Abstract: A collection device with a selective display of test results and method thereof are disclosed. A structured collection procedure defining data collection times and the associated context of the collection also defines what information regarding the results of the collection may be viewable by a user performing the structured collection procedure on the device. In this manner, the patient can be monitored according to the structured collection procedure while preventing the patient from modifying his or her behavior based on collection results.

Abstract: Methods for decentralized monitoring of a progression of a diabetic state of a patient include contemporaneously obtaining an initial set of venous blood samples and an initial set of capillary blood samples after a standardized metabolic challenge from the patient in a centralized setting, wherein the diabetic state is diagnosed using the initial set of venous blood samples and a first test baseline is established by correlating the initial set of capillary blood samples with the initial set of venous blood samples, implementing a therapy, performing decentralized testing after reaching a target event, wherein a status test is obtained from a status set of capillary blood samples obtained from the patient after a subsequent standardized metabolic challenge, and comparing the status test with the first test baseline to determine an effectiveness of the therapy.

Abstract: An electrochemical biosensor with electrode elements that possess smooth, high-quality edges. These smooth edges define gaps between electrodes, electrode traces and contact pads. Due to the remarkable edge smoothness achieved with the present invention, the gaps can be quite small, which provides marked advantages in terms of test accuracy, speed and the number of different functionalities that can be packed into a single biosensor. Further, the present invention provides a novel biosensor production method in which entire electrode patterns for the inventive biosensors can be formed all at one, in nanoseconds—without regard to the complexity of the electrode patterns or the amount of conductive material that must be ablated to form them.

Abstract: A biosensor container comprising a housing defining an internal glucose test strip compartment. The housing has an engagement portion for retaining a detachable means for storing data, and the means for storing data has data stored thereon specific to a batch of glucose test strips. At least one of the housing and the means for storing data includes at least one data reading element that is externally accessible when the means for storing data is retained by the engagement portion of the housing. The container includes various fail safe features to prevent mishandling and insure the user obtains the correct results. The housing includes means for connecting to the bG meter only when the means for storing data is retained by the housing. The housing further includes means for dispensing glucose test strips only when the housing is in either of an attached-to meter mode or a stand-alone mode.

Abstract: An electrochemical biosensor with electrode elements that possess smooth, high-quality edges. These smooth edges define gaps between electrodes, electrode traces and contact pads. Due to the remarkable edge smoothness achieved with the present invention, the gaps can be quite small, which provides marked advantages in terms of test accuracy, speed and the number of different functionalities that can be packed into a single biosensor. Further, the present invention provides a novel biosensor production method in which entire electrode patterns for the inventive biosensors can be formed all at one, in nanoseconds—without regard to the complexity of the electrode patterns or the amount of conductive material that must be ablated to form them.

Abstract: A test strip with a sample receiving chamber having a novel flared portion that terminates in a sample receiving opening. The flared portion provides a reservoir from which sample fluid can be drawn into the capillary or sample receiving chamber. The wider opening provided by the present invention is easier to “target” with a sample fluid. In preferred embodiments, the hydrophilic reagent layer extends to the dosing end or side of the test strip and further promotes wicking of the sample into the sample receiving chamber and thus reduces dose hesitation. In other preferred embodiments, a tapered dosing end is provided on the test strip in combination with the flared portion, and this combination create a test strip that will draw sample fluid into the sample receiving chamber regardless of where along the dosing edge of the test strip the fluid sample makes contact.

Abstract: A test strip with a sample receiving chamber having a novel flared portion that terminates in a sample receiving opening. The flared portion provides a reservoir from which sample fluid can be drawn into the capillary or sample receiving chamber. The wider opening provided by the present invention is easier to “target” with a sample fluid. In preferred embodiments, the hydrophilic reagent layer extends to the dosing end or side of the test strip and further promotes wicking of the sample into the sample receiving chamber and thus reduces dose hesitation. In other preferred embodiments, a tapered dosing end is provided on the test strip in combination with the flared portion, and this combination create a test strip that will draw sample fluid into the sample receiving chamber regardless of where along the dosing edge of the test strip the fluid sample makes contact.

Abstract: Methods for decentralized monitoring of a progression of a diabetic state of a patient include contemporaneously obtaining an initial set of venous blood samples and an initial set of capillary blood samples after a standardized metabolic challenge from the patient in a centralized setting, wherein the diabetic state is diagnosed using the initial set of venous blood samples and a first test baseline is established by correlating the initial set of capillary blood samples with the initial set of venous blood samples, implementing a therapy, performing decentralized testing after reaching a target event, wherein a status test is obtained from a status set of capillary blood samples obtained from the patient after a subsequent standardized metabolic challenge, and comparing the status test with the first test baseline to determine an effectiveness of the therapy.

Abstract: A test strip with a sample receiving chamber having a novel flared portion that terminates in a sample receiving opening. The flared portion provides a reservoir from which sample fluid can be drawn into the capillary or sample receiving chamber. The wider opening provided by the present invention is easier to “target” with a sample fluid. In preferred embodiments, the hydrophilic reagent layer extends to the dosing end or side of the test strip and further promotes wicking of the sample into the sample receiving chamber and thus reduces dose hesitation. In other preferred embodiments, a tapered dosing end is provided on the test strip in combination with the flared portion, and this combination create a test strip that will draw sample fluid into the sample receiving chamber regardless of where along the dosing edge of the test strip the fluid sample makes contact.

