ADJUSTING INSULIN DELIVERY RATES

• US 20170203037A1
• Filed: 01/13/2017
• Published: 07/20/2017
• Est. Priority Date: 01/14/2016
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Desborough, Lane, Mazlish, Bryan
• Granted Patent: US 10,307,538 B2
• Time in Patent Office: 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 comprising:

generating a first plurality of insulin delivery profiles, each of the first plurality of insulin delivery profiles including a first series of insulin delivery actions spanning a first time interval;

projecting a first plurality of future blood glucose values for each insulin delivery profile of the first plurality of insulin delivery profiles for a plurality of times spanning the first time interval, each projected future blood glucose values being projected using at least one up-to-date blood glucose level for a person with diabetes;

selecting a first profile of the first plurality of insulin delivery profiles based at least in part upon a comparison between the first plurality of future blood glucose values for each insulin delivery profile and at least one target blood glucose level;

delivering a first dose of insulin using an insulin pump 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;

projecting a second plurality of future blood glucose values for each insulin delivery profile of the second plurality of insulin delivery profiles for a plurality of times spanning the third time interval;

selecting a second profile of the second plurality of insulin delivery profiles based at least in part upon a comparison between the second plurality of future blood glucose values for each insulin delivery profile and at least one 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 each profile of the first and second plurality of insulin delivery profiles comprises a series of insulin delivery actions that deliver insulin 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 at least one profile delivers insulin at 0 times the baseline basal rate for at least the second time interval, at least one profile delivers insulin at the baseline basal rate for at least the second time interval, and at least one profile delivers insulin at 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 cost function, wherein differences between each projected future blood glucose level and one or more target blood glucose levels increase a calculated cost function value for each insulin delivery profile.

10. The method of claim 9, wherein the cost function value increase is greater for differences where the projected blood glucose level is below the target blood glucose level compared to equal magnitude differences where the projected blood glucose level is above the target blood glucose level.

11. The method of claim 10, wherein the 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 1, wherein predicting future blood glucose includes:

determining an effect on blood glucose due to carbohydrates; and

determining an effect on blood glucose due to insulin.

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

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

15. The method of claim 10, wherein predicting future blood glucose includes determining an effect of insulin on board and carbohydrates on board.

16. The method of claim 1, wherein the up-to-date blood glucose level is obtained from one of a continuous glucose monitor (CGM) or a blood glucose monitor (BGM).

17. A system comprising:

a glucose sensor configured to generate a plurality of glucose sensor data points;

a control device configured to;

generate a first plurality of insulin delivery profiles, each of the first plurality of insulin delivery profiles including a first series of insulin delivery actions spanning a first time interval;

project a first plurality of future blood glucose values for each insulin delivery profile of the first plurality of insulin delivery profiles for a plurality of times spanning the first time interval, each projected future blood glucose values being projected using at least one up-to-date blood glucose level from the glucose sensor;

select a first profile of the first plurality of insulin delivery profiles based at least in part upon a comparison between the first plurality of future blood glucose values for each insulin delivery profile and at least one target blood glucose level;

generate a first signal to deliver a first dose of insulin for a second time interval after a previous dose of insulin, the first dose of insulin corresponding to a first action in the first series of insulin delivery actions of the first profile, the second time interval being shorter than the first time interval;

generate 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;

project a second plurality of future blood glucose values for each insulin delivery profile of the second plurality of insulin delivery profiles for a plurality of times spanning the third time interval;

select a second profile of the second plurality of insulin delivery profiles based at least in part upon a comparison between the second plurality of future blood glucose values for each insulin delivery profile and at least one target blood glucose level; and

generate a second signal to deliver a second dose of insulin for a fourth time interval after the end of the second time interval, the fourth time interval being shorter than the third time interval; and

an insulin pump configured to deliver insulin based on the first signal and the second signal of the control device.

18. The system of claim 17, wherein the control device comprises a communication device to transmit the plurality of glucose sensor data points to a computing device.

19. The system of claim 17, wherein the first plurality of insulin delivery profiles includes between 5 profiles and 100 profiles, wherein at least one profile delivers insulin at 0×

baseline basal rate for at least the second time interval, at least one profile delivers insulin at the baseline basal rate for at least the second time interval, and at least one profile delivers insulin at 2×

baseline basal rate for at least the second time interval.

20. The system of claim 17, wherein the first time interval is at least 3 hours and no more than 5 hours and the second time interval is at least 10 minutes and no more than 30 minutes.