SIGNAL PROCESSING FOR CONTINUOUS ANALYTE SENSOR
First Claim
1. A method for estimating an analyte value from a continuous analyte sensor, the method comprising:
- receiving a data stream from the continuous analyte sensor for a first time period; and
estimating at least one analyte value for a second time period based on the data stream, wherein the step of estimating at least one analyte value comprises selecting an algorithm from a plurality of algorithms based at least in part on an analysis of the data stream.
1 Assignment
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Accused Products

Abstract
Systems and methods for dynamically and intelligently estimating analyte data from a continuous analyte sensor, including receiving a data stream, selecting one of a plurality of algorithms, and employing the selected algorithm to estimate analyte values. Additional data processing includes evaluating the selected estimative algorithms, analyzing a variation of the estimated analyte values based on statistical, clinical, or physiological parameters, comparing the estimated analyte values with corresponding measure analyte values, and providing output to a user. Estimation can be used to compensate for time lag, match sensor data with corresponding reference data, warn of upcoming clinical risk, replace erroneous sensor data signals, and provide more timely analyte information encourage proactive behavior and preempt clinical risk.
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Analyte monitoring device and methods of use | ||
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Analyte monitoring device and methods of use | ||
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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RF tag on test strips, test strip vials and boxes | ||
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Therasense Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Therasense Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Analyte monitoring device and methods of use | ||
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Signal processing for continuous analyte sensor | ||
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Electronic devices having integrated reset systems and methods thereof | ||
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Udo Hoss, Gary A. Stafford
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Analyte sensor devices, connections, and methods | ||
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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25 Claims
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1. A method for estimating an analyte value from a continuous analyte sensor, the method comprising:
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receiving a data stream from the continuous analyte sensor for a first time period; and estimating at least one analyte value for a second time period based on the data stream, wherein the step of estimating at least one analyte value comprises selecting an algorithm from a plurality of algorithms based at least in part on an analysis of the data stream. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A system for estimating an analyte value from a continuous analyte sensor, the system comprising:
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an input module operatively connected to the continuous analyte sensor that receives a data stream for a first time period; and a processor module comprising programming configured to select an algorithm from a plurality of algorithms based on an analysis of the data stream, wherein the processor further comprises programming configured to estimate at least one analyte value using the selected algorithm. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A method for estimating an analyte value from a continuous analyte sensor, the method comprising:
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receiving a data stream from the continuous analyte sensor for a first time period;
selecting at least one algorithm from a plurality of algorithms based on an analysis of the data stream; andevaluating the algorithm based on at least one parameter selected from the group consisting of a statistical parameter, a physiological parameter, and a clinical parameter; and
employing the selected algorithm based on the step of evaluating to estimate at least one analyte value. - View Dependent Claims (16, 17)
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18. A system for estimating analyte values from a continuous analyte sensor the system comprising:
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an input module operatively connected to the continuous analyte sensor that receives a data stream for a first time period; and a processor module comprising programming configured to select an algorithm from a plurality of algorithms based on an analysis of the data stream, that evaluates the algorithm based on a parameter selected from the group consisting of statistical parameters, physiological parameters, and clinical parameters, and that employs a selected algorithm based on the algorithm evaluation to estimate at least one analyte value. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25)
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1 Specification
This application is a division of U.S. application Ser. No. 11/007,920, filed Dec. 8, 2004, which claims the benefit of U.S. Provisional Application No. 60/528,382, filed Dec. 9, 2003, U.S. Provisional Application No. 60/587,787, filed Jul. 13, 2004, and U.S. Provisional Application No. 60/614,683, filed Sep. 30, 2004. Each above-referenced application is hereby incorporated by reference herein in its entirety.
The present invention relates generally to systems and methods for measuring and analyzing data obtained from a continuous analyte sensor. More particularly, the present invention relates to dynamic and intelligent estimation of analyte values from a continuous analyte sensor.
Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which may cause an array of physiological derangements (for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye) associated with the deterioration of small blood vessels. A hypoglycemic reaction (low blood sugar) may be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.
Conventionally, a person with diabetes carries a self-monitoring blood glucose (SMBG) monitor, which typically comprises uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes will normally only measure his or her glucose levels two to four times per day. Unfortunately, these time intervals are so far apart that the person with diabetes will likely find out too late, sometimes incurring dangerous side effects, of a hyper- or hypo-glycemic condition. In fact, it is not only unlikely that a person with diabetes will take a timely SMBG value, but the person with diabetes will not know if their blood glucose value is going up (higher) or down (lower) based on conventional methods, inhibiting their ability to make educated insulin therapy decisions.
Some attempts have been made to continuously measure the glucose concentration in a person with diabetes. Typically, these continuous glucose sensors have required a reference glucose monitor (for example, SMBG) to provide reference glucose values in order to calibrate and/or interpret data from the continuous glucose monitor. While the use of these reference glucose values can be helpful, they can also cause numerous inconsistencies and instabilities in the data output of the continuous glucose sensor. As one example, a time lag can be caused by an interstitial fluid sample measured by an implantable glucose sensor as compared with a blood sample measured by an external reference glucose monitor, which can cause inaccurate calibration, outlier detection, and data output. Additionally, the static use of algorithms may not adequately represent physiological trends in a human, for example.
There exists a need for improvements in data processing of continuous glucose sensors in order to better handle the inconsistencies and instabilities that occur in glucose measurements and associated data analysis.
Accordingly, in a first embodiment, a method for estimating an analyte value from a continuous analyte sensor is provided, the method comprising receiving a data stream from the continuous analyte sensor for a first time period, thereby obtaining a measured analyte value; estimating at least one analyte value for a second time period based on the data stream; and comparing the estimated analyte value with the measured analyte value.
In an aspect of the first embodiment, the step of receiving a data stream comprises receiving a data stream that has been algorithmically smoothed.
In an aspect of the first embodiment, the step of receiving the data stream comprises receiving a raw data stream.
In an aspect of the first embodiment, the step of estimating at least one analyte value further comprises selecting an algorithm from a plurality of algorithms based on an analysis of the data stream prior to estimating at least one analyte value.
In an aspect of the first embodiment, the step of selecting an algorithm is conditional upon at least one value selected from the group consisting of analyte concentration, rate of change, acceleration, and an individual historical pattern of the data stream.
In an aspect of the first embodiment, the step of selecting an algorithm comprises employing the plurality of algorithms on the data stream and determining which of the plurality of algorithms best correlates with the data stream.
In an aspect of the first embodiment, the algorithm is selected from the group consisting of polynomial regression, autoregressive algorithms, Fourier transform, Wavelet transform, neural network-based mapping, fuzzy logic based pattern matching, and Genetic-Algorithms based pattern matching.
