Roche Diabetes Care, Inc.

Other

Roche Diagnostics Gmbh

F. Hoffmann-la Roche Ag

Christian Ringemann

David L Duke

Chinmay Uday Manohar

Wolfgang Petrich

Alan Greenburg

Carina Horn

Timo Ottenstein

Markus Plum

Joachim Hoenes

Herbert Wieder

Bernd Steiger

Guenther Schmelzeisen-Redeker

Bernd Limburg

Markus Serr

Nelli Steinke

Nikolaus Schmitt

Alexander Ibach

Simon Aigner

Andreas Weller

Gabriele Chemnitius

Alexa Freifrau Von Ketteler

Günther Schmelzeisen-Redeker

Alexa Von Ketteler

A sensor device for detecting at least one analyte in a body fluid of a user. The sensor device includes an evaluation device for evaluating a data stream of time-dependent concentrations c of the analyte. The evaluation device includes a comparator device for comparing a current value c(t) of the concentration c with a first threshold value L and a second threshold value H, wherein H>L. The evaluation device defines a tolerance time interval. Further, the evaluation device, by using the comparator device, is configured to detect if the concentration c rises and exceeds the first threshold value L during the tolerance time interval and to prepare a warning signal W accordingly. The evaluation device is configured to suppress an output of the warning signal W at least until the tolerance time interval expires, under the precondition that c(t)<H during the tolerance time interval.

Sensor device for detecting at least one analyte in a body fluid of a user

The disclosure relates to a method and system for controlling glucose levels comprising receiving behavioral sensor measurements and analyte sensor measurements, determining a plurality of analyte profiles from continuous analyte sensor measurements; grouping the plurality of analyte profiles into clusters; assigning a selected behavioral parameter or a selected pattern of behavioral parameters to each analyte profile in a first cluster, and providing a treatment recommendation.

System and a method for automatically managing continuous glucose monitoring measurements indicative of glucose level in a bodily fluid

Methods and systems are disclosed for treating a person with diabetes by basal rate adjustment of insulin from a therapy delivery device based on risk associated with a glucose state of the person with diabetes. A method may include determining a current risk metric associated with a detected glucose state. The method may include determining a current risk metric associated with the detected glucose state based on a weighted average of cumulative hazard values of return paths generated from a glucose state distribution around a detected glucose state. The method may include calculating an adjustment to a basal rate of a therapy delivery device based on the current risk metric associated with the detected glucose state and a reference risk metric associated with a reference glucose level.

Risk-based control-to-range blood glucose diabetes management device

A method for detecting an interferent contribution in a biosensor is disclosed. Herein, the biosensor has a first electrode (), a second electrode, and a third electrode (), wherein the first electrode () and the second electrode are covered by a membrane, wherein the first electrode () further includes an enzyme or wherein the first electrode () is covered by an enzyme layer. Further, the first electrode (), the second electrode, and the third electrode () are connected via a potentiostat, wherein, in a normal operational mode, via the potentiostat an electrical potential difference is applied between the first electrode () and the second electrode in a manner that the first electrode () allows for oxidative processes and the third electrode () allows for reductive processes. The method comprises the steps of: The method allows deducting the presence and, preferably, the amount of the interferent in an unambiguous way and is, generally, applicable in case of more than one kind of interferent. Neither additional working electrodes nor supplementary circuit components are required. The method is implementable within sensor electronics architectures of standard biosensors and, thus, applicable in already existing biosensor systems.

Method for detecting an interferent contribution in a biosensor

A method providing a signal quality degree associated with an analyte value measured in a continuous monitoring system is disclosed. The method includes: receiving a measured analyte value from a biosensor; determining at least two impact parameters, wherein each of the impact parameters is influenced by an operational status of the continuous monitoring system and wherein each of the impact parameters is capable of exerting an influence on the signal quality of the biosensor and wherein the influence of each of the impact parameters on the signal quality of the biosensor is expressed by a weight assigned to each of the impact parameters; and determining the signal quality degree associated with the measured analyte value as a function of the weights and the corresponding impact parameters; and providing the signal quality degree associated with the analyte value. A method of calibration using the signal quality degree is also disclosed.

Method for providing a signal quality degree associated with an analyte value measured in a continuous monitoring system

Methods are provided for deriving/determining an analyte concentration that include recording measurement values during a time development indicating a progress of a detection reaction of at least one test substance and a body fluid sample and providing at least one measurement curve F(t) containing the measurement values, where the detection reaction is known to be influenced by the analyte concentration and at least one disturbance variable Y. The methods also include deriving an end value of the measurement curve to form a first variable x, and deriving at least one fit parameter by taking into account an exponential characteristic of the measurement curve, and where the fit parameter forms at least one second variable x. The methods further include deriving/determining the analyte concentration by using at least one multivariate evaluation algorithm adapted to combine xand x. Also provided are computer programs and devices that incorporate the same.

Methods of determining an analyte concentration in a body fluid sample having disturbance variables, as well as computer programs and devices therefor

The invention concerns a method and an apparatus for determining the concentration of an analyte in a body fluid, where the following measures are proposed: providing a layered test element () including an enzyme-based chemistry layer which is responsive to the analyte by a color change, applying a sample of the body fluid onto the test element (), detecting by means of a photometric reflectance measuring device () a reflectance value of the test element (), correcting the measured reflectance value by a predetermined offset value attributed to the test element (), determining a concentration value of the analyte using the offset-corrected reflectance value.

