INSULIN DELIVERY METHODS, SYSTEMS AND DEVICES

• US 20180200441A1
• Filed: 01/12/2018
• Published: 07/19/2018
• Est. Priority Date: 01/13/2017
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Desborough, Lane, Mazlish, Bryan
• Granted Patent: US 11,033,682 B2
• Time in Patent Office: Days
• 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: A61K 38/28 Insulins
• CPC Class Codes: A61M 2205/35 Communication
• 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 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A method of insulin delivery, the method may include obtaining one or more blood glucose readings of a user, and, based on the blood glucose readings, generating a set of insulin delivery actions that may include delivery of a baseline basal rate or predefined variations of the baseline basal rate. The method may also include monitoring previous insulin delivery actions to the user to determine whether the previous insulin delivery actions include insulin beyond a threshold amount, where the previous insulin delivery actions may include delivery of the baseline basal rate or predefined variations of the baseline basal rate, and, based on the previous insulin delivery actions including insulin beyond the threshold amount, adjusting the set of insulin delivery actions.

Claims

1. A method of insulin delivery, the method comprising:

obtaining one or more blood glucose readings of a user;

based on the blood glucose readings, generating a set of insulin delivery actions, the set of insulin delivery actions including delivery of a baseline basal rate or predefined variations of the baseline basal rate;

monitoring previous insulin delivery actions to the user to determine whether the previous insulin delivery actions include insulin beyond a threshold amount, the previous insulin delivery actions including delivery of the baseline basal rate, or predefined variations of the baseline basal rate; and

based on the previous insulin delivery actions including insulin beyond the threshold amount, adjusting the set of insulin delivery actions.

2. The method of claim 1, wherein adjusting the set of insulin delivery actions includes changing all delivery actions in the set of delivery actions to deliver insulin at the baseline basal rate.

3. The method of claim 2, wherein adjusting the set of insulin delivery actions includes exiting a feedback delivery mode of insulin delivery.

4. The method of claim 1, wherein monitoring previous insulin delivery actions to the user comprises including an amount of insulin delivered below the threshold amount.

5. The method of claim 4, further comprising determining whether Total IOB Ratio is above or below a threshold value, wherein the Total IOB Ratio is based on basal insulin and bolus insulin and is determined by:

Total IOB Ratio=Nominal Basal IOB_t+Bolus IOB_t+Basal Adjust IOB_t/Nominal Basal IOB_t.

6. The method of claim 1, wherein monitoring previous insulin delivery actions to the user comprises including the amount of insulin delivered above the threshold amount.

7. The method of claim 6, wherein monitoring previous insulin delivery actions to the user comprises tracking a plurality of delivery actions delivering predefined variations of the baseline basal rate above the baseline basal rate, and further comprising including approximately a total daily basal dose in the threshold amount.

8. The method of claim 1, further comprising including approximately 0.17 of the total daily basal dose in the threshold amount.

9. The method of claim 1, further comprising including consecutive insulin delivery actions above the baseline basal rate for a threshold amount of time in the threshold amount.

10. The method of claim 9, further comprising defining the threshold amount of time to include one of approximately two hours, three hours, four hours, five hours, or six hours.

11. The method of claim 1, further comprising defining the predefined variations of the baseline basal rate to include at least one of 0×

, 1×

, 2×

, or 3×

the baseline basal rate.

12. The method of claim 1, further comprising:

receiving an acknowledgement of the adjustment to the set of insulin delivery actions; and

in response to receiving the acknowledgment, allowing the delivery actions to include delivery of the baseline basal rate or the predefined variations of the baseline basal rate.

13. The method of claim 1, further comprising:

receiving an indication that the user is transitioning from long-acting insulin injections; and

in response to receiving the indication and in response to a delivery mode including a feedback delivery mode, adjusting the threshold such that insulin delivery below the baseline basal rate is allowed until a predefined period of time after a delivery of long-acting insulin.

14. The method of claim 1, further comprising:

receiving an indication that the user is transitioning from long-acting insulin injections; and

in response to receiving the indication and in response to a delivery mode including a standard delivery mode, adjusting the baseline basal rate to a reduced amount until a predefined period of time after a delivery of long-acting insulin.

15. The method of claim 14, further comprising defining the reduced amount to include approximately 25% of the baseline basal rate.

16. A method of insulin delivery, the method comprising:

obtaining one or more blood glucose readings of a user;

based on the blood glucose readings, generating a set of insulin delivery actions, the set of insulin delivery actions including delivery of a baseline basal rate or predefined variations of the baseline basal rate;

calculating an amount of basal insulin on board (IOB) due to the insulin delivery actions that are of a baseline basal rate or a predefined variation of the baseline basal rate; and

delivering insulin at or below the baseline basal rate whenever basal IOB exceeds a threshold.

17. The method of claim 16, further comprising determining the threshold by calculating a basal IOB Ratio comparing the basal IOB to an insulin on board that would be determined based only if the baseline basal rate were delivered, wherein the threshold is a basal IOB Ratio selected from a number between 1.6 and 1.9.

18. The method of claim 16, further comprising determining the threshold by calculating an amount of insulin on board that exceeds a percentage of a calculation of a typical daily dosage of basal insulin, wherein the percentage is between 10% and 25% of the calculation of a typical daily dosage of basal insulin.

19. A method of insulin delivery, the method comprising:

obtaining one or more blood glucose readings of a user;

based on the blood glucose readings, generating a set of insulin delivery actions, the set of insulin delivery actions including delivery of a baseline basal rate or predefined variations of the baseline basal rate;

calculating a total IOB due to all insulin delivery actions including that of a baseline basal rate, a predefined variation of the baseline basal rate, and insulin boluses; and

delivering insulin at or above the baseline basal rate whenever Total IOB is below a threshold.

20. The method of claim 19, further comprising determining the threshold by calculating a total IOB ratio comparing the total IOB to an IOB that would be determine if only the baseline basal rate were delivered, wherein the threshold is selected from a number between 0.2 and 0.6, and wherein an estimated blood glucose level (EGV) includes the estimated blood glucose level, a target blood glucose level, an insulin sensitivity factor, and the IOB.

21. An insulin delivery monitoring system comprising:

an insulin delivery device configured to deliver insulin to a user; and

a controller configured to perform or control performance of operations, the operations comprising;

obtaining one or more blood glucose readings of a user;

based on the blood glucose readings, generating a set of insulin delivery actions, the set of insulin delivery actions including delivery of a baseline basal rate or predefined variations of the baseline basal rate;

at least one of monitoring previous insulin delivery actions to the user to determine whether the previous insulin delivery actions include insulin beyond a threshold amount, calculating an amount of basal insulin on board (IOB) due to the insulin delivery actions, or calculating a total IOB due to the previous insulin delivery actions; and

based on the previous insulin delivery actions, adjusting the set of insulin delivery actions.