In an aspect of the first embodiment, the step of selecting an algorithm further comprises applying a physiological boundary to the selected algorithm.
In an aspect of the first embodiment, the method further comprises evaluating the selected algorithm by applying an evaluation function prior to employing the selected algorithm to estimate the analyte value, wherein the evaluation function is selected from the group consisting of a data association function, a curvature formula, and a physiological boundary.
In an aspect of the first embodiment, the step of analyzing a variation comprises analyzing a variation of the estimated analyte value based on a parameter selected from a statistical parameter, a clinical parameter, or a physiological parameter.
In an aspect of the first embodiment, the step of analyzing a variation comprises determining a physiological variation from the estimated analyte value.
In an aspect of the first embodiment, the step of analyzing a variation comprises determining a statistical variation from the estimated analyte value based on a statistical parameter.
In an aspect of the first embodiment, the step of comparing comprises determining a deviation between the estimated analyte value and the measured analyte value.
In an aspect of the first embodiment, the step of analyzing a variation comprises analyzing a variation of the estimated analyte value based on the deviation determined by the step of comparing.
In an aspect of the first embodiment, the method further comprises a step of recognizing a pattern by monitoring a physiological parameter over time.
In an aspect of the first embodiment, the step of analyzing a variation comprises analyzing a variation in the physiological parameter to determine a variation of the estimated analyte value.
In an aspect of the first embodiment, the step of analyzing a variation comprises determining a variation of the estimated analyte value based on a clinical risk of the estimated analyte value to the user.
In an aspect of the first embodiment, the method further comprises providing output based on the estimated analyte data.
In an aspect of the first embodiment, the output displays an estimated analyte value to the user.
In an aspect of the first embodiment, the output displays an estimated path of analyte values for a future time period.
In an aspect of the first embodiment, the output displays an estimated analyte value at a future point in time.
In an aspect of the first embodiment, the output displays an estimated future time period of clinical risk.
In an aspect of the first embodiment, the time period of clinical risk is determined when an estimated analyte value falls outside of a normal analyte threshold.
In an aspect of the first embodiment, the analyte is blood glucose and the normal analyte threshold is from about 100 mg/dL to about 160 mg/dL.
In an aspect of the first embodiment, the normal analyte threshold is from about 80 mg/dL to about 200 mg/dL.
In an aspect of the first embodiment, the normal analyte threshold is from about 55 mg/dL to about 220 mg/dL.
In an aspect of the first embodiment, the output displays at least one clinically acceptable target analyte value.
In an aspect of the first embodiment, the target analyte value is customizable by the user.
In an aspect of the first embodiment, the target analyte value is based on an individual physiological pattern.
In an aspect of the first embodiment, a parameter utilized in determining a therapy recommendation is customizable by the user.
In an aspect of the first embodiment, the output comprises an icon that has a shape representative of the analyzed variation of the estimated analyte value.
In an aspect of the first embodiment, the output comprises a dynamic visual representation of the analyzed variation of estimated analyte value.
In an aspect of the first embodiment, the output prompts the user to obtain a reference analyte value.
In an aspect of the first embodiment, the output provides at least one alarm selected from the group consisting of a visual alarm, an audible alarm, and a tactile alarm, wherein the alarm is provided based on a clinical risk associated with the estimated analyte value.
In an aspect of the first embodiment, the alarm is based on at least one parameter selected from the group consisting of an analyte value, a rate of change, acceleration of a rate of change, and an individual physiological pattern.
In an aspect of the first embodiment, the output continuously provides estimated analyte values.
In an aspect of the first embodiment, the output selectively provides the estimated analyte value based on an event trigger.
In an aspect of the first embodiment, the output provides a clinical risk zone that is displayed on a screen.
In an aspect of the first embodiment, the clinical risk zone comprises at least one of a shaded region, a colored region, and a patterned region.
In an aspect of the first embodiment, the clinical risk zone is bounded by a threshold.
In an aspect of the first embodiment, the output provides the estimated analyte value and the variation of the estimated analyte value on a trend graph.
In an aspect of the first embodiment, the output provides the estimated analyte value and the variation of the estimated analyte value on a gradient bar.
In an aspect of the first embodiment, the output is sent to a personal computer.
In an aspect of the first embodiment, the output is sent to a modem.
In an aspect of the first embodiment, the output is sent to an insulin pen.
In an aspect of the first embodiment, the output is sent to an insulin pump.
In a second embodiment, a method for estimating an analyte value from a continuous analyte sensor is provided, the method comprising receiving a data stream from the continuous analyte sensor for a time period; estimating at least one analyte value for a future time based on the data stream; analyzing a variation of the estimated analyte value based on a parameter selected from the group consisting of a statistical parameter, a clinical parameter, or a physiological parameter; and providing an output based on the estimated analyte value and the variation of the estimated analyte value.
In an aspect of the second embodiment, the method further comprises evaluating the selected algorithm by applying an evaluation function prior to employing the selected algorithm to estimate the analyte value, wherein the evaluation function is selected from the group consisting of a data association function, a curvature formula, and a physiological boundary.
In a third embodiment, a method for estimating an analyte value from a continuous analyte sensor is provided, the method comprising receiving a data stream from the continuous analyte sensor for a time period; selecting at least one algorithm from a plurality of algorithms based on an analysis of the data stream; evaluating the algorithm based on at least one parameter selected from the group consisting of a statistical parameter, a physiological parameter, and a clinical parameter; and employing the selected algorithm based on the step of evaluating to estimate at least one analyte value.
In an aspect of the third embodiment, the method further comprises evaluating the selected algorithm by applying an evaluation function prior to employing the selected algorithm to estimate the analyte value, wherein the evaluation function is selected from the group consisting of a data association function, a curvature formula, and a physiological boundary.
In an aspect of the third embodiment, the method further comprises analyzing a variation of the estimated analyte value based on a parameter selected from a statistical parameter, a clinical parameter, and a physiological parameter.
In an aspect of the third embodiment, the output further comprises a therapy recommendation to help the user obtain a target analyte value.
In a fourth embodiment, a method for matching a data pair using data from a continuous analyte sensor with data from a reference analyte source is provided, the method comprising receiving a data stream from the continuous analyte sensor, the data comprising at least one sensor data point; receiving reference data from a reference analyte monitor, the data comprising at least one reference data point; estimating at least one analyte value for a time period during which no data exists based on the data stream; and creating at least one matched data pair by matching the reference data to the analyte value.
In an aspect of the fourth embodiment, the step of receiving the data stream comprises receiving a data stream that has been algorithmically smoothed.
