Blood glucose meter and computer-implemented method for improving glucose management through modeling of circadian profiles

• US 8,756,043 B2
• Filed: 07/26/2012
• Issued: 06/17/2014
• Est. Priority Date: 07/26/2012
• Status: Active Grant

• Current Assignee: Rimidi, Inc.
• Original Assignee: Rimidi Diabetes, Inc.
• Inventors: Albisser, Anthony Michael, Ide, Lucienne Marie
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US13/559,552
• Publication Number:
  US 20140032195A1
• Time in Patent Office: 691 Days
• Field of Search: None
• US Class Current: 703/11
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• 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 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A blood glucose meter and computer-implemented method for improving glucose management through modeling of circadian profiles is provided. For each daily meal period, two sets of pre- and post-meal period data are collected into a circadian profile and stored on a glucose meter, including a level of blood glucose of a diabetic patient and a dosage of diabetes medication. A model of predicted blood glucose for the patient is created from the blood glucose levels in each record as expected blood glucose values and predicted errors and visualized in a log-normal distribution. Target ranges for blood glucose at each meal period are determined and superimposed over the expected blood glucose values. Pharmacodynamics of the medication are obtained. An incremental change in dosing of the medication is propagated over a model day and the expected blood glucose values and their predicted errors are adjusted in response to the incremental dosing change.

Claims

1. A computer-implemented method for improving glucose management with a glucose meter through modeling of circadian profiles, comprising the steps of:

defining a plurality of meal periods that each occur each day at a set time;

building a circadian profile for a diabetic patient, comprising the steps of;

choosing an observational time frame for the circadian profile comprising a plurality of days that have occurred recently;

collecting at least two sets of pre- and post-meal period data that were recorded at each of the meal periods that occurred each day in the observational time frame and stored on a glucose meter;

reading a level of blood glucose on a test strip provided to the glucose meter by the diabetic patient for each of the meal periods;

identifying doses of diabetes medication, which were respectively taken during each of the meal periods as the readings of the blood glucose levels; and

storing the blood glucose level and the diabetes medication doses into the circadian profile in a record for each of the meal periods; and

creating a model of glucose management for the diabetic patient, comprising the steps of;

defining a modeling period comprising a plurality of days, which each comprise the same plurality of the meal periods that occurred each day in the observational time frame;

estimating expected blood glucose values and their predicted errors at each of the meal periods occurring each day in the modeling period from the blood glucose levels in each record based on the meal periods in the circadian profile that respectively occur at the same set times and visualizing the expected blood glucose values and their predicted errors over time for each meal period occurring each day in the modeling period in a log-normal distribution;

determining target ranges for blood glucose at each of the meal periods occurring each day in the modeling period and superimposing the target ranges over the expected blood glucose values for each meal period occurring each day in the modeling period in the log-normal distribution;

selecting one of the meal periods that occurs on one of the days in the modeling period and modeling a change in the dose of the diabetes medication for the selected meal period, comprising the steps of;

obtaining a dose-response characteristic comprising a blood glucose lowering effect over time for the modeled change in the dose of the diabetes medication, wherein the blood glucose lowering effect has been normalized with blood glucose lowering effects of diabetes medications based on the same change in the dose;

propagating the normalized blood glucose lowering effect over time for the modeled change in the dose of the diabetes medication to the expected blood glucose values, beginning with the selected meal period and continuing with each of the meal periods occurring subsequently in the modeling period, the normalized blood glucose lowering effect being adjusted in proportion to the set time of each subsequent meal period until the normalized blood glucose lowering effect is exhausted; and

visualizing the expected blood glucose values as propagated and their predicted errors in the log-normal distribution,

wherein the steps of building the circadian profile are performed on a suitably-programmed glucose meter and the steps of creating the model are performed on a suitably-programmed computer.

2. A method according to claim 1, further comprising the steps of:

modeling an incremental change in the dose of the diabetes medication for the selected meal period;

applying the normalized blood glucose lowering effect of the diabetes medication in proportion to the dose as incrementally changed until the expected blood glucose values in the log-normal distribution move into the target ranges; and

providing the incrementally changed dose of the diabetes medication as a suggested incremental dosing change.

