U.S. patent application number 10/664368 was filed with the patent office on 2005-09-08 for method and a system for assisting a user in a medical self treatment, said self treatment comprising a plurality of actions.
Invention is credited to Aasmul, Soren, Christensen, Lars Hofmann, Poulsen, Jens Ulrik.
Application Number | 20050197621 10/664368 |
Document ID | / |
Family ID | 26065918 |
Filed Date | 2005-09-08 |
United States Patent
Application |
20050197621 |
Kind Code |
A1 |
Poulsen, Jens Ulrik ; et
al. |
September 8, 2005 |
Method and a system for assisting a user in a medical self
treatment, said self treatment comprising a plurality of
actions
Abstract
This invention relates to a method of assisting a user in a
medical self treatment, said self treatment comprising a plurality
of actions, said method comprising the steps of collecting in a one
or more databases data representing values of parameters relevant
for said self treatment, and the step of processing said one or
more databases to provide for alternative choices between two or
more action and a corresponding value for each two or more actions.
The invention also relates to a computer system having means for
performing the method according to the invention, and a computer
readable medium having a program recorded thereon, where the
program when executed is to make the computer execute the method
according to the invention
Inventors: |
Poulsen, Jens Ulrik; (Virum,
DK) ; Christensen, Lars Hofmann; (Jyllinge, DK)
; Aasmul, Soren; (Holte, DK) |
Correspondence
Address: |
Reza Green, Esq.
Novo Nordisk Pharmaceuticals, Inc.
100 College Road West
Princeton
NJ
08540
US
|
Family ID: |
26065918 |
Appl. No.: |
10/664368 |
Filed: |
September 17, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10664368 |
Sep 17, 2003 |
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09462128 |
Oct 30, 2000 |
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6656114 |
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09462128 |
Oct 30, 2000 |
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PCT/DK99/00670 |
Nov 30, 1999 |
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60111721 |
Dec 9, 1998 |
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Current U.S.
Class: |
604/67 ;
702/19 |
Current CPC
Class: |
G16H 20/30 20180101;
A61B 5/0002 20130101; A61B 2560/0406 20130101; A61M 2205/505
20130101; G16H 50/50 20180101; A61B 5/14532 20130101; A61B
2560/0443 20130101; Y10S 128/921 20130101; G16H 20/17 20180101;
Y10S 128/92 20130101; A61M 2205/52 20130101; G16H 10/60 20180101;
A61M 5/003 20130101; G16H 70/20 20180101; A61B 2562/0219 20130101;
A61M 5/24 20130101; G16H 20/60 20180101 |
Class at
Publication: |
604/067 ;
702/019 |
International
Class: |
A61M 031/00; G01N
033/48; G06F 019/00; G01N 033/50 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 30, 1998 |
DK |
199801578 |
Claims
1. A system for assisting a diabetic subject in controlling blood
glucose levels, the system comprising: a. an insulin delivery unit;
b. a blood glucose monitor; c. a master module that includes a
processor that is configured to receive a blood glucose value from
the blood glucose monitor and to run a model that predicts a future
glucose value and compares that value with a target value and then
predict a dose of insulin that will result in an acceptable blood
glucose level; and d. wherein the dose of insulin is transmitted to
the insulin delivery unit.
2. The system of claim 1, wherein the processor is configured to
receive other data from the subject.
3. The system of claim 2 wherein the data includes information on
size and type of meal to be ingested and anticipated duration and
intensity of exercise.
4. A system for assisting a diabetic subject in controling blood
glucose levels, the system comprising: a. A first device; b. A
blood glucose monitor; c. A master module that includes a processor
that is configured to receive a blood glucose value from the sensor
and to run a model that predicts a glucose value and compares that
value with a target value and then predicts one or more courses of
treatment that will result in an acceptable blood glucose
level.
5. The system of claim 4, wherein the first device receives a
proposed course of treatment for the subject to implement.
6. The system of claim 5, wherein the first device is an insulin
delivery device.
7. A tool for assisting a diabetic in achieving glycemic control,
the tool comprising: a. A processor configured to model the human
carbohydrate metabolism b. An input means for receiving data about
the subject c. a proposal generator for proposing one or more
courses of treatment that will result in a future blood glucose
level being in acceptable range, wherein the processor will only
propose a course of treatment if there is a corresponding device
present that can carry out the proposed course of treatment.
8. The tool of claim 7, wherein the processor is configured to
propose at least one course of treatment includes administering a
dose of insulin and wherein that proposal is automatically
transmitted to an insulin delivery device.
Description
[0001] The present invention relates to a method of assisting a
user in a medical self treatment, said self treatment comprising a
plurality of actions.
[0002] The present invention also relates to a system/an apparatus
for assisting a user in a medical self treatment, said self
treatment comprising a plurality of actions.
[0003] In the following a user/patient will be a patient having
diabetes.
[0004] For a number of years it has been possible to purchase
various devices for the treatment of diabetes, e.g. for injecting
insulin, for measuring blood sugar (such a device is referred to as
BGM in the following), for withdrawing blood samples, and other
accessories, the purpose of which is to enable the patient to nurse
his disease discretely and with a high standard of safety.
[0005] Many diabetic patients are elderly people who can easily get
insecure with respect to the medical equipment. It is very
reassuring and therefore also very important that the user can have
feedback from the system which confirms to the user that everything
is OK right from the technical function of the system to the
patient's physiological condition. This stretches out a
psychological safety net under the patient, which contributes to
improving the quality of life of patients having a disease such as
diabetes.
[0006] Traditionally, diabetic people live under strict rules of
"do's and don'ts". There is a historical need in order to comply
with a therapeutic regimen. The purpose of this being a well
controlled blood glucose level (BGL) and thereby a much lesser risk
of later complications. This is a highly undesirably situation from
a `quality-of-life` point of view. It often results in bad
mood--which is known to lead to a poor BGL regulation. Thus an evil
circle is created which is hard for the diabetic to break.
