Abstract: A process for the manufacture of small sensors with reproducible surfaces, including electrochemical sensors. One process includes forming channels in the surface of a substrate and disposing a conductive material in the channels to form an electrode. The conductive material can also be formed on the substrate by other impact and non-impact methods. In a preferred embodiment, the method includes cutting the substrate to form a sensor having a connector portion and a transcutaneous portion, the two portions having edges that define one continuous straight line.

Abstract: A lancing device and method for self-collecting a sample of body fluid by penetrating a body tissue at a sampling site. The invention includes a housing geometry configured for ease of use at different sampling sites on the body, even by persons having reduced dexterity and/or poor vision. Depth of penetration is selectively controlled by adjusting the stroke range of a spring-driven lancet carrier. A pressure applicator is included for stimulating flow of the body fluid. A transparent portion permits observation of the sampling site.

Abstract: A glucose meter module integrated into a holster device that can securely accommodate another device such as a portable server device or an insulin pump is described. The glucose measuring module and the health device communicate with each other by a short range wireless modality. In the case in which the accommodated device is a server, such as personal digital assistant or cell phone, the device stores data in a memory, displays data on a visual display, and can wirelessly transmit such data to other devices within a personal area network. In the case where the accommodated device is a cell phone, the phone can further transmit data to remote sites. In the case where the accommodated device is an insulin pump, wirelessly received data are stored in a memory, are available for visual display on the insulin pump, and can be incorporated into the electronic processes that regulate the performance of the pump.

Abstract: A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

Abstract: A lancing device and method for self-collecting a sample of body fluid by penetrating a body tissue at a sampling site. The invention includes a housing geometry configured for ease of use at different sampling sites on the body, even by persons having reduced dexterity and/or poor vision. Depth of penetration is selectively controlled by adjusting the stroke range of a spring-driven lancet carrier. A pressure applicator is included for stimulating flow of the body fluid. A transparent portion permits observation of the sampling site.

Abstract: An integrated lancing and measurement device is provided comprising a sensor designed to determine the amount and/or concentration of analyte in a biological fluid having a volume of less than about 1 ?L. A piercing member is adapted to pierce and retract from a site on the patient to cause the fluid to flow therefrom, and the sensor is positioned adjacent to the site on the patient so as to receive the fluid flowing from the site to generate an electrical signal indicative of the concentration of the analyte in the fluid. The sensor is comprised of a working electrode comprising an analyte-responsive enzyme and a redox mediator, and a counter electrode. An analyte monitor is operatively connected to the sensor and adapted to measure the signal generated by the sensor. Also provided are analyte measuring methods that optionally employ the integrated lancing and measurement device.

Abstract: Method and apparatus for providing sensor guard for data monitoring and detection system having a sensor for detecting one or more glucose levels, the sensor including a work electrode disposed on a base material, a reference electrode disposed on the base material, and a guard electrode disposed on the base material, where the guard electrode is maintained substantially at equipotential to the work electrode, and a transmitter operatively coupled to the work electrode and the reference electrode of the sensor for receiving said detected glucose levels, where the transmitter is further configured to transmit a respective signal corresponding to each of the detected glucose levels using a data transmission protocol including wireless data transmission protocols, to a receiver which is configured to receive the transmitted signals corresponding to said detected glucose levels is provided.

Abstract: Method and apparatus for providing a housing integrated with a sensor introducer and a sensor in analyte monitoring system to deploy the sensor and retain the introducer within the housing upon sensor deployment, and mounting a transmitter to the housing to receive the sensor data is described. The housing may be placed on the skin of a patient and a spring biased mechanism, separately provided and coupled to the introducer or by integrally configuring the introducer, triggers the introducer to deploy the insertion mechanism for placement of the sensor at a predetermined depth under the skin of the patient.

Abstract: Method and apparatus for providing a leak detection circuit for data monitoring and management system using the guard trace of a glucose sensor by applying a leak detection test signal to determine whether a leakage current is present is provided. The leak detection circuit may includes an interface circuit such as a capacitor coupled to the guard trace to detect the leakage current when the leak detection test signal is applied to the guard trace, such that the user or patient using the data monitoring and management system such as glucose monitoring systems may be promptly and accurately notified of a failed sensor, and to alert the user to replace the sensor.

