Use of targeted glycemic profiles in the calibration of a noninvasive blood glucose monitor
First Claim
1. A method of calibrating a non-invasive blood glucose measurement instrument to an individual, said method comprising the steps of:
- providing one or more targeted glycemic profiles;
manipulating said individual'"'"'s blood glucose level such that patterns of said profiles are reproduced by subject'"'"'s own glycemic profile;
performing reference blood glucose measurements at predetermined intervals;
gathering non-invasive spectral measurements with said non-invasive glucose measurement instrument at said predetermined intervals; and
generating a calibration that correlates said reference measurements and said spectral samples, such that an algorithm predicts a blood glucose level from a new spectral sample.
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Abstract
A method of calibrating a non-invasive blood glucose measurement instrument to a diabetic test subject employs targeted glycemic profiles in anti-correlated pairs. During calibration, reference blood glucose determinations are made using conventional invasive sampling methods. Concurrently, noninvasive spectral measurements are made using the noninvasive glucose monitor. Through controlled oral ingestion by the subject of calculated amounts of carbohydrate, the subject'"'"'s blood glucose level is manipulated to mimic the patterns of the targeted profiles. During a first visit, a first profile of a pair is induced; during a second visit the inverse of the first profile is induced. The targeted profiles produce reference blood glucose values in which correlation to sampling factors is reduced or eliminated, thus the resulting calibration is correlated to glucose, and not to other analytes, sampling factors or environmental factors. A formula is provided for calculating the required amount of carbohydrate to ingest to induce a targeted glycemic profile in a test subject.
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Citations
31 Claims
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1. A method of calibrating a non-invasive blood glucose measurement instrument to an individual, said method comprising the steps of:
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providing one or more targeted glycemic profiles;
manipulating said individual'"'"'s blood glucose level such that patterns of said profiles are reproduced by subject'"'"'s own glycemic profile;
performing reference blood glucose measurements at predetermined intervals;
gathering non-invasive spectral measurements with said non-invasive glucose measurement instrument at said predetermined intervals; and
generating a calibration that correlates said reference measurements and said spectral samples, such that an algorithm predicts a blood glucose level from a new spectral sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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16. The method of claim 15, further comprising the step of calculating peak insulin activity based on said rate, said maximum and said minimum.
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17. The method of claim 1, wherein said step of manipulating said individual'"'"'s blood glucose profile comprises the steps of:
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calculating a required amount of carbohydrate to ingest to effect an increase in blood glucose level from a starting value to a target value according to the formula;
where CHO represents said required amount of carbohydrate, and wherein X comprises an index representing said individual'"'"'s sensitivity to carbohydrate; and orally ingesting said required amount of carbohydrate by said individual.
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18. The method of claim 17, further comprising the step of calculating said individual'"'"'s insulin response, wherein said rate of change comprises an indicator of onset of peak activity of exogenous insulin.
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19. The method of claim 17, wherein a percentage of a calibration visit required for said individual'"'"'s blood glucose level to fluctuate from maximum to minimum level is calculated according to:
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20. The method of claim 17, wherein said carbohydrate comprises any of:
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liquid food;
solid food; and
liquid and solid food.
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21. The method of claim 17, wherein X is a generalized value selected from a range of approximately 1 to 3.
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22. The method of claim 17, wherein said manipulating step further comprises the step of:
administering low-carbohydrate meals to effect a decrease in said individual'"'"'s blood glucose level.
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23. The method of claim 17, wherein said manipulating step further comprises the step of:
administering insulin to effect a rapid decrease in said individual'"'"'s blood glucose level.
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24. The method of claim 1, wherein said step of performing reference blood glucose measurements comprises the steps of:
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drawing blood samples; and
analyzing said blood samples for glucose using a blood glucose analyzer.
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25. The method of claim 1, wherein said non-invasive glucose measurement instrument comprises a Near IR spectrometer instrument.
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26. The method of claim 1, wherein said predetermined intervals are approximately fifteen minutes in length.
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27. The method of claim 1, wherein said step of generating said calibration comprises the steps of:
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creating a calibration data set and a test data set from said reference blood glucose values and said spectral measurements, wherein said blood glucose values are correlated to said spectral measurements;
generating an algorithm based on said calibration data set and said test set that predicts a blood glucose value from a new spectral measurement.
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28. The method of claim 1, wherein said individual is human.
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29. The method of claim 1, wherein said individual is diabetic.
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30. The method of claim 1, wherein said providing step comprises:
providing a pair of said targeted profiles.
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31. The method of claim 1, wherein said providing step comprises:
providing a two pairs of said targeted profiles.
Specification