Method and apparatus for determining the concentration of an analyte in a body fluid

Methods are provided for detecting an analyte concentration/presence in a body fluid sample that include providing a set of at least two different evaluation rules, each evaluation rule adapted to derive a set characteristic values from an optical measurement curve, where at least one first characteristic value is derived from at least one first evaluation rule and at least one second characteristic value is derived from at least one second evaluation rule. The methods also include performing at least one multivariate analysis of the at least one first and second characteristic values by using at least one predetermined multivariate evaluation algorithm to derive at least one estimate value for at least one target variable Y of the state variables. The methods also include determining at least one analyte concentration by using the at least one target variable Y. Also provided are computer programs and devices that incorporate the same.

Methods of evaluating medical measurement curves, as well as computer programs and devices therefor

Methods for detecting an analyte in a body fluid are described as well as devices and systems adapted for performing such methods. In embodiments of the method, a sample of body fluid is applied to a test element having at least one test field including at least one test material that is adapted to change at least one measurable property in the presence of the analyte. The test element further includes a capillary to guide the sample across said test field in a flow direction. The test element also includes first and second measurement locations offset from each other in the flow direction. The measurable property is measured in at least one first measurement location, providing at least one first measurement value, and it is measured in at least one second measurement location, providing at least one second measurement value. The analyte is detected by using an evaluation algorithm having at least two input variables, wherein at least one first input variable of the at least two input variables includes a difference between the first measurement value and the second measurement value, and at least one second input variable of the at least two input variables includes information relating to an analyte-induced change of the measurable property of the test material in at least part of the test field.

Method and device for generating a corrected value of an analyte concentration in a sample of a body fluid

The present disclosure refers to a method for determining a blood glucose level for a patient, the method comprising detecting a present sensor signal in a present continuous interstitial blood glucose measurement for a patient; providing measurement data representing the present sensor signal; providing sensor signal correction data representing a patient-specific signal correction, the sensor signal correction data being determined from a former interstitial blood glucose measurement for the patient and comprising at least one of time delay data representing a patient-specific time delay &#x394;t between a blood glucose value measured in a continuous interstitial blood glucose measurement and a blood glucose reference value measured in a capillary blood glucose measurement, and sensor sensitivity data representing, for the patient, a patient-specific sensor sensitivity for the sensor, determining corrected measurement data representing a corrected present sensor signal by applying the sensor signal correction data to the present sensor signal; and determining a blood glucose level for the patient from the corrected measurement data.

Method and system for method for determining a blood glucose level for a patient

A method for providing a signal quality degree associated with an analyte value measured in a continuous monitoring system is disclosed. The method includes the steps of: receiving a measured analyte value from a biosensor; determining at least two impact parameters, wherein each of the impact parameters is influenced by an operational status of the continuous monitoring system and wherein each of the impact parameters is capable of exerting an influence on the signal quality of the biosensor and wherein the influence of each of the impact parameters on the signal quality of the biosensor is expressed by a weight assigned to each of the impact parameters; and determining the signal quality degree associated with the measured analyte value as a function of the weights and the corresponding impact parameters; and providing the signal quality degree associated with the analyte value. Further methods are also disclosed.

A method and system of determining a basal rate adjustment of insulin in a continuous glucose monitoring system of a person with diabetes is provided. The method includes receiving, by at least one computing device, a signal representative of at least one glucose measurement; detecting, by the at least one computing device, a glucose state of the person based on the signal, the detected glucose state including a glucose level of the person and a rate of change of the glucose level; determining, by the at least one computing device, a current risk metric, the current risk metric indicating a risk of at least one of a hypoglycemic condition and a hyperglycemic condition of the person; and calculating, by the at least one computing device, an adjustment to a basal rate of a therapy delivery device based on the current risk metric and a control-to-range algorithm comprising at least one aggressiveness parameter.

Control-to-range aggressiveness

Methods and systems are disclosed for determining a basal rate adjustment of insulin in a continuous glucose monitoring system of a person with diabetes. A method may include receiving, by at least one computing device, a signal representative of at least one glucose measurement and detecting, by the at least one computing device, a glucose state of the person based on the signal, the detected glucose state including a glucose level of the person and a rate of change of the glucose level. The method may also include calculating, by the at least one computing device, an adjustment to a basal rate of a therapy delivery device based on a control-to-range algorithm and at least one failsafe constraint to account for changes in the insulin sensitivity of the person with diabetes or inaccurate glucose measurement.

Control-to-range failsafes

Methods and systems are disclosed for determining a basal rate adjustment of insulin based on risk associated with a glucose state of a person with diabetes. A method may include detecting a glucose state of the person based on a received glucose measurement signal and determining a current risk metric associated with the detected glucose state. The method may include determining a current risk metric associated with the detected glucose state based on a weighted average of cumulative hazard values of return paths generated from a glucose state distribution around a detected glucose state. The method may include calculating an adjustment to a basal rate of a therapy delivery device based on the current risk metric associated with the detected glucose state and a reference risk metric associated with a reference glucose level.

Risk-based control-to-range

An analytical apparatus is disclosed for detecting at least one analyte in a sample, where in an analyte measurement at least an electrical or optical property changeable by presence of the analyte at least one test chemical of a test element is recorded, and where the analytical apparatus also can perform at least one quality measurement on the at least one test chemical such as an intrinsic luminescence, which is recorded and from the intrinsic luminescence a conclusion is drawn on a quality of the test chemical and thus the test element. Methods also are disclosed for detecting at least one analyte in a sample that include a quality measurement of the at least one test chemical of the test strip.

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Mannheim, Germany

Christian Ringemann