Method and system for providing integrated analyte monitoring and infusion system therapy management

• US 8,206,296 B2
• Filed: 08/07/2006
• Issued: 06/26/2012
• Est. Priority Date: 08/07/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jennewine, R. Curtis
• Primary Examiner(s): MALLARI, PATRICIA C
• APPLICATION: US 20090054750A1
• Time in patent office: 2150 Days
• Field of Search: 600/347, 600/365
• US Class Current: 600/365
• 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 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• 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: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Method and system for providing diabetes management and insulin therapy based on substantially real time glucose monitoring system is provided.

Claims

1. A method, comprising:

receiving, at a medical device, data associated with monitored glucose related levels measured by a glucose sensor for a first predetermined time period substantially in real time, the medical device having a processor unit;

retrieving, using the processor unit, one or more therapy profiles associated with the monitored glucose related levels;

determining, using the processor unit, a rate of change of the monitored glucose related levels for the first predetermined time period;

extrapolating, using the processor unit, a projected glucose related level based on the monitored glucose related levels and the determined rate of change of the monitored glucose related levels;

comparing, using the processor unit, the projected glucose related level with a corresponding -monitored glucose related level;

confirming, using the processor unit, the monitored glucose related levels within a second predetermined time period after insulin therapy initiation, based at least in part on the comparison of the projected glucose related level with the corresponding monitored glucose related level, to determine whether the insulin therapy is having an intended therapeutic effect;

generating, using the processor unit, one or more modifications to the retrieved one or more therapy profiles based on the data associated with the monitored glucose related levels, and

updating, using the processor unit, an insulin sensitivity factor on an ongoing basis based at least in part on the comparison of the projected glucose related level with the corresponding monitored glucose related level.

2. The method of claim 1 further including displaying, on a display, the generated one or more modifications to the retrieved one or more therapy profiles.

3. The method of claim 2 wherein the generated one or more modifications to the retrieved one or more therapy profiles is displayed as one or more of an alphanumeric output display, a graphical output display, an icon display, a video output display, a color display or an illumination display.

4. The method of claim 1 wherein the first predetermined time period includes a time period between 15 minutes and six hours.

5. The method of claim 1 wherein the one or more therapy profiles includes a basal profile, a correction bolus, a temporary basal profile, an insulin sensitivity, an insulin on board level, and an insulin absorption rate.

6. The method of claim 1 wherein retrieving, using the processor unit, one or more therapy profiles associated with the monitored glucose related levels includes retrieving a current glucose rate of change information.

7. The method of claim 6 wherein generating, using the processor unit, one or more modifications to the retrieved one or more therapy profiles includes determining a modified glucose rate of change information based on the received data associated with monitored glucose related levels.

8. The method of claim 7 further including generating, using the processor unit, an output alert based on the modified glucose rate of change information.

9. The method of claim 7 further including determining, using the processor unit, an glucose level projection information based on the modified glucose rate of change information.

10. The method of claim 1, wherein a first predetermined number of monitored glucose related levels are received over the first predetermined time period.

11. The method of claim 10, further comprising discarding, using the processor unit, up to a second predetermined number of monitored glucose related levels in the first predetermined time period, wherein the second predetermined number is based on a predetermined margin of error.

12. The method of claim 11, wherein the first predetermined number equals a total number of monitored glucose related levels measured by the glucose sensor in the first predetermined time period less the second predetermined number.

13. A system for providing diabetes management, comprising:

an interface unit;

one or more processors coupled to the interface unit; and

a memory storing instructions which, when executed by the one or more processors, causes the one or more processors to receive data associated with monitored glucose related levels for a predetermined time period substantially in real time, retrieve one or more therapy profiles associated with the monitored glucose related levels, determine a rate of change of the monitored glucose related levels for the predetermined time period, extrapolate a projected glucose related level based on the monitored glucose related levels and the determined rate of change of the monitored glucose related levels, compare the projected glucose related level with a corresponding monitored glucose related level, confirm automatically the monitored glucose related levels within a second predetermined time period after insulin therapy initiation, based at least in part on the comparison of the projected glucose related level with the corresponding monitored glucose related level, to determine whether the insulin therapy is having an intended therapeutic effect, generate one or more modifications to the retrieved one or more therapy profiles based on the data associated with the monitored glucose related levels, and update an insulin sensitivity factor on an ongoing basis based at least in part on the comparison of the projected glucose related level with the corresponding monitored glucose related level.

14. The system of claim 13 wherein the memory further stores instructions which, when executed by the one or more processors, causes the one or more processors to display the generated one or more modifications to the retrieved one or more therapy profiles.

15. The system of claim 14 wherein when the memory further stores instructions which, when executed by the one or more processors, causes the one or more processors to display the generated one or more modifications to the retrieved one or more therapy profiles as one or more of an alphanumeric output display, a graphical output display, an icon display, a video output display, a color display or an illumination display.

16. The system of claim 13 wherein the predetermined time period includes one of a time period between 15 minutes and six hours.

17. The system of claim 13 wherein the one or more therapy profiles includes a basal profile, a correction bolus, a temporary basal profile, an insulin sensitivity, an insulin on board level, and an insulin absorption rate.

18. The system of claim 13 wherein the memory further stores instructions which, when executed by the one or more processors, causes the one or more processors to retrieve a current glucose rate of change information.

19. The system of claim 18 wherein the memory further stores instructions which, when executed by the one or more processors, causes the one or more processors to determine a modified glucose rate of change information based on the received data associated with monitored glucose related levels.

20. The system of claim 19 wherein the memory further stores instructions which, when executed by the one or more processors, causes the one or more processors to generate an output alert based on the modified glucose rate of change information.

21. The system of claim 19 wherein the memory further stores instructions which, when executed by the one or more processors, causes the one or more processors to determine a glucose level projection information based on the modified glucose rate of change information.

22. The system of claim 13 wherein the interface unit includes an input unit and an output unit, the input unit configured to receive the one or more glucose related data, and the output unit configured to output the one or more of the generated modifications to the retrieved one or more therapy profiles.

23. The system of claim 13 wherein the interface unit and the one or more processors are operatively coupled to one or more of a housing of an infusion device or a housing of an glucose monitoring system.

24. The system of claim 23 wherein the infusion device includes an external insulin pump.