IP Library Granted Patent US 9,618,517
Granted Patent B2
US 9,618,517 · App. 13/768,783 · Granted Apr 11, 2017

Analyte measurement method and system with error trapping

Inventors: Stephen Mackintosh (Inverness, GB); David McColl (Inverness, GB)
Assignee: LifeScan Scotland Limited
G01N33/66G01N27/3274
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Quick Facts
Patent No.
US 9,618,517
App. No.
13/768,783
Granted
Apr 11, 2017
Kind
B2
Abstract

Described and illustrated herein are systems and exemplary methods of operating an analyte measurement system having a meter and a test strip. The methods and systems describe herein allow for trapping various errors during calculation of the analyte due to variations in the structure and materials making up the test strip and ambient temperatures.

Claims (308)

1. A method for determining a glucose concentration with a system having a test strip and a meter having a test circuit including a microprocessor, the method comprising:

initiating a chemical reaction between a reference electrode and a second working electrode coated with a reagent layer and between the reference electrode and a first working electrode coated with a reagent layer of the test strip;

measuring a primary test current and a secondary test current on one of the first and second working electrodes;

determining whether a difference between the primary test current and secondary test current is less than zero;

if the difference between the primary test current and secondary test current is less than zero, then deriving a glucose concentration based on a plurality of test currents in which the plurality of measured test currents comprises first, second, third, fourth, and fifth test currents and K comprises a value from about 1.0 to about 2.0, and wherein the deriving comprises calculating a value representative of glucose concentration with an equation of the form:

G

=

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

-

intercept

slope

where:

G comprises the glucose concentration;

I i comprises the first test current;

I 2 comprises the second test current;

I 3 comprises the third test current;

I 4 comprises the fourth test current;

I 5 comprises the fifth test current;

a comprises a first tuning parameter and b comprises a second tuning parameter;

intercept comprises an intercept value determined from a linear regression of a plot of

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

 versus a reference glucose concentration; and

slope comprises a slope value determined from a linear regression of a plot of

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

 versus the reference glucose concentration; and

if the difference between the primary test current and secondary test current is not less than zero, then returning an error.

2. The method of claim 1 , in which the primary test current comprises a current being sampled at about an initiation of the measuring step.

3. The method of claim 1 , in which the secondary test current comprises a current being sampled at about 0.8 seconds after the initiation of the measuring step.

4. The method of claim 1 , in which K comprises a value from about 1 to about 1.4.

5. The method of claim 1 , in which K comprises a value of about 1.4.

6. The method of claim 1 , in which the first test current comprises a test current measured from about 0.98 to about 1.00 seconds after initiation of the measuring.

7. The method of claim 1 , in which the second current comprises a test current measured from about 1.98 to about 2.00 seconds after initiation of the measuring.

8. The method of claim 1 , in which the third current comprises a test current measured from about 2.43 to about 2.45 seconds after initiation of the measuring.

9. The method of claim 1 , in which the fourth current comprises a test current measured from about 2.61 to about 2.63 seconds after initiation of the measuring.

10. The method of claim 1 , in which the fifth current comprises a test current measured from about 2.70 to about 2.72 seconds after initiation of the measuring.

11. The method of claim 1 , in which first tuning parameter comprises a value from about 9.9 to about 10.2 and second tuning parameter comprises a value from about 10.8 to about 11.2.

12. A method for determining a glucose concentration with a system having a test strip and a meter having a test circuit including a microprocessor, the method comprising:

initiating a chemical reaction between a reference electrode and a second working electrode coated with a reagent layer and between the reference electrode and a first working electrode coated with a reagent layer of the test strip;

sampling a plurality of test currents after a blood sample is applied to the test strip;

determining a current ratio from respective tertiary test currents sampled from each of the second and first working electrodes;

querying as to whether the current ratio of the second working electrode to the first working electrode is less than about K, and if the current ratio of the second working electrode to the first working electrode is less than about K, then deriving a glucose concentration based on the plurality of test currents in which the plurality of measured or sampled test currents comprises first, second, third, fourth, and fifth test currents and K comprises a constant and wherein the deriving comprises calculating a value representative of glucose concentration with an equation of the form:

G

=

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

-

intercept

slope

where:

G comprises the glucose concentration;

I i comprises the first test current;

I 2 comprises the second test current;

I 3 comprises the third test current;

I 4 comprises the fourth test current;

I 5 comprises the fifth test current;

a comprises a first tuning parameter and b comprises a second tuning parameter;

intercept comprises an intercept value determined from a linear regression of a plot of

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

 versus a reference glucose concentration; and

slope comprises a slope value determined from a linear regression of a plot of

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

 versus the reference glucose concentration; and

if the current ratio of the second working electrode to the first working electrode is not less than about K, then returning an error.

13. The method of claim 12 , in which the first test current comprises a test current measured from about 0.98 to about 1.00 seconds after initiation of the measuring.

14. The method of claim 12 , in which the second current comprises a test current measured from about 1.98 to about 2.00 seconds after initiation of the measuring.

15. The method of claim 12 , in which the third current comprises a test current measured from about 2.43 to about 2.45 seconds after initiation of the measuring.

16. The method of claim 12 , in which the fourth current comprises a test current measured from about 2.61 to about 2.63 seconds after initiation of the measuring.

17. The method of claim 12 , in which the fifth current comprises a test current measured from about 2.70 to about 2.72 seconds after initiation of the measuring.

18. The method of claim 12 , in which first tuning parameter comprises a value from about 9.9 to about 10.2 and second tuning parameter comprises a value from about 10.8 to about 11.2.

