# US 10,307,538 B2 · Adjusting insulin delivery rates

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- Number: US 10,307,538 B2
- Document ID: US10307538B2
- Status: Granted
- Kind: B2
- Application number: 15/406,313
- Filed: 2017-01-13
- Published: 2017-07-20
- Granted: 2019-06-04
- Earliest claimed: 2016-01-14
- Assignees: Bigfoot Biomedical, Inc.
- Applicants: Bigfoot Biomedical, Inc.
- Inventors: Lane Desborough; Bryan Mazlish
- Web page: https://patentgrep.com/patent/US10307538B2

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4839: {combined with drug delivery}
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body}
- A61M 5/14248: {of the skin patch type}
- A61M 5/145: using pressurised reservoirs, e.g. by means of pistons
- G16H 20/17: delivered via infusion or injection
- G16H 40/60: for the operation of medical equipment or devices
- G16H 40/67: for remote operation
- A61B 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2205/3303: Using a biosensor
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/201: Glucose concentration
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 50/30: for calculating health indices; for individual health risk assessment
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A method may include generating a first plurality of insulin delivery profiles that include a first series of insulin delivery actions spanning a first time interval, projecting a first plurality of future blood glucose values for each profile of the first plurality of profiles using up-to-date blood glucose levels, selecting one of the first plurality of profiles based upon comparing future blood glucose values for each profile and target blood glucose levels, delivering insulin for a second time interval that corresponds to a first action of the first profile, generating a second plurality of insulin delivery profiles for a third time interval, projecting a second plurality of future blood glucose values for each profile of the second plurality of profiles for the third time interval, and delivering a second dose of insulin for a fourth time interval shorter than the third time interval.

## Claims

### Claim 1

A method of efficiently determining insulin dosing by a computer processor for an insulin pump, the method comprising:
generating a first plurality of insulin delivery profiles, each of the first plurality of insulin delivery profiles including a first series of preset insulin delivery actions spanning a first time interval, the first series of preset insulin delivery action comprising deliveries of insulin at one or more multiples or ratios of a baseline basal insulin rate, the first plurality of insulin delivery profiles consisting of a first predetermined maximum number of delivery profiles;
projecting a first plurality of future blood glucose values for each of the first plurality of insulin delivery profiles for a plurality of times spanning the first time interval, each of the projected first plurality of future blood glucose values being projected using an at least one up-to-date blood glucose level for a person with diabetes;
determining differences between each of the projected first plurality of future blood glucose values and the at least one first target blood glucose level;
selecting a first profile of the first plurality of insulin delivery profiles based at least in part upon minimizing the differences between each of the projected first plurality of future blood glucose values and at least one first target blood glucose level;
delivering a first dose of insulin for the person with diabetes for a second time interval after a previous dose of insulin, the first dose of insulin corresponding to a first action or first series of actions of the first profile, the second time interval being shorter than the first time interval;
generating a second plurality of insulin delivery profiles for a time period extending from the end of the second time interval for a third time interval, each of the second plurality of insulin delivery profiles including a second series of preset insulin delivery actions, the second plurality of insulin delivery profiles consisting of a second predetermined maximum number of insulin delivery profiles;
projecting a second plurality of future blood glucose values for each of the second plurality of insulin delivery profiles for a plurality of times spanning the third time interval;
determining differences between each of the projected second plurality of future blood glucose values and an at least one second target blood glucose level;
selecting a second profile of the second plurality of insulin delivery profiles based at least in part upon minimizing the differences between each of the projected second plurality of future blood glucose values and the at least one second target blood glucose level; and
delivering a second dose of insulin using the insulin pump for a fourth time interval after the end of the second time interval, the fourth time interval being shorter than the third time interval.

### Claim 2 (depends on 1)

The method of claim 1, wherein the second series of preset insulin delivery actions comprise insulin deliveries at one or more multiples or ratios of a baseline basal insulin rate.

