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

• US 7,029,443 B2
• Filed: 10/21/2002
• Issued: 04/18/2006
• 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.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Assistant Examiner(s): Alexander, John D
• Application Number:
  US10/277,468
• Publication Number:
  US 20040078065A1
• Time in Patent Office: 1,275 Days
• Field of Search: 607/5, 607/9, 607/22, 607/25, 607/18, 600/300, 600/347, 600/509, 600/513, 604 65- 67
• US Class Current: 600/365
• 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 external programmer device in communication with an implantable medical device implanted within a patient, the method comprising:

receiving signals from the implantable device representative of electrical cardiac signals;

receiving signals representative of corresponding patient blood glucose levels;

determining parameters relating the electrical cardiac signals to the blood glucose levels for the particular patient; and

transmitting the parameters to the implantable device such that the implantable device can thereafter derive patient blood glucose levels from subsequently detected electrical cardiac signals.

2. The method of claim 1 wherein receiving signals from the implantable device representative of electrical cardiac signals comprises receiving signals representative of T-wave amplitudes and QT intervals.

3. The method of claim 2 wherein determining parameters relating T-wave amplitudes and QT intervals to blood glucose levels comprises correlating a plurality of blood glucose levels with corresponding T-wave amplitudes and QT intervals based on a pre-determined general functional relationship so as to derive parameters specifying the functional relationship for the particular patient.

4. The method of claim 3 wherein the signals representative of T-wave amplitudes are T-wave amplitude fractions and wherein the signals representative of QT intervals are QTc interval deltas and wherein the pre-determined general functional relationship is:

blood glucose level =A−

B*QTc−

C*(T-wave amplitude fraction)

wherein A, B and C are the parameters to be determined that specify the functional relationship for the particular patient.

5. The method of claim 4 wherein transmitting the parameters to the implantable device comprises:

transmitting the parameters A, B and C to the implantable device.

6. The method of claim 4 wherein correlating a plurality of blood glucose levels with corresponding T-wave amplitude fractions and QTc delta values comprises performing multiple regression statistical analysis on the plurality of blood glucose levels with corresponding T-wave amplitude fractions and QTc delta values.

7. The method of claim 2 wherein receiving signals from the implantable device representative of patient T-wave amplitudes and QT intervals is performed throughout a pre-determined range of blood glucose levels.

8. The method of claim 7 wherein receiving signals from the implantable device further comprises:

receiving signals from the implantable device representative of patient T-wave amplitudes and QT intervals while the blood glucose level of the patient rises to a predetermined upper threshold; and

receiving signals from the implantable device representative of patient T-wave amplitudes and QT intervals while the blood glucose level of the patient decreases from the upper threshold to a pre-determined lower threshold.

9. The method of claim 8 wherein the lower threshold is 40 mg/dl and the upper threshold is 300 mg/dl.

10. The method of claim 1 wherein receiving signals representative of corresponding patient blood glucose levels comprises receiving signals from an external blood glucose monitor.

11. The method of claim 1 wherein the implantable device includes an insulin pump and further comprising generating and transmitting control signals to the implantable device specifying control of the insulin pump based on detected blood glucose levels.

12. The method of claim 1 wherein the implantable device includes the capability of generating warning signals and further comprising generating and transmitting control signals to the implantable device specifying upper and lower blood glucose bounds for use in triggering warning signals.

13. The method of claim 12 wherein the upper bound is 120 mg/dl and the lower bound is 60 mg/dl.

14. An external system for use with an implantable medical device implanted within a patient, the system comprising:

means for receiving signals from the implantable device representative of electrical cardiac signals;

means for inputting signals representative of corresponding patient blood glucose levels;

means for determining parameters relating the electrical cardiac signals to the blood glucose levels for the particular patient; and

means for transmitting the parameters to the implantable device.

15. An external system for use with an implantable medical device implanted within a patient, the system comprising:

a calibration system operative to determine parameters relating electrical cardiac signals of the patient in which the device is implanted to blood glucose levels of the patient; and

a telemetry unit operative to transmit the parameters to the implantable device for use by the implantable device.

16. A method performed by one or more external devices in conjunction with an implantable medical device implanted within a patient, the method comprising:

externally providing for an increase in blood glucose levels within the patient while internally detecting and recording electrical cardiac signals and externally detecting and recording patient blood glucose levels for a plurality of blood glucose levels;

externally decreasing the blood glucose levels while continuing to internally detect and record electrical cardiac signals and externally detect and record patient blood glucose levels for a plurality of blood glucose levels;

externally receiving the recorded electrical cardiac signals and the recorded patient blood glucose levels and determining parameters relating the electrical cardiac signals to the patient blood glucose levels; and

transmitting the parameters to the implanted device for use by the implanted device to derive blood glucose levels for the patient from subsequently detected electrical cardiac signals.

17. The method of claim 16 wherein detecting and recording electrical cardiac signals comprises detecting and recording signals representative of T-wave amplitudes and QT intervals.

18. The method of claim 16 wherein the patient is not an insulin-dependent diabetic and wherein providing for an increase in blood glucose levels within the patient comprises administering glucose to the patient.

19. The method of claim 16 wherein the patient is an insulin-dependent diabetic and wherein providing for an increase in blood glucose levels within the patient comprises withholding insulin from the patient.