U.S. patent application number 16/588035 was filed with the patent office on 2020-05-14 for systems for predicting hypoglycemia and methods of use thereof.
The applicant listed for this patent is Eco-Fusion. Invention is credited to Oren Fuerst.
Application Number | 20200152329 16/588035 |
Document ID | / |
Family ID | 54009725 |
Filed Date | 2020-05-14 |
United States Patent
Application |
20200152329 |
Kind Code |
A1 |
Fuerst; Oren |
May 14, 2020 |
SYSTEMS FOR PREDICTING HYPOGLYCEMIA AND METHODS OF USE THEREOF
Abstract
The present invention provides for a computer system that
includes at least one server having software stored on a
non-transient computer readable medium; where, upon execution of
the software, the at least one server is at least configured to: i)
receiving, in real-time, an input from a user; ii) receiving, in
real-time, physiological data representative of a physiological
measurement of physiological characteristic of the user; iii)
comparing, in real-time, the physiological measurement of the user
to a pre-determined physiological value associated with the
physiological characteristic retrieved from a database; iv) based
on the comparing, determining, in real-time, that a difference
between the physiological measurement of the user and the
pre-determined physiological value is higher or smaller than the
predetermined threshold value, and then: v) generating, in
real-time, at least one alert; vi) transmitting, in real-time, the
at least one alert.
Inventors: |
Fuerst; Oren; (Ramat
Hasharon, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Eco-Fusion |
Ramat Gan |
|
IL |
|
|
Family ID: |
54009725 |
Appl. No.: |
16/588035 |
Filed: |
September 30, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15121225 |
Aug 24, 2016 |
10431340 |
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PCT/IB2015/000932 |
Feb 27, 2015 |
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16588035 |
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61946565 |
Feb 28, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G06F 19/3456 20130101;
G16H 50/20 20180101; G16H 10/60 20180101; G16H 20/10 20180101; G16H
50/30 20180101; G06F 19/3418 20130101; G16H 40/63 20180101; G16H
40/67 20180101 |
International
Class: |
G16H 50/20 20060101
G16H050/20; G16H 50/30 20060101 G16H050/30; G16H 40/67 20060101
G16H040/67 |
Claims
1. A computer system, comprising: a) at least one server having
software stored on a non-transient computer readable medium;
wherein, upon execution of the software, the at least one server is
at least configured to: i) receiving, in real-time, an input from a
user, wherein the input comprises user data consisting of: food
intake of the user, glucose readings of the user, medication intake
by the user, insulin dose taken by the user, or any combination
thereof; ii) receiving, in real-time, physiological data
representative of at least one physiological measurement of at
least one physiological characteristic of the user, wherein the at
least one physiological characteristic is selected from the group
consisting of: heart rate, heart rate variability, oxygen
saturation, temperature, galvanic skin response, or any combination
thereof; iii) comparing, in real-time, the at least one
physiological measurement of the user to at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database;
iv) based on the comparing, determining, in real-time, that a
difference between the at least one physiological measurement of
the user and the at least one pre-determined physiological value
is: a) higher than a predetermined threshold value, or b) smaller
than the predetermined threshold value, and then: v) generating, in
real-time, at least one alert when the at least one pre-determined
physiological value is higher than the predetermined threshold
value; vi) transmitting, in real-time, the at least one alert to at
least one of: the user, at least one family member, at least one
medical practitioner, or any combination thereof; and vii) when the
at least one pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
2. A computer method, comprising: i) receiving, in real-time, an
input from a user, wherein the input comprises user data consisting
of: food intake of the user, glucose readings of the user,
medication intake by the user, insulin dose taken by the user, or
any combination thereof; ii) receiving, in real-time, physiological
data representative of at least one physiological measurement of at
least one physiological characteristic of the user, wherein the at
least one physiological characteristic is selected from the group
consisting of: heart rate, heart rate variability, oxygen
saturation, temperature, galvanic skin response, or any combination
thereof; iii) comparing, in real-time, the at least one
physiological measurement of the user to at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database;
iv) based on the comparing, determining, in real-time, that a
difference between the at least one physiological measurement of
the user and the at least one pre-determined physiological value
is: a) higher than a predetermined threshold value, or b) smaller
than the predetermined threshold value, and then: v) generating, in
real-time, at least one alert when the at least one pre-determined
physiological value is higher than the predetermined threshold
value; vi) transmitting, in real-time, the at least one alert to at
least one of: the user, at least one family member, at least one
medical practitioner, or any combination thereof; and vii) when the
at least one pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
Description
RELATED APPLICATIONS
[0001] This application claims the priority of U.S. provisional
application No. 61/946,565; filed Feb. 28, 2014; entitled "SYSTEM
AND METHOD OF PREDICTING HYPOGLYCEMIA," which is incorporated
herein by reference in its entirety for all purposes.
TECHNICAL FIELD
[0002] In some embodiments, the instant invention is related to
computer methods/systems to predict hypoglycemia.
BACKGROUND
[0003] Individuals with type 1 diabetes adhering to strict glycemic
control are prone to suffer severe hypoglycemia. Other
well-established risk factors for hypoglycemia include a history of
severe hypoglycemia and impaired awareness of hypoglycemia. The
role of hypoglycemia may be a factor predisposing young adults to
sudden arrhythmic death.
