Adaptive Hypoglycaemia Alert System and Method

• US 20100030092A1
• Filed: 11/14/2007
• Published: 02/04/2010
• Est. Priority Date: 11/14/2006
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Kristensen, Leif Engmann, Deleuran, Tue, Bengtsson, Henrik
• Application Number:
  US12/447,067
• Publication Number:
  US 20100030092A1
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 onset or presence of a hypoglycaemic condition in a living being is estimated by obtaining ECG signals, which are processed together with secondary input, such as skin impedance, information about a condition of the living being, or blood glucose level, to estimate whether the living being is experiencing or approaching a hypoglycaemic condition. An output alert may be generated. Feedback indicative of a possible misestimate of the onset or presence of the hypoglycaemic condition is received to allow a system incorporating the invention to adapt and personalize to a specific living being. The feedback may influence one or more sensitivity or specificity settings. Settings of the system may be influenced by the location or rate of movement of the living being.

Claims

1. A system for estimating the onset or presence of a hypoglycaemic condition in a living being, the system comprising a memory, a processor, and:

at least one first sensor element for obtaining ECG signals representative of the living being'"'"'s ECG;

at least one secondary input element for receiving at least one secondary input parameter;

an output generator for generating an alert signal;

the processor being programmed to;

process the ECG signals, the at least one secondary input parameter and at least one reference value stored in the a memory to estimate the onset or presence of the hypoglycaemic condition;

cause the output generator to generate the alert signal in case the hypoglycaemic condition is occurring or approaching;

receive a feedback input indicative of a possible misestimate of the onset or presence of the hypoglycaemic condition, adjust said reference value in response to the feedback input, and store the adjusted reference value in the memory.

2. A system according claim 1, wherein:

the at least one reference value comprises at least one sensitivity setting;

the feedback input comprises at least one sensitivity-influencing input;

the processor is programmed to vary the sensitivity setting under influence of the sensitivity-influencing input.

3. A system according to claim 2, wherein the sensitivity-influencing input comprises at least one of:

quantity of a past medication of the living being;

time lapse since a past medication of the living being;

the living being'"'"'s blood glucose level;

input describing the living being'"'"'s past meal and/or drink intake;

time;

dose of last medication of the living being;

a physical location of the living being;

an input, upon which the level of the living being'"'"'s physical activity can be determined;

a manually entered input; and

a user-specified sensitivity setting.

4. A system according to claim 3, wherein the sensitivity-influencing input comprises the physical location of the living being, and wherein the processor is programmed to vary the sensitivity setting in case said physical location is a vehicle.

5. A system according to claim 3, wherein the sensitivity-influencing input comprises the physical location of the living being, the system further comprising a location detector for detecting said physical location.

6. A system according to claim 5, wherein at least the processor and the output generator are incorporated in a portable device, and wherein the location detector is adapted to be secured to a specific physical location, the system further comprising a location interface causing the system to change the sensitivity when the location detector is within communication reach of the portable device.

7. A system according to claim 3, wherein the sensitivity-influencing input comprises the input, upon which the level of the living being'"'"'s physical activity can be determined, and wherein the processor is programmed to set change the sensitivity in response to said input.

8. A system according to claim 1, further comprising an operator interface for selecting a detection mode, and wherein said sensitivity setting is influenced by the selected detection mode.

9. A system according to claim 1, wherein said at least one secondary input parameter comprises at least one of:

the living being'"'"'s skin impedance;

a radio-spectroscopy signal;

the living being'"'"'s body temperature;

an acoustic signal;

a signal indicative of optical reflection of the patient'"'"'s skin;

a signal indicative of respiration characteristics of the living being;

the living being'"'"'s pulse;

the living being'"'"'s blood glucose level;

a manually entered user-input;

time;

input describing the living being'"'"'s past meal and/or drink intake; and

a signal indicating the living being'"'"'s activity.

10. A system according to claim 9, wherein the manually entered user-input is indicative of at least one of:

a personal condition;

a metabolic state or parameter;

the living being'"'"'s physical activity; and

the living being'"'"'s location.

11. A system according to claim 1, wherein the processor is programmed to estimate the onset or presence of the hypoglycaemic condition without receiving an EEG signal as an input.

12. A system according to claim 1, wherein at least the processor and the output generator are incorporated in a portable device.

13. A system according to claim 12, further comprising a medication delivery apparatus housed within the portable device.

14. A system according to claim 1, wherein said at least one secondary input parameter comprises the living being'"'"'s blood glucose level measured by Blood Glucose Monitoring (BGM) or Continuous Glucose Monitoring (CGM).

15. A system according to claim 14, comprising a blood glucose meter capable of communicating with the processor via a wired or wireless communication interface.

16. A system according to claim 1, wherein said at least one secondary input parameter comprises a manually entered user-input indicative of an observed symptom of a hypoglycaemic episode.

17. A method of generating an alert signal in case of detection of the onset or presence of a hypoglycaemic condition in a living being, comprising:

obtaining ECG signals representative of the living being'"'"'s ECG;

receiving at least one secondary input parameter;

processing the ECG signals, the at least one secondary input parameter and at least one reference value to estimate the onset or presence of the hypoglycaemic condition;

generating an alert signal if the onset or presence of the hypoglycaemic condition is estimated;

receiving a feedback input indicative of a possible inaccuracy of the estimation of the detecting of the onset or presence of the hypoglycaemic condition;

adjusting the at least one reference value in response to the feedback input; and

storing the adjusted reference value.

18. A method according to claim 17, wherein the at least one reference value comprises at least one sensitivity setting and the feedback input comprises at least one sensitivity-influencing input.

19. A method according to claim 18, wherein the sensitivity-influencing input comprises at least one of:

quantity of a past medication of the living being;

time lapse since a past medication of the living being;

the living being'"'"'s blood glucose level;

input describing the living being'"'"'s past meal and/or drink intake;

time;

dose of last medication of the living being;

a physical location of the living being;

an input, upon which the level of the living being'"'"'s physical activity can be determined;

a manually entered input;

a user-specified sensitivity setting.