Method and apparatus for predicting the risk of hypoglycemia

Surgery – Diagnostic testing

Reexamination Certificate

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C600S365000, C128S920000

Reexamination Certificate

active

06923763

ABSTRACT:
The invention relates to a method which utilizes blood glucose (“BG”) sampling, insulin infusion/injection records, heart rate (“HR”) information and heart rate varability (“HRV”) information to estimate BG in the near future and to estimate of the risk of the onset of hypoglycemia. The invention also relates to an apparatus for predicting BG levels and for assessing the risk of the onset of hypoglycemia in the near future. The invention is based on two predetermined bio-mathematical routines: a network model of BG fluctuations and a BG profile for assessment of the risk of hypoglycemia.

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Kovatchev, et al., “Assessment of Risk for Severe Hypoglycemia Among Adults with IDDM,” Diabetes Care, vol. 21, No. 11, pp. 1870-1875, (Nov., 1998).
Kovatchev, et al., “Modeling Insulin-Glucose Dynamics During Insulin Induced Hypoglycemia. Evaluation of Glucose Counterregulation,” Journal of Theoretical Medicine, vol. 1, pp. 313-323, (Oct. 21, 1998).
Kovatchev, et al., “Dynamic network model of glucose counter-regulation in subjects with insulin-requiring diabetes,” Methods in Enzymology, vol. 321, pp. 396-410: Numerical Computer Methods, Part C, 2000.
Cox, D.J., Kovatchev, B.P., Julian, D.M., Gonder-Frederick, L.A., Polonsky, W.H., Schlundt, D.G. and Clarke, W.L. (1994). Frequency of Severe Hypoglycemia in Insulin-Dependent Diabetes Mellitus can be Predicted from Self-Monitoring Blood Glucose Data. (1994). J.of Clin. Endocrinology & Metabolism, 79(6), pp. 1659-1662.
Kovatchev, B.P., Cox, D.J., Gonder-Frederick, L.A. and Clarke, W. (1997). Symmetrization of the Blood Glucose Measurement Scale and Its Applications. Diabetes Care, vol. 20, No. 11, pp. 1655-1658.

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