SHER Even capable and motivated people with Type 1 diabetes are not able to keep their blood glucose in their target range all of the time. Continuous glucose monitoring helps, but it is imperfect - not only in terms of accuracy and reliability, but also in the way existing CGM systems interact with the user. This submission is the subject United States Patent 7670288, which was granted just last month (attached). The key concept it describes will to 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, insulin delivery, 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’s rising or falling too fast. These systems have thresholds for high and low blood glucose concentration, 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 glucose concentration (rising or falling at >2 mg/dL/min, for example). When these traditional thresholds 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 range from high and low states, and for managing situations that begin with a target blood glucose, 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 blood glucose 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 blood glucose 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 few hours based on the user’s expectations or plans. Then, upper and lower blood glucose thresholds are generated that bracket the fluctuating blood glucose prediction, and then a notification is generated if blood glucose evolves in a way that deviates substantially from 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 may even form the basis of an interactive game. Establishing the fluctuating thresholds can be as 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 the CGM display less than with traditional thresholds. • Fluctuating thresholds enable a fully active notification system in any situation without excessive alarms. • Fluctuating thresholds provide earlier warning if blood glucose does not evolve as expected or planned. • Fluctuating thresholds provide feedback on the user’s prediction; this facilitates learning. • With fluctuating thresholds, the focus on prediction is psychologically superior to the focus 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 pages with columns) are illustrative. In the patent, the term “threshold profile” or TP is used to describe the paired fluctuating upper or lower blood glucose thresholds. The graph below illustrates actual blood glucose that is rising up until 10:30PM, at which time the user establishes fluctuating upper or lower blood glucose thresholds so that notification will occur if blood glucose does not reverse its upward trend and return to normal in the timeframe expected.

Figure 1A
400 350 300 blood glucose (mg/dL) 250 200 BGC before TP activation 150 100 50 0 0:30 2:30 3:00 21:00 21:30 22:00 22:30 23:00 23:30 3:30 0:00 1:00 1:30 2:00 4:00 4:30 TP upper threshold TP lower threshold

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