[0007] Additionally, in certain cultures/societies there is a
reluctance against using syringes/needles to administer medication
and people therefore choose alternative ways to try to comply with
a regimen. However, this often has the unfortunate result that
people choose alternatives that do not fully or at all correspond
to the optimal regimen and thereby choose wrong alternatives with
adverse effects.
[0008] Further, the metabolism is a very complex and dynamic
system. It is very hard to get and maintain an overview for the
diabetic as many factors play a role. It is very likely that the
diabetic looses an overview or relies on too simple rules of
operation or eventually neglect the illness.
[0009] Various systems trying to ease the hazels of diabetes have
been proposed over time. These systems have basically an accounting
role and simply keep track of whatever input the user specifies. In
these systems input of food and exercise are usually a task that
the user needs to initiate. Systems that rely on the user to take
action can be hard to make function well due to the user's
reluctance to deal with it.
[0010] Patent specification WO 95/32480 discloses a medical
information reporting system which has a patient sensor device
controlled via a patient operated interface device by a
micro-controller which writes data to a memory and a report writer.
The specification further discloses a warning algorithm with zone
boundary values which is specified by the user and consent to by a
physician. This system simply keep track of whatever input the user
specifies.
[0011] Patent specification WO 94/24929 discloses a patient support
and monitoring system, which has a database located at a remote
location for collection of information in a remote database from
sensors and a medicine administration system. This system also keep
track of whatever input the user specifies and may initiate a
medical reaction on the basis of received parameters.
[0012] The object of the invention is to provide a method which
provides a user with a freedom of operation with respect to a
self-treatment.
[0013] This is achieved by guiding the user with respect to a self
treatment by presenting options/possibilities in such a way that
compliance to a regimen may be obtained in numerous ways.
[0014] More particularly, the invention relates to a method of
assisting a user in a medical self treatment, said self treatment
comprising a plurality of actions, said method comprising the steps
of
[0015] collecting in a one or more databases data representing
values of parameters relevant for said self treatment, where said
method further comprises the step of
[0016] processing said one or more databases to provide the patient
with!! SaaS' forslag!! alternative choices between two or more
actions and a corresponding dose for each two or more actions.
[0017] Hereby, the user's self-treatments change from restrictions
to possibilities thereby enhancing the overall `quality-of-life`
for the user and better ensuring that the user's self-treatment
complies better or fully with a specified regimen by choosing
proposed choices which complies with the regimen. This avoids that
the user chooses actions and alternatives which do not fully or at
all correspond to the optimal regimen due to a lack of a clear
overview of the complex factors involved in the self-treatment.
[0018] By providing the user with a number of options he may choose
the one(s) he likes best and still obtain the right and full
treatment instead of choosing the easiest and most appealing course
of action on his own, which may be wrong or insufficient and result
in adverse effects.
[0019] Additionally, the possibility of choices fulfilling a
prescribed regimen makes the patient feel more in control of the
treatment and enhances the therapeutic value of the treatment and
improves the patient's ability to adapt his treatment to his daily
life.
[0020] Additionally, the user's feeling of being ill is reduced,
since the user has options of choices instead of a dictation of
actions.
[0021] An additional object of the invention is to estimate one or
more future values for one of said parameters, in order to obtain
information of the user's condition in the near future, hereby
enhancing the possibilities of presenting better/more relevant
choices.
[0022] One way of estimating one or more future values may be done
on the basis on a dynamic model representing the human
metabolism.
[0023] An additional object of the invention is to provide
effective monitoring of electronic data/information which are used
by a patient for self-treatment of a disease, so that a greater
level of safety, both functionally and emotionally, and an
effective feedback to the patient are obtained.
[0024] The invention also relates to computer system having means
for executing a program, where the program when executed is to make
the computer execute the method according to claims 1-19.
[0025] By computer system is meant a system comprising processing
means and being programmable at one time or another in order to
execute a set of instructions/commands like a system for the
self-treatment of a patient e.g. comprising one or more of sensor,
medication administering device, data collection, and displaying
means or a general computer system as a PC, laptop, palmtop, or a
system having at least one device comprising a micro controller
adapted to execute a program (either in hard- and/or software), and
so on.
[0026] The invention further relates to a computer readable medium
having a program recorded thereon, where the program when executed
is to make the computer execute the method according to claims
1-19.
[0027] The computer readable medium may e.g. be a CD-ROM, magnetic
disk, ROM circuit, a network connection or generally any medium
that may provide a computer system with information of how to
execute instructions/commands.
[0028] The above mentioned system and method need as good as
possible data collection in order to present relevant and useful
choices/proposals to the user. In a preferred embodiment a
system/method relating to individual apparatuses, which are
provided with electronic communications equipment so that the
apparatuses--when in a state of mutual communication--frequently
exchange information between them, are provided. Hereby a greater
functional safety can be achieved and the total data capacity of
the system can be increased, so that the feedback possibilities,
e.g. of the system checking that every apparatus is OK and set up
properly and of the patient be given a number of possible and up to
date choices to choose from in a given situation, are
increased.
[0029] The individual devices may be arranged for various
respective functions relevant to the treatment of e.g. diabetes,
such as: a lancet device, a body fluid analyser, one or more drug
administration apparatuses for administering a predetermined dose
of medication to the patient. Further, there may be a number of
other aids which the diabetic patient uses, e.g. test strips for
the blood analyser, needles, napkins for wiping off blood, extra
insulin cartridge, glucose tablets, waste containers, etc.
[0030] The apparatuses according to the example may communicate
information such as: amount of medication, type of medication, the
concentration of relevant substances in the body e.g. body fluid
level/concentration, time stamp, amount of food (e.g. amount or
units of carbohydrate), measurement of physical activity,
notification (e.g. alert and warning) to the patient, body
characteristics (e.g. weight, blood pressure etc.) and inventory
logistics. This ensures that relevant information, for e.g. a drug
administration system like a doser, i.e. number of units of
insulin, insulin type and time and date for administering, can
automatically be stored, displayed, received and transmitted to and
from all the relevant apparatuses and more particularly in one or
more database accessible by a system/method for processing in order
to obtain the results described above and later. The doser could
also receive information regarding a predetermined number of units
of insulin to be administered and automatically set the amount of
medication to be administered by electromechanical means. In this
way elderly and handicapped people do not have to set the relevant
amount of medication themselves but just activate the doser and a
confirmation of the actual administered dose may be used as
input.