Abstract: A collection device with a selective display of test results and method thereof are disclosed. A structured collection procedure defining data collection times and the associated context of the collection also defines what information regarding the results of the collection may be viewable by a user performing the structured collection procedure on the device. In this manner, the patient can be monitored according to the structured collection procedure while preventing the patient from modifying his or her behavior based on collection results.

Abstract: In one embodiment, a modular diabetes management system includes a portable, stand-alone blood glucose meter and a portable docking device that includes an internal receptacle sized and structured to receive and house the blood glucose meter. The docking device is generally operable to interface with the blood glucose meter and perform various diabetes management functions. For example, the docking device may be operable to analyze blood glucose measurement data stored on the blood glucose meter, configure the blood glucose meter, and/or interact with an insulin delivery device, just to name a few possibilities. Other embodiments include unique methods, systems, kits, assemblies, equipment, and/or apparatus which are related to the management of diabetes.

Abstract: A biosensor container comprising a housing defining an internal glucose test strip compartment. The housing has an engagement portion for retaining a detachable means for storing data, and the means for storing data has data stored thereon specific to a batch of glucose test strips. At least one of the housing and the means for storing data includes at least one data reading element that is externally accessible when the means for storing data is retained by the engagement portion of the housing. The container includes various fail safe features to prevent mishandling and insure the user obtains the correct results. The housing includes means for connecting to the bG meter only when the means for storing data is retained by the housing. The housing further includes means for dispensing glucose test strips only when the housing is in either of an attached-to meter mode or a stand-alone mode.

Abstract: The invention concerns a process for producing a diagnostic test element for analyzing a body fluid in which a lancing member that can puncture a body part is provided with a collecting channel for body fluid obtained by the puncture, wherein the collecting channel exhibits capillary action, and wherein a sensor member for an optical or electrochemical measurement is connected to the lancing member. According to the invention, the sensor member and the lancing member can be joined together as interlocking connecting components wherein a measuring element of the sensor member is inserted into the collecting channel through an insertion opening of the lancing member.

Abstract: An electrochemical biosensor with electrode elements that possess smooth, high-quality edges. These smooth edges define gaps between electrodes, electrode traces and contact pads. Due to the remarkable edge smoothness achieved with the present invention, the gaps can be quite small, which provides marked advantages in terms of test accuracy, speed and the number of different functionalities that can be packed into a single biosensor. Further, the present invention provides a novel biosensor production method in which entire electrode patterns for the inventive biosensors can be formed all at one, in nanoseconds—without regard to the complexity of the electrode patterns or the amount of conductive material that must be ablated to form them.

Abstract: An electrochemical biosensor with electrode elements that possess smooth, high-quality edges. These smooth edges define gaps between electrodes, electrode traces and contact pads. Due to the remarkable edge smoothness achieved with the present invention, the gaps can be quite small, which provides marked advantages in terms of test accuracy, speed and the number of different functionalities that can be packed into a single biosensor. Further, the present invention provides a novel biosensor production method in which entire electrode patterns for the inventive biosensors can be formed all at one, in nanoseconds—without regard to the complexity of the electrode patterns or the amount of conductive material that must be ablated to form them.

Abstract: A method of making a biosensor is provided. The method includes providing an electrically conductive material on a base and partially removing the conductive material using laser ablation from the base so that less than 90% of the conductive material remains on the base and at least one electrode pattern is formed from the conductive material. The at least one electrode pattern has an edge extending between two points. A standard deviation of the edge from a line extending between two points is less than about 6 ?m along the length of the edge.

Abstract: A method of making a biosensor is provided. The biosensor includes an electrically conductive material on a base and electrode patterns formed on the base, the patterns having different feature sizes. The conductive material is partially removed from the base using broad field laser ablation so that less than 90% of the conductive material remains on the base and that the electrode pattern has an edge extending between two points.

Abstract: An electrochemical biosensor with electrode elements that possess smooth, high-quality edges. These smooth edges define gaps between electrodes, electrode traces and contact pads. Due to the remarkable edge smoothness achieved with the present invention, the gaps can be quite small, which provides marked advantages in terms of test accuracy, speed and the number of different functionalities that can be packed into a single biosensor. Further, the present invention provides a novel biosensor production method in which entire electrode patterns for the inventive biosensors can be formed all at one, in nanoseconds—without regard to the complexity of the electrode patterns or the amount of conductive material that must be ablated to form them.

Abstract: A system for testing for analytes in a sample of biological fluid includes a test strip that defines a cavity for receiving the sample. At least two sets of electrodes are adjacent the sample cavity, including one for measuring one property of the sample, and another for measuring one or more other properties of the sample, such as temperature and/or the presence or magnitude of confounding variables. The measurements are combined to yield the desired result. At least one set of working and counter electrodes each have a plurality of elongated “fingers” interdigitated with those of the other electrode in the set. The gaps between fingers can be quite small, so that the two electrode sets together can operate in a small measurement volume of sample. Additional electrodes can be included that measure the presence or sufficiency of the sample, and additional traces on the strip can act as configuration identifiers.

Abstract: A test strip with a sample receiving chamber having a novel flared portion that terminates in a sample receiving opening. The flared portion provides a reservoir from which sample fluid can be drawn into the capillary or sample receiving chamber. The wider opening provided by the present invention is easier to “target” with a sample fluid. In preferred embodiments, the hydrophilic reagent layer extends to the dosing end or side of the test strip and further promotes wicking of the sample into the sample receiving chamber and thus reduces dose hesitation. In other preferred embodiments, a tapered dosing end is provided on the test strip in combination with the flared portion, and this combination create a test strip that will draw sample fluid into the sample receiving chamber regardless of where along the dosing edge of the test strip the fluid sample makes contact.