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Control-to-range failsafes

  • US 10,332,632 B2
  • Filed: 06/01/2016
  • Issued: 06/25/2019
  • Est. Priority Date: 06/01/2016
  • Status: Active Grant
First Claim
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1. A method of determining a basal rate adjustment of insulin in a continuous glucose monitoring system of a person with diabetes, the method comprising:

  • receiving, by at least one computing device, a signal representative of at least one glucose measurement;

    detecting, by the at least one computing device, a glucose state of the person based on the signal, the detected glucose state including a glucose level of the person and a rate of change of the glucose level;

    calculating, by the at least one computing device, an adjustment to a basal rate of a therapy delivery device based on a control-to-range algorithm and at least one failsafe constraint to account for changes in the insulin sensitivity of the person with diabetes or inaccurate glucose measurement, wherein the therapy delivery device has a nominal basal rate representing an unadjusted basal rate set for the person with diabetes;

    wherein the failsafe constraint is calculated in accordance with a method selected from the group consisting of;

    (a) calculating bolus recommendations with a bolus calculator, the computing device comprising the bolus calculator, andtreating increases in the basal rate as a bolus and inputting the bolus into the bolus calculator if the increase is greater than a threshold representing a predetermined multiple of the nominal basal rate;

    (b) determining if the basal rate is at or below a threshold value, andlimiting the control-to-range algorithm to increasing the basal rate to a limiting nominal basal rate for a specified period of time if the basal rate is at or below the threshold value;

    (c) limiting the amount that the control-to-range algorithm may increase a basal rate multiplier during each evaluation period to a maximum basal multiplier delta;

    (d) determining the sum of basal rate increases over a defined time span,determining if the sum of basal rate increases is greater than the insulin equivalent of a predetermined allocation of rescue carbohydrates, andlimiting the basal rate increase if the sum of basal rate increases is greater than the insulin equivalent;

    (e) determining if the basal rate remains above 1.1×

    the nominal basal rate for a predetermined period of time,alerting the person with diabetes to test their blood sugar and input the tested blood sugar into the continuous glucose monitoring system as an input blood sugar measurement, andaccessing agreement between the input blood sugar measurement and the detected glucose level of the person with diabetes within a predetermined metric of quality, wherein if the at least one computing device determines the input blood sugar measurement and the detected glucose level of the person with diabetes are not in agreement within the predetermined metric of quality, the control-to-range algorithm is turned off or the aggressiveness is reduced until the sensor in the continuous glucose monitoring system is replaced or the sensor is recalibrated and confirmed to be accurate; and

    (f) combinations thereof.

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