Insulin pump based expert system

• US 9,833,177 B2
• Filed: 02/24/2014
• Issued: 12/05/2017
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Blomquist, Michael
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US14/187,414
• Publication Number:
  US 20140171772A1
• Time in Patent Office: 1,380 Days
• Field of Search: 604 65- 67, 604131-155, 604503
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• 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: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• 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 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• 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 apparatus comprising a pump configured to deliver insulin, an input configured to receive blood glucose data, a user interface, and a controller communicatively coupled to the pump, the input, and the user interface. The controller includes a blood glucose data module to compare the blood glucose data to a target blood glucose level for an insulin pump user. The controller is configured to present a question related to the blood glucose level via the user interface when the blood glucose level is different than the target blood glucose level, receive a response to the question via the user interface, and present a recommended user action based at least in part on the response. Other devices, systems, and methods are disclosed.

Claims

1. A method comprising:

receiving sensor glucose data representative of a blood glucose level of a user from a continuous glucose monitor at a device that includes an insulin pump via a wireless connection, the continuous glucose monitor including a glucose sensor that provides the sensor glucose data;

monitoring the sensor glucose data with a controller of the device;

determining with the controller, from the sensor glucose data, that a sensor glucose level of a user is below a lowest acceptable glucose level above which the user'"'"'s glucose level should be maintained;

alerting the user that the sensor glucose level is below the lowest acceptable glucose level;

displaying to the user on a display of the device a recommendation for the user to initiate a blood glucose measurement with a separate device; and

automatically suspending an operation being carried out by the device upon determining that the sensor glucose level of the user is below the lowest acceptable glucose level.

2. The method of claim 1, wherein alerting the user that the sensor glucose level is below the lowest acceptable glucose level includes activating an alarm.

3. The method of claim 1, wherein the alarm is selected from one or more of the group consisting of:

an audible alarm, a visual alarm, and a vibratory alarm.

4. The method of claim 1, further comprising storing in memory of the device a lowest acceptable glucose level programmed by the user.

5. The method of claim 1, wherein the operation being carried out by the device relates to basal delivery of insulin with the device.

6. The method of claim 5, wherein the operation relating to basal delivery of insulin is a basal rate test for determining a basal rate for delivery of insulin to the user to maintain a blood glucose level of the user within a target range.

7. The method of claim 1, further comprising:

prompting the user for a response relating to the sensor glucose level; and

operating the device based at least in part on the user response.

16. The method of claim 1, wherein the glucose sensor provides the sensor glucose data based on a sampled signal sensed from either blood or interstitial fluid of the user.

8. A system comprising:

a pump configured to deliver insulin;

an input configured to receive sensor glucose data representative of a blood glucose level of a user from a continuous glucose monitor via a wireless connection, the continuous glucose monitor including a glucose sensor that provides the sensor glucose data;

a user interface; and

a controller communicatively coupled to the pump, the input, and the user interface, the controller including a blood glucose data module configured to compare the sensor glucose data to a lowest acceptable glucose level above which a user'"'"'s glucose level should be maintained for the user, and wherein the controller is configured to;

determine from the sensor glucose data that a sensor glucose level of the user is below the lowest acceptable glucose level for the user;

alert the user that the sensor glucose level is below the lowest acceptable glucose level;

display to the user on the user interface a recommendation for the user to initiate a blood glucose measurement with a separate device; and

automatically suspend an operation being carried out by the pump upon determining that the sensor glucose level of the user is below the lowest acceptable glucose level.

9. The system of claim 8, wherein the controller is further configured to alert the user that the sensor glucose level is below the lowest acceptable glucose level by activating an alarm.

10. The system of claim 9, wherein the alarm is selected from one or more of the group consisting of:

an audible alarm, a visual alarm, and a vibratory alarm.

11. The system of claim 8, further comprising a memory communicatively coupled to the controller and wherein the controller is further configured to store in the memory a lowest acceptable glucose level programmed by the user.

12. The system of claim 8, wherein the operation being carried out by the pump relates to basal delivery of insulin with the pump.

13. The system of claim 12, wherein the operation relating to basal delivery of insulin is a basal rate test for determining a basal rate for delivery of insulin to the user to maintain a blood glucose level of the user within a target range.

14. The system of claim 8, wherein the controller is configured to:

prompt the user for a response relating to the sensor glucose level; and

operate the pump based at least in part on the user response.

15. The system of claim 8, further comprising a continuous glucose monitoring sensor.

17. The method of claim 8, wherein the glucose sensor provides the sensor glucose data based on a sampled signal sensed from either blood or interstitial fluid of the user.