Non-invasive measurement of blood glucose using instruments that have less precise detection capability

• US 6,064,896 A
• Filed: 05/06/1998
• Issued: 05/16/2000
• Est. Priority Date: 05/06/1998
• Status: Expired due to Term

• Current Assignee: Futrex, Inc.
• Original Assignee: Futrex, Inc.
• Inventors: Rosenthal, Robert D.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/073,941
• Time in Patent Office: 741 Days
• Field of Search: 600/300, 600/310, 600/316, 600/318, 600/319, 600/322, 600/365, 128/920, 128/921, 356/39
• US Class Current: 600/316
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

A method and apparatus are disclosed for improving an accuracy characteristic of a quantitative measurement instrument for measuring a blood analyte concentration by using lower precision sensor devices. One embodiment of the method includes calculating a correction factor based on an elapsed time from a last meal and a substantially typical rise and fall pattern of blood analyte concentrations in the bloodstream. The correction factor is part of a regression analysis equation employed by the blood analyte measurement instrument. A second embodiment includes a method whereby a series of indicator variables are allocated based on the elapsed time from a last meal, and uses the indicator variables in a regression analysis equation. An apparatus having an introducer means for introducing an energy into blood present in a body part of a subject, a detector for detecting the energy emerging from the body part, with the detector producing an electrical signal indicative of the emerging energy, an input element for entering a time from a last meal of the subject, a storage element for storing a regression equation and a correction factor, and a processor for using the regression equation and the correction factor to yield a predicted value of the blood analyte concentration.

Claims

1. A method for increasing an accuracy characteristic of a quantitative measurement instrument for measuring a blood analyte concentration, said method comprising:

obtaining an energy absorption measurement through a body part of an individual;

determining an elapsed time since a last intake of nutrients by said individual which results in an increase of said blood analyte of at least a minimum predetermined amount;

calculating a correction factor based on said elapsed time from said last intake of nutrients; and

adding said correction factor to a regression analysis equation, wherein said regression analysis equation yields a predicted value of said blood analyte concentration.

2. The method of claim 1, wherein said blood analyte concentration is a blood glucose concentration.

3. The method of claim 1, wherein the step of obtaining said energy absorption measurement comprises the step of using a near-infrared optical absorption measurement.

4. The method of claim 1, wherein the step of obtaining said energy absorption measurement comprises the step of using a mid-infrared optical absorption measurement.

5. The method of claim 1, wherein the step of obtaining said energy absorption measurement comprises the step of using a far-infrared optical absorption measurement.

6. The method of claim 1, wherein the step of obtaining said energy absorption measurement comprises the step of using a radio-frequency absorption measurement.

7. The method of claim 1, wherein said correction factor has a rate of change represented by a multiplier of about positive two for a time period extending from said meal until about two hours after said meal.

8. The method of claim 1, wherein said correction factor has a rate of change represented by a multiplier of about negative one for a time period extending from about two hours after said meal onward.

9. The method of claim 1, wherein said correction factor is set at about one and sixth tenths if a measurement is a first measurement following an overnight fast.

10. The method of claim 1, wherein said correction factor is limited to a maximum value of about four for measurements made greater than about six hours after said meal.

11. A method for increasing an accuracy characteristic of a quantitative measurement instrument for measuring a blood analyte concentration, said method comprising:

obtaining an energy absorption measurement through a body part of an individual;

determining an elapsed time since a last meal; and

allocating a plurality of indicator variables to form a regression analysis equation based on said elapsed time since said last meal, wherein said regression analysis equation yields a predicted value of said blood analyte concentration.

12. The method of claim 11, wherein said blood analyte concentration is a blood glucose concentration.

13. The method of claim 11, wherein the step of obtaining said energy absorption measurement comprises the step of using a near-infrared optical absorption measurement.

14. The method of claim 11, wherein the step of obtaining said energy absorption measurement comprises the step of using a mid-infrared optical absorption measurement.

15. The method of claim 11, wherein the step of obtaining said energy absorption measurement comprises the step of using a far-infrared optical absorption measurement.

16. The method of claim 11, wherein the step of obtaining said energy absorption measurement comprises the step of using a radio-frequency absorption measurement.