In an aspect of the fourth embodiment, the step of receiving reference data comprises downloading reference data via a cabled connection.
In an aspect of the fourth embodiment, the step of receiving reference data comprises downloading reference data via a wireless connection.
In an aspect of the fourth embodiment, the step of receiving reference data from a reference analyte monitor comprises receiving within a receiver an internal communication from a reference analyte monitor integral with the receiver.
In an aspect of the fourth embodiment, the algorithm is selected from the group consisting of polynomial regression, autoregressive algorithms, Fourier transform, Wavelet transform, neural network-based mapping, fuzzy logic based pattern matching, and Genetic-Algorithm matching.
In an aspect of the fourth embodiment, the method further comprises evaluating the selected algorithm by applying an evaluation function prior to employing the selected algorithm to estimate the analyte value, wherein the evaluation function is selected from the group consisting of a data association function, a curvature formula, and a physiological boundary.
In an aspect of the fourth embodiment, the method further comprises comparing the estimated analyte value with the corresponding measured analyte value to determine a time lag between the estimated analyte value and the corresponding measured analyte value.
In a fifth embodiment, a method for compensating for a time lag of continuous analyte sensor data by estimating an analyte value for a present time from which the continuous analyte sensor data is delayed is provided, the method comprising receiving a data stream from the continuous analyte sensor, wherein the data stream comprises a physiological time lag from the present time or a computational time lag from the present time; continuously estimating or periodically estimating analyte values for a present time period based on the data stream to compensate for the physiological time lag or the computational time lag in the analyte sensor data; and continuously providing or periodically providing an output to a user based on the estimated analyte values, such that the output of the estimated analyte values provides present time analyte values to the user.
In an aspect of the fifth embodiment, the analyte value estimation step further comprises selecting an algorithm from a plurality of algorithms based on analysis of the data stream prior to estimating the analyte values.
In an aspect of the fifth embodiment, the algorithm selection is conditional upon at least one value selected from the group consisting of analyte concentration, rate of change, acceleration, and an individual historical pattern of the data stream.
In an aspect of the fifth embodiment, the method further comprises evaluating the selected algorithm by applying a data association function, a curvature formula, or physiological boundaries prior to employing the selected algorithm to estimate analyte values.
In an aspect of the fifth embodiment, the method further comprises analyzing a variation of the estimated analyte values based on parameters selected from the group consisting of statistical parameters, clinical parameters, and physiological parameters.
In an aspect of the fifth embodiment, the step of analyzing a variation comprises determining a physiological variation from estimated analyte values.
In an aspect of the fifth embodiment, the step of analyzing a variation comprises determining a statistical variation from the estimated analyte values based on a statistical parameter.
In an aspect of the fifth embodiment, the method further comprises comparing the estimated analyte values with the measured analyte values to determine a deviation between the estimated analyte values and the measured analyte values.
In an aspect of the fifth embodiment, the step of analyzing a variation comprises analyzing a variation of the estimated analyte values based on the deviation determined by the step of comparing.
In an aspect of the fifth embodiment, the output displays estimated analyte values to the user.
In an aspect of the fifth embodiment, the output further comprises a therapy recommendation to help the user obtain a target analyte value.
In an aspect of the fifth embodiment, the output comprises an icon that has a shape representative of the analyzed variation of the estimated analyte value.
In a sixth embodiment, a method for estimating analyte values from a continuous analyte sensor is provided, the method comprising receiving a data stream from the continuous analyte sensor for a time period; and estimating one or more analyte values for a time period based on the data stream, wherein analyte estimation comprises performing an algorithm to estimate analyte values and applying physiological boundaries to the estimated analyte values.
In an aspect of the sixth embodiment, the analyte value estimation step further comprises selecting an algorithm from a plurality of algorithms based on analysis of the data stream prior to estimating the analyte values.
In an aspect of the sixth embodiment, the algorithm selection is conditional upon at least one of analyte concentration, rate of change, acceleration, and individual historical patterns of the data stream.
In an aspect of the sixth embodiment, the algorithm is selected from the group consisting of polynomial regression, autoregressive algorithms, Fourier transform, Wavelet transform, neural network-based mapping, fuzzy logic based pattern matching, and Genetic-Algorithm matching.
In an aspect of the sixth embodiment, the method further comprises evaluating the selected algorithm by applying a data association function, a curvature formula, or physiological boundaries prior to employing the selected algorithm to estimate analyte values.
In an aspect of the sixth embodiment, the method further comprises analyzing a variation of the estimated analyte values based on statistical, clinical, or physiological parameters.
In an aspect of the sixth embodiment, the time period of clinical risk is determined when an estimated analyte value falls outside of a normal analyte threshold.
In an aspect of the sixth embodiment, the output selectively provides estimated analytes value based on an event trigger.
In a seventh embodiment, a method for displaying analyte data from a continuous analyte sensor is provided, the method comprising receiving a data stream from the continuous analyte sensor for a time period; calibrating the data stream using a conversion function to determine at least one calibrated analyte value; analyzing a variation of at least one calibrated analyte value based on a parameter selected from the group consisting of a statistical parameter, a clinical parameter, and a physiological parameter; and providing an output based on the calibrated analyte value and the variation of the calibrated analyte value.
In an aspect of the seventh embodiment, the output comprises a numerical representation of a calibrated analyte value and a variation of the calibrated analyte value.
In an aspect of the seventh embodiment, the output comprises a numerical representation of a range of possible analyte values.
In an aspect of the seventh embodiment, the output further comprises an arrow representing a rate of change of the calibrated analyte values.
In an eighth embodiment, a system for estimating analyte data from a continuous analyte sensor is provided, the system comprising an input module operatively connected to the continuous analyte sensor that receives a data stream comprising a plurality of time spaced sensor data points from the analyte sensor; and a processor module comprising programming that estimates at least one analyte value for a time period based on the data stream and compares the estimated analyte value with a corresponding measured analyte value.
In an aspect of the eighth embodiment, the input module is adapted to receive a data stream that has been algorithmically smoothed.
In an aspect of the eighth embodiment, the input module is adapted to receive a raw data stream.
In an aspect of the eighth embodiment, the programming to estimate an analyte value further comprises programming to select an algorithm from a plurality of algorithms based on analysis of the data stream prior to estimating the analyte value.
In an aspect of the eighth embodiment, the processor module further comprises programming to select the algorithm conditional upon at least one parameter selected from the group consisting of an analyte concentration, a rate of change, acceleration of a rate of change, and an individual historical pattern of the data stream.
