Insulin delivery safety

• US 9,597,451 B2
• Filed: 02/11/2010
• Issued: 03/21/2017
• Est. Priority Date: 02/13/2009
• 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 M.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US13/201,311
• Publication Number:
  US 20120059352A1
• Time in Patent Office: 2,595 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 50/50 for simulation or modelling of medical disorders

Abstract

Embodiments of the present disclosure are directed to systems, devices/apparatuses and methods for assessing a residual insulin value for a user/patient. Such embodiments may be implemented by selecting a first value corresponding to a duration of insulin action; selecting a second value corresponding to a lock out time duration, selecting a first time period beginning at a time point T0 minus the first value and ending at the time point T0 minus the second value, selecting one or more boluses delivered during the first time period; for each of the one or more boluses selecting a corresponding residual insulin value estimated at the time point T0, computing the cumulative residual insulin value by summation of the corresponding residual insulin values.

Claims

1. A method for delivering an adjusted insulin bolus into a body of a patient comprising:

providing a remote control unit comprising a memory therein, the remote control unit communicative with a fluid dispensing unit comprising a reusable part and a disposable part, the disposable part containing a battery therein;

selecting a first time corresponding to a duration of insulin action;

selecting a second time corresponding to a lock out time duration;

receiving input for a selection of a first time period beginning at a time point T₀ minus the first time and ending at the time point T₀ minus the second time;

receiving input for a selection of one or more boluses delivered during the first time period;

receiving input for a selection of a corresponding residual insulin value estimated at the time point T₀ for each of the one or more boluses;

computing a cumulative residual insulin value based on the corresponding residual insulin values; and

computing an adjusted insulin bolus based on the cumulative residual insulin value;

wherein the residual insulin value estimated at the time point T₀ corresponds to a first portion of the one or more boluses, and the method further comprises recording, in the memory of the remote control unit, a second portion of the one or more boluses.

2. The method of claim 1, wherein selecting the first time comprises:

receiving a first value corresponding to at least one of the first time and the duration of insulin action, and/or

retrieving a first value corresponding to at least one of the first time and the duration of insulin action from the memory.

3. The method of claim 1, wherein selecting the second time comprises:

receiving a second value corresponding to at least one of the second time and the lock out time duration, and/or

retrieving a second value corresponding to at least one of the second time and the lock out time duration from the memory.

4. The method of claim 1, wherein selecting the first time period comprises receiving or computing the first time period at about the time point T₀.

5. The method of claim 1, further comprising receiving a request for dispensing an insulin bolus at about the time point T₀.

6. The method of claim 5, wherein the requested insulin bolus dose does not correspond to a residual insulin value.

7. The method of claim 1, wherein selecting the one or more boluses includes retrieving the one or more boluses from the memory.

8. The method of claim 1, wherein computing the cumulative residual insulin value includes summation of the corresponding residual insulin values.

9. The method of claim 6, wherein computing the adjusted insulin bolus further corresponds to the requested insulin bolus dose.

10. The method of claim 1, the fluid dispensing unit having one or more housings containing a pump and a reservoir, the pump being configured for dispensing the computed adjusted insulin bolus from the reservoir into a body of a user.

11. The method of claim 1, further comprising providing a processor, the processor having a bolus recommendation application operating thereon configured for computing the adjusted insulin bolus dose associated with the cumulative residual insulin value.

12. The method of claim 1, further comprising:

receiving an estimated amount of carbohydrates consumed or to be consumed by a user;

determining a first insulin bolus dose corresponding to the estimated amount of carbohydrates, without considering a residual insulin value, and

determining a second insulin bolus dose established by subtracting the cumulative residual insulin from the first insulin bolus.

13. The method of claim 1, wherein the lock out time duration corresponds to at least one of a glycemic index (GI), glycemic load (GL), type of insulin and insulin absorption rate.

14. The method of claim 1, wherein the duration of insulin action and/or the lock out time duration are configurable by a user.

15. The method of claim 1, wherein the lock out time duration is selected between about one and about sixty minutes.

16. The method of claim 1, further comprising delivering the adjusted insulin bolus into the body of the patient.

17. The method of claim 1, wherein the method further comprises notifying the patient that the adjusted insulin bolus is about to be delivered.

18. The method of claim 1, wherein at least one of the one or more boluses and the computed adjusted insulin bolus is selected from the group consisting of a normal bolus, long bolus, combination bolus, food bolus, a correction bolus and any combination thereof.

19. A system for determining and delivering an adjusted insulin bolus into a body of a patient comprising:

a remote control unit comprising a memory therein, the remote control unit communicative with a fluid dispensing unit comprising a reusable part and a disposable part, the disposable part containing a battery therein;

the fluid dispensing unit comprising one or more integrally connected housings containing a pump and a reservoir,

a processor, the processor having a bolus recommendation application operating thereon configured for carrying out the following steps;

receiving a first time corresponding to a duration of insulin action;

receiving a second time corresponding to a lock out time duration indicative of a period of time directly prior to an administration of the adjusted insulin bolus and within the duration of insulin action;

receiving a first time period beginning at a time point T₀ minus the first time and ending at the time point T₀ minus the second time, wherein the first time period corresponds to an effective duration of insulin action;

receiving a selection of a plurality of boluses delivered during the first time period;

receiving a selection of a corresponding residual insulin value estimated at the time point T₀ for each of the boluses;

computing a cumulative residual insulin value based on the corresponding residual insulin values; and

computing an adjusted insulin bolus based on the cumulative residual insulin value,

wherein the pump is configured for dispensing the computed adjusted insulin bolus from the reservoir into the body of the patient; and

wherein the residual insulin value estimated at the time point T₀ corresponds to a first portion of the plurality of boluses, and wherein the memory on the remote control unit is configured to store a second portion of one or more boluses.

20. The system of claim 19, wherein:

the effective duration of insulin action corresponding to the first time period is indicative of a defined time period between a start of the duration of insulin action and a start of the lock out time duration;

the first portion of the plurality of boluses is associated with the first time period comprising the effective duration of insulin action; and

the second portion of one or more boluses is associated with a second time period outside of the first time period.