3. A method according to claim 1, further comprising the steps of:

defining a threshold of hypoglycemic risk expressed as a blood glucose value; and

identifying each of the expected blood glucose values in the log-normal distribution exhibiting a risk of falling below the hypoglycemic risk threshold.

4. A method according to claim 1, further comprising the steps of:

defining a threshold of hyperglycemic occurrence expressed as a blood glucose value; and

identifying each of the expected blood glucose values in the log-normal distribution exhibiting a risk of rising above the hyperglycemic occurrence threshold.

5. A method according to claim 1, further comprising the step of:

defining the meal periods as comprising, within each day, breakfast, lunch, dinner, and bedtime meal periods.

6. A method according to claim 1, further comprising the step of:

deriving the target ranges for the blood glucose from high and low blood glucose values as published in consensus practice guidelines or as specified by a caregiver of the diabetic patient.

7. A method according to claim 1, further comprising the step of:

modeling the diabetes medication as no more than one shorter-acting drug, which comprises a physiologic mechanism of action principally spanning no more than three to eight hours, and one longer-acting drug, which comprises a physiologic mechanism of action principally spanning one half day to no more than one full day.

8. A method according to claim 1, further comprising the step of:

modeling the diabetes medication as a glucose lowering medication taken by the diabetic patient either in addition to or in lieu of insulin.

9. A method according to claim 1, further comprising the step of:

deriving expected glycated hemoglobin from a mean of readings of the blood glucose levels during the observational time frame.

10. A method according to claim 1, further comprising the step of:

collectively adjusting the target ranges for the blood glucose at each of the meal periods occurring each day in the modeling period upward or downward based on a physiological condition specific to the diabetic patient.

11. A method according to claim 1, further comprising the steps of:

including a body weight of the diabetic patient in the circadian profile; and

performing a trend analysis of the body weight over any preceding observational time frames.

12. A non-transitory computer readable storage medium storing code for executing on a computer system to perform the method according to claim 1.

13. A blood glucose meter for managing diabetes with circadian profiles, comprising:

an electronically-stored database implemented on a glucose meter and comprising a plurality of records, each record comprising a circadian profile, comprising;

a plurality of meal period categories that each occur each day at a set time and divide each circadian profile into the meal period categories;

an observational time frame comprising a plurality of days that have occurred recently;

at least two of typical measurements of pre-meal and post-meal self-measured blood glucose that were recorded at each of the meal period categories that occurred each day in the observational time frame; and

doses of diabetes medication that were respectively taken during each of the meal period categories for which the blood glucose measurements were recorded; and

an executable application stored on the glucose meter and configured to execute on a suitably-programmed computer to model glucose management, comprising;

a collection module configured to offload the database from the glucose meter and to collect the blood glucose measurements along a category axis comprising each of the meal period categories;

a statistical engine configured to determine expected blood glucose values and their predicted errors at each of the meal period categories occurring each day in the modeling period from the blood glucose measurements based on the meal period categories on the category axes in the circadian profile that respectively occur at the same set times and to visualize the expected blood glucose values and their predicted errors over time for each meal period category occurring each day in the modeling period in a log-normal distribution on the computer; and

a change modeling module configured to select one of the meal period categories that occurs on one of the days in the modeling period and to model a change in the dose of the diabetes medication for the selected meal period category, comprising;

a dose-response characteristic module configured to obtain a dose-response characteristic comprising a blood glucose lowering effect over time for the modeled change in the dose of the diabetes medication, wherein the blood glucose lowering effect has been normalized with blood glucose lowering effects of diabetes medications based on the same change in the dose;

a dosing module configured to propagate the normalized blood glucose lowering effect for the modeled change in the dose of the diabetes medication to the expected blood glucose values, beginning with the selected meal period category and continuing with each of the meal period categories occurring subsequently in the modeling period, the normalized blood glucose lowering effect being adjusted in proportion to the set time of each subsequent meal period category until the normalized blood glucose lowering effect is exhausted; and

a visualization module configured to visualize the expected blood glucose values as propagated and their predicted errors in the log-normal distribution.

14. A glucose meter according to claim 13, further comprising:

target ranges stored in the database for the expected blood glucose values at each of the meal period categories occurring each day in the modeling period in the log-normal distribution; and

a target module configured to superimpose the target ranges over the expected blood glucose values for each meal period category occurring each day in the modeling period in the log-normal distribution on the computer.

