System for monitoring safety in medication delivery for diabetes management

• US 8,876,803 B2
• Filed: 02/10/2014
• Issued: 11/04/2014
• Est. Priority Date: 05/22/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Budiman, Erwin S.
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US14/177,122
• Publication Number:
  US 20140228743A1
• Time in Patent Office: 267 Days
• Field of Search: 604/504
• US Class Current: 604/890.1
• 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: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An integrated diabetes management (IDM) system includes a safety layer which, in one configuration has two components, one located between a glucose sensor and a controller and a second component located between a controller and a pump, to monitor various aspects of signals and modify those signals for compatibility and safety purposes. In one application, the safety layer receives output control signals from a controller and modifies those control signals as a function of an actual amount of insulin delivered to the user. The safety layer allows for an increased level of safety in the IDM system and permits development of separate hardware and software upgrades with the safety layer assuring that compatibility between components will continue.

Claims

1. An integrated diabetes management system, comprising:

a glucose sensor configured to sense glucose and provide sensor glucose data representative of sensed glucose;

a delivery device configured to deliver medication in response to a delivery control signal;

a controller programmed to receive the sensor glucose data, to calculate a delivery level of medication based on the received sensor glucose data, and to provide an output control signal as a function of the received sensor glucose data to effect the calculated delivery level of medication; and

a safety layer programmed to receive at least one of the sensor glucose data and the output control signal, and to modify at least one of the received sensor glucose data and the output control signal so that at least one of the glucose data would be modified to become modified glucose data and the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal to achieve the calculated delivery level of medication without reconfiguration of either the glucose sensor or the programming of the controller to calculate the delivery level.

2. The integrated diabetes management system of claim 1, wherein the safety layer is further programmed to monitor the amount of medication delivered and to modify the output control signal at least partially as a function of the monitored amount of medication delivered.

3. The integrated diabetes management system of claim 2, wherein the amount of medication delivered monitored by the safety layer comprises insulin on board.

4. The integrated diabetes management system of claim 1, wherein the safety layer is further programmed to modify at least one of the sensor glucose data and the output control signal in accordance with a characteristic of at least one of the glucose sensor and the delivery device.

5. The integrated diabetes management system of claim 1, wherein the safety layer is programmed to modify the sensor glucose data as a function of delivery device output.

6. The integrated diabetes management system of claim 1, wherein the safety layer is programmed to modify the output control signal as a function of delivery device output.

7. The integrated diabetes management system of claim 1, further comprising:

a communication module;

wherein the controller comprises a controller calculation software module configured to provide the output control signal;

wherein the communication module is configured to provide the delivery control signal to the delivery device; and

wherein the safety layer is configured to intercept the output control signal and substitute the modified control signal to the communication module without any reconfiguration of the communication module or the controller calculation software module.

8. The integrated diabetes management system of claim 1, wherein:

the controller comprises a controller calculation software module configured to receive glucose data and provide the output control signal; and

the safety layer is configured to intercept the sensor glucose data from the glucose sensor and substitute the modified glucose data to the controller calculation software module without any reconfiguration of the glucose sensor or the controller calculation software module.

9. The integrated diabetes management system of claim 1, wherein:

the delivery device has a maximum delivery rate; and

the safety layer is further programmed to;

determine the maximum delivery rate of the delivery device;

determine the amount of medication to be delivered by the output control signal; and

if the output control signal is configured for a higher delivery rate than the maximum delivery rate of the delivery device, the safety layer calculates a modified delivery rate and schedule based at least in part on the maximum delivery rate of the delivery device to achieve delivery of the same amount of medication as configured by the output control signal.

10. The integrated diabetes management system of claim 9, wherein the safety layer is further programmed to taper the modified delivery rate over the delivery schedule.

11. The integrated diabetes management system of claim 9, further comprising a visual display;

wherein the safety layer is further programmed to display the modified delivery rate and the delivery schedule.

12. The integrated diabetes management system of claim 1, wherein:

the glucose sensor includes an output having a first range representative of glucose levels;

the controller has an input having a second range representative of glucose levels,

wherein the second range is different from the first range; and

the safety layer is configured to receive glucose data from the glucose sensor, modify the received glucose data for compatibility with the second range, and substitute the modified glucose data to the input of the controller.

13. The integrated diabetes management system of claim 1, wherein:

the glucose sensor provides glucose data having a first format;

the controller is configured to receive glucose data having a second format; and

the safety layer is further programmed to;

determine if the first format and the second format are equivalent;

if the first and second data formats are not equivalent, the safety layer is programmed to modify the glucose data signals to the second format and substitute the modified glucose signals to the controller.

14. The integrated management system of claim 1, wherein the safety layer further comprises:

an input safety module operably connected to the glucose sensor; and

an output safety module operably connected to the medication delivery device.

15. The integrated diabetes management system of claim 14, wherein the output safety module provides feedback to the input safety module.

16. The integrated diabetes management system of claim 15, wherein the feedback comprises a function of a limit on the delivery device and the modified control signal and wherein the modified glucose data is further determined as a function of the feedback.

17. The integrated diabetes management system of claim 14, wherein:

the delivery control signal is representative of a required medication amount for delivery, and

wherein the safety layer determines a maximum delivery rate of the medication delivery device and is configured to calculate a delivery schedule as a factor of the maximum delivery rate and the required medication amount, the required medication amount being determined at least partially by the sensed glucose.

18. The integrated diabetes management system of claim 17, further comprising:

a memory module; and

an input,

wherein the safety layer is configured to store the required medication amount in the memory and update the required medication amount according to a remaining delivery schedule, the modified output control signal, and a delivery command received at the input.

19. The integrated diabetes management system of claim 17, wherein the delivery schedule is a tapered delivery of insulin.

20. The integrated diabetes management system of claim 1, wherein the safety layer is further programmed to provide the modified control signal such that it conforms to a current-driven hardware standard.

21. The integrated diabetes management system of claim 1, wherein the safety layer is further programmed to provide the modified control signal such that it conforms to a voltage-driven hardware standard.