DECISIONS SUPPORT FOR PATIENTS WITH DIABETES

• US 20160082187A1
• Filed: 09/23/2014
• Published: 03/24/2016
• Est. Priority Date: 09/23/2014
• Status: Abandoned Application

• Current Assignee: Animas Corporation (Johnson & Johnson)
• Original Assignee: Animas Corporation (Johnson & Johnson)
• Inventors: SCHAIBLE, Thomas, MCCANN, Thomas, CAPURRO, Jorge
• Application Number:
  US14/494,018
• Publication Number:
  US 20160082187A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• 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 2205/3592 using telemetric means, e.g. radio or optical transmission
• 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 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A decision support system includes a measurement device configured to continuously measure a physiological parameter of a patient. An insulin delivery device provides insulin to the patient per an initial basal profile and the parameter measurements. A storage device holds historical data of insulin delivery to the patient. A processor determines deviations of the delivery of insulin from the basal profile for one or more time period(s) using the historical data, computes a respective first basal-profile adjustment for each of the one or more time period(s) using the determined deviations, and annunciates the computed first basal-profile adjustment(s). A method of recommending a basal-rate adjustment includes measuring the parameter, infusing the patient with insulin and storing the historical data, determining the deviations from the basal profile, computing the first basal-profile adjustments, and annunciating the computed first basal-profile adjustment(s).

Claims

1. A decision support system for a patient, the system comprising:

a) a measurement device configured to continuously measure a physiological parameter of the patient;

b) an insulin delivery device configured to provide insulin to the patient according to an initial basal profile and the continuous measurements of the physiological parameter;

c) a storage device holding historical data of insulin delivery to the patient by the insulin delivery device; and

d) a processor coupled to the storage device, the processor being configured to;

i) determine deviations of the delivery of insulin from the basal profile for one or more time period(s) using the historical data;

ii) compute a respective first basal-profile adjustment for each of the one or more time period(s) using the determined deviations; and

iii) annunciate the computed first basal-profile adjustment(s).

2. The system according to claim 1, wherein the one or more time period(s) include a plurality of time periods and the processor is further adapted to:

a) determine whether or not at least one of the plurality of time periods has deviations that are significantly different than an overall deviation of the plurality of time periods using a chi-squared (χ

²) test; and

b) determine a single first basal-profile adjustment for at least two different ones of the plurality of time periods if the deviations for the at least one of the plurality of time periods are not significantly different than the overall deviation.

3. The system according to claim 1, wherein the processor is further adapted to adjust the initial basal profile based upon the computed first basal-profile adjustment(s).

4. The system according to claim 1, further including a display, the processor configured to annunciate the computed first basal-profile adjustment(s) by presenting a visual indication thereof on the display.

5. The system according to claim 4, wherein each first basal-profile adjustment includes a respective delivery rate and the visual indication includes textual representation(s) of the respective delivery rate(s).

6. The system according to claim 1, further including a user interface adapted to receive input, the processor further adapted to receive the historical data via the user interface and store the received historical data in the storage device.

7. The system according to claim 1, wherein the historical data includes bolus data and the processor is further configured to filter meal data out of the historical data using the bolus data.

8. The system according to claim 1, wherein the measurement device comprises a continuous glucose monitor and the measured physiological parameter comprises blood glucose.

9. The system according to claim 8, wherein the processor is further configured to store blood glucose measurements of the patient and filter meal data out of the historical data using the stored measurements of the blood glucose.

10. The system according to claim 8, wherein the processor is further configured to:

a) store a plurality of the blood glucose measurements;

b) determine deviations of blood glucose level from a stored aim range for one or more time period(s) using the stored blood glucose measurements;

c) compute a respective second basal-profile adjustment for each of the one or more time period(s) using the determined deviations; and

d) annunciate the respective second basal-profile adjustment(s).

11. The system according to claim 10, wherein the processor is further configured to filter meal data out of the stored blood glucose measurements using the historical data.

12. The system according to claim 10, wherein the processor is configured to determine the deviations of blood glucose level by determining the extent to which each of the stored blood glucose measurements is outside the stored aim range, and determining that the deviation for one of the time period(s) is zero if the stored measurements during that time period are within the stored aim range.

13. The system according to claim 8, wherein the processor is further configured to:

a) store a plurality of the blood glucose measurements for a selected time period;

b) select two stored measurements using the historical data, the two stored measurements corresponding to a glucose correction bolus during the selected time period;

c) determine a glucose effect of the glucose correction bolus using the selected stored measurements and a stored aim range;

d) compute an adjustment to an insulin sensitivity factor for the selected time period using the determined glucose effect; and

e) annunciate the computed adjustment to the insulin sensitivity factor.

14. The system according to claim 8, wherein the storage device holds an insulin-carbohydrate ratio and the processor is further configured to:

a) store a plurality of the blood glucose measurements for a selected time period;

b) select at least one stored measurement using the historical data, the selected at least one stored measurement corresponding to carbohydrate correction boluses during the selected time period;

c) determine a respective deviation for each of the selected stored measurements with respect to a stored aim range;

d) compute an adjustment to the insulin-carbohydrate ratio for the selected time period using the determined deviations and the insulin-carbohydrate ratio; and

e) annunciate the respective adjustment to the insulin-carbohydrate ratio.

15. The system according to claim 14, wherein the storage device further holds a glucose-carbohydrate ratio and the processor is further configured to compute the adjustment to the insulin-carbohydrate ratio using the stored glucose-carbohydrate ratio.

16. A method of recommending a basal-rate adjustment for an insulin-delivery system, the method comprising:

continuously measuring a physiological parameter of a patient;

repeatedly infusing the patient with insulin according to an initial basal profile and the continuous physiological parameter measurements;

storing historical data of the delivery of insulin;

using a processor, automatically determining deviations of the delivery of insulin from the basal profile for one or more time period(s) using the stored historical data;

using the processor, automatically computing a respective first basal-profile adjustment for each of the time period(s) using the determined deviations; and

using the processor, automatically annunciating the computed first basal-profile adjustment(s).

17. The method according to claim 16, wherein the physiological parameter is blood glucose.

18. The method according to claim 17, further including automatically performing the following using the processor:

storing a plurality of the blood glucose measurements;

determining deviations of blood glucose level from a stored aim range for one or more time period(s) using the stored measurements;

computing a respective second basal-profile adjustment for each of the time period(s) using the determined deviations; and

annunciating the computed second basal-profile adjustment(s).

19. The method according to claim 17, further including automatically performing the following using the processor:

storing a plurality of the blood glucose measurements for a selected time period;

selecting two stored measurements using the historical data, the two selected measurements corresponding to a glucose correction bolus during the selected time period;

determining a glucose effect of the glucose correction bolus using the selected stored measurements and a stored aim range;

computing an adjustment to an insulin sensitivity factor for the selected time period using the determined glucose effect; and

annunciating the computed adjustment to the insulin sensitivity factor.

20. The method according to claim 17, further including automatically performing the following using the processor:

storing a plurality of the blood glucose measurements for a selected time period;

selecting at least one of the stored measurements using the historical data, the at least one selected measurement corresponding to carbohydrate correction boluses during the selected time period;

determining a respective deviation for each selected stored measurements with respect to a stored aim range;

computing an adjustment to the insulin-carbohydrate ratio for the selected time period using the determined deviations and the insulin-carbohydrate ratio; and

annunciating the computed adjustment to the insulin-carbohydrate ratio.