Insulin delivery system and methods with risk-based set points

Patent metadata

Field	Value
Publication number	US-12383166-B2
Application number	US-201715601282-A
Country	US
Kind code	B2
Filing date	May 22, 2017
Priority date	May 23, 2016
Publication date	Aug 12, 2025
Grant date	Aug 12, 2025

Abstract

A method may include obtaining blood glucose level readings over a diurnal period for each of a plurality of days and determining an estimated variability of the blood glucose levels over the diurnal period for the plurality of days. The method may also include modifying, based on the estimated variability of the blood glucose level, a target blood glucose level to a modified target blood glucose level, and delivering insulin, using an insulin pump, during the diurnal period based on the modified target blood glucose level.

First claim

What is claimed is:

1. A method comprising:
obtaining glucose value readings over a period for each of a plurality of days;
analyzing variability of the glucose values over the period for the plurality of days to determine a measurement of the variability of the glucose values over the period for the plurality of days, wherein determining the measurement of the variability comprises:
determining a measurement of dispersion of the glucose value readings;
determining a measurement of central tendency of the glucose value readings; and
subtracting a multiple of the measurement of dispersion from the measurement of central tendency to determine the measurement of variability of the glucose values;
comparing the measurement of the variability of the glucose values over the period for the plurality of days to a first threshold glucose value and a second threshold glucose value, wherein the first threshold glucose value is lower than the second threshold glucose value;
determining that the measurement of variability either falls below the first threshold glucose value or falls above the second threshold glucose value,
responsive to determining that the measurement of the variability of the glucose values over the period for the plurality of days falls below the first threshold glucose value, increasing a target glucose value to an increased modified target glucose value;
responsive to determining that a measurement of the variability of the glucose values over the period for the plurality of days falls above the second threshold glucose value, decreasing the target glucose value to a decreased modified target glucose value; and
delivering insulin, using an insulin pump, based on one of the increased or decreased modified target glucose values.

2. The method of claim 1 , wherein increasing a target glucose value comprises incrementally increasing the target glucose value to the increased modified target glucose value, with the provision that the increased modified target glucose value is capped at a maximum glucose value.

3. The method of claim 2 , wherein the first threshold glucose value is at least partially determined by a fear of hypoglycemia index (FHI) set by a user.

4. The method of claim 2 , wherein the increase between the increased modified target glucose value and the target glucose value is determined based at least partially on the determined measurement of central tendency and the determined measurement of dispersion of the glucose value readings for each of the plurality of days.

5. The method of claim 1 , wherein the increased modified target glucose value is capped at a maximum target glucose value.

6. The method of claim 1 , wherein decreasing the target glucose value comprises incrementally decreasing the target glucose value to the decreased modified target glucose value, with the provision that the decreased modified target glucose value is limited by a minimum target glucose value.

7. The method of claim 6 , wherein the second threshold glucose value is at least partially determined by a fear of hypoglycemia index (FHI) set by a user.

8. The method of claim 6 , wherein the decrease between the decreased modified target glucose value and the target glucose value is determined based at least partially on a determined measurement of central tendency and a determined measurement of dispersion of glucose values.

9. The method of claim 8 , wherein the target glucose value is decreased by no more than 2 mg/dL per day.

10. The method of claim 9 , further comprising delivering insulin during an adjacent period in the same direction based at least partially on one of the increased or decreased modified target glucose values and to smooth changes in target glucose values between adjacent periods.

11. The method of claim 1 , wherein delivering insulin based on the increased or decreased modified target glucose value includes:
generating a first plurality of insulin delivery profiles, each of the first plurality of insulin delivery profiles including a first series of insulin delivery actions spanning a first time interval extending over the period and subsequent periods;
projecting a first plurality of future blood glucose values for each insulin delivery profile of the first plurality of insulin delivery profiles for a plurality of times spanning the first time interval, each projected future blood glucose values being projected using at least one up-to-date glucose value for a person with diabetes (PWD);
selecting a first profile of the first plurality of insulin delivery profiles based at least in part upon a comparison between the first plurality of future blood glucose values for each insulin delivery profile and a plurality of increased or decreased modified target glucose values for each period overlapping with the first time interval; and
delivering a first dose of insulin using the insulin pump for a second time interval after a previous dose of insulin, the first dose of insulin corresponding to a first action in the first series of insulin delivery actions of the first profile, the second time interval being equal to or shorter than the period.

12. The method of claim 1 , wherein analyzing the variability in the glucose values over the period for the plurality of days includes weighting the glucose values from more recent days of the plurality of days more heavily than the glucose values from older days of the plurality of days.

13. The method of claim 1 , wherein analyzing variability in the glucose values over the period for the plurality of days includes excluding from the plurality of days glucose values from days older than a cutoff date.

14. A system comprising:
a glucose sensor configured to generate glucose value readings;
an insulin pump configured to deliver insulin based on a message; and
a control device comprising:
at least one processor; and
at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the control device to:
obtain glucose value readings over a period for each of a plurality of days;
analyze variability in the glucose values over the period for the plurality of days to determine a measurement of the variability of the glucose values over the period for the plurality of days, wherein determining the measurement of the variability comprises:
determining a measurement of dispersion of the glucose value readings;
determining a measurement of central tendency of the glucose value readings; and
subtracting a multiple of the measurement of dispersion from the measurement of central tendency to determine the measurement of variability of the glucose values;
compare the measurement of the variability of the glucose values over the period for the plurality of days to a first threshold glucose value and a second threshold glucose value, wherein the first threshold glucose value is lower than the second threshold glucose value;
determine that the measurement of variability either falls below the first threshold glucose value or falls above the second threshold glucose value,
responsive to determining that the measurement of the variability of the glucose values over the period for the plurality of days falls below the first threshold glucose value, increase a target glucose value to an increased modified target glucose value;
responsive to determining that a measurement of the variability of the glucose values over the period for the plurality of days falls above the second threshold glucose value, decrease the target glucose value to a decreased modified target glucose value;
generate a messag

Assignees

• Insulet Corp

Inventors

• Desborough Lane
• Mazlish Bryan

Classifications

• A61M2230/201

  Glucose concentration · CPC title

• A61M2205/8206

  battery-operated · CPC title

• A61M2205/52

  with memories providing a history of measured variating parameters of apparatus or patient · CPC title

• A61M2205/502

  User interfaces, e.g. screens or keyboards · CPC title

• A61M2005/14296

  Pharmacokinetic models · CPC title