### Claim 3 (depends on 2)

The method of claim 2, wherein each profile of the first and second plurality of insulin delivery profiles consists of insulin delivery rates of between 0 and 3 times the baseline basal insulin rate, inclusive of 0 and 3 times the baseline basal insulin rate.

### Claim 4 (depends on 2)

The method of claim 2, wherein the first plurality of insulin delivery profiles includes between 5 profiles and 100 profiles, wherein the first plurality of insulin delivery profiles comprises:
at least one first profile of the first plurality of insulin delivery profiles comprising insulin delivered at an insulin delivery rate of 0 times the baseline basal rate for at least the second time interval;
at least one second profile of the first plurality of insulin delivery profiles comprising insulin delivered at an insulin delivery rate of the baseline basal rate for at least the second time interval; and
at least one third profile of the first plurality of insulin delivery profiles comprising insulin delivered at an insulin delivery rate of twice the baseline basal rate for at least the second time interval.

### Claim 5 (depends on 1)

The method of claim 1, wherein at least one of the first plurality of insulin delivery profiles includes an inflection point between a first insulin delivery amount for a first portion of the first series of insulin delivery actions and a second insulin delivery amount for a second portion of the first series of insulin delivery actions.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first time interval is at least 2 hours and the second time interval is at least 5 minutes and no more than 90 minutes.

### Claim 7 (depends on 6)

The method of claim 6, wherein the first time interval is at least 3 hours and the second time interval is at least 10 minutes and no more than 30 minutes.

### Claim 8 (depends on 1)

The method of claim 1, wherein the first profile of the first plurality of insulin delivery profiles is selected based on a calculated cost function for each of the first plurality of insulin delivery profiles.

### Claim 9 (depends on 8)

The method of claim 8, wherein the first profile is selected based on having the lowest calculated cost function, wherein differences between each of the first plurality of projected future blood glucose levels and the at least one first target blood glucose level increase a calculated cost function value for each insulin delivery profile of the first plurality of insulin delivery profiles.

### Claim 10 (depends on 9)

The method of claim 9, wherein the calculated cost function value is increased by a greater amount for differences where each of the first plurality of projected future blood glucose level is below the least one first target blood glucose level compared to equal magnitude differences where each projected future blood glucose level is above the at least one first target blood glucose level.

### Claim 11 (depends on 10)

The method of claim 10, wherein the calculated cost function includes a bias or insulin delivery profiles that either maintain a delivery of insulin at a rate equal to a previously delivered rate or that deliver insulin at a baseline basal rate.

### Claim 12 (depends on 11)

The method of claim 11, wherein the effect on blood glucose due to carbohydrates is determined using
GCt=kc(1−αc)Bcdt(1−αcB)1−B,
wherein:
αc=e−tsτc, and ts is a sampling time and τc is a carbohydrate time constant,
B is the backward shift operator, and
cdt=floor(τdc/ts), where τdc is the carbohydrate deadtime.

### Claim 13 (depends on 11)

The method of claim 11, wherein the effect on blood glucose due to insulin is determined using
Gi=Ki(1−αc)Bidt(1−αiB)1−B,
wherein:
αi=e−tsτi, and ts is a sampling time and τi is a is the insulin time constant,
B is the backward shift operator, and
idt=floor(τdi/ts), where τdi is the insulin deadtime.

### Claim 14 (depends on 10)

The method of claim 10, wherein the projecting of the first plurality of future blood glucose values includes determining an effect of insulin on board and carbohydrates on board.

### Claim 15 (depends on 1)

The method of claim 1, wherein the projecting of the first plurality of future blood glucose values includes:
determining an effect on blood glucose due to carbohydrates; and
determining an effect on blood glucose due to insulin.

### Claim 16 (depends on 1)

The method of claim 1, wherein the at least one first target blood glucose level and the at least one second target blood glucose level are the same.

### Claim 17 (depends on 1)

The method of claim 1, wherein the at least one first target blood glucose level and the at least one second target blood glucose level are different.