Analyte Monitoring: Stabilizer for Subcutaneous Glucose Sensor with Incorporated Antiglycolytic Agent

• US 20140336486A1
• Filed: 07/29/2014
• Published: 11/13/2014
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ouyang, Tianmei, Liu, Zenghe, Cho, Hyun, Feldman, Benjamin J.
• Granted Patent: US 10,219,728 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

An analyte sensor including an antiglycolytic agent or a precursor thereof and a chelating agent that stabilizes the antiglycolytic agent positioned proximate to the working electrode of the sensor. Also provided are systems and methods of using the electrochemical analyte sensors in analyte monitoring.

Claims

1. -57. (canceled)

58. A method for monitoring a level of glucose in a subject, the method comprising:

positioning a glucose sensor into skin of a subject at an analyte determination site, wherein the sensor comprises;

a working electrode comprising a sensing layer disposed thereon, wherein the sensing layer comprises an glucose responsive enzyme;

a membrane disposed over at least a portion of the sensing layer; and

a counter electrode;

determining a clinically accurate level of glucose from the signals generated by the sensor immediately following positioning of the glucose sensor into the skin of the subject at the analyte determination site,

wherein determining over a period of time provides for monitoring the glucose level in the subject.

59. The method according to claim 58, wherein the method comprises determining clinically accurate levels as assessed by the Clark Error Grid immediately after positioning the sensor at the analyte determination site.

60. The method according to claim 58, wherein the method comprises determining clinically accurate levels as assessed by the MARD analysis immediately after positioning the sensor at the analyte determination site.

61. The method according to claim 58, wherein the method comprises determining clinically accurate levels as assessed by the Parks Error Grid immediately after positioning the sensor at the analyte determination site.

62. The method according to claim 58, wherein the method comprises determining clinically accurate levels as assessed by the Continuous Glucose Error Grid immediately after positioning the sensor at the analyte determination site.

63. The method according to claim 58, wherein clinically accurate levels of glucose from the signals generated by the sensor are automatically determined immediately following positioning of the glucose sensor into the skin of the subject at the analyte determination site.

64. The method according to claim 58, wherein clinically accurate levels of glucose from the signals generated by the sensor are determined continuously following positioning of the glucose sensor into the skin of the subject at the analyte determination site.

65. The method according to claim 58, wherein clinically accurate levels of glucose from the signals generated by the sensor are determined periodically following positioning of the glucose sensor into the skin of the subject at the analyte determination site.

66. The method according to claim 65, wherein clinically accurate levels of glucose from the signals generated by the sensor are determined for one hour or more following positioning of the glucose sensor into the skin of the subject at the analyte determination site.

67. The method according to claim 65, wherein clinically accurate levels of glucose from the signals generated by the sensor are determined for three days or more following positioning of the glucose sensor into the skin of the subject at the analyte determination site.

68. The method according to claim 65, wherein clinically accurate levels of glucose from the signals generated by the sensor are determined for weeks following positioning of the glucose sensor into the skin of the subject at the analyte determination site.

69. The method according to claim 58, wherein the glucose sensor is positioned into the skin of the subject after one calibration of the sensor.

70. The method according to claim 58, wherein the glucose sensor is positioned into the skin of the subject without calibrating the sensor.

71. The method according to claim 58, wherein clinically accurate level of glucose from the signals generated by the sensor comprises observing no spurious glucose measurements.

72. The method according to claim 58, wherein the sensing layer further comprises an electron transfer agent.

73. The method according to claim 72, wherein the glucose responsive enzyme and electron transfer agent are bonded to the sensing layer.

74. The method according to claim 58, wherein the glucose sensor further comprises one of:

an interferent-eliminating layer; and

a biocompatible layer

75. The method according claim 58, wherein the method further comprises processing the signals generated by the sensor with a processor on a sensor control unit.

76. The method according to claim 75, wherein the method further comprises transmitting the processed signals with a transmitter.