19. A method for determining a glucose concentration with a system having a test strip and a meter having a test circuit including a microprocessor, the method comprising:

initiating a chemical reaction between a reference electrode and a second working electrode coated with a reagent layer and between the reference electrode and a first working electrode coated with a reagent layer of the test strip;

measuring a primary test current and a secondary test current on one of the first and second working electrodes;

determining whether a difference between the primary test current and secondary test current is less than zero;

determining a current ratio from respective tertiary test currents sampled from each of the second and first working electrodes;

evaluating whether a current ratio from respective tertiary test currents sampled from each of the second and first working electrodes is greater than about K, in which K comprises a constant; and

upon either or both of the difference being less than zero or the current ratio being greater than about K, returning an error otherwise deriving a glucose concentration based on the plurality of test currents in which the plurality of measured or sampled test currents comprises first, second, third, fourth, and fifth test currents, K is between about 1.0 and 1.4, and wherein the deriving comprises calculating a value representative of glucose concentration with an equation of the form:

G

=

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

-

intercept

slope

where:

G comprises the glucose concentration;

I 1 comprises the first test current;

I 2 comprises the second test current;

I 3 comprises the third test current;

I 4 comprises the fourth test current;

I 5 comprises the fifth test current;

a comprises a first tuning parameter and b comprises a second tuning parameter;

intercept comprises an intercept value determined from a linear regression of a plot of

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

 versus a reference glucose concentration; and

slope comprises a slope value determined from a linear regression of a plot of

[

(

I

1

I

2

)

(

a

-

b

I

3

I

4

)

x

I

5

]

 versus the reference glucose concentration.

20. The method of claim 19 , in which the first test current comprises a test current measured from about 0.98 to about 1.00 seconds after initiation of the measuring.

21. The method of claim 19 , in which the second current comprises a test current measured from about 1.98 to about 2.00 seconds after initiation of the measuring.

22. The method of claim 19 , in which the third current comprises a test current measured from about 2.43 to about 2.45 seconds after initiation of the measuring.

23. The method of claim 19 , in which the fourth current comprises a test current measured from about 2.61 to about 2.63 seconds after initiation of the measuring.

24. The method of claim 19 , in which the fifth current comprises a test current measured from about 2.70 to about 2.72 seconds after initiation of the measuring.

25. The method of claim 19 , in which first tuning parameter comprises a value from about 9.9 to about 10.2 and second tuning parameter comprises a value from about 10.8 to about 11.2.

Assignments (16)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 18, 2026
From: LIFESCAN GLOBAL CORPORATION; LIFESCAN CHINA, LLC; LIFESCAN IP HOLDINGS, LLC
To: LIFESCAN ENTERPRISES LLC
Reel/Frame 075848/0012 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: ANKURA TRUST COMPANY, LLC
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0495 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: WILMINGTON SAVINGS FUND SOCIETY, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0316 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: WILMINGTON SAVINGS FUND SOCIETY, FSBWILMINGTON SAVINGS FUND SOCIETY, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073928/0626 →
ASSIGNMENT OF PATENT SECURITY INTERESTS (1ST LIEN) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SUCCESSOR AGENT
Reel/Frame 072567/0482 →
TRANSFER OF SECURITY AGREEMENT RECORDED AT REEL 063740, FRAME 0080 Recorded Nov 12, 2024
From: BANK OF AMERICA, N.A., AS RESIGNING AGENT
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SUCCESSOR AGENT
Reel/Frame 069340/0243 →
TRANSFER OF SECURITY AGREEMENT RECORDED AT REEL 047179, FRAME 0150 Recorded Nov 11, 2024
From: BANK OF AMERICA, N.A., AS RESIGNING AGENT
To: ANKURA TRUST COMPANY, LLC, AS SUCCESSOR AGENT
Reel/Frame 069314/0022 →
RELEASE OF SECOND LIEN PATENT SECURITY AGREEMENT RECORDED OCT. 3, 2018, REEL/FRAME 047186/0836 Recorded Jun 28, 2023
From: BANK OF AMERICA, N.A.
To: LIFESCAN IP HOLDINGS, LLC; JANSSEN BIOTECH, INC.; JOHNSON & JOHNSON CONSUMER INC.
Reel/Frame 064206/0176 →
SECOND LIEN PATENT SECURITY AGREEMENT Recorded May 23, 2023
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A.
Reel/Frame 063740/0080 →
FIRST LIEN PATENT SECURITY AGREEMENT Recorded May 22, 2023
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A.
Reel/Frame 063712/0430 →
CORRECTIVE ASSIGNMENT TO CORRECT THE DELETING PROPERTY NUMBER 6990849, 7169116, 7351770, 7462265,7468125, 7572356, 8093903, 8486245, 8066866 AND ADD 10431140 PREVIOUSLY RECORDED AT REEL: 050839 FRAME: 0634. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded May 12, 2023
From: LIFESCAN SCOTLAND LTD.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 064656/0141 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: CILAG GMBH INTERNATIONAL
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 050840/0006 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: LIFESCAN SCOTLAND LTD.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 050839/0634 →
SECURITY AGREEMENT Recorded Oct 3, 2018
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047186/0836 →
SECURITY AGREEMENT Recorded Oct 2, 2018
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047179/0150 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 17, 2013
From: MACKINTOSH, STEPHEN; MCCOLL, DAVID
To: LIFESCAN SCOTLAND LIMITED
Reel/Frame 030232/0858 →
Continuity (2)
Provisional Application 61387366 · Sep 28, 2010
Related Publication 20130217053A1 · Aug 22, 2013