Abstract: A collection device for performing a structured collection procedure may include a processor that executes program instructions communicably coupled to at least one memory. The processor can initiate a schedule of events of the structured collection procedure upon one or more entry criterions being met and segregate the at least one memory into a primary data store and a secondary data store. The processor can write structured patient data collected in accordance to the schedule of events to the secondary data store. The processor can transform a relevant portion of the structured patient data into an evaluated data object. The processor can generate a data abstraction based in part upon the evaluated data object. The processor can link the primary data store and the secondary data store with the data abstraction.

Abstract: Systems and methods for automatically displaying patterns in biological data may include one or more processors, and machine readable instructions. The machine readable instructions can cause the one or more processors to divide biological data into segments of interest. The one or more processers can transform, automatically, each of the segments of interest into a set of features according to a mathematical algorithm. Further, the one or more processers can cluster, automatically, the segments of interest into groups of clustered segments according to a clustering algorithm. The segments of interest can be grouped in the groups of clustered segments based at least in part upon the set of features. A cluster center can be associated with one of the groups of clustered segments. Moreover, the one or more processers can present, automatically, the cluster center on a human machine interface.

Abstract: Methods for performing a structured collection procedure by utilizing a collection device are disclosed herein, in which a collection procedure is initiated for performing one or more data collections for one or more data event instances occurring according to a schedule of events. Each data event instances comprises a data collection pertaining to a biomarker to be performed according to one or more conditions of an adherence criterion. Each data event instance is determined to be successful or unsuccessful on the basis of actual performance of the data collection and meeting certain conditions of the predetermined adherence criteria for the data event instance. Contextual information for successful data collections is generated and a data file generated for storing records relating to successful data collections.

Abstract: Embodiments related to a system and method managing the implementation, execution, data collection, and data analysis of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor causes the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and mark/indicate the structured collection procedure as completed if no exception occurred during performance of an event in the schedule of events.

Abstract: Embodiments of methods of performing a structured collection protocol on a collection device comprise providing a plurality of prior biomarker samples, wherein the prior biomarker samples comprise at least one measured value and plurality of contextualized data components linked to the prior biomarker samples, setting a first criterion, wherein the first criterion classifies prior biomarker samples as similar if prior biomarker samples share at least one identical contextualized data component, grouping biomarker samples that are determined to be similar based on the first criterion, calculating expected values for future biomarker samples which satisfy the first criterion, wherein the calculation is based on at least a subset of the group of similar prior biomarker samples, setting a second criterion, wherein the second criterion is an acceptable variance from the calculated expected values, a threshold, or both, collecting one or more biomarker samples which satisfy the first criterion, and evaluating via t

Abstract: Embodiments of methods of querying a diabetic patient regarding compliance with adherence criteria comprises instructing the diabetic patient to collect at least one sample in a sampling set of biomarker data, wherein each sampling set comprises a sufficient plurality of samples recorded over a collection period, comparing the collected samples to an acceptable range, wherein the acceptable range encompasses biomarker values that would be expected upon compliance with the adherence criteria, and informing the diabetic patient if at least one sample is an unacceptable value which falls outside of the acceptable range, and performing at least one additional task after detecting the unacceptable value.

Abstract: A therapy delivery system having an open architecture and method of providing thereof are disclosed. The present invention provides a therapy dosage module having a control algorithm that can be replaced with a predefined or independently defined control algorithm. The tools necessary to create and test such control algorithms in the therapy dosage module in a simulated environment before implementing it in a live therapy system are also disclosed.

Abstract: A system and method described herein simplifies data entry by a subject of a structured blood glucose test as well as helps with dietary compliance by providing specific dietary suggestions to the user. The system includes a portable device configured to be possessed by the subject. The portable device has a location detection system configured to provide data indicative of the location of the subject. A food database provides to the portable device a list of food items that are limited based on foods available at the location, such as a restaurant. The portable device is configured to receive a selection from the list that is indicative of a food consumed by the subject. A blood glucose meter reads blood glucose readings from the subject. The food database is configured to store the blood glucose readings and information about the foods consumed by the subject. Compliance to a prescribed dietary regimen can be monitored by the user and/or a physician.

Abstract: Embodiments of a testing method for optimizing a therapy to a diabetic patient comprise collecting at least one sampling set of biomarker data, computing a probability distribution function, a hazard function, a risk function, and a risk value for the sampling set of biomarker data wherein, wherein the probability distribution function is calculated to approximate the probability distribution of the biomarker data, the hazard function is a function which yields higher hazard values for biomarker readings in the sampling set indicative of higher risk of complications, the risk function is the product of the probability distribution function and the hazard function, and the risk value is calculated by the integral of the risk function, minimizing the risk value by adjusting the diabetic patient's therapy, and exiting the testing method when the risk value for at least one sampling set is minimized to an optimal risk level.

Abstract: Methods and systems for authorizing access to a medical device are disclosed. The methods and systems use authorization certificates to allow and prevent access to one or more operations of the medical device. The methods and systems also allow the tracking of changes made to the medical device by an authorized user.

