Safety features for integrated insulin delivery system

• US 8,257,300 B2
• Filed: 05/21/2010
• Issued: 09/04/2012
• 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., Hayter, Gary A., Crouther, Nathan, Taub, Marc B., Harper, Wesley Scott, Wei, Charles
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): FLICK, JASON E
• Application Number:
  US12/785,104
• Publication Number:
  US 20100298765A1
• Time in Patent Office: 837 Days
• Field of Search: 604/66
• US Class Current: 604/66
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• 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 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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

Abstract

Safety features are applied to an integrated insulin delivery system to enhance safety while accounting for glucose sensor bias and calibration errors. One safety feature includes comparisons of calibrations of the sensor to nominal sensitivity and taking action, such as limiting insulin delivery or taking a further calibration of the sensor. In another feature, an automatic resumption of a basal delivery rate is programmed into the delivery device to avoid the possibility of complete loss of delivery of insulin in the event that communication with the delivery device is disrupted. Other features include steps taken to avoid hypoglycemia in the event that the sensor is negatively biased.

Claims

1. A closed loop system for the delivery of insulin to a patient, the system comprising:

a continuous glucose sensor configured to provide a glucose level signal representative of sensed glucose, the sensor having a nominal sensor sensitivity and having a more current sensor sensitivity;

a memory in which is stored a threshold difference value representative of a difference between a nominal sensor sensitivity and a more current sensor sensitivity;

an insulin delivery device configured to deliver insulin to a patient in response to delivery closed loop control signals; and

a closed loop controller programmed to provide delivery closed loop control signals to the insulin delivery device based on receiving the glucose level signal and based on a value of an uncertainty parameter, and further programmed to receive the nominal sensor sensitivity, to receive the more current sensor sensitivity, to compare the more current sensor sensitivity to the nominal sensor sensitivity to determine a measured difference value, to access the memory to obtain the threshold difference value, to compare the measured difference value to the threshold difference value and if the measured difference value exceeds the threshold difference value, to determine a safety adjustment parameter for the delivery closed loop control signals to control the delivery device not only in accordance with the sensor glucose level signal, but also by increasing the value of the uncertainty parameter based on the amount that the measured difference value exceeds the threshold difference value in addition to cessation of closed loop control and requesting a new blood glucose measurement.

2. The closed loop system of claim 1 wherein the controller is further programmed with at least one safety-oriented component that modifies closed loop control behavior of the controller such that the behavior of the controller is a function of uncertainty.

3. The closed loop system of claim 1 wherein the closed loop controller estimates the uncertainty based on present and past data from the glucose sensor as well as past offline data.

4. The closed loop system of claim 1 wherein the controller is further programmed to detect uncertainty inferred from a sensor calibration anomaly and adjusts at least one parameter selected from the list of closed loop controller parameters consisting of one or more of target glucose range limits, a variance of one or more glucose state estimates, a variance of one or more glucose sensor measurement channels, a decision by the controller based upon data available from the glucose sensor and at least one other selected parameter value to request a recalibration, and a decision by the controller based upon data available from the glucose sensor and at least one other selected parameter value to terminate closed-loop operation.

5. The closed loop system of claim 1 wherein the difference between the nominal sensitivity and more current sensitivity can be either positive or negative and the controller is programmed to provide delivery control signals dependent upon whether the difference is positive or negative.

6. A closed loop system for the delivery of insulin to a patient, the system comprising:

a continuous glucose sensor configured to provide a glucose level signal representative of sensed glucose, the sensor having a nominal sensor sensitivity and having a more current sensor sensitivity;

a memory in which is stored a threshold difference value representative of a difference between a nominal sensor sensitivity and a more current sensor sensitivity;

an insulin delivery device configured to deliver insulin to a patient in response to delivery closed loop control signals; and

a closed loop controller programmed to provide delivery closed loop control signals to the insulin delivery device based on receiving the glucose level signal and based on a value of an uncertainty parameter, and further programmed to receive the nominal sensor sensitivity, to receive the more current sensor sensitivity, to compare the more current sensor sensitivity to the nominal sensor sensitivity to determine a measured difference value, to access the memory to obtain the threshold difference value, to compare the measured difference value to the threshold difference value and if the measured difference value exceeds the threshold difference value, to determine a safety adjustment parameter for the delivery closed loop control signals to control the delivery device not only in accordance with the sensor glucose level signal, but also by one or more of increasing the value of the uncertainty parameter based on the amount that the measured difference value exceeds the threshold difference value as well as based on present and past data from the continuous glucose sensor as well as past offline data, a variance of target glucose range limits, a variance of one or more glucose state estimates, a variance of one or more glucose sensor measurement channels, a decision by the controller based upon data available from the glucose sensor and at least one other selected parameter value to request a recalibration, and a decision by the controller based upon data available from the glucose sensor, and at least one other selected parameter value to terminate closed-loop operation.

7. The closed loop system of claim 6 wherein the difference between the nominal sensitivity and more current sensitivity can be either positive or negative and the controller is further programmed to provide delivery control signals dependent upon whether the difference is positive or negative.