U.S. patent application number 16/574056 was filed with the patent office on 2020-01-23 for insulin management.
This patent application is currently assigned to Aseko, Inc.. The applicant listed for this patent is Aseko, Inc.. Invention is credited to Robert C. Booth, Harry Hebblewhite.
Application Number | 20200027544 16/574056 |
Document ID | / |
Family ID | 53753956 |
Filed Date | 2020-01-23 |
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United States Patent
Application |
20200027544 |
Kind Code |
A1 |
Booth; Robert C. ; et
al. |
January 23, 2020 |
Insulin Management
Abstract
A method of administering insulin includes receiving blood
glucose measurements of a patient at a data processing device from
a glucometer. Each blood glucose measurement is separated by a time
interval and includes a blood glucose time associated with a time
of measuring the blood glucose measurement. The method also
includes receiving patient information at the data processing
device and selecting a subcutaneous insulin treatment for tube-fed
patients from a collection of subcutaneous insulin treatments. The
selection is based on the blood glucose measurements and the
patient information. The subcutaneous insulin treatment program for
tube-fed patients determines recommended insulin doses based on the
blood glucose times. The method also includes executing, using the
data processing device, the selected subcutaneous insulin
treatment.
Inventors: |
Booth; Robert C.; (Columbus,
NC) ; Hebblewhite; Harry; (Atlanta, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Aseko, Inc. |
Greenville |
SC |
US |
|
|
Assignee: |
Aseko, Inc.
Greenville
SC
|
Family ID: |
53753956 |
Appl. No.: |
16/574056 |
Filed: |
September 17, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15862310 |
Jan 4, 2018 |
10453568 |
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16574056 |
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14524756 |
Oct 27, 2014 |
9898585 |
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15862310 |
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14524756 |
Oct 27, 2014 |
9898585 |
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14524756 |
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62009575 |
Jun 9, 2014 |
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61934300 |
Jan 31, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2005/14296
20130101; G06F 19/3468 20130101; A61M 2205/3553 20130101; A61M
2205/581 20130101; A61M 2205/507 20130101; A61M 2205/3592 20130101;
A61M 2005/14208 20130101; A61B 5/4839 20130101; A61M 2205/35
20130101; G16H 40/67 20180101; A61M 2205/50 20130101; A61M 5/1723
20130101; A61M 2005/1726 20130101; A61M 2205/18 20130101; A61M
2205/52 20130101; A61M 2230/201 20130101; G16H 10/40 20180101; A61M
5/14 20130101; A61M 2205/502 20130101; A61M 2205/3327 20130101;
A61M 2205/3584 20130101; G16H 20/60 20180101; A61P 3/10 20180101;
G16H 80/00 20180101; G16H 20/17 20180101; A61B 5/14532 20130101;
A61B 5/4848 20130101 |
International
Class: |
G16H 20/60 20060101
G16H020/60; G16H 10/40 20060101 G16H010/40; G16H 80/00 20060101
G16H080/00; G16H 40/67 20060101 G16H040/67; G16H 20/17 20060101
G16H020/17; A61M 5/14 20060101 A61M005/14; A61B 5/00 20060101
A61B005/00; A61B 5/145 20060101 A61B005/145; A61M 5/172 20060101
A61M005/172 |
Claims
1. A method comprising: receiving, at a data processing device, a
glucose measurement of a patient and a glucose time associated with
measuring the glucose measurement; obtaining, by the data
processing device, patient information for the patient, the patient
information comprising: a target glucose range for the patient, the
target glucose range comprising a range of glucose values between
and including a lower limit glucose value and an upper limit
glucose value greater than the lower limit glucose value; and
sequential scheduled glucose times and sequential time intervals
throughout a day for obtaining scheduled glucose measurements of
the patient, each sequential scheduled glucose time occurring
within a respective one of the sequential time intervals;
determining, by the data processing device, which of the sequential
time intervals includes the glucose time for the received glucose
measurement of the patient; setting, by the data processing device,
a countdown timer to a duration of time that expires at the
scheduled glucose time occurring within the sequential time
interval subsequent to the sequential time interval that includes
the glucose time for the received glucose measurement of the
patient; determining, by the data processing device, a correction
bolus based on the glucose measurement by calculating:
CB=(GM-GM.sub.Target)/CF; wherein CB is the correction bolus, GM is
the glucose measurement, GM.sub.Target is a midpoint of the target
glucose range for the patient, and CF is a correction factor; and
transmitting, by the data processing device, the correction bolus
to a patient display during the sequential time interval that
includes the glucose time for the received glucose measurement of
the patient, the patient display configured to display a number of
units of insulin corresponding to a value of the correction
bolus.
2. The method of claim 1, further comprising executing, by the data
processing device, a subcutaneous treatment program configured to
display on a screen in communication with the data processing
device a graphical user interface, wherein the subcutaneous
treatment program is configured to display, in the graphical user
interface, the countdown timer indicating a remaining time until
the scheduled glucose time occurring within the sequential time
interval subsequent to the sequential time interval that includes
the glucose time for the received glucose measurement of the
patient.
3. The method of claim 2, wherein the subcutaneous treatment
program is further configured to display, in the graphical user
interface, a glucose due message at the scheduled glucose time
occurring within the sequential time interval subsequent to the
sequential time interval that includes the glucose time for the
received glucose measurement of the patient.
4. The method of claim 1, wherein receiving the glucose measurement
of the patient comprises receiving the glucose measurement from a
glucose meter in communication with the data processing device.
5. The method of claim 1, wherein receiving the glucose measurement
of the patient comprises receiving the glucose measurement from a
continuous glucose monitoring system in communication with the data
processing device.
6. The method of claim 1, further comprising executing, by the data
processing device, a subcutaneous treatment program configured to
display on a screen in communication with the data processing
device a graphical user interface, wherein the subcutaneous
treatment program is configured to: display, in the graphical user
interface, a glucose input field, wherein receiving the glucose
measurement of the patient comprises receiving the glucose
measurement via a manual input to the glucose input field.
7. The method of claim 1, further comprising: determining the
correction factor using the data processing device by calculating:
CF=CFR/TDD wherein CF is the correction factor, CFR is a constant
determined from a statistical correlation, and TDD is a total daily
dose of insulin per day.
