Systems and methods for disease control and management

• US 10,818,389 B2
• Filed: 11/12/2018
• Issued: 10/27/2020
• Est. Priority Date: 02/22/2007
• Status: Active Grant

• Current Assignee: WellDoc, Inc
• Original Assignee: WellDoc, Inc
• Inventors: Sysko, Ryan A., Sysko, Suzanne K., Minor, James M., Iyer, Anand K., Fletcher, Andrew V.
• Primary Examiner(s): Reyes, Reginald R
• Application Number:
  US16/186,996
• Publication Number:
  US 20190180855A1
• Time in Patent Office: 715 Days
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

Methods, computer-readable media, and systems for providing disease management. In one implementation, a system develops a treatment recommendation for a patient based on patient data. The system may receive patient data, execute a basic model of the physiological system of the patient to generate a modified model for the patient based on the patient data, perform a statistical analysis of the patient data to detect data excursions of the parameter values; use the modified model to determine factors causing the data excursions; and use the model to develop a treatment recommendation to ameliorate negative effects of the disease.

Claims

1. A system for management of a user having a glucose condition, comprising:

an insulin delivery device configured to execute instructions, as part of a treatment recommendation, to deliver insulin, the insulin delivery device having a pump and a transmitter to output at least insulin intake data, including a dosage and a time of insulin intake, and to receive instructions; and

a disease management server, comprising;

a receiver for wirelessly receiving user data, including at least the insulin intake data, transmitted from the insulin delivery device, glucose data, including glucose measurements and timing of measurement of glucose, from a glucose measuring device, and physical activity data from a pedometer worn by the user or exercise equipment used by the user;

one or more processors configured to apply an algorithm to the received user data, wherein executing the algorithm includes;

executing a basic model of a physiological system generic to any user, the basic model being based on a plurality of parameters of the physiological system, the plurality of parameters including an insulin intake, a time of insulin intake, a glucose level, a time of measurement of glucose level, physical activity of the user, and a time of physical activity of the user;

adjusting the basic model based on the received user data to generate a modified model specific to a physiological system of the user, wherein generating the modified model includes determining a rate of change in glucose level of the user over a time interval based on glucose inventory;

performing a statistical analysis of the user data to detect data excursions of values of one or more parameters, of the plurality of parameters, of the physiological system of the user, wherein a data excursion is a value of a parameter that is outside an expected range of values of the parameter;

outputting an alert to a provider associated with the user when a data excursion is detected;

executing the modified model to determine factors causing the data excursions of the values of the one or more parameters;

generating, using the modified model and the determined factors, one or more instructions, as part of the treatment recommendation, relating to adjusting one or both of a time and a dose of insulin;

wirelessly receiving additional user data, the additional user data including at least glucose measurements from the glucose measuring device; and

automatically updating the modified model based on the received additional user data; and

an output device for outputting the treatment recommendation, including the one more instructions relating to adjusting the one or both of the time and the dose of insulin, to at least the insulin delivery device,

wherein, when the insulin delivery device receives the one more instructions relating to adjusting the one or both of the time and the dose of insulin, the insulin delivery device delivers a dose of insulin at a time based on the one or more instructions relating to adjusting the one or both of the time and the dose of insulin.

2. The system of claim 1, wherein the user data further includes at least one of:

(a) user carbohydrate intake, or

(b) corresponding time for the user carbohydrate intake.

3. The system of claim 1, wherein the executing the basic model comprises applying an algorithm to the user data in a current state in conjunction with auxiliary user data comprising at least one of a user blood lipid level, a user blood pressure, a user age, a user gender, a user height and weight, or a user race.

4. The system of claim 1, wherein the one or more processors are further configured to develop instructions for collection of the user data to improve the basic model, wherein the instructions for collection comprise an instruction for the glucose measuring device to change a timing of glucose measurement.

5. The system of claim 1, wherein the using the modified model to develop the one more instructions, as part of the treatment recommendation, comprises using the modified model to develop a plurality of treatment recommendations at predetermined intervals.

