Granted Patent B2

US 12,646,601 · App. 18/137,179 · Granted Jun 2, 2026

Inventor: Rangarajan Narayanaswami (Weston, MA)

Assignee: INSULET CORPORATION

G16H20/10A61B5/14532A61B5/14546A61M5/1723A61M5/14248A61M2202/0486A61M2205/3303A61M2205/502A61M2205/52A61M2230/201

Abstract

Claims (90)

1 . A drug delivery system, comprising:

a processor operable to execute programming instructions;

a user interface including a touchscreen display and user input circuitry;

a memory operable to store the programming instructions; and

a communication circuitry coupled to the processor and operable to receive and transmit communication signals, wherein the processor is operable to:

receive an indication that a user is starting a ketogenic diet;

retrieve a baseline total daily insulin value;

calculate a keto total daily insulin value using the retrieved baseline total daily insulin value; and

utilize the keto total daily insulin value in the calculation of a keto basal dosage of insulin or a keto bolus dosage of insulin.

2 . The drug delivery system of claim 1 , further comprising:

a glucose sensor operable to transmit glucose measurement values during a period of time;

a ketone sensor operable to transmit ketone levels, wherein the communication circuitry is operable to receive transmissions of the glucose measurement values and the ketone values; and

the processor is operable to:

receive a glucose measurement value during a post prandial portion of the period of time and during a nighttime portion of the period of time;

receive a ketone level during the post prandial portion of the period of time;

calculate a new total daily insulin value based on the received glucose measurement value and the received ketone level; and

adapt the keto basal dosage and the keto bolus dosage based on the new total daily insulin.

3 . The drug delivery system of claim 1 , wherein the processor is further operable to:

receive a glucose measurement value during a post prandial portion of the period of time and during a nighttime portion of the period of time;

receive a ketone level during the post prandial portion of the period of time;

calculate a new total daily insulin value based on the received glucose measurement value and the received ketone level; and

adapt the keto basal dosage and the keto bolus dosage based on the new total daily insulin.

4 . The drug delivery system of claim 1 , wherein the processor is further operable to:

determine, based on an input received from a graphical user interface presenting on the touchscreen display, whether the user is starting a ketogenic diet; and

in response to the determination that the user is starting the ketogenic diet, determine a time period over which the user is expected to continue the ketogenic diet.

5 . The drug delivery system of claim 4 , wherein the processor is further operable to:

in response to the determination that the user is participating in the diet cycle, generating a prompt in the graphical user interface presented on the touchscreen display, whether the ketogenic diet is on fixed days of the week; and

in response to an indication that the ketogenic diet is on fixed days of the week, present an interactive calendar with days of the week for selection by a user.

6 . The drug delivery system of claim 1 , wherein the processor, when calculating the keto total daily insulin value using the retrieved baseline total daily insulin value, is further operable to:

multiply the retrieved baseline total daily insulin value by a keto day factor, wherein the keto day factor is less than 1.

7 . The drug delivery system of claim 1 , wherein the processor is further operable to:

receive an indication that a user is starting a non-ketogenic diet;

retrieve the new total daily insulin value, which is a keto day total daily insulin value;

calculate a non-keto total daily insulin value using the keto day total daily insulin value; and

utilize the non-keto total daily insulin value in the calculation of a non-keto basal dosage of insulin or a non-keto bolus dosage of insulin.

8 . The drug delivery system of claim 7 , wherein the processor, when calculating the non-keto total daily insulin value using the keto day total daily insulin value, is further operable to:

multiply the keto day total daily insulin value by a non-keto day factor, wherein the non-keto day factor is greater than 1.

9 . A drug delivery system, comprising:

a processor operable to execute programming instructions;

a user interface including a display and user input circuitry;

a memory operable to store the programming instructions; and

communication circuitry coupled to the processor and is operable to receive and transmit communication signals, wherein the processor is operable to:

receive ketone levels from a ketone sensor;

generate a prompt on the user interface inquiring whether a user's diet for a time period is a keto diet or a non-keto diet; and

based on the received ketone levels of the user, generate an indication of whether the user is adhering to a keto diet.

