METHOD AND SYSTEM TO INDICATE HYPERGLYCEMIA OR HYPOGLYCEMIA FOR PEOPLE WITH DIABETES

• US 20140024907A1
• Filed: 07/19/2012
• Published: 01/23/2014
• Est. Priority Date: 07/19/2012
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: HOWELL, Frances Wilson, MacLEOD, Janice, RODBARD, David
• Application Number:
  US13/553,655
• Publication Number:
  US 20140024907A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• 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 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Various methods and systems to manage diabetes of a subject using data relating to patterns to provide insight into how a patient'"'"'s daily activities impact glycemic control of the subject. These patterns help to identify very specific areas of glycemic excursions, enable patients and HCPs to more easily identify patterns of hypoglycemia and hyperglycemia in order to take steps to improve glycemic control of the person with diabetes.

Claims

1. A system for management of diabetes of a subject, the system comprising:

at least one glucose monitor for measurements of the glucose levels of the subject;

an insulin infusion pump configured for communication with the at least one blood glucose monitor and delivery of insulin to the subject; and

a controller in communication with at least the insulin infusion pump and the at least one glucose monitor, the controller being configured to receive or transmit data regarding glucose levels and dosing of insulin from the at least one glucose monitor and pump for analysis the controller so that at least one of a hypoglycemic or hyperglycemic state of the subject is determined by;

evaluation of the glucose measurements measured over distinct fasting periods for hypoglycemia or hyperglycemia during fasting, and in the event a first proportion of such blood glucose measurements measured over distinct fasting periods is less than a hypoglycemic threshold, provide an indication of hypoglycemia over a duration spanning the distinct fasting periods, or alternatively, in the event a second proportion of such blood glucose measurements measured over distinct fasting periods is greater than a hyperglycemic threshold, annunciating an indication of hyperglycemia over a duration spanning the distinct fasting periods; and

ascertainment from the glucose measurements measured after external events have occurred to the user for hypoglycemia or hyperglycemia after such external events and provide an indication of hypoglycemia or hyperglycemia whenever a portion of the blood glucose measurements measured after the external disturbance is at or below a hypoglycemic threshold or whenever the blood glucose measurements measured after the external disturbance is at or above a hyperglycemic threshold.

2. A method for managing diabetes of a subject with at least a blood glucose monitor, the method comprising:

conducting, with the blood glucose monitor, a plurality of blood glucose measurements of the subject;

storing the plurality of blood glucose measurements in a memory;

evaluating the plurality of blood glucose measurements measured over distinct fasting periods for hypoglycemia or hyperglycemia during fasting, and in the event a first proportion of such blood glucose measurements measured over distinct fasting periods is less than a hypoglycemic threshold, annunciating an indication of hypoglycemia over a duration spanning the distinct fasting periods, or alternatively, in the event a second proportion of such blood glucose measurements measured over distinct fasting periods is greater than a hyperglycemic threshold, annunciating an indication of hyperglycemia over a duration spanning the distinct fasting periods.

4. The method of claim 2, further comprising:

ascertaining from the plurality of blood glucose measurements measured within a predetermined time after an external event to the user for hypoglycemia or hyperglycemia after such external event and annunciating an indication of hypoglycemia or hyperglycemia whenever a portion of the blood glucose measurements measured after the external event is at or below a hypoglycemic threshold or whenever the blood glucose measurements measured after the external event is at or above a hyperglycemic threshold.

5. The method of claim 2, in which the evaluating comprises the steps of:

determining a number (N1) of blood glucose measurements from the blood glucose measured over distinct fasting periods in which each of the (N1) number of blood glucose measurements is at or above a hypoglycemic threshold;

calculating hypoglycemic value (V1) which is approximately the number (N1) divided by the number of the blood glucose measured over distinct fasting periods and multiplied by 100; and

annunciating hypoglycemia of the user during duration covering the distinct fasting periods whenever the number (N1) is equal to or greater than a first predetermined value and the hypoglycemic value (V1) is equal to or greater than a second predetermined value.

6. The method of claim 2, in which the evaluating comprises the steps of:

determining a number (N2) of blood glucose measurements from the blood glucose measured over distinct fasting periods in which each of the number (N2) of blood glucose measurements is at or above a hyperglycemic threshold;

calculating hyperglycemic value (V2) which is approximately the number (N2) divided by the number of the blood glucose measured over distinct fasting periods and multiplied by 100; and

annunciating hyperglycemia of the user during duration covering the distinct fasting periods whenever the number (N2) is equal to or greater than a third predetermined value and the hyperglycemic value (V2) is equal to or greater than a fourth predetermined value.

