# US 11,298,053 B2 · Insulin pump based expert system

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- Number: US 11,298,053 B2
- Document ID: US11298053B2
- Status: Granted
- Kind: B2
- Application number: 15/830,415
- Filed: 2017-12-04
- Published: 2018-04-05
- Granted: 2022-04-12
- Earliest claimed: 2007-05-30
- Assignees: Tandem Diabetes Care, Inc.
- Applicants: Tandem Diabetes Care, Inc.
- Inventors: Michael Blomquist
- Web page: https://patentgrep.com/patent/US11298053B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/7475: {User input or interface means, e.g. keyboard, pointing device, joystick}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G16H 10/20: for electronic clinical trials or questionnaires
- G16H 20/17: delivered via infusion or injection
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- 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}
- A61B 2560/045: with a separable interface unit, e.g. for communication
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2230/201: Glucose concentration
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## 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

### Claim 1

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; and
a controller communicatively coupled to the pump and the input, the controller configured to:
monitor the sensor glucose data from the continuous glucose monitor while the pump is delivering a basal rate of insulin to the user;
compare the sensor glucose data to a target low glucose level;
determine a rate of change of the blood glucose level of the user from the sensor glucose data;
generally continuously monitor the rate of change;
determine based on the generally continuous monitoring of the rate of change that, although the sensor glucose data does not indicate that the glucose level of the user is below the target low glucose level that the rate of change indicates that the glucose level of the user is at risk of going below the target low glucose level due to the basal rate of insulin being delivered to the user;
provide a message on a user interface relating to the risk of going below the target low glucose level; and
reducing a rate of basal insulin being delivered to the user in response to the risk of going below the target low glucose level.

### Claim 2 (depends on 1)

The system of claim 1, wherein the controller providing a message relating to the risk of going below the target low glucose level includes providing a message relating to a corrective action responsive to the risk of going below the target low glucose level.

### Claim 3 (depends on 2)

The system of claim 2, wherein the corrective action is a recommendation to ingest carbohydrates.

### Claim 4 (depends on 1)

The system of claim 1, wherein the controller is further configured to implement a corrective action in response to the risk of going below the target low glucose level.

### Claim 5 (depends on 4)

The system of claim 4, wherein the implemented corrective action is a recommendation to ingest carbohydrates.

### Claim 6 (depends on 4)

The system of claim 4, wherein the controller is configured to determine that, although the sensor glucose data does not indicate that the glucose level of the user is below the target low glucose level that the rate of change indicates that the glucose level of the user is at risk of going below the target low glucose level by applying one or more rules to the rate of change.

### Claim 7

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; and
a controller communicatively coupled to the pump and the input, the controller configured to:
monitor the sensor glucose data from the continuous glucose monitor while the pump is delivering a basal rate of insulin to the user;
compare the sensor glucose data to a target low glucose level;
determine a rate of change of the blood glucose level of the user from the sensor glucose data;
generally continuously monitor the rate of change;
determine, based on the generally continuous monitoring of the rate of change that, although the sensor glucose data does not indicate that the glucose level of the user is below the target low glucose level that the rate of change indicates that the glucose level of the user is at risk of going below the target low glucose level due to the basal rate of insulin being delivered to the user; and
implement a corrective action in response to the risk of going below the target low glucose level, including reducing a basal rate of insulin being delivered to the user.

### Claim 8 (depends on 7)

The system of claim 7, wherein the implemented corrective action is a recommendation to ingest carbohydrates.

### Claim 9 (depends on 7)

The system of claim 7, wherein the controller is further configured to provide a message on a user interface relating to the risk of going below the target low glucose level.

### Claim 10 (depends on 9)

The system of claim 9, wherein the controller providing a message relating to the risk of going below the target low glucose level includes providing a message relating to the corrective action.

### Claim 11 (depends on 10)

The system of claim 10, wherein the corrective action is a recommendation to ingest carbohydrates.

### Claim 12 (depends on 7)

The system of claim 7, wherein the controller is configured to determine that, although the sensor glucose data does not indicate that the glucose level of the user is below the target low glucose level that the rate of change indicates that the glucose level of the user is at risk of going below the target low glucose level by applying one or more rules to the rate of change.

### Claim 13 (depends on 1)

The system of claim 1, wherein the controller is configured to reduce the basal rate of insulin being delivered to the user in response to a manual instruction from the user to reduce the basal rate of insulin.

### Claim 14 (depends on 13)

The system of claim 13, where the controller is further configured to present a recommendation to reduce the basal rate of insulin to the user and to reduce the basal rate of insulin if the user accepts the recommendation.

### Claim 15 (depends on 7)

The system of claim 7, wherein the controller is configured to reduce the basal rate of insulin being delivered to the user in response to a manual instruction from the user to reduce the basal rate of insulin.

### Claim 16 (depends on 15)

The system of claim 15, where the controller is further configured to present a recommendation to reduce the basal rate of insulin to the user and to reduce the basal rate of insulin if the user accepts the recommendation.