8. The method of claim 7, further comprising determining, by the
data processing device, the total daily dose (TDD) of insulin for
the current day based on all basal doses and correction doses of
insulin administered to the patient on an immediately previous
day.
9. The method of claim 1, further comprising: determining, by the
data processing device, that the glucose time for the received
glucose measurement of the patient is before the patient consumes
breakfast; determining, by the data processing device, which target
range of values among a plurality of target ranges of values
includes the received glucose measurement of the patient;
determining, by the data processing device, an adjustment factor
for adjusting a current day's recommended basal dose for
administration to the patient based on the corresponding target
range of values that includes the received glucose measurement;
determining, by the data processing device, a value of the current
day's recommended basal dose by multiplying the adjustment factor
times a previous day's recommended basal dose; and transmitting, by
the data processing device, the value of the current day's
recommended basal dose to the patient display, the patient display
configured to display a number of units of insulin corresponding to
the value of the current day's recommended basal dose.
10. The method of claim 9, wherein the plurality of target ranges
of values comprises: a first target range of values including
glucose values less than a first configurable constant; a second
target range of values including glucose values greater than or
equal to the first configurable constant and less than the lower
limit glucose value of the target glucose range for the patient; a
third target range of values including glucose values greater than
or equal to the lower limit glucose value and less than the upper
limit glucose value of the target glucose range for the patient; a
fourth target range of values including glucose values greater than
or equal to the upper limit glucose value and less than a second
configurable constant; a fifth target range of values including
glucose values greater than or equal to the second configurable
constant and less than a third configurable constant; and a sixth
target range of values including glucose values greater than or
equal to the third configurable constant.
11. A system comprising: a dosing controller including a data
processing device and a non-transitory computer-readable medium in
communication with the data processing device, the data processing
device configured to perform operations comprising: receiving a
glucose measurement of a patient and a glucose time associated with
measuring the glucose measurement; obtaining patient information
for the patient, the patient information comprising: a target
glucose range for the patient, the target glucose range comprising
a range of glucose values between and including a lower limit
glucose value and an upper limit glucose value greater than the
lower limit glucose value; and sequential scheduled glucose times
and sequential time intervals throughout a day for obtaining
scheduled glucose measurements of the patient, each sequential
scheduled glucose time occurring within a respective one of the
sequential time intervals; determining which of the sequential time
intervals includes the glucose time for the received glucose
measurement of the patient; setting a countdown timer to a duration
of time that expires at the scheduled glucose time occurring within
the sequential time interval subsequent to the sequential time
interval that includes the glucose time for the received glucose
measurement of the patient; determining a correction bolus based on
the glucose measurement by calculating: CB=(GM-GM.sub.Target)/CF;
wherein CB is the correction bolus, GM is the glucose measurement,
GM.sub.Target is a midpoint of the target glucose range for the
patient, and CF is a correction factor; and transmitting the
correction bolus to a patient display during the sequential time
interval that includes the glucose time for the received glucose
measurement of the patient, the patient display configured to
display a number of units of insulin corresponding to a value of
the correction bolus.
12. The system of claim 11, wherein the operations further comprise
executing a subcutaneous treatment program configured to display on
a screen in communication with the data processing device a
graphical user interface, wherein the subcutaneous treatment
program is configured to display, in the graphical user interface,
the countdown timer indicating a remaining time until the scheduled
glucose time occurring within the sequential time interval
subsequent to the sequential time interval that includes the
glucose time for the received glucose measurement of the
patient.
13. The system of claim 12, wherein the subcutaneous treatment
program is further configured to display, in the graphical user
interface, a glucose due message at the scheduled glucose time
occurring within the sequential time interval subsequent to the
sequential time interval that includes the glucose time for the
received glucose measurement of the patient.
14. The system of claim 11, wherein receiving the glucose
measurement of the patient comprises receiving the glucose
measurement from a glucose meter in communication with the data
processing device.
15. The system of claim 11, wherein receiving the glucose
measurement of the patient comprises receiving the glucose
measurement from a continuous glucose monitoring system in
communication with the data processing device.
16. The system of claim 11, wherein the operations further comprise
executing a subcutaneous treatment program configured to display on
a screen in communication with the data processing device a
graphical user interface, wherein the subcutaneous treatment
program is configured to: display, in the graphical user interface,
a glucose input field, wherein receiving the glucose measurement of
the patient comprises receiving the glucose measurement via a
manual input to the glucose input field.
17. The system of claim 11, wherein the operations further
comprise: determining the correction factor using the data
processing device by calculating: CF=CFR/TDD wherein CF is the
correction factor, CFR is a constant determined from a statistical
correlation, and TDD is a total daily dose of insulin per day.
18. The system of claim 17, wherein the operations further comprise
determining the total daily dose (TDD) of insulin for the current
day based on all basal doses and correction doses of insulin
administered to the patient on an immediately previous day.
19. The system of claim 11, wherein the operations further
comprise: determining that the glucose time for the received
glucose measurement of the patient is before the patient consumes
breakfast; determining which target range of values among a
plurality of target ranges of values includes the received glucose
measurement of the patient; determining an adjustment factor for
adjusting a current day's recommended basal dose for administration
to the patient based on the corresponding target range of values
that includes the received glucose measurement; determining a value
of the current day's recommended basal dose by multiplying the
adjustment factor times a previous day's recommended basal dose;
and transmitting the value of the current day's recommended basal
dose to the patient display, the patient display configured to
display a number of units of insulin corresponding to the value of
the current day's recommended basal dose.
20. The system of claim 19, wherein the plurality of target ranges
of values comprises: a first target range of values including
glucose values less than a first configurable constant; a second
target range of values including glucose values greater than or
equal to the first configurable constant and less than the lower
limit glucose value of the target glucose range for the patient; a
third target range of values including glucose values greater than
or equal to the lower limit glucose value and less than the upper
limit glucose value of the target glucose range for the patient; a
fourth target range of values including glucose values greater than
or equal to the upper limit glucose value and less than a second
configurable constant; a fifth target range of values including
glucose values greater than or equal to the second configurable
constant and less than a third configurable constant; and a sixth
target range of values including glucose values greater than or
equal to the third configurable constant.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This U.S. patent application is a continuation of, and
claims priority under 35 U.S.C. .sctn. 120 from, U.S. patent
application Ser. No. 15/862,310, filed on Jan. 4, 2018, which is a
continuation of U.S. patent application Ser. No. 14/524,756, filed
on Oct. 27, 2014, which claims priority under 35 U.S.C. .sctn.
