# US 11,896,370 B2 · Method and/or system for assessing a patient's glycemic response

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- Number: US 11,896,370 B2
- Document ID: US11896370B2
- Status: Granted
- Kind: B2
- Application number: 16/886,618
- Filed: 2020-05-28
- Published: 2020-09-17
- Granted: 2024-02-13
- Earliest claimed: 2012-01-19
- Assignees: Medtronic MiniMed, Inc.
- Applicants: Medtronic MiniMed, Inc.
- Inventors: Benyamin Grosman; Francine R. Kaufman; Desmond Barry Keenan; Anirban Roy
- Web page: https://patentgrep.com/patent/US11896370B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/4839: {combined with drug delivery}
- A61B 5/4866: {Evaluating metabolism (using breath test A61B5/083)}
- 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}
- A61M 5/142: Pressure infusion, e.g. using pumps
- G16H 20/17: delivered via infusion or injection
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61B 5/1451: {for interstitial fluid}
- A61B 5/6849: {in combination with a needle set}
- 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

Subject matter disclosed herein relates to a method and/or system for tailoring insulin therapies to physiological characteristics of a patient. In particular, observations of a blood glucose concentration of a patient responsive to a meal profile and an insulin profile may be used for estimating one or more physiological parameters.

## Claims

### Claim 1

A method of monitoring and affecting a blood glucose concentration of a patient, the method comprising:
determining, using a controller, a meal consumption model indicative of a plurality of different blood glucose concentrations of the patient at a plurality of times responsive to ingestion of a meal, wherein the meal comprises a plurality of glycemic components adapted to release glucose in the patient in different amounts at different times;
determining, using the controller, an insulin model indicative of effects on the blood glucose concentration of the patient responsive to insulin infused in the patient;
obtaining one or more observations of the blood glucose concentration of the patient;
computing values for physiological parameters using the controller by relating the meal consumption model and the insulin model with the one or more observations of the blood glucose concentration of the patient, wherein the physiological parameters are specific to the patient and are to model the blood glucose concentration of the patient and comprise a first meal response gain parameter, a second meal response gain parameter, and a plurality of delay parameters; and
infusing insulin to the patient, using an insulin pump responsive to commands generated by the controller based, at least in part, on the physiological parameters, wherein the physiological parameters are used by the controller to generate the commands to control insulin infusion by the insulin pump.

### Claim 2 (depends on 1)

The method of claim 1, wherein the plurality of different glycemic components comprises at least a first glycemic component and a second glycemic component, wherein, if ingested, the first glycemic component being capable of releasing glucose at a first rate and causing a first spike in the blood glucose concentration at a first time, and the second glycemic component being capable of releasing glucose at a second rate and causing a second spike in the blood glucose concentration at a second time.

### Claim 3 (depends on 2)

The method of claim 2, wherein the first rate of the first glycemic component is greater than the second rate of the second glycemic component, and wherein the first time of the first glycemic component is prior to the second time of the second glycemic component.

### Claim 4 (depends on 1)

The method of claim 1, wherein the insulin model comprises an expression of subcutaneous insulin and an expression of insulin infused.

### Claim 5 (depends on 4)

The method of claim 4, wherein the insulin model is defined, at least in part, according to a pharmacokinetic model.

### Claim 6 (depends on 1)

The method of claim 1, and further comprising applying at least one of the physiological parameters in determining a meal bolus and one or more correction boluses, wherein the one or more correction boluses comprise a square bolus that is smaller than the meal bolus.

### Claim 7 (depends on 1)

The method of claim 1, and further comprising applying at least one of the physiological parameters in determining limits to an amount of the insulin to be specified in an insulin pump command.

### Claim 8 (depends on 1)

The method of claim 1, and further comprising applying at least one of the physiological parameters to tune parameters of the controller to determine an amount of the insulin to be infused to the patient on discrete command intervals.

### Claim 9 (depends on 1)

The method of claim 1, wherein at least one of the physiological parameters comprises a blood glucose concentration of the patient observed following a fasting period during an infusion of insulin to the patient at a constant basal rate.