SUMMARY OF INVENTION
[0004] In some embodiments, the instant invention provides for a
computer system, including: a) at least one server having software
stored on a non-transient computer readable medium; where, upon
execution of the software, the at least one server is at least
configured to: i) receiving, an input from a user, where the input
includes user data consisting of: food intake of the user, glucose
readings of the user, medication intake by the user, stress related
events in the preceding day, insulin dose taken by the user, or any
combination thereof; ii) receiving, in real-time, physiological
data representative of at least one physiological measurement of at
least one physiological characteristic of the user, where the at
least one physiological characteristic is selected from the group
consisting of: heart rate, heart rate variability, oxygen
saturation, temperature, galvanic skin response, or any combination
thereof; iii) comparing, in real-time, the at least one
physiological measurement of the user to at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database;
iv) based on the comparing, determining, in real-time, that a
difference between the at least one physiological measurement of
the user and the at least one pre-determined physiological value
is: a) higher than a predetermined threshold value, or b) smaller
than the predetermined threshold value, and then: v) generating, in
real-time, at least one alert when the at least one pre-determined
physiological value is higher than the predetermined threshold
value; vi) transmitting, in real-time, the at least one alert to at
least one of: the user, at least one family member, at least one
medical practitioner, or any combination thereof; and vii) when the
at least one pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
[0005] In some embodiments, the instant invention provides for a
computer method, including: i) receiving, an input from a user or
from his medical record, where the input includes user data
consisting of: food intake of the user, stress related events in
the preceding day, glucose readings of the user, medication intake
by the user, insulin dose taken by the user, or any combination
thereof; ii) receiving, in real-time, physiological data
representative of at least one physiological measurement of at
least one physiological characteristic of the user, where the at
least one physiological characteristic is selected from the group
consisting of: heart rate, heart rate variability, oxygen
saturation, temperature, galvanic skin response, or any combination
thereof; iii) comparing, in real-time, the at least one
physiological measurement of the user to at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database;
iv) based on the comparing, determining, in real-time, that a
difference between the at least one physiological measurement of
the user and the at least one pre-determined physiological value
is: a) higher than a predetermined threshold value, or b) smaller
than the predetermined threshold value, and then: v) generating, in
real-time, at least one alert when the at least one pre-determined
physiological value is higher than the predetermined threshold
value; vi) transmitting, in real-time, the at least one alert to at
least one of: the user, at least one family member, at least one
medical practitioner, or any combination thereof; and vii) when the
at least one pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
[0006] In some embodiments, the instant invention provides for a
computer system, including: a) at least one server having software
stored on a non-transient computer readable medium; where, upon
execution of the software, the at least one server is at least
configured to: i) receiving, in real-time, an input from a user,
where the input includes user data consisting of: food intake of
the user, glucose readings of the user, medication intake by the
user, insulin dose taken by the user, or any combination thereof;
ii) receiving, in real-time, physiological data representative of
at least one physiological measurement of at least one
physiological characteristic of the user, where the at least one
physiological characteristic is selected from the group consisting
of: heart rate, heart rate variability, oxygen saturation,
temperature, galvanic skin response, or any combination thereof;
iii) comparing, in real-time, the at least one physiological
measurement of the user to at least one pre-determined
physiological value associated with the at least one physiological
characteristic retrieved from at least one database; iv) based on
the comparing, determining, in real-time, that a difference between
the at least one physiological measurement of the user and the at
least one pre-determined physiological value is: a) higher than a
predetermined threshold value, or b) smaller than the predetermined
threshold value, and then: v) generating, in real-time, at least
one alert when the at least one pre-determined physiological value
is higher than the predetermined threshold value; vi) transmitting,
in real-time, the at least one alert to at least one of: the user,
at least one family member, at least one medical practitioner, or
any combination thereof; and vii) when the at least one
pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
[0007] In some embodiments, the instant invention provides for a
computer method, including: i) receiving, in real-time, an input
from a user, where the input includes user data consisting of: food
intake of the user, glucose readings of the user, medication intake
by the user, insulin dose taken by the user, or any combination
thereof; ii) receiving, in real-time, physiological data
representative of at least one physiological measurement of at
least one physiological characteristic of the user, where the at
least one physiological characteristic is selected from the group
consisting of: heart rate, heart rate variability, oxygen
saturation, temperature, galvanic skin response, or any combination
thereof; iii) comparing, in real-time, the at least one
physiological measurement of the user to at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database;
iv) based on the comparing, determining, in real-time, that a
difference between the at least one physiological measurement of
the user and the at least one pre-determined physiological value
is: a) higher than a predetermined threshold value, or b) smaller
than the predetermined threshold value, and then: v) generating, in
real-time, at least one alert when the at least one pre-determined
physiological value is higher than the predetermined threshold
value; vi) transmitting, in real-time, the at least one alert to at
least one of: the user, at least one family member, at least one
medical practitioner, or any combination thereof; and vii) when the
at least one pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The present invention will be further explained with
reference to the attached drawings, wherein like structures are
referred to by like numerals throughout the several views. The
drawings shown are not necessarily to scale, with emphasis instead
generally being placed upon illustrating the principles of the
present invention. Further, some features may be exaggerated to
show details of particular components.
[0009] The figures constitute a part of this specification and
include illustrative embodiments of the present invention and
illustrate various objects and features thereof. Further, the
figures are not necessarily to scale, some features may be
exaggerated to show details of particular components. In addition,
any measurements, specifications and the like shown in the figures
are intended to be illustrative, and not restrictive. Therefore,
specific structural and functional details disclosed herein are not
to be interpreted as limiting, but merely as a representative basis
for teaching one skilled in the art to variously employ the present
invention.
[0010] FIGS. 1 and 2 illustrates some embodiments of the inventive
system of the present invention, showing users with type 1 diabetes
connecting over network servers in accordance with the
invention.
[0011] FIG. 3 illustrates some embodiments of the inventive system
of the present invention, showing a system receiving inputs
provided by a user diagnosed with type 1 diabetes.
[0012] FIG. 4 illustrates some embodiments of the inventive system
of the present invention, showing a wristband configured to include
the system of the present invention.
[0013] FIG. 5 illustrates a flow diagram of an embodiment of the
inventive system of the present invention.
[0014] FIG. 6 illustrates an embodiment of the inventive system of
the present invention, showing sensors for use in connection with
the system.
[0015] FIG. 7 illustrates an embodiment of a watch configured to
use the inventive system.
DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0016] Among those benefits and improvements that have been
disclosed, other objects and advantages of this invention will
become apparent from the following description taken in conjunction
with the accompanying figures. Detailed embodiments of the present
invention are disclosed herein; however, it is to be understood
that the disclosed embodiments are merely illustrative of the
invention that may be embodied in various forms. In addition, each
of the examples given in connection with the various embodiments of
the invention which are intended to be illustrative, and not
restrictive.
[0017] Throughout the specification and claims, the following terms
take the meanings explicitly associated herein, unless the context
clearly dictates otherwise. The phrases "in one embodiment" and "in
some embodiments" as used herein do not necessarily refer to the
same embodiment(s), though it may. Furthermore, the phrases "in
another embodiment" and "in some other embodiments" as used herein
do not necessarily refer to a different embodiment, although it
may. Thus, as described below, various embodiments of the invention
may be readily combined, without departing from the scope or spirit
of the invention.
