the number of adherence violations has not exceeded the acceptable number of adherence violations, and if a designation has been made in the structured collection procedure, to provide the help message for the event.

15. A collection device according to claim 12 wherein the program instructions, which when executed by the processor, further cause the processor to provide on the display a query message designated in the structured collection procedure if the number of adherence violations has not exceeded the acceptable number of adherence violations, and if a designation has been made in the structured collection procedure, to provide the query message for the event.

16. A collection device according to claim 15 wherein the program instructions, which when executed by the processor, further cause the processor to provide on the display helping information designated in the structured collection procedure if a response received by the processor to the query message is a request for the helping information.

17. A collection device according to claim 16 wherein the program instructions, which when executed by the processor further cause the processor to provide on the display a second query message designated in the structured collection procedure after providing the helping information.

18. A collection device according to claim 17 wherein the program instructions, which when executed by the processor further cause the processor to send a message to a clinician if a response received by the processor to the second query message is to send the message to the clinician.

19. A collection device according to claim 1 wherein the program instructions, which when executed by the processor further cause the processor to check whether the collected patient data in memory is deviating from an expected behavior.

20. A collection device according to claim 19 wherein the program instructions, which when executed by the processor, further cause the processor to provide on the display a contact message designated in the structured collection procedure if the collected patient data in memory is deviating from the expected behavior.

21. A collection device according to claim 1 wherein the program instructions, which when executed by the processor, further cause the processor to provide on the display starting information before the one or more entry criteria is met at some unknown time, wherein the starting information provides at least the purpose of the structured collection procedure and the conditions needed to meet the one or more entry criteria.

22. A collection device according to claim 1 wherein the program instructions, which when executed by the processor, further cause the processor to provide on the display a selectable report, which when selected, displays current status information of the structured collection procedure.

23. A collection device according to claim 22 wherein the current status information comprises one or more of the following pieces of information regarding the structured collection procedure:

progress of completion, outcome of the collection procedure, number of violations, type of violation, events completed, events left to complete, cost based analysis, and a comparison of previous executions of the structured collection procedure with current results or results of other types of structured collection procedures.

24. A collection device according to claim 1, wherein the status report is provided by the processor, if for the event in which the one or more adherence criteria is not met during the structured collection procedure, a violation is designated in the collection procedure by a selectable violation parameter provided in the structured collection procedure.

25. A collection device according to claim 1, wherein the processor ends automatically the structured collection procedure when the number of adherence violations exceeds the acceptable number of adherence violations in a predefined period of time.

29. The collection device of claim 1 wherein the one or more adherence and/or acceptance criteria comprises two or more criteria comprising the defined range of values and a predetermined value, and wherein the patient data comprises an average value used to determine a percentage of adherence.

30. The collection device of claim 1 wherein the memory is configured to store an email address or internet protocol (IP) address of the physician, and the processor is configured to automatically send messages to the physician, the messages comprising:

that the patient has started the structured collection procedure via satisfying the entry criteria, that the patient has failed one of the events by not satisfying the one or more adherence criteria, and that the patient has completed the structured collection procedure when the exit criteria is satisfied; and

wherein the display is configured to expose the patient to a partial reporting of on-going results in anticipation of a reporting the patient will receive via the display upon completion of the structured collection procedure.

31. The collection device of claim 1 further comprising a subcutaneous tissue fluid sampling device such that the monitoring of the blood glucose levels is continuous.

26. A portable, hand-held collection device which performs a structured collection procedure which addresses a medical question and improves compliancy with the structured collection procedure, said device comprising:

a glucose meter configured to perform a blood glucose measurement on a test strip read by a measurement engine comprising;

the measurement engine for reading the test strip;

a display;

a memory;

a processor connected to the memory and the display;

wherein the glucose meter comprises a housing containing therein the measurement engine, the display is exhibited on one face of the housing, and the housing has at one end a port for receiving the test strip; and

program instructions which when executed by the processor cause the processor to;

initiate a schedule of events of the structured collection procedure upon one or more entry criteria being met,

collect patient data for the structured collection procedure by monitoring blood glucose levels and when entered in response to a request in accordance with an event provided in the schedule of events after initiation,

store automatically in the memory the collected patient data,

assess automatically whether the collected patient data in response to the request meets one or more adherence and/or acceptance criteria, wherein the one or more adherence and/or acceptance criteria is a different criteria from the entry criteria, wherein the one or more adherence and/or acceptance criteria comprises a defined range of values, and if the patient data does not fall within the range, the processor is configured to prompt for additional patient data and automatically extend the events in the schedule of events if an assessment provided by the processor is that steps leading up to taking of the patient data were not accomplished;

associate automatically with the stored collected patient data a unique identifier in the memory if satisfying the one or more adherence and/or acceptance criteria

end automatically the structured collection procedure upon one or more exit criteria being met, wherein the exit criteria establishes requirements which need to be met for exiting or completing the structured collection procedure such that adequate contextual data is collected to answer the medical question addressed by the structured collection procedure and wherein the schedule of events of the structured collection procedure continues onto a next event by which to collect further patient data until the requirements for the exit criteria are met,

calculate overall adherence based on the patient data stored in memory, and

provide automatically a status report based on the calculated adherence, wherein the status report is one of a prediction displayed on the display and a status message sent automatically to a clinician; and

wherein when executed by the processor, the program instructions further cause the processor to;

check whether the patient data collected in response to the request which do not meet the one or more adherence criteria causes an adherence violation, to count the number of adherence violations, and end automatically the structured collection procedure when the number of adherence violations exceeds an acceptable number of adherence violations for a particular type of violation, wherein the type of violation is indicated by the processor, which is configured to provide type codes for what caused the violation, and the processor is configured to provide the type codes of;

a measurement taken before a window, the measurement taken after the window, the measurement skipped, incorrect amount of a medication taken, the medication is not taken, and the medication is taken at an incorrect time; and

wherein the processor sets, for each type code, the number of adherence violations for the automatic ending of the procedure to address the medical question and improve the compliancy with the structured collection procedure; and

wherein the glucose meter comprises a microprocessor, a power source, and an indicator, the indicator connected to the processor and which operates under the control of the processor to emit audible, tactile, and/or visual alerts to the individual of daily times for the blood glucose measurement; and

the glucose meter sends a message to a physician when the individual fails to complete one of the one or more adherence criteria, wherein a communication link between a computer of the physician and the blood glucose meter is established upon connection via a web server.

27. A collection device according to claim 26 wherein the program instructions, which when executed by the processor, further cause the processor to run automatically one or more additional structured collection procedures after the one or more exit criteria is met, and to calculate the overall adherence based on the patient data stored in memory when exit criteria of the last of the one or more additional structured collection procedures is met.

28. A collection device according to claim 27 wherein the status report is one of a prediction displayed on the display by the processor and a status message sent automatically to a clinician.