Status reporting of a structured collection procedure

Patent metadata

Field	Value
Publication number	US-10437962-B2
Application number	US-81889410-A
Country	US
Kind code	B2
Filing date	Jun 18, 2010
Priority date	Dec 23, 2008
Publication date	Oct 8, 2019
Grant date	Oct 8, 2019

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.

First claim

What is claimed is:

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 mess

Assignees

• Soni Abhishek S
• Galley Paul J
• Greenburg Alan
• Bousamra Steven
• Weinert Stefan
• Diebold Eric
• Roche Diabetes Care Inc

Inventors

• Soni Abhishek S
• Galley Paul J
• Greenburg Alan
• Bousamra Steven
• Weinert Stefan
• Diebold Eric

Classifications

• G16H50/70

  for mining of medical data, e.g. analysing previous cases of other patients · CPC title

• G16H50/20

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title

• G16H20/17

  delivered via infusion or injection · CPC title

• A61B5/7275

  Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor · CPC title

• G16H10/20

  for electronic clinical trials or questionnaires · CPC title