ADJUSTING INSULIN DELIVERY RATES

• US 20170232195A1
• Filed: 01/13/2017
• Published: 08/17/2017
• 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 10,806,859 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 displaying to a user an interface at which the user inputs a fear of hypoglycemia index (FHI), the FHI corresponding to an acceptable probability of a blood glucose level being below a threshold blood glucose level. The method may also include receiving blood glucose data for a person with diabetes (PWD). The method may additionally include calculating a probability of the PWD having a blood glucose level below the threshold blood glucose level based on the variability of the received blood glucose data. The method may also include setting one or more target blood glucose levels to align the probability of the PWD having a blood glucose level below the threshold blood glucose level with the acceptable probability associated with the user input FHI. The method may additionally include delivering insulin, using the insulin delivery device, based on the target blood glucose level.

Claims

1. A method comprising:

obtaining a fear of hypoglycemia index (FHI) from a user, the FHI corresponding to an acceptable probability of a blood glucose level being below a threshold blood glucose level;

receiving blood glucose data for a person with diabetes (PWD);

calculating a probability of the PWD having a blood glucose level below the threshold blood glucose level based on the variability of the received blood glucose data;

setting one or more target blood glucose levels to align the probability of the PWD having a blood glucose level below the threshold blood glucose level with the acceptable probability associated with the user input of FHI; and

delivering insulin, using an insulin delivery device, based on the target blood glucose level.

2. The method of claim 1, wherein a plurality of target blood glucose levels are set for a plurality of diurnal time periods and independently modified for each diurnal time period based on a calculated probability of the PWD having a blood glucose level falling below the threshold blood glucose level during that diurnal time period.

3. The method of claim 1, wherein the insulin delivery device is an insulin pump.

4. The method of claim 3, wherein delivering insulin, using the insulin pump, based on the one or more target blood glucose levels comprises:

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

selecting a first profile of the first plurality of basal insulin delivery profiles that approximates the one or more target blood glucose levels based on projected blood glucose levels for each of the first plurality of basal insulin delivery profiles; and

delivering a dose of insulin using the insulin pump for a second time interval after a previous dose of insulin, the 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.

5. The method of claim 4, wherein the first plurality of basal insulin delivery profiles are each evaluated using a cost function evaluating the differences between the projected blood glucose levels and the one or more target blood glucose levels, and the first profile is selected based on the cost function.

6. The method of claim 1, wherein the FHI from the user is obtained by a user interface that includes an interactive feature with a plurality of possible FHI values by which the user inputs the FHI by selecting a displayed possible FHI.

7. The method of claim 6, wherein the FHI values displayed include at least one of a numerical blood glucose level, a probability of going below a low threshold glucose level, a probability of going above a high threshold glucose level, and a textual description of a preferred glucose level.

8. The method of claim 1, wherein the user is the PWD, a caregiver to the PWD, or a healthcare professional.

9. A system comprising:

an interactive user device configured to obtain a fear of hypoglycemia index (FHI) from a user, the FHI corresponding to an acceptable probability of crossing a threshold blood glucose level;

an insulin pump configured to deliver insulin based on a message;

a control device configured to;

calculate a probability of a person with diabetes (PWD) having a blood glucose level that falls below the threshold blood glucose level based on the variability of blood glucose levels for that PWD;

determine, based on the FHI and the probability of the PWD crossing the threshold blood glucose level, one or more target blood glucose levels to align the probability of the PWD having a blood glucose level that falls below the threshold blood glucose level with the acceptable probability associated with a user selected FHI;

determine insulin delivery information based on the one or more target blood glucose levels; and

generate the message used by the insulin pump to deliver insulin based on the determined insulin delivery information.

10. The system of claim 9, wherein the interactive user device and the control device are components of the same device.

11. The system of claim 9, wherein the insulin pump and the control device are components of different devices.

12. The system of claim 9, wherein the control device stores a plurality of target blood glucose levels for a plurality of diurnal time periods and independently modifies each diurnal time period based on a calculated probability of the PWD having a blood glucose level falling below the threshold blood glucose level during that diurnal time period.

13. The system of claim 9, wherein the control device determines the insulin delivery information by:

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

selecting a first profile of the first plurality of basal insulin delivery profiles that approximates the one or more target blood glucose levels based on projected blood glucose levels for each of the plurality of insulin delivery profiles; and

wherein generating the message is further based on a dose of insulin corresponding to a first action or series of actions in the first series of the first profile, the second time interval shorter than the first time interval.

14. The system of claim 13, wherein the first plurality of basal insulin delivery profiles are each evaluated using a cost function evaluating the differences between the projected blood glucose levels and at least the one or more target blood glucose levels and the first profile is selected based on the cost function.

15. The system of claim 9, wherein the interactive user device includes a user interface that includes an interactive feature with a plurality of possible FHI values by which the user inputs the FHI.

16. The system of claim 15, wherein the FHI values include at least one of a numerical blood glucose level, a probability of going below a low threshold glucose level, a probability of going above a high threshold glucose level, and a textual description of a preferred glucose level, by which the user inputs the FHI.

17. The system of claim 9, wherein the insulin delivery information includes a profile or a rate.

18. A non-transitory computer readable medium containing instructions that, when executed by a processor, are configured to perform operations, the operations comprising:

receiving a selection of a fear of hypoglycemia index (FHI), the FHI corresponding to an acceptable probability of crossing a threshold blood glucose level;

calculating a probability of a person with diabetes (PWD) having a blood glucose level falling below the threshold blood glucose level based on variability of blood glucose values for the PWD;

setting, based on the FHI and the probability of the PWD having a blood glucose level falling below the threshold blood glucose level, one or more target blood glucose levels to align the probability of the PWD having a blood glucose level falling below the threshold blood glucose level with the acceptable probability associated with a user selected FHI; and

generating a message to an insulin pump to deliver insulin based on the one or more target blood glucose levels.

19. The non-transitory computer readable medium of claim 18, wherein the user selected FHI is received through a user interface that includes an interactive feature with a plurality of possible FHI values by which a user inputs the user selected FHI.

20. The non-transitory computer readable medium of claim 19, wherein the user interface includes at least one of a numerical blood glucose level, a probability of going below a low threshold glucose level, a probability of going above a high threshold glucose level, and a textual description of a preferred glucose level, by which the user inputs the user selected FHI.