Health monitoring system

• US 9,907,515 B2
• Filed: 02/02/2017
• Issued: 03/06/2018
• Est. Priority Date: 06/22/2010
• Status: Active Grant

• Current Assignee: Sansum Diabetes Research Institute, Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Doyle, III, Francis J., Dassau, Eyal, Zissser, Howard, Harvey, Rebecca
• Primary Examiner(s): GIRMA, FEKADESELASS
• Application Number:
  US15/422,811
• Publication Number:
  US 20170156682A1
• Time in Patent Office: 397 Days
• Field of Search: None
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: 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 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A machine for processing continuous glucose monitoring data and issuing an alert if hypoglycemia is imminent has three modules: (a) a pre-processing module that receives and modulates continuous glucose monitoring data by reducing noise and adjusting for missed data points and shifts due to calibration; (b) a core algorithm module that receives data from the pre-processing module and calculates a rate of change to make a hypoglycemia prediction, and determine if hypoglycemia is imminent; and (c) an alarm mode module that receives data from the core algorithm and issues an audio or visual alert or warning message or a negative feedback signal to an insulin delivery device if hypoglycemia is imminent.

Claims

1. A method of continuous glucose monitoring (CGM), comprising:

processing the CGM data with a control algorithm to determine an appropriate insulin delivery and direct an insulin pump to make the delivery; and

executing a health monitoring system (HMS) comprising steps;

(a) calculating a rate of change of glucose concentration of the person based on the CGM data;

(b) determining that a hypoglycemia condition is expected to occur based on the CGM data and the calculated rate of change of the glucose concentration of the person; and

(c) issuing an alert prompting the person to take an action to avoid the hypoglycemia condition, wherein the action comprises consuming carbohydrates,

wherein the HMS functions as a process monitoring module executed in real time, and the control algorithm and HMS evaluate the CGM data differently to provide an extra safety layer;

wherein determining that the hypoglycemia condition is expected to occur comprises comparing the glucose concentration data to a first adjustable threshold and comparing the rate of change of the glucose concentration to a second adjustable threshold, and determining that the hypoglycemia condition is expected to occur within an adjustable time window.

2. The method of claim 1, wherein the alert is an electronic, visual and/or audio alert prompting the person to consume the carbohydrates.

3. The method of claim 1, wherein the alert is sent to a cellular phone.

4. The method of claim 2, wherein the alert is sent to a cellular phone.

5. A system for continuous glucose monitoring (CGM) of a diabetic person, comprising:

a CGM device;

an insulin delivery pump;

a pump controller configured with a control algorithm to use data from the CGM device to determine an appropriate insulin delivery and direct the insulin delivery pump to make the delivery; and

a health monitoring system (HMS) comprising a processor configured to execute an HMS algorithm using the CGM data to calculate a rate of change of glucose concentration of the person and determine that a hypoglycemia condition is expected to occur based on the CGM data and the calculated rate of change of the glucose concentration of the person; and

a signal generator configured to generate an electronic, visual and/or audio alert in response to the impending hypoglycemia condition prompting the user to take an action to avoid the hypoglycemia condition, wherein the action comprises consuming carbohydrates,

wherein the HMS functions as a process monitoring module executed in real time, and the control algorithm and HMS evaluate the CGM data differently to provide an extra safety layer;

wherein the HMS algorithm compares the glucose concentration data to a first adjustable threshold, and compares the rate of change of the glucose concentration to a second adjustable threshold, and determines that the hypoglycemia condition is expected to occur within an adjustable time window.