Methods of assessing diabetes treatment protocols based on protocol complexity levels and patient proficiency levels

1. A method of treating diabetes of a patient comprising:

collecting contextual information in response to responses received via a collection device prompting the patient with medical or treatment related questions before or during execution of a diabetes treatment protocol on the collection device;

determining a protocol complexity level corresponding to a degree of difficulty of completing the diabetes treatment protocol by utilizing a processor;

determining, based on the collected contextual information, a patient proficiency level corresponding to a skill set of the patient in conducting the diabetes treatment protocol by utilizing the processor;

comparing the protocol complexity level to the patient proficiency level, wherein the comparison is performed by the processor; and

subjecting the patient to a different diabetes treatment protocol executed on the collection device based on the comparison showing that the patient possesses a level of skill for the different diabetes treatment protocol, wherein the different diabetes treatment protocol comprises administering insulin to the patient.

2. The method of claim 1 further comprising supplementing procedures for performing the diabetes treatment protocol upon the comparison showing that the patient proficiency level is below the protocol complexity level.

3. The method of claim 2 wherein the supplemented procedures comprise training materials, tutorials, additional instructions for one or more of the tasks, or combinations thereof.

4. The method of claim 1 further comprising instructing the patient to exit the diabetes treatment protocol upon the comparison showing that the patient proficiency level is below the protocol complexity level.

5. The method of claim 1 further comprising automatically generating a status report based on the comparison of the protocol complexity level to the patient proficiency level.

6. The method of claim 5 wherein the status report provides a probability of success for the patient in performing the diabetes treatment protocol.

7. The method of claim 1 further comprising instructing the patient to perform tasks of the diabetes treatment protocol.

8. The method of claim 7 further comprising re-calculating the patient proficiency level after performing one or more of the tasks of the diabetes treatment protocol.

9. The method of claim 7 wherein one or more of the tasks of the diabetes treatment protocol are scored individually.

10. The method of claim 9 wherein the protocol complexity level is computed from the individual scores for the tasks in the diabetes treatment protocol.

11. The method of claim 1 further comprising determining whether the patient has adhered to the diabetes treatment protocol.

12. The method of claim 11 further comprising automatically generating a status report when the patient has failed to adhere to the diabetes treatment protocol.

13. The method of claim 11 further comprising instructing the patient to contact a health care provider upon the determination that the patient has failed to adhere to the diabetes treatment protocol.

14. The method of claim 1 wherein the patient proficiency level is further determined based on a patient's answers to a survey, a patient's prior or a current diabetes treatment regimen, or combinations thereof.

15. The method of claim 1 further comprising selecting another diabetes treatment protocol upon the comparison showing that the patient proficiency level is below the protocol complexity level for the diabetes treatment protocol during execution of the diabetes treatment protocol on the collection device.

16. The method of claim 1 further comprising setting diabetes treatment goals, and developing at least one diabetes treatment protocol in accordance with the diabetes treatment goals.

17. The method of claim 1 further comprising providing one or more diabetes treatment protocols to facilitate selection by the patient or healthcare provider of the diabetes treatment protocol to be performed.

18. The method of claim 1 comprising determining a protocol task complexity level for at least one task of the diabetes treatment protocol upon the comparison showing that the protocol complexity level is greater than the patient proficiency level of the diabetes treatment protocol, the protocol task complexity level corresponding to a degree of difficulty of completing at least one task in the diabetes treatment protocol;

determining a patient task proficiency level corresponding to the skill set of the patient in conducting at least one of the tasks of the diabetes treatment protocol; and

comparing the protocol task complexity level to the patient task proficiency level.

19. The method of claim 18 further comprising selecting one or more different tasks of the diabetes treatment protocol upon the comparison showing that the patient task proficiency level is below the protocol task complexity level.

20. The method of claim 18 further comprising supplementing the procedures for that task upon the comparison showing that the patient task proficiency level is below the protocol task complexity level.

