# US 12,183,445 B2 · Apparatus for optimizing a patient's insulin dosage regimen

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- Number: US 12,183,445 B2
- Document ID: US12183445B2
- Status: Granted
- Kind: B2
- Application number: 18/229,420
- Filed: 2023-08-02
- Published: 2024-02-29
- Granted: 2024-12-31
- Earliest claimed: 2008-04-04
- Assignees: Hygieia, Inc.
- Applicants: Hygieia, Inc.
- Inventors: Eran Bashan; Israel Hodish
- Web page: https://patentgrep.com/patent/US12183445B2

## CPC

- G16H 20/17: delivered via infusion or injection
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G16H 10/00: ICT specially adapted for the handling or processing of patient-related medical or healthcare data (for medical reports G16H15/00; for therapies or health-improving plans G16H20/00; for the handling or processing of medical images G16H30/00)
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61M 5/142: Pressure infusion, e.g. using pumps
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- 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)}

## Abstract

An apparatus for optimizing a patient's insulin dosage regimen over time, comprising: at least a first computer-readable memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen and the patient's blood-glucose-level measurements determined at a plurality of times; a processor operatively connected to the at least first computer-readable memory, the processor programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the one or more components of the patient's present insulin dosage regimen in order to maintain the patient's future blood-glucose-level measurements within a predefined range; and a display operative to display information corresponding to at least the patient's present insulin dosage regimen.

## Claims

### Claim 1

An apparatus for optimizing an insulin dosage regimen of a patient over time, comprising:
at least a first computer-readable memory for storing: programming instructions, a plurality of data inputs corresponding to one or more components in the insulin dosage regimen of the patient, and a plurality of blood-glucose-level measurements of the patient determined at a plurality of times over a predefined period of time;
a timer for counting to a periodic update evaluation of the insulin dosage regimen of the patient over the predefined period of time;
a processor configured to communicate with the at least first computer-readable memory and execute the programming instructions stored in the at least first computer-readable memory to cause the apparatus to perform a method comprising:
querying whether the timer has reached the periodic update evaluation;
determining, at the end of the predefined period of time, from the plurality of blood-glucose-level measurements of the patient determined at the plurality of times whether and by how much to adjust at least one of the one or more components of the insulin dosage regimen of the patient in order to maintain future blood-glucose-level measurements of the patient within a predefined range, and whether an excessive number of hypoglycemic events have occurred over the predefined period of time;
reducing, upon a determination that an excessive number of hypoglycemic events have occurred over the predefined period of time, at least one of the one or more components of the insulin dosage regimen of the patient;
preventing, upon a reduction in at least one of the one or more components of the insulin dosage regimen of the patient, an increase in an insulin dosage of the patient at a next periodic update evaluation;
wherein a long-acting insulin dosage of the patient may not be adjustable so that any two successive such adjusted dosages fall below and above the dosage which they immediately succeed;
wherein when a periodic evaluation of the patient insulin dosage regimen is undertaken, the insulin dosage regimen is treated as having been adjusted even if there has been no adjustment made to the insulin dosage regimen; and
wherein any time the insulin dosage regimen is adjusted, whether in consequence of a periodic update evaluation or an asynchronous update, the timer counting to the next periodic update evaluation is reset.

### Claim 2 (depends on 1)

The apparatus of claim 1, further comprising data entry means for entering into the at least first computer-readable memory at least one of the plurality of data inputs corresponding to at least one of the one or more components of the insulin dosage regimen of the patient and at least one of the plurality of blood-glucose-level measurements of the patient determined at the plurality of times, the data entry means operatively connected to the at least first computer-readable memory.

### Claim 3 (depends on 1)

The apparatus of claim 1, further comprising a glucose meter operative to provide to the at least first computer-readable memory at least one of the plurality of data inputs corresponding to at least one of the plurality of blood-glucose-level measurements of the patient determined at the plurality of times.

### Claim 4 (depends on 3)

The apparatus of claim 3, further comprising data entry means for entering into the at least first computer-readable memory at least one of the plurality of data inputs corresponding to at least one of the one or more components of the insulin dosage regimen of the patient.

