Method and device for improving glycemic control based on residual insulin

• US 8,734,383 B2
• Filed: 06/23/2010
• Issued: 05/27/2014
• Est. Priority Date: 06/25/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Gescheit, Iddo, Shapira, Gali
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US13/380,287
• Publication Number:
  US 20120220939A1
• Time in Patent Office: 1,434 Days
• Field of Search: 604/66, 604/151, 705/2
• US Class Current: 604/66
• 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 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Disclosed are systems, devices, and methods, including a system that includes a processor-based device implementing at least a residual insulin (RI) determination unit configured to determine a residual insulin in the patient'"'"'s body at a particular time instance based on bolus doses previously delivered to the body of the patient, each bolus dose being associated with at least one dose value and a time representative of the time that dose value was delivered to the patient'"'"'s body, and based on dose dependent RI time records that each includes at least a dose value and an associated duration value representative of dose-dependent duration of therapeutic effectiveness of the associated at least the dose value. The system also includes a pump to controllably dispense the insulin from a reservoir to the body of the patient based on the residual insulin determined by the RI determination unit.

Claims

1. A drug delivery system for administration of insulin to a body of a patient, the system comprising:

a processor-based device implementing at least a residual insulin (RI) determination unit, the RI determination unit configured to;

receive one or more bolus records, each of the bolus records being associated with a respective bolus dose delivered to the patient and includes at least an associated bolus dose value, an associated time representative of the time the respective bolus dose was delivered to the patient, and an associated duration value representative of dose-dependent duration of therapeutic effectiveness of the associated dose value; and

determine a residual insulin in the patient'"'"'s body based on the associated bolus dose value, the associated time, and the associated duration value associated with each of the one or more bolus records; and

a pump to controllably dispense the insulin from a reservoir to the body of the patient based on the residual insulin determined by the RI determination unit.

2. The system of claim 1, wherein the RI determination unit is located in a remote control.

3. The system of claim 1 further including a screen to display at least the residual insulin determined by the RI determination unit.

4. The system of claim 1, further including a user interface for receiving one or more values associated with the one or more bolus records and/or a confirmation of the user.

5. The system of claim 4, wherein the user interface includes at least one of:

buttons, switches, keys, a keyboard, a touch-sensitive screen, and a voice command interface.

6. The system of claim 4, further including a transceiver configured to receive and/or transmit data related to operation of the RI determination unit.

7. A method for determining residual insulin (RI) for use with an insulin delivery device, the method comprising:

receiving one or more bolus records, each of the bolus records being associated with a respective bolus dose delivered to a patient and includes at least an associated bolus dose value, an associated time representative of the time the respective bolus dose was delivered to the patient, and an associated duration value representative of dose-dependent duration of therapeutic effectiveness of the associated dose value; and

determining, based on the associated bolus dose value, the associated time, and the associated duration value associated with each of the one or more bolus records, a residual insulin in the patient'"'"'s body at a particular time instance.

8. The method of claim 7, wherein the associated duration value of dose dependent RI records is based on one or more of:

insulin type, site of cannula insertion and insulin delivery, physical activity, body temperature, fluid absorption characteristics, weight, age, gender, CIR, IS, and concentration of insulin.

9. The method of claim 7, further comprising:

determining a bolus amount to be delivered to the patient'"'"'s body based on the determined residual insulin.

10. The method of claim 9, further comprising:

delivering the determined bolus amount to the patient'"'"'s body.

11. The method of claim 7, wherein the step of determining the residual insulin in the patient'"'"'s body at the particular time instance comprises:

determining the residual insulin in the patient'"'"'s body by performing one or more of;

matching, using data tables, a first dose value of at least one of the one or more bolus records to data corresponding to one or more dose dependent RI time records arranged in the data tables, and determining the residual insulin value for the dose value of the at least one of the one or more bolus doses using relationships, determined based on the data corresponding the one or more dose dependent RI time records, that relate the dose value of the at least one of the one or more bolus records to a corresponding RI time determined using the determined relationship.

12. The method of claim 7, wherein the step of determining the residual insulin in the patient'"'"'s body at the particular time instance comprises:

determining for a delivered bolus of at least one of the one or more bolus records an associated RI time equivalent to the duration value associated with a dose value from one or more dose dependent RI time records closest in value to a dose value of the delivered bolus.

13. The method of claim 7, wherein the step of determining the residual insulin in the patient'"'"'s body at the particular time instance comprises:

generating a graph of RI time versus bolus dose based, at least in part, on one or more dose dependent RI time records; and

determining an RI time for a given delivered bolus value from one of the one or more bolus records in accordance with the generated graph.

14. The method of claim 7, wherein the step of determining the residual insulin in the patient'"'"'s body at the particular time instance comprises:

determining for each of the one or more bolus records an associated individual residual insulin at the particular time instance based, at least in part, on one or more dose dependent RI time records; and

determining a sum of the determined individual residual insulin for each of the one or more bolus records.

15. The method of claim 14, wherein determining the sum of the determined individual residual insulin comprises:

determining a weighted sum of the determined individual residual insulin according to the relationship Σ

_j=1ⁿ α

_jRI_j where RI_j is the determined individual residual insulin for the j^th bolus record from the one or more bolus records, and α

_j is an associated weight to apply to the determined residual insulin.

16. The method of claim 7, wherein the step of determining the residual insulin in the patient'"'"'s body at the particular time instance comprises:

tailoring the residual insulin to the patient based on patient-specific characteristics.

17. The method of claim 16, wherein the step of tailoring the residual insulin is performed by using at least one of:

linear curve fitting, non-linear curve fitting, Bayesian models, neural network, fuzzy logic, genetic algorithms, linear regression, machine learning procedures, and statistical learning procedures.

18. The method of claim 7, wherein a duration value of one of the one or more dose dependent RI time records for a bolus used to cover a meal with a low glycemic index (GI) or glycemic load (GL) is lower than another duration value of another of the one or more dose dependent RI time records used to cover a meal with high glycemic index.

19. A computer program comprising computer-executable instructions, which when executed on a suitable computer device, perform the method of claim 7.

20. A non-transitory computer readable medium comprising computer-executable instructions recorded thereon for performing the method of claim 7.