119(e) to U.S. Provisional Application 61/934,300, filed on Jan.
31, 2014, and U.S. Provisional Application 62/009,575, filed on
Jun. 9, 2014. The disclosures of these prior applications are
considered part of the disclosure of this application and are
hereby incorporated by reference in their entireties.
TECHNICAL FIELD
[0002] This disclosure relates to a system for managing insulin
administration or insulin dosing.
BACKGROUND
[0003] Today, nearly 40% of patients admitted to acute care
hospitals in the United States experience either hyperglycemia or
hypoglycemia, both serious medical conditions. Many of these
patients have diabetes while others have fluctuating blood sugars
due to trauma, drug reactions, stress and other factors. Nurses and
doctors managing these patients manually calculate insulin doses
using complex paper protocols.
[0004] Manual calculation may not be accurate due to human error,
which can lead to patient safety issues. Different institutions use
multiple and sometimes conflicting protocols to manually calculate
an insulin dosage. Moreover, the protocols may include extra
paperwork that nurses and physicians have to manage, which in turn
leads to workflow inefficiencies, additional operating costs, and
employee satisfaction issues. SCIP (Surgical Care Improvement
Project) scores, length of stay, readmission and even mortality
rates adversely affect sub-optimal glycemic management.
[0005] The prevalent method of regulating continuous intravenous
insulin infusion is by using a set of written instructions, known
as a paper protocol. Paper protocols often involve a tree of
conditional statements and some use of tables of numbers, for which
a given blood glucose value dictates the use of a different column
of insulin rates. The complexity of these paper protocols
multiplies the probability of error by the nurses using them. These
errors can lead to hypoglycemic events.
SUMMARY
[0006] One aspect of the disclosure provides a method of
administering insulin. The method includes receiving blood glucose
measurements of a patient at a data processing device from a
glucometer. The blood glucose measurements are separated by a time
interval and include a blood glucose time associated with a time of
measuring the blood glucose measurement. The method also includes
receiving patient information at the data processing device. The
method includes selecting, using the data processing device, a
subcutaneous insulin treatment program for tube-fed patients from a
collection of subcutaneous insulin treatments. The selection is
based on the blood glucose measurements and the patient
information. The subcutaneous insulin treatment program for
tube-fed patients determines the recommended insulin doses based on
the blood glucose times. The method also includes executing, using
the data processing device, the selected subcutaneous insulin
treatment for tube-fed patients.
[0007] Implementations of the disclosure may include one or more of
the following optional features. In some implementations, the
method includes: receiving, at the data processing device, a
configurable constant; storing the configurable constant in
non-transitory memory associated with the data processing device;
and determining a correction factor using the data processing
device. The configurable constant may be determined from a
published statistical correlation. The method may also include
determining a pre-meal correction bolus, using the data processing
device. The method may include determining, using the data
processing device, a post-prandial correction bolus. The method may
also include receiving, at the data processing device, a half-life
value of the rapid-acting insulin; and determining, using the data
processing device, the mean lifetime of the rapid-acting
insulin.
[0008] In some implementations, the method includes receiving, at
the data processing device, a governing blood glucose value, and
determining, using the data processing device, an adjustment factor
based on the received governing blood glucose value. Determining
the adjustment factor may include determining when the governing
blood glucose value is within a pre-configured range of values, and
setting the adjustment factor to a preconfigured adjustment factor
associated with the pre-configured range of values. Determining the
adjustment factor may further include determining the governing
blood glucose value is within one of multiple pre-configured ranges
of values and setting the adjustment factor to a pre-configured
adjustment factor associated with the pre-configured range of
values that includes the governing blood glucose value. In some
implementations, the method includes determining, using the data
processing device, a Carbohydrate-to-Insulin Ratio based on the
adjustment factor.
[0009] The subcutaneous insulin treatment program for tube-fed
patients includes receiving, at the processing device, a blood
glucose time associated with a time of measuring of the blood
glucose measurement and determining, using the data processing
device, if the blood glucose time is within a pre-configured time
interval. The method further includes setting a timer for a next
blood glucose measurement based on the pre-configured time interval
and determining, using the data processing device, a correction
insulin does based on the blood glucose time. In some
implementations, the pre-configured time interval includes one of
six pre-configured time intervals each spaced four hours apart from
the next beginning at 00:00, or one of four pre-configured time
intervals each spaced six hours apart from the next beginning at
00:00.
[0010] In some examples, the method includes, when the blood
glucose time is within a first one of four pre-configured time
intervals each spaced six hours apart from the next: setting, using
the data processing device, the blood glucose measurement as a
governing blood glucose value; determining, using the data
processing device, an adjustment factor for adjusting a value of
recommended equal-boluses based on the governing blood glucose
value; and retrieving, using the data processing device, a previous
day's value of recommended equal-boluses. The method further
includes determining, using the data processing device, a new value
of recommended equal-boluses by multiplying the adjustment factor
times the previous day's value of recommended equal-boluses. The
new value of recommended equal-boluses corresponds to an insulin
dose of rapid-acting insulin or regular insulin to be administered
to the patient at scheduled blood glucose measurements.
[0011] In some implementations, the method includes, when the blood
glucose is within a second one of four pre-configured time
intervals each spaced six hours apart from the next: setting, using
the data processing device, the blood glucose measurement as a
governing blood glucose value; determining, using the data
processing device, an adjustment factor for adjusting a current
day's recommended basal dose based on the governing blood glucose
value; and retrieving, using the data processing device, a previous
day's recommended basal dose. The method further includes
determining, using the data processing device, the current day's
recommended basal dose by multiplying the adjustment factor times
the previous day's recommended basal dose. The current day's
recommended basal dose corresponds to an insulin does of
long-acting insulin to be administered to the patient at a
configurable frequency of one, two, or three times per day.
[0012] When the blood glucose time is within a third of one of six
pre-configured time intervals each spaced four hours apart from the
next, the method includes: setting, using the data processing
device, the blood glucose measurement as a governing blood glucose
value; determining, using the data processing device, an adjustment
factor for adjusting a current day's recommended basal dose based
on the governing blood glucose value; and retrieving, using the
data processing device, a previous day's recommended basal dose.
