Medical diagnosis, therapy, and prognosis system for invoked events and methods thereof

• US 8,712,748 B2
• Filed: 05/12/2008
• Issued: 04/29/2014
• Est. Priority Date: 06/27/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Thukral, Ajay, Galley, Paul, Chittajallu, Siva, Weinert, Stefan
• Primary Examiner(s): HARWARD, SOREN T
• Application Number:
  US12/119,201
• Publication Number:
  US 20090006129A1
• Time in Patent Office: 2,178 Days
• Field of Search: None
• US Class Current: 703/11
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A diagnosis, therapy and prognosis system (DTPS) and method thereof to help either the healthcare provider or the patient in diagnosing, treating and interpreting data are disclosed. The apparatus provides data collection based on protocols, and mechanism for testing data integrity and accuracy. The data is then driven through an analysis engine to characterize in a quantitative sense the metabolic state of the patient'"'"'s body. The characterization is then used in diagnosing the patient, determining therapy, evaluating algorithm strategies and offering prognosis of potential use case scenarios.

Claims

1. A computerized method for providing medical diagnosis, therapy and prognosis of an actual patient with a chronic disease on a computer, the method comprising:

specifying on the computer one or more testing protocols that address specific diagnosis and continuous drug therapy needs of the actual patient, wherein the one or more testing protocols each specify a manner for collecting one or more actual measurements of one or more physiological parameters of the actual patient in order to provide collected data of the actual patient, wherein the manner provides at least a manner in which the collected data is to be collected;

receiving the collected data of the actual patient;

specifying on the computer a patient-specific model selected via a user interface of the computer after receiving the collected data of the actual patient;

performing analysis on the computer to determine parameters of the patient-specific model before applying the collected data to the patient-specific model;

performing model verification of the parameters on the computer to further ensure that the patient-specific model has captured appropriate dynamics that address the specific diagnosis and therapy needs of the patient;

modifying the patient-specific model via the user interface if the model verification of the parameters indicates that the patient-specific model has not captured appropriate dynamics that address the specific diagnosis and therapy needs of the patient;

applying the collected data of the actual user collected per the one or more protocols to perform analysis on the computer using the patient-specific model to provide at least one recommended patient-specific therapy, wherein the collected data has passed quality checks indicating that the collected data is relevant to generate changes to the therapy of the patient;

validating that the provided at least one recommended patient-specific therapy is a valid therapy, and if not valid, providing a different at least one recommended patient-specific therapy if no portion of the provided at least one recommended patient-specific therapy is identified as only needing modification; and

providing on the computer the validated recommended patient-specific therapy for approval; and

wherein the patient-specific model comprises an impulse response model described by the equation;

2. The computerized method according to claim 1 further comprises tuning the recommended patient-specific therapy.

3. The computerized method according to claim 1 further comprises defining and implementing test scenarios on the computer that help in testing the recommended patient-specific therapy and quantifying the quality of therapy potentially achievable using the recommended patient-specific therapy.

4. The computerized method according to claim 1 further comprises defining and implementing test scenarios on the computer that help in performing the model verification of the parameters.

5. The computerized method according to claim 1 further comprises providing a plurality of recommended patient-specific therapies, and testing the recommended patient-specific therapies against several critical test scenarios and evaluating expected therapy outcomes to provide a prognosis based on a selected one of the recommended patient-specific therapies.

6. The computerized method according to claim 1 further comprises performing mathematical analysis to evaluate stability, sensitivity, robustness, and provided an indication of confidence for the recommended patient-specific therapy.

7. The computerized method according to claim 1 further comprises confirming that the dynamics of the patient-specific model by simulating special test cases to evaluate dynamic response against at least one of literature data and clinical data.

8. The computerized method according to claim 1 further comprises providing mathematical analysis tools, visualization tools, and data presentation tools to help perform the analysis on the computer.

9. The computerized method according to claim 1 further comprises providing a simulated environment to defining and implementing test scenarios on the computer that help in performing the model verification of the parameters.

10. The computerized method according to claim 1 further comprises implementing the recommended patient-specific therapy on a portable unit.

11. The computerized method according to claim 1 further comprises collecting the data per the one or more protocols from a patient data collection device.

