Assessing measures of glycemic variability

• US 9,743,865 B2
• Filed: 06/25/2016
• Issued: 08/29/2017
• Est. Priority Date: 10/23/2007
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bugler, Jolyon Robert
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US15/193,007
• Publication Number:
  US 20160302702A1
• Time in Patent Office: 430 Days
• Field of Search: 600309, 600345-366
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• 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

Abstract

Methods, devices and systems for receiving an instruction to determine a glycemic variation level, retrieving a stored metric for determining the glycemic variation level, retrieving one or more parameters associated with the retrieved metric analysis, determining the glycemic variation level based on the retrieved one or more parameters for the retrieved metric analysis, and outputting the determined glycemic variation level when it is determined that the retrieved one or more parameters associated with the retrieved metric analysis meets a predetermined condition are disclosed.

Claims

1. An apparatus, comprising:

one or more processing units;

an output component operatively coupled to the one or more processing units; and

a memory operatively coupled to the one or more processing units, the memory for storing instructions which, when executed by the one or more processing units, causes the one or more processing units to;

obtain glycemic data over a period of time;

store the glycemic data in the memory;

determine whether the time period over which the stored glycemic data was obtained meets a predetermined minimum period of time;

determine whether the stored glycemic data meets a predetermined condition based on a parameter of a glycemic variation metric; and

output a failure notification using the output component when the time period over which the stored glycemic data was obtained does not meet the predetermined minimum period of time and when the stored glycemic data does not meet the predetermined condition based on the parameter of the glycemic variation metric.

2. The apparatus of claim 1, wherein the glycemic variation metric includes one or more of a standard deviation analysis, Mean Amplitude of Glycemic Excursions (MAGE) analysis, Glycemic Risk Assessment Diabetes Excursion (GRADE) analysis, Lability index analysis, a number of glycemic variation episode excursions analysis, a duration of each glycemic variation episode excursion analysis, an average maximum excursion value analysis, or a low/high blood glucose index analysis.

3. The apparatus of claim 1, wherein the parameter of the glycemic variation metric is a cumulative subject value at a given point in time, and further, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to determine whether the stored glycemic data meets the predetermined condition based on the parameter of the glycemic variation metric by determining whether the cumulative subject value at the given point in time is within 10% of a true parameter value for the glycemic variation metric.

4. The apparatus of claim 1, wherein the predetermined minimum period of time is at least 50 days.

5. The apparatus of claim 1, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to determine a glycemic variation level using the glycemic variation metric when the time period over which the stored glycemic data was obtained exceeds the predetermined minimum period of time and when the stored glycemic data meets the predetermined condition based on the parameter of the glycemic variation metric.

6. The apparatus of claim 2, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to:

determine a glycemic variation level using the glycemic variation metric, the parameter of the glycemic variation metric, and the stored glycemic data, and output the determined glycemic variation level using the output component, when the time period over which the stored glycemic data was obtained exceeds the predetermined minimum period of time and when the stored glycemic data meets the predetermined condition based on the parameter of the glycemic variation metric.

7. The apparatus of claim 6, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to output the determined glycemic variation level using the output component by displaying a graphical representation of the determined glycemic variation level over time.

8. The apparatus of claim 7, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to output the graphical representation in real time.

9. The apparatus of claim 5, further comprising a therapy unit operatively coupled to the one or more processing units, the therapy unit including a controller configured to control administration of a therapy based on the determined glycemic variation level.

10. The apparatus of claim 1, wherein the parameter of the glycemic variation metric is a value for a minimum number of glucose data over the predetermined minimum period of time, and wherein the predetermined condition is whether the stored glycemic data has a number of glucose data points greater than the value for the minimum number of glucose data over the predetermined minimum period of time.

11. A system, comprising:

sensor electronics, operatively coupled to an analyte sensor in contact with bodily fluid of a user, to communicate glycemic data based on signals received from the analyte sensor; and

a computing device, comprising;

one or more processing units;

a communication component;

an output component operatively coupled to the one or more processing units; and

a memory operatively coupled to the one or more processing units, the memory for storing instructions which, when executed by the one or more processing units, causes the one or more processing units to;

obtain glycemic data from the sensor electronics over a period of time using the communication component;

store the glycemic data in the memory;

determine whether the time period over which the stored glycemic data was obtained meets a predetermined minimum period of time;

determine whether the stored glycemic data meets a predetermined condition based on a parameter of a glycemic variation metric; and

output a failure notification using the output component when the time period over which the stored glycemic data was obtained does not meet the predetermined minimum period of time and when the stored glycemic data does not meet the predetermined condition based on the parameter of the glycemic variation metric.

12. The system of claim 11, wherein the glycemic variation metric includes one or more of a standard deviation analysis, Mean Amplitude of Glycemic Excursions (MAGE) analysis, Glycemic Risk Assessment Diabetes Excursion (GRADE) analysis, Lability index analysis, a number of glycemic variation episode excursions analysis, a duration of each glycemic variation episode excursion analysis, an average maximum excursion value analysis, or a low/high blood glucose index analysis.

13. The system of claim 12, wherein the parameter of the glycemic variation metric is a cumulative subject value at a given point in time, and wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to determine whether the stored glycemic data meets the predetermined condition based on the parameter of the glycemic variation metric by determining whether the cumulative subject value at the given point in time is within a predetermined range of a true parameter value for the glycemic variation metric.

14. The system of claim 11, wherein the predetermined minimum period of time is at least 50 days.

15. The system of claim 11, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to determine a glycemic variation level using the glycemic variation metric when the time period over which the stored glycemic data was obtained exceeds the predetermined minimum period of time and when the stored glycemic data meets the predetermined condition based on the parameter of the glycemic variation metric.

16. The system of claim 15, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to determine the glycemic variation level, the parameter of the glycemic variation metric, and the stored glycemic data, and output the determined glycemic variation level using the output component, when the time period over which the stored glycemic data was obtained exceeds the predetermined minimum period of time and when the stored glycemic data meets the predetermined condition based on the parameter of the glycemic variation metric.

17. The system of claim 16, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to output the determined glycemic variation level using the output component by displaying a graphical representation of the determined glycemic variation level over time.

18. The system of claim 17, wherein the memory for storing instructions, when executed by the one or more processing units, causes the one or more processing units to output the graphical representation in real time.

19. The system of claim 15, further comprising a therapy unit operatively coupled to the computing device, and including a controller configured to control administration of a therapy based on the determined glycemic variation level.

20. The system of claim 11, wherein the parameter of the glycemic variation metric is a value for a minimum number of glucose data over the predetermined minimum period of time, and wherein the predetermined condition is whether the stored glycemic data has a number of glucose data points greater than the value for the minimum number of glucose data over the predetermined minimum period of time.