In an aspect of the eighth embodiment, the processor module runs the plurality of algorithms on the data stream and determines which of the plurality of algorithms best correlates with the data stream.
In an aspect of the eighth embodiment, the processor module comprises programming to apply a physiological boundary to the selected algorithm.
In an aspect of the eighth embodiment, the processor module further comprises programming to evaluate the selected algorithm by applying a data association function, a curvature formula, or physiological boundaries prior to employing the selected algorithm to estimate analyte values.
In an aspect of the eighth embodiment, the processor module further comprises programming to analyze a variation of the estimated analyte value based on a parameter selected from the group consisting of statistical parameters, clinical parameters, and physiological parameters.
In an aspect of the eighth embodiment, the programming to analyze a variation comprises determining a physiological variation from the estimated analyte value.
In an aspect of the eighth embodiment, the programming to analyze a variation comprises determining statistical variation from the estimated analyte value based on statistical parameters.
In an aspect of the eighth embodiment, the programming to compare the estimated analyte value with the measured analyte value further comprises determining a deviation between the estimated analyte value and the measured analyte value.
In an aspect of the eighth embodiment, the programming to analyze a variation comprising analyzing a variation of the estimated analyte values based on the deviation determined by the comparison step.
In an aspect of the eighth embodiment, the processor module further comprises programming to recognize a pattern by monitoring a physiological pattern over time.
In an aspect of the eighth embodiment, the programming to analyze a variation comprises analyzing the physiological pattern to determine a variation of the estimated analyte value.
In an aspect of the eighth embodiment, the programming to analyze a variation comprises determining the variation of the estimated analyte value based on a clinical risk of the estimated analyte value to the user.
In an aspect of the eighth embodiment, the system further comprises an output module comprising programming to output data based on the estimated analyte data.
In a ninth embodiment, a system for estimating analyte values from a continuous analyte sensor, the system comprising an input module operatively connected to the continuous analyte sensor that receives a data stream comprising a plurality of time spaced sensor data points from the analyte sensor; a processor module comprising programming that estimates at least one analyte value for a future time based on the data stream, and analyzes a variation of the estimated analyte value based on a parameter selected from the group consisting of a statistical parameter, a clinical parameter, and a physiological parameter; and an output module associated with the processor module and comprising programming to output analyte data based on at least one estimated analyte value and the variation of the estimated analyte value.
In an aspect of the ninth embodiment, the input module is adapted to receive a data stream that has been algorithmically smoothed.
In an aspect of the ninth embodiment, the input module is adapted to receive a raw data stream.
In an aspect of the ninth embodiment, the programming to estimate an analyte value further comprises programming to select an algorithm from a plurality of algorithms based on analysis of the data stream prior to estimating the analyte value.
In an aspect of the ninth embodiment, the programming to select an algorithm is conditional upon at least one parameter selected from the group consisting of an analyte concentration, a rate of change, an acceleration of a rate of change, and an individual historical pattern of the data stream.
In an aspect of the ninth embodiment, the programming to select an algorithm further comprises employing the plurality of algorithms on the data stream and determining which of the plurality of algorithms best correlates with the data stream.
In an aspect of the ninth embodiment, the algorithms are selected from the group consisting of polynomial regression, autoregressive algorithms, Fourier transform, Wavelet transform, neural network-based mapping, fuzzy logic based pattern matching, and Genetic-Algorithm matching.
In an aspect of the ninth embodiment, the processor module further comprises programming to apply a physiological boundary to the selected algorithm.
In an aspect of the ninth embodiment, the processor module further comprises programming to evaluate the selected algorithm by applying a data association function, a curvature formula, or physiological boundaries prior to employing the selected algorithm to estimate the analyte value.
In an aspect of the ninth embodiment, the programming to analyze a variation comprises determining a physiological variation from the estimated analyte value.
In an aspect of the ninth embodiment, the programming to analyze a variation comprises determining statistical variation from the estimated analyte value based on a statistical parameter.
In an aspect of the ninth embodiment, the processor module compares the estimated analyte value with the measured analyte value to determine a deviation between the estimated analyte value and the measured analyte value.
In an aspect of the ninth embodiment, the programming to analyze a variation comprises analyzing a variation of the estimated analyte value based on the deviation.
In an aspect of the ninth embodiment, the processor module further comprises programming to recognize a pattern by monitoring a physiological pattern over time.
In an aspect of the ninth embodiment, the programming to analyze a variation comprises analyzing the physiological pattern to determine a variation of the estimated analyte value.
In an aspect of the ninth embodiment, the programming to analyze a variation comprises determining the variation of the estimated analyte value based the clinical risk of the estimated analyte value to the user.
In an aspect of the ninth embodiment, the output displays estimated analyte value to the user.
In a tenth embodiment, a system for estimating analyte values from a continuous analyte sensor is provided, the system comprising an input module operatively connected to the continuous analyte sensor that receives a data stream comprising a plurality of time spaced sensor data points from the analyte sensor; and a processor module comprising programming that selects an algorithm from a plurality of algorithms based on an analysis of the data stream, that evaluates the algorithm based on a parameter selected from the group consisting of statistical parameters, physiological parameters, and clinical parameters, and that employs a selected algorithm based on the algorithm evaluation to estimate at least one analyte value.
In an eleventh embodiment, a system for matching data pairs from a continuous analyte sensor with data from a reference analyte source, the system comprising a sensor input module operatively connected to the continuous analyte sensor that receives a data stream comprising a plurality of time spaced sensor data points from the analyte sensor; a reference input module receiving reference data from a reference analyte monitor, including at least one reference data point; and a processor module comprising programming that estimates at least one analyte value for a time period during which no data exists based on the data stream and creates at least one matched data pair by matching reference analyte data to the estimated analyte value.
In a twelfth embodiment, a system for compensating for a time lag of continuous analyte sensor data by estimating an analyte value for a present time from which the continuous analyte sensor data is delayed is provided, the system comprising an input module operatively connected to the continuous analyte sensor that receives a data stream comprising a plurality of time spaced sensor data points from the analyte sensor; a processor module comprising programming that continuously estimates or periodically estimates analyte values for the present time period based on the data stream to compensate for the physiological or computational time lag in the analyte sensor data; and an output module associated with the processor module and comprising programming to continuously provide or periodically provide an output to the user based on the estimated analyte values, such that output of the estimated analyte values provides present time analyte values to the user.
In a thirteenth embodiment, a system for estimating analyte values from a continuous analyte sensor is provided, the system comprising an input module operatively connected to the continuous analyte sensor that receives a data stream comprising a plurality of time spaced sensor data points from the analyte sensor; and a processor module comprising programming that estimates at least one analyte value for a time period based on the data stream, wherein the analyte estimation comprises performing an algorithm to estimate an analyte value and applying a physiological boundary to the estimated analyte value.
