Method of monitoring safety in medication delivery for diabetes management

• US 8,647,321 B2
• Filed: 10/04/2012
• Issued: 02/11/2014
• 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:
  US13/645,233
• Publication Number:
  US 20130096530A1
• Time in Patent Office: 495 Days
• Field of Search: 604/504
• US Class Current: 604/504
• 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

Glucose sensor signals and medication delivery control signals are monitored and these signals are modified for compatibility and safety purposes. In one application, output control signals from a controller directed to a delivery device are modified as a function of an actual amount of insulin delivered to the user. The safety layer method allows for an increased level of safety in an integrated delivery management (“IDM”) system and permits the development of separate hardware and software upgrades for components of the IDM system while assuring that compatibility between components will continue and safety is increased.

Claims

1. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal;

receiving glucose data, calculating an output control signal, and providing the output control signal as a function of the received sensor glucose data;

monitoring the amount of medication delivered;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal;

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

communicating the modified output control signal as the delivery control signal;

wherein modifying at least one of the glucose data and the output control signal includes modifying as a function of the monitored amount of medication delivered.

2. A method of diabetes management comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal;

receiving glucose data and providing an output control signal as a function of the received glucose data;

safety monitoring the sensor glucose data between the steps of providing sensor glucose data and receiving glucose data;

separately safety monitoring the output control signal and providing feedback to the safety monitoring of the sensor glucose data step;

monitoring the amount of medication delivered;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal; and

communicating the modified output control signal as the delivery control signal;

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

wherein the step of providing feedback comprises providing feedback as a function of a limit on the delivery of medication and on the modified output control signal; and

wherein the step of modifying glucose data further includes modifying glucose data as a function of the feedback.

3. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal;

receiving glucose data, calculating the output control signal, and providing an output control signal as a function of the received glucose data;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal;

communicating the modified output control signal as the delivery control signal; and

intercepting the output control signal and substituting the modified control signal as the delivery control signal without reconfiguring the step of calculating the output control signal or the step of communicating a delivery control signal.

4. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal;

receiving glucose data, calculating the output control signal, and providing an output control signal as a function of the received glucose data;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal;

intercepting the sensor glucose data and substituting the modified glucose data for calculation of the output control signal without any reconfiguration of a glucose sensor or the step of calculating the output control signal.

5. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal by a delivery device having a maximum delivery rate;

receiving glucose data and providing an output control signal as a function of the received glucose data;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal;

determining the maximum delivery rate of the delivery device;

determining 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, calculating 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.

6. The method of diabetes management of claim 5, further comprising the step of 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 the delivery schedule.

8. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal;

receiving sensor glucose data by a controller, the controller programmed to provide an output control signal as a function of the received glucose data;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal;

wherein the glucose sensor signals have a first range representative of glucose levels;

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

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

receiving sensor glucose data, modifying the received sensor glucose data for compatibility with the second range, and substituting the modified glucose data to the input of the controller.

9. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal;

receiving sensor glucose data by a controller, the controller programmed to provide an output control signal as a function of the received glucose data;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal;

wherein the sensor glucose data has a first format;

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

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

if the first and second data formats are not equivalent, modifying the glucose data signals to the second format and substituting the modified glucose signals to the controller.

10. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal;

receiving sensor glucose data and providing an output control signal as a function of the received glucose data;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal; and

providing feedback from an output safety module operably connected to a medication delivery device to an input safety module operably connected to a glucose sensor;

wherein the feedback comprises a function of a limit on the delivery device and the modified control signal, wherein the modified glucose data is further determined as a function of the feedback.

11. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication in response to a delivery control signal;

receiving sensor glucose data and providing an output control signal as a function of the received glucose data;

receiving at least one of the sensor glucose data and the output control signal, and modifying at least one of the sensor glucose data and the output control signal;

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal;

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

determining a maximum delivery rate of the medication delivery device and calculating 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.

12. The method of diabetes management of claim 11, further comprising storing the required medication amount in a memory and updating the required medication amount according to the remaining delivery schedule, the modified output control signal, and a delivery command received at an input.

13. The method of diabetes management of claim 11, further comprising tapering a delivery of insulin.

14. A method of diabetes management, comprising:

sensing glucose and providing sensor glucose data representative of sensed glucose;

delivering medication by a medication delivery device in response to a delivery control signal;

receiving sensor glucose data, calculating an output control signal, and providing the output control signal as a function of the received glucose data;

monitoring the amount of medication delivered;

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

wherein the glucose data would be modified to become modified glucose data;

wherein the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal;

communicating the delivery control signal to the delivery device;

providing feedback from an output safety module operably connected to a medication delivery device to an input safety module connected to a glucose sensor; and

intercepting the output control signal and substituting the modified control signal as the delivery control signal without reconfiguring the step of calculating the output control signal or the step of communicating a delivery control signal.

15. The method of diabetes management of claim 14, further comprising determining a maximum delivery rate of the medication delivery device and calculating 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.