### Claim 5 (depends on 3)

The apparatus of claim 3, wherein the processor is operative to associate with the at least one of the plurality of data inputs corresponding to at least one of the plurality of blood-glucose-level measurements of the patient determined at the plurality of times at least one identifier indicative of when the at least one of the plurality of measurements were input into the at least first computer-readable memory.

### Claim 6 (depends on 5)

The apparatus of claim 5, further comprising data entry means enabling a user to define the at least one identifier associated with the at least one of the plurality of data inputs corresponding to at least one of the plurality of blood-glucose-level measurements of the patient.

### Claim 7 (depends on 5)

The apparatus of claim 5, further comprising data entry means enabling a user to confirm the correctness of the at least one identifier associated with the at least one of the plurality of data inputs corresponding to at least one of the plurality of blood-glucose-level measurements of the patient.

### Claim 8 (depends on 5)

The apparatus of claim 5, further comprising data entry means enabling a user to modify the at least one identifier associated with the at least one of the plurality of data inputs corresponding to at least one of the plurality of blood-glucose-level measurements of the patient.

### Claim 9 (depends on 1)

The apparatus of claim 1, further comprising an insulin pump operatively connected to the processor, the insulin pump operative to deliver insulin to the patient according to the insulin dosage regimen of the patient.

### Claim 10 (depends on 9)

The apparatus of claim 9, further comprising data entry means for entering into the at least first computer-readable memory at least one of the plurality of data inputs corresponding to at least one of the one or more components of the insulin dosage regimen of the patient and at least one of the plurality of the blood-glucose-level measurements of the patient determined at the plurality of times, the data entry means operatively connected to the at least first computer-readable memory.

### Claim 11 (depends on 9)

The apparatus of claim 9, further comprising a glucose meter operative to provide to the at least first computer-readable memory at least one of the plurality of data inputs corresponding to at least one of the plurality of blood-glucose-level measurements of the patient determined at the plurality of times.

### Claim 12 (depends on 11)

The apparatus of claim 11, further comprising data entry means for entering into the at least first computer-readable memory the at least one of the plurality of data inputs corresponding to the at least one of the one or more components of the insulin dosage regimen of the patient.

### Claim 13 (depends on 11)

The apparatus of claim 11, wherein the processor is operative to associate with the at least one of the plurality of data inputs corresponding to the at least one of the plurality of blood-glucose-level measurements of the patient determined at the plurality of times at least one identifier indicative of when the at least one of the plurality of measurements was input into the at least first computer-readable memory.

### Claim 14 (depends on 13)

The apparatus of claim 13, further comprising data entry means enabling a user to define the at least one identifier associated with the at least one of the plurality of data inputs corresponding to the at least one of the plurality of blood-glucose-level measurements of the patient.

### Claim 15 (depends on 13)

The apparatus of claim 13, further comprising data entry means enabling a user to confirm the correctness of the at least one identifier associated with the plurality of data inputs corresponding at least to the plurality of blood-glucose-level measurements of the patient.

### Claim 16 (depends on 13)

The apparatus of claim 13, further comprising data entry means enabling a user to modify the at least one identifier associated with the at least one of the plurality of data inputs corresponding to at least one of the plurality of blood-glucose-level measurements of the patient.

### Claim 17 (depends on 10)

The apparatus of claim 10, wherein the plurality of data inputs further comprise data inputs corresponding to a weight of the patient, and the data entry means facilitate entering into the at least first computer-readable memory the data inputs corresponding to the weight of the patient.

### Claim 18 (depends on 10)

The apparatus of claim 10, wherein the plurality of data inputs further comprise data inputs corresponding to foods consumed by the patient, the data entry means facilitate entering into the at least first computer-readable memory data inputs corresponding to the foods consumed by the patient, and the processor is operative to determine from the data inputs corresponding to the foods consumed by the patient a number of carbohydrates associated the foods.

### Claim 19 (depends on 10)

The apparatus of claim 10, wherein the plurality of data inputs further comprise data inputs corresponding to a number of insulin units administered by the patient on a periodic basis, and the data entry means facilitate entering into the at least first-computer-readable memory the data inputs corresponding to the number of insulin units administered by the patient.

### Claim 20 (depends on 9)

The apparatus of claim 9, wherein the insulin pump is operative to provide to the at least first computer-readable memory data inputs corresponding to a rate at which insulin is delivered to the patient by the pump according to the insulin dosage regimen of the patient.