6. The system of claim 5, wherein the intervals are determined based on a most-recent user data collection time.

7. The system of claim 1, wherein the one or more processors are further configured to perform the statistical analysis employing a statistical design of experiments methodology to identify the factors causing the data excursions.

8. The system of claim 1, wherein the one or more instructions further relate to changing recommended combinations of available medications.

9. The system of claim 1, wherein the generating the modified model comprises utilizing equations that simulate interaction of primary factors affecting the rate of change in glucose level of the user, wherein the primary factors are calculated based on the user data, and the primary factors comprise at least one of a rate of digestion of user carbohydrate intake, cellular uptake of glucose by the user, and impact of glucose inventory in liver, skeletal muscle, or fat tissues of the user.

10. The system of claim 9, wherein an equation for cellular uptake of glucose by the user is a function of at least one of the glucose level, level of insulin acting as a catalyst, resistance factors, or digestive-activated hormones, and

wherein the level of insulin is calculated based on at least one of user medication doses, user pancreatic production, or insulin kinetics.

14. The system of claim 1, wherein the treatment recommendation includes at least one instruction for the user to provide the additional user data.

11. A system for management of a user having a glucose condition, comprising:

an insulin delivery device configured to operate a user-interactive interface and to execute instructions, as a part of a treatment recommendation, to deliver insulin, the insulin delivery device having a transmitter to output at least insulin intake data, including a dose and a time of insulin intake, and to receive instructions; and

a disease management server, comprising;

a receiver for wirelessly receiving user data, including at least the insulin intake data, transmitted from the insulin delivery device, and glucose data, including glucose measurements and times of measurement of glucose, from a glucose measuring device, wherein the glucose measurements are received at predetermined intervals;

one or more processors configured to execute an algorithm to the received user data, wherein executing the algorithm includes;

executing a basic model of a physiological system generic to any user, the basic model being based on a plurality of parameters of the physiological system, the plurality of parameters including an insulin intake, a time of insulin intake, a glucose level, a time of measurement of glucose level, activity of the user, and a time of activity of the user, wherein executing the basic model comprises applying an algorithm to the user data in a current state in conjunction with auxiliary user data comprising each of user blood lipid level, blood pressure, age, gender, height and weight, and race;

adjusting the basic model based on the received user data to generate a modified model specific to a physiological system of the user, wherein generating the modified model includes determining a rate of change in glucose level of the user over a time interval based on glucose inventory, and utilizing equations that simulate interaction of primary factors affecting the rate of change in glucose level of the user, wherein the primary factors are calculated based on the user data, and the primary factors comprise a rate of digestion of user carbohydrate intake, cellular uptake of glucose by the user, and impact of glucose inventory in liver, skeletal muscle, and fat tissues of the user, an equation for cellular uptake of glucose by the user is a function of at least one of the glucose level, level of insulin acting as a catalyst, resistance factors, or digestive-activated hormones, and wherein the level of insulin is calculated based on each of user medication doses, user pancreatic production, and insulin kinetics;

performing a statistical analysis of the user data to detect data excursions of values of one or more parameters, of the plurality of parameters, of the physiological system of the user, wherein a data excursion is a value of a parameter that is outside an expected range of values of the parameter;

outputting an alert to a health care provider associated with the user when a data excursion is detected;

executing the modified model to determine factors causing the data excursions of the values of the one or more parameters;

generating, using the modified model and the determined factors, one or more instructions, as part of the treatment recommendation, relating to adjusting one or more of a time and a dose of insulin and a combination of medication, wherein using the modified model to develop the one or more instructions, as part of the treatment recommendation, comprises using the modified model to develop a plurality of treatment recommendations at predetermined intervals, wherein the predetermined intervals are based on a most-recent user data collection time;

wirelessly receiving additional user data, the additional user data including at least glucose measurements from the glucose measuring device;

automatically updating the modified model based on the received additional user data;