15. A glucose meter according to claim 14, further comprising:

an incremental dosing submodule configured on the computer to model an incremental and quantitative change in the dosing dose of the diabetes medication for the selected meal period category, to adjust the expected blood glucose values and their predicted errors in the log-normal distribution based on the normalized blood glucose lowering effect of the diabetes medication in proportion to the dose as incrementally quantitatively changed until the expected blood glucose values in the log-normal distribution move into the target ranges, and to suggest the incrementally quantitatively changed dose of the diabetes medication.

16. A glucose meter according to claim 13, further comprising:

a threshold of at least one of hypoglycemic risk and hyperglycemic occurrence, which are both expressed as blood glucose values stored in the database; and

a warning module configured on the computer to identify each of the expected blood glucose values in the log-normal distribution exhibiting either a risk of falling below the hypoglycemic risk threshold or rising above the hyperglycemic occurrence threshold.

17. A computer-implemented method for managing diabetes using a glucose meter with circadian profiles, comprising the steps of:

structuring a database on a glucose meter comprising a plurality of records, each record comprising a circadian profile, comprising;

defining a plurality of meal period categories that each occur each day at a set time and dividing each circadian profile into the meal period categories;

choosing an observational time frame for the circadian profile comprising a plurality of days that have occurred recently;

storing at least two of typical measurements of pre-meal and post-meal self-measured blood glucose that were recorded at each of the meal period categories that occurred each day in the observational time frame; and

identifying doses of diabetes medication that were respectively taken during each of the meal period categories for which the blood glucose measurements were recorded; and

storing a program on the glucose meter for modeling glucose management on a suitably-programmed computer, comprising;

defining a modeling period comprising a plurality of days, which each comprise the same plurality of the meal period categories that occurred each day in the observational time frame;

collecting the blood glucose measurements along a category axis comprising each of the meal period categories;

determining expected blood glucose values and their predicted errors at each of the meal period categories occurring each day in the modeling period from the blood glucose measurements based on the meal period categories on the category axes in the circadian profile that respectively occur at the same set times and visualizing the expected blood glucose values and their predicted errors over time for each meal period category occurring each day in the modeling period in a log-normal distribution; and

selecting one of the meal period categories that occurs on one of the days in the modeling period and modeling a change in the dose of the diabetes medication for the selected meal period category, comprising;

obtaining a dose-response characteristic comprising a blood glucose lowering effect over time for the modeled change in the dose of the diabetes medication, wherein the blood glucose lowering effect has been normalized with blood glucose lowering effects of diabetes medications based on the same change in the dose;

propagating the normalized blood glucose lowering effect for the modeled change in the dose of the diabetes medication to the expected blood glucose values, beginning with the selected meal period category and continuing with each of the meal period categories occurring subsequently in the modeling period, the normalized blood glucose lowering effect being adjusted in proportion to the set time of each subsequent meal period category until the normalized blood glucose lowering effect is exhausted; and

visualizing the expected blood glucose values as propagated and their predicted errors in the log-normal distribution,

wherein the modeling steps are performed on the computer.

18. A method according to claim 17, further comprising the steps of:

determining target ranges for the expected blood glucose values at each of the meal period categories occurring each day in the modeling period; and

superimposing the target ranges over the expected blood glucose values for each meal period category occurring each day in the modeling period in the log-normal distribution on the computer.

19. A method according to claim 18, further comprising the steps of:

modeling an incremental and quantitative change in the dose of the diabetes medication for the selected meal period category on the computer;

adjusting the expected blood glucose values and their predicted errors in the log-normal distribution based on the normalized blood glucose lowering effect of the diabetes medication in proportion to the dose as incrementally quantitatively changed until the expected blood glucose values in the log-normal distribution move into the target ranges; and

suggesting the incrementally quantitatively changed dose of the diabetes medication.

20. A method according to claim 17, further comprising the steps of:

defining a threshold of at least one of hypoglycemic risk and hyperglycemic occurrence, which are both expressed as blood glucose values; and

identifying on the computer each of the expected blood glucose values in the log-normal distribution exhibiting either a risk of falling below the hypoglycemic risk threshold or rising above the hyperglycemic occurrence threshold.

21. A non-transitory computer readable storage medium storing code for executing on a computer system to perform the method according to claim 17.