Method, system and computer program product for CGM-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction insulin delivery

• US 10,842,419 B2
• Filed: 08/04/2017
• Issued: 11/24/2020
• 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:
  US15/669,111
• Publication Number:
  US 20170337348A1
• Time in Patent Office: 1,208 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 end 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, the method comprising:

determining, by a glucose meter, blood glucose concentration by continuously making direct metabolic measurements using a non-invasive technique;

continuously assessing, by a processor, a risk of hypoglycemia based on at least the blood glucose concentration, the processor being configured to communicate with the glucose meter;

evaluating, by the processor or another processor which is different from the processor, risk of hypoglycemia based on the assessed risk of hypoglycemia, the another processor being configured to communicate with the processor; and

outputting, by the processor or the another processor, to an output device a result of said evaluation.

2. The method of claim 1, wherein the determining of the blood glucose concentration comprises:

using a near-infrared radiation (IR) diffuse-reflection laser spectroscopy.

3. The method of claim 1, wherein the determining of the blood glucose concentration comprises:

facilitating transdermal movement of glucose along a concentration gradient by using a permeability enhancer.

4. The method of claim 3, wherein the permeability enhancer includes at least one of a sodium cholate, sodium glycocholate, sodium glycodeoxycholate, taurodeoxycholate, sodium deoxycholate, sodium lauryl sulfate, salt, natural bile salt, derivatives of saturated and unsaturated fatty acids, surfactants, bile salt analogs, derivatives of bile salts, or synthetic permeation enhancers.

5. The method of claim 1, wherein the determining of the blood glucose concentration comprises:

collecting perspiration through a skin patch.

6. The method of claim 5, comprising:

stimulating a secretion associated with the perspiration using a cholinergic agent from the eccrine sweat gland.

7. The method of claim 1, wherein the determining of the blood glucose concentration comprises:

sampling a substance through skin into a receptacle on a surface of the skin using iontophoresis.

8. The method of claim 7, comprising:

coupling the sampling with a glucose-specific biosensor or glucose-specific electrodes to monitor blood glucose.

9. The method of claim 7, wherein the iontophoresis comprises:

moving an analyte into a collection reservoir; and

detecting the analyte in the collection reservoir using a biosensor.

10. The method of claim 1, wherein the assessing of the risk of hypoglycemia is based on the blood glucose concentration and data obtained from the patient'"'"'s insulin pump.

11. The method of claim 1, wherein the assessing of the risk of hypoglycemia is based on the blood glucose concentration and at least one of meal information, physical activity, or a heart rate.

12. The method of claim 11, wherein the physical activity causes variable insulin sensitivity.

13. The method of claim 1, wherein the result is 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 patent intervention being needed.

14. The method of claim 13, wherein the attenuation or intervention, or both, are in part determined using a model predictive control.

15. The method of claim 13, wherein the attenuation or intervention, or both, are in part determined using a proportional-integral-derivative (PID) control.

16. The method of claim 13, wherein the attenuation or intervention, or both, are in part determined using a neural network.