Methods and Systems for Analyzing Glucose Data Measured From a Person Having Diabetes

• US 20160287184A1
• Filed: 04/02/2015
• Published: 10/06/2016
• Est. Priority Date: 04/02/2015
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Diebold, Eric R, Duke, David L, Greenburg, Alan
• Granted Patent: US 10,617,363 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/725 using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Methods and systems are disclosed analyzing a glucose level of a person having diabetes. The method, in at least one example, comprises receiving into a computing device a plurality of measured glucose values from a continuous glucose monitoring system coupled to a person having diabetes, analyzing the plurality of measured glucose values with a probability analysis tool on the computing device to determine a glucose threshold (g_Io), and a boundary glucose value (g_ρ) at a probability threshold where the person having diabetes requires at least a predetermined insulin dose, and comparing, with the computing device, the boundary glucose value (g_ρ) to the glucose threshold (g_Io), wherein if the boundary glucose value (g_ρ) is greater than the glucose threshold (g_Io) then the computing device performs an alert on a user interface.

Claims

1. A method for analyzing a glucose level of a person having diabetes, the method comprising:

receiving into a computing device a plurality of measured glucose values from a continuous glucose monitoring system coupled to a person having diabetes;

analyzing the plurality of measured glucose values with a probability analysis tool on the computing device to determine a glucose threshold (g_Io) and a boundary glucose value (g_ρ

) at a probability threshold where the person having diabetes requires at least a predetermined insulin dose; and

comparing, with the computing device, the boundary glucose value (g_ρ

) to the glucose threshold (g_Io), wherein if the boundary glucose value (g_ρ

) is greater than the glucose threshold (g_Io) then the computing device performs an alert on a user interface.

2. The method of claim 1, further comprising determining a maximum safe insulin bolus.

3. The method of claim 2, further comprising producing an alarm on the user interface if a manual bolus request exceeds the maximum safe insulin bolus.

4. The method of claim 1, wherein the boundary glucose value (g_ρ

) is

g_ρ

=√

{square root over (2σ

_g²)}erf<sup>−

1</sup>(2ρ

−

1)+g,

wherein

σ

_g² is a variance of glucose measurement,

ρ

is the probability threshold that the person having diabetes requires at least a predetermined insulin dose, and

g is a glucose result from the plurality of measured glucose values.

5. The method of claim 1, wherein the glucose threshold (g_Io) is

g_Io=g_m+cI₀,

wherein,

g_m is a maximum allowable glucose,

c is a correction factor, and

I₀ is a minimum insulin dose.

6. The method of claim 1, wherein the predetermined insulin dose is 1 unit.

7. The method of claim 1, wherein the glucose threshold is dependent on the time of day.

8. The method of claim 1, wherein the probability threshold is selected from a group consisting of 99%, 98%, 90%, 75%, and 50%.

9. The method of claim 1, wherein a day is broken into a plurality of time blocks, at least one of the plurality of time blocks having a different glucose threshold than the remaining time blocks.

10. The method of claim 1, wherein the predetermined insulin dose is higher during a period of sleep than a waking period.

11. The method of claim 1, wherein the plurality of measured glucose values comprises periodic glucose measurements taken approximately every one minute.

12. The method of claim 5, wherein at least one of the maximum allowable glucose, the minimum insulin dose, and the correction factor are supplied by a bolus calculator.

13. The method of claim 1, wherein the alert may be a display, sound, vibration, or any combination thereof.

14. The method of claim 1, wherein the alert indicates that a glucose measurement should be taken.

15. The method of claim 14, further comprising administering a predetermined safety insulin bolus to the person having diabetes, if the glucose measurement is not performed and a correction dose is not administered.

16. The method of claim 15, wherein the glucose measurement is a self-monitored blood glucose measurement.

17. The method of claim 15, wherein the glucose measurement is an additional measurement taken by the continuous glucose monitoring system and triggered by the user.

18. The method of claim 15, further comprising determining an insulin bolus dose with the computing device using the glucose measurement.

19. The method of claim 18, wherein the determining of the insulin bolus dose uses at least one of a rate of change measurement of the plurality of measured glucose values, a trend in the plurality of measured glucose values, and a pattern in the plurality of measured glucose values.

20. The method of claim 18, wherein the determining of the insulin bolus dose uses at least one rate of change measurement of the plurality of measured glucose values, and a predicted glucose value, wherein the correction dose is

21. The method of claim 20, wherein time t is about 20 minutes to about 60 minutes.

22. A system for analyzing a glucose level of a person having diabetes, the system comprising:

a controller comprising a computer readable medium having computer executable instructions for performing the method comprising;

receiving into a computing device a plurality of measured glucose values from a glucose sensor coupled to a person having diabetes;

analyzing the plurality of measured glucose values with a probability analysis tool on the computing device to determine a probability (P_ID) that the person having diabetes requires at least a predetermined insulin dose; and

comparing, with the computing device, the probability (P_ID) to a threshold probability (P_T), wherein if the probability (P_ID) is greater than the threshold probability (P_T) then the computing device executes an alert;

a bolus calculator in communication with the controller, the bolus calculator capable of determining an insulin bolus based on the plurality of measured glucose values.

23. The system of claim 22, wherein the method performed on the controller further comprises determining a maximum safe insulin bolus.

24. The system of claim 22, wherein the controller is configured to produce an alarm on the user interface if a manual bolus request entered in the user interface exceeds the maximum safe insulin bolus.

25. The system of claim 22, wherein the method performed by the computer executable instructions further comprises determining a glucose rate of change of the plurality of measured glucose values, the glucose rate of change being used by the bolus calculator to modify the insulin bolus.

26. The system of claim 22, wherein the controller further comprising a user interface, wherein the method further comprises displaying on the user interface the modified insulin bolus.

27. The system of claim 22, wherein the rate of change may be used to predict a glucose level at a future time for use by the bolus calculator.