[0018] In addition, as used herein, the term "or" is an inclusive
"or" operator, and is equivalent to the term "and/or," unless the
context clearly dictates otherwise. The term "based on" is not
exclusive and allows for being based on additional factors not
described, unless the context clearly dictates otherwise. In
addition, throughout the specification, the meaning of "a," "an,"
and "the" include plural references. The meaning of "in" includes
"in" and "on."
[0019] In some embodiments, the present invention is an alert
mechanism for hypoglycemia. In some embodiments, the present
invention is a non-invasive alert system for hypoglycemia. In some
embodiments, the present invention is an alarm system. In some
embodiments, the present invention is configured to save the lives
of diabetics.
[0020] In some embodiments, the present invention is an alert
mechanism for nocturnal hypoglycemia. In some embodiments, the
alert mechanism is based on a deviation from the calculated
expected value of at least one of the following: heart beat, heart
beat variability, low frequency heart beat, high frequency heart
beat variability, and blood saturation level. In some embodiments,
the present invention is based on at least one of the following
input parameters: last measurement of the glucose level, food eaten
prior to going to sleep, physical activity during the preceding
day, and stress level prior to going to sleep.
[0021] FIG. 1 illustrates an embodiment of the present
invention.
[0022] FIG. 2 illustrates an embodiment of the network architecture
of the present invention.
[0023] FIG. 3 illustrates an embodiment of the system of the
present invention.
[0024] FIG. 4 is an embodiment of a hand with the wristband.
[0025] FIG. 5 is a block flow diagram of the process of the present
invention.
[0026] FIG. 6 is an embodiment of a view of a sample of typical PPG
(Photoplethysmography) sensors with Motion immunity using a 3d
Accelerometer sensor. In some embodiments, the sensor can be used
as a sensor to detect Heart Rate Variability (HRV). In some
embodiments, additional sensors can be added to include other
parameters, such as blood oxygen.
[0027] FIG. 7 illustrates an embodiment of a wrist-band of the
present invention.
Hypoglycemia
[0028] Individuals with type 1 diabetes adhering to strict glycemic
control are prone to suffer from severe hypoglycemia. Other typical
risk factors for hypoglycemia include a history of severe
hypoglycemia and impaired awareness of hypoglycemia. Despite
advanced technology and new insulin analogs, the fear of
hypoglycemia is still a problem which complicates the management of
diabetes. Without being bound by theory, the role of hypoglycemia
may be a factor predisposing young adults to sudden arrhythmic
death.
[0029] People diagnosed with type 1 diabetes require daily insulin
injections to manage their condition. The short-term complication
of administering insulin injections is hypoglycemia (i.e., low
blood glucose levels). Undetected and/or untreated hypoglycemia can
lead to seizures, comas, and hospitalization. People with type 1
diabetes typically have between a 14% to 50% chance of experiencing
hypoglycemia at night, and only a few of events are identified. At
night, people with type-1 diabetes are at increased risk of
undetected hypoglycemia as they are asleep and their autonomic
responses are reduced. Between 2% and 4% of people with type-1
diabetes die due to hypoglycemia. According to recent reports, as
many as 6% to 10% of deaths in individuals with type-1 diabetes
result from hypoglycemia. Thus, hypoglycemia is one of the most
dangerous, costly, and difficult diabetes complications to
manage.
[0030] In some embodiments, the inventive system of the present
invention allows for the monitoring of symptoms of hypoglycemia,
which may be idiosyncratic/unique/personalized to a person, but
people generally learn to recognize his/her unique symptoms. In
some embodiments, symptoms of hypoglycemia are neurogenic
(autonomic) symptoms which, for example, may include, but are not
limited to, palpitations, tremor, hunger, and sweating. In some
embodiments, neuroglycopenic symptoms typically include behavioral
changes, difficulty thinking, confusion, or any combination
thereof. In some embodiments, neuroglycopenic manifestations can
include seizure, coma, and even death. In some embodiments,
hypoglycemia (in people diagnosed with type 1 diabetes) is the
result of the interplay of relative or absolute insulin excess and
included physiological defenses against falling plasma glucose
concentrations. In some embodiments, a typically used concentration
to define the lower limit of normal glucose is 70 mg/dl (3.9
mmol/l), though in someone with diabetes, hypoglycemic symptoms can
occur at higher glucose levels, or may fail to occur at lower. In
some embodiments, concentration to define the lower limit of normal
glucose can be in the range of 80 mg/dl to 120 mg/dl (4.4 mmol/l to
6.7 mmol/l). In some embodiments, a lower limit of a concentration
of glucose is a pre-determined physiological value associated with
the at least one physiological characteristic that can be stored on
at least one database. In some embodiments, an at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database
is a glucose measurement of 70 mg/dl (3.9 mmol/l). In some
embodiments, an at least one pre-determined physiological value
associated with the at least one physiological characteristic
retrieved from at least one database is a glucose measurement of 80
mg/dl (4.4 mmol/l). In some embodiments, an at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database
is a glucose measurement of between 80 mg/dl to 120 mg/dl (4.4
mmol/l to 6.7 mmol/l).
[0031] In some embodiments, an at least one pre-determined
physiological value associated with the at least one physiological
characteristic retrieved from at least one database is a glucose
measurement of between 70 mg/dl to 110 mg/dl. In some embodiments,
an at least one pre-determined physiological value associated with
the at least one physiological characteristic retrieved from at
least one database is a glucose measurement of between 70 mg/dl to
100 mg/dl. In some embodiments, an at least one pre-determined
physiological value associated with the at least one physiological
characteristic retrieved from at least one database is a glucose
measurement of between 70 mg/dl to 90 mg/dl. In some embodiments,
an at least one pre-determined physiological value associated with
the at least one physiological characteristic retrieved from at
least one database is a glucose measurement of between 70 mg/dl
(3.9 mmol/L to 80 mg/dl (4.4 mmol/L). In some embodiments, an at
least one pre-determined physiological value associated with the at
least one physiological characteristic retrieved from at least one
database is a glucose measurement of between 70 mg/dl (3.9 mmol/L)
to 120 mg/dl (6.7 mmol/L). In some embodiments, an at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database
is a glucose measurement of between 90 mg/dl to 120 mg/dl (6.7
mmol/L). In some embodiments, an at least one pre-determined
physiological value associated with the at least one physiological
characteristic retrieved from at least one database is a glucose
measurement of between 100 mg/dl (5.6 mmol/L) to 120 mg/dl (6.7
mmol/L). In some embodiments, an at least one pre-determined
physiological value associated with the at least one physiological
characteristic is a glucose measurement of between 110 mg/dl (6.7
mmol/L) to 120 mg/d. (6.7 mmol/L)
[0032] In some embodiments, the system of the present invention is
configured to identify insulin excess, where insulin excess can
result from the pharmacokinetic imperfections of any insulin
preparation and/or insulin secretagogues used to treat diabetes in
the context of an array of factors such as food intake, exercise,
drug (including alcohol) interactions, altered sensitivity to
insulin, and insulin clearance. As used herein, a "secretagogue"
refers to a substance that causes another substance to be secreted,
for example, but not limited to, sulfonylureas which are insulin
secretagogues (i.e., triggering insulin release). In some
embodiments, included physiological defenses against falling plasma
glucose concentrations can result from the pathophysiology of
glucose counterregulation, i.e., the mechanisms that normally
prevent and/or rapidly correct hypoglycemia, at least in type-1
and/or advanced type-2 diabetes.
