Blood glucose monitor and method of use thereof

• US 9,538,943 B1
• Filed: 10/31/2011
• Issued: 01/10/2017
• Est. Priority Date: 10/29/2010
• Status: Active Grant

• Current Assignee: William Howard Cross
• Original Assignee: William Howard Cross
• Inventors: Cross, William Howard, Denton, Frank Russell III
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/317,863
• Time in Patent Office: 1,898 Days
• Field of Search: 600309-344
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0257 using atmospheric pressure
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• 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
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The invention is an improved blood glucose monitor and method of use thereof, comprising the combination of a noninvasive blood glucose detector with a blood sample reader for invasively obtained samples and a monitor for tracking blood glucose concentrations over time. The invention enables real time calibration of noninvasive blood glucose detection for continuous monitoring.

Claims

1. An integrated blood glucose monitoring device comprising a single housing, containing therein the following components:

a) a blood glucose monitor;

b) a noninvasive detector for blood glucose, wherein said detector is in communication with the blood glucose monitor;

c) a blood sampler that is in communication with the blood glucose monitor;

d) a data storage module that is in communication with the blood glucose monitor;

e) a detector for a non-physiological ancillary factor, wherein the factor is selected from the group consisting of time of day, passage of time, ambient external pressure, atmospheric pressure, atmospheric humidity, electronic signal-to-noise ratio, and electronic signal drift;

f) an ancillary monitor that is in communication with the data storage module and the detector for a non-physiological ancillary factor; and

g) a computing processor unit that is in communication with the data storage module;

wherein;

i) the blood glucose monitor is capable of;

A) using an input from the blood sampler as a benchmark to calibrate a value detected by the noninvasive detector for blood glucose;

B) using an input from the data storage module to calibrate a value detected by the noninvasive detector for blood glucose; and

C) storing in the data storage module data from the calibration;

ii) the ancillary monitor is capable of;

A) comparing between values detected by the detector for a non-physiological ancillary factor and values detected by the blood sampler; and

B) storing in the data storage module data from the comparison; and

iii) the computing processor unit is capable of calculating a prediction of evolution of blood glucose values by application of a parametric model to successive values that are stored in the data storage module, wherein the stored successive values are measured or calculated values obtained from at least one component selected from the group consisting of;

blood sampler, noninvasive detector, blood glucose monitor, ancillary factor detector, and ancillary monitor.

2. The integrated device according to claim 1, further comprising a data access interface that is in communication with the data storage module.

3. The integrated device according to claim 1, further comprising an alarm circuit that is in communication with at least one of the blood glucose monitor, ancillary monitor and computing processor.

4. The integrated device according to claim 1, further comprising an alarm circuit that is in communication with the computing processor, wherein the integrated devices additionally comprises at least one module that is selected from the group consisting of a display and a status transmitter, and wherein that module is in communication with the alarm circuit.

5. The integrated device according to claim 4, wherein the module is a status transmitter that is further in communication with a status receiver.

6. The device according to claim 1, further comprising an ancillary factor detector for a physiological condition, wherein said detector is in communication with an ancillary monitor and said monitor is in communication with the data storage module.

7. A method for monitoring blood glucose, comprising using a device according to claim 1 to determine a concentration or rate of change for blood glucose levels according to the following steps:

a) transmitting into the body of a subject an electromagnetic wave at an energy level below a level that would compromise the integrity of tissues;

b) receiving from the subject'"'"'s body an electromagnetic wave that was transmitted into the body at step (a), and detecting said received wave by means of the noninvasive detector of blood glucose;

c) correlating data from said noninvasive detector with a relative level of blood glucose;

d) receiving a sample of blood in the blood sampler;

e) determining a glucose concentration of said blood sample by means of said sampler;

f) storing a glucose concentration value from at least one of said detector and said sampler in the data storage module of claim 1;

g) comparing and calibrating a glucose concentration value from said detector with a benchmark value from said sampler by means of the blood glucose monitor of claim 1;

h) tracking an environmental condition by means of the non-physiological ancillary factor detector of claim 1;

i) by means of the ancillary monitor of claim 1, comparing a signal value from said ancillary detector with another signal value from said ancillary detector and or with a signal value from said blood sampler;

wherein steps a and d may be performed in any order relative to each other.

8. The method for monitoring blood glucose according to claim 7, further comprising in any order the step of transferring information to or from the blood glucose monitoring device by means of a data access interface that is in communication with the data storage module.

9. The method for monitoring blood glucose according to claim 7, further comprising the step of comparing blood glucose concentration values from the blood glucose monitor with a programmed boundary for health and safety, wherein the comparison is performed by means of an alarm circuit that is in communication with the blood glucose monitor.

10. The method for monitoring blood glucose according to claim 7, further comprising the step of issuing an alarm by means of an alarm circuit that is in communication with the blood glucose monitor and also in communication with at least one module that is a display or status transmitter, in the event that data for a blood glucose concentration or a blood glucose concentration rate change falls outside a programmed boundary for health and safety.

11. The method for monitoring blood glucose according to claim 7, further comprising the step of transmitting a signal by means of a status transmitter that is in communication with an alarm circuit that is respectively in communication with the blood glucose monitor, wherein the transmitted signal is received by a remote status receiver.

12. The method for monitoring blood glucose according to claim 7, further comprising the step of detecting one or more values for a physiological condition other than the concentration of glucose in the blood or the rate of change for blood glucose concentrations, wherein said other physiological condition is detected by means of an ancillary factor detector that is in communication with an ancillary monitor that is respectively in communication with the data storage module.

13. The method for monitoring blood glucose according to claim 7, further comprising displaying data on the blood glucose concentration and the environmental condition on a display that is in communication with an alarm circuit that is respectively in communication with the blood glucose monitor.

14. The method according to claim 7 wherein the transmitted and received wave is of a type that is detectable noninvasively by a sensor for a modality that is selected from the group consisting of:

ultrasound, optical coherence tomography, infrared light, near-infrared light, thermal infrared spectroscopy, Raman spectroscopy, nuclear magnetic resonance, electron spin resonance, polarized light, electromagnetic waves, radiofrequency waves, impedance spectroscopy, dielectric spectroscopy, photoacoustic technology, beam-splitting optics, and reverse iontophoresis.

15. The method of claim 7 wherein the subject is selected from the group consisting of humans, pets, livestock, research animals and display animals.