17. The method of claim 11, wherein a first indicator variable is assigned a value of one if said energy absorption measurement is obtained after a period of fasting, said first indicator variable is assigned a value of zero otherwise.

18. The method of claim 17, wherein a second indicator variable is assigned a value of one if said energy absorption measurement is obtained within about one half hour of said meal, said second indicator variable is assigned a value of zero otherwise.

19. The method of claim 18, wherein third and fourth indicator variables are assigned a collective value of one if said energy absorption measurement is obtained between about one half and about one and a half hours after said meal, with a division of said collective value between said third and fourth indicator variables being determined by linear interpolation, said third and fourth indicator variables are assigned a value of zero otherwise.

20. The method of claim 19, wherein said fourth indicator variable and a fifth indicator variable are assigned a collective value of one if said energy absorption measurement is obtained between about one and a half and about two and a half hours after said meal, with a division of said collective value between said fourth and fifth indicator variables being determined by linear interpolation, said fourth and fifth indicator variables are assigned a value of zero otherwise.

21. The method of claim 20, wherein said fifth indicator variable and a sixth indicator variable are assigned a collective value of one if said energy absorption measurement is obtained between about two and a half and about three and a half hours after said meal, with a division of said collective value between said fifth and sixth indicator variables being determined by linear interpolation, said fifth and sixth indicator variables are assigned a value of zero otherwise.

22. The method of claim 21, wherein said sixth indicator variable and a seventh indicator variable are assigned a collective value of one if said energy absorption measurement is obtained between about three and a half and about four and a half hours after said meal, with a division of said collective value between said sixth and seventh indicator variables being determined by linear interpolation, said sixth and seventh indicator variables are assigned a value of zero otherwise.

23. The method of claim 22, wherein said seventh indicator variable and a eighth indicator variable are assigned a collective value of one if said energy absorption measurement is obtained between about four and a half and about five and a half hours after said meal, with a division of said collective value between said seventh and eighth indicator variables being determined by linear interpolation, said seventh and eighth indicator variables are assigned a value of zero otherwise.

24. The method of claim 23, wherein said eighth indicator variable and a ninth indicator variable are assigned a collective value of one if said energy absorption measurement is obtained between about five and a half and about six and a half hours after said meal, with a division of said collective value between said eighth and ninth indicator variables being determined by linear interpolation, said eighth and ninth indicator variables are assigned a value of zero otherwise.

25. The method of claim 24, wherein said ninth indicator variable is assigned a value of one if said energy absorption measurement is obtained after about six and a half hours after said meal, said ninth indicator variable is assigned a value of zero otherwise.

26. A quantitative measurement instrument for non-invasive measurement of a blood analyte concentration, comprising:

introducing means including an energy source for introducing energy into blood present in a body part of a subject;

detector circuit means for detecting said energy emerging from said body part, said detector circuit means producing a first electrical signal indicative of said energy emerging from said body part;

input means for entering a time from a last intake of nutrients by said subject;

storage means for storing a regression equation and a correction factor, said correction factor having a value dependent on said entered time from a last intake of nutrients; and

processing means for processing said first electrical signal by using said regression equation and said correction factor to yield a predicted value of said blood analyte concentration, with said correction factor increasing an accuracy characteristic of said quantitative measurement instrument, by taking into account the elapsed time of said last intake of nutrients in said regression equation.

27. The quantitative measurement instrument of claim 26, wherein said blood analyte concentration is a blood glucose concentration.

28. The quantitative measurement instrument of claim 26, wherein said energy comprises near-infrared energy.

29. The method of claim 26, wherein said energy comprises mid-infrared energy.

30. The method of claim 26, wherein said energy comprises far-infrared energy.

31. The quantitative measurement instrument of claim 26, wherein said energy comprises a radio-frequency energy.

32. A method for increasing an accuracy characteristic of a quantitative measurement instrument which utilizes a regression analysis equation for measuring a blood analyte concentration, said method comprising:

obtaining an energy absorption measurement through a body part of an individual;

determining an elapsed time since a last intake of nutrients by said individual which results in an increase of said blood analyte of at least a minimum predetermined amount; and

modifying said regression analysis equation as a function of said elapsed time so as to obtain a blood analyte concentration measurement having increased accuracy by taking into account said last intake of nutrients.