[0033] In some embodiments, the system of the present invention is
configured to identify heart rate (HR) variability, which is
typically used to detect autonomic dysfunction in clinical
settings. In some embodiments, a dysfunction of the autonomic
nervous system can be associated with increased mortality after
myocardial infarction in patients with diabetes (i.e., type 1
and/or type 2 diabetes) and in the general population. In some
embodiments, adults with type-1 diabetes may exhibit a marked
decrease in the low-frequency component of heart rate variability
during spontaneous nocturnal hypoglycemia. In some embodiments, a
decrease in the low-frequency component of heart rate variability
during spontaneous nocturnal hypoglycemia correlates with a decline
in glucose concentration during hypoglycemic events by, e.g., but
not limited to, exhibiting a significant, positive correlation with
the decrease of the low-frequency component of HR variability
(e.g., but not limited to, r=0.48; P=0.04). In some embodiments,
the correlation of a decrease in the low-frequency component of
heart rate variability with a decline in glucose concentration
during hypoglycemic events can serve as a prediction mechanism,
where additional medical and non medical parameters can be utilized
as additional parameters in order to define a pathway for the HRV
during the night, and hence to look for deviations from the pathway
that will trigger a plurality of alerts, as such deviations may
indicate a spontaneous nocturnal hypoglycemia.
[0034] In some embodiments, the present invention is an alert
system configured to obtain/receive and/or store/record: (i) the
last glucose reading prior to a user going to sleep, (ii) the food
intake of the user, (iii) the medication taken by the user, and
(iv) heart rate and/or heart rate variability parameters of the
user. In an embodiment, the system is configured to calculate an
expected heart rate and/or heart rate variability, and where an
identification of extreme deviations from these values occurs, the
system is configured to create and/or deliver a hypoglycemia alert
to a user, an emergency contact(s), a doctor, a hospital, or any
combination thereof. In some embodiments, the calculation of heart
rate and/or heart rate variability occurs after a measurement of a
person's heart rate is recorded by the system. In some embodiments,
the system is configured to obtain, record, calculate, or any
combination thereof, a plurality of measurements from a plurality
of samples obtained during a plurality of time points. In some
embodiments, the system is configured to operate without a blood
glucose test. In some embodiments, the system is configured to
allow an input of results derived from recent blood glucose
test(s).
[0035] FIG. 3 illustrates an embodiment of the system of the
present invention. FIG. 3 shows, as a non-limiting example, a
wristband (the system of the present invention can also be combined
in an armband or any other non-invasive wearable sensor) 710 worn
by a user 720, where the wristband is configured to communicate by
a communication standard such as, but not limited to, Bluetooth 730
with a mobile device such as, but not limited to, an iPhone 740. In
an embodiment, the system includes a mobile device 740 which is
configured to incorporate an application/software configured to
capture a plurality of bio-signals, e.g., but not limited to, heart
rate and the heart rate variability of a user, generated/obtained
from the wristband 710. In an embodiment, the system is configured
to obtain additional biosignals captured from a user's body from a
plurality of sensors housed on the wristband including, but not
limited to, blood oxygen, galvanic response, skin temperature, or
any combination thereof.
[0036] FIG. 4 illustrates an embodiment of the system of the
present invention, where the system is configured to calculate
heart rate variability by use of, e.g., but not limited to, the
mobile device, where the heart rate variability is measured and
identified by the system when the frequency of the heart
beat-to-beat sampling is sufficiently/substantially high, for
example, but not limited to, a measurement of about 108 hz. In
another embodiment, the system is configured to send
information/data from an application/software to, e.g., but not
limited to, a Data Center 750, where the Data Center manages Big
Data analysis. In an embodiment, information/data is managed by:
(i) being stored and/or compared to a plurality of users' data,
(ii) benchmarking the user's data to the user's historical data,
(iii) back-testing, (iv) storing, (v) routing data/information to
medical personnel (e.g., but not limited to, doctors, nurses, nurse
practitioners, EMTs, etc., or any combination thereof), or any
combination thereof.
[0037] In some embodiments, the system of the present invention is
configured to identify/measure a sudden drop in the heart rate
variability and/or component(s) of heart rate variability (e.g.,
but not limited to, the low frequency component(s)), where the
sudden drop in the heart rate variability and/or component of heart
rate variability is/are an indication(s) of a forthcoming
hypoglycemic event. In some embodiments, the system includes an
alert configured to trigger an alarm on, e.g., but not limited to,
at least one mobile phone. In another embodiment, the system is
configured to alert the user to wake-up and eat and/or drink a
carbohydrate containing food stuff (i.e., any food stuff that, when
metabolized by the user, will provide sugar to the user). In some
embodiments, the system is configured to send at least one alert/a
plurality of alerts to at least one medical team and/or at least
one family member of the user. In some embodiments, the system is
configured to remind/alert a user to test the user's glucose level
before the user drinks and/or cats. In some embodiments, the system
is configured to remind/alert a user to test the user's glucose
level after the user drinks and/or eats. In some embodiments, the
application/software of the system is configured to receive an
input/entry or a plurality of inputs/entries of the user's glucose
level(s) into the application, where the input(s)/entry(ies) allow
for the application/software to adjust and learn to adjust itself,
if required.
