Method and implantable system for blood-glucose concentration monitoring using parallel methodologies

• US 8,630,692 B2
• Filed: 04/30/2009
• Issued: 01/14/2014
• Est. Priority Date: 04/30/2009
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wenzel, Brian Jeffrey, Farazi, Taraneh Ghaffari, Park, Euljoon, Falkenberg, Eric, Benser, Michael E.
• Primary Examiner(s): CANELLA, KAREN A
• Application Number:
  US12/433,414
• Publication Number:
  US 20100280348A1
• Time in Patent Office: 1,720 Days
• Field of Search: 600/365
• US Class Current: 600/323
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

In an implantable medical device for monitoring glucose concentration in the blood, a blood-glucose concentration analysis is performed using correlations of blood-glucose concentration with measures of metabolic oxygen consumption including oxymetric, and/or temperature. Analysis of electrocardiographic data is used in a parallel method to detect and/or confirm the onset and/or existence and/or extent of hypoglycemia and/or hyperglycemia. Blood-glucose concentration calculation is enhanced by using the combination of the oxygen metabolism analysis and electrocardiographic analysis.

Claims

1. A method, for use by an implantable medical device, for monitoring a level of blood-glucose concentration, the method comprising:

(a) generating a first metric of blood-glucose concentration by monitoring one or more property of one or more cardiac electrical signal;

(b) generating a second metric of blood-glucose concentration by monitoring one or more property of oxygen metabolism;

(c) using one of the first metric of blood-glucose concentration or the second metric of blood-glucose concentration to detect one of hypoglycemia, normoglycemia or hyperglycemia; and

(d) using the other one of first metric of blood-glucose concentration or the second metric of blood-glucose concentration to confirm or not confirm the detection at step (c) of the one of hypoglycemia, normoglycemia or hyperglycemia.

2. The method of claim 1, wherein step (a) comprises generating the first metric of blood-glucose concentration by analyzing at least one of:

a T-wave amplitude, a Q-T interval, or an S-T segment deviation.

3. The method of claim 1, wherein step (b) comprises generating the second metric of blood-glucose concentration using a metabolic oxygen conformation method which utilizes cardiac output, temperature and blood-oxygen data in combination with stored information regarding a relationship of the cardiac output, temperature and blood-oxygen data to blood-glucose concentration.

4. The method of claim 1, wherein step (b) comprises generating the second metric of blood-glucose concentration by monitoring at least one of:

a metric of venous oxygen saturation, a metric of hematocrit, or a metric of arterial oxygen saturation.

5. The method of claim 1, wherein step (d) comprises using the first metric of blood-glucose concentration to confirm a detection at step (c) that used the second metric of blood-glucose concentration if both the first metric of blood-glucose concentration and the second metric of blood-glucose concentration are indicative of the same one of hypoglycemia, normoglycemia or hyperglycemia.

6. The method of claim 1, wherein step (d) comprises using the second metric of blood-glucose concentration to confirm a detection at step (c) that used the first metric of blood-glucose concentration if both the first metric of blood-glucose concentration and the second metric of blood-glucose concentration are indicative of the same one of hypoglycemia, normoglycemia or hyperglycemia.

7. The method of claim 1, wherein step (a) is performed a plurality of times;

step (b) is performed in response to generating at step (a) a first metric of blood-glucose concentration that is used at step (c) to detect one of hypoglycemia or hyperglycemia; and

step (d) is performed in response to generating at step (b) a second metric of blood-glucose concentration.

8. The method of claim 1, wherein step (b) is performed a plurality of times;

step (a) is performed in response to generating at step (b) a second metric of blood-glucose concentration that is used at step (c) to detect one of hypoglycemia or hyperglycemia; and

step (d) is performed in response to generating at step (a) a first metric of blood-glucose concentration.

9. The method of claim 1, further comprising controlling a therapy in response to the detection at step (c), and confirmation at step (d), of the one of hypoglycemia, normoglycemia or hyperglycemia.

10. The method of claim 1, further comprising generating a warning signal if one of hypoglycemia or hyperglycemia is detected at step (c) and confirmed at step (d).

11. A method, for use by an implantable medical device, for monitoring a level of blood-glucose concentration, the method comprising:

(a) generating a first measure of blood-glucose concentration by analyzing one or more property of one or more cardiac electrical signal;

(b) generating a second measure of blood-glucose concentration by analyzing at least one of venous oxygen saturation, hematocrit, or arterial oxygen saturation; and

(c) using one of the first measure of blood-glucose concentration or the second measure of blood-glucose concentration to detect one of hypoglycemia, normoglycemia or hyperglycemia; and

(d) using the other one of first measure of blood-glucose concentration or the second measure of blood-glucose concentration to confirm or not confirm the detection at step (c) of the one of hypoglycemia, normoglycemia or hyperglycemia.

12. The method of claim 11, wherein step (b) comprises generating the second measure of blood-glucose concentration using a metabolic oxygen conformation method which utilizes cardiac output, temperature and blood-oxygen data in combination with stored information regarding a relationship of the cardiac output, temperature and blood-oxygen data to blood-glucose concentration.

13. The method of claim 11, wherein step (d) comprises using the other one of the first measure of blood-glucose concentration or the second measure of blood-glucose concentration to confirm the detection at step (c) of the one of hypoglycemia, normoglycemia or hyperglycemia if both the first measure of blood-glucose concentration and the second measure of blood-glucose concentration are indicative of the same one of hypoglycemia, normoglycemia or hyperglycemia.

14. The method of claim 11, wherein step (a) comprises generating the first measure of blood-glucose concentration by analyzing at least one of:

a T-wave amplitude, a Q-T interval, or an S-T segment deviation.

15. The method of claim 11, wherein:

step (a) is performed repeatedly;

step (b) is initiated in response to generating at step (a) a first measure of blood-glucose concentration that is used at step (c) to detect one of hypoglycemia or hyperglycemia; and

step (d) is initiated upon completion of step (c).

16. The method of claim 11, wherein:

step (b) is performed repeatedly;

step (a) is initiated in response to generating at step (b) a second measure of blood-glucose concentration that is used at step (c) to detect one of hypoglycemia or hyperglycemia; and

step (d) is initiated upon completion of step (c).

17. The method of claim 11, further comprising controlling a therapy in response to the detection at step (c), and confirmation at step (d), of the one of hypoglycemia, normoglycemia or hyperglycemia.

18. The method of claim 11, further comprising generating a warning signal if one of hypoglycemia or hyperglycemia is detected at step (c) and confirmed at step (d).

19. A method, for use by an implantable medical device, for monitoring a level of blood-glucose concentration, the method comprising:

(a) generating a first measure of blood-glucose concentration dependent on one or more property of one or more cardiac electrical signal;

(b) generating a second measure of blood-glucose concentration dependent on one or more of venous oxygen saturation, hematocrit, or arterial oxygen saturation measured using an implanted oxymeter; and

(c) using one of the first measure of blood-glucose concentration or the second measure of blood-glucose concentration to detect one of hypoglycemia, normoglycemia or hyperglycemia; and

(d) using the other one of first measure of blood-glucose concentration or the second measure of blood-glucose concentration to confirm or not confirm the detection at step (c) of the one of hypoglycemia, normoglycemia or hyperglycemia.

20. The method of claim 19, wherein step (a) comprises generating the first measure of blood-glucose concentration dependent on at least one of:

a T-wave amplitude, a Q-T interval, or an S-T segment deviation.