Systems and methods for glycemic control during pump disconnection

• US 8,911,423 B2
• Filed: 07/10/2008
• Issued: 12/16/2014
• Est. Priority Date: 07/12/2007
• 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
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US12/170,936
• Publication Number:
  US 20090048152A1
• Time in Patent Office: 2,350 Days
• Field of Search: 604 65- 67, 604/504, 128/DIG.13
• US Class Current: 604/504
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00

Abstract

Techniques and devices are described for allowing a diabetes patient to safely disconnect an insulin infusion system device for a time period. In one aspect, the techniques and devices can be implemented by receiving a maximum glucose amount, a minimum glucose amount, and a contemplated disconnection time; receiving a current glucose amount of the user; determining an expected increase in glucose of the user based on the contemplated disconnection time, an insulin sensitivity of the user and a contemplated basal insulin dose; validating the contemplated disconnection time based on at least one of the expected increase in glucose, the maximum glucose amount, and the minimum glucose amount; and, administering a therapeutic action to the user based on the validation of the contemplated disconnection time.

Claims

1. A method for controlled disconnection of a therapeutic treatment device comprising:

providing a processor for at least one of programming and operating the treatment device;

receiving a current amount of glucose in a user'"'"'s body;

automatically determining, by the processor, an amount of insulin for dispensing into the user'"'"'s body as a function of the current amount of glucose and a contemplated disconnection time; and

upon the processor determining an amount of insulin for dispensing, initiating dispensing of the determined amount of insulin into the user'"'"'s body without additional user input of a percentage of the determined amount of insulin for dispensing into the user'"'"'s body.

2. The method of claim 1, wherein the amount of insulin is determined based on at least one of:

an insulin sensitivity, a target glucose level, an amount of residual insulin, the maximum glucose amount and the minimum glucose amount, a portion of a bolus in progress.

3. The method of claim 1, further comprising continuously monitoring the current amount of glucose in the user'"'"'s body.

4. The method of claim 1, wherein the contemplated disconnection time is configurable by the user.

5. The method of claim 1, wherein the dispensing the determined amount of insulin into the user is performed prior to disconnection and/or after reconnection of the therapeutic treatment device.

6. The method of claim 1, wherein the dispensing of the determined amount of insulin into the user'"'"'s body comprises:

dispensing a first portion of a bolus amount into the user'"'"'s body prior to disconnection of the therapeutic treatment device; and

dispensing a second portion of the bolus amount into the user'"'"'s body after reconnection of the therapeutic treatment device.

7. The method of claim 1, wherein the amount of insulin for dispensing into the user'"'"'s body is further determined in correspondence with an amount of basal insulin.

8. The method of claim 1, further comprising alerting the user to limit the contemplated disconnection time.

9. The method of claim 1, further comprising measuring blood glucose using a glucose measuring device that is accommodated in at least one of:

a remote control and a dispensing unit of the therapeutic treatment device.

10. The method of claim 1, wherein the therapeutic treatment device comprises an insulin dispensing unit to dispense the determined amount of insulin to the user'"'"'s body.

11. The method of claim 10, wherein the insulin dispensing unit is skin adherable.

12. The method of claim 10, wherein the insulin dispensing unit is connectable and disconnectable to and from the body of user.

13. The method of claim 12, wherein the therapeutic treatment device further comprises a skin securable cradle enabling repeated connection and disconnection of the insulin dispensing unit to and from the body of user.

14. The method of claim 1, further comprising receiving at least one of a maximum and a minimum tolerable blood glucose level for the user, wherein the amount of insulin for dispensing into the user'"'"'s body is determined as a function of the current amount of glucose, the contemplated disconnection time, and the at least one of the maximum and minimum tolerable blood glucose level.

15. The method of claim 14, wherein the maximum tolerable blood glucose level is determined for preventing hyperglycemia of the user, and the minimum tolerable blood glucose level is determined for preventing hypoglycemia of the user.