[0038] FIG. 5 illustrates an embodiment of the system of the
present invention, including an initial setting up phase 9.1, where
the system is configured to receive a plurality of inputs
provided/delivered by a user which define his preference set, for
example, but not limited to, medications, including dosing and
morning/afternoon/evening medication, favorite foods, glycemic
index for different foods if needed, for example, when the user's
known digestion is different from the otherwise known glycemic
index. In another embodiment, at step 9.2, the system is configured
to receive a user's entry/input, where the user's entry/input can
be the user's last food intake before going to sleep, as well as
the information related to last glucose reading before going to
sleep, stress level (if, for example, the wrist band was not worn
during the day and the information was not captured during the day
by the system already), information regarding insulin and other
medications taken and which might still be influencing the glucose
level in his body (such as, e.g., but not limited to, stress and
anxiety reducing medication). In an embodiment, at stage 9.3, the
system is configured to continuously analyze information/data input
and/or collected from the wrist band. In another embodiment, the
information/data can include multi-parameters from at least one of
the following measurements: beat-to-beat heart rate, heart rate
variability and heart rate variability components, oxygen level,
skin temperature, galvanic skin response, or any combination
thereof. In another embodiment, the system is configured to analyze
the information/data for changes/deviations compared with an
expected information/data projected for the same time during the
night sleep for the same user when compared to a benchmark on the
data base, which is located at the mobile device 740 and the data
center 750 and/or the cpu level located on the wrist band 710. In
some embodiments, the expected value can be derived many different
ways, for example using the historical pattern of the same user or
similar users or patients given similar scenarios of food intake
and glucose readings before going to sleep. In an embodiment, by
way of non-limiting illustration, the pattern of a person of a Type
II diabetic with a glucose reading prior to going to sleep of 100
and an average stress day can be compared to the average population
pathway. In some embodiments, a pathway of a reading of 120 with a
stressful day (as measured by, e.g., but not limited to,
questionnaires and HRV or galvanic skin readings) and an evening
meal filled with carbs will be compared to a population of similar
pattern. In some embodiments, pattern recognition and parameters of
interest may correlate to the above parameters but can correlate to
combination of parameters, as such parameters may arise from
statistical analysis using tools such as discriminant or principal
component analysis. In an embodiment, the system is configured to
compare the calculated expected values with the actual. In an
embodiment, the system is configured to receive/record/account the
prior information known about the user, such as, but not limited
to, the food eaten in the meal prior to going to sleep, the glucose
level as tested prior to going to sleep, in the tests measured on
the day(s) preceding, or any combination thereof. In an embodiment,
the system is configured to trigger and/or send at least one alert
(e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 etc. alerts) when, according
to the comparison of the system noted in 9.5, there is a
substantially significant change from what would have been
expected, to: wake up the person 9.6.1, to alert the family, 9.6.2,
alert the medical team 9.6.3, or any combination thereof.
[0039] In another embodiment, the system of the present invention
includes triggers for an alarm which is configured to be adjusted
based on the habits of the user. In an embodiment, the system is
configured to receive (i) food entries from the user, where the
food entries were consumed before going to sleep, where the
software/application is configured to calculate the amount and/or
type of carbohydrates, (ii) medication entries from the user
(including, but not limited to, Bolus and Basal insulin brand and
dosing), (iii) any personal settings, or any combination
thereof.
[0040] In some embodiments, the amount of food and medication prior
to going to sleep will have an impact on the probability of
hypoglycemia and the time during sleep, if at all, of an
hypoglycemia event to occur. In some embodiments, additional events
on the day prior to the night sleep influence the likelihood of
hypoglycemia to occur. In some embodiment, levels of stress are
configured to be measured by the wristband by the HRV that was
measured during the preceding day, as captured by the
application/software of the system. In an embodiment, there is a
correlation between higher the level of stress and the higher
occurrence for a hypoglycemic event. In some embodiments,
loss/reduction of autonomic function can result in a reduction in
HRV may also have negative effects on the user's body's ability to
process and/or store glucose.
The Autonomic Nervous System
[0041] Table 1 outlines which organs are affected by the
sympathetic (SNS) and parasympathetic (PSNS) nervous systems.
Typically, the SNS initiates a "fight or flight" response to
stress. The SNS increases heart rate, dilates or opens the lungs,
inhibits digestion and dilates the pupils, providing the body with
the resources it needs to protect itself in times of danger. The
PSNS conversely, is known as the "rest and digest" system; it
promotes digestion, reduces heart rate, increases salivation,
increases urine secretion from the kidneys and constricts the
pupils. On a day-to-day basis, these two pathways work in parallel
to maintain homeostatic balance within the body.
TABLE-US-00001 TABLE 1 Blood Mechanism of Action Hormone glucose
Inhibition of gluconeogenesis (liver) Glucose entry stimulation
(muscle) Insulin .dwnarw. Stimulation of glucose storage, --
glycogen formation (liver, muscle) Adrenaline .uparw. --
Stimulation of glycogen breakdown to active molecules (liver,
muscle) Glucagon .uparw. Stimulation of glucose storage (liver) --
Stimulation of glucose formation from non-carbohydrate substrates
(liver) Cortisol .uparw. -- Stimulation of glucose formation from
non-carbohydrate substrates (liver) Growth .uparw. -- Mobilization
of triglycerides hormone
Glucose
[0042] Glucose levels in the blood and tissues are maintained via a
series of different processes, largely stimulated by different
hormones. Ingested food is broken down by enzymes into simple
sugars (monosaccharides), which are absorbed through the gut wall
and transported to the liver. Glucose can directly enter the liver,
brain, kidney and red blood cells. It uses insulin to enter muscle
and adipose (fat) tissue cells. In the liver and muscle cells
glucose is converted to glycogen, its storage form. The reverse
process is the degradation of glycogen to form glucose and
glucose-6-phostphate (G6P). In muscle, G6P is used to produce ATP,
the unit of energy required for contraction. Glucose may also be
used for the synthesis of other substances such as glycoproteins
and glycolipids or it may be transformed into fat and stored as
adipose tissue. All of these processes work together to maintain a
normal range of blood glucose, from 3.8 to 6.1 mmol/L. Table 1
summarizes the effects of different hormones on blood glucose
levels.
