System for the self-monitoring and regulation of blood glucose

• US 10,182,748 B2
• Filed: 03/19/2012
• Issued: 01/22/2019
• Est. Priority Date: 03/17/2011
• Status: Active Grant

• Current Assignee: University of Newcastle Upon TYNE
• Original Assignee: University of Newcastle Upon TYNE
• Inventors: Catt, Michael, Trenell, Michael
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Xie, Dacheng
• Application Number:
  US14/002,341
• Publication Number:
  US 20140005499A1
• Time in Patent Office: 2,500 Days
• Field of Search: 600300-301, 600316, 600317, 600319, 600348, 600365
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• 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: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

The present invention relates to a self monitoring device for attachment to the body, which incorporates real-time and correlated measurement of body movement and physiological analytes of metabolism (e.g. glucose) that can be modulated by physical activity. The system enables real time and personalized modulation of the selected physiological analyte(s) through appropriately selected cued activities and other evidence based clinical guidance dependent on previous and current analyte levels correlated with previous and current patterns of movement. The system also allows for personalization of the outputs with regular calibration to the user.

Claims

1. A system for regulation of blood glucose, the system comprising:

a movement sensor;

a glucose monitor;

an output device for providing a signal to a subject;

a microcontroller having a memory associated therewith;

wherein the movement sensor is adapted to take and record real-time continuous or regular movement readings to determine movement of a subject;

wherein the glucose monitor is adapted to take and record continuous or semi-continuous real-time readings of levels of blood glucose present in the subject;

wherein the memory associated with the microcontroller stores historical readings from the movement sensor and the glucose monitor;

wherein the microcontroller compares real-time readings with recorded historical readings and determines a rate and a direction of change of the levels of blood glucose and associated levels of physical activity; and

wherein the microcontroller recommends a type of physical activity dependent on

     1) at least one of the rate and direction of change of the real time glucose level correlated with

     2) a current activity level from the movement sensor, using the historical readings as a reference; and

wherein the output device displays the recommended type of physical activity; and

wherein the recommended type of physical activity is monitored in real time using the movement sensor and an effect of the recommended type of physical activity on the blood glucose is monitored in real time by the glucose monitor and feedback to adjust the recommended type of physical activity is given by the output device if at least one of the rate and change of blood glucose is determined by the microcontroller to not be within a predetermined range.

2. The system as in claim 1 wherein the system can also determine a measure of total movement or type of movement.

3. The system as in claim 1 comprising a clock.

4. The system as in claim 1 wherein movement and basal glucose levels over a set time period can be analysed by the microcontroller and target activity levels set for a forthcoming time period, wherein an activity program is based on analyzing the basal glucose levels and wherein the activity program facilitates improved basal glucose clearance by interrupting sedentary behavior.

5. The system as in claim 1 wherein the movement sensor comprises a pedometer.

6. The system as in claim 1 wherein the movement sensor comprises an accelerometer.

7. The system as in claim 1 wherein the movement sensor comprises an gyroscope.

8. The system as in claim 1 wherein the movement sensor is a MEMS based accelerometer.

9. The system as in claim 1 comprising at least one of temperature sensors and skin conductivity sensors.

10. The system as in claim 1 wherein the movement sensor is provided with means for associating the movement sensor with a body of the subject.

11. The system as in claim 1 wherein the glucose monitor is at least one of non-invasive and minimally invasive.

12. The system as in claim 1 wherein the physiological analyte sensor is a microneedle array based sensor.

13. The system as in claim 1 wherein physiological analyte sensor is an optical sensor.

14. The system as in claim 1 wherein the physiological analyte sensor is transdermal.

15. The system as in claim 1 wherein the output device comprises at least one of a visual, an audible, and a tactile output.

16. The system as in claim 1 wherein the output device comprises a viewing screen.

17. The system as in claim 1 wherein the output device comprises means for providing real time location information.

18. The system as in claim 17 wherein the means for providing real time location information is a global positioning system receiver.

19. The system of claim 1, wherein the glucose monitor takes samples at a frequency of approximately five minutes or less.

20. A method for the regulation of physiological analytes utilizing the system of claim 1 wherein:

the movement sensor takes and records continuous or regular movement readings to determine movement of the subject;

levels of one or more physiological analytes present in the subject are taken and recorded;

readings are compared to recorded historical readings to determine a rate and a direction of change of the levels of one or more physiological analytes and associated levels of physical activity; and

if the levels of one or more of the physiological analytes fit a certain profile a signal is sent to the subject.

21. The method as in claim 20 wherein multiple signals are available for selection for provision to the user and the signal provided to the user is selected depending on at least one of the rate and the direction of change of analyte levels.

22. The method as in claim 21 wherein multiple signals are available for selection for provision to the user and the signal provided to the user is selected to prompt a known activity which, in accordance with historical data, will direct analyte levels in a desired direction.