16. The method of claim 1, further comprising determining, by the processor, the contemplated disconnection time based on the current amount of glucose.

17. The method of claim 1, wherein prior to determining the amount of insulin for dispensing, the method further comprises receiving, by the processor, a plurality of contemplated disconnection times, wherein the amount of insulin is determined by the processor for each contemplated disconnection times as a function of the current amount of glucose and each respective contemplated disconnection time.

18. The method of claim 1, further comprising:

receiving a contemplated disconnection time; and

validating, by the processor, the contemplated disconnection time as a function of the current amount of blood glucose,

wherein the determined amount of insulin for dispensing into the user'"'"'s body corresponds to the validated contemplated disconnection time.

19. The method of claim 18, wherein validating the contemplated disconnection time comprises calculating the expected blood glucose change during the contemplated disconnection time.

20. The method of claim 19, wherein upon the expected blood glucose rising during the contemplated disconnection time to a level which is smaller than a maximum tolerable blood glucose level, therein the therapeutic device disconnection is enabled.

21. The method of claim 19, wherein upon the expected blood glucose rising during the contemplated disconnection time to a level which is larger than the maximum tolerable blood glucose level, therein determining the amount of insulin for dispensing into the user'"'"'s body further comprises calculating the expected blood glucose decrease due to delivery of the determined amount.

22. The method of claim 21, wherein:

upon the expected blood glucose decreasing to a value above a minimum tolerable blood glucose level, therein the determined amount of insulin is delivered prior to disconnection;

and

upon the expected blood glucose decreasing to a value below the minimum tolerable blood glucose level, therein the contemplated disconnection time is limited by the processor and the determined amount of insulin is adjusted in accordance with a new contemplated disconnection time.

23. The method of claim 1, further comprising alarming the user when the contemplated disconnection time is approaching or has lapsed.

24. The method of claim 1, wherein initiation of the determined amount of insulin into the user'"'"'s body is performed without any additional user input.

25. A method for controlled disconnection of a therapeutic treatment device comprising:

providing a processor for at least one of programming and operating the treatment device;

receiving a current amount of glucose in a user'"'"'s body;

receiving a contemplated disconnection time;

validating, by the processor, the contemplated disconnection time as a function of the current amount of blood glucose;

automatically determining, by the processor, an amount of insulin for dispensing into the user'"'"'s body which corresponds to the validated contemplated disconnection time; and

upon the processor determining an amount of insulin for dispensing, initiating dispensing of the determined amount of insulin into the user'"'"'s body.

26. A method for controlled disconnection of a therapeutic treatment device comprising:

providing a processor for at least one of programming and operating the treatment device;

receiving a current amount of glucose in a user'"'"'s body;

receiving a contemplated disconnection time;

validating, by the processor, the contemplated disconnection time as a function of the current amount of blood glucose;

automatically determining, by the processor, an amount of insulin for dispensing into the user'"'"'s body which corresponds to the validated contemplated disconnection time; and

upon the processor determining an amount of insulin for dispensing, initiating dispensing of the determined amount of insulin into the user'"'"'s body without additional user input of a percentage of the determined amount of insulin for dispensing into the user'"'"'s body.

27. The method of claim 26, wherein initiation of the determined amount of insulin into the user'"'"'s body is performed without any additional user input.

28. A method for controlled disconnection of a therapeutic treatment device comprising:

providing a processor for at least one of programming and operating the treatment device;

receiving a current amount of glucose in a user'"'"'s body;

receiving at least one of a maximum and a minimum tolerable blood glucose level for the user,

automatically determining, by the processor, an amount of insulin for dispensing into the user'"'"'s body as a function of the current amount of glucose, a contemplated disconnection time and at least one of a maximum and a minimum tolerable blood glucose level of the user; and

upon the processor determining an amount of insulin for dispensing, initiating dispensing of the determined amount of insulin into the user'"'"'s body.