Devices, systems and methods for adjusting fluid delivery parameters

• US 10,369,281 B2
• Filed: 09/07/2010
• Issued: 08/06/2019
• Est. Priority Date: 09/08/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Shapira, Gali, Gescheit, Iddo
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US13/395,010
• Publication Number:
  US 20120226259A1
• Time in Patent Office: 3,255 Days
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Devices, systems and methods for adjusting fluid delivery based on past or historical fluid delivery data and/or personal parameters of a user are disclosed. Devices, and corresponding systems and methods, may comprise a dispensing unit configured to deliver a fluid from a reservoir into the body of a user and a processor having instructions operating thereon to retrieve data relating to one or more time windows from a memory, assess a correction delivery for the one or more time windows based on the data, determine a new CIR value for the one or more time windows if the correction delivery regularly follows a meal bolus and/or determine a new basal delivery profile for the one or more time windows if the correction delivery regularly precedes a meal bolus.

Claims

1. A method for determining a parameter of a fluid delivery program for a fluid delivery system used by a user and controlling drug delivery by the fluid delivery system to the user, the fluid delivery system comprises:

one or more processors,

memory readable by the one or more processors and storing computer instruction for the fluid delivery program and data, and

a dispensing unit having a dispensing mechanism connected to a cannula that penetrates skin to deliver a therapeutic fluid into subcutaneous tissue of the user, in which operation of the dispensing mechanism of the dispensing unit is controlled by the one or more processors according to the fluid deliver program, the method comprising;

reading from the memory and executing the computer instructions by the one or more processors of the fluid delivery system

retrieving, using one or more processors, the data from the memory, the data corresponding to one or more time windows;

assessing, using one or more processors, a correction delivery for the one or more time windows based on the data;

determining, using one or more processors, a new carbohydrate-to-insulin ratio (CIR) value for the one or more time windows if the correction delivery regularly follows a meal bolus;

determining, using one or more processors, a new basal delivery profile for the one or more time windows if the correction delivery regularly precedes a meal bolus; and

controlling the dispensing mechanism of the dispensing unit by the one or more processors according to the fluid deliver program updated with either the new carbohydrate-to-insulin ratio (CIR) value or the new basal delivery profile to deliver the therapeutic fluid into the subcutaneous tissue of the user.

2. The method of claim 1, wherein:

the data includes a first amount of fluid delivered via one or more correction boluses and a second amount of fluid not delivered due to one or more delivery suspensions; and

the correction delivery is based on, at least in part, a difference between the first amount and second amount of fluid.

3. The method of claim 2, wherein assessing the correction delivery includes subtracting the second amount of fluid from the first amount of fluid.

4. The method of claim 2, wherein assessing the correction delivery comprises averaging the correction delivery of at least two time windows of the one or more time windows, each of the at least two time windows corresponding to the same time period on a different day.

5. The method of claim 4, wherein assessing the correction delivery comprises:

calculating a standard deviation of the average correction delivery; and

determining whether the standard deviation is smaller than a predetermined amount of fluid.

6. The method of claim 4, wherein assessing the correction delivery comprises determining whether the average correction delivery exceeds a predetermined amount of fluid.

7. The method of claim 1, further comprising notifying the user about the determination of the new CIR value and/or new basal delivery profile.

8. The method of claim 1, wherein the new basal delivery profile precedes the one or more time windows for which the correction delivery was assessed to compensate for a lag period between a change in delivery rate and pharmacological effect.

9. The method of claim 2, further comprising enabling inputting, via a user interface, of at least one of the one or more correction boluses and the one or more delivery suspensions.

10. The method of claim 1, wherein the determination of the modification of the new CIR value and/or new basal delivery profile is based on influencing scenarios.

11. The method of claim 1, further comprising validating the correction delivery.

12. The method of claim 3, wherein when the correction delivery regularly follows a meal bolus, the method further comprises determining a new CIR value lower than a programmed CIR value, if a value representative of the result of subtracting the second amount of fluid from the first amount of fluid is higher than zero.

13. The method of claim 3, wherein when the correction delivery regularly follows a meal bolus, the method further comprises determining a new CIR value higher than a programmed CIR value, if a value representative of the result of subtracting the second amount of fluid from the first amount of fluid is lower than zero.

14. The method of claim 3, wherein when the correction delivery regularly precedes a meal bolus, the method further comprises determining a new basal delivery profile higher than a programmed basal delivery profile, if a value representative of the result of subtracting the second amount of fluid from the first amount of fluid is higher than zero.