developing instructions for collection of the user data to improve the basic model, wherein the instructions for collection comprise an instruction for the glucose measuring device to change a timing of glucose measurement; and

performing the statistical analysis employing a statistical design of experiments methodology to identify the factors causing the data excursions;

an output device for outputting the treatment recommendation, including the one or more instructions relating to adjusting the one or more of the time and the dose of the insulin, to the insulin delivery device, wherein, when the insulin delivery device receives the one or more instructions relating to adjusting the one or both of the time and the dose of the insulin, the insulin delivery device delivers a dose of insulin at a time based on the one or more instructions relating to adjusting the one or both of the time and the dose of the insulin;

and

a health care provider interface operable to receive information about the user, including the alert to the health care provider and the treatment recommendation, from the disease management server.

12. The system of claim 11, wherein the glucose condition is diabetes.

13. The system of claim 11, wherein the insulin delivery device includes a pump.

15. A system for management of a user having a glucose condition, comprising:

an insulin delivery device configured to execute instructions, as part of a treatment recommendation, to deliver insulin, the insulin delivery device having a pump and a transmitter to output at least insulin intake data, including a dose and a time of insulin intake, and to receive instructions; and

a disease management server, comprising;

a receiver for wirelessly receiving user data, including at least the insulin intake data, transmitted from the insulin delivery device, and glucose data, including glucose measurements and timing of measurement of glucose level, from a glucose measuring device;

one or more processors configured to execute an algorithm to the received user data, wherein executing the algorithm includes;

executing a basic model of a physiological system generic to any user, the basic model being based on a plurality of parameters of the physiological system, the plurality of parameters including an insulin intake, a time of insulin intake, a glucose level, and a time of measurement of glucose level, wherein executing the basic model comprises applying an algorithm to the user data in a current state in conjunction with auxiliary user data comprising at least one of a user blood lipid level, a user blood pressure, a user age, a user gender, a user height and weight, or a user race;

adjusting the basic model based on the received user data to generate a modified model specific to a physiological system of the user, wherein generating the modified model includes determining a rate of change in glucose level of the user over a time interval based on received glucose measurements and times of measurement of glucose level of the user, and utilizing equations that simulate interaction of primary factors affecting the rate of change in glucose level of the user, wherein the primary factors are calculated based on the user data, and the primary factors comprise at least one of a rate of digestion of user carbohydrate intake, cellular uptake of glucose by the user, and impact of glucose inventory in liver, skeletal muscle, or fat tissues of the user;

performing a statistical analysis of the user data to detect data excursions of values of one or more parameters, of the plurality of parameters, of the physiological system of the user, wherein a data excursion is a value of a parameter that is outside an expected range of values of the parameter;

outputting an alert to a provider associated with the user when a data excursion is detected;

executing the modified model to determine factors causing the data excursions of the values of the one or more parameters;

generating, using the modified model and the determined factors, instructions, as part of the treatment recommendation, relating to adjusting one or more of a time and a dose of insulin, and a time of measurement of glucose level, wherein using the modified model to develop the instructions, as part of the treatment recommendation, comprises using the modified model to develop a plurality of treatment recommendations at predetermined intervals, the predetermined intervals being based on a most-recent user data collection time;

wirelessly receiving additional user data, the additional user data including at least glucose measurements from the glucose measuring device; and

automatically updating the modified model based on the received additional user data; and

an output device for outputting the treatment recommendation, including the instructions, to the insulin delivery device and the glucose measuring device,

wherein, when the insulin delivery device receives the instructions relating to adjusting the one or more of the time and the dose of the insulin, the insulin delivery device delivers a dose of insulin at a time based on the instructions relating to adjusting the one or both of the time and the dose of the insulin, and, when the glucose measuring device receives the instructions relating to adjusting the time of measurement of the glucose level, the glucose measuring device adjusts the time of measurement of the glucose level based on the instructions relating adjusting the time of measurement of the glucose level.