The method further includes determining, using the data processing
device, the current day's recommended basal dose by multiplying the
adjustment factor times the previous day's recommended basal dose.
The current day's recommended basal dose corresponds to an insulin
dose of long-acting insulin to be administered to the patient at a
configurable frequency of one, two, or three times per day.
[0013] In some examples, the method further includes transmitting
the subcutaneous insulin treatment program for tube-fed patients to
an administration device in communication with the data processing
device. The administration device includes a doser and an
administration computing device in communication with the doser.
The administration computing device, when executing the
subcutaneous insulin treatment program for tube-fed patients,
causes the doser to administer the recommended doses of insulin
determined by the subcutaneous insulin treatment program for
tube-fed patients. The administration device includes at least one
of an insulin injection pen or an insulin pump.
[0014] Another aspect of the disclosure provides a system for
administering insulin. The system includes a glucometer measuring
blood glucose of a patient at separate time interval and a dosing
controller in communication with the glucometer. The dosing
controller includes a data processing device and non-transitory
memory in communication with the data processing device. The dosing
controller receives blood glucose measurements of a patient from
the glucometer, receives patient information, selects a
subcutaneous insulin treatment from a collection of subcutaneous
insulin treatments based on the blood glucose measurements and the
patient information, and executes the selected subcutaneous insulin
treatment. Each blood glucose measurement is separated by a time
interval and includes a blood glucose time associated with a time
of measuring the blood glucose measurement.
[0015] The dosing controller may further determine a pre-meal
correction bolus and determine a post-prandial correction bolus. In
some implementations, the dosing controller receives a half-life
value of the rapid-acting insulin (e.g., from an external computing
device or manually entered via a user interface) and determines the
mean lifetime of the rapid-acting insulin.
[0016] In some examples, the dosing controller receives a governing
blood glucose value (e.g., from an external computing device or
manually entered via a user interface) and determines an adjustment
factor based on the received governing blood glucose value. The
dosing controller may further determine the adjustment factor by
determining when the governing blood glucose value is within a
pre-configured range of values and set the adjustment factor to a
pre-configured adjustment factor associated with the pre-configured
range of values that includes the governing blood glucose value.
The dosing controller further determines a carbohydrate-to-insulin
ratio based on the adjustment factor.
[0017] In some implementations, during the subcutaneous insulin
treatment program for tube-fed patients, the dosing controller
receives a blood glucose time associated with a time of measuring
the blood glucose measurement and determines if the blood glucose
time is within a pre-configured time interval. The dosing
controller further sets a time for a next blood glucose measurement
based on the pre-configured time interval and determines a
correction insulin dose based on the blood glucose type. The
pre-configured time interval includes one of six pre-configured
time intervals each spaced four hours apart from the next beginning
at 00:00 or one of four pre-configured time intervals each spaced
six hours apart from the next beginning at 00:00.
[0018] In some examples, when the blood glucose time is within a
first one of four pre-configured time intervals each spaced six
hours apart from the next, the dosing controller sets the blood
glucose measurement as a governing blood glucose value and
determines an adjustment factor for adjusting a value of
recommended equal-boluses based on the governing blood glucose
value. The dosing controller further retrieves a previous day's
value of recommended equal-boluses and determines a new value of
recommended equal-boluses by multiplying the adjustment factor
times the previous day's value of recommended equal-boluses. The
new value of recommended equal-boluses corresponds to an insulin
dose of rapid-acting insulin or regular insulin to be administered
to the patient at scheduled blood glucose measurements.
[0019] When the blood glucose time is within a second one of six
pre-configured time intervals each spaced four hours apart from the
next, the dosing controller sets the blood glucose measurement as a
governing blood glucose value. The dosing controller further
determines an adjustment factor for adjusting a value of
recommended equal-boluses based on the governing blood glucose
value, retrieves a previous day's value of recommended
equal-boluses and determines a new value of recommended
equal-boluses by multiplying the adjustment factor times the
previous day's value of recommended equal-boluses. The new value of
recommended equal-boluses corresponds to an insulin dose of
rapid-acting insulin or regular insulin to be administered to the
patient at scheduled blood glucose measurements. When the blood
glucose time is within a second one of six pre-configured time
intervals each spaced four hours apart from the next, the dosing
controller sets the blood glucose measurement as a governing blood
glucose value and determines an adjustment factor for adjusting a
current day's recommended basal dose based on the governing blood
glucose value. The dosing controller further retrieves a previous
day's recommended basal dose and determines the current day's
recommended basal dose by multiplying the adjustment factor times
the previous day's recommended basal dose. The current day's
recommended basal dose corresponding to an insulin dose of
long-acting insulin to be administered to the patient at a
configurable frequency of one, two, or three times per day.
[0020] When the blood glucose time is within a second one of six
pre-configured time intervals each spaced four hours apart from the
next, the dosing controller sets the blood glucose measurement as a
governing blood glucose value and determines an adjustment factor
for adjusting a current day's recommended basal dose based on the
governing blood glucose value. The dosing controller further
retrieves a previous day's recommended basal dose and determines
the current day's recommended basal dose by multiplying the
adjustment factor times the previous day's recommended basal dose.
The current day's recommended basal dose corresponds to an insulin
dose of long-acting insulin to be administered to the patient at a
configurable frequency of one, two, or three times per day.
[0021] The dosing controller transmits the subcutaneous insulin
treatment program for tube-fed patients to an administration device
in communication with the dosing controller. The administration
device includes a doser and an administration computing device in
communication with the doser. The administration device, when
executing the selected subcutaneous insulin treatment, causes the
doser to administer the recommended doses of insulin determined by
the subcutaneous insulin treatment program for tube-fed patients.
The administration device includes at least one of an insulin
injection pen or an insulin pump.
[0022] The details of one or more implementations of the disclosure
are set forth in the accompanying drawings and the description
below. Other aspects, features, and advantages will be apparent
from the description and drawings, and from the claims.
DESCRIPTION OF DRAWINGS
[0023] FIG. 1A is a schematic view of an exemplary system for
monitoring blood glucose level of a patient.
[0024] FIG. 1B is a schematic view of an exemplary system for
monitoring blood glucose level of a patient.
[0025] FIG. 1C is a schematic view of an exemplary administration
device in communication with a dosing controller.
