ANALYTE MONITORING SYSTEM AND METHOD

• US 20080071158A1
• Filed: 06/07/2007
• Published: 03/20/2008
• Est. Priority Date: 06/07/2006
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Peyser, Thomas, McGarraugh, Geoffrey, Mazza, John, Rebrin, Kerstin, Feldman, Benjamin, Goodnow, Timothy
• Application Number:
  US11/759,925
• Publication Number:
  US 20080071158A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

Devices and methods for monitoring an analyte are provided. Embodiments include continuous analyte sensors having a high degree of accuracy.

Claims

1. A method of monitoring glucose levels using a single glucose sensor, comprising:

transcutaneously positioning a glucose sensor in a patient for a period of time;

determining glucose concentration of the patient using the transcutaneously positioned glucose sensor; and

using one or more additional devices during the period of time only to calibrate the glucose sensor but not to confirm the accuracy of the transcutaneously positioned glucose sensor.

2. The method of claim 1, wherein the glucose sensor has at least about 85% of its paired data points within zone A and at least about 95% of its paired data points within zone A and zone B of the Clarke Error Grid.

3. The method of claim 1, wherein the glucose concentration is determined over a period of time ranging from about 1 day to about 7 days.

4. The method of claim 1, wherein the glucose sensor has at least about 85% of its paired data points within zone A of the Clarke Error Grid.

5. The method of claim 1, wherein the glucose sensor has at least about 90% of its paired data points within zone A of the Clarke Error Grid.

6. The method of claim 1, wherein the glucose sensor has more than approximately 90% of its paired data points within zone A of the Clarke Error Grid.

7. The method of claim 1, comprising determining a health related information based on the determined glucose concentration.

8. The method of claim 7 wherein the health related information includes one or more of a food intake, medication dosage level, or activity level.

9. The method of claim 8, wherein the medication dosage level includes insulin dosage level.

10. The method of claim 1, comprising transmitting data associated with the determined glucose concentration.

11. The method of claim 10 wherein transmitting includes one or more of a wired transmission or a wireless transmission.

12. The method of claim 1 wherein calibration of the glucose sensor includes performing single point calibration.

13. An analyte monitoring system, comprising:

an analyte sensor configured to detect one or more analyte levels of a patient;

a transmitter unit operatively coupled to the analyte sensor, the transmitter unit configured to transmit one or more signals associated with the detected one or more analyte levels; and

a receiver unit configured to receive the transmitted one or more signals associated with the detected one or more analyte levels;

wherein the accuracy of the detected one or more analyte levels relied upon to make a clinically relevant decision is established without using a blood glucose measurement.

14. The system of claim 13 where clinically relevant decision includes healthcare decision.

15. The system of claim 13 wherein the clinically relevant decision includes a bolus amount determination.

16. The system of claim 13 wherein the blood glucose measurement includes a confirmatory blood glucose measurement.

17. The system of claim 13 wherein the detected one or more analyte level is calibrated.

18. The system of claim 13 wherein the detected one or more analyte levels is calibrated using single point calibration.

19. The system of claim 13 wherein the transmitter unit is configured to wirelessly transmit the one or more signals to the receiver unit.

20. The system of claim 13, wherein the analyte sensor has at least about 85% of its paired data points within zone A and at least about 95% of its paired data points within zone A and zone B of the Clarke Error Grid.