System and method for detecting hypoglycemia using an implantable medical device based on pre-symptomatic physiological responses

• US 8,019,410 B1
• Filed: 08/22/2007
• Issued: 09/13/2011
• Est. Priority Date: 08/22/2007
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bharmi, Rupinder, Wenzel, Brian Jeffrey, Bornzin, Gene A.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K
• Application Number:
  US11/843,480
• Time in Patent Office: 1,483 Days
• Field of Search: 600/365, 600/516, 600/517
• US Class Current: 600/516
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured

Abstract

An intracardiac electrogram (IEGM) or other suitable electrical cardiac signal is sensed. Values representative of a pre-symptomatic physiologic response to a hypoglycemic event are derived from the cardiac signal. Then, hypoglycemia is detected based on the values representative of the pre-symptomatic physiologic response. In one example, both temporal morphological parameters and spectral parameters affected by pre-symptomatic hypoglycemia are derived from the cardiac signal. Hypoglycemia is then detected based on a combination of the temporal and spectral parameters using, e.g., a linear discriminator. By detecting hypoglycemia based on parameters affected by pre-symptomatic hypoglycemia, suitable warnings can be generated and therapies initiated before the condition becomes symptomatic.

Claims

1. A method for use with an implantable medical device for detecting hypoglycemia within a patient in which the device is implanted, said method comprising:

sensing an electrical cardiac signal;

deriving values representative of a pre-symptomatic physiologic response to a hypoglycemic event from the cardiac signal by deriving temporal morphological parameters within the cardiac signal that are affected by pre-symptomatic hypoglycemia and deriving spectral parameters from the cardiac signal that are affected by pre-symptomatic hypoglycemia; and

detecting hypoglycemia based on the values representative of the pre-symptomatic physiologic response.

2. The method of claim 1 wherein the temporal morphological parameters include one or more of:

T-wave morphological parameters;

P-wave morphological parameters;

QRS morphological parameters;

far-field waveform morphological parameters;

QT dynamics parameters;

heart rate parameters;

paced depolarization integrals (PDIs) and T-wave integrals.

3. The method of claim 1 wherein the temporal morphological parameters derived from the cardiac signal include one or more of:

respiration rate and respiration depth.

4. The method of claim 1 wherein deriving values representative of the pre-symptomatic physiologic response includes deriving parameters representative of one or more of the mean, standard deviation and variance of the values.

5. The method of claim 1 wherein deriving values representative of the pre-symptomatic physiologic response includes deriving parameters representative of trends within the values.

6. The method of claim 1 wherein deriving spectral parameters from the cardiac signal includes first deriving temporal parameters from the cardiac signal that are affected by pre-symptomatic hypoglycemia and then deriving spectral characteristics from the temporal parameters.

7. The method of claim 6 wherein deriving spectral parameters includes applying a Fast Fourier Transform (FFT) to the temporal parameters.

8. The method of claim 1 wherein deriving spectral parameters includes deriving a mean spectral power.

9. The method of claim 1 wherein deriving spectral parameters includes determining a ratio of relatively low frequency components to relatively high frequency components of the cardiac signal.

10. The method of claim 1 wherein detecting hypoglycemia based on the values representative of the pre-symptomatic physiologic response includes detecting hypoglycemia based on a combination of temporal parameters derived from the cardiac signals and spectral parameters derived from the cardiac signal.

11. The method of claim 1 wherein detecting hypoglycemia based on the values representative of the pre-symptomatic physiologic response includes applying the values to decision logic programmed to recognize hypoglycemia based on the values.

12. The method of claim 11 wherein applying the values to decision logic includes applying the values to a linear discriminator programmed to recognize hypoglycemia based on the values.

13. The method of claim 11 wherein applying the values to the decision logic includes the initial step of detecting and eliminating outliers within the values.

14. The method of claim 11 wherein applying the values to the decision logic includes the initial steps of detecting patient body position and normalizing the values based on body position.

15. The method of claim 11 wherein applying the values to the decision logic includes the initial steps of detecting cardiac rhythm type within the patient and normalizing the values based on rhythm type.

16. The method of claim 11 wherein applying the values to the decision logic includes the initial steps of detecting patient activity level and normalizing the values based on activity level.

17. The method of claim 1 further including inputting the gender of the patient and wherein detecting hypoglycemia is performed based on the values representative of the pre-symptomatic physiologic response and patient gender.

18. The method of claim 1 further including inputting aspects of patient history for the patient and wherein detecting hypoglycemia is performed based on the values representative of the pre-symptomatic physiologic response and patient history.

19. The method of claim 18 further including monitoring for symptoms of hypoglycemia and wherein detecting hypoglycemia is performed based on values representative of the pre-symptomatic physiologic response and information pertaining to symptoms, if any, of hypoglycemia.

20. The method of claim 19 wherein monitoring for symptoms of hypoglycemia includes detecting episodes of tachycardia within the patient.

21. The method of claim 19 wherein monitoring for symptoms of hypoglycemia includes detecting tremors within the patient.

22. The method of claim 19 wherein monitoring for symptoms of hypoglycemia includes inputting information pertaining to symptoms from an external device.

23. The method of claim 19 wherein monitoring for symptoms of hypoglycemia includes inputting from an external device, information pertaining to one or more of the following symptoms:

excessive perspiration, tremors, skin pallor, anxiety, hunger, warmth, light-headedness, weakness, headache, confusion, lack of coordination, and speech difficulty.

24. The method of claim 1 further including the step of detecting blood glucose levels within the patient and wherein detecting hypoglycemia includes detecting hypoglycemia based on a combination of the values representative of the pre-symptomatic physiologic response and blood glucose levels.

25. The method of claim 1 including recording diagnostic information based on the detection of hypoglycemia, wherein the diagnostic information includes trends, if any, in the values representative of the pre-symptomatic physiologic response to the hypoglycemic event.

26. A system for use with an implantable medical device for detecting hypoglycemia within a patient in which the device is implanted, said system comprising:

an electrical cardiac signal detector operative to detect an electrical cardiac signal within the patient;

a pre-symptomatic physiologic response detector operative to derive values representative of a pre-symptomatic physiologic response to a hypoglycemic event from the cardiac signal by deriving temporal morphological parameters within the cardiac signal that are affected by pre-symptomatic hypoglycemia and deriving spectral parameters from the cardiac signal that are affected by pre-symptomatic hypoglycemia; and

a hypoglycemia detector operative to detect hypoglycemia based on the values representative of a pre-symptomatic physiologic response to a hypoglycemic event.

27. A system for use with an implantable medical device for detecting hypoglycemia within a patient in which the device is implanted, said system comprising:

means for detecting an electrical cardiac signal within the patient;

means for deriving values representative of a pre-symptomatic physiologic response to a hypoglycemic event from the cardiac signal by deriving temporal morphological parameters within the cardiac signal that are affected by pre-symptomatic hypoglycemia and deriving spectral parameters from the cardiac signal that are affected by pre-symptomatic hypoglycemia; and

means for detecting hypoglycemia based on the values representative of a pre-symptomatic physiologic response to a hypoglycemic event.