[0026] FIG. 2A is a schematic view of an exemplary process for
monitoring the blood glucose level of a patient.
[0027] FIG. 2B is a schematic view of an exemplary display for
inputting patient information.
[0028] FIG. 2C is a schematic view of an exemplary display for
selecting a patient from a list of patients.
[0029] FIG. 3 is a schematic view of an exemplary dose calculation
process of FIG. 2A.
[0030] FIG. 4A is a schematic view of an exemplary calculation of
the intravenous time interval of FIG. 2A.
[0031] FIGS. 4B and 4C are schematic views of an exemplary display
showing the time a next blood glucose measurement is due.
[0032] FIG. 4D is a schematic view of an exemplary display for
inputting patient information.
[0033] FIG. 4E is a schematic view of an exemplary display of
patient information and a timer for a patient's next blood glucose
measurement.
[0034] FIGS. 5A and 5B are schematic views of an exemplary meal
bolus process of FIG. 2A.
[0035] FIGS. 5C and 5D are schematic views of exemplary displays
requesting information from the user.
[0036] FIGS. 6A and 6B are schematic views of an exemplary
subcutaneous transition process of FIG. 2A.
[0037] FIG. 6C is a schematic view of an exemplary warning to the
user relating to the patient.
[0038] FIG. 6D is a schematic view of an exemplary display
inquiring whether the patient should continue treatment or
stop.
[0039] FIG. 6E is a schematic view of an exemplary display
requesting information from the user relating to the patient.
[0040] FIG. 6F is a schematic view of an exemplary display showing
the recommended dose of insulin.
[0041] FIG. 6G is a schematic view of an exemplary view to the user
relating to transitioning a patient to subcutaneous delivery.
[0042] FIG. 7 is a schematic view of an exemplary correction
boluses process.
[0043] FIG. 8 is a schematic view of an exemplary adjustment factor
process.
[0044] FIGS. 9A and 9B are a schematic view of an exemplary
subcutaneous standard program.
[0045] FIGS. 9C-9E are schematic views of exemplary displays
requesting information from the user relating to the patient.
[0046] FIG. 10 is a schematic view of an exemplary subcutaneous for
tube-fed patients process.
[0047] FIG. 11 is a schematic view of an exemplary subcutaneous
process without meal boluses.
[0048] FIGS. 12A and 12B are a schematic view of an exemplary
meal-by-meal subcutaneous process without carbohydrate
counting.
[0049] FIGS. 13A and 13B are a schematic view of an exemplary
meal-by-meal subcutaneous process with carbohydrate counting.
[0050] FIGS. 14A and 14B are a schematic view of an exemplary
subcutaneous non-diabetic process.
[0051] FIG. 15 is a schematic view of an exemplary arrangement of
operations for administering insulin.
[0052] FIG. 16 is a schematic view of an exemplary arrangement of
operations for administering insulin.
[0053] Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION
[0054] Diabetic hospital patients who eat meals often have poor
appetites; consequently, co-ordination of meal boluses and meals is
difficult. Meal boluses without meals cause hypoglycemia; meals
without meal boluses cause hyperglycemia. Different providers may
use different methods of adjusting doses: some may use formulas of
their own; some may use paper protocols that are complex and
difficult for the nurse to follow, leading to a high incidence of
human error; and some may use heuristic methods. There is no
guarantee of consistency. Moreover, for diabetic patients who do
not eat meals, there is no currently no computerized method of
tracking the patient's status. For non-diabetic patient who get
include due to "stress hyperglycemia" when they are very sick or
undergoing surgery, there is no current method of monitoring their
recovery when the stress subsides and their need for insulin
rapidly decreases. If the dose regimen does not decrease rapidly
also, hypoglycemia may result. Therefore, it is desirable to have a
clinical support system 100 (FIGS. 1A and 1B) that monitors
patients' blood glucose level.
[0055] Referring to FIG. 1A-1C, in some implementations, a clinical
decision support system 100 analyzes inputted patient condition
parameters for a patient 10 and calculates a personalized dose of
insulin to bring and maintain the patient's blood glucose level
into a target range BG.sub.TR. Moreover, the system 100 monitors
the glucose levels of a patient 10 and calculates recommended
intravenous or subcutaneous insulin dose to bring the patient's
blood glucose into the preferred target range BG.sub.TR over a
recommended period of time. A qualified and trained healthcare
professional 40 may use the system 100 along with clinical
reasoning to determine the proper dosing administered to a patient
10. Therefore, the system 100 is a glycemic management tool for
evaluation a patient's current and cumulative blood glucose value
BG while taking into consideration the patient's information such
as age, weight, and height. The system 100 may also consider other
information such as carbohydrate content of meals, insulin doses
being administered to the patient 10, e.g., long-acting insulin
doses for basal insulin and rapid-acting insulin doses for meal
boluses and correction boluses. Based on those measurements (that
may be stored in non-transitory memory 24, 114, 144), the system
100 recommends an intravenous dosage of insulin, glucose, or saline
or a subcutaneous basal and bolus insulin dosing recommendation or
prescribed dose to adjust and maintain the blood glucose level
towards a configurable (based on the patient's information)
physician's determined blood glucose target range BG.sub.TR. The
system 100 also considers a patient's insulin sensitivity or
improved glycemic management and outcomes. The system 100 may take
into account pertinent patient information such as demographics and
previous results, leading to a more efficient use of healthcare
resources. Finally, the system 100 provides a reporting platform
for reporting the recommendations or prescribed dose(s) to the user
40 and the patient 10. In addition, for diabetic patients who eat
meals, the system 100 provides faster, more reliable, and more
efficient insulin administration than a human monitoring the
insulin administration. The system 100 reduces the probability of
human error and insures consistent treatment, due to the system's
capability of storing and tracking the patient's blood glucose
levels BG, which may be used for statistical studies. As for
patients who are tube-fed or do not eat meals, the system 100
provides dedicated subprograms, which in turn provide basal insulin
and correction boluses but no meal boluses. Patients who are
tube-fed or who do not eat usually have a higher basal insulin
level than patients who eat, because the carbohydrates in the
nutritive formula are accounted--for in the basal insulin. The
system 100 provides a meal-by-meal adjustment of Meal Boluses
without carbohydrate counting, by providing a dedicated subprogram
that adjusts meal boluses based on the immediately preceding meal
bolus and the BG that followed it. The system 100 provides a
meal-by-meal adjustment of Meal Boluses with carbohydrate counting
by providing a dedicated subprogram that adjusts meal boluses based
a Carbohydrate-to-Insulin Ratio (CIR) that is adjusted at each
meal, based on the CIR used at the immediately preceding meal bolus
and the BG that followed it.