Abstract: Method and system for providing a subscription based replenishment transaction of consumable items such as glucose test strips including a data network, a user terminal operatively coupled to the data network, the user terminal configured to receive and transmit data over the data network, and a server terminal operatively coupled to the data network, the server terminal configured to receive from the user terminal a request for establishing an account associated with a consumable item, receive from the user terminal one or more predetermined parameters associated with the account, and generate the account based on the one or more predetermined parameters, where the one or more predetermined parameters include a user specified consumable replenishment level received from the user terminal is disclosed.

Abstract: Novel transition metal complexes of iron, cobalt, ruthenium, osmium, and vanadium are described. The transition metal complexes can be used as redox mediators in enzyme based electrochemical sensors. In such instances, transition metal complexes accept electrons from, or transfer electrons to, enzymes at a high rate and also exchange electrons rapidly with the sensor. The transition metal complexes include at least one substituted or unsubstituted biimidazole ligand and may further include a second substituted or unsubstituted biimidazole ligand or a substituted or unsubstituted bipyridine or pyridylimidazole ligand. Transition metal complexes attached to polymeric backbones are also described.

Abstract: A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.

Abstract: Method and apparatus for providing EMC Class-B compliant RF transmission for a data monitoring and detection system having a sensor for detecting one or more glucose levels, a transmitter configured to transmit a respective signal corresponding to each of the detected glucose levels using a data transmission protocol including wireless data transmission protocols, to a receiver which is configured to receive the transmitted signals corresponding to the detected glucose levels is provided. When placed in an EMC Class-B compliant mode the monitoring and detection system along with any associated patient treatment units would be allowed to operate in hospital environments and on commercial aircraft during flight.

Abstract: Novel transition metal complexes of iron, cobalt, ruthenium, osmium, and vanadium are described. The transition metal complexes can be used as redox mediators in enzyme-based electrochemical sensors. The transition metal complexes include substituted or unsubstituted (pyridyl)imidazole ligands. Transition metal complexes attached to polymeric backbones are also described.

Abstract: A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

Abstract: Thin films of transition metal complex-based redox polymers are electrodeposited on electrodes. When hydrated, an electrodeposited film conducts electrons by electron exchange between backbone-bound, but mobile, functional segments of its redox polymer constituents. These functional segments, or redox complexes, have labile ligands in their inner coordination spheres. The backbones of the redox polymers have strongly coordinating ligands. Electrodeposition results from coordinative crosslinking by exchange of labile ligands and strongly coordinating ligands between polymer chains. When a biological macromolecule or protein, such as a redox enzyme, is added to the solution from which the redox polymer is electrodeposited, it is co-electrodeposited on the electrode surface. When the co-deposited film contains redox enzymes, for example, the modified electrode may be used to catalyze the electrooxidation or electroreduction of substrates of the enzymes.

Abstract: A measurement module for glucose testing includes a glucose testing measurement module housing, a test strip receptacle formed in the housing, and a connector portion formed in the housing and shaped to permit mechanical removable attachment of the housing to a hand-held computer. Electronics determine the amount of glucose present in a sample of body fluid, when the test strip is positioned in the receptacle and the body fluid is placed on a test strip, and communicate the glucose amount to the hand-held computer via the connector portion.

Abstract: A process for the manufacture of small sensors with reproducible surfaces, including electrochemical sensors. One process includes forming channels in the surface of a substrate and disposing a conductive material in the channels to form an electrode. The conductive material can also be formed on the substrate by other impact and non-impact methods. In a preferred embodiment, the method includes cutting the substrate to form a sensor having a connector portion and a transcutaneous portion, the two portions having edges that define one continuous straight line.

Abstract: A method of determining the percentage of glycated hemoglobin in a blood sample is disclosed wherein at least one of the assay steps is performed electrochemically. The method includes determining the total amount of hemoglobin in a sample by electrochemically measuring, in an oxygen electroreduction reaction at a cathode, the amount of oxygen in the sample. Because the amount of oxygen dissolved in the sample is known, the total hemoglobin is determined by subtracting the amount of free oxygen from the total oxygen measured, recognizing the fast equilibrium Hb+O2?HbO2. This can be followed by determining the amount of glycated hemoglobin in the sample. The cathode reaction is accomplished by contacting the sample with an enzyme, the enzyme being a copper-containing enzyme having four copper ions per active unit. The family of these enzymes includes, for example, laccases and bilirubin oxidases.

Abstract: A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.