Adjusting insulin delivery rates

• US 10,835,671 B2
• Filed: 01/13/2017
• Issued: 11/17/2020
• 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:
  US15/406,329
• Publication Number:
  US 20170203038A1
• Time in Patent Office: 1,404 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 delivering insulin, using an insulin pump and a controller, over a first diurnal time period based on a baseline basal insulin rate stored in memory. The controller may receive blood glucose data to control delivery of insulin via the insulin pump in amounts variable from the baseline basal insulin rate to control blood glucose levels for a person with diabetes (PWD). The method may also include modifying the baseline basal insulin rate stored in the memory for a second diurnal time period that is at least 20 hours after the first diurnal period based on an amount of insulin actually delivered during the first diurnal time period.

Claims

1. A method comprising:

providing an insulin delivery system, the insulin delivery system comprising an insulin pump and a controller, wherein the controller comprises a memory storing a schedule of baseline basal insulin rates over a 24-hour period, each baseline basal insulin rate being set for a diurnal time period over the 24-hour period, the schedule of baseline basal insulin rates including a first baseline basal insulin rate for a first diurnal time period and a second baseline basal insulin rate for a second diurnal time period, which related to the first diurnal time period and is at least 20 hours after the first diurnal time period;

delivering insulin, using the insulin delivery system, over the first diurnal time period responsive to the first baseline basal insulin rate of the schedule of baseline basal insulin rates that is stored in the memory for the first diurnal time period, wherein the controller receives at least blood glucose data and controls delivery of insulin via the insulin pump in amounts variable from the first baseline basal insulin rate for the first diurnal time period responsive to the received at least blood glucose data to control blood glucose levels of a person with diabetes;

calculating an updated baseline basal insulin rate for the second diurnal time period as a function of the first baseline basal insulin rate stored for the first diurnal time period, the second baseline basal insulin rate of the schedule of baseline basal insulin rates previously stored for the second diurnal time period, and an amount of insulin actually delivered during the first diurnal time period, wherein a difference between the updated baseline basal insulin rate and the second baseline basal insulin rate previously stored for the second diurnal time period is less than the difference between the first baseline basal insulin rate stored for the first diurnal time period and a rate at which insulin was actually delivered during the first diurnal time period; and

replacing the second baseline basal insulin rate of the schedule of baseline basal insulin rates previously stored in the memory for the second diurnal time period with the updated baseline basal insulin rate for the second diurnal time period, wherein the insulin delivery system waits to deliver insulin according to the updated baseline basal insulin rate until at least 20 hours after the first diurnal time period.

2. The method of claim 1, wherein a carbohydrate-to-insulin ratio (CR) for the second diurnal time period is also modified responsive to the rate at which insulin was actually delivered during the first diurnal time period.

3. The method of claim 1, wherein an insulin sensitivity factor (ISF) for the second diurnal time period is also modified responsive to the rate at which insulin was actually delivered during the first diurnal time period.

4. The method of claim 1, wherein the second diurnal time period is one of a same time period on another day or a time period within two hours prior to the same time period on the another day.

5. The method of claim 1, wherein the updated baseline basal insulin rate is an increased rate relative to the second baseline basal insulin rate previously stored for the second diurnal time period if a ratio of the rate at which insulin was actually delivered during the first diurnal time period to the rate dictated by the first baseline basal insulin rate for the first diurnal time period exceeds a predetermined first threshold and is a decreased rate relative to the second baseline basal insulin rate that if the ratio falls below a predetermined second threshold.

6. The method of claim 5, wherein the updated baseline basal insulin rate for the second diurnal time period is an increased rate or a decreased rate relative to the second baseline basal insulin rate by a fixed amount or a percentage that is less than a difference between the rate at which insulin was actually delivered during the first diurnal time period and the rate dictated by the first baseline basal insulin rate.

7. The method of claim 6, wherein the updated baseline basal insulin rate is an increased rate or a decreased rate relative to the second baseline basal insulin rate by a percentage between about 1% and about 5% second baseline basal insulin rate.

