IP Library Granted Patent US 11,723,565
Granted Patent B2
US 11,723,565 · App. 16/009,922 · Granted Aug 15, 2023

Methods and systems for providing calibration point acceptance criteria for calibrating an analyte sensor

Inventors: Xiaoxiao Chen (Washington, DC); Andrew Dehennis (Germantown, MD); Srinivasan Rajaraman (Germantown, MD)
Assignee: Senseonics, Incorporated
A61B5/1495A61B5/0031A61B5/1459A61B5/14503A61B5/14532A61B5/150022A61B5/686A61B5/742G01N33/66G01N33/96A61B5/0004A61B5/0026A61B5/15142A61B2560/0223A61B2560/0252
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Quick Facts
Patent No.
US 11,723,565
App. No.
16/009,922
Granted
Aug 15, 2023
Kind
B2
Abstract

A method and transceiver for calibrating an analyte sensor using one or more reference measurements. In some embodiments, the method may include receiving a first reference analyte measurement (RM1) and determining whether the RM1 is unexpected. In some embodiments, the method may include, if the RM1 was determined to be unexpected, receiving a second reference analyte measurement (RM2). In some embodiments, the method may include determining whether one or more of the RM1 and the RM2 are acceptable as calibration points. In some embodiments, the method may include, if one or more of the RM1 and the RM2 are determined to be acceptable as calibration points, accepting one or more of the RM1 and the RM2 as calibration points. In some embodiments, the method may include calibrating the analyte sensor using at least one or more of the RM1 and the RM2 as calibration points.

Claims (54)

1. An analyte monitoring method comprising:

using a light source of an analyte sensor of an analyte monitoring system to emit excitation light that interacts with indicator molecules of an analyte indicator of the analyte sensor;

using the indicator molecules of the analyte indicator with which the excitation light interacts to emit emission light;

using the analyte sensor to generate sensor data indicative of an amount or concentration of an analyte in proximity to the analyte indicator, wherein using the analyte sensor to generate the sensor data comprises using a photodetector of the analyte sensor to generate a measurement indicative of a level of the emission light emitted by the indicator molecules;

using a transceiver interface device of the analyte sensor to convey the sensor data;

using a sensor interface device of a transceiver of the analyte monitoring system to receive the sensor data conveyed by the analyte sensor;

using the transceiver to receive a first reference analyte measurement (RM1);

using a processor of the transceiver to determine that the RM1 is unexpected;

after determining that the RM1 is unexpected, using the transceiver to receive a second reference analyte measurement (RM2);

using the processor of the transceiver to use the sensor data to calculate a first sensor analyte measurement (SM1) without using the RM1 for calibration;

using the processor of the transceiver to use the sensor data to calculate a second sensor analyte measurement (SM2) with the RM1 used for calibration;

using the processor of the transceiver to determine that one or more of the RM1 and the RM2 are acceptable as calibration points, wherein determining that one or more of the RM1 and the RM2 are acceptable as calibration points comprises comparing the RM2 with the SM1 and comparing the RM2 with the SM2;

using the processor of the transceiver to accept one or more of the RM1 and the RM2 as calibration points; and

using the processor of the transceiver to calibrate the analyte sensor using at least one or more of the RM1 and the RM2 as calibration points.

2. The method of claim 1 , wherein the RM1 is a self-monitoring blood glucose (SMBG) measurement obtained from a finger-stick blood sample.

3. The method of claim 1 , wherein determining that the RM1 is unexpected comprises determining that the RM1 is not within a threshold amount of a sensor analyte measurement.

4. The method of claim 3 , wherein the threshold amount varies based on one or more of the sensor analyte measurement and the RM1.

5. The method of claim 1 , wherein determining that one or more of the RM1 and the RM2 are acceptable as calibration points further comprises:

determining that the difference between the RM2 and the SM2 is within a threshold amount; and

determining that the RM2 is closer to the SM2 than to the SM1.

6. The method of claim 5 , wherein accepting one or more of the RM1 and the RM2 as calibration points comprises accepting both the RM1 and the RM2 as calibration points.

7. The method of claim 6 , wherein calibrating the analyte sensor uses at least the RM1 and the RM2 as calibration points.

8. The method of claim 1 , wherein determining that one or more of the RM1 and the RM2 are acceptable as calibration points comprises:

determining that the difference between the RM2 and the SM1 is within the threshold amount; and

determining that the RM2 is closer to the SM1 than to the SM2.

9. The method of claim 8 , wherein accepting one or more of the RM1 and the RM2 as calibration points comprises accepting the RM2 for calibration and not accepting the RM1 for calibration.

10. The method of claim 9 , wherein calibrating the analyte sensor uses at least the RM2 and does not use the RM1.

11. The method of claim 1 , wherein accepting one or more of the RM1 and the RM2 as calibration points comprises storing one or more of the RM1 and the RM2 in a calibration point memory.