Abstract: A technique and system utilizing a portable memory card in which data for an individual is stored and identified based on a personal identification number or key. With this system, a glucose meter and a health care provider are able to track testing data across multiple meters as well as between various individuals. Moreover, the system is configured to retrospectively collect structured testing data in which, while a structured test may have been intended but the specific questions or data input were not available at the time, the individual is allowed to update the data after the structured testing window. By having the data stored on a portable memory card, the individual is able to keep the data in their possession and also helps with patient confidentiality.

Abstract: A method and system in which a short range wireless signal containing an activation code is received with a glucose meter. Upon receiving the signal, the glucose meter awakens from a low power state. A dormant function on the glucose meter that corresponds to the activation code is activated in response to receiving the short range wireless signal. In one example, the glucose meter includes an RFID tag configured to receive an RFID signal. A device reader coupled to a health care provider computer transmits the RFID signal. The dormant function on the glucose meter can include any number of functions, such as a structured glucose test and/or the ability to automatically generate reports.

Abstract: A system and method described herein simplifies data entry by a subject of a structured blood glucose test as well as helps with dietary compliance by providing specific dietary suggestions to the user. The system includes a portable device configured to be possessed by the subject. The portable device has a location detection system configured to provide data indicative of the location of the subject. A food database provides to the portable device a list of food items that are limited based on foods available at the location, such as a restaurant. The portable device is configured to receive a selection from the list that is indicative of a food consumed by the subject. A blood glucose meter reads blood glucose readings from the subject. The food database is configured to store the blood glucose readings and information about the foods consumed by the subject. Compliance to a prescribed dietary regimen can be monitored by the user and/or a physician.

Abstract: Embodiments of methods of performing a structured collection protocol on a collection device comprise providing a plurality of prior biomarker sample, wherein the prior biomarker samples comprise at least one measured value and plurality of contextualized data components linked to the prior biomarker samples, setting a first criterion, wherein the first criterion classifies prior biomarker samples as similar if prior biomarker samples share at least one identical contextualized data component, grouping biomarker samples that are determined to be similar based on the first criterion, calculating expected values for future biomarker samples which satisfy the first criterion, wherein the calculation is based on at least a subset of the group of similar prior biomarker samples, setting a second criterion, wherein the second criterion is an acceptable variance from the calculated expected values, a threshold, or both, collecting one or more biomarker samples which satisfy the first criterion, and evaluating via th

Abstract: Embodiments of methods of querying a diabetic patient regarding compliance with adherence criteria comprises instructing the diabetic patient to collect at least one sample in a sampling set of biomarker data, wherein each sampling set comprises a sufficient plurality of samples recorded over a collection period, comparing the collected samples to an acceptable range, wherein the acceptable range encompasses biomarker values that would be expected upon compliance with the adherence criteria, and informing the diabetic patient if at least one sample is an unacceptable value which falls outside of the acceptable range, and performing at least one additional task after detecting the unacceptable value.

Abstract: A method is provided for constructing a structured test having user-defined adherence criteria. The method includes: presenting a patient with a plurality of contextual criterion for a structured test; receiving selection of one or more contextual criterion from the plurality of contextual criterion; and constructing a structured test that includes the contextual criterion selected by the patient. During administration of the structured test, each of the contextual criteria selected by the patient is evaluated.

Abstract: A therapy delivery system having an open architecture and method of providing thereof are disclosed. The present invention provides a therapy dosage module having a control algorithm that can be replaced with a predefined or independently defined control algorithm. The tools necessary to create and test such control algorithms in the therapy dosage module in a simulated environment before implementing it in a live therapy system are also disclosed.

Abstract: A collection device for performing a structured collection procedure may include a processor that executes program instructions communicably coupled to at least one memory. The processor can initiate a schedule of events of the structured collection procedure upon one or more entry criterions being met and segregate the at least one memory into a primary data store and a secondary data store. The processor can write structured patient data collected in accordance to the schedule of events to the secondary data store. The processor can transform a relevant portion of the structured patient data into an evaluated data object. The processor can generate a data abstraction based in part upon the evaluated data object. The processor can link the primary data store and the secondary data store with the data abstraction.

Abstract: In one embodiment, a method of performing a structured collection protocol by utilizing a collection device comprising a processor may include collecting at least one sample using the collection device. The at least one sample can be associated with biomarker data. A classification can be associated with the at least one sample via the processor. The classification can be based upon an intended use of the at least one sample. Compliance with an adherence criteria for the at least one sample can be determined via the processor. When the at least one sample is not compliant with the adherence criteria, an adherence event can be associated with the at least one sample, and the processor can perform at least one additional task that is based upon the classification associated with the at least one sample.

Abstract: A therapy delivery system having an open architecture and method of providing thereof are disclosed. The present invention provides a therapy dosage module having a control algorithm that can be replaced with a predefined or independently defined control algorithm. The tools necessary to create and test such control algorithms in the therapy dosage module in a simulated environment before implementing it in a live therapy system are also disclosed.