Abstract: Method embodiments for performing a structured collection protocol by utilizing a collection device comprise collecting one or more sampling sets of biomarker data, wherein each sampling set comprises a sufficient plurality of sampling instances recorded over a collection period.

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: Embodiments related to a system and method managing the implementation, execution, data collection, data analysis and status reporting 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 cause the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criteria 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 criteria being met at some unknown time. Status reporting can be provided throughout the execution of the collection procedure.

Abstract: A system for determining drug administration information may comprise an input device providing for user input of feed forward information having a first parameter component and a second parameter component, a data storage device and a processor. The data storage device may have stored therein a map correlating values of the first and second parameters to drug administration information. The processor may be responsive to user input of the feed forward information to determine corresponding drug administration information according to the map.

Abstract: Embodiments of a testing method suitable for diabetic persons to optimize their administered insulin dosage comprise collecting one or more sampling sets of biomarker data, wherein each sampling set comprises a sufficient plurality of non-adverse sampling instances and wherein each sampling instance comprises an acceptable biomarker reading at a single point in time recorded upon compliance with adherence criteria, determining a biomarker sampling parameter from each sampling set, comparing the biomarker sampling parameter to a target biomarker range, calculating an insulin adjustment parameter associated with the biomarker sampling parameter if the biomarker sampling parameter falls outside the target biomarker range, adjusting the insulin dosage by the insulin adjustment parameter if the biomarker sampling parameter falls outside the target biomarker range and if the insulin dosage does not exceed maximum dosage, and exiting the testing method if the adjusted insulin dosage is optimized.

Abstract: A structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof are disclosed which implement a structured collection procedure based on a medical use case and/or question which provides at least one or more parameters defining entry criterion, a schedule of events, adherence criterion, and exit criterion. The entry criterion establish conditions needed to be met prior to obtaining biomarker data from the patient. Each event can include one or more of a performance time, patient guidance to perform the event, a request for information from the patient a request for patient action, and a request for collection of biomarker data from the patient. The adherence criterion can be used to assess whether an event performed is acceptable to addressing the medical use case and/or question, and the exit criterion establishes conditions needed to be met prior to exiting the collection procedure.

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 providing for user intervention in a medical control arrangement may comprise a first user intervention mechanism responsive to user selection thereof to produce a first user intervention signal, a second user intervention mechanism responsive to user selection thereof to produce a second user intervention signal, and a processor executing a drug delivery algorithm forming part of the medical control arrangement. The processor may be responsive to the first user intervention signal to include an intervention therapy value in the execution of the drug delivery algorithm, and responsive to the second user intervention signal to exclude the intervention therapy value from the execution of the drug delivery algorithm. The medical control arrangement may be a diabetes control arrangement, the drug delivery algorithm may be an insulin delivery algorithm, and the intervention therapy value may be, for example, an intervention insulin quantity or an intervention carbohydrate quantity.