In a fourteenth embodiment, a system for displaying analyte data from a continuous analyte sensor is provided, the system comprising an input module operatively connected to the continuous analyte sensor that receives a data stream comprising a plurality of time spaced sensor data points from the analyte sensor; a processor module comprising programming that calibrates the data stream using a conversion function to determine a calibrated analyte value and analyze a variation of the calibrated analyte value based on statistical, clinical, or physiological parameters; and an output module associated with the processor module and comprising programming to output data based on the calibrated analyte value and the variation of calibrated analyte value.
The following description and examples illustrate some exemplary embodiments of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain exemplary embodiment should not be deemed to limit the scope of the present invention.
In order to facilitate an understanding of the disclosed invention, a number of terms are defined below.
The term “analyte,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. In some embodiments, the analyte for measurement by the sensor heads, devices, and methods is analyte. However, other analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Becker muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose/gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β); lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky'"'"'s disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain embodiments. The analyte can be naturally present in the biological fluid, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternatively, the analyte can be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbituates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC), Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and 5-Hydroxyindoleacetic acid (FHIAA).
The term “continuous analyte sensor,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a device that continuously or continually measures a concentration of an analyte, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer. In one exemplary embodiment, the continuous analyte sensor is a glucose sensor such as described in U.S. Pat. No. 6,001,067, which is incorporated herein by reference in its entirety.
The term “continuous analyte sensing,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, the period in which monitoring of an analyte is continuously or continually performed, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer.
The terms “reference analyte monitor,” “reference analyte meter,” and “reference analyte sensor,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, a device that measures a concentration of an analyte and can be used as a reference for the continuous analyte sensor, for example a self-monitoring blood glucose meter (SMBG) can be used as a reference for a continuous glucose sensor for comparison, calibration, or the like.
The term “biological sample,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, sample of a host body, for example, blood, interstitial fluid, spinal fluid, saliva, urine, tears, sweat, or the like.
The term “host,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, mammals such as humans.
The term “processor,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a computer system, state machine, or the like that performs arithmetic and logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.
The term “ROM,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, read-only memory, which is a type of data storage device manufactured with fixed contents. ROM is broad enough to include EEPROM, for example, which is electrically erasable programmable read-only memory (ROM).
The term “RAM,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a data storage device for which the order of access to different locations does not affect the speed of access. RAM is broad enough to include SRAM, for example, which is static random access memory that retains data bits in its memory as long as power is being supplied.
The term “A/D Converter,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, hardware and/or software that converts analog electrical signals into corresponding digital signals.
The term “RF transceiver,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a radio frequency transmitter and/or receiver for transmitting and/or receiving signals.
The terms “raw data stream” and “data stream,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, an analog or digital signal directly related to the analyte concentration measured by the analyte sensor. In one example, the raw data stream is digital data in “counts” converted by an A/D converter from an analog signal (for example, voltage or amps) representative of an analyte concentration. The terms broadly encompass a plurality of time spaced data points from a substantially continuous analyte sensor, which comprises individual measurements taken at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes or longer.
The terms “calibrated data” and “calibrated data stream,” as used herein, are broad terms, and are used in their ordinary sense, including, but not limited to, data that has been transformed from its raw state to another state using a function, for example a conversion function, to provide a meaningful value to a user. The terms “smoothed data” and “filtered data,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, data that has been modified to make it smoother and more continuous and/or to remove or diminish outlying points, for example, by performing a moving average of the raw data stream.
The term “counts,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a unit of measurement of a digital signal. In one example, a raw data stream measured in counts is directly related to a voltage (for example, converted by an A/D converter), which is directly related to current from a working electrode.
The term “electronic circuitry,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, the components (for example, hardware and/or software) of a device configured to process data. In the case of an analyte sensor, the data includes biological information obtained by a sensor regarding the concentration of the analyte in a biological fluid. U.S. Pat. Nos. 4,757,022, 5,497,772 and 4,787,398, which are hereby incorporated by reference in their entirety, describe suitable electronic circuits that can be utilized with devices of certain embodiments.
The term “potentiostat,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an electrical system that controls the potential between the working and reference electrodes of a two-electrode cell or three-electrode cell at a preset value. The potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.
The term “electrical potential,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, the electrical potential difference between two points in a circuit, which is the cause of the flow of a current.
The terms “operably connected” and “operably linked,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, one or more components being linked to another component(s) in a manner that allows transmission of signals between the components. For example, one or more electrodes can be used to detect the amount of glucose in a sample and convert that information into a signal; the signal can then be transmitted to an electronic circuit. In this case, the electrode is “operably linked” to the electronic circuit. These terms are broad enough to include wired and wireless connectivity.
The term “algorithm,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, the computational processes (for example, programs) involved in transforming information from one state to another, for example using computer processing.
The term “estimation algorithm,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, the processing involved in estimating analyte values from measured analyte values for a time period during which no data exists (e.g., for a future time period or during data gaps). This term is broad enough to include one or a plurality of algorithms and/or computations. This term is also broad enough to include algorithms or computations based on mathematical, statistical, clinical, and/or physiological information.
The term “regression,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, finding a line in which a set of data has a minimal measurement (for example, deviation) from that line. Regression can be linear, non-linear, first order, second order, and so forth. One example of regression is least squares regression.
The terms “recursive filter” and “auto-regressive algorithm,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, an equation in which includes previous averages are part of the next filtered output. More particularly, the generation of a series of observations whereby the value of each observation is partly dependent on the values of those that have immediately preceded it. One example is a regression structure in which lagged response values assume the role of the independent variables.
The terms “velocity” and “rate of change,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, time rate of change; the amount of change divided by the time required for the change. In one embodiment, these terms refer to the rate of increase or decrease in an analyte for a certain time period.
The term “acceleration” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, the rate of change of velocity with respect to time. This term is broad enough to include deceleration.
The term “variation,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a divergence or amount of change from a point, line, or set of data. In one embodiment, estimated analyte values can have a variation including a range of values outside of the estimated analyte values that represent a range of possibilities based on known physiological patterns, for example.
The term “deviation,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a statistical measure representing the difference between different data sets. The term is broad enough to encompass the deviation represented as a correlation of data.
The terms “statistical parameters” and “statistical,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, information computed from the values of a sampling of data. For example, noise or variability in data can be statistically measured.
The term “statistical variation,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, divergence or change from a point, line, or set of data based on statistical information. The term “statistical information” is broad enough to include patterns or data analysis resulting from experiments, published or unpublished, for example.
