Adjusting insulin delivery rates

• US 10,307,538 B2
• Filed: 01/13/2017
• Issued: 06/04/2019
• Est. Priority Date: 01/14/2016
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Desborough, Lane, Mazlish, Bryan
• Primary Examiner(s): Zhang, Jenna
• Application Number:
  US15/406,313
• Publication Number:
  US 20170203037A1
• Time in Patent Office: 872 Days
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• 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 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/60 : for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. The method of claim 11, wherein the effect on blood glucose due to carbohydrates is determined using

GCt=kc(1−

α

c)Bcdt(1−

α

cB)1−

B,

wherein;

α

_c=e−

t_sτ

_c, and t_s is a sampling time and τ

_c is a carbohydrate time constant,

B is the backward shift operator, and

c_dt=floor(τ

_dc/t_s), where τ

_dc is the carbohydrate deadtime.

13. The method of claim 11, wherein the effect on blood glucose due to insulin is determined using

Gi=Ki(1−

α

c)Bidt(1−

α

iB)1−

B,

wherein;

α

_i=e−

t_sτ

_i, and t_s is a sampling time and τ

_i is a is the insulin time constant,

B is the backward shift operator, and

i_dt=floor(τ

_di/t_s), where τ

_di is the insulin deadtime.

14. 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.

15. 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.

16. 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.

17. 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.