Accuracy of continuous glucose sensors

• US 10,194,850 B2
• Filed: 07/14/2015
• Issued: 02/05/2019
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kovatchev, Boris P., King, Christopher R.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/799,329
• Publication Number:
  US 20160007890A1
• Time in Patent Office: 1,302 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence

Abstract

A method, apparatus, and a kit are capable of improving accuracy of CGS devices using dynamic outputs of continuous glucose sensors.

Claims

1. A method for improving accuracy of a continuous glucose sensor (CGS), comprising:

calibrating the CGS at a first time;

dynamically monitoring a CGS value and a rate of CGS change over time;

determining, at a second time, whether a first condition is met, wherein the first condition is met if an absolute value of the rate of CGS change at the second time is less than a first predetermined value, and wherein the absolute value of the rate of CGS change is an absolute value of a first order time derivative of the CGS value;

in response to the first condition not being met, maintaining the calibration of the CGS at the first time;

in response to the first condition being met, determining whether a second condition is met;

in response to a determination that the first condition and the second condition are met, calibrating the CGS at the second time.

2. The method of claim 1, wherein the first predetermined value is 1 mg/dL/time.

3. The method of claim 1, wherein determining whether the second condition is met comprises determining whether an absolute change between the CGS value at the second time and the CGS value at the first time is greater than a second predetermined value;

and

wherein the method further comprises, in response to a determination that the second condition is not met, maintaining the calibration of the CGS at the first time.

4. The method of claim 3, wherein the second predetermined value is at least 15 mg/dL.

5. The method of claim 3, wherein the second predetermined value is at least 20 mg/dL.

6. The method of claim 3, wherein the second predetermined value is at least 30 mg/dL.

7. The method of claim 3, wherein the second predetermined value is at least 40 mg/dL.

8. The method of claim 1, further comprising:

improving accuracy of a CGS output by remedying a physiology time lag between a blood glucose level and a glucose level in an interstitial fluid that interacts with the blood glucose.

9. The method of claim 8, wherein the step of improving accuracy of the CGS output further comprises:

deriving a mathematical equation describing a time dependence of the CGS output on the blood glucose level;

deriving the time dependence on the blood glucose level as a function of the CGS output; and

applying the derived function to a set of CGS raw outputs so as to predict a blood glucose level at a later time to correct the CGS output.

10. The method of claim 9, wherein the mathematical equation is derived based on a model that includes a description of a diffusion interaction between the blood glucose and the glucose in the interstitial fluid.

11. The method of claim 9, wherein the mathematical equation is derived based on a model that includes a description of an assumption of the glucose in the interstitial fluid.

12. The method of claim 1, further comprising, in response to only the first condition being met, calibrating the CGS at the second time.

13. A method for improving the accuracy of a glucose sensor, comprising:

requesting and receiving a first blood glucose reference value when the glucose sensor measures a first in vivo glucose value;

calibrating the glucose sensor using the first blood glucose reference value and the first in vivo glucose value;

measuring, by the glucose sensor, a second in vivo glucose value and a rate of in vivo glucose change;

determining if an absolute rate of in vivo glucose change value is less than a first predetermined value;

determining if an absolute difference between the second in vivo glucose value and the first in vivo glucose value is greater than a second predetermined value;

in response to a determination that the absolute rate of in vivo glucose change value is less than the first predetermined value, and a determination that the absolute difference between the second in vivo glucose value and the first in vivo glucose value is greater than the second predetermined value, requesting and receiving a second blood glucose reference value; and

calibrating the glucose sensor using the second blood glucose reference value and the second in vivo glucose value,

wherein the absolute rate of in vivo glucose change value is based on a first order time derivative of the second in vivo glucose value.

14. A system for improving an accuracy of a glucose sensor, comprising:

at least one processing unit;

memory coupled to the at least one processing unit, wherein the memory is configured to store program modules and instructions comprising;

an accuracy improving module accessible to an output of the glucose sensor, further comprising;

a decision making mechanism capable of determining a calibration at a second time based upon at least one of a dynamically monitored output of the glucose sensor, wherein the decision making mechanism is configured to;

determine if an absolute rate of in vivo glucose change value at the second time is less than a first predetermined value,

determine if an absolute difference between an in vivo glucose value at the second time and an in vivo glucose value at a first time is greater than a second predetermined value, and

in response to a determination that the absolute rate is less than the first predetermined value, and the absolute difference is greater than the second predetermined value, calibrating the glucose sensor,

wherein the absolute rate of in vivo glucose change value is based on a first order time derivative of the in vivo glucose value at the second time.

15. The system of claim 14, wherein the accuracy improving module further comprises:

an initial request module capable of initiating an initial calibration at a predetermined time sequence.

16. The system of claim 15, wherein the decision making mechanism further comprises:

a monitoring module capable of dynamically monitoring the output from the glucose sensor, wherein the output comprises an in vivo glucose value and a rate of in vivo glucose change.