21. The method of claim 1 , wherein the processor being programmed with calculation instructions for the protocol complexity level which corresponds to a degree of difficulty of completing the diabetes treatment protocol, the method further comprises:

selecting a calculation methodology for the protocol complexity level utilizing the processor, wherein the processor selects the calculation methodology appropriate for the diabetes treatment protocol by executing the programmed calculation instructions, wherein the selected calculation methodology utilizes

predefined protocol complexity values associated with known diabetes treatment protocols,

task complexity values which are assigned to one or more tasks of the diabetes treatment protocol, or

combinations thereof; and

computing the protocol complexity level of the diabetes treatment protocol using the selected calculation methodology.

22. The method of claim 21 wherein the calculation methodology calculates the protocol complexity level by weighting task complexity values differently, weighting task values evenly, ignoring task complexity values for specific tasks, or combinations thereof.

23. The method of claim 21 further comprising adjusting the protocol complexity level upon determination that a duration of the diabetes treatment protocol or a number of steps of the diabetes treatment protocol increases or decreases an overall complexity of the diabetes treatment protocol.

24. The method of claim 21 wherein the protocol complexity level is calculated from the combination of predefined diabetes protocol complexity values and protocol task complexity level.

25. The method of claim 24 wherein predefined diabetes protocol complexity values are weighted more, less or the same as the protocol task complexity level in the calculation of the protocol complexity level.

26. The method of claim 24 wherein the protocol task complexity levels consider one or more factors selected from the group consisting of a frequency of insulin administration, a frequency of biomarker collection, the complexity of biomarker collection, a time of day of biomarker collection, a risk of adverse events associated with each task in the diabetes treatment protocol, and combinations thereof.

27. The method of claim 26 further comprising recalculating the protocol complexity level upon changes to the diabetes treatment protocol.

28. A collection device for supporting diabetes treatment of a patient, comprising:

a meter configured to measure one or more selected biomarkers;

a processor disposed inside the meter and coupled to memory,

software having instructions that when executed by the processor causes the processor to:

collect contextual information in response to responses received via prompts by the collection device to the patient with medical or treatment related questions before or during execution of a diabetes treatment protocol on the collection device;

compute a protocol complexity level corresponding to a degree of difficulty of completing the diabetes treatment protocol;

compute, based on the collected contextual information, a patient proficiency level corresponding to a skill set of the patient in conducting the diabetes treatment protocol;

compare the patient proficiency level and the protocol complexity level; and

execute on the collection device a different diabetes treatment protocol based on the comparison which shows that the patient possess a level of skill for the different diabetes treatment protocol, wherein the different diabetes treatment protocol comprises an administration of insulin to the patient; and

a display unit configured to provide the results of the comparison.

29. A collection device for supporting diabetes treatment of a patient, comprising:

a meter configured to measure one or more selected biomarkers;

a processor disposed inside the meter and coupled to memory;

software having instructions that when executed by the processor causes the processor to:

collect contextual information in response to responses received via prompts by the collection device to the patient with medical or treatment related questions before or during execution of a diabetes treatment protocol on the collection device;

select a calculation methodology appropriate for computing the protocol complexity level of the diabetes treatment protocol wherein the selected calculation methodology utilizes

predefined protocol complexity values associated with known diabetes treatment protocols,

task complexity values which are assigned to one or more tasks of the diabetes treatment protocol, or

combinations thereof;

compute the protocol complexity level corresponding to a degree of difficulty of completing of the diabetes treatment protocol;

compute, based on the collected contextual information, a patient proficiency level corresponding to a skill set of the patient in conducting the diabetes treatment protocol;

compare the patient proficiency level and the protocol complexity level; and

execute on the collection device a different diabetes treatment protocol based on the comparison which shows that the patient possess a level of skill for the different diabetes treatment protocol, wherein the different diabetes treatment protocol comprises an administration of insulin to the patient; and

a display unit configured to output the computed protocol complexity level.