HIGH/LOW BLOOD GLUCOSE RISK ASSESSMENT SYSTEMS AND METHODS

• US 20150095042A1
• Filed: 09/27/2013
• Published: 04/02/2015
• Est. Priority Date: 09/27/2013
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Aykroyd, Timothy N., Day, Amy C., Galley, Paul J., Rees, Christen A., Surridge, Nigel A., la Bastide, Sebastiaan
• Application Number:
  US14/039,762
• Publication Number:
  US 20150095042A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A blood glucose (bG) measurement engine selectively measures bG levels in blood samples input to a handheld diabetes management device. A computer readable medium includes code executed by a processor to: identify a period of N days, the period including the current date and N−1 days immediately prior to the current date, wherein N is an integer greater than 6; determine a total number of the N days during which the patient input at least two blood samples; and, when the total number of the N days is greater than M, M being an integer greater than zero and less than or equal to N: calculate a value based on the bG levels of blood samples input during the period; based on the value, classify the patient as having a first, second, or third risk of being hypoglycemic in the future.

Claims

1. A handheld diabetes management device for assessing a patient'"'"'s risk of future hypoglycemia, the handheld diabetes management device comprising:

a blood glucose (bG) measurement engine that selectively measures bG levels in blood samples input to the handheld diabetes management device;

a display;

a clock tracking a current date and time;

a processor; and

a computer readable medium including code executed by the processor to;

identify a period of N days, the period including the current date and N−

1 days immediately prior to the current date, wherein N is an integer greater than 6;

determine a total number of the N days during which the patient input at least two blood samples to the handheld diabetes management device; and

when the total number of the N days is greater than M, M being an integer greater than zero and less than or equal to N;

calculate a value based on the bG levels of blood samples input to the handheld diabetes management device during the period;

based on the value, classify the patient as having a first, second, or third risk of being hypoglycemic in the future, the second risk being greater than the first risk, and the third risk being greater than the second risk; and

display the classification of the patient'"'"'s risk of being hypoglycemic on the display.

2. The handheld diabetes management device of claim 1 wherein N is equal to 28.

3. The handheld diabetes management device of claim 2 wherein M is equal to 14.

4. The handheld diabetes management device of claim 1 wherein calculating the value includes calculating the value based on all the bG levels of blood samples input to the handheld diabetes management device during the period.

5. The handheld diabetes management device of claim 1 wherein classifying includes:

classifying the patient as having the first risk when the value is less than a first predetermined value;

classifying the patient as having the second risk when the value is greater than the first predetermined value and less than a second predetermined value; and

classifying the patient as having the third risk when the value is greater than the second predetermined value.

6. The handheld diabetes management device of claim 1 wherein calculating the value includes:

determining initial values (r(bg)) for the blood samples, respectively, using the equation;

r(bG)=10*[1.509*(ln(bG)^1.084−

5.381)]²,

where r(bg) is the initial value for a blood sample, ln is the natural log function, and bG is the bG level of the blood sample;

determining a minimum one of the initial values;

determining secondary values (rl(bg)) for the blood samples, respectively, using the relationships;

rl(bG)=r(bG) if bG<

the minimum one of the r(bG)values; and

rl(bG)=0 if bG>

the minimum one of the r(bG)values; and

setting the value equal to an average of the secondary values.

7. The handheld diabetes management device of claim 6 wherein classifying includes:

classifying the patient as having the first risk when the value is less than 2.5;

classifying the patient as having the second risk when the value is greater than 2.5 and less than 5.0; and

classifying the patient as having the third risk when the value is greater than 5.0.

8. The handheld diabetes management device of claim 1 wherein N is greater than 13.

9. The handheld diabetes management device of claim 1 wherein N is greater than 20.

10. The handheld diabetes management device of claim 1 wherein N is greater than 27.

11. The handheld diabetes management device of claim 1 wherein M is greater than 13.

12. A method for assessing a patient'"'"'s risk of future hypoglycemia, the method performed by a handheld diabetes management device, and the method comprising:

determining blood glucose (bG) values based on blood samples input to the handheld diabetes management device, each of the bG values indicative of an amount of glucose in one of the blood samples;

tracking a current date and time;

identifying a period of N days, the period including the current date and N−

1 days immediately prior to the current date, wherein N is an integer greater than 6;

determining a total number of the N days during which the patient input at least two blood samples to the handheld diabetes management device; and

when the total number of the N days is greater than M, M being an integer greater than zero and less than or equal to N;

calculating a low blood glucose index (LBGI) value based on the bG values of blood samples input to the handheld diabetes management device during the period;

based on the LBGI value, classifying the patient as having a first, second, or third risk of being hypoglycemic in the future, the second risk being greater than the first risk, and the third risk being greater than the second risk; and

displaying the classification of the patient'"'"'s risk of being hypoglycemic on a display of the handheld diabetes management device.

13. The method of claim 12 wherein N is equal to 28.

14. The method of claim 13 wherein M is equal to 14.

15. The method of claim 12 wherein calculating the LBGI value includes calculating the LBGI value based on all the bG values of the blood samples input to the handheld diabetes management device during the period.

16. The method of claim 12 wherein classifying includes:

classifying the patient as having the first risk when the LBGI value is less than a first predetermined value; and

classifying the patient as having the second risk when the LBGI value is greater than the first predetermined value and less than a second predetermined value.

17. The method of claim 16 wherein classifying further includes:

classifying the patient as having the third risk when the LBGI value is between the first and second predetermined values.

18. The method of claim 12 wherein calculating the value includes:

determining initial values (r(bg)) for the blood samples, respectively, using the equation;

r(bG)=10*[1.509*(ln(bG)^1.084−

5.381)]²,

where r(bg) is the initial value for a blood sample, ln is the natural log function, and bG is the bG level of the blood sample;

determining a minimum one of the initial values;

determining secondary values (rl(bg)) for the blood samples, respectively, using the relationships;

rl(bG)=r(bG) if bG<

the minimum one of the r(bG)values; and

rl(bG)=0 if bG≧

the minimum one of the r(bG)values; and

setting the value equal to an average of the secondary values.

19. The method of claim 18 wherein classifying includes:

classifying the patient as having the first risk when the LBGI value is less than 2.5;

classifying the patient as having the second risk when the LBGI value is greater than 2.5 and less than 5.0; and

classifying the patient as having the third risk when the LBGI value is greater than 5.0.

20. A diabetes management system for assessing a patient'"'"'s risk of future hypoglycemia, the diabetes management system comprising:

a handheld diabetes management device including;

a blood glucose (bG) measurement engine that selectively measures bG levels in blood samples input to the handheld diabetes management device; and

a communication module that selectively transmits data indicative of stored bG data; and

a mobile device that is external to the handheld diabetes management device, that receives the data indicative of the stored bG data from the handheld diabetes management device, and that;

identifies a period of N days, the period including a current date and N−

1 days immediately prior to the current date, wherein N is an integer greater than 6;

determines a total number of the N days during which the patient input at least two blood samples to the handheld diabetes management device; and

when the total number of the N days is greater than M, M being an integer greater than zero and less than or equal to N;

calculates a value based on the bG levels of blood samples input to the handheld diabetes management device during the period;

based on the value, classifies the patient as having a first, second, or third risk of being hypoglycemic in the future, the second risk being greater than the first risk, and the third risk being greater than the second risk; and

displays the classification of the patient'"'"'s risk of being hypoglycemic on a display of the mobile device.