[0031] Other types of drug administration systems like an inhaler
adapted to administer a dose of medication in an air stream or a
tablet dispenser may be included instead or in combination with the
doser. The inhaler and/or tablet dispenser may also communicate
with the other units for relevant information like the doser
according to the invention.
[0032] It is especially useful to transmit the data from all
apparatuses to the functional master module/apparatus containing
the highest priority program for safe keeping, calibration and
updating of data and possible transmission to e.g. an external unit
like a PC or database for further data acquisition, storage and
processing. In this way the patient, a physician or an expert
care-team can obtain the behavior over time of the patient, and a
check for compliance to a diet or treatment given to the patient by
a physician or an expert care-team can be made. This enhances the
possibility of choices according to the invention.
[0033] Additionally, it is also possible for the patient to
manually input information about the treatment. This information
may be historic information as well as information about a future
scheme (behavioral pattern) e.g. planned physical exercise,
administering of insulin, intake of food and other medications.
This information may be collected and thus serve as an electronic
diabetes diary or may be used to notify the patient through the
receiving means as to whether the planned actions are dangerous or
not. The patient can further receive recommended amounts of
medication, exercise, food, etc. from a physician, from an
expert-team or automatically. All this information may be used to
estimate one or more future parameter values, e.g. BGL.
[0034] It is evident that since the apparatuses are to be carried
by the patient, there is a potential lack of space for an advanced
input device e.g. a keyboard.
[0035] Therefore, information which cannot be input on a
standardized form e.g. personal comments on the treatment may be
typed into the apparatus by the patient using a simple input device
once and can subsequently be chosen from a list, if needed
again.
[0036] Preferably, all the apparatuses of the system exchange
information so that every apparatus (or at least every apparatus
within range) is updated with the combined information, but still
one particular apparatus is the link to any outside systems, so
that every bit of information is mirrored for better safety and
backup. This demands a greater amount of total memory capacity for
the system.
[0037] For a BGM according to an embodiment of the invention the
relevant information could be the time and date for measurement,
measured level/concentration of blood glucose which could be stored
or transmitted to another apparatus.
[0038] For a doser according to an embodiment of the invention the
relevant information could be the type of medication (e.g. long
acting or short acting insulin), number of units of insulin to be
administered and the time and date of the administering. This
information could both be set manually by the patient or remotely
by a physician, an expert care-team or automatically.
[0039] For an inhaler according to an embodiment of the invention
the relevant information could be the type of medication, the
number of units of medication to be administered and the time and
date of the administering. This information could both be set
manually by the patient or remotely by a physician, an expert
care-team or automatically.
[0040] For a storage container according to an embodiment of the
invention the relevant information could be used to keep track of
the contents of the container so that every time an object (e.g.
cartridge, needle, etc.) is used, the storage container will update
the inventory list. This list could be transferred to a unit of
highest priority immediately or later, which could in turn update
the patient's total holdings of objects, so that the system could
notify the patient when he should order a new stock of objects in
order to keep all the different proposed actions available. The
ordering could also be done automatically by the system if the
inventory list is transferred to an external unit, which greatly
improves the confidence, comfort and safety of the patient.
[0041] For a tablet dispenser according to an embodiment of the
invention the relevant information could be the number of dispensed
tablets, the number of remaining tablets, the time of dispension
and the type of dispensed tablets. The dispenser could store and/or
communicate this information to an available unit of highest
priority or other units within communication range.
[0042] In the following a preferred embodiment according to the
invention is described in detail. This particular embodiment is
meant as one example only of the invention and should not as such
limit the scope of protection as claimed in the appended
claims.
[0043] The term "Margin Maker" is used in the following for a
method/system according to the invention.
[0044] The invention will now be explained in detail with reference
to the FIGS. 1-8, in which
[0045] FIG. 1 shows a flowchart for an embodiment of the invention
illustrating an exemplary implementation of a Margin Maker
system;
[0046] FIGS. 2a, 2b and 2c show examples of user interfaces
presenting and receiving choices to and from a user;
[0047] FIG. 3 illustrates a schematic diagram of an exemplary
expert system using a model;
[0048] FIG. 4 shows a more detailed representation of a time
dependent dynamic patient model according to the invention;
[0049] FIG. 5 shows an example of a preferred system which may
contain an embodiment according to the invention;
[0050] FIG. 6 shows another embodiment according to the
invention;
[0051] FIG. 7 illustrates the general concept according to an
embodiment of the invention with respect to communication and
exchange of information;
[0052] FIG. 8 illustrates the communication between a system of
apparatuses and a central system.
[0053] FIG. 1 shows a flowchart for an embodiment of the invention
illustrating an exemplary implementation of a Margin Maker
system.
[0054] In step 101 input data is provided/updated. More
specifically different types of input data are updated as
represented by the steps 102-105.
[0055] In step 102 data from a care-team is provided/updated. This
data describes individual user/patient characteristics which are
true/valid in the time interval between consultations with the
care-team. The data is typically derived as a result of tests
performed by health care professionals (e.g. insulin sensitivity)
and entered into the system by the care-team, e.g. wireless via a
mobile telephone system as described in connection with FIG. 8.
[0056] In step 103 treatment input data is provided from various
devices, e.g. from a system of portable apparatus as described
above and in connection with FIGS. 5-7.
[0057] Input data specified manually by a user may also be input in
step 103. Manually specified input data may e.g. be a value
representing the body temperature of the user e.g. because he is
feverish. Manually specified input may preferably if it differs
from his normal value.
