ALERT SYSTEM FOR HYPO AND HYPERGLYCEMIA PREVENTION BASED ON CLINICAL RISK
A device for generating alerts for Hypo and Hyperglycemia Prevention from Continuous Glucose Monitoring (CGM) determines a dynamic risk based on both information of glucose level and a trend obtainable from a CGM signals. The device includes a display whose color depends on the DR (for example, red for high DR, green for low risk). When DR exceeds a certain threshold, alerts are generated to suggest the patient to pay attention to the current glucose reading and to its trend, both of which are shown on the display in numbers and symbols (e.g. an arrow with different slope or color).
1 . A system for communicating glycemic risk to a patient, comprising:
a continuous glucose monitoring device configured to generate a series of data points indicative of a glucose level of the patient;
one or more processors configured to, on an iterative basis:
calculate a rate of change of the glucose level based on the series of data points;
determine a rate-of-change arrow angle based on the rate of change of the glucose level; and
calculate a dynamic risk score using one or more glucose levels of the patient during a first period of time and the rate of change of the glucose level during the first period of time; and
a display device configured to display information indicative of the dynamic risk score and an arrow angled from horizontal by the rate-of-change arrow angle.
2 . The system of claim 1 , wherein calculating the dynamic risk score comprises performing a nonlinear transformation that converts a current glucose level of the one or more glucose levels and the rate of change of the glucose level.
3 . The system of claim 1 , wherein the one or more processors are further configured to generate a perceptible alarm when the dynamic risk score exceeds a predetermined threshold, the perceptible alarm comprising an alarm selected from the group consisting of a blinking display, a brightly colored display, a vibratory alarm, an audible alarm, and combinations thereof.
4 . The system of claim 1 , wherein the one or more processors are further configured to cause the display device to display a color selected from a color scale comprising a plurality of colors, each color corresponding to a respective glycemic risk level as determined by the dynamic risk score.
5 . The system of claim 1 , wherein the one or more processors are further configured to generate a smoothed glucose value that is indicative of the series of data points.
6 . The system of claim 1 , wherein the display device is further configured to display a trend box that indicates a continuous glucose monitoring data trend.
7 . The system of claim 6 , wherein a color is displayed with or on the trend box.
8 . The system of claim 1 , wherein the arrow is a trend arrow indicative of a continuous glucose monitoring data trend.
9 . The system of claim 8 , wherein a color of the trend arrow changes based on the calculated dynamic risk score.
10 . The system of claim 1 , wherein the one or more processors are further configured to:
evaluate the rate of change of the glucose level using a regularized deconvolution algorithm based on the series of data points and a signal to noise ratio associated with the series of data points;
generate a smoothed glucose level based on the series of data points; and
wherein the dynamic risk score is based upon the smoothed glucose level and the evaluated rate of change of the glucose level.
11 . The system of claim 10 , wherein calculating the dynamic risk score comprises performing a nonlinear transformation that converts a current glucose level of the one or more glucose levels and the rate of change of the glucose level.
12 . The system of claim 1 , wherein the one or more processors are further configured to:
determine a signal to noise ratio (SNR) associated with the series of data points;
responsive to a determination that the SNR is at a first SNR level, evaluate the rate of change of the glucose level using a first algorithm;
responsive to a determination that the SNR is at a second SNR level, and wherein the first SNR level is lower than the second SNR level, evaluate the rate of change of the glucose level using a second algorithm; and
generate a smoothed glucose level based on the series of data points,
wherein the dynamic risk score is based upon the smoothed glucose level and the calculated rate of change of the glucose level.
13 . The system of claim 12 , wherein the first algorithm is based on a differential change in glucose level over time (dg/dt) based on the series of data points.
14 . The system of claim 12 , wherein the first algorithm comprises a regularized deconvolution algorithm.
15 . The system of claim 12 , wherein the second algorithm comprises evaluating a differential change in glucose over time (dg/dt).
16 . The system of claim 15 , wherein the second algorithm comprises evaluating the differential change as first order finite differences.
17 . The system of claim 12 , wherein calculating the dynamic risk score comprises performing a nonlinear transformation that converts a current glucose level of the one or more glucose levels and the rate of change of the glucose level.
18 . A method for communicating glycemic risk to a patient, comprising:
generating, by a continuous glucose monitoring device, a series of data points indicative of a glucose level in the patient;
iteratively calculating a rate of change of the glucose level based on the series of data points;
iteratively calculating an angle that is a function of the rate of change of the glucose level;
iteratively determining a dynamic risk score, the dynamic risk score being calculated using one or more sets of the glucose level of the patient and the rate of change of the glucose level for at least a first period of time; and
displaying, on a display device, information indicative of the dynamic risk score and an arrow that is angled from horizontal by the calculated angle.