7. The method of claim 5, in which the hypoglycemic threshold comprises about 70 mg/dL, the first predetermined value comprises about 2 and the second predetermined value comprises about 5.

8. The method of claim 6, in which the hyperglycemic threshold comprises about 180 mg/dL, the third predetermined value comprises about 3 and the fourth predetermined value comprises about 50.

20. The method of claim 6, in which the blood glucose measurements measured over distinct fasting periods comprise blood glucose measurements tagged by the user as taken during fasting.

3. A method for managing diabetes of a subject with at least a blood glucose monitor, the method comprising:

conducting, with at least the blood glucose monitor, a plurality of blood glucose measurements of the subject;

storing the plurality of blood glucose measurements in a memory;

ascertaining from the plurality of blood glucose measurements measured after external events have occurred to the user for hypoglycemia or hyperglycemia after such external events and annunciating an indication of hypoglycemia or hyperglycemia whenever a portion of the blood glucose measurements measured after the external disturbance is at or below a hypoglycemic threshold or whenever the blood glucose measurements measured after the external disturbance is at or above a hyperglycemic threshold.

9. The method of one of claim 3 or claim 4, in which in which the external events comprise an event selected from a group consisting essentially of exercise, psychological stress, physical stress, drug intake, illness, or combinations thereof.

10. The method of claim 9, in which the ascertaining comprises the steps of:

determining from the blood glucose measurements taken within a predetermined time period after the external event in the form of insulin delivery, a first post-insulin BG number (I1) of blood glucose measurements that are at or below a hypoglycemic threshold;

calculating a post-insulin hypoglycemic value (IN1) which is approximately the first post-insulin number (I1) of blood glucose measurements divided by a total number of blood glucose measurements measured after each insulin dosing and multiplied by 100; and

annunciating hypoglycemia of the user after the external events in the form of insulin dosing whenever the hypoglycemic value (IN1) is greater than a predetermined value.

11. The method of claim 9, in which the ascertaining comprises the steps of:

determining from the blood glucose measurements taken within a predetermined time period after insulin dosing, a second post-insulin number (I2) of blood glucose measurements that are at or above a hyperglycemic threshold;

calculating a hyperglycemic value (IN2) which is approximately the second post-insulin number (I2) of blood glucose measurements divided by a total number of blood glucose measurements measured after the insulin dosing and multiplied by 100; and

annunciating hyperglycemia of the user after the external events in the form of insulin dosing whenever the hyperglycemic value (IN2) is greater than another predetermined value.

12. The method of claim 10, in which the hypoglycemic threshold comprises about 70 mg/dL, and the predetermined value comprises about 5.

13. The method of claim 11, in which the hyperglycemic threshold comprises about 180 mg/dL and the another predetermined value comprises about 50.

14. The method of one of claims 10 and 11, in which the predetermined time period after insulin dosing comprises any time period from about 1.5 hours to about 4 hours.

15. The method of claim 9, in which the ascertaining comprises the steps of:

determining from the blood glucose measurements taken within a predetermined time period after each distinct external disturbance a first number (IEE1) of blood glucose measurements that are at or below a hypoglycemic threshold;

calculating a hypoglycemic value (INE1) which is approximately the first number (IEE1) of blood glucose measurements divided by a total number of blood glucose measurements measured after each external disturbance and multiplied by 100; and

annunciating hypoglycemia of the user after external events whenever the hypoglycemic value (INE1) is greater than a predetermined value.

16. The method of claim 9, in which the ascertaining comprises the steps of:

determining from the blood glucose measurements taken within a predetermined time period after each distinct external disturbance a second number (IEE2) of blood glucose measurements that are at or above a hyperglycemic threshold;

calculating a hyperglycemic value (INE2) which is approximately the second number (IEE2) of blood glucose measurements divided by a total number of blood glucose measurements measured after each external disturbance and multiplied by 100; and

annunciating hyperglycemia of the user after external events whenever the hyperglycemic value (INE2) is greater than another predetermined value.

17. The method of claim 15, in which the hypoglycemic threshold comprises about 70 mg/dL, and the predetermined value comprises about 5.

18. The method of claim 16, in which the hyperglycemic threshold comprises about 180 mg/dL and the another predetermined value comprises about 50.

19. The method of one of claim 15 or 16, in which the predetermined time period after each distinct external disturbance comprises about 4 hours.