IP Library Granted Patent US 8,551,320
Granted Patent B2
US 8,551,320 · App. 12/464,935 · Granted Oct 8, 2013

System and method for measuring an analyte in a sample

Inventors: Alastair M. Hodges (Blackburn South, AU); Ronald C. Chatelier (Bayswater, AU)
Assignee: LifeScan, Inc.
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Quick Facts
Patent No.
US 8,551,320
App. No.
12/464,935
Filed
May 13, 2009
Granted
Oct 8, 2013
Kind
B2
Art Unit
1759
USPC
205/775
Abstract

Methods for calculating an analyte concentration of a sample are provided. In one exemplary embodiment the method includes steps that are directed toward accounting for inaccuracies that occur as a result of temperature variations in a sample, a meter, or the surrounding environment. In another exemplary embodiment the method includes steps that are directed toward determining whether an adequate sample is provided in a meter because insufficient samples can result in inaccuracies. The methods that are provided can be incorporated into a variety of mechanisms, but they are primarily directed toward glucose meters for blood samples and toward meters for controls solutions.

Claims (49)

1. A method for measuring a temperature corrected glucose concentration over a temperature range, the method comprising the steps of:

applying in a test meter a first test voltage for a first time between a first electrode and a second electrode in communication with a sample disposed on a test strip within the test meter, the first time interval being sufficient to oxidize a reduced mediator at the second electrode;

following the application of the first test voltage, applying a second test voltage for a second time interval between the first electrode and the second electrode sufficient to oxidize the reduced mediator at the first electrode;

calculating a first glucose concentration based on test current values during the first time interval and the second time interval;

measuring a temperature value using a temperature reading device incorporated into the test meter that receives the test strip; and

calculating a temperature corrected glucose concentration based on the first glucose concentration and the temperature value, wherein the step of calculating the temperature corrected concentration includes the additional steps of:

calculating a correction value based on the temperature value and the first glucose concentration; and

calculating a temperature corrected concentration based on the first glucose concentration and the correction value, wherein the correction value is calculated with a first function if the temperature value is greater than a first temperature threshold, and wherein the correction value is calculated with a second function if the temperature value is not greater than a first temperature threshold, and in which the first function is a first equation, the first equation being:

Corr 2 =−K 1 ( T−T RT )+ K 2 ×G 1 ( T−T RT )

Where Corr 2 is the correction value, K 1 is a first constant, T is a temperature value, T RT is a room temperature value, K 2 is a second constant and G 1 is the first glucose concentration.

2. The method of claim 1 , in which the correction value is about zero when the temperature value is about equal to room temperature value.

3. The method of claim 2 , in which the room temperature is about 22 degrees Celsius.

4. The method of claim 1 , further comprising the additional steps of:

determining whether the applied sample is a control solution; and

calculating the correction value with a third function if the applied sample is control solution.

5. A method for measuring a temperature corrected glucose concentration over a temperature range, the method comprising the steps of:

applying in a test meter a first test voltage for a first time between a first electrode and a second electrode in communication with a sample disposed on a test strip within the test meter, the first time interval being sufficient to oxidize a reduced mediator at the second electrode;

following the application of the first test voltage, applying a second test voltage for a second time interval between the first electrode and the second electrode sufficient to oxidize the reduced mediator at the first electrode;

calculating a first glucose concentration based on test current values during the first time interval and the second time interval;

measuring a temperature value using a temperature reading device incorporated into the test meter that receives the test strip; and

calculating a temperature corrected glucose concentration based on the first glucose concentration and the temperature value, wherein the step of calculating the temperature corrected concentration includes the additional steps of:

calculating a correction value based on the temperature value and the first glucose concentration; and

calculating a temperature corrected concentration based on the first glucose concentration and the correction value, wherein the correction value is calculated with a first function if the temperature value is greater than a first temperature threshold, and wherein the correction value is calculated with a second function if the temperature value is not greater than a first temperature threshold, and in which the second function is a second equation, the second equation being:

Corr 2 =−K 3 ( T−T RT )+ K 4 ×G 1 ( T−T RT )+ K 5 ×G 1 ( T−T 1 )+ K 6 ×G 1 ( T−T 1 )

where Corr 2 is the correction value, K 3 is a third constant, T is a temperature value, T RT is a room temperature value, K 4 is a fourth constant, G 1 is a first glucose concentration, K 5 is a fifth constant, T 1 is a first temperature threshold and K 6 is a sixth constant.

