System and method for evaluating impaired glucose tolerance and diabetes mellitus within a patient using an implantable medical device

• US 7,462,150 B1
• Filed: 06/09/2006
• Issued: 12/09/2008
• Est. Priority Date: 06/09/2006
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bharmi, Rupinder
• Primary Examiner(s): Nasser, Jr.; Robert L.
• Assistant Examiner(s): Toth; Karen E
• Application Number:
  US11/450,937
• Time in Patent Office: 914 Days
• Field of Search: 600/300, 600/365
• US Class Current: 600/300
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/025 within occluders, e.g. responsive to Korotkoff sounds electric stethoscopes A61B7/04
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability

Abstract

Techniques are described for use by a pacemaker or implantable cardioverter/defibrillator (ICD) or other implantable medical device. The techniques are provided for evaluating the likelihood that the patient, in which the device is implanted, has impaired glucose tolerance (IGT) or diabetes mellitus. Briefly, a value representative of sleep quality of the patient is detected and then the likelihood that the patient has IGT or diabetes mellitus is determined based on the sleep quality value. In this regard, it has been found that a decrease in overall sleep quality is associated with an increased likelihood of IGT or diabetes mellitus, which is in turn associated with an increased risk of mortality. Hence, sleep quality may be used as a proxy for evaluating the likelihood that the patient has IGT or diabetes mellitus and for assessing associated mortality risk.

Claims

1. A method for use with an implantable medical device for use within a patient, the method comprising:

detecting a value representative of sleep quality of the patient; and

evaluating the likelihood that the patient has an abnormal glucose level medical condition, the evaluation performed based on the sleep quality value.

2. The method of claim 1 wherein the abnormal glucose level medical condition includes one or more of impaired glucose intolerance (IGT) and diabetes mellitus.

3. The method of claim 1 wherein detecting sleep quality within the patient includes detecting sleep efficiency (SE) associated with a period of sleep.

4. The method of claim 3 wherein detecting sleep efficiency (SE) includes

detecting a total quality sleep time (TQST) associated with a period of sleep;

detecting a total amount of time the patient spent in the sleep position (TSSP) during the period of sleep; and

calculating a ratio of total quality sleep time (TQST) to time spent in sleep position (TSSP).

5. The method of claim 4 wherein detecting total quality sleep time (TQST) includes:

detecting the onset (SO) of the period of sleep;

detecting a final awakening (FA) from the period of sleep;

calculating the total sleep period (TSP) as the time from sleep onset (SO) to final awakening (FA);

detecting any time the patient spends moving (TSM) during the total sleep period (TSP);

detecting any temporary awake time (TAT) during the total sleep period (TSP); and

calculating total quality sleep time (TQST) as total sleep period (TSP) less any intervening time the patient spends moving (TSM) during the total sleep period (TSP) and less any temporary awake time (TAT) during the total sleep period (TSP).

6. The method of claim 5 wherein detecting sleep onset (SO) and detecting final awakening (FA) is performed, in part, based on changes in one or more of (a) heart rate variability, (b) cardiac signal morphology, (c) respiration rate and (d) respiration depth, each derived from an intracardiac electrogram (IEGM) of the patient sensed using implanted leads, and (e) blood pressure sensed using an implanted blood pressure sensor.

7. The method of claim 5 wherein detecting any time the patient spends moving (TSM) is performed, in part, based on changes in one or more of (a) the morphology of an IEGM of the patient sensed using implanted leads, (b) paced depolarization integral (PDI) sensed using implanted leads, and (c) patient movement sensed using an implanted activity sensor.

8. The method of claim 5 wherein detecting any temporary awake time (TAT) is performed, in part, based on changes in one or more of (a) heart rate variability derived from an IEGM sensed using implanted leads, (b) patient motion sensed using an implanted activity sensor and (c) blood pressure sensed using an implanted blood pressure sensor.

9. The method of claim 5 wherein detecting total time of the patient spent in sleep position (TSSP) is performed, in part, based on patient posture sensed using an implanted posture sensor.

10. The method of claim 1 wherein detecting sleep quality within the patient includes

detecting a total sleep period (TSP);

and

determining an amount of deviation from a predetermined normal sleep range (NSR).

11. The method of claim 1 wherein evaluating the likelihood of that patient has the abnormal glucose level medical condition includes equating a decrease in sleep quality with an increased likelihood that the medical condition is present within the patient.

12. The method of claim 1 further including detecting an increased risk of mortality based on the sleep quality value.

13. The method of claim 12 wherein detecting an increased risk of mortality includes associating a decrease in sleep quality with an increased risk of mortality.

14. A system for use in an implantable medical device for use within a patient comprising:

a sleep quality detection system operative to detect a value representative of sleep quality of the patient; and

a sleep quality-based medical condition evaluation system operative to evaluate the likelihood that the patient has an abnormal glucose level medical condition, the evaluation performed based on the sleep quality value.

15. The system of claim 14 wherein the sleep quality detection system is operative to detect sleep efficiency (SE) associated with a period of sleep.

16. A system for use with an implantable medical device comprising:

means for detecting a value representative of sleep quality of a patient in which the device is implanted;

means for detecting an increased likelihood that the patient has an abnormal glucose level medical condition, the detection performed based on the sleep quality value; and

means for controlling recordation of diagnostic information in response to the detection of an increased likelihood of the abnormal glucose level medical condition.