The term “clinical risk,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an identified danger or potential risk to the health of a patient based on a measured or estimated analyte concentration, its rate of change, and/or its acceleration. In one exemplary embodiment, clinical risk is determined by a measured glucose concentration above or below a threshold (for example, 80-200 mg/dL) and/or its rate of change.
The term “clinically acceptable,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an analyte concentration, rate of change, and/or acceleration associated with that measured analyte that is considered to be safe for a patient. In one exemplary embodiment, clinical acceptability is determined by a measured glucose concentration within a threshold (for example, 80-200 mg/dL) and/or its rate of change.
The terms “physiological parameters” and “physiological boundaries,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, the parameters obtained from continuous studies of physiological data in humans and/or animals. For example, a maximal sustained rate of change of glucose in humans of about 4 to 5 mg/dL/min and a maximum acceleration of the rate of change of about 0.1 to 0.2 mg/dL/min2 are deemed physiologically feasible limits; values outside of these limits would be considered non-physiological. As another example, the rate of change of glucose is lowest at the maxima and minima of the daily glucose range, which are the areas of greatest risk in patient treatment, thus a physiologically feasible rate of change can be set at the maxima and minima based on continuous studies of glucose data. As a further example, it has been observed that the best solution for the shape of the curve at any point along glucose signal data stream over a certain time period (for example, about 20 to 30 minutes) is a straight line, which can be used to set physiological limits. These terms are broad enough to include physiological parameters for any analyte.
The terms “individual physiological patterns” and “individual historical patterns,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, patterns obtained by monitoring a physiological characteristic, such as glucose concentration, in a mammal over a time period. For example, continual or continuous monitoring of glucose concentration in humans can recognize a “normal” pattern of turnaround at the human'"'"'s lowest glucose levels.
The term “physiological variation,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, divergence or change from a point, line, or set of data based on known physiological parameters and/or patterns.
The terms “data association” and “data association function,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, a statistical analysis of data and particularly its correlation to, or deviation from, a particular line. A data association function is used to show data association. For example, a measured glucose data stream as described herein can be analyzed mathematically to determine its correlation to, or deviation from, an estimated data stream for a corresponding time period; this correlation or deviation is the data association. Examples of data association functions include, but are not limited to, linear regression, non-linear mapping/regression, rank (for example, non-parametric) correlation, least mean square fit, mean absolute deviation (MAD), and/or mean absolute relative difference (MARD).
The terms “clinical error grid,” “clinical error analysis” and “error grid analysis,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, an analysis method that assigns a specific level of clinical risk to an error between two time corresponding analyte measurements. Examples include Clarke Error Grid, Consensus Grid, mean absolute relative difference, rate grid, or other clinical cost functions.
The term “Clarke Error Grid,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an error grid analysis, which evaluates the clinical significance of the difference between a reference glucose value and a sensor generated glucose value, taking into account 1) the value of the reference glucose measurement, 2) the value of the sensor glucose measurement, 3) the relative difference between the two values, and 4) the clinical significance of this difference. See Clarke et al., “Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose,” Diabetes Care, Volume 10, Number 5, September-October 1987, which is incorporated by reference herein in its entirety.
The term “rate grid”, as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to an error grid analysis, which evaluates the clinical significance of the difference between a reference glucose value and a continuous sensor generated glucose value, taking into account both single-point and rate-of-change values. One example of a rate grid is described in Kovatchev, B. P.; Gonder-Frederick, L. A.; Cox, D. J.; Clarke, W. L. Evaluating the accuracy of continuous glucose-monitoring sensors: continuous glucose-error grid analysis illustrated by TheraSense Freestyle Navigator data. Diabetes Care 2004, 27, 1922-1928.
The term “curvature formula,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a mathematical formula that can be used to define a curvature of a line. Some examples of curvature formulas include Euler and Rodrigues'"'"' curvature formulas.
The term “time period,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an amount of time including a single point in time and a path (for example, range of time) that extends from a first point in time to a second point in time.
The term “measured analyte values,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an analyte value or set of analyte values for a time period for which analyte data has been measured by an analyte sensor. The term is broad enough to include data from the analyte sensor before or after data processing in the sensor and/or receiver (for example, data smoothing, calibration, or the like).
The term “estimated analyte values,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an analyte value or set of analyte values, which have been algorithmically extrapolated from measured analyte values. Typically, estimated analyte values are estimated for a time period during which no data exists. However, estimated analyte values can also be estimated during a time period for which measured data exists, but is to be replaced by algorithmically extrapolated data due to a time lag in the measured data, for example.
The term “alarm,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, audible, visual, or tactile signals that are triggered in response to detection of clinical risk to a patient. In one embodiment, hyperglycemic and hypoglycemic alarms are triggered when present or future clinical danger is assessed based on continuous analyte data.
The terms “target analyte values” and “analyte value goal,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, an analyte value or set of analyte values that are clinically acceptable. In one example, a target analyte value is visually or audibly presented to a patient in order to aid in guiding the patient in understanding how they should avoid a clinically risky analyte concentration.
The terms “therapy” and “therapy recommendations,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, the treatment of disease or disorder by any method. In one exemplary embodiment, a patient is prompted with therapy recommendations such as “inject insulin” or “consume carbohydrates” in order to avoid a clinically risky glucose concentration.
The terms “customize” and “customization,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, to make changes or specifications to a program so that it meets an individual'"'"'s needs.
The term “computer,” as used herein, is broad term and is used in its ordinary sense, including, but not limited to, machine that can be programmed to manipulate data.
The term “modem,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an electronic device for converting between serial data from a computer and an audio signal suitable for transmission over a telecommunications connection to another modem.
The term “insulin pen,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an insulin injection device generally the size of a pen that includes a needle and holds a vial of insulin. It can be used instead of syringes for giving insulin injections.
The term “insulin pump,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, a device that delivers a continuous supply of insulin into the body. The insulin flows from the pump through a plastic tube (called a catheter) that is connected to a needle inserted into the skin and taped in place, for example.
Certain embodiments provide a continuous analyte sensor that measures a concentration of analyte within a host and provides a data stream representative of the concentration of the analyte in the host, and a receiver that processes the data stream received from the analyte sensor for output as a meaningful value to a user or device. In some embodiments, the analyte sensor is integral with the receiver, while in other embodiments, the analyte sensor is operatively linked to the receiver, for example, via a wired link or a wireless link.
