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

Abstract

Embodiments of methods of assessing a diabetes treatment protocol comprise determining a protocol complexity level corresponding to a degree of difficulty of completing the diabetes treatment protocol by utilizing the processor, determining 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 via the processor, and providing an output based on the comparison.

1 . A method of assessing a diabetes treatment protocol by utilizing a processor comprising:
 determining a protocol complexity level corresponding to a degree of difficulty of completing the diabetes treatment protocol by utilizing the processor;   determining 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   providing an output based on the comparison.   
     
     
         2 . The method of  claim 1  further comprising supplementing procedures for performing the diabetes treatment protocol if the patient proficiency level is below the protocol complexity level. 
     
     
         3 . The method of  claim 1  further comprising instructing the patient to exit the diabetes treatment protocol if the patient proficiency level is below the protocol complexity level. 
     
     
         4 . 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. 
     
     
         5 . The method of  claim 4  wherein the status report provides a probability of success for the patient in performing the diabetes treatment protocol. 
     
     
         6 . The method of  claim 1  further comprising instructing the patient to perform the tasks of the diabetes treatment protocol if the patient proficiency level is equal to or above the protocol complexity level of the diabetes treatment protocol. 
     
     
         7 . The method of  claim 1  further comprising determining whether the patient has adhered to the diabetes treatment protocol. 
     
     
         8 . The method of  claim 7  further comprising automatically generating a status report when the patient has failed to adhere to the diabetes treatment protocol. 
     
     
         9 . The method of  claim 1  further comprising re-calculating the patient proficiency level after performing one or more tasks of the diabetes treatment protocol. 
     
     
         10 . The method of  claim 7  further comprising instructing the patient to contact a health care provider if the patient has failed to adhere to the diabetes treatment protocol. 
     
     
         11 . The method of  claim 1  wherein one or more of the tasks of the diabetes treatment protocol are scored individually. 
     
     
         12 . The method of  claim 11  wherein the protocol complexity level is computed from the individual scores for the tasks in the diabetes treatment protocol. 
     
     
         13 . The method of  claim 1  wherein the patient proficiency level is determined based on a patient's answers to a survey, a patient's prior or current diabetes treatment regimen, or combinations thereof. 
     
     
         14 . 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. 
     
     
         15 . The method of  claim 1  further comprising selecting a different diabetes treatment protocol if the patient proficiency level is below the protocol complexity level. 
     
     
         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 if 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 a different diabetes treatment protocol or selecting one or more different tasks of the diabetes treatment protocol if 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 if the patient task proficiency level is below the protocol task complexity level. 
     
     
         21 . A collection device for assessing a diabetes treatment protocol, 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:
 compute a protocol complexity level corresponding to a degree of difficulty of completing the diabetes treatment protocol; 
 compute a patient proficiency level corresponding to a skill set of the patient in conducting the diabetes treatment protocol; and 
 compare the patient proficiency level and the protocol complexity level; and 
   a display unit configured to provide the results of the comparison.   
     
     
         22 . A method of calculating a protocol complexity level for a diabetes treatment protocol by utilizing a processor, 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 comprising:
 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.   
     
     
         23 . The method of  claim 22  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. 
     
     
         24 . The method of  claim 22  further comprising adjusting the protocol complexity level if it is determined 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. 
     
     
         25 . The method of  claim 22  wherein the protocol complexity level is calculated from the combination of predefined diabetes protocol complexity values and protocol task complexity level. 
     
     
         26 . The method of  claim 25  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. 
     
     
         27 . The method of  claim 25  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. 
     
     
         28 . The method of  claim 27  further comprising recalculating the protocol complexity level upon changes to the diabetes treatment protocol. 
     
     
         29 . A method of calculating a patient proficiency level for a diabetes treatment protocol by utilizing a processor, the processor being programmed with calculation instructions for the patient proficiency level corresponding a patient skill set in performing the diabetes treatment protocol, the method comprising:
 selecting a calculation methodology for the patient proficiency level via 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 patient proficiency levels, 
 prior patient proficiency levels calculated based on stored data of previously performed treatment protocol or any tasks of the treatment protocol, or 
 combinations thereof; and 
   computing the patient proficiency level for the diabetes treatment protocol based on the selected calculation methodology.   
     
     
         30 . The method of  claim 29  wherein the patient proficiency level is determined from contextualized data associated with a biomarker reading. 
     
     
         31 . The method of  claim 29  wherein the patient proficiency level is computed based on stored data comprising a comparison of requested estimated values and measured values. 
     
     
         32 . The method of  claim 29  wherein the patient proficiency level is computed based on stored data comprising a calculation of the progress of treatment during the previously performed treatment protocol or any tasks of the treatment protocol 
     
     
         33 . The method of  claim 29  wherein the patient proficiency level is computed based on stored data whereby the previously performed treatment protocol comprising a protocol which prompts the patient to answer treatment related questions 
     
     
         34 . The method of  claim 29  wherein the patient proficiency level is computed based on the patient adherence level, wherein the patent proficiency level is computed from the previously performed treatment protocol or any tasks of the treatment protocol 
     
     
         35 . The method of  claim 29  wherein the patient proficiency level is computed from a combination of patient adherence levels, predefined patient proficiency levels, patent sophistication levels, patient preferences, or combinations thereof. 
     
     
         36 . The method of  claim 29  wherein the patient proficiency level is determined based on a patient's answers to a survey, a patient's prior or current diabetes treatment regimen, or combinations thereof. 
     
     
         37 . The method of  claim 29  further comprising recalculating the patient proficiency level upon changes to the diabetes treatment protocol. 
     
     
         38 . A collection device configured to assess a protocol complexity level for a diabetes treatment protocol, 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:
 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; and 
 
 compute the protocol complexity level of the diabetes treatment protocol; 
   
       and
 a display unit configured to output the computed protocol complexity level. 
 
     
     
         39 . A collection device configured to assess a patient proficiency level for a diabetes treatment protocol, 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:
 select a calculation methodology appropriate for computing the patient proficiency level of the diabetes treatment protocol, wherein the selected calculation methodology utilizes
 predefined patient proficiency levels, 
 prior patient proficiency levels calculated based on stored data of previously performed treatment protocol or any tasks of the treatment protocol, or 
 combinations thereof, and 
 
 compute the patient proficiency level of the diabetes treatment protocol; 
   
       and
 a display unit configured to output the computed patient proficiency level.