Method to recalibrate continuous glucose monitoring data on-line

• US 9,858,386 B2
• Filed: 11/02/2010
• Issued: 01/02/2018
• Est. Priority Date: 11/02/2009
• Status: Active Grant

• Current Assignee: Universita' Degli Studi Di Padova (Repubblica Italiana)
• Original Assignee: Universita' Degli Studi Di Padova (Repubblica Italiana)
• Inventors: Cobelli, Claudio, De Nicolao, Giuseppe, Facchinetti, Andrea, Guerra, Stefania, Sparacino, Giovanni
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US13/504,858
• Publication Number:
  US 20120215087A1
• Time in Patent Office: 2,618 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• 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: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

In a method of recalibrating continuous glucose monitoring data from a user, operable on a digital processor, an indication from the user that the user has taken a meal is received (806). A self-monitored of blood glucose levels from the user (810) at two separate times during a day corresponding to when the user has taken a meal. A glucose signal is received from a continuous glucose monitoring sensor (818) at times corresponding to the two separate times that the user has taken a meal. Two reconstructed blood glucose values based on the glucose signal from the continuous monitoring sensor at times when the at least two self-monitored of blood glucose levels are received from the user. A linear regression is performed (822) using y=ax+b, wherein x corresponds to the two reconstructed blood glucose values and y corresponds to the two self-monitored of blood glucose levels thereby generating an estimation of a and b. A recalibration signal, including the estimation of a and b, is transmitted to the continuous glucose monitoring sensor (824) based on the linear regression.

Claims

1. A system for recalibrating continuous glucose monitoring data from a user, comprising:

a. a processor;

b. a continuous glucose monitoring sensor, in communication with the processor, configured to provide data to generate a glucose signal of continuously monitored glucose values representing interstitial glucose values; and

c. a recalibration module, configured to;

i. receive an indication that the user has taken a meal;

ii. receive at least two self-monitored blood glucose levels corresponding to separate times after the user has taken the meal;

iii. receive the glucose signal from the continuous glucose monitoring sensor;

iv. generate reconstructed blood glucose values indicative of plasma glucose concentration values by converting at least some of the glucose signal representing interstitial glucose values into a plasma glucose concentration signal;

v. select at least two reconstructed blood glucose values among the generated reconstructed blood glucose values corresponding to times associated with the at least two self-monitored blood glucose levels;

vi. generate a first parameter and a second parameter by performing a linear regression using the at least two selected reconstructed blood glucose values and the at least two self-monitored blood glucose levels; and

vii. produce a recalibration signal of the continuously monitored glucose values using the first parameter and the second parameter.

2. The system of claim 1, wherein the calibration module is configured to convert the at least some of the glucose signal into the plasma glucose concentration signal with a deconvolution procedure based on a dynamic model of a blood glucose to interstitial glucose system.

3. The system of claim 1, wherein the calibration module is configured to generate a request to the user for a self monitored blood glucose level at a first predetermined period after the user has had the meal.

4. The system of claim 3, wherein the first predetermined period comprises thirty minutes.

5. The system of claim 4, wherein the calibration module is configured to generate a request to the user for a self monitored blood glucose level at a second predetermined period after the user has had the meal.

6. The system of claim 5, wherein the second predetermined period comprises three hours.

7. The system of claim 1, wherein the processor and the continuous glucose monitoring sensor are in communication with each other via a global computer network.

8. The system of claim 1, wherein the recalibration module is further configured to execute each day after the user has taken two different meals.

9. A method of recalibrating continuous glucose monitoring data from a user, operable on a processor, comprising:

a. receiving from a receiver an indication that the user has taken a meal;

b. receiving from the receiver at least two self-monitored blood glucose levels corresponding to separate times after the user has taken the meal;

c. receiving a glucose signal of continuously monitored glucose values representing interstitial glucose values obtained from a continuous glucose monitoring sensor;

d. generating reconstructed blood glucose values indicative of plasma glucose concentration values by converting at least some of the glucose signal representing interstitial glucose values into a plasma glucose concentration signal;

e. selecting at least two reconstructed blood glucose values among the generated reconstructed blood glucose values corresponding to times associated with the at least two self-monitored blood glucose levels;

f. generating a first parameter and a second parameter by performing a linear regression using the at least two selected reconstructed blood glucose values and the at least two self-monitored blood glucose levels; and

g. producing a recalibration signal of the continuously monitored glucose values using the first parameter and the second parameter.

10. The method of claim 9, wherein the converting the at least some of the glucose signal into the plasma glucose concentration signal includes using a deconvolution procedure based on a dynamic model of a blood glucose to interstitial glucose system.

11. The method of claim 9, further comprising generating a request to the user for a self monitored blood glucose level at a first predetermined period after the user has had the meal.

12. The method of claim 11, wherein the first predetermined period comprises thirty minutes.

13. The method of claim 12, further comprising generating a request to the user for a self monitored blood glucose level at a second predetermined period after the user has had the meal.

14. The method of claim 13, wherein the second predetermined period comprises three hours.

15. The method of claim 9, further comprising communicating data from the continuous glucose monitoring sensor to the processor and from the processor to the continuous glucose monitoring sensor via a global computer network.