Roche Diagnostics Operations, Inc.

Roche Operations Ltd.

Roche Diabetes Care, Inc.

F. Hoffmann-la Roche Ag

Paul Douglas Walling

Nigel A Surridge

Raghbir Singh Bhullar

Brian S Hill

Eric R Diebold

Randall K Riggles

Tom Funke

David W Burke

Terry Allen Beaty

Harvey B Buck, Jr

Abhishek S Soni

Stefan Weinert

Steven Bousamra

Juergen Rasch-Menges

Vladimir Svetnik

Melani G Sullivan

Nigel Anthony Surridge

Melani Sullivan

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.

Methods and apparatus for decentralized diabetes monitoring

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&#x2014;without regard to the complexity of the electrode patterns or the amount of conductive material that must be ablated to form them.

Biosensor and method of making

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.

Devices and methods relating to electrochemical biosensors

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.

Test strip with flared sample receiving chamber

A biosensor having multiple electrical functionalities located both within and outside of the measurement zone in which a fluid sample is interrogated. Incredibly small and complex electrical patterns with high quality edges provide electrical functionalities in the biosensor and also provide the electrical wiring for the various other electrical devices provided in the inventive biosensor. In addition to a measurement zone with multiple and various electrical functionalities, biosensors of the present invention may be provided with a user interface zone, a digital device zone and/or a power generation zone. The inventive biosensors offer improved ease of use and performance, and decrease the computational burden and associated cost of the instruments that read the biosensors by adding accurate yet cost-effective functionalities to the biosensors themselves.

Biosensor with multiple electrical functionalities

Growing community of inventors

Indianapolis, IN, United States of America

Paul Douglas Walling