8. The method of claim 6, wherein a stored CR or a stored ISF for the second diurnal time period is also increased or decreased by a fixed amount or percentage when the second baseline basal insulin rate is replaced with the updated baseline basal insulin rate.

9. The method of claim 8, wherein the stored CR, and the stored ISF are each increased or decreased by a percentage between about 1% and about 5%, and wherein the updated baseline basal insulin rate is an increased rate or a decreased rate relative to the second baseline basal insulin rate by a percentage between about 1% and about 5% second baseline basal insulin rate.

10. The method of claim 5, wherein a difference between the updated baseline basal insulin rate and the second baseline basal insulin rate stored in the memory is based at least partially on the ratio, but is less than a difference between the rate at which insulin was actually delivered during the first diurnal time period and the rate dictated by the first baseline basal insulin rate.

11. The method of claim 5, wherein a stored CR and a stored ISF for the second diurnal time period are increased when the updated baseline basal insulin rate is less than the second baseline basal insulin rate and decreased when the updated baseline basal insulin rate is more than the second baseline basal insulin rate.

12. The method of claim 1, wherein delivering insulin, using an insulin pump and the controller, over the first diurnal time period includes:

(a) 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 and responsive to the schedule of baseline basal insulin rates stored in the memory for a plurality of diurnal time periods within the first time interval;

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

(c) selecting a first profile of the first plurality of basal 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;

(d) delivering a first dose of insulin for at least part of the first diurnal time period using the insulin pump for a second time interval, the second time interval being no greater than the first diurnal time period; and

(e) optionally repeating steps (a) through (d) until insulin is delivered for an entire first diurnal time period.

13. The method of claim 12, wherein each action in the first series of insulin delivery actions includes one of delivering 0, 1, or 2 times the first baseline basal insulin rate.

14. The method of claim 12, wherein the at least one up-to-date blood glucose level is determined using an ISF, CR, or combination thereof for the first diurnal time period.

15. The method of claim 1, wherein the controller receives insulin or food consumption data to control delivery of insulin.

16. The method of claim 1, further comprising modifying a third baseline basal insulin rate for a third diurnal time period immediately adjacent to the second diurnal time period to smooth a transition between adjacent diurnal time periods.

17. The method of claim 1, further comprising delivery of insulin during the second diurnal time period responsive to the updated baseline basal insulin rate.

18. A system comprising:

an insulin pump configured to deliver insulin responsive to a message;

a glucose sensor configured to generate blood glucose data; and

a controller including a memory, the memory having stored thereon a schedule of baseline basal insulin rates associated with a 24-hour period, the schedule of baseline basal insulin rates including a first baseline basal insulin rate for a first diurnal time period and a second baseline basal insulin rate for a second diurnal time period, which related to the first diurnal time period and is at least 20 hours after the first diurnal time period, the controller configured to;

generate messages to deliver insulin over the first diurnal time period responsive to the first baseline basal insulin rate of the schedule of baseline basal insulin rates;

during the first diurnal time period, receive blood glucose data from the glucose sensor and control generation of the messages to deliver insulin in amounts variable from the first baseline basal insulin rate responsive to at least the received blood glucose data to control blood glucose levels of a person with diabetes;

calculate an updated baseline basal insulin rate for the second diurnal time period as a function of the first baseline basal insulin rate stored for the first diurnal time period, the second baseline basal insulin rate of the schedule of baseline basal insulin rates previously stored for the second diurnal time period, and an amount of insulin actually delivered during the first diurnal time period, wherein a difference between the updated baseline basal insulin rate and the second baseline basal insulin rate previously stored for the second diurnal time period is less than the difference between the first baseline basal insulin rate stored for the first diurnal time period and a rate at which insulin was actually delivered during the first diurnal time period; and

replace the second baseline basal insulin rate of the schedule of baseline basal insulin rates previously stored in the memory for the second diurnal time period with the updated baseline basal insulin rate for the second diurnal time period, wherein the system waits to deliver insulin according to the updated baseline basal insulin rate until at least 20 hours after the first diurnal time period.

19. The system of claim 18, wherein the controller is part of the insulin pump.

20. The system of claim 18, wherein the controller is a separate device from the insulin pump.