SYSTEM FOR THE SELF-MONITORING AND REGULATION OF BLOOD GLUCOSE

• US 20140005499A1
• Filed: 03/19/2012
• Published: 01/02/2014
• 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
• Granted Patent: US 10,182,748 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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 personalised 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 personalisation of the outputs with regular calibration to the user.

Claims

1. A system for the regulation of physiological analytes, the system comprising:

a movement sensor;

a physiological analyte sensor;

an output device for providing a signal to a subject;

a data processing module;

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

wherein the physiological analyte sensor is adapted to take and record continuous or regular readings of levels of one or more physiological analytes present in the subject;

wherein the data processing module compares readings with 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

wherein the output device is adapted to provide a signal to the subject if the levels of one or more of the physiological analytes fit a certain profile.

2. The system as in claim 1 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.

3. The system as in claim 1 wherein the output device is adapted to provide a signal to the subject if the levels of at least one of the physiological analytes fall out with a pre-determined range.

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

5. The system as in claim 1 comprising a data storage module which stores historical readings from the sensors.

6. The system as in claim 5 wherein the data storage module is integrated into the data processing module.

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

8. The system as in claim 1 wherein movement and analyte readings over a set time period can be analysed by the data processing module and target activity levels set for a forthcoming time period.

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

10. The system as in claim 1 wherein the movement sensor records movement in at least one axis with a dynamic range of at least +/−

2 g.

11. The system as in claim 1 wherein the movement sensor records movement with a dynamic range of at least +/−

2 g.

12. The system as in claim 1 wherein the movement sensor records movement with a dynamic range of at least +/−

8 g.

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

14. The system as in claim 13 wherein the accelerometer is configured to acquire acceleration estimates on each axis at a sampling frequency of at least 8 Hz.

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

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

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

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

19. The system as in claim 1 wherein the physiological analyte sensor senses glucose levels in the subject.

20. The system as in claim 1 wherein the physiological analyte sensor is a continuous glucose measurement sensor.

21. The system as in claim 1 wherein the physiological analyte sensor is at least one of non-invasive and minimally invasive.

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

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

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

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

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

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

28. The system as in claim 27 wherein the means for providing real time location information is a global positioning system receiver.

29. 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.

30. The method as in claim 29 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.

31. The method as in claim 30 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.