[0058] This data describes the actual treatment received by the
patient (e.g. insulin intake as a function of time) and the
resulting effect on the user (e.g. blood glucose level as a
function of time). The data is gathered by the various devices used
by the patient in his home-treatment and communicated automatically
to the Margin Maker.
[0059] In step 104 the previous choices, i.e. input from the user,
are provided/updated.
[0060] This is a record of the previous activities which the user
has chosen to perform and which are either not yet confirmed by
other input means (e.g. insulin injection prior to synchronization
between the insulin doser an the Margin Maker) or not confirmable
by other input means (e.g. physical exercise or food intake).
[0061] In step 105 information of time is provided from a system
clock in the form of a time stamp. Additionally the date may be
specified as well.
[0062] It is necessary for the method to know the time because the
alternative proposals available to the user change over time.
[0063] The information provided/updated in the steps 102-105 is
collected in a database as a dataset at step 106.
[0064] Prior to processing the input data the system performs a
test at step 107 to find out if the amount and/or quality of the
input information is sufficient to produce valid and relevant
proposals for user behaviour to present for the user of the Margin
Maker system.
[0065] If the test fails, i.e. the input data is insufficient to
produce a relevant output, the user is made aware of the fact that
at the moment the Margin Maker is unable to offer guidance due to
lack of input information and displays a request for more
(comprehensive) data and issues a warning at step 108.
[0066] If the test is successful, the method continues in step 109,
where the provided/inputted data is processed in an expert system
e.g. using a model.
[0067] The expert system is in principle a model of a control loop
for the blood glucose level in a human. Based on the input and the
historical data accumulated in the Margin Maker the parameters of
the model is adapted to mimic and predict the blood glucose control
of the individual user of the Margin Maker system. Refer to FIGS. 3
and 4 for a more detailed description of the expert system.
[0068] For each of the n possible user actions implemented in the
Margin Maker system the model is fed with information of the
present blood glucose level, the target blood glucose level, the
current time, the n-1 user actions set to their present value
(ceteris paribus), and 1 user action is treated as a variable
parameter. After n recalculations of the control loop, one for each
of the n possible user actions treated as the variable parameter,
the expert system has derived n ways of bringing the present blood
glucose level to its target value. Then an evaluation of the n
alternative proposals is needed in order to exclude proposals that
are not implementable (e.g. it is not possible to eat a negative
amount of food), thereby providing the `up to n` valid and
implementable proposals of possible choices 110.
[0069] In general, the sooner proposals are chosen, i.e. a is
situation is acted upon, the more options/proposals is available to
the user. Put in another way, as the time goes the
proposals/options become fewer and fewer as well as more and more
restrictive, since the user's situation gets more and more serious,
i.e. drifts away from a normal BGL, if not paid attention to/acted
upon.
[0070] Another criteria for exclusion of proposals may e.g. be in a
system, as described above, comprising different portable/handheld
devices that the specific device being used to implement the
proposal is present and activated among a user selected group of
the devices. In this way the user will only be presented with
proposals that he actually has the possibility of executing.
[0071] Finally, the time is considered variable in the expert
system--other things being equal--to test whether a potentially
dangerous situation is expected to occur within a given time frame.
If this is found to be the case, a warning flag is set in step
111.
[0072] In step 112 a test whether the warning flag has been set is
executed. If the test is true/yes (i.e. the warning flag has been
set) a warning signal is sent to the user in step 113, regardless
of whether the user is accessing the system, e.g. by audio to
attract the user's attention and/or by activation of the display
containing appropriate information. After the signal is given the
method continues in step 115 where the warning and proposals are
presented as will be described later.
[0073] If the test in step 112 results in false/no, another test is
executed in step 114 as to whether the system is accessed by the
user. If this is not the case, the method continues from the
beginning in step 101 and awaits new and/or updated input since the
present situation does not specifically require the attention of
the user (warning flag not set).
[0074] If the test in step 114 is true and the user is
accessing/has activated the system, step 115 is executed.
[0075] In step 115 the valid and implementable proposals are
presented to the user. Any warnings are also displayed to the user
if the preceding step was step 113 in order to alert the user and
obtain an immediate action from the user. Issued warnings could
e.g. comprise information that the user should seek medical
attendance or administer a given medication as quickly as possible,
etc.
[0076] The proposals may e.g. be presented in the form shown in
FIGS. 2a, 2b and 2c or other suitable forms.
[0077] In step 116 the system awaits a user choice of one of the
proposed actions or a time out from the system.
[0078] Each of the proposals presented to the user of the Margin
Maker will bring his/her blood glucose level "back on track" but
that does not in any way exclude the possibility that the user
chooses only to partly follow a suggested proposal, e.g.
administering half the dose of medication instead of the proposed
dosage, or to combine several proposals fully or in part. Once the
user has entered his/her choice the Margin Maker performs a rerun
of the flowchart to update the relevant proposals, given the new
situation. An example of proposals and selected choices is shown in
FIG. 2a.
[0079] If the user chooses to do nothing, the system will
eventually issue a time out and perform a rerun of the flowchart to
update the relevant proposals taking into account that time has
elapsed since the last user action.
[0080] Hereby a user is presented with a number of choices each
fulfilling a regimen where he may choose the one(s) he likes best
and still obtain the right and full treatment instead of choosing
the easiest and most appealing course of action on his own, which
may be wrong or insufficient and result in adverse effects.
[0081] Additionally, the possibility of choices makes the patient
feel more in control of the treatment and enhances the therapeutic
value of the treatment and improves the patient's ability to adapt
his treatment to his daily life.
[0082] FIGS. 2a, 2b and 2c show examples of user interfaces
presenting and receiving choices to and from a user.
[0083] FIG. 2a shows an example of a user interface where one
column 201 comprises different graphical icons 205-210 each
representing one choice of action according to a proposal. Shown in
this example are icons 205-210 for administering fast acting
insulin 205, administering slow acting insulin 206, administering
tablets of a given type 207, exercise 208, intake of food 209, and
intake of alcohol 210. Additionally, other icons like administering
tablets of another kind, administering a dosage medication from an
inhaler, etc. may be presented if these options are available to
the user.