10 . The drug delivery system of claim 9 , wherein the processor is further operable to:

in response to a response to the prompt indicating the user's diet for the time period is a keto diet, determine whether a user's post prandial ketone levels received from a ketone sensor are greater than a first ketone value and less than a second ketone value; and

in response to the user's post ketone levels being within the first ketone value and the second ketone value, generate an adherence indication.

11 . The drug delivery system of claim 9 , wherein the processor is further operable to:

in response to a response to the prompt indicating the user's diet for the time period is not a keto diet, determine whether a user's post prandial ketone levels received from a ketone sensor are less than the first ketone value; and

in response to the user's post ketone levels being less than the first ketone value, generate an adherence indication.

12 . The drug delivery system of claim 11 , wherein the processor is further operable to:

in response to the user's post prandial ketone levels being greater than the first ketone value, send a notice to a user device with query confirming the time period is a keto time period.

13 . The drug delivery system of claim 9 , wherein the processor is further operable to:

in response to the user's post prandial ketone levels being outside a range of the first ketone value and the second ketone value, send a notice to a user device with query confirming today is a keto time period.

14 . The drug delivery system of claim 9 , wherein:

the first ketone value is approximately 0.5 mmol/L and the second ketone value is approximately 5 mmol/L.

15 . The drug delivery system of claim 9 , wherein the processor is further operable to:

receive a glucose value from a glucose sensor;

determine whether the received ketone levels are greater than a first ketone value;

in response to the received ketone levels being greater than the first ketone value, determine whether the received glucose value exceeds a predetermined glucose value; and

in response to the received glucose value exceeding the predetermined glucose value, increase a delivery of insulin and generate a prompt on the touchscreen display for the user to increase consumption of liquids, or

in response to the received glucose value being less than the predetermined glucose value, generate a prompt on the touchscreen display for the user to increase consumption of liquids and to ingest carbohydrates.

16 . A controller of a drug delivery system, comprising:

a processor operable to execute programming instructions;

a memory operable to store the programming instructions; and

communication circuitry coupled to the processor and be operable to receive and transmit communication signals, wherein the processor, when executing the programming instructions, is operable to:

obtain ketone levels of a user;

evaluate the obtained ketone levels with reference to a plurality of ketone thresholds;

based on the result of the evaluation, selecting a further action to be performed, wherein the further action is at least one of generating a notification to seek medical attention, generating a notification to ingest carbohydrates, generating a notification that the processor will increase drug delivery, or a combination thereof.

17 . The controller of the drug delivery system of claim 16 , wherein:

the plurality of ketone thresholds include a first ketone threshold, a second ketone threshold, a third ketone threshold and an extreme ketone threshold, and

the processor, when evaluating the obtained ketone levels with reference to the plurality of ketone thresholds, is further operable to:

compare a latest ketone value of the obtained ketone levels to a second ketone threshold of the plurality of ketone thresholds;

in response to the latest ketone value being greater than the first ketone threshold, compare the latest ketone value to a third ketone threshold;

in response to the latest ketone value being greater than the third ketone threshold, compare the latest ketone value to an extreme ketone threshold; and

in response to the latest ketone value being greater than the extreme ketone threshold, selecting generating the notification the user is to seek medical attention as the selected further action.

18 . The controller of the drug delivery system of claim 16 , wherein the processor, when executing the programming instructions, is further operable to:

obtain glucose levels of the user;

evaluate the glucose level to a maximum glucose threshold;

based on the evaluation of the obtained ketone levels with reference to the plurality of ketone thresholds and the evaluation of the glucose level to the maximum glucose threshold, provide an indication for additional action by the processor.

19 . The controller of the drug delivery system of claim 16 , wherein the processor is further operable to:

determine the user is experiencing ketoacidosis; and

increase delivery of insulin.

20 . The controller of the drug delivery system of claim 18 , wherein the processor is further operable to:

determine whether the user is experiencing diabetic ketoacidosis;

in response to the determination indicating a drop below a minimum glucose threshold value, perform at least one of:

generate a prompt on the user interface for the user to ingest carbs,

elevate a minimum target setpoint or the minimum glucose threshold value, or

reduce a basal rate of drug delivery.

Assignments (2)

Continuity (2)

References Cited (400)