User-defined structured testing for use in diabetes care

• US 10,448,869 B2
• Filed: 05/13/2011
• Issued: 10/22/2019
• Est. Priority Date: 05/13/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Bousamra, Steven A.
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US13/107,301
• Publication Number:
  US 20120289802A1
• Time in Patent Office: 3,084 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS

Abstract

A method is provided for constructing a structured test having user-defined adherence criteria. The method includes: presenting a patient with a plurality of contextual criterion for a structured test; receiving selection of one or more contextual criterion from the plurality of contextual criterion; and constructing a structured test that includes the contextual criterion selected by the patient. During administration of the structured test, each of the contextual criteria selected by the patient is evaluated. Sample data acquired during the structured test is reported as compliant when each of the context criterion selected by the patient was met during the administration of the structured test or tagged as non-compliant when at least one contextual criterion was not met during the administration of the structured test.

Claims

1. A method for measuring glucose levels of a patient, comprising:

receiving, by a diabetes management device, from the patient an objective for a structured test;

identifying, by the diabetes management device, a test template that corresponds to the objective from a plurality of predefined test templates, where the identification of a test template is in response to receiving an objective for the structured test from the patient and the identified test template specifies one or more collection events for obtaining blood glucose measurements;

presenting, by the diabetes management device, the patient with a plurality of contextual criterion for the identified test template, where the presenting the patient with the plurality of contextual criterion is in response to receiving an objective for the structured test from the patient and the plurality of contextual criterion are associated with the identified test template and the plurality of contextual criterion differ amongst the test templates in the plurality of predefined test templates;

receiving, by the diabetes management device, one or more contextual criterion selected by the patient from the plurality of contextual criterion;

constructing, by the diabetes management device, a structured test in accordance with the selected contextual criterion and the identified test template, where the construction of the structured test is in response to receiving one or more contextual criterion and the structured test includes one or more collection events and a prompt of the patient to input information pertaining to the selected contextual criterion; and

administering, by the diabetes management device, the structured test to the patient by prompting the patient to provide a sample of blood to a glucose meter,

receiving, by the diabetes management device, data indicative of a glucose measurement for the patient in response to prompting the patient to provide a sample of blood;

presenting, by the diabetes management device, a query to the patient for each contextual criterion in the structured test;

receiving, by the diabetes management device, replies to the queries from the patient; and

associating, by the diabetes management device, the replies with the data indicative of the glucose measurement in a memory of the diabetes management device.

2. The method of claim 1 further comprises presenting the patient with a plurality of objectives for conducting a structured test, such that each of objectives correlates to one of a plurality of test templates.

3. The method of claim 1 further comprises presenting the patient with a set of contextual criterion for the selected test template such that contextual criterion associated with a given test template differ from contextual criterion associated with other test template amongst the plurality of predefined test templates.

4. The method of claim 1 wherein administering the structured test to the patient further comprises prompting the patient to input a sample of blood into a glucose meter before and after a given event within a window of time that encapsulates the given event and presenting a query to the patient for contextual data regarding another event that differs from the given event.

5. The method of claim 4 further comprises presenting a query to the patient for contextual data regarding another event that occurs outside the window of time.

6. The method of claim 4 further comprises prompting the patient to input a sample of blood into the glucose meter at a time that occurs outside of the window of time.

7. The method of claim 1 further comprises defining adherence criterion for the structured test and reporting data collected during the structured test when the adherence criterion for the structured test is met.

8. The method of claim 7 further comprises defining the adherence criterion based on the selected contextual criterion.

9. A diabetes management device, comprises:

a test configuration module configured to receive an objective for a structured test from a user of the device and operable to identify a test template that corresponds to the objective from a plurality of predefined test templates, where the identified test template specifies one or more collection events for obtaining blood glucose measurements, the test configuration module in data communication with a display of the device to present a plurality of contextual criterion for the identified test template, where the plurality of contextual criterion are associated with the identified test template and the plurality of contextual criterion differ amongst the test templates in the plurality of predefined test templates, and operable to receive selection of one or more contextual criterion by the user from the plurality of contextual criterion;

a test builder module configured to receive the contextual criterion selected by the user and construct a structured test in accordance with the selected contextual criterion and the identified test template, where the structured test includes one or more collection events and a prompt of the patient to input information pertaining to the selected contextual criterion; and

a test administration module operable to administer the structure test to a patient by prompting the patient to perform a glucose measurement, wherein, in response to prompting the patient, the test administration module receives data indicative of a glucose measurement for the patient, presents a query to the patient for each contextual criterion in the structured test;

receives replies to the queries from the patient, and associates the replies with the data indicative of the glucose measurement in a storage device,

where the test configuration module, the test builder module and the test administration module are implemented as computer-executable instructions by a computer processor of the device.

10. The diabetes management device of claim 9 further comprises a blood glucose measuring module that selectively measures blood glucose in a blood sample.

11. The diabetes management device of claim 9 wherein the test configuration module presents the user with a plurality of objectives for conducting a structured test, such that each of objectives correlates to one of the plurality of predefined test templates.

12. The diabetes management device of claim 9 wherein the test configuration module presents the user with a set of contextual criterion for the selected test template such that contextual criterion associated with a given test template differs from contextual criterion associated with another test template amongst the plurality of predefined test templates.

13. The diabetes management device of claim 9 wherein the test administrator module evaluates whether a given contextual criterion selected by the patient have been met during the administration of the structured test;

and reports sample data acquired during the structured test as compliant when the given contextual criterion selected by the patient was met during the administration of the structured test.

14. The diabetes management device of claim 9 wherein the test administrator module tags sample data acquired during the structured test as non-compliant when the given contextual criterion was not met during the administration of the structured test.

15. The diabetes management device of claim 9 further includes a port formed in the housing and is configured to receive a test strip for glucose measurement;

and a blood glucose measurement module cooperatively operable with a test strip inserted in the port to determine a glucose measurement from the test strip.