Data processing associated with various embodiments calculates estimated analyte values from measured analyte values that can be useful to 1) compensate for a time lag associated with the analyte concentration measured sensor as compared to a reference source, for example, 2) estimate approaching clinical risk and warn a patient or doctor in an effort to avoid the clinical risk, 3) ensure accurate calibration of sensor data with reference data by dynamically and intelligently matching reference data with corresponding sensor data, for example, 4) replace data during periods of high signal noise or inaccurate data, and/or 5) provide future estimated analyte values that encourage more timely proactive behavior by a patient. The systems and methods calculate estimated analyte values based on algorithms that dynamically and intelligently determine which estimative algorithm best fits the present data stream, for example, using first or second order regression, considering physiological boundaries, evaluating the estimative algorithm for data association, determining possible variations around the estimated analyte values due to statistical, clinical, or physiological considerations, and/or comparing the estimated analyte values with time corresponding measured analyte values.
Some embodiments further generate data output, which can be in the form of real-time output to a user on screen or other user interface, for example, on the receiver. Data output can include real-time measured analyte values, estimated analyte values, possible variations of estimated analyte values, targets or goals for analyte values, or the like. Additionally or alternatively, data output can be sent to a device external from the receiver, for example, a computer, modem, or medical device. In some embodiments, input from the user or from another device, such as insulin injections (time and amount), meal times, exercise, personalized therapy recommendations, or the like, can be input into the receiver and processed to provide more customized data analysis and/or data output.
Accordingly, the systems and methods calculate estimated analyte values in a timely, accurate, and reliable manner based on measured analyte values, which can be helpful for proactively caring for a patient'"'"'s condition. Estimated analyte values can provide information useful in warning a patient of upcoming clinical risk. Additionally, targets and/or goals set for a patient'"'"'s analyte values, based on present analyte conditions, and can be useful in proactively avoiding clinical risk. Furthermore, therapy recommendations can be provided that are useful in guiding a patient away from clinical risk.
The systems and methods of the preferred embodiments provide an analyte sensor that measures a concentration of analyte of interest or a substance indicative of the concentration or presence of the analyte. The analyte sensor uses any known method, including invasive, minimally invasive, and non-invasive sensing techniques, to provide an output signal indicative of the concentration of the analyte of interest. In some embodiments, the analyte sensor is a continuous device, for example a subcutaneous, transdermal, or intravascular device. In some embodiments, the device can take a plurality of intermittent measurements. The analyte sensor can use any method of analyte-measurement, including enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, radiometric, or the like. Generally, the analyte sensor can be any sensor capable of determining the level of any analyte in the body, for example glucose, oxygen, lactase, hormones, cholesterol, medicaments, viruses, or the like. It should be understood that the devices and methods described herein can be applied to any device capable of continually or continuously detecting a concentration of analyte and providing an output signal that represents the concentration of that analyte.
In one preferred embodiment, the analyte sensor is an implantable glucose sensor, such as described with reference to U.S. Pat. No. 6,001,067 and co-pending U.S. patent application Ser. No. 10/633,367 entitled, “SYSTEM AND METHODS FOR PROCESSING ANALYTE SENSOR DATA,” filed Aug. 1, 2003, which are incorporated herein by reference in their entirety. In another preferred embodiment, the analyte sensor is a transcutaneous glucose sensor, such as described with reference to U.S. Provisional Patent Application 60/587,787 and 60/614,683. In one alternative embodiment, the continuous glucose sensor comprises a transcutaneous sensor such as described in U.S. Pat. No. 6,565,509 to Say et al., for example. In another alternative embodiment, the continuous glucose sensor comprises a subcutaneous sensor such as described with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al. or U.S. Pat. No. 6,484,046 to Say et al., for example. In another alternative embodiment, the continuous glucose sensor comprises a refillable subcutaneous sensor such as described with reference to U.S. Pat. No. 6,512,939 to Colvin et al., for example. In another alternative embodiment, the continuous glucose sensor comprises an intravascular sensor such as described with reference to U.S. Pat. No. 6,477,395 to Schulman et al., for example. In another alternative embodiment, the continuous glucose sensor comprises an intravascular sensor such as described with reference to U.S. Pat. No. 6,424,847 to Mastrototaro et al. All of the above patents are incorporated by reference herein in their entirety.
Referring again to
The processor 16 is the central control unit that performs the processing, such as storing data, analyzing data streams, calibrating analyte sensor data, estimating analyte values, comparing estimated analyte values with time corresponding measured analyte values, analyzing a variation of estimated analyte values, downloading data, and controlling the user interface by providing analyte values, prompts, messages, warnings, alarms, or the like. The processor includes hardware and software that performs the processing described herein, for example read-only memory (ROM) provides permanent or semi-permanent storage of data, storing data such as sensor ID, receiver ID, and programming to process data streams (for example, programming for performing estimation and other algorithms described elsewhere herein) and random access memory (RAM) stores the system'"'"'s cache memory and is helpful in data processing.
An output module 18, which is integral with and/or operatively connected with the processor 16, includes programming for generating output based on the data stream received from the sensor 10 and its processing incurred in the processor 16. In some embodiments, output is generated via a user interface 20.
The user interface 20 comprises a keyboard 22, speaker 24, vibrator 26, backlight 28, liquid crystal display (LCD) screen 30, and one or more buttons 32. The components that comprise the user interface 20 include controls to allow interaction of the user with the receiver. The keyboard 22 can allow, for example, input of user information about himself/herself, such as mealtime, exercise, insulin administration, customized therapy recommendations, and reference analyte values. The speaker 24 can produce, for example, audible signals or alerts for conditions such as present and/or estimated hyper- and hypoglycemic conditions in a person with diabetes. The vibrator 26 can provide, for example, tactile signals or alerts for reasons such as described with reference to the speaker, above. The backlight 28 can be provided, for example, to aid the user in reading the LCD 30 in low light conditions. The LCD 30 can be provided, for example, to provide the user with visual data output, such as described in more detail below with reference to
In some embodiments, estimated analyte values, such as described, for example with reference to
In some embodiments, prompts or messages can be displayed on the user interface to convey information to the user, such as reference outlier values, requests for reference analyte values, therapy recommendations, deviation of the measured analyte values from the estimated analyte values, or the like. Additionally, prompts can be displayed to guide the user through calibration or trouble-shooting of the calibration.