[0084] At column 202 the n proposals suggested by Margin Maker are
shown (corresponds to step 115 in FIG. 1), where each proposal of
action, if executed, brings the current BGL to the target BGL. In
this example the Margin Maker has proposed to the user/patient
either to administer 10 units (IU) of fast acting insulin,
administer 0 IU of slow acting insulin, administer two tablets of a
given type, exercise for 60 minutes, intake 0 units of food, or
drink 0 units of alcohol.
[0085] At column 203 the user input is shown. After he has input
the choice and amount of action, the Margin Maker displays and
derives updated proposals on the basis of the changed situation.
Here the user has chosen to administer 5 IU of fast acting insulin,
and the Margin Maker now presents the updated proposals at column
202', given the new situation and taking into account the user's
choice.
[0086] The updated proposals at column 202' are now to administer
additionally 5 IU of fast acting insulin, administer 0 IU of slow
acting insulin, administer one tablet of a given type, exercise for
30 minutes, intake 0 units of food, or drink 0 units of
alcohol.
[0087] The user now chooses to exercise 30 minutes, which is shown
at column 203', and the model updates the proposals accordingly.
The proposals shown at column 202" show that after the user has
performed the specified choices/actions his BGL should be at the
target level.
[0088] The columns 204 represent previous and later proposals and
user input, so it is possible to scroll through the values for
different points in time.
[0089] This specific form of user interface requires a display of a
certain quality or with a certain resolution. Other more simple
forms may be provided, e.g. as shown in FIG. 2c, either instead or
in combination in devices with a smaller display.
[0090] Alternatively, the display will only display one column of
icons 201, proposals 202 and user input 203 at a time, e.g. with
buttons to scroll through previous proposals and input.
[0091] The user may input data in many different ways according to
specific embodiments of the invention as generally known in the
art, e.g. utilising a touch screen with a stylus, touch pad and a
cursor on the display, etc.
[0092] It is evident that if the apparatuses are to be carried by
the patient, there is a potential lack of space for an advanced
input device e.g. a keyboard. Therefore, information which cannot
be input on a standardized form e.g. personal comments on the
treatment is typed into the apparatus by the patient using a simple
input device once and can subsequently be chosen from a list, if
needed again.
[0093] Preferably, a system comprising a plurality of portable
devices with mutual data communication, as described above, is used
in connection with the Margin Maker.
[0094] In this way e.g. a doser may communicate an administered
dose to the device containing the Margin Maker automatically or by
user request and the different devices may communicate measured
values representing physiological parameters automatically or by
user request, e.g. a BGM may communicate the measured BGL as input
to the Margin Maker.
[0095] Additionally, information of which devices are present and
activated may be transmitted to the device containing the Margin
Maker which may hereby only present proposals with a corresponding
present and/or activated device, so that e.g. if a doser containing
slow acting insulin is not available to the user, then the icon 206
and the corresponding proposal will not be displayed at all.
[0096] In FIG. 2b an example of a user interface is shown where
input of information is given to the Margin Maker which is needed
in order to derive the proposals of actions. Shown is a column 220
containing icons 224 representing a value obtained from the BGM and
225 representing a value for the temperature of the user. The
corresponding values, specified at a given time, are listed in a
column 221 and are in this example 10.5 mmol/l and 37.5.degree. for
the BGM and the temperature, respectively. The other columns 222
represents values specified at different points in time where in
this example no values are specified. Alternatively, only columns
having a specified value are shown in the user interface e.g. with
a corresponding time stamp.
[0097] The columns 223 represent previous and later user input, so
it is possible to scroll through the values for different points in
time.
[0098] This information is used by the Margin Maker together with
additional information to better estimate the target glucose level
and obtain a measure of the present glucose level. The input
temperature is used by the expert system to determine whether the
user is feverish or not as this influences the required amount of
insulin.
[0099] This information may either be input manually by the user,
automatically or both, e.g. by a BGM device and/or a temperature
sensor with communication means which may communicate with a Margin
Maker device (may correspond to step 103 in FIG. 1).
[0100] FIG. 2c shows an example of a different user interface which
may be more suited for a smaller display. Shown is an example of a
graph 230 with a time axis 231 and three BGL bars 232 and 232'
obtained at three different points in time of the day. Two
previously obtained BGLs 232 and one BGL 232' obtained at the
actual time. The BGL may be obtained from a BGM and may be received
either automatically or manually by the Margin Maker as input for
the expert system as described above.
[0101] Also shown are two bars 233 representing the dose of
insulin, that the user chose to administer previously after
obtaining the BGLs 232, respectively. The dosages 233 may have been
fully or partly as proposed by the Margin Maker at the respective
time. Alternatively, the user may have administered the dosages 233
completely on his own and just specified the dosage and type of
medication. The actual dosages 233 administered may have been
specified (together with the time and type of insulin) by user
input or via communication from the administering doser to a device
containing the Margin Maker.
[0102] The previously obtained BGLs 232 and administered dosages
233 together with the BGL 232', obtained at the actual time and
other relevant input, as described in connection with FIG. 1, and
used to predict a future course of BGL for the user and derive one
or more proposals to the user in order to account for the future
course of BGL.
[0103] The Margin Maker has proposed in this example that the user
should administer a dosage as indicated by the blinking bar 233'.
Additionally, other proposals may be shown elsewhere. The proposed
dosage and type of insulin may be transmitted automatically to a
corresponding doser, so if the user wishes to follow this proposal
fully he just has to activate a button on the doser to accurately
receive the proposed dosage. Alternatively, the user may manually
specify the proposed dosage on the doser.
[0104] Additionally, the user may choose to only administer a part
of the proposed dosage (which may also be transmitted automatically
after indication by the user) if he e.g. wants to exercise as well.
