ANALYTE TESTING METHOD AND SYSTEM

• US 20110184653A1
• Filed: 01/21/2011
• Published: 07/28/2011
• Est. Priority Date: 01/22/2010
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: RHO, Hee Jun, MATIAN, Greg, HARMON, Kirk, RAY, Pinaki, PRICE, David
• Application Number:
  US13/011,672
• Publication Number:
  US 20110184653A1
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Various methods and systems to manage diabetes using data relating to testing compliance, bolus dosing, or cannula usage are described and illustrated.

Claims

1. A method of monitoring therapeutic bolus compliance with an analyte testing device and a therapeutic dispensing device, in which each of both devices each includes a microprocessor coupled to a memory, the method comprising:

obtaining from the memory of the analyte testing device data including a number of hyperglycemic occurrences and a time stamp for each of the hyperglycemic occurrences, the hyperglycemic occurrences based on a physic;

collecting from the memory of the therapeutic dispensing device a time stamp for each bolus of dispensed therapeutic;

identifying a hyperglycemic occurrence that does not have at least one bolus of dispensed therapeutic within a predetermined time range of the hypoglycemic occurrence;

calculating a percentage of hyperglycemic occurrences that do not have at least one bolus of dispensed therapeutic within the predetermined time range; and

annunciating the percentage of hyperglycemic occurrences that do not have at least one bolus of dispensed therapeutic within the predetermined time range.

2. The method of claim 1, in which the predetermined time range comprises about one hour before to about one hour after the time stamp of the hyperglycemic occurrence.

3. The method of claim 1, in which the calculating comprises:

determining data including a total number of hyperglycemic occurrences and a number of hyperglycemic occurrences that do not have at least one bolus of dispensed therapeutic within the predetermined time range; and

dividing the number of hyperglycemic occurrences that do not have at least one bolus of dispensed therapeutic within the predetermined time range by a total number of hyperglycemic occurrences.

4. The method of claim 1, in which the calculating comprises determining a result for a following equation:

%H_NB=[H_NB/H_T]×

100, where

%H_NB is the percentage of hyperglycemic occurrences that do not have at least one bolus of dispensed therapeutic within the predetermined time range,

H_NB is the number of hyperglycemic occurrences that do not have at least one bolus of dispensed therapeutic within the predetermined time range, and

H_T is the total number of hyperglycemic occurrences.

5. The method of claim 1, in which the hyperglycemic occurrence comprises a glucose concentration greater than about 200 milligrams per deciliter.

6. The method of claim 1, in which the identifying comprises automatically determining whether a glucose measurement comprises a hypoglycemic occurrence.

7. The method of claim 1 further comprising:

assaying a plurality of blood samples to measure glucose before the obtaining from the memory of the analyte testing device.

8. The method claim 1, in which the therapeutic dispensing device comprises a device selected from the group consisting of an insulin pump and an insulin pen and combinations thereof.

9. The method of claim 1, in which the annunciating comprises displaying on a screen of a device selected from the group consisting of a personal computer, the analyte testing device, or the therapeutic dispensing device and combinations thereof.

10. A method of monitoring insulin bolus compliance with an analyte testing device and a therapeutic dispensing device, in which each of both devices each includes a microprocessor coupled to a memory, the method comprising:

obtaining from the memory of the analyte testing device data including a number of hyperglycemic occurrences and a time stamp for each of the hyperglycemic occurrences;

collecting from the memory of the therapeutic dispensing device a time stamp for each bolus of dispensed therapeutic;

identifying a hyperglycemic occurrence that has at least one bolus of dispensed therapeutic within a predetermined time range of the hypoglycemic occurrence;

calculating a percentage of hyperglycemic occurrences that have at least one bolus of dispensed therapeutic within the predetermined time range; and

annunciating the percentage of hyperglycemic occurrences that have at least one bolus of dispensed therapeutic within the predetermined time range.

11. A diabetes management system comprising:

a plurality of glucose test strips, each test strip configured to receive a physiological sample;

a test strip port connector configured to receive the plurality of test strips; and

a data management device comprising;

a housing;

a microprocessor coupled to a memory, display, and power supply disposed proximate the housing, the microprocessor coupled to the test strip sensor to obtain data including a number of hyperglycemic occurrences and a time stamp for each of the hyperglycemic occurrences, the microprocessor configured to collect a time stamp for each bolus of dispensed therapeutic so that a percentage of hyperglycemic occurrences that do not have at least one bolus of dispensed therapeutic within the predetermined time range is determined by the microprocessor.

12. A method of monitoring analyte testing compliance with an analyte testing device and a therapeutic dispensing device, in which each of both devices each includes a microprocessor coupled to a memory, the method comprising:

obtaining from the memory of the analyte testing device a time stamp for each of the glucose measurements;

collecting from the memory of the therapeutic dispensing device data including a number of bolus events and a time stamp for each bolus event;

identifying a bolus event that does not have at least one glucose measurement within a predetermined time range of the bolus event;

calculating a percentage of bolus events that do not have at least one glucose measurement within the predetermined time range; and

annunciating the percentage of bolus events that do not have at least one glucose measurement within the predetermined time range.

13. The method of claim 12, in which the predetermined time range comprises about one hour before to about one hour after the time stamp of the bolus event.

14. The method of claim 12, in which the calculating comprises:

determining data including a total number of bolus events and a number of bolus events that do not have at least one glucose measurement within the predetermined time range;

dividing the number of bolus events that do not have at least one glucose measurement within the predetermined time range by a total number of bolus events.

15. The method of claim 12, in which the calculating comprises determining a result of a following equation:

%B_NG=[B_NG/B_T]×

100, where

%B_NG is the percentage of bolus events that do not have at least one glucose measurement within the predetermined time range,

B_NG is the number of bolus events that do not have at least one glucose measurement within the predetermined time range, and

B_T is the total number of bolus events.

16. The method of claim 12, in which a bolus event comprises a predetermined amount of insulin injected with the therapeutic dispensing device.

17. The method of claim 12 further comprising:

assaying a plurality of blood samples to measure glucose before the obtaining from the memory of the analyte testing device.

18. The method claim 12, in which the therapeutic dispensing device comprises an insulin pump or insulin pen.

19. The method of claim 12, in which the annunciating comprises displaying on a screen of a device selected from the group consisting of a personal computer, the analyte testing device, or the therapeutic dispensing device and combinations thereof.

20. A method of monitoring an average number of days in between cannula fills of a therapeutic dispensing device that delivers a therapeutic agent to a user via a cannula, the method comprising:

(i) selecting a user interface option to perform a cannula fill procedure when a cannula is coupled to the therapeutic dispensing device;

(ii) pumping an amount of therapeutic agent to fill the cannula;

(iii) saving to a memory of the therapeutic dispensing device or an analyte-testing device a time stamp in which the cannula fill procedure was performed;

(iv) repeating steps (i) to (iii) three or more times;

(v) calculating an average number of days in between cannula fills; and

(vi) annunciating the average number of days in between cannula fills.

21. The method of claim 20, in which the annunciating comprises alerting a user where the average number of days in between cannula fills is greater than about three days.

22. The method of claim 20, in which the annunciating comprises displaying on a screen of a device, the device selected from the group consisting of a personal computer, the therapeutic dispensing device, or the analyte testing device, and combinations thereof.

23. The method of claim 20, in which the calculating of the average number of days in between cannula fills comprises determining a result for the following equation: