Methods and devices for prediction of hypoglycemic events
First Claim
1. A method for predicting a hypoglycemic event in a subject, said method comprising, determining (i) a threshold glucose value that corresponds to said hypoglycemic event, and (ii) a threshold skin conductance and/or temperature value that is correlated with said hypoglycemic event, obtaining a series of glucose measurement values at selected time intervals using a method comprising obtaining a raw signal specifically related to a glucose amount or concentration in the subject for a given time interval, correlating the raw signal with a glucose measurement value indicative of the amount or concentration of glucose present in the subject in said given time interval, repeating said obtaining and correlating to provide a series of glucose measurement values at selected time intervals, predicting a glucose measurement value at a further time interval subsequent to said series of glucose measurement values, and comparing said predicted glucose measurement value to said threshold glucose value, when the predicted glucose measurement value is less than or equal to the threshold glucose value a hypoglycemic is predicted;
- measuring skin conductance and/or temperature of the subject concurrently simultaneously, or sequentially with said obtaining of the series of glucose measurement values to obtain a skin conductance and/or temperature value or trend of skin conductance and/or temperature values, and comparing said skin conductance and/or temperature value or trend of skin conductance and/or temperature values with said threshold skin conductance and/or temperature value to determine whether said skin conductance and/or temperature value or trend of skin conductance and/or temperature values indicates a hypoglycemic event;
predicting a hypoglycemic event in said subject when both (i) comparing the predicted glucose measurement value to said threshold glucose value indicates a hypoglycemic event at said further time interval and (ii) comparing said skin conductance and/or temperature value or trend of skin conductance and/or temperature values with said threshold skin conductance and/or temperature value indicates a hypoglycemic event and providing an alert to the subject when a hypoglycemic event is predicted.
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Abstract
Described herein are methods, devices, and microprocessors useful for predicting a hypoglycemic event in a subject. The hypoglycemic predictive approach described herein utilizes information obtained from a data stream, e.g., frequently obtained glucose values (current and/or predicted), body temperature, and/or skin conductance, to predict incipient hypoglycemic events and to alert the user.
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Citations
36 Claims
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1. A method for predicting a hypoglycemic event in a subject, said method comprising,
determining (i) a threshold glucose value that corresponds to said hypoglycemic event, and (ii) a threshold skin conductance and/or temperature value that is correlated with said hypoglycemic event, obtaining a series of glucose measurement values at selected time intervals using a method comprising obtaining a raw signal specifically related to a glucose amount or concentration in the subject for a given time interval, correlating the raw signal with a glucose measurement value indicative of the amount or concentration of glucose present in the subject in said given time interval, repeating said obtaining and correlating to provide a series of glucose measurement values at selected time intervals, predicting a glucose measurement value at a further time interval subsequent to said series of glucose measurement values, and comparing said predicted glucose measurement value to said threshold glucose value, when the predicted glucose measurement value is less than or equal to the threshold glucose value a hypoglycemic is predicted; -
measuring skin conductance and/or temperature of the subject concurrently simultaneously, or sequentially with said obtaining of the series of glucose measurement values to obtain a skin conductance and/or temperature value or trend of skin conductance and/or temperature values, and comparing said skin conductance and/or temperature value or trend of skin conductance and/or temperature values with said threshold skin conductance and/or temperature value to determine whether said skin conductance and/or temperature value or trend of skin conductance and/or temperature values indicates a hypoglycemic event;
predicting a hypoglycemic event in said subject when both (i) comparing the predicted glucose measurement value to said threshold glucose value indicates a hypoglycemic event at said further time interval and (ii) comparing said skin conductance and/or temperature value or trend of skin conductance and/or temperature values with said threshold skin conductance and/or temperature value indicates a hypoglycemic event and providing an alert to the subject when a hypoglycemic event is predicted. - View Dependent Claims (2, 3, 4, 5, 6, 7, 10, 11, 12, 14)
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8-9. -9. (canceled)
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13. The method of claim 4412 wherein said enzyme is glucose oxidase.
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15. A glucose monitoring system for measuring glucose in a subject, said system comprising, in operative combination:
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a sensing mechanism in operative contact with the subject or with a glucose-containing sample extracted from the subject, wherein said sensing mechanism obtains a raw signal specifically related to glucose amount or concentration in the subject;
a first device to obtain skin conductance readings or temperature readings from the subject, and one or more microprocessors in operative communication with the sensing mechanism, wherein said microprocessors comprise programming to (i) control the sensing mechanism to obtain a series of raw signals at selected time intervals, (ii) correlate the raw signals with measurement values indicative of the amount or concentration of glucose present in the subject to obtain a series of glucose measurement values, (iii) predict a glucose measurement value at a further time interval, subsequent to obtaining the series of glucose measurement values, (iv) compare said predicted glucose measurement value to a threshold glucose value, wherein a predicted glucose measurement value less than or equal to the threshold glucose value is designated to be hypoglycemic, (v) control the first device to measure skin conductance readings or temperature readings of the subject, (vi) compare said skin conductance readings or temperature readings with a threshold skin conductance or temperature value or trend of skin conductance or temperature values to determine whether said skin conductance readings or temperature readings indicate a hypoglycemic event, (vii) predict a hypoglycemic event in said subject when both (a) comparing said predicted glucose measurement value to said threshold glucose value indicates a hypoglycemic event at said further time intervals, and (b) comparing said skin conductance readings or temperature readings with a threshold skin conductance or temperature value or trend of skin conductance or temperature values indicates a hypoglycemic event; and
(viii) control providing an alert to the subject when a hypoglycemic event is predicted. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 24, 25, 35)
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23. The monitoring system of claim, wherein both skin conductance readings and temperature readings are used to predict the likelihood of a hypoglycemic event.
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26. One or more microprocessors, comprising programming to:
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(i) control a sensing mechanism to obtain a series of raw signals at selected time intervals, wherein each raw signal is related to an amount or concentration of glucose in a subjects (ii) correlate the raw signals with glucose measurement values indicative of the amount or concentration of glucose present in the subject to obtain a series of glucose measurement values-, (iii) predict a glucose measurement value at a further time interval, subsequent to obtaining the series of glucose measurement values;
(iv) compare said predicted glucose measurement value to a threshold lucose value, wherein a predicted lucose measurement value less than or equal to the threshold glucose value is designated to be hypoglycemic;
(v) control a first device to measure skin conductance readings or temperature readings of the subject;
(vi) compare said skin conductance readings or temperature readings with a threshold skin conductance or temperature value or trend of skin conductance or temperature values to determine whether said skin conductance readings or temperature readings indicate a hypoglycemic event; and
(vii) predict a hypoglycemic event in said subject when both (a) comparing said predicted glucose measurement value to said threshold glucose value indicates a hypoglycemic event at said further time interval, and (b) comparing said skin conductance readings or temperature readings with a threshold skin conductance or temperature value or trend of skin conductance or temperature values indicates a hypoglycemic event (viii) control providing an alert to the subject when a hypoglycemic event is predicted. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 36)
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Specification