After the Margin Maker has registered the user's choice of only
administering a part of the proposed dosage of medication, the
expert system is updated accordingly and new proposals are derived
taking into account the new situation.
[0105] The user interfaces described in connection with FIGS. 2a,
2b and 2c are just examples and other interfaces may be just as
applicable. Alternatively, the user interface may be character
based and using no graphics thereby reducing the complexity of the
system with respect to implementation.
[0106] FIG. 3 illustrates a schematic diagram of an exemplary
expert system using a model.
[0107] A number of models have been proposed in order to describe
the metabolism of the insulin dependent diabetic patient.
Furthermore, some effort has been put into constructing systems for
controlling the blood glucose level using insulin.
[0108] In the following one expert system is described as an
example but other expert systems known in the prior art may be used
with similar results. The shown expert system comprises input
variables 301 and 302, physiological parameters and model inputs
306, proposal generators 305, patient actions 304, and a patient
model 303, all of which will be described in the following.
[0109] An input variable "Desired blood glucose level" 301 is
specified in the expert system and is preferably (pre)determined by
the care-team or other professionals. The variable 301 may be
similar to the blood glucose level of a healthy person, but may due
to regimen differ from this value, e.g. be higher in order to
prevent hypoglycaemia.
[0110] Another input variable used by the expert system is the
variable "Blood glucose measurement" 302 representing the BGL at a
given time.
[0111] The patient may measure the BGL, giving the blood glucose
measurement variable 302, with a certain frequency or use a
continuous blood glucose sensor. Given the dynamics of the human
metabolism, there is a certain lower limit of the sample frequency
which will allow the expert system to work properly.
[0112] The patient model 303 is a dynamic model which describes the
metabolism of the diabetic patient. The model 303 incorporates
parameters 306 such as e.g. weight of the patient and insulin
sensitivity, which vary from patient to patient and may be
considered constant between consultations of the care-team. The
model 303 may also incorporate model input 306 such as injections
of long acting insulin, fast acting insulin, oral diabetic agents,
exercise, food intake, alcohol intake and fever. Given a certain
combination of model input 306, the model 303 describes the blood
glucose level over time. The model 303 describes some key state
variables of the human metabolism.
[0113] The proposal generators 305 are the analogy of regulators in
a control system. The input to the proposal generators 305 is the
difference between the desired blood glucose level 301 and the
actual blood glucose level 302 and the state variables of the
patient model. Given the input each proposal generator 305 proposes
a patient action and a corresponding amount/dosage--eat a certain
amount of food, exercise for a certain amount of time, inject a
certain amount of fast acting insulin, etc.--as indicated in the
proposal boxes 305. The proposals are calculated, presuming that
only one of the proposals is followed.
[0114] The patient has the final decision as indicated by patient
action 304 for each possible action in the expert system. He may or
may not choose to follow the proposals. By choosing one of the
proposals fully or partly, his action 304 is fed into the patient
model, either by manual input or automatically by the diabetes
specific devices--the dosers or the blood glucose monitor. The
patient model 303 now generates a new input to the proposal
generators 305 which represents the updated situation.
[0115] FIG. 4 shows a more detailed representation of a time
dependent dynamic patient model according to the invention. This
model is used by the expert system to give a prediction/estimate of
a future BGL.
[0116] In the literature many such models are described. Here a
very simple one of applicant's origin is taken to explain the
principles. This model can be developed to a high degree of detail,
if needed.
[0117] The model 400 simulates the dynamics of the carbohydrate
metabolism. Based on the input of one or more of the following
parameters
[0118] BGL,
[0119] dosage of medication,
[0120] type of medication,
[0121] food intake,
[0122] drinks intake,
[0123] exercise,
[0124] time stamp,
[0125] insulin sensitivity
[0126] weight of the user,
[0127] blood pressure,
[0128] temperature, and
[0129] other.
[0130] The model is tuned in to mimic the user's carbohydrate
metabolism closely. By the continuous tuning by input of updated
data from the expert system a drift away from a close mimic of the
true status is prevented. The structure of the model 400 matches
the functionalities of the metabolism to a needed degree. Due to
this correspondence the expert system/model 400 will be able to
predict trends or even future BGL.
[0131] The expert system continuously gives suggestions about the
user's freedom of operation. Based on all recorded events a margin
for exercise and food is suggested.
[0132] If suggestions are confirmed (e.g. tapping an indication on
the touch screen of the handheld device), these are regarded as
input to the algorithm and used for future suggestions.
[0133] Preferably, the dialogue is implemented via a graphic
display showing the history, and input is given either via a touch
screen or traditional buttons.
[0134] In order for the expert system to give recommendations and
margins as described above it is needed to predict how things will
evolve from any known state.
[0135] This can be done using a model 400 of the carbohydrate
metabolism as an engine for the Margin Maker concept.
[0136] Shown in the figure is a model 400 with two pools: Body
Blood Glucose 402 and Insulin 401. Each has a filling source 403,
403' and a drain 404, 404' (i.e. two rates), respectively. Body
Blood Glucose 402 has the filling source POG (Production of
Glucose) 403 and the drain UOG (Use of Glucose) 404, and Insulin
401 has the filling source POI (Production of Insulin) 403' and the
drain UOI (Use of Insulin) where all the rates 403, 403', 404 and
404' may vary with time dependent on the parameters controlling the
rates.
[0137] The parameters controlling the rates, e.g. food, dosing,
exercise, etc., are given in the table below.
[0138] The model 400 can also be expressed in terms of a set of
differential equations for the states 402 and 401, each being
controlled by their respective rates 403, 404 for the state Body
Blood Glucose 402 and 403' and 4041 for the state Insulin 401. In
this form the model can be implemented in a microprocessor
relatively easily and display the results of the latest input for
any given time.
