CGM-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction of insulin delivery

• US 9,750,438 B2
• Filed: 08/30/2013
• Issued: 09/05/2017
• Est. Priority Date: 02/25/2009
• Status: Active Grant

• Current Assignee: University of Virginia Patent Foundation (University of Virginia)
• Original Assignee: University of Virginia Patent Foundation (University of Virginia)
• Inventors: Kovatchev, Boris P., Breton, Marc D., Patek, Stephen D.
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/015,831
• Publication Number:
  US 20140046159A1
• Time in Patent Office: 1,467 Days
• 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 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: 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: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• 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
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

An aspect of an embodiment or partial embodiment of the present invention (or combinations of various embodiments in whole or in part of the present invention) comprises, but not limited thereto, a method and system (and related computer program product) for continually assessing the risk of hypoglycemia for a patient and then determining what action to take based on that risk assessment. A further embodiment results in two outputs: (1) an attenuation factor to be applied to the insulin rate command sent to the pump (either via conventional therapy or via open or closed loop control) and/or (2) a red/yellow/green light hypoglycemia alarm providing to the patient an indication of the risk of hypoglycemia. The two outputs of the CPHS can be used in combination or individually.

Claims

1. A computer-implemented method for preventing or mitigating hypoglycemia in a patient, comprising:

receiving by a processor continuous metabolic measurements associated with the subject from a metabolic measurement device continuously making direct metabolic measurements;

continuously assessing by a processor a risk of hypoglycemia based on the received metabolic measurements;

evaluating by a processor risk of hypoglycemia based on the assessed risk of hypoglycemia; and

outputting to an output device a result of said evaluation, selected from one of;

a) no action being needed;

b) attenuation of insulin delivery being needed;

c) additional patient intervention being needed; and

d) attenuation of insulin delivery and additional patient intervention being needed.

2. A computer-implemented method for preventing or mitigating hypoglycemia in a subject, comprising:

receiving by a processor continuous metabolic measurements associated with the subject from a metabolic measurement device continuously making direct metabolic measurements;

assessing by a processor a risk of hypoglycemia based on the received metabolic measurements;

evaluating by a processor the risk of hypoglycemia based on the assessed risk of hypoglycemia; and

outputting an alarm when the risk of hypoglycemia exceeds a predetermined threshold.

3. A computer-implemented method for preventing or mitigating hypoglycemia in a subject, comprising:

receiving continuous metabolic measurements associated with the subject from a metabolic measurement device continuously making direct metabolic measurements;

assessing a risk of hypoglycemia based on the received metabolic measurements;

evaluating the risk of hypoglycemia based on the assessed risk of hypoglycemia;

providing a shut-down signal to an insulin pump to cease delivery of insulin to said subject for a predetermined time, upon evaluation of risk of hypoglycemia exceeding a predetermined threshold;

outputting an alarm alerting the subject that risk of hypoglycemia exceeds said predetermined threshold; and

enabling the subject to override said shut-down signal and continue delivery of insulin to said subject from said insulin pump.

4. A computer-implemented method for preventing or mitigating hypoglycemia in a subject, comprising:

receiving, by a processor, metabolic measurements associated with the subject from a metabolic measurement device continuously making direct metabolic measurements;

assessing, by a processor, a risk of hypoglycemia based on the received metabolic measurements; and

outputting to an output device a result of said evaluation, wherein the result is one of;

a) no action being needed;

b) attenuation of insulin being needed;

c) subject intervention being needed; and

d) attenuation of insulin and subject intervention being needed.