15. The method of claim 3, wherein when the correction delivery regularly precedes a meal bolus, the method further comprises determining a new basal delivery profile lower than a programmed basal delivery profile, if a value representative of the result of subtracting the second amount of fluid from the first amount of fluid is lower than zero.

16. The method of claim 3, comprising computing the value representative of the result of subtracting the second amount of fluid from the first amount of fluid based on an average of the subtraction.

17. The method of claim 1, further comprising storing, in a memory, the new CIR value and/or new basal delivery profile.

18. The method of claim 1, further comprising initiating delivery of fluid in correspondence with the new CIR value and/or new basal delivery profile.

21. The method of claim 1, further comprising notifying via the one or more processors the user to modify the basal delivery profile with the new basal delivery profile and/or the CIR value with the new CIR value if a total over- or under-delivered amount of insulin exceeds a threshold value.

22. The method of claim 21, wherein the threshold value is set by the user or a caregiver.

23. The method of claim 1, further comprising averaging via the one or more processors an over- or under-delivered amount of insulin over a certain time period and rejecting via the one or more processors the new basal delivery profile and/or the new CIR value if a standard deviation (SD) of the average of the over- or under-delivered amount of insulin does not exceed a pre-defined threshold.

24. The method of claim 23, wherein the certain time period is selected from the range of 4 to 20 days.

25. The method of claim 8, wherein the new basal delivery profile precedes the one or more time windows by an amount of time selected from the range of 30 to 60 minutes.

26. The method of claim 1, wherein the data is historical data relating to one or more past fluid delivery parameters of the user corresponding with the one or more time windows.

27. The method of claim 1, wherein the determining of the new CIR value for the one or more time windows if the correction delivery regularly follows a meal bolus results from a sum of over-delivered and under-delivered amounts of insulin for the one or more time windows over a period of time that is greater than two days being an amount of insulin under-delivered or over-delivered not equal to zero.

28. The method of claim 27, wherein when the correction delivery regularly follows a meal bolus from the sum of over-delivered and under-delivered amounts of insulin for the one or more time windows over the period of time that is greater than two days not being equal to zero, the method further comprises averaging the sum over the period of time by the processor, and presenting by the processor the averaged sum as a recommendation for the new CIR value.

29. The method of claim 27, wherein the period of time is selected from 3 to 7 days.

19. A non-transitory machine-readable medium comprising computer-executable instructions stored thereon, which when executed on a processor, perform the method of determining a parameter of a fluid delivery program for a fluid delivery system used by a user and controlling drug delivery by the fluid delivery system to the user, the method comprising:

retrieving via using the processor, data from memory of the fluid delivery system, the data corresponding to one or more time windows;

assessing via using the processor, a correction delivery for the one or more time windows based on the data;

determining via using the processor, a new carbohydrate-to-insulin ratio (CIR) value for the one or more time windows if the correction delivery regularly follows a meal bolus;

determining via using the processor, a new basal delivery profile for the one or more time windows if the correction delivery regularly precedes a meal bolus; and

controlling via using the processor, a dispensing mechanism of the fluid delivery system according to the fluid deliver program updated with either the new carbohydrate-to-insulin ratio (CIR) value or the new basal delivery profile to deliver the therapeutic fluid into subcutaneous tissue of the user.

20. A method for determining a parameter of a fluid delivery program for a fluid delivery system used by a user, the fluid delivery system comprises:

one or more processors,

memory readable by the one or more processors and storing computer instruction for the fluid delivery program and data, and

a dispensing unit having a dispensing mechanism connected to a cannula that penetrates skin to deliver a therapeutic fluid into subcutaneous tissue of the user, in which operation of the dispensing mechanism of the dispensing unit is controlled by the one or more processors according to the fluid deliver program, the method comprising;

reading from the memory and executing the computer instructions by the one or more processors of the fluid delivery system

retrieving, using the one or more processors, data from the memory, the data corresponding to one or more time windows;

assessing, using the one or more processors, a correction delivery for the one or more time windows based on the data;

determining, using the one or more processors, one or more revised drug delivery parameters based on the correction delivery, wherein a new carbohydrate-to-insulin ratio (CIR) value for the one or more time windows is determined by the one or more processors as one of the revised drug delivery parameters if the correction delivery regularly follows a meal bolus, and a new basal delivery profile for the one or more time windows is determined by the one or more processors as one of the revised drug delivery parameters if the correction delivery regularly precedes a meal bolus; and

modifying present and/or future drug delivery to the user, via the dispensing mechanism of the dispensing unit, based on the determination upon the one or more revised drug delivery parameters if the one or more revised drug delivery parameters do not exceed one or more threshold values.