[0139] The differential equations for the model 400 may be
expressed as:
BBG(t)=BBG(t-dt)+(POG-UOG)*dt
[0140] INFLOWS: POG=f(F,t)
[0141] OUTFLOWS: UOG=g(BM+KD+IIUOG+E,t)
I(t)=I(t-dt)+(POI-UOI)*dt
[0142] INFLOWS: POI=h(MPI,t)
[0143] OUTFLOWS: UOI=j(HL,t)
[0144] The factors are explained in the table below:
1 Factor Explanation Unit Function Input/Output D Dosing IU Output
to the user about possible insulin doses to take. Alternatively the
user can give input about a wanted amount of insulin and the system
can suggest appropriate food intake. Whenever an insulin dose is
taken the system automatically loads the value into the model and
the predictions are calculated accordingly. E Exercise mol Output
to the user about possible exercise to take in the given situation.
Alternatively the user can give input about a wanted amount
exercise and the system can suggest appropriate food intake. The
user accepting the suggestion will be an input to the system and
calculation will be accordingly. Conversion to mol will be made by
the system. F Food intake mol Output to the user about possible
food to take in the given situation. The user accepting the
suggestion will work as an input to the system and calculation will
be accordingly. Alternatively the user can give input about a
wanted amount of food and the system can suggest either dosing of
insulin or exercise. Conversion to mol will be made by the system.
Concentrations and levels BBG Body Blood mol Simulated total amount
of glucose in the blood. Glucose It is calculated as the
integration over time of production and usage of glucose. Between
measurements it is used to give an estimate of the user's current
BGL. At measurements the BBG is updated according to the measured
BGL. BGL Blood mol/l This calculated by dividing the BBG with the
Glucose blood volume. Level The model has the ability to predict
the BGL over time and the value is very important to the user and
can be displayed at any time. Every time the user makes a
measurement of the actual BGL this is automatically loaded into the
model by the system and it overrules the calculated one and resets
the model. Initial value: 5 mmol/l I Insulin mol Insulin level in
the body. The model has the ability to predict the Insulin level
over time. It is calculated as the integration over time of
production and usage of insulin. The initial value is set by the
physician according to measurements and can be calibrated by the
physician when the user meets for consultations. Rates POG
Production mol/min This rate is driven by the food intake entered
and Of Glucose accepted by the user. It is also a function of time
as different types of food have different dynamic impact on BGL.
POI Production mol/min This rate is driven by the injected insulin
through Of Insulin a conversion factor (MPI). It is also a function
of time as different types of insulin have different dynamic
impacts on BGL. UOI Use Of mol/min This rate is defined by the half
life (IHL) of insulin Insulin by which the level decays
exponentially. UOG Use Of mol/min This rate is driven by 4 factors:
Basal Metabolism Glucose (BM), Kidney Diurese (KD), Insulin Induced
Use Of Glucose (IIUOG), Exercise (E). Constants & Transfer
functions BM Basal mol/min Constant for each Individual determined
by the Metabolism e physician. Typical value: 0.56 mol/min IHL
Insulin Half min The metabolism of insulin is usually expressed in
Life terms of half life. Typical value: 10 min IIUOG Insulin
mol/min This factor describes the nonlinear relation Induced
between insulin in the body and the Use Of disappearance of glucose
from the blood. This Glucose factor can be measured or derived from
literature. KD Kidney mol/min This factor describes the nonlinear
relation Diurese between diurese and BGL. At BGL levels below 10
mmol/l the KD is virtually zero. Above 10 mmol/l an increasing KD
will occur MPI Mol Per IU mol/IU Conversion factor between
International Units of insulin and mol
[0145] This model 400 is just one relatively simple example of a
model that may be used to predict a future BGL.
[0146] Alternatively, the model and/expert system or parts hereof
may be located in a stationary unit with greater computational
power and receive input and transmit information regarding proposed
choices.
[0147] FIG. 5 shows an example of a system which may contain an
embodiment according to the invention.
[0148] Shown is a doser 20 with a cap 10 where the cap 10, in an
embodiment, functions as the functional master module. In the
preferred embodiment the Margin Maker resides in the functional
master module. The functional master module 10 has displaying means
11 and buttons 36 for operation and selection of proposed
choices.
[0149] The doser 20 is a conventional doser with has transmitting
and receiving means 12. This enables the doser 20 to transmit
stored data, i.e. the time, date, is amount and type of medication,
to the functional master module 10 for storage and presentation
there via the master modules receiving means 12. Additionally, the
transmitted data may be input to the Margin Maker automatically,
thereby updating the model and deriving and presenting new
proposals/choices, reflecting the updated situation, to the user on
the display 11.
[0150] The doser 20 can also receive information via the receiving
means 12 from the master module 10. This information could for
instance be a predetermined amount of medication as dictated by a
proposal from the Margin Maker if the user chooses to administer
the full amount given by the proposal. The received information is
then used to automatically set the correct amount of medication to
be administered so that the patient does not have to worry about
that aspect. Alternatively, if the user only wishes to administer
only a part of the proposed dosage, he may indicate this via the
buttons 36 or directly on the doser 20, after which information of
the administered dose is sent to the Margin Maker as input and used
to update the model.
[0151] Also shown is a BGM 30 which has means 34 for inserting test
strips 52 containing a sample of blood, for analysis by the BGM 30
by operating the buttons 36. The result of the analysis is stored
and either shown in the display 32 or transmitted to the master
module 10 via the transmitting means 12 for storage and input to
the Margin Maker and presentation on the larger display 11 or both.
The patient can at the same time be presented with the last couple
of results over a time period.
[0152] A test strip container 50 is provided for the safe
keeping/storing of test strips 52 in the space 55 and can be
added/attached through locking means 31. With this addition, a test
strip 52 will always be available.
[0153] Further shown is a lancet device 40 removably attached to
the BGM 30 or the test strip container 50 by the locking means 31.
This lancet device 40 is used by first loading the lancet device
through the grip 44 and then pressing the button 42, which releases
the lancet, piercing the skin, so that a blood sample can be
obtained. With this inclusion, the lancet device 40 is always at
hand. This has the advantage that a lancet device 40 is always
available, for taking a blood sample and applying it to a test
strip 52. The test strip 52 can then be inserted via the means 34
into the BGM 30, which will start analysing the blood sample and,
after completion of the analysis, will show the result in the
display 32. It is very useful to have the BGM 30 and the lancet
device 40 attached together in one compact unit, since a BGM 30
would not normally be used without the lancet device 40.
