System for monitoring safety in medication delivery for diabetes management

• US 9,833,571 B2
• Filed: 10/30/2014
• Issued: 12/05/2017
• Est. Priority Date: 05/22/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Budiman, Erwin S.
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US14/528,891
• Publication Number:
  US 20150057636A1
• Time in Patent Office: 1,132 Days
• Field of Search: 604504
• 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. A method of diabetes management, comprising:

sensing glucose level from a glucose sensor and providing sensor glucose data representative of sensed glucose level;

calculating an output control signal as a function of the sensor glucose data;

delivering medication in response to a delivery control signal;

monitoring the amount of medication delivered;

modifying at least one of the sensor glucose data and the output control signal as a function of the monitored amount of medication delivered, wherein the sensor glucose data becomes modified sensor glucose data and the output control signal becomes a modified output control signal;

performing at least one of;

intercepting the output control signal and substituting the modified output control signal as the delivery control signal without reconfiguring the step of calculating the output control signal; and

intercepting the sensor glucose data and substituting the modified sensor glucose data for calculation of the output control signal without reconfiguring the glucose sensor,

wherein the delivery control signal is based on at least one of the modified sensor glucose data and the modified output control signal.

2. The method of diabetes management of claim 1, wherein a communication module communicates the delivery control signal to a medication delivery device.

3. The method of diabetes management of claim 1, further comprising the step of monitoring insulin on board.

4. The method of diabetes management of claim 3, wherein the output control signal is at least partially modified as a function of the monitored insulin on board.

5. The method of diabetes management of claim 1, further comprising:

determining a maximum delivery rate of a medication delivery device;

determining an amount of medication to be delivered based on the delivery control signal; and

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

6. The method of diabetes management of claim 5, further comprising tapering the modified delivery rate over the delivery schedule.

7. The method of diabetes management of claim 5, further comprising visually displaying the modified delivery rate and delivery schedule.

8. The method of diabetes management of claim 1, wherein the sensor glucose data has a first range representative of glucose levels and a controller for calculating the output control signal as a function of the sensor glucose data has an input having a second range representative of glucose levels, the second range being different from the first range, and the method comprising:

altering the sensor glucose data for compatibility with the second range; and

substituting the altered sensor glucose data to the input of the controller.

9. The method of diabetes management of claim 1, wherein the sensor glucose data has a first format and a controller for calculating the output control signal as a function of the sensor glucose data is programmed to receive sensor glucose data in a second format, the method comprising:

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

if the first and second formats are not equivalent, altering the sensor glucose data to the second format; and

substituting the altered sensor glucose data to the input of the controller.