[0056] Hyperglycemia is a condition that exists when blood sugars
are too high. While hyperglycemia is typically associated with
diabetes, this condition can exist in many patients who do not have
diabetes, yet have elevated blood sugar levels caused by trauma or
stress from surgery and other complications from hospital
procedures. Insulin therapy is used to bring blood sugar levels
back into a normal range.
[0057] Hypoglycemia may occur at any time when a patient's blood
glucose level is below a preferred target. Appropriate management
of blood glucose levels for critically ill patients reduces
co-morbidities and is associated with a decrease in infection
rates, length of hospital stay, and death. The treatment of
hyperglycemia may differ depending on whether or not a patient has
been diagnosed with Type 1 diabetes mellitus, Type 2 diabetes
mellitus, gestational diabetes mellitus, or non-diabetic stress
hyperglycemia. The blood glucose target range BG.sub.TR is defined
by a lower limit, i.e., a low target BG.sub.TRL and an upper limit,
i.e., a high target BG.sub.TRH.
[0058] Stress-related hyperglycemia: Patients often get "stress
hyperglycemia" if they are very sick or undergoing surgery. This
condition requires insulin. In diabetic patients, the need for
insulin is visibly increased. In non-diabetic patients, the stress
accounts for the only need for insulin, and as the patients
recover, the stress subsides, and their need for insulin rapidly
decreases. For non-diabetic patients, the concern is that their
need for insulin decreases faster than their dose regimen, leading
to hypoglycemia.
[0059] Diabetes Mellitus has been treated for many years with
insulin. Some recurring terms and phrases are described below:
[0060] Injection: Administering insulin by means of manual syringe
or an insulin "pen," with a portable syringe named for its
resemblance to the familiar writing implement.
[0061] Infusion: Administering insulin in a continuous manner by
means of an insulin pump for subcutaneous insulin or an intravenous
apparatus 123a, both of which are capable of continuous
administration.
[0062] Intravenous Insulin Therapy: Intravenous infusion of insulin
has been approved by the U.S. Food and Drug Administration as an
acceptable indication for use. Intravenous infusion is the fastest
of all insulin administration routes and, typically, only available
in the hospital setting. For instance, in intensive care units, the
patients may be fed by intravenous glucose infusion, by intravenous
Total Parenteral Nutrition (TPN), or by a tube to the stomach.
Patients are often given insulin in an intravenous infusion at an
insulin infusion rate IIR. The IIR is regulated by the frequent
testing of blood glucose, typically at intervals between about 20
minutes and 2 hours. This is combined with a protocol in which a
new IIR is computed after each blood glucose test.
[0063] Basal-Bolus Therapy: Basal-bolus therapy is a term that
collectively refers to any insulin regimen involving basal insulin
and boluses of insulin.
[0064] Basal Insulin: Insulin that is intended to metabolize the
glucose released by a patient's the liver during a fasting state.
Basal insulin is administered in such a way that it maintains a
background level of insulin in the patient's blood, which is
generally steady but may be varied in a programmed manner by an
insulin pump 123a. Basal insulin is a slow, relatively continuous
supply of insulin throughout the day and night that provides the
low, but present, insulin concentration necessary to balance
glucose consumption (glucose uptake and oxidation) and glucose
production (glucogenolysis and gluconeogenesis). A patient's Basal
insulin needs are usually about 10 to 15 mU/kg/hr and account for
30% to 50% of the total daily insulin needs; however, considerable
variation occurs based on the patient 10.
[0065] Bolus Insulin: Insulin that is administered in discrete
doses. There are two main types of boluses, Meal Bolus and
Correction Bolus.
[0066] Meal Bolus: Taken just before a meal in an amount which is
proportional to the anticipated immediate effect of carbohydrates
in the meal entering the blood directly from the digestive system.
The amounts of the Meal Boluses may be determined and prescribed by
a physician 40 for each meal during the day, i.e., breakfast,
lunch, and dinner. Alternatively, the Meal Bolus may be calculated
in an amount generally proportional to the number of grams of
carbohydrates in the meal. The amount of the Meal Bolus is
calculated using a proportionality constant, which is a
personalized number called the Carbohydrate-to-Insulin Ratio (CIR)
and calculated as follows:
Meal Insulin Bolus={grams of carbohydrates in the meal}/CIR (1)
[0067] Correction Bolus CB: Injected immediately after a blood
glucose measurement; the amount of the correction bolus is
proportional to the error in the BG (i.e., the bolus is
proportional to the difference between the blood glucose
measurement BG and the patient's personalized Target blood glucose
BG.sub.Target). The proportionality constant is a personalized
number called the Correction Factor, CF, and is calculated as
follows:
CB=(BG-BG.sub.Target)/CF (2)
[0068] A Correction Bolus CB is generally administered in a fasting
state, after the previously consumed meal has been digested. This
often coincides with the time just before the next meal.
[0069] There are several kinds of Basal-Bolus insulin therapy
including Insulin Pump therapy and Multiple Dose Injection
therapy:
[0070] Insulin Pump Therapy: An insulin pump 123a is a medical
device used for the administration of insulin in the treatment of
diabetes mellitus, also known as continuous subcutaneous insulin
infusion therapy. The device includes: a pump, a disposable
reservoir for insulin, and a disposable infusion set. The pump 123a
is an alternative to multiple daily injections of insulin by
insulin syringe or an insulin pen and allows for intensive insulin
therapy when used in conjunction with blood glucose monitoring and
carbohydrate counting. The insulin pump 123a is a battery-powered
device about the size of a pager. It contains a cartridge of
insulin, and it pumps the insulin into the patient via an "infusion
set", which is a small plastic needle or "canula" fitted with an
adhesive patch. Only rapid-acting insulin is used.
