Method and system for providing basal profile modification in analyte monitoring and management systems

• US 9,669,162 B2
• Filed: 03/16/2016
• Issued: 06/06/2017
• Est. Priority Date: 11/04/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Sloan, Mark Kent, Hayter, Gary Alan
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US15/071,610
• Publication Number:
  US 20160193410A1
• Time in Patent Office: 447 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• 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 2205/3303 Using a biosensor
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• 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 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Method and system for providing basal profile modification in insulin therapy for use with infusion devices includes periodically monitoring the analyte levels of a patient for a predetermined period of time in order to determine, based on the monitored analyte levels, an appropriate modification factor to be incorporated into the underlying basal profile which was running at the time the periodic monitoring of the analyte levels were performed.

Claims

1. A method of improving diabetes management with an electronic analyte monitoring and management system comprising a sensor, one or more processing units, and an infusion device, the method comprising:

continuously or semi-continuously monitoring, using the sensor, an analyte level of a user, wherein the monitoring occurs during a time segment in which a medication was administered to the user according to a first medication delivery profile;

determining, using the one or more processing units, a frequency of an analyte level deviation during the time segment;

determining, using the one or more processing units, a second medication delivery profile for administration of the medication during the time segment when the frequency of the analyte level deviation exceeds a threshold; and

administering the medication with the infusion device according to the second medication delivery profile such that the frequency of the analyte level deviation is reduced.

2. The method of claim 1, further comprising:

outputting a notification associated with the second medication delivery profile; and

after outputting the notification, receiving an indication of acceptance of the second medication profile prior to administering the medication with the infusion device according to the second medication delivery profile.

3. The method of claim 1, wherein the first medication delivery profile is a first basal medication delivery profile, the second medication delivery profile is a second basal medication delivery profile, and wherein the method comprises:

administering a bolus medication dose; and

determining, using the one or more processing units, the second basal delivery profile by converting the bolus medication dose into the second basal delivery profile.

4. The method of claim 1, wherein determination of the second medication delivery profile occurs each time a bolus medication dose is administered.

5. The method of claim 1, wherein the first medication delivery profile is a first basal medication delivery profile, the second medication delivery profile is a second basal medication delivery profile, and wherein the method comprises determining, using the one or more processing units, the second basal delivery profile by adjusting a loop gain applied to the first basal medication delivery profile.

6. The method of claim 5, wherein the analyte level deviation is a first analyte level deviation, the method comprising:

continuously or semi-continuously monitoring, using the sensor, an analyte level of the user, wherein the monitoring occurs during a period of time in which medication was administered to the user according to the second basal medication delivery profile;

determining, using the one or more processing units, a second analyte level deviation during the period of time; and

determining, using the one or more processing units, a third basal medication delivery profile for administration of the medication.

7. The method of claim 1, wherein the analyte level deviation is a glucose excursion.

8. The method of claim 1, wherein the analyte level deviation is a deviation from a target glucose mean.

9. The method of claim 1, further comprising determining a magnitude of the analyte level deviation, wherein determining, using the one or more processing units, the second medication delivery profile comprises modifying the first basal delivery profile in proportion to the magnitude of the analyte level deviation.

10. The method of claim 1, wherein determination of the second medication delivery profile occurs when the frequency of the analyte level deviation exceeds a threshold as measured over a plurality of days.

11. An apparatus, comprising:

an infusion device adapted to administer a medication to a user according to instructions from one or more processing units;

a sensor adapted to continuously or semi-continuously sense an analyte level of the user;

the one or more processing units operatively coupled with the infusion device and the sensor; and

a data storage unit operatively coupled to the one or more processing units, the data storage unit having stored therein executable programming instructions which, upon execution, cause the one or more processing units to;

determine a frequency of an analyte level deviation during a time segment;

determine a second medication delivery profile for administration of the medication during the time segment when the frequency of the analyte level deviation exceeds a threshold; and

cause administration of the medication by the infusion device according to the second medication delivery profile such that the frequency of the analyte level deviation is reduced.

12. The apparatus of claim 11, wherein the executable programming instructions, upon execution, further cause the one or more processing units to:

cause the output of a notification associated with the second medication delivery profile; and

process an indication of acceptance of the second medication profile before causing administration of the medication with the infusion device according to the second medication delivery profile.

13. The apparatus of claim 11, wherein the first medication delivery profile is a first basal medication delivery profile, the second medication delivery profile is a second basal medication delivery profile, and wherein the executable programming instructions, upon execution, further cause the one or more processing units to determine the second basal delivery profile by conversion of an administered bolus medication dose into the second basal delivery profile.

14. The apparatus of claim 11, wherein the executable programming instructions, upon execution, further cause the one or more processing units to determine the second medication delivery profile each time a bolus medication dose is administered.

15. The apparatus of claim 11, wherein the first medication delivery profile is a first basal medication delivery profile, the second medication delivery profile is a second basal medication delivery profile, and wherein the executable programming instructions, upon execution, further cause the one or more processing units to determine the second basal delivery profile by adjusting a loop gain applied to the first basal medication delivery profile.

16. The apparatus of claim 15, wherein the analyte level deviation is a first analyte level deviation, and wherein the executable programming instructions, upon execution, further cause the one or more processing units to:

determine that a second analyte level deviation occurred during a period of time in which medication was administered to the user according to the second basal medication delivery profile; and

determine a third basal medication delivery profile for administration of the medication.

17. The apparatus of claim 11, wherein the analyte level deviation is a glucose excursion.

18. The apparatus of claim 11, wherein the analyte level deviation is a deviation from a target glucose mean.

19. The apparatus of claim 11, wherein the executable programming instructions, upon execution, further cause the one or more processing units to:

determine a magnitude of the analyte level deviation; and

determine the second medication delivery profile at least in part by a modification to the first basal delivery profile in proportion to the magnitude of the analyte level deviation.

20. The apparatus of claim 11, wherein the executable programming instructions, upon execution, further cause the one or more processing units to determine the second medication delivery profile when the frequency of the analyte level deviation exceeds a threshold as measured over a plurality of days.