Roche Diabetes Care, Inc.

Roche Diagnostics Operations, Inc.

Boehringer Mannheim Gmbh

F. Hoffmann-la Roche Ag

P Douglas Walling

Stefan Weinert

Steven Bousamra

Juergen Rasch-Menges

Abhishek S Soni

Christoph Eisenhardt

Alan Greenburg

Ulrich Porsch

Heino Eikmeier

John F Price

Karl Werner

Birgit Kraeling

Michael J Celentano

Lance Scott Kuhn

Chi-Neng Arthur Han

Martin T Gerber

Klaus H Pollmann

Joseph E Bateson

Kent M Kost

M Luann Ochs

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.

Structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof

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.

Management method and system implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device

Embodiments of a testing method for diabetics to optimize their administered insulin dosage comprise collecting sampling sets of biomarker data, each sampling set comprising a sufficient plurality of non-adverse sampling instances and each sampling instance comprising 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 the insulin dosage does not exceed maximum dosage, and exiting the testing method if the adjusted insulin dosage is optimized. The insulin dosage is optimized when biomarker sampling parameters fall within the target biomarker range.

Systems and methods for optimizing insulin dosage

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. The insulin dosage is optimized when one or more biomarker sampling parameters fall within a target biomarker range.

Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device

A remote measurement system measures the concentrations of analytes in fluid samples. The system includes a metering device that can receive signals from a test strip or alternatively interrogate the test strip to obtain information. The test strip includes an area for receiving a fluid sample and electrochemically producing a current response that is sensed within the fluid sample. The test strip also includes an antenna and a radio frequency signal circuit for transmitting a signal indicative of the current response of a fluid sample to be analyzed. The metering device receives the signal and can convert it into a readable display in some embodiments. Remote electrochemical analysis of a fluid sample is thereby obtained.

System and method for the electrochemical measurement of an analyte employing a remote sensor

A new electrochemical biosensor and method of its use. The electrochemical biosensor has a pair of electrodes consisting of a working electrode and a counter electrode made of the same electrically conducting materials. The counter electrode may be the same size or smaller than the working electrode. The biosensor includes a sample receiving portion wherein a portion of the electrode surfaces is covered by a reagent that includes a redox mediator and an enzyme. A fluid that contains an analyte is added to the sample receiving portion. A reaction involving the analyte, enzyme and redox mediator occurs. After this reaction is complete, an electrical potential difference is applied between the electrodes. Diffusion limited current is measured and correlated to the concentration of analyte in the fluid.

Assay method with enzyme electrode system

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Indianapolis, IN, United States of America

P Douglas Walling