Integrated insulin delivery system having safety features to prevent hypoglycemia

• US 10,130,765 B2
• Filed: 11/11/2013
• Issued: 11/20/2018
• 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., Hayter, Gary A., Crouther, Nathan, Taub, Marc B., Harper, Wesley Scott, Wei, Charles
• Primary Examiner(s): Flick, Jason
• Application Number:
  US14/077,181
• Publication Number:
  US 20140180203A1
• Time in Patent Office: 1,835 Days
• Field of Search: 604 66
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 by controlling medication delivery including the 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, and terminating an extended bolus or temporary basal rate in view of a glucose signal indicating imminent carbohydrate deficiency. 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.

Claims

1. 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 programmed 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 the bolus and to set the programmed basal rate to zero for a predetermined period of time after commencement of the bolus delivery.

2. The system of claim 1 wherein the predetermined period of time is based upon an amount of insulin delivered in a preceding closed-loop cycle.

3. The system of claim 1 wherein the predetermined period of time is based upon a level of insulin on board (IOB) and the programmed basal delivery rate.

4. The system of claim 1, wherein the bolus is an extended bolus.

5. The system of claim 4, wherein the controller is further programmed to interrupt the extended bolus.

6. The system of claim 4, wherein the controller is further programmed to interrupt the extended bolus if the patient is in a carbohydrate deficient state.

7. 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 programmed 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 the bolus and to set the programmed basal rate to zero for a predetermined period of time.

8. The system of claim 7, wherein the predetermined period of time is based upon an amount of insulin delivered in a preceding closed-loop cycle.

9. The system of claim 7, wherein the predetermined period of time is based upon a level of insulin on board (IOB) and the programmed basal delivery rate.

10. The system of claim 7, wherein the bolus is an extended bolus.

11. The system of claim 10, wherein the controller is further programmed to interrupt the extended bolus.

12. The system of claim 10, wherein the controller is further programmed to interrupt the extended bolus based on if the patient is in a carbohydrate deficient state.