Additionally, data output from the output module 18 can provide wired or wireless, one- or two-way communication between the receiver 12 and an external device 34. The external device 34 can be any device that wherein interfaces or communicates with the receiver 12. In some embodiments, the external device 34 is a computer, and the receiver 12 is able to download historical data for retrospective analysis by the physician, for example. In some embodiments, the external device 34 is a modem, and the receiver 12 is able to send alerts, warnings, emergency messages, or the like, via telecommunication lines to another party, such as a doctor or family member. In some embodiments, the external device 34 is an insulin pen, and the receiver 12 is able to communicate therapy recommendations, such as insulin amount and time to the insulin pen. In some embodiments, the external device 34 is an insulin pump, and the receiver 12 is able to communicate therapy recommendations, such as insulin amount and time to the insulin pump. The external device 34 can include other technology or medical devices, for example pacemakers, implanted analyte sensor patches, other infusion devices, telemetry devices, or the like.
The user interface 20 including keyboard 22, buttons 32, a microphone (not shown), and the external device 34 can be configured to allow input of data. Data input can be helpful in obtaining information about the patient (for example, meal time, exercise, or the like), receiving instructions from a physician (for example, customized therapy recommendations, targets, or the like), and downloading software updates, for example. Keyboard, buttons, touch-screen, and microphone are all examples of mechanisms by which a user can input data directly into the receiver. A server, personal computer, personal digital assistant, insulin pump, and insulin pen are examples of external devices that can provide useful information to the receiver. Other devices internal or external to the sensor that measure other aspects of a patient'"'"'s body (for example, temperature sensor, accelerometer, heart rate monitor, oxygen monitor, or the like) can be used to provide input helpful in data processing. In one embodiment, the user interface can prompt the patient to select an activity most closely related to their present activity, which can be helpful in linking to an individual'"'"'s physiological patterns, or other data processing. In another embodiment, a temperature sensor and/or heart rate monitor can provide information helpful in linking activity, metabolism, and glucose excursions of an individual. While a few examples of data input have been provided here, a variety of information can be input, which can be helpful in data processing as will be understood by one skilled in the art.
Reference is now made to
At a block 40, the calibration process 38 receives continuous sensor data (for example, a data stream), including one or more time-spaced sensor data points, hereinafter referred to as “data stream,” “sensor data,” or “sensor analyte data.” The calibration process 38 receives the sensor data from the continuous analyte sensor 10, which can be in communication (for example, wired or wireless) with the receiver 12. Some or all of the sensor data point(s) can be smoothed or replaced by estimated signal values such as described with reference to co-pending U.S. patent application Ser. No. 10/632,537 entitled, “SYSTEMS AND METHODS FOR REPLACING SIGNAL ARTIFACTS IN A GLUCOSE SENSOR DATA STREAM,” filed Aug. 22, 2003, which is incorporated herein by reference in its entirety. During the initialization of the sensor, for example, prior to initial calibration, the receiver 12 receives and stores the sensor data, however it may not display any data to the user until initial calibration and optionally stabilization of the sensor 10 has been determined.
At a block 42, the calibration process 38, receives analyte values from a reference analyte monitor, including one or more reference glucose data points, hereinafter referred as “reference data” or “reference analyte data.” In an example wherein the analyte sensor is a continuous glucose sensor, the reference analyte monitor can be a self-monitoring blood glucose (SMBG) meter. However, in alternative embodiments, the reference analyte monitor can be any source capable of providing a corresponding analyte value. Additionally, in some alternative embodiments, wherein the continuous analyte sensor is self-calibrating, a calibrating reference value can be provided by a source internal to the continuous sensor, for example oxygen, folic acid, or other subcutaneous fluid constants.
In some embodiments, the calibration process 38 monitors the continuous analyte sensor data stream to determine a preferred time for capturing reference analyte concentration values for calibration of the continuous sensor data stream. In an example wherein the analyte sensor is a continuous glucose sensor, when data (for example, observed from the data stream) changes too rapidly, the reference glucose value may not be sufficiently reliable for calibration due to unstable glucose changes in the host. In contrast, when sensor glucose data are relatively stable (for example, relatively low rate of change), a reference glucose value can be taken for a reliable calibration. In one embodiment, the calibration process 38 can prompt the user via the user interface to “calibrate now” when the analyte sensor is considered stable.
In some embodiments, the calibration process 38 can prompt the user via the user interface 20 to obtain a reference analyte value for calibration at intervals, for example when analyte concentrations are at high and/or low values. In some additional embodiments, the user interface 20 can prompt the user to obtain a reference analyte value for calibration based upon certain events, such as meals, exercise, large excursions in analyte levels, faulty or interrupted data readings, or the like. In some embodiments, the estimative algorithms can provide information useful in determining when to request a reference analyte value. For example, when estimated analyte values indicate approaching clinical risk, the user interface 20 can prompt the user to obtain a reference analyte value.
In some embodiments, certain acceptability parameters can be set for reference values. In an example wherein the analyte sensor is a glucose sensor, the receiver may only accept reference glucose data between about 40 and about 400 mg/dL.
In some embodiments, the calibration process 38 performs outlier detection on the reference data and time corresponding sensor data. Outlier detection compares a reference analyte value with a time corresponding measured analyte value to ensure a predetermined statistically, physiologically, or clinically acceptable correlation between the corresponding data exists. In an example wherein the analyte sensor is a glucose sensor, the reference glucose data is matched with substantially time corresponding calibrated sensor data and the matched data are plotted on a Clarke Error Grid to determine whether the reference analyte value is an outlier based on clinical acceptability, such as described in more detail with reference U.S. patent application Ser. No. 10/633,367 entitled, “SYSTEM AND METHODS FOR PROCESSING ANALYTE SENSOR DATA,” filed Aug. 1, 2003, which is incorporated herein by reference in its entirety. In some embodiments, outlier detection compares a reference analyte value with a corresponding estimated analyte value, such as described in more detail with reference to
At a block 44, the calibration process 38 matches reference analyte data (for example, one or more reference glucose data points) with substantially time corresponding sensor analyte data (for example, one or more sensor glucose data points) to provide one or more matched data pairs. In one embodiment, one reference data point is matched to one time corresponding sensor data point to form a matched data pair. In another embodiment, a plurality of reference data points are averaged (for example, equally or non-equally weighted average, mean-value, median, or the like) and matched to one time corresponding sensor data point to form a matched data pair. In another embodiment, one reference data point is matched to a plurality of time corresponding sensor data points averaged to form a matched data pair. In yet another embodiment, a plurality of reference data points are averaged and matched to a plurality of time corresponding sensor data points averaged to form a matched data pair.
In one embodiment, a time corresponding sensor data comprises one or more sensor data points that occur, for example, 15±5 min after the reference glucose data timestamp (for example, the time that the reference glucose data is obtained). In this embodiment, the 15 minute time delay has been chosen to account for an approximately 10 minute delay introduced by the filter used in data smoothing and an approximately 5 minute membrane-related time lag (for example, the time necessary for the glucose