6. The method of claim 5 , in which the correction value is about zero when the temperature value is about equal to room temperature value.

7. The method of claim 6 , in which the room temperature is about 22 degrees Celsius.

8. The method of claim 5 , said method further comprising the additional steps of:

determining whether the applied sample is a control solution; and

calculating the correction value with a third function if the applied sample is control solution.

9. The method of claim 1 or 5 , in which the step of calculating the temperature corrected concentration further comprises:

adding the correction value to the first glucose concentration to give the temperature corrected concentration if the first glucose concentration is less than a glucose threshold.

10. The method of claim 1 or 5 , in which the step of calculating the temperature corrected concentration further comprises:

dividing the correction value by one hundred and adding one to give an intermediate term; and

multiplying the intermediate term times the first glucose concentration to give a temperature corrected concentration.

11. The method of claim 1 or 5 that further comprises the following step,

determining if the correction value is greater than a threshold value, then setting the correction value to the threshold value, where the threshold value is about ten.

12. A method for measuring a temperature corrected glucose concentration over a temperature range, the method comprising the steps of:

applying in a test meter a first test voltage for a first time between a first electrode and a second electrode in communication with a sample disposed on a test strip within the test meter, the first time interval being sufficient to oxidize a reduced mediator at the second electrode;

following the application of the first test voltage, applying a second test voltage for a second time interval between the first electrode and the second electrode sufficient to oxidize the reduced mediator at the first electrode;

calculating a first glucose concentration based on test current values during the first time interval and the second time interval;

measuring a temperature value using a temperature reading device incorporated into the test meter that receives the test strip; and

calculating a temperature corrected glucose concentration based on the first glucose concentration and the temperature value, wherein the step of calculating the temperature corrected concentration includes the additional steps of:

calculating a correction value based on the temperature value and the first glucose concentration;

calculating a temperature corrected concentration based on the first glucose concentration and the correction value, wherein the correction value is calculated with a first function if the temperature value is greater than a first temperature threshold, wherein the correction value is calculated with a second function if the temperature value is not greater than a first temperature threshold, said method further including the steps of

determining whether the applied sample is a control solution; and

calculating the correction value with a third function if the applied sample is a control solution, and in which the third function is a third equation, the third equation being:

Corr 2 =−K 7 ( T−T RT )+ K 8 ×G 1 ( T−T RT )

where Corr 2 is the correction value, K 7 is a first constant, T is a temperature value, T RT is a room temperature value, K 8 is a second constant and G 1 is the first glucose concentration.

Assignments (20)
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 →
SECURITY INTEREST Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: ACQUIOM AGENCY SERVICES LLC, AS COLLATERAL AGENT
Reel/Frame 073890/0305 →
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 →
SECURITY AGREEMENT Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 073893/0622 →
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 →
CORRECTIVE ASSIGNMENT TO CORRECT THE PROPERTY LIST BY ADDING PATENTS 6990849;7169116; 7351770;7462265;7468125; 7572356;8093903; 8486245;8066866;AND DELETE 10881560. PREVIOUSLY RECORDED ON REEL 050836 FRAME 0737. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 28, 2023
From: LIFESCAN INC.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 064782/0443 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: CILAG GMBH INTERNATIONAL
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 050837/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: LIFESCAN INC.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 050836/0737 →
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 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE'S COMPANY NAME SHOULD BE CORRECTED TO DELETE THE WORDS "LIFESCAN, DIVISION OF" PREVIOUSLY RECORDED ON REEL 023532 FRAME 0943. ASSIGNOR(S) HEREBY CONFIRMS THE CORRECT NAME OF THE ASSIGNEE SHOULD BE CILAG GMBH INTERNATIONAL. Recorded Dec 3, 2009
From: LIFESCAN, INC.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 023602/0241 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 18, 2009
From: LIFESCAN, INC.
To: LIFESCAN, DIVISION OF CILAG GMBH INTERNATIONAL
Reel/Frame 023532/0943 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 1, 2009
From: HODGES, ALASTAIR M.; CHATELIER, RONALD C.
To: LIFESCAN, INC.
Reel/Frame 022760/0926 →
Continuity (2)
Provisional Application 61131572 · Jun 9, 2008
Related Publication 20090301899A1 · Dec 10, 2009