The Autonomic Nervous System & Glucose
[0043] In healthy individuals, when blood glucose levels fall the
SNS is activated, stimulating glucose production in the liver and
kidney and reducing muscle use of glucose by way of adrenaline
release. Vagal (parasympathetic) stimulation has the opposite
effect: insulin release from the pancreas, which stimulates glucose
uptake by cells; reduction in glucose release from tissues and
increased glycogen formation by the liver. Hypoglycemia, or low
blood sugar, leads to sympathetic activation increasing blood
glucose levels, while hyperglycaemia, high blood sugar, results in
parasympathetic activation to reduce blood glucose levels. These
two systems work in unison to maintain healthy blood glucose
levels. Therefore, impaired parasympathetic regulation (decreased
HRV) increases risk for chronic hyperglycaemia and
hyperinsulinaemia (raised insulin levels, also known as insulin
resistance), which is a pre-cursor for diabetes mellitus.
Diabetes & Heart Rate Variability (HRV)
[0044] In some embodiments, the system of the present invention is
configured to identify a correlation between insulin resistance and
HRV; specifically, diabetic patients (DM) show lower than average
HRV. In some embodiments, the system can include parameters such
as, but not limited to, the disease background of the diabetes
patient when calculating the expected values of the HRV throughout
the night. In some embodiments, a correlation exists between
insulin resistance (as indicated by raised fasting serum insulin
levels) and reduced HRV; specifically, an overall decline in HRV in
both diabetic and non-diabetic populations can occur, with a
greater decrease in participants with diabetes. In some
embodiments, there is an increased risk among diabetics for
autonomic neuropathies can lead to loss of sensation in the
peripheries and in extreme cases, infected wounds resulting in limb
loss (often known as diabetic foot). In some embodiments, there are
correlations between HRV and insulin sensitivity, diabetes, fasting
blood glucose and even glycosylated haemoglobin (HbA1c). In some
embodiments, diabetic subjects have a more rapid temporal decrease
in HRV conditional on baseline HRV than nondiabetic subjects, e.g.,
but not limited to: adjusted mean annual changes (95% CI) (ms/year)
in the SD (i.e., standard deviation) of all normal-to-normal R-R
(i.e., interbeat) intervals can be -0.65 (-0.69 to -0.61) for those
with normal fasting glucose vs. -0.95 (-1.09 to -0.81) for diabetic
subjects, in root mean square of successive differences in
normal-to-normal R-R intervals -0.35 (-0.39 to -0.30) vs. -0.66
(-0.82 to -0.51), and in R-R interval 6.70 (6.37-7.04) vs. 3.89
(2.72-5.05). In some embodiments, HRV of severely obese patients
with insulin resistance can improve once the patient has a gastric
bypass and/or has a decrease in insulin resistance. In some
embodiments, the normal-to-normal R-R intervals can be -0.69 to
-0.65 in individuals with normal fasting glucose. In some
embodiments, the normal-to-normal R-R intervals can be -0.65 to
-0.61 in individuals with normal fasting glucose. In some
embodiments, the R-R intervals can be -1.00 to -0.81 for diabetic
subjects. In some embodiments, the R-R intervals can be -0.90 to
-0.81 for diabetic subjects. In some embodiments, the R-R intervals
can be -1.09 to -0.9 for diabetic subjects. In some embodiments,
the R-R intervals can be -1.09 to -1 for diabetic subjects. In some
embodiments, the root mean square of successive differences in
normal-to-normal R-R intervals can be -0.39 to -0.35 in individuals
with normal fasting glucose. In some embodiments, the root mean
square of successive differences in normal-to-normal R-R intervals
can be -0.35 to -0.30 in individuals with normal fasting glucose.
In some embodiments, the root mean square of successive differences
in diabetic subjects can be -0.7 to -0.51. In some embodiments, the
root mean square of successive differences in diabetic subjects can
be -0.6 to -0.51. In some embodiments, the root mean square of
successive differences in diabetic subjects can be -0.82 to -0.6.
In some embodiments, the root mean square of successive differences
in diabetic subjects can be -0.82 to -0.7. In some embodiments, the
R-R interval in individuals with normal fasting glucose can be
6.5-7.04. In some embodiments, the R-R interval in individuals with
normal fasting glucose can be 6.8-7.04. In some embodiments, the
R-R interval in individuals with normal fasting glucose can be
6.37-6.8. In some embodiments, the R-R interval in individuals with
normal fasting glucose can be 6.37-6.5. In some embodiments, the
R-R interval in diabetic subjects can be 3-5.05. In some
embodiments, the R-R interval in diabetic patients can be 4-5.05.
In some embodiments, the R-R interval in diabetic subjects can be
2.72-4. In some embodiments, the R-R interval in diabetic subjects
can be 2.72-3.
Illustrative Operating Environments
[0045] FIG. 1 illustrates one embodiment of an environment in which
the system of the present invention may operate. However, not all
of these components may be required to practice the invention, and
variations in the arrangement and type of the components may be
made without departing from the spirit or scope of the present
invention. In some embodiments, the system and method may include a
large number of members and/or concurrent transactions. In other
embodiments, the system and method are based on a scalable computer
and network architecture that incorporates varies strategies for
assessing the data, caching, searching, and database connection
pooling. An example of the scalable architecture is an architecture
that is capable of operating multiple servers.
[0046] In embodiments, members of the computer system 102-104
include virtually any computing device capable of receiving and
sending a message over a network, such as network 105, to and from
another computing device, such as servers 106 and 107, each other,
and the like. In embodiments, the set of such devices includes
devices that typically connect using a wired communications medium
such as personal computers, multiprocessor systems,
microprocessor-based or programmable consumer electronics, network
PCs, and the like. In embodiments, the set of such devices also
includes devices that typically connect using a wireless
communications medium such as cell phones, smart phones, pagers,
walkie talkies, radio frequency (RF) devices, infrared (IR)
devices, CBs, integrated devices combining one or more of the
preceding devices, or virtually any mobile device, and the like.
Similarly, in embodiments, client devices 102-104 are any device
that is capable of connecting using a wired or wireless
communication medium such as a PDA, POCKET PC, wearable computer,
and any other device that is equipped to communicate over a wired
and/or wireless communication medium.