[0154] In this way, information relevant to the Margin Maker and
the individual devices 20, 30 may automatically be received and
transmitted between the functional master module 10 and the various
devices 20, 30, which ensure an automatical update of the
system.
[0155] Alternatively, the Margin Maker may only present choices to
the user where there is a present and activated device for
performing these choices (where applicable), e.g. a proposal of
administering a certain amount of long acting insulin is only
presented if a doser containing long acting insulin is present, or
a doser and a separate cartridge containing long acting insulin.
The functional master module is responsible for keeping track of
which individual devices that are present and activated.
[0156] If the device containing the master module and/or the Margin
Maker, the system may designate a new master module and a new
Margin Maker either by transmitting and/or activating the relevant
information in the designated device(s).
[0157] FIG. 6 shows another embodiment according to the invention.
Two dosers 610 are shown. The dosers 610 may contain different
types of insulin (fast and slow acting). Also shown is a device 600
with a display 602, buttons for operation 601. In this particular
embodiment the device 600 is both the functional master module and
the Margin Maker. The device 600 is also provided with the
functionality of a BGM and a slot 603 for receiving test strips
containing a blood sample.
[0158] The dosers 610 and the BGM functionality may, together with
user specified input e.g. a the device 600, provide the Margin
Maker with relevant input information to the model and/or expert
system, so that the Margin Maker may present the resulting choices
on the display 602.
[0159] FIG. 7 illustrates the general concept according to an
embodiment of the invention with respect to communication and
exchange of information. Here the system consists of the portable
units: a functional master module, a doser, a BGM, an inhaler, the
remote units: Remote Receiver, Physician/Expert Care-team and
Stationary Unit and a Communication Interface between them.
[0160] The functional master module controls the information and
data flow between itself and the other apparatuses and is collects
relevant data and information from all the other portable units and
uses this information to update the model accordingly. This data
and information could e.g. be amount of medication, type of
medication, body fluid concentration, time stamp (date and time)
and inventory logistics. Additionally, the patient can manually
input information and data related to amount of food, measurement
of physical activity in the way described above.
[0161] This data and information can then be transmitted via a
communication interface (which may be built into the master module)
to external units like a database for data acquisition of the
patient's data over time or a computer which the patient uses to be
kept informed about his treatment. Alternatively, all the
apparatuses could communicate to all the others.
[0162] The information in the database can be accessed by a
physician or an expert care-team who could easily and quickly check
for compliance to e.g. a diet or treatment course/progress. The
physician or expert care-team could send a notification (e.g.
alert, warning and/or change of regimen) to the patient if the data
shows an inappropriate future treatment span. The patient could
also be notified of a future appointment in this way or receive
guidance.
[0163] The system gives the patient a number of choices to a given
situation based on the model as described earlier. The patient
could e.g. be informed that the blood glucose level/concentration
is quite high and the patient could be presented with the choices
of either exercising for given amount of time or administering a
given amount of a given type of medication. The possibility of
choices makes the patient feel more in control of the treatment and
enhances the therapeutic value of the treatment.
[0164] FIG. 8 illustrates two dosers and their communication paths.
The dosers are identical for the typical patient, one doser
containing fast acting insulin, the other doser containing slow
acting insulin. The dosers comprise a micro controller and memory.
The dosers are capable of holding information about the insulin
type they contain. This information may either be obtained by the
doser reading e.g. a bar code on the cartridge or the information
may be input from the patient. Thus the features of the doser
enable it to log information about the insulin treatment (insulin
type size of the dose and time stamp).
[0165] One doser is equipped with a cap unit 73 which acts as a
storage container for an extra insulin cartridge, needles etc. The
storage container is capable of keeping track of the contents of
the container which enables it to keep the inventory list updated,
as described earlier in the present document.
[0166] The other doser is equipped with a cap unit 74 comprising a
BGM, a micro controller and memory. This enables the cap unit 74 to
log information about the blood glucose concentration (with time
stamp).
[0167] All the dosers 71, 72 and the cap units 73, 74 comprise an
interface which enables them to exchange data. In the present
example the functional master device comprises the Margin Maker and
is the BGM cap unit 74, which, in addition to the local interface,
comprises an interface that enables it to communicate with external
units through standard communication links (RS-232, Wireless local
area network, phone, cellular phone, pager, satellite link, etc.).
Through these communication links, the patient's treatment data can
be transferred to the patient's own computer 80 or via e.g. the
telephone system 75 to the patient's electronic medical record on a
central server 76. From here, the treatment data may be accessed by
the patient e.g. from a web page, using a stationary computer 77, a
laptop computer 78, a handheld computer 79, etc. Apart from the
patient, the care-team can access the patient's treatment data. The
patient's master unit 74 can receive data from the central server
76, in addition to transmitting data.
[0168] This system has the advantage that the system can function
on 3 levels:
[0169] If one of the patient's devices 71, 72, 73, 74 is isolated
by means of communication, it will log data.
[0170] When the patient's devices 71, 72, 73, 74 are within
communication distance, the treatment data are transferred to the
master unit 74, enabling it to supply the patient with an overview
of his treatment and present choices as well as warnings or alarms
if data shows that a potential dangerous situation may occur.
[0171] When the master device 74 is connected to the central server
76 through standard communication links, the treatment data is
transferred to the patient's electronic medical record. This
enables an expert system on the central server to notify the
care-team if needed. The care-team may send information back to the
user or send help if needed.
[0172] Furthermore it is well known that due to the safety of the
patient, the development of a medical device is a time consuming
task. Using a local communication form between the patient's
devices 71, 72, 73, 74 has the advantage that only the master
device 74 need to be redesigned to keep up with the continuous
change in the standard communication links.
* * * * *