System and method for monitoring blood glucose levels using an implantable medical device

• US 20040077962A1
• Filed: 10/21/2002
• Published: 04/22/2004
• Est. Priority Date: 10/21/2002
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kroll, Mark W.
• Granted Patent: US 7,016,720 B2
• Time in Patent Office: Days
• US Class Current: 600/513
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/355 Detecting T-waves
• CPC Class Codes: A61B 5/36 Detecting PQ interval, PR interval or QT interval
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

T-wave amplitude and QT interval are derived from patient cardiac signals. Then blood glucose levels are determined based on a combination of the T-wave amplitude and the QT interval. By using a combination of both T-wave-based and QT interval-based signals, blood glucose levels can be reliably detected throughout a wide range of blood glucose levels. Once the blood glucose level has been detected, the implanted device compares the blood glucose level against upper and lower acceptable bounds and appropriate warning signals are generated if the level falls outside the bounds. In one example, wherein an implantable insulin pump is additionally provided, the pump is controlled based on the detected blood glucose level to maintain glucose levels within an acceptable range. A calibration technique is also provided for determining patient-specific parameters for use in the detection of blood glucose levels.

Claims

1. A method performed by an implantable medical device, the method comprising:

detecting T-wave amplitude based on cardiac signals;

detecting QT interval based on cardiac signals; and

deriving a blood glucose level based on a combination of the detected T-wave amplitude and the detected QT interval.

2. The method of claim 1 further including the steps of converting T-wave amplitude into a T-wave amplitude fraction and converting QT interval into a corrected QT (QTc) interval delta and wherein the step of deriving blood glucose levels includes the step of determining the blood glucose level based on a combination of the T-wave amplitude fraction and the QTc delta.

3. The method of claim 2 wherein the step of determining the blood glucose level includes the step of calculating:

blood glucose level=A−

B*(QTc delta)−

C*(T-wave amplitude fraction)

wherein A, B and C are predetermined coefficients.

4. The method of claim 3 wherein:

A is in the range of 250-270;

B is in the range of 1.25-1.50; and

C is in the range of 160-180.

5. The method of claim 2 wherein the step of converting T-wave amplitude into a T-wave amplitude fraction includes the steps of:

inputting a T-wave baseline value; and

converting T-wave amplitude into a T-wave amplitude fraction using the T-wave baseline value.

6. The method of claim 2 wherein the step of converting QT interval into QTc interval includes the steps of:

inputting a QT interval baseline value;

measuring heart rate based on cardiac electrical signals;

converting QT interval into QTc interval based on the heart rate; and

converting the QTc interval into a QT interval delta using the QT baseline value.

7. The method of claim 1 further including the steps of:

comparing the blood glucose level against an upper bound and, if the blood glucose levels exceeds the upper bound, generating a warning signal indicating the blood glucose level is to high.

8. The method of claim 7 wherein the upper bound is 120 mg/dl.

9. The method of claim 1 further including the steps of:

comparing the blood glucose level against a lower bound and, if the blood glucose levels falls below the lower bound, generating a warning signal indicating the blood glucose level is too low.

10. The method of claim 9 wherein the lower bound is 60 mg/dl.

11. The method of claim 1 wherein the implantable device includes an insulin pump and wherein the method includes the further step of controlling the insulin pump based on the blood glucose level.

12. The method of claim 1 including the further step of controlling the functions of the implanted device based on the blood glucose level.

13. The method of claim 1 further including the step of recording the blood glucose level for subsequent transmission to an external device.

14. An implantable glucose monitor comprising:

means for detecting cardiac signals;

means for detecting T-wave amplitude based on the cardiac signals;

means for detecting QT interval based on the cardiac signals; and

means for deriving blood glucose levels based on a combination of the detected T-wave amplitude and the detected QT interval.

15. An implantable medical device comprising:

a cardiac signal detection unit operative to detect T-waves and QT intervals; and

a glucose monitoring system operative to derive blood glucose levels based on a combination of the detected T-waves and the detected QT intervals.

16. The implantable medical device of claim 15 wherein the glucose monitoring system is further operative to:

convert detected T-waves into T-wave amplitude fractions;

convert detected QT intervals into corrected QT (QTc) interval deltas; and

to determine the blood glucose level based on a combination of the T-wave amplitude fractions and the QTc deltas.

17. The implantable medical device of claim 16 wherein the glucose monitoring system is further operative to calculate:

blood glucose level=A−

B*(QTc delta)−

C*(T-wave fraction)

wherein A, B and C are predetermined coefficients.

18. The implantable medical device of claim 15 wherein the glucose monitoring system is mounted within a device can and wherein the cardiac signal detection unit includes one or more of:

at least one defibrillation coil for mounting within the ventricle of a patient and circuitry for detecting a voltage signal between the coil and the device can; and

a plurality of electrodes for mounting at various locations within the ventricle of the patient and circuitry for averaging voltage signals separately detected between the plurality of electrodes and the device can.

19. A method performed by an implantable medical device, the method comprising:

detecting patient cardiac signals;

deriving a corrected QT interval from the cardiac signals; and

deriving blood glucose levels based on the corrected QT interval within at least a predetermined range of blood glucose levels.

20. The method of claim 19 wherein the predetermined range of blood glucose levels is the range below 90 mg/dl.

21. A method performed by an implantable medical device, the method comprising:

detecting patient cardiac signals;

detecting a T-wave amplitude based on the cardiac signals;

detecting at least one additional feature of the cardiac signals wherein the at least one additional feature is known to exhibit a substantially monotonically-varying response as a function of blood glucose levels; and

deriving a blood glucose level based on a combination of the detected T-wave amplitude and the additional cardiac signal feature.

22. The method of claim 21 performed wherein the additional feature is a QT interval.

23. The method of claim 21 performed wherein the additional feature is heart rate variability.

24. The method of claim 21 performed wherein the additional feature is QT dispersion.

25. The method of claim 21 performed wherein the additional feature is at least one of RT and ST interval.