[0047] In embodiments, each member device within member devices
102-104 may include a browser application that is configured to
receive and to send web pages, and the like. In embodiments, the
browser application may be configured to receive and display
graphics, text, multimedia, and the like, employing virtually any
web based language, including, but not limited to Standard
Generalized Markup Language (SMGL), such as HyperText Markup
Language (HTML), a wireless application protocol (WAP), a Handheld
Device Markup Language (HDML), such as Wireless Markup Language
(WML), WMLScript, XML, JavaScript, and the like. In some
embodiments, programming may include either Java, .Net, QT, C, C++
or other suitable programming language.
[0048] In embodiments, member devices 102-104 may be further
configured to receive a message from another computing device
employing another mechanism, including, but not limited to email,
Short Message Service (SMS), Multimedia Message Service (MMS),
instant messaging (IM), internet relay chat (IRC), mIRC, Jabber,
and the like or a Proprietary protocol.
[0049] In embodiments, network 105 may be configured to couple one
computing device to another computing device to enable them to
communicate. In some embodiments, network 105 may be enabled to
employ any form of computer readable media for communicating
information from one electronic device to another. Also, in
embodiments, network 105 may include a wireless interface, and/or a
wired interface, such as the Internet, in addition to local area
networks (LANs), wide area networks (WANs), direct connections,
such as through a universal serial bus (USB) port, other forms of
computer-readable media, or any combination thereof. In
embodiments, on an interconnected set of LANs, including those
based on differing architectures and protocols, a router may act as
a link between LANs, enabling messages to be sent from one to
another.
[0050] Also, in some embodiments, communication links within LANs
typically include twisted wire pair or coaxial cable, while
communication links between networks may utilize analog telephone
lines, full or fractional dedicated digital lines including T1, T2,
T3, and T4, Integrated Services Digital Networks (ISDNs), Digital
Subscriber Lines (DSLs), wireless links including satellite links,
or other communications links known to those skilled in the art.
Furthermore, in some embodiments, remote computers and other
related electronic devices could be remotely connected to either
LANs or WANs via a modem and temporary telephone link. In essence,
in some embodiments, network 105 includes any communication method
by which information may travel between client devices 102-104, and
servers 106 and 107.
[0051] FIG. 2 shows another exemplary embodiment of the computer
and network architecture that supports the method and system. The
member devices 202a, 202b thru 202n shown each at least includes a
computer-readable medium, such as a random access memory (RAM) 208
coupled to a processor 210 or FLASH memory. The processor 210 may
execute computer-executable program instructions stored in memory
208. Such processors comprise a microprocessor, an ASIC, and state
machines. Such processors comprise, or may be in communication
with, media, for example computer-readable media, which stores
instructions that, when executed by the processor, cause the
processor to perform the steps described herein. Embodiments of
computer-readable media may include, but are not limited to, an
electronic, optical, magnetic, or other storage or transmission
device capable of providing a processor, such as the processor 210
of client 202a, with computer-readable instructions. Other examples
of suitable media may include, but are not limited to, a floppy
disk, CD-ROM, DVD, magnetic disk, memory chip, ROM, RAM, an ASIC, a
configured processor, all optical media, all magnetic tape or other
magnetic media, or any other medium from which a computer processor
can read instructions. Also, various other forms of
computer-readable media may transmit or carry instructions to a
computer, including a router, private or public network, or other
transmission device or channel, both wired and wireless. The
instructions may comprise code from any computer-programming
language, including, for example, C, C++, C #, Visual Basic, Java,
Python, Peri, and JavaScript.
[0052] Member devices 202a-n may also comprise a number of external
or internal devices such as a mouse, a CD-ROM, DVD, a keyboard, a
display, or other input or output devices. Examples of client
devices 202a-n may be personal computers, digital assistants,
personal digital assistants, cellular phones, mobile phones, smart
phones, pagers, digital tablets, laptop computers, Internet
appliances, and other processor-based devices. In general, a client
device 202a may be any type of processor-based platform that is
connected to a network 206 and that interacts with one or more
application programs. Client devices 202a-n may operate on any
operating system capable of supporting a browser or browser-enabled
application, such as Microsoft.TM., Windows.TM., or Linux. The
client devices 202a-n shown may include, for example, personal
computers executing a browser application program such as Microsoft
Corporation's Internet Explorer.TM., Apple Computer, Inc.'s
Safari.TM., Mozilla Firefox, and Opera. Through the client devices
202a-n, users, 212a-n communicate over the network 206 with each
other and with other systems and devices coupled to the network
206. As shown in FIG. 1B, server devices 204 and 213 may be also
coupled to the network 206.
[0053] In some embodiments, the term "mobile electronic device" may
refer to any portable electronic device that may or may not be
enabled with location tracking functionality. For example, a mobile
electronic device can include, but is not limited to, a mobile
phone, Personal Digital Assistant (PDA), Blackberry.TM., Pager,
Smartphone, or any other reasonable mobile electronic device. For
ease, at times the above variations are not listed or are only
partially listed, this is in no way meant to be a limitation.
[0054] In some embodiments, the terms "proximity detection,"
"locating," "location data," "location information," and "location
tracking" as used herein may refer to any form of location tracking
technology or locating method that can be used to provide a
location of a mobile electronic device, such as, but not limited
to, at least one of location information manually input by a user,
such as, but not limited to entering the city, town, municipality,
zip code, area code, cross streets, or by any other reasonable
entry to determine a geographical area; Global Positions Systems
(GPS); GPS accessed using Bluetooth.TM.; GPS accessed using any
reasonable form of wireless and/or non-wireless communication;
WiFi.TM. server location data; Bluetooth.TM. based location data;
triangulation such as, but not limited to, network based
triangulation, WiFi.TM. server information based triangulation,
Bluetooth.TM. server information based triangulation; Cell
Identification based triangulation, Enhanced Cell Identification
based triangulation, Uplink-Time difference of arrival (U-TDOA)
based triangulation, Time of arrival (TOA) based triangulation,
Angle of arrival (AOA) based triangulation; techniques and systems
using a geographic coordinate system such as, but not limited to,
longitudinal and latitudinal based, geodesic height based,
cartesian coordinates based; Radio Frequency Identification such
as, but not limited to, Long range RFID, Short range RFID; using
any form of RFID tag such as, but not limited to active RFID tags,
passive RFID tags, battery assisted passive RFID tags; or any other
reasonable way to determine location. For ease, at times the above
variations are not listed or are only partially listed, this is in
no way meant to be a limitation.
