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Published by Amy Tenderich

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Published by: Amy Tenderich on Apr 30, 2010
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FLUCTUATING BLOOD GLUCOSE NOTIFICATION THRESHOLDSPHILIP M. SHER Even capable and motivated people with Type 1 diabetes are not able to keep their bloodglucose in their target range all of the time. Continuous glucose monitoring helps, but itis imperfect - not only in terms of accuracy and reliability, but also in the way existingCGM systems interact with the user. This submission is the subject United States Patent7670288, which was granted just last month (attached). The key concept it describes willto be useful as part of any system that involves continuous glucose monitoring, whether that is a stand-alone CGM or part of a closed-loop system that incorporates CGM, insulindelivery, and control software.Traditional systems that involve CGM produce alerts, alarms, and other types of notifications based on what blood glucose is doing – it’s too high, or it’s too low, or it’srising or falling too fast. These systems have thresholds for high and low blood glucoseconcentration, which are static thresholds (high is >180 mg/dL and low is <80 mg/dL, for example). They also have thresholds for rapid rates of change of blood glucoseconcentration (rising or falling at >2 mg/dL/min, for example). When these traditionalthresholds are crossed, a notification is generated. Traditional thresholds work well for detecting and alerting the CGM user to highs and lows or impending highs and lows.However, they are less helpful for managing a quick and safe return to the target rangefrom high and low states, and for managing situations that begin with a target bloodglucose, but which can be expected to entail a transient high or low.The key concept of this submission is a new kind of threshold, termed fluctuating bloodglucose notification thresholds, which address the deficiencies of traditional thresholds.Unlike traditional thresholds, the new thresholds are for blood glucose concentration, but
they are not static – that is, they may fluctuate (rise and/or fall) over time, just as bloodglucose itself may fluctuate (rise and/or fall) over time. The user predicts, or software predicts and the user approves, the way that blood glucose will evolve over the next fewhours based on the user’s expectations or plans. Then, upper and lower blood glucosethresholds are generated that bracket the fluctuating blood glucose prediction, and then anotification is generated if blood glucose evolves in a way that deviates substantiallyfrom the blood glucose prediction – that is, if blood glucose crosses the fluctuating upper or lower threshold.The new, fluctuating thresholds may be used all of the time or only part of the time,optionally in combination with traditional thresholds. The fluctuating thresholds mayeven form the basis of an interactive game. Establishing the fluctuating thresholds can beas easy for the user as designating two predicted points on a graph of blood glucose.The new, fluctuating thresholds offer several advantages:
Once fluctuating thresholds are established, the user needs to think and look at theCGM display less than with traditional thresholds.
Fluctuating thresholds enable a fully active notification system in any situation withoutexcessive alarms.
Fluctuating thresholds provide earlier warning if blood glucose does not evolve asexpected or planned.
Fluctuating thresholds provide feedback on the user’s prediction; this facilitateslearning.
With fluctuating thresholds, the focus on prediction is psychologically superior to thefocus on perfection that attends traditional thresholds.United States Patent 7670288 provides more information concerning context and the problem addressed (columns 1-4) and advantages and details of use (columns 16-23).Fourteen examples (columns 23-29) with accompanying figures (sheets preceding pageswith columns) are illustrative. In the patent, the term “threshold profile” or TP is used todescribe the paired fluctuating upper or lower blood glucose thresholds.The graph below illustrates actual blood glucose that is rising up until 10:30PM, at whichtime the user establishes fluctuating upper or lower blood glucose thresholds so thatnotification will occur if blood glucose does not reverse its upward trend and return tonormal in the timeframe expected.

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