12. The method of claim 1 , wherein calibrating the analyte sensor comprises calibrating a conversion function used to convert sensor data received from the analyte sensor into a sensor analyte measurement.

13. The method of claim 1 , further comprising storing the unexpected RM1 in a calibration point memory;

wherein determining that one or more of the RM1 and the RM2 are acceptable as calibration points comprises determining that the RM2 is acceptable and that the RM1 is not acceptable; and

wherein the method further comprises, in response to determining that RM1 is not acceptable, deleting the RM1 from the calibration point memory.

14. An analyte monitoring system comprising:

an analyte sensor comprising:

an analyte indicator comprising indicator molecules;

a light source configured to emit excitation light that interacts with the indicator molecules;

a photodetector; and

a transceiver interface device, wherein the analyte sensor is configured to generate sensor data indicative of an amount or concentration of an analyte in proximity to the analyte indicator, generating the sensor data comprises using the photodetector to generate a measurement indicative of a level of emission light emitted by the indicator molecules, and the transceiver interface device is configured to convey the sensor data; and

a transceiver comprising:

a sensor interface device configured receive the sensor data conveyed by the analyte sensor;

a display interface device configured to convey information to a display device and to receive information from the display device; and

a processor configured to:

receive a first reference analyte measurement (RM1) from the display device via the display interface device;

determine that the RM1 is unexpected;

after determining that the RM1 is unexpected, receive a second reference analyte measurement (RM2) from the display device via the display interface device;

use the sensor data to calculate a first sensor analyte measurement (SM1) without using the RM1 for calibration;

use the sensor data to calculate a second sensor analyte measurement (SM2) with the RM1 used for calibration;

determine that one or more of the RM1 and the RM2 are acceptable as calibration points, wherein determining that one or more of the RM1 and the RM2 are acceptable as calibration points comprises comparing the RM2 with the SM1 and comparing the RM2 with the SM2;

accept one or more of the RM1 and the RM2 as calibration points; and

calibrate the analyte sensor using at least one or more of the RM1 and the RM2 as calibration points.

15. The analyte monitoring system of claim 14 , wherein the sensor interface device comprises an antenna configured to receive wirelessly the sensor data from the analyte sensor.

16. The analyte monitoring system of claim 14 , further comprising the display device.

17. The analyte monitoring system of claim 14 , wherein the transceiver interface device comprises an inductive element, and a sensor interface device comprises an inductive element.

18. The method of claim 1 , wherein the transceiver interface device comprises an inductive element, and a sensor interface device comprises an inductive element.

Assignments (10)
SECURITY INTEREST Recorded Sep 11, 2023
From: SENSEONICS, INCORPORATED
To: HERCULES CAPITAL, INC.
Reel/Frame 064866/0963 →
RELEASE OF SECURITY INTEREST Recorded Sep 7, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
To: SENSEONICS, INCORPORATED; SENSEONICS HOLDINGS, INC.
Reel/Frame 064834/0962 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 26, 2023
From: CHEN, XIAOXIAO; DEHENNIS, ANDREW; RAJARAMAN, SRINIVASAN
To: SENSEONICS, INCORPORATED
Reel/Frame 064060/0062 →
RELEASE OF SECURITY INTEREST Recorded Apr 14, 2023
From: ALTER DOMUS (US) LLC, AS COLLATERAL AGENT
To: SENSEONICS HOLDINGS, INC.; SENSEONICS, INCORPORATED
Reel/Frame 063338/0890 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Aug 14, 2020
From: SENSEONICS, INCORPORATED
To: ALTER DOMUS (US) LLC, AS COLLATERAL AGENT
Reel/Frame 053496/0292 →
RELEASE OF SECURITY INTEREST IN PATENTS AND TRADEMARKS Recorded Aug 14, 2020
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, COLLATERAL AGENT
To: SENSEONICS, INCORPORATED; SENSEONICS HOLDINGS, INC.
Reel/Frame 053498/0275 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT - FIRST LIEN Recorded Apr 24, 2020
From: SENSEONICS, INCORPORATED; SENSEONICS HOLDINGS, INC.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
Reel/Frame 052492/0109 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT -SECOND LIEN Recorded Apr 24, 2020
From: SENSEONICS, INCORPORATED; SENSEONICS HOLDINGS, INC.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
Reel/Frame 052490/0160 →
RELEASE OF SECURITY INTEREST Recorded Mar 23, 2020
From: SOLAR CAPITAL LTD., AS AGENT
To: SENSEONICS, INCORPORATED
Reel/Frame 052207/0242 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Aug 1, 2019
From: SENSEONICS, INCORPORATED
To: SOLAR CAPITAL LTD., AS AGENT
Reel/Frame 049926/0827 →