[0055] In some embodiments, near-field wireless communication (NFC)
can represent a short-range wireless communications technology in
which NFC-enabled devices are "swiped," "bumped," "tap" or
otherwise moved in close proximity to communicate. In some
embodiments, NFC could include a set of short-range wireless
technologies, typically requiring a distance of 10 cm or less.
[0056] In some embodiments, NFC may operate at 13.56 MHz on ISO/IEC
18000-3 air interface and at rates ranging from 106 kbit/s to 424
kbit/s. In some embodiments, NFC can involve an initiator and a
target; the initiator actively generates an RF field that can power
a passive target. In some embodiment, this can enable NFC targets
to take very simple form factors such as tags, stickers, key fobs,
or cards that do not require batteries. In some embodiments, NFC
peer-to-peer communication can be conducted when a plurality of
NFC-enable devices within close proximity of each other.
[0057] In some embodiments, in addition to the glucose level,
additional parameters can be used for the prediction of the
hypoglycemia.
[0058] In some embodiments, the instant invention provides for a
computer system, including: a) at least one server having software
stored on a non-transient computer readable medium; where, upon
execution of the software, the at least one server is at least
configured to: i) receiving, an input from a user, where the input
includes user data consisting of: food intake of the user, glucose
readings of the user, medication intake by the user, stress related
events in the preceding day, insulin dose taken by the user, or any
combination thereof; ii) receiving, in real-time, physiological
data representative of at least one physiological measurement of at
least one physiological characteristic of the user, where the at
least one physiological characteristic is selected from the group
consisting of: heart rate, heart rate variability, oxygen
saturation, temperature, galvanic skin response, or any combination
thereof; iii) comparing, in real-time, the at least one
physiological measurement of the user to at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database;
iv) based on the comparing, determining, in real-time, that a
difference between the at least one physiological measurement of
the user and the at least one pre-determined physiological value
is: a) higher than a predetermined threshold value, or b) smaller
than the predetermined threshold value, and then: v) generating, in
real-time, at least one alert when the at least one pre-determined
physiological value is higher than the predetermined threshold
value; vi) transmitting, in real-time, the at least one alert to at
least one of: the user, at least one family member, at least one
medical practitioner, or any combination thereof; and vii) when the
at least one pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
[0059] In some embodiments, the instant invention provides for a
computer method, including: i) receiving, an input from a user or
from his medical record, where the input comprises user data
consisting of: food intake of the user, stress related events in
the preceding day, glucose readings of the user, medication intake
by the user, insulin dose taken by the user, or any combination
thereof; ii) receiving, in real-time, physiological data
representative of at least one physiological measurement of at
least one physiological characteristic of the user, where the at
least one physiological characteristic is selected from the group
consisting of: heart rate, heart rate variability, oxygen
saturation, temperature, galvanic skin response, or any combination
thereof; iii) comparing, in real-time, the at least one
physiological measurement of the user to at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database;
iv) based on the comparing, determining, in real-time, that a
difference between the at least one physiological measurement of
the user and the at least one pre-determined physiological value
is: a) higher than a predetermined threshold value, or b) smaller
than the predetermined threshold value, and then: v) generating, in
real-time, at least one alert when the at least one pre-determined
physiological value is higher than the predetermined threshold
value; vi) transmitting, in real-time, the at least one alert to at
least one of: the user, at least one family member, at least one
medical practitioner, or any combination thereof; and vii) when the
at least one pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
[0060] In some embodiments, the instant invention provides for a
computer system, including: a) at least one server having software
stored on a non-transient computer readable medium; where, upon
execution of the software, the at least one server is at least
configured to: i) receiving, in real-time, an input from a user,
where the input includes user data consisting of: food intake of
the user, glucose readings of the user, medication intake by the
user, insulin dose taken by the user, or any combination thereof;
ii) receiving, in real-time, physiological data representative of
at least one physiological measurement of at least one
physiological characteristic of the user, where the at least one
physiological characteristic is selected from the group consisting
of: heart rate, heart rate variability, oxygen saturation,
temperature, galvanic skin response, or any combination thereof;
iii) comparing, in real-time, the at least one physiological
measurement of the user to at least one pre-determined
physiological value associated with the at least one physiological
characteristic retrieved from at least one database; iv) based on
the comparing, determining, in real-time, that a difference between
the at least one physiological measurement of the user and the at
least one pre-determined physiological value is: a) higher than a
predetermined threshold value, or b) smaller than the predetermined
threshold value, and then: v) generating, in real-time, at least
one alert when the at least one pre-determined physiological value
is higher than the predetermined threshold value; vi) transmitting,
in real-time, the at least one alert to at least one of: the user,
at least one family member, at least one medical practitioner, or
any combination thereof; and vii) when the at least one
pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
[0061] In some embodiments, the instant invention provides for a
computer method, including: i) receiving, in real-time, an input
from a user, where the input comprises user data consisting of:
food intake of the user, glucose readings of the user, medication
intake by the user, insulin dose taken by the user, or any
combination thereof; ii) receiving, in real-time, physiological
data representative of at least one physiological measurement of at
least one physiological characteristic of the user, where the at
least one physiological characteristic is selected from the group
consisting of: heart rate, heart rate variability, oxygen
saturation, temperature, galvanic skin response, or any combination
thereof; iii) comparing, in real-time, the at least one
physiological measurement of the user to at least one
pre-determined physiological value associated with the at least one
physiological characteristic retrieved from at least one database;
iv) based on the comparing, determining, in real-time, that a
difference between the at least one physiological measurement of
the user and the at least one pre-determined physiological value
is: a) higher than a predetermined threshold value, or b) smaller
than the predetermined threshold value, and then: v) generating, in
real-time, at least one alert when the at least one pre-determined
physiological value is higher than the predetermined threshold
value; vi) transmitting, in real-time, the at least one alert to at
least one of: the user, at least one family member, at least one
medical practitioner, or any combination thereof; and vii) when the
at least one pre-determined physiological value is smaller than the
predetermined threshold value, causing to continue measuring, in
real-time, the at least one physiological characteristic of the
user.
[0062] While a number of embodiments of the present invention have
been described, it is understood that these embodiments are
illustrative only, and not restrictive, and that many modifications
may become apparent to those of ordinary skill in the art. Further
still, the various steps may be carried out in any desired order
(and any desired steps may be added and/or any desired steps may be
eliminated).
* * * * *