Granted Patent B2

US 9,835,578 · App. 13/929,495 · Granted Dec 5, 2017

Inventor: Michael Malecha (Muir of Ord, GB)

Assignee: LifeScan Scotland Limited

G01N27/3274

Abstract

Claims (104)

1. A glucose concentration measurement system comprising:

a biosensor having a plurality of electrodes including at least two electrodes with an enzyme disposed thereon; and

a meter including:

a temperature sensing device issuing a temperature signal indicative of a temperature proximate the biosensor;

a microcontroller, responsive to the temperature signal, and coupled to a power source, memory and the plurality of electrodes of the biosensor and in which the microcontroller is programmed to:

measure ambient temperature proximate the biosensor;

drive a signal to the at least two electrodes when a fluid sample with a glucose analyte is deposited proximate the at least two electrodes;

measure a signal output from the at least two electrodes during an electrochemical reaction;

calculate an uncompensated glucose concentration from the signal output;

adjust the uncompensated glucose concentration to a final glucose concentration based on a compensation term,

increasing the compensation term as a function of increasing glucose concentration;

(a) increasing the compensation term as the ambient temperature proximate the biosensor decreases from about twenty-two (22) degrees Celsius to about five (5) degrees Celsius: and

(b) maintaining the compensation term at a value of about zero (0) as the ambient temperature proximate the biosensor varies from about twenty-two (22) degrees Celsius to about forty-five (45) degrees Celsius; and

annunciate the final glucose concentration in which the microcontroller is configured to:

(a) apply a first signal to the plurality of electrodes so that a hematocrit level of the fluid sample is determined;

(b) estimate a glucose concentration based on a predetermined sampling time point during a test sequence;

(c) apply a second signal to the plurality of electrodes; and

(d) measure output signals from the plurality of electrodes at a specified sampling time during the test sequence dictated by the determined hematocrit level so that a glucose concentration is calculated from the output signals of the plurality of electrodes, the specified sampling time being selected from a look-up table programmed into the microcontroller that includes a matrix having measured or estimated glucose concentrations provided in the leftmost column of the matrix and estimated or measured levels of the hematocrit level provided in the topmost row of the matrix with the specified sampling times being provided in the remaining cells of the matrix to derive the specified sampling time based on the determined hematocrit level and the estimated glucose concentration.

2. The system of claim 1 , in which the microcontroller determines the uncompensated glucose concentration with an equation of the form:

G

0

=

[

I

T

-

Intercept

Slope

]

where

G O represents an uncompensated glucose concentration;

I T represents a signal measured at the selected SpecifiedSamplingTime;

Slope represents the value obtained from calibration testing of a batch of test strips of which this particular strip comes from; and

Intercept represents the value obtained from calibration testing of a batch of test strips of which this particular strip comes from.

3. The system of claim 1 , in which the microcontroller estimates the glucose concentration with an equation of the form:

G

est

=

(

I

E

-

x

2

)

x

1

Where

G est represents the estimated glucose concentration;

I E is the signal measured at about 2.5 seconds;

x 1 comprises a calibration slope of a particular batch of biosensors;

x 2 comprises a calibration intercept of a particular batch of biosensors; and

in which the microcontroller determines the uncompensated glucose concentration with an equation of the form:

G

o

=

(

I

S

-

x

4

)

x

3

where:

G O represents the uncompensated glucose concentration;

x 3 comprises a calibration slope of a particular batch of biosensors; and

x 4 comprises the intercept of a particular batch of biosensors.

4. A glucose measurement system comprising: a test strip including:

a substrate;

a plurality of electrodes connected to respective electrode connectors; and

a glucose meter including:

a housing;

a test strip port connector configured to connect to the respective electrode connectors of the test strip;

a temperature sensing device issuing a temperature signal indicative of a temperature proximate the biosensor;

a microprocessor, responsive to the temperature signal, and in electrical communication with the test strip port connector to apply electrical signals or sense electrical signals from the plurality of electrodes, wherein the microprocessor is configured to:

(a) apply a first signal to the plurality of electrodes so that a hematocrit level of a fluid sample is determined;

(b) estimate a glucose concentration based on a predetermined sampling time point during a test sequence;

(c) apply a second signal to the plurality of electrodes at a specified sampling time point during the test sequence dictated by the determined hematocrit level so that an uncompensated glucose concentration is calculated from the second signal in which the specified sampling time point is selected from a look-up table programmed into the microprocessor, the look-up table including a matrix in which estimated glucose concentrations are set forth in the leftmost column of the matrix and measured or estimated levels of the hematocrit level are set forth in the topmost row of the matrix with the specified sampling time points being provided in the remaining cells of the matrix; and

(d) compensate the uncompensated glucose concentration with a compensation term that:

(i) increases for uncompensated glucose concentration values that are increasing;

(ii) increases as the ambient temperature proximate the biosensor decreases from about twenty-two (22) degrees Celsius to about five (5) degrees Celsius: and

(iii) maintained at a value of about zero (0) for ambient temperatures proximate the biosensor which vary from about twenty-two (22) degrees Celsius to about forty-five (45) degrees Celsius; and

annunciate the final glucose concentration value.

5. The system of claim 4 , in which the plurality of electrodes comprises at least two electrodes to measure the hematocrit level and at least two other electrodes to measure the glucose concentration.

6. The system of claim 5 , in which the at least two electrodes and the at least two other electrodes are disposed in the same chamber provided on the substrate.

7. The system of claim 5 , in which the at least two electrodes and the at least two other electrodes are disposed in respective two different chambers provided on the substrate.

8. The system of claim 5 , in which all of the electrodes are disposed on the same plane defined by the substrate.

9. The system of claim 5 , in which a reagent is disposed proximate the at least two other electrodes and no reagent is disposed on the at least two electrodes.

10. The system of claim 5 , in which the final glucose concentration is determined from the second signal within about 10 seconds of a start of the test sequence.

11. A glucose meter comprising:

a housing;

a test strip port connector configured to connect to respective electrode connectors of a test strip; and

means for:

(a) sensing a temperature of the environment proximate the housing;

(b) determining a specified sampling time based on a sensed or estimated hematocrit level of a sample deposited on a plurality of electrodes of the test strip, the specified sampling time being at least one time point or interval referenced from a start of a test sequence upon deposition of a sample on the test strip, in which the specified sampling time is selected from a look-up table, the look-up table including a matrix in which different qualitative categories of an estimated glucose concentration are set forth in the leftmost column of the matrix and different qualitative categories of a sensed or estimated hematocrit level of the sample are set forth in the topmost row of the matrix and the specified sampling times are provided in the remaining cells of the matrix:

(c) determining an uncompensated glucose concentration based on the specified sampling time;

(d) compensating the uncompensated glucose concentration with a compensation term that:

(i) increases as a function of increasing glucose concentrations;

(ii) increases as the ambient temperature proximate the biosensor decreases from about twenty-two (22) degrees Celsius to about five (5) degrees Celsius;

(iii) is maintained at a value of about zero (0) as the ambient temperature proximate the biosensor varies from about twenty-two (22) degrees Celsius to about forty-five (45) degrees Celsius; and

(e) annunciating the final glucose concentration value.

12. The meter of claim 11 , in which the means for determining includes means for applying a first signal to the plurality of electrodes so that a batch slope defined by the hematocrit level of a fluid sample is derived and for applying a second signal to the plurality of electrodes so that the compensated glucose concentration is determined based on the derived batch slope and the specified sampling time.

Assignments (18)

Continuity (2)