INTEGRATED INSULIN DELIVERY SYSTEM HAVING DELIVERY SAFETY FEATURES

• US 20120330227A1
• Filed: 08/31/2012
• Published: 12/27/2012
• 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
• Granted Patent: US 8,579,854 B2
• Time in Patent Office: Days
• 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

An integrated insulin delivery system having safety features for controlling medication delivery includes automatic resumption of basal rate after a particular event, such as termination of a bolus, expiration of a time period, delayed resumption after the bolus has terminated, IOB comparison, and others. Other safety features include overriding a delivery control that may result in hypoglycemia, terminating an extended bolus or temporary basal rate in view of a glucose signal indicating imminent carbohydrate deficiency, and controlling the delivery rate to take an asymmetrical bias range of a glucose sensor into account to avoid hypoglycemia.

Claims

1-4. -4. (canceled)

5. A 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;

an insulin delivery device configured to deliver insulin in response to delivery control signals at a basal rate and as a bolus; and

a controller programmed to receive the sensor glucose level signal and to provide a delivery control signal to an insulin delivery device to suspend a basal delivery rate during the provision of a bolus delivery and to automatically resume a preprogrammed basal delivery rate after a selected event.

6. The system of claim 5 wherein the delivery control signal comprises automatic resumption of the basal delivery rate after termination of the bolus rate.

7. The system of claim 5 wherein the delivery control signal comprises automatic resumption of the basal delivery rate after a selected period of time has elapsed since termination of the basal delivery rate.

8. The system of claim 5 wherein the delivery control signal comprises automatic resumption of the basal delivery rate after comparison of a value of insulin on board as determined by the processor to a selected threshold value for insulin on board stored in a memory in operable communication with the processor.

9. A 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;

an insulin delivery device configured to deliver insulin in response to delivery control signals at a basal rate and as a bolus; and

a controller programmed to receive the sensor glucose level signal and to provide a delivery control signal to the insulin delivery device according to a model, the model including a monitor on the lower level of insulin over the course of time such that if the delivery control signal reduces the insulin delivery below a threshold or terminates insulin delivery, the processor model programming of the processor results in an intervention in the delivery of insulin by the pump to avoid hypoglycemia.

10. The delivery system of claim 9 wherein the model programming of the processor results in an intervention in the delivery of insulin until the risk of over-compensating in an opposite direction is determined to be higher than not intervening in the insulin delivery.

11. The delivery system of claim 10 wherein the model programming of the processor results in an intervention of the insulin delivery within a selected duration but when the selected duration is exceeded and the model programming of the processor suggests that the risk level is still unacceptable, the model programming of the processor evaluates taking another action, such as recalibration or termination of full or partial system automation.

12. A 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;

an insulin delivery device configured to deliver insulin to a patient in response to delivery control signals at a basal rate and as a bolus; and

a controller programmed to receive the sensor glucose level signal and to provide a delivery control signal to the insulin delivery device to deliver insulin in a manner that accounts for an asymmetrical bias range of the glucose sensor such that inaccuracy in the sensor may be tolerated with limited hyperglycemia while avoiding hypoglycemia.

13. A system for the delivery of insulin to a patient, the system comprising:

a continuous glucose monitor configured to provide a glucose level signal representative of sensed glucose;

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

a controller programmed to provide control signals to the delivery device to result in a basal rate of delivery and bolus delivery, the controller also programmed to receive the glucose level signal and to indicate recommended changes to the delivery of insulin and/or alter the delivery of insulin as a function of the glucose level signals.

14. The delivery system of claim 13 wherein the controller provides delivery control signals to alter the delivery of insulin based on a glucose level signal indicating existing, imminent, or a trend toward carbohydrate deficiency.

15. The delivery system of claim 13 wherein the controller provides delivery control signals to terminate an extended bolus and to terminate a temporary basal rate that exceeds a programmed basal rate in response to a glucose signal indicating existing or imminent carbohydrate deficiency.

16. The delivery system of claim 13 wherein the controller provides delivery control signals to terminate a programmed basal rate and alter future basal delivery of insulin in response to a glucose signal indicating existing or imminent carbohydrate deficiency.

17. The delivery system of claim 13 wherein the controller:

receives the glucose level signal from the sensor;

informs a patient of a trend in the patient'"'"'s glucose level toward carbohydrate deficiency; and

indicates an option of consuming carbohydrates to alter the trend to the patient.