Assessing Measures Of Glycemic Variability

• US 20090105568A1
• Filed: 10/23/2008
• Published: 04/23/2009
• 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 R.
• Granted Patent: US 8,409,093 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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

12. A method, comprising:

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.

1. An apparatus, comprising:

a memory configured to store one or more executable instructions;

a control unit operatively coupled to the memory and configured to retrieve the one or more executable instructions for execution;

an input unit operatively coupled to the control unit for inputting one or more instructions to the control unit to execute one or more routines; and

an output unit operatively coupled to the control unit for outputting one or more information, the output unit including a glycemic variability indicator associated with a determined variation in a glycemic level;

wherein the glycemic variability indicator is provided to the output unit when the glycemic variation data is determined to be sufficient for a selected one or more metric to determine glycemic variability.

2. The apparatus of claim 1 wherein the control unit includes one or more of a microprocessor, an application specific integrated circuit, or a state machine.

3. The apparatus of claim 1 wherein the one or more metric includes one or more of a standard deviation, MAGE, GRADE, Lability index, a number of glycemic variation episode excursions, a duration of each glycemic variation episode excursion, an average maximum excursion value, or a low/high blood glucose index.

4. The apparatus of claim 3 wherein the one or more glycemic variation episode excursion includes deviation from a predetermined hypoglycemic threshold parameter or from a predetermined hyperglycemic threshold parameter.

5. The apparatus of claim 3 wherein each of the one or more metric includes a predetermined amount of data associated with the metric for glycemic variability determination.

6. The apparatus of claim 1 wherein the glycemic variability indicator is provided to the output unit only when the glycemic variation data is determined to be sufficient.

7. The apparatus of claim 1 wherein the glycemic variation data includes number of glucose data samples.

8. The apparatus of claim 7 wherein the number of glucose data samples are stored in the memory unit.

9. The apparatus of claim 1 including a communication unit operatively coupled to the control unit, the communication unit configured to send or receive data to or from a remote location.

10. The apparatus of claim 9 wherein the remote location includes one or more of a remote data processing terminal, an analyte monitoring system, a blood glucose meter device, a server terminal, a personal digital assistant, a mobile telephone, or a messaging device.

11. The apparatus of claim 9 wherein the communication unit is configured for wired or wireless communication.

13. The method of claim 12 wherein the predetermined condition includes a predetermined stabilization level.

14. The method of claim 12 wherein the predetermined condition includes availability of number of glucose data over a predetermined time period.

15. The method of claim 14 wherein the predetermined time period is associated with the retrieved metric analysis.

16. The method of claim 12 wherein the glycemic variation level is output as one or more of an audible indication, a visual indication, a vibratory indication, or one or more combinations thereof.

17. The method of claim 12 including storing the determined glycemic variation level.

18. The method of claim 12 including outputting an indication of unsuccessful glycemic variation level when it is determined that the retrieved one or more parameters associated with the retrieved metric analysis does not meet the predetermined condition.

19. The method of claim 12 wherein the one or more metric analysis includes one or more of a standard deviation analysis, MAGE analysis, 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.

13-1. The method of claim 12 wherein the determined glycemic variation level is output only when it is determined that the retrieved one or more parameters meets the predetermined condition.

20. An apparatus, comprising:

a storage unit for storing one or more executable instructions;

a microprocessor operatively coupled to the storage unit for accessing the one or more executable instructions, which, when executed receives an instruction to determine a glycemic variation level, retrieves a stored metric for determining the glycemic variation level, retrieves one or more parameters associated with the retrieved metric analysis, determines the glycemic variation level based on the retrieved one or more parameters for the retrieved metric analysis, and outputs 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.