[0071] Multiple Dose Injection (MDI): MDI involves the subcutaneous
manual injection of insulin several times per day using syringes or
insulin pens 123b. Meal insulin is supplied by injection of
rapid-acting insulin before each meal in an amount proportional to
the meal. Basal insulin is provided as a once, twice, or three time
daily injection of a dose of long-acting insulin. Other dosage
frequencies may be available. Advances continue to be made in
developing different types of insulin, many of which are used to
great advantage with MDI regimens:
[0072] Long-acting insulins are non-peaking and can be injected as
infrequently as once per day. These insulins are widely used for
Basal Insulin. They are administered in dosages that make them
appropriate for the fasting state of the patient, in which the
blood glucose is replenished by the liver to maintain a steady
minimum blood glucose level.
[0073] Rapid-acting insulins act on a time scale shorter than
natural insulin. They are appropriate for boluses.
[0074] In some examples, critically ill patients are ordered nil
per os (NPO), which means that oral food and fluids are withheld
from the patient 10. Typically these patients 10 are unconscious,
have just completed an invasive surgical procedure, or generally
have difficulty swallowing. Intravenous insulin infusion is
typically the most effective method of managing blood glucose
levels in these patients. A patient 10 may be NPO and receiving a
steady infusion of intravenous glucose, Total Parenteral Nutrition,
tube feeding, regular meals that include carbohydrates, or not
receiving any nutrition at all. In cases where the patient 10 is
not receiving any nutrition, blood glucose is typically replaced by
endogenous production by the liver.
[0075] As a patient's condition improves, an NPO order may be
lifted, allowing the patient 10 to commence an oral caloric intake.
In patients 10 with glycemic abnormalities, additional insulin may
be needed to cover the consumption of carbohydrates. These patients
10 generally receive one-time injections of insulin in the
patient's subcutaneous tissue.
[0076] Subcutaneous administration of mealtime insulin in
critically ill patients 10 can introduce a patient safety risk if,
after receiving the insulin injection, the patient 10 decides not
to eat, is unable to finish the meal, or experiences emesis.
[0077] Continuous intravenous infusion of mealtime insulin, over a
predetermined time interval, allows for an incremental fulfillment
of the patient's mealtime insulin requirement, while minimizing
patient safety risks. If a patient 10 decides he/she is unable to
eat, the continuous intravenous infusion may be stopped or, if a
patient 10 is unable to finish the meal, the continuous intravenous
infusion rate may be decreased to compensate for the reduction in
caloric intake.
[0078] The pharmacokinetics (what the body does to a drug over a
period of time, which includes the processes of absorption,
distribution, localization in tissues, biotransformation, and
excretion) and pharmacodynamics (what a drug does to the body)
actions of insulin significantly improve when administering insulin
via an intravenous route, which is a typical method of delivery for
hospitalized patients 10. The management of prandial insulin
requirements using an intravenous route can improve patient safety,
insulin efficiency, and the accuracy of insulin dosing. The
majority of patients who require continuous intravenous insulin
infusion therapy may also need to be transitioned to a subcutaneous
insulin regimen for ongoing control of blood glucose, regardless of
diabetes mellitus (DM) diagnosis. Moreover, the timing, dosing, and
process to transition patients 10 from a continuous intravenous
route of insulin administration to a subcutaneous insulin regimen
is complex and should be individualized based on various patient
parameters. Failure to individualize this approach could increase
the risk of severe hypoglycemia during the transition process. If
not enough insulin is given, the patient 10 may experience acute
post-transition hyperglycemia, requiring re-initiation of a
continuous intravenous insulin infusion. Therefore, the clinical
decision support system 100 calculates a personalized dose of
insulin to bring and maintain the patient's blood glucose level
into a target range BG.sub.TR, while taking into consideration the
condition of the patient 10.
[0079] The clinical decision support system 100 includes a glycemic
management module 50, an integration module 60, a surveillance
module 70, and a reporting module 80. Each module 50, 60, 70, 80 is
in communication with the other modules 50, 60, 70, 80 via a
network 20. In some examples, the network 24 (discussed below)
provides access to cloud computing resources that allows for the
performance of services on remote devices instead of the specific
modules 50, 60, 70, 80. The glycemic management module 50 executes
a process 200 (e.g., an executable instruction set) on a processor
112, 132, 142 or on the cloud computing resources. The integration
module 60 allows for the interaction of users 40 with the system
100. The integration module 60 receives information inputted by a
user 40 and allows the user 40 to retrieve previously inputted
information stored on a storage system (e.g., one or more of cloud
storage resources 24, a non-transitory memory 144 of a hospital's
electronic medical system 140, a non-transitory memory 114 of the
patient device 110, or other non-transitory storage media in
communication with the integration module 60). Therefore, the
integration module 60 allows for the interaction between the users
40 and the system 100 via a display 116, 146. The surveillance
module 70 considers patient information 208a received from a user
40 via the integration module 60 and information received from a
glucometer 124 that measures a patient's blood glucose value BG and
determines if the patient 10 is within a threshold blood glucose
value BG.sub.TH. In some examples, the surveillance module 70
alerts the user 40 if a patient's blood glucose values BG are not
within a threshold blood glucose value BG.sub.TH. The surveillance
module 70 may be preconfigured to alert the user 40 of other
discrepancies between expected values and actual values based on
pre-configured parameters (discussed below). For example, when a
patient's blood glucose value BG drops below a lower limit of the
threshold blood glucose value BG.sub.THL. The reporting module 80
may be in communication with at least one display 116, 146 and
provides information to the user 40 determined using the glycemic
management module 50, the integration module 60, and/or the
surveillance module 70. In some examples, the reporting module 80
provides a report that may be displayed on a display 116, 146
and/or is capable of being printed.
[0080] The system 100 is configured to evaluate a glucose level and
nutritional intake of a patient 10. The system 100 also evaluates
whether the patient 10 is transitioning to a subcutaneous insulin
regime. Based on the evaluation and analysis of the data, the
system 100 calculates an insulin dose, which is administered to the
patient 10 to bring and maintain the blood glucose level of the
patient 10 into the blood glucose target range BG.sub.TR. The
system 100 may be applied to various devices, including, but not
limited to, intravenous infusion pumps 123a, subcutaneous insulin
infusion pumps 123a, glucometers, continuous glucose monitoring
systems, and glucose sensors. In some implementations, as the
system 100 is monitoring the patient's blood glucose values BG and
the patient's insulin intake, the system 100 notifies the user 40
if the patient 10 receives more than 500 units/hour of insulin
because the system 100 considers these patients 10 to be insulin
resistant.