### Claim 10 (depends on 1)

The method of claim 1, and further comprising computing an insulin infusion basal rate for the patient based, at least in part, on at least one of the physiological parameters.

### Claim 11

A special purpose computing apparatus, the special purpose computing apparatus comprising:
a memory; and
a processor in communication with the memory, wherein the processor is configured to:
determine a meal consumption model indicative of a plurality of different blood glucose concentrations of a patient at a plurality of times responsive to ingestion of a meal, wherein the meal comprises a plurality of glycemic components adapted to release glucose in the patient in different amounts at different times;
determine an insulin model indicative of effects on the blood glucose concentration of the patient responsive to insulin infused in the patient;
obtain one or more observations of a blood glucose concentration of the patient;
compute values for physiological parameters based, at least in part, on application of the meal consumption model and the insulin model to the one or more observations of the blood glucose concentration of the patient, wherein the physiological parameters to be specific to the patient, to model a blood glucose concentration of the patient, and to comprise a first meal response gain parameter, a second meal response gain parameter and a plurality of delay parameters; and
cause infusion of the insulin to the patient by generating one or more commands to an infusion pump for infusion of the insulin to the patient, the one or more commands based, at least in part, on one or more of the physiological parameters.

### Claim 12 (depends on 11)

The special purpose computing apparatus of claim 11, wherein the insulin model to comprise an expression of subcutaneous insulin and an expression of insulin infused.

### Claim 13 (depends on 12)

The special purpose computing apparatus of claim 12, wherein the insulin model to be defined, at least in part, according to a pharmacokinetic model.

### Claim 14 (depends on 11)

The special purpose computing apparatus of claim 11, wherein the processor further to apply at least one of the physiological parameters to determine a meal bolus and one or more correction boluses, wherein the one or more correction boluses to comprise a square bolus that is smaller than the meal bolus.

### Claim 15 (depends on 11)

The special purpose computing apparatus of claim 11, wherein the processor further to apply at least one of the physiological parameters to determine limits to an amount of the insulin to be specified in an insulin pump command.

### Claim 16 (depends on 11)

The special purpose computing apparatus of claim 11, wherein the processor further to apply at least one of the physiological parameters to tune parameters of the processor to determine an amount of the insulin to be infused to the patient on discrete command intervals.

### Claim 17 (depends on 11)

The special purpose computing apparatus of claim 11, wherein at least one of the physiological parameters to comprise a blood glucose concentration of the patient to be observed following a fasting period during an infusion of insulin to the patient at a constant basal rate.

### Claim 18 (depends on 11)

The special purpose computing apparatus of claim 11, wherein the processor further to compute an insulin infusion basal rate for the patient to be based, at least in part, on at least one of the physiological parameters.

### Claim 19 (depends on 11)

The special purpose computing apparatus of claim 11, wherein the special purpose computing apparatus further is for use with a glucose sensor, and wherein the special purpose computing apparatus further comprises a continuous glucose monitoring device to provide the one or more observations of the blood glucose concentration of the patient to be based, at least in part, on signals generated by the glucose sensor.

### Claim 20

An article, the article comprising:
a non-transitory storage medium comprising machine-readable instructions stored thereon which are executable by a special purpose computing apparatus to:
determine a meal consumption model indicative of a plurality of different blood glucose concentrations of a patient at a plurality of times responsive to ingestion of a meal, wherein the meal comprises a plurality of glycemic components adapted to release glucose in the patient in different amounts at different times;
determine an insulin model indicative of effects on the blood glucose concentration of the patient responsive to insulin infused in the patient;
obtain one or more observations of a blood glucose concentration of the patient;
compute values for physiological parameters based, at least in part, on application of the meal consumption model and the insulin model to the one or more observations of the blood glucose concentration of the patient, wherein the physiological parameters to be specific to the patient, to model a blood glucose concentration of the patient, and to comprise a first meal response gain parameter, a second meal response gain parameter and a plurality of delay parameters; and
cause infusion of the insulin to the patient by generating one or more commands to an infusion pump for the infusion of the insulin to the patient, the one or more commands based, at least in part, on one or more of the physiological parameters.