Formulation and manipulation of databases of analyte and associated values

• US 20020045808A1
• Filed: 08/10/2001
• Published: 04/18/2002
• Est. Priority Date: 08/18/2000
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Potts, Russell O., Tierney, Michael J., Lesho, Matthew J., Wei, Charles W., Ford, Russell
• Granted Patent: US 6,633,772 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references
• CPC Class Codes: Y10S 707/99945 Object-oriented database structure processing
• CPC Class Codes: Y10S 707/99948 Application of database or data structure, e.g. distributed, multimedia, or image

Abstract

The present invention relates to methods of formulating analyte data databases, the databases themselves, and methods of manipulating the same. In one aspect the present invention includes the formulation of analyte data points, derived data, and data attributes databases comprising data points collected using an analyte monitoring device capable of frequent monitoring of analyte concentrations or amounts. Such data points may comprise acquired data (e.g., values corresponding to analyte concentrations or amounts as measured by said analyte monitoring device). These data points are then associated with one or more relevant data attributes. The resulting databases may be manipulated to determine relationships among the components of the database.

Claims

1. A method of formulating one or more analyte data database, said method comprising:

collecting analyte measurement values from one or more subject using an analyte monitoring device for each subject, said analyte monitoring device (i) comprising a transdermal sampling device, and (ii) providing frequent analyte measurement values, wherein said analyte measurement values comprise acquired data points that are specifically related to analyte amount or concentration in the subject; and

formulating said one or more analyte data databases by associating each of said data points with one or more data attributes.

2. The method of claim 1, wherein said data points further comprise derived data determined from one or more acquired data points and the derived data are associated with the data points from which they are derived.

3. The method of claim 2, wherein each of said derived data are associated with one or more data attributes.

4. The method of claim 1, wherein said analyte measurement values are collected from a single individual.

5. The method of claim 1, wherein said analyte measurement values are collected from more than one individual.

6. The method of claim 5, wherein said formulating further comprises compiling multiple databases from each database where the data points are collected from a single individual and the data points for each single individual are associated with one or more relevant data attributes.

7. The method of claim 1, wherein said analyte is a biological analyte.

8. The method of claim 7, wherein said biological analyte is glucose.

9. The method of claim 2, wherein said analyte is glucose and said derived data comprises glucose amount or concentration.

10. The method of claim 9, wherein said analyte monitoring device is a glucose monitoring device, said glucose monitoring device comprising a transdermal sampling device, a sensing device, a display, and means to provide an audible alert when glucose levels in a subject being monitored are outside of a predetermined range.

11. The method of claim 10, wherein said acquired data points comprise electrochemical signals.

12. The method of claim 11, wherein said data attributes are selected from the group consisting of:

chronological information, user perspiration levels, device operating temperature, missed measurements;

skipped measurements, user body temperature, user skin conductance, environmental variables, alarm events, activity codes, total excursion, mean value, statistical function, subject code, demographic information, physical characteristics, and disease-associated characteristics.

13. The method of claim 1, wherein said analyte monitoring device is capable of measuring more than one analyte.

14. The method of claim 13, wherein one of said analytes is glucose.

16. The database of claim 15, wherein said data points further comprise derived data determined from one or more acquired data points and the derived data are associated with the data points from which they are derived.

17. The database of claim 16, wherein each of said derived data are associated with one or more data attributes.

18. The database of claim 15, wherein said analyte measurement values are collected from a single individual.

19. The database of claim 15, wherein said analyte measurement values are collected from more than one individual.

20. The database of claim 19, wherein said formulating further comprises compiling multiple databases from each database where the data points are collected from a single individual and the data points for each single individual are associated with one or more relevant data attributes.

21. The database of claim 15, wherein said analyte is a biological analyte.

22. The database of claim 21, wherein said biological analyte is glucose.

23. The database of claim 16, wherein said analyte is glucose and said derived data comprises glucose amount or concentration.

24. The database of claim 23, wherein said analyte monitoring device is a glucose monitoring device, said glucose monitoring device comprising a transdermal sampling device, a sensing device, a display, and means to provide an audible alert when glucose levels in a subject being monitored are outside of a predetermined range.

25. The database of claim 24, wherein said acquired data points comprise electrochemical signals.

26. The database of claim 25, wherein said data attributes are selected from the group consisting of:

chronological information, user perspiration levels, device operating temperature, missed measurements;

skipped measurements, user body temperature, user skin conductance, environmental variables, alarm events, activity codes, total excursion, mean value, statistical function, subject code, demographic information, physical characteristics, and disease-associated characteristics.

27. The database of claim 15, wherein said analyte monitoring device is capable of measuring more than one analyte.

28. The database of claim 27, wherein one of said analytes is glucose.

15. An analyte data database formulated from data points collected using an analyte monitoring device, said analyte monitoring device (i) comprising a transdermal sampling device, and (ii) providing frequent analyte measurement values, wherein said analyte measurement values comprise data points that are specifically related to analyte amount or concentration, and the data points are associated with one or more relevant data attributes.

29. A method of manipulating an analyte data database, comprising

providing the analyte data database of claim 15;

and

manipulating said data points via said attributes associated with said data points to determine relationships between said data points and said attributes.

30. A method of manipulating an analyte data database, comprising

providing the analyte data database of claim 15;

and

manipulating said attributes via said data points associated with said attributes to determine relationships between said attributes and said data points.