12. The computerized method according to claim 1 further comprises using the computer to govern the collection of the data, the performing of analysis on the data, the applying of the data to the patient-specific model, and the providing of the recommended patient-specific therapy.

13. The computerized method according to claim 1 wherein the data collected includes at least one of event activities and physiological measurements which update the analysis for provided the recommended patient-specific therapy.

14. The computerized method according to claim 1 further comprises approving the recommended patient-specific therapy as a prescription, and scheduling, controlling, and monitoring the prescription.

15. The computerized method according to claim 1 further comprises approving the recommended patient-specific therapy as a prescription, controlling implementation of the prescription open loop with a portable device providing administration of the prescription directly to the patient.

16. The computerized method according to claim 1 further comprises approving the recommended patient-specific therapy as a prescription, and controlling implementation of the prescription closed loop with a portable device providing administration of the prescription directly to the patient.

17. The computerized method according to claim 15 further comprises commanding the portable unit to dispense medication and perform a measurement task according to the prescription.

18. The computerized method according to claim 16 further comprises commanding the portable unit to dispense medication and perform a measurement task each with at least one given input characteristic, and using the at least one input characteristic to update the algorithm.

19. The computerized method of claim 1, wherein the computer comprises a client-server computer system environment.

20. A computerized method for providing medical diagnosis, therapy and prognosis of an actual patient with a chronic disease on a computer, the method comprising:

specifying on the computer one or more testing protocols that address metabolic, physiological, and lifestyle information of the actual patient, wherein the one or more testing protocols specify a manner for collecting one or more actual measurements of one or more physiological parameters of the actual patient in order to provide collected data of the actual patient, wherein the manner provides at least a manner in which the collected data is to be collected;

receiving the collected data of the actual patient;

specifying on the computer at least one patient-specific model selected via a user interface of the computer after receiving the collected data of the actual patient, said at least one patient-specific model being based on the metabolic, physiological, and lifestyle information of the patient, wherein the at least one patient specific model is selected from the group consisting of physiological models and metabolic models for determining a drug dose based on the pharmacokinetics and pharmacodynamics of the drug model;

performing analysis on the computer to determine parameters of the patient-specific model before applying the collected data to the patient-specific model;

performing model verification of the parameters on the computer to further ensure that the patient-specific model has captured appropriate dynamics that address the specific diagnosis and therapy needs of the patient;

modifying the patient-specific model via the user interface if the model verification of the parameters indicates that the patient-specific model has not captured appropriate dynamics that address the specific diagnosis and therapy needs of the patient;

applying the collected data of the actual user collected per the one or more protocols to perform analysis on the computer using the patient-specific model to provide at least one recommended patient-specific therapy, wherein the collected data has passed quality checks indicating that the collected data is relevant to generate changes to the therapy of the patient;

validating that the provided at least one recommended patient-specific therapy is a valid therapy, and if not valid, providing a different at least one recommended patient-specific therapy if no portion of the provided at least one recommended patient-specific therapy is identified as only needing modification; and

providing on the computer the validated, recommended patient-specific therapy for approval; and

wherein the patient-specific model comprises an impulse response model described by the equation;

21. The method of claim 20, wherein the parameters comprise glucose measurements, HbA1C levels, ketone levels, and free fatty acid levels.

22. The method of claim 20, wherein the one or more testing protocols are selected from the group consisting of a blood glucose test, a body temperature test, a body weight test, a blood pressure test, an HbA1C monitoring device, patient meal intake test, patient exercise test, and patient illness test.

23. The method of claim 20, wherein the metabolic, physiological, and lifestyle information of the patient is selected from the group consisting of the particular illness targeted, illness severity, therapy types available, patient age, patient weight, patient sex, propensity to follow dietary schedule, propensity to follow a therapy schedule, propensity to exercise on a regular basis.

24. The method of claim 20, wherein the testing protocols are chosen from the group consisting of glucose measurements, body temperature measurements, heart rate measurements, blood pressure measurements, weight measurements, menses measurements, stress measurements, illness measurement, meal measurement, carbohydrate measurement, physical activity measurement, doctor visit measurements, intervention measurements, meal intake measurements, and exercise performance measurements.