[0081] In some examples the clinical decision support system 100
includes a network 20, a patient device 110, a dosing controller
160, and a service provider 130. The patient device 110 may
include, but is not limited to, desktop computers or portable
electronic device (e.g., cellular phone, smartphone, personal
digital assistant, barcode reader, personal computer, or a wireless
pad) or any other electronic device capable of sending and
receiving information via the network 20.
[0082] The patient device 110 includes a data processor 112 (e.g.,
a computing device that executes instructions), and non-transitory
memory 114 and a display 116 (e.g., touch display or non-touch
display) in communication with the data processor 112. In some
examples, the patient device 110 includes a keyboard 118, speakers
212, microphones, mouse, and a camera.
[0083] The service provider 130 may include a data processor 132 in
communication with non-transitory memory 134. The service provider
130 provides the patient 10 with a process 200 (see FIG. 2) (e.g.,
a mobile application, a web-site application, or a downloadable
program that includes a set of instructions) executable on a
processor 112, 132, 142 of the dosing controller 160 and accessible
through the network 20 via the patient device 110, intravenous
infusion pumps 123a, hospital electronic medical record systems
140, or portable blood glucose measurement devices 124 (e.g.,
glucose meter or glucometer). Intravenous infusion pumps infuse
fluids, medication or nutrients into a patient's circulatory
system. Intravenous infusion pumps 123a may be used intravenously
and, in some instances, subcutaneous, arterial and epidural
infusions are used. Intravenous infusion pumps 123a typically
administer fluids that are expensive or unreliable if administered
manually (e.g., using a pen 123b) by a nurse or doctor 40.
Intravenous infusion pumps 123a can administer a 0.1 ml per hour
injection, injections every minute, injections with repeated
boluses requested by the patient, up to a maximum number per hours,
or fluids whose volumes vary by the time of day.
[0084] In some implementations, an electronic medical record system
140 is located at a hospital 42 (or a doctor's office) and includes
a data processor 142, a non-transitory memory 144, and a display
146 (e.g., touch display or non-touch display). The transitory
memory 144 and the display 146 are in communication with the data
processor 142. In some examples, the hospital electronic medical
system 140 includes a keyboard 148 in communication with the data
processor 142 to allow a user 40 to input data, such as patient
information 208a (FIGS. 2A and 2B). The non-transitory memory 144
maintains patient records capable of being retrieved, viewed, and,
in some examples, modified and updated by authorized hospital
personal on the display 146.
[0085] The dosing controller 160 is in communication with the
glucometer 124 and includes a computing device 112, 132, 142 and
non-transitory memory 114, 134, 144 in communication with the
computing device 112, 132, 142. The dosing controller 160 executes
the process 200. The dosing controller 160 stores patient related
information retrieved from the glucometer 124 to determine an
insulin dose rate IRR based on the received blood glucose
measurement BG.
[0086] Referring to FIG. 1C, in some implementations, the insulin
device 123 (e.g., administration device), in communication with the
dosing controller 160, capable of executing instructions for
administering insulin according to a subcutaneous insulin treatment
program selected by the dosing controller 160. The administration
device 123 may include the insulin pump 123a or the pen 123b. The
administration device 123 is in communication with the glucometer
124 and includes a computing device 112a, 112b and non-transitory
memory 114a, 114b in communication with the computing device 112a,
112b. The administration device 123 includes a doser 223a, 223b in
communication with the administration computing device 112a, 112b
for administering insulin to the patient. For instance, the doser
223a of the insulin pump 123a includes an infusion set including a
tube in fluid communication with an insulin reservoir and a cannula
inserted into the patient's 10 body and secured via an adhesive
patch. The doser 223b of the pen 123b includes a needle for
insertion into the patient's 10 body for administering insulin from
an insulin cartridge. The administration device 123 may receive a
subcutaneous insulin treatment program selected by and transmitted
from the dosing controller 160, while the administration computing
device 112a, 112b may execute the subcutaneous insulin treatment
program. Executing the subcutaneous insulin treatment program by
the administration computing device 112a, 112b causes the doser
223a, 223b to administer doses of insulin specified by the
subcutaneous insulin treatment program. For instance, units for the
doses of insulin may be automatically set or dialed in by the
administration device 123a, 123b and administered via the doser
223a, 223b to the patient 10.
[0087] The network 20 may include any type of network that allows
sending and receiving communication signals, such as a wireless
telecommunication network, a cellular telephone network, a time
division multiple access (TDMA) network, a code division multiple
access (CDMA) network, Global system for mobile communications
(GSM), a third generation (3G) network, fourth generation (4G)
network, a satellite communications network, and other
communication networks. The network 20 may include one or more of a
Wide Area Network (WAN), a Local Area Network (LAN), and a Personal
Area Network (PAN). In some examples, the network 20 includes a
combination of data networks, telecommunication networks, and a
combination of data and telecommunication networks. The patient
device 110, the service provider 130, and the hospital electronic
medical record system 140 communicate with each other by sending
and receiving signals (wired or wireless) via the network 20. In
some examples, the network 20 provides access to cloud computing
resources, which may be elastic/on-demand computing and/or storage
resources 24 available over the network 20. The term `cloud`
services generally refers to a service performed not locally on a
user's device, but rather delivered from one or more remote devices
accessible via one or more networks 20.
[0088] Referring to FIGS. 1B and 2A-2C, the process 200 receives
parameters (e.g., patient condition parameters) inputted via the
client device 110, the service provider 130, and/or the hospital
system 140, analyzes the inputted parameters, and determines a
personalized dose of insulin to bring and maintain a patient's
blood glucose level BG into a preferred target range BG.sub.TR.
[0089] In some implementations, before the process 200 begins to
receive the parameters, the process 200 may receive a username and
a password (e.g., at a login screen displayed on the display 116,
146) to verify that a qualified and trained healthcare professional
40 is initiating the process 200 and entering the correct
information that the process 200 needs to accurately administer
insulin to the patient 10. The system 100 may customize the login
screen to allow a user 40 to reset their password and/or username.
Moreover, the system 100 may provide a logout button (not shown)
that allows the user 40 to log out of the system 100. The logout
button may be displayed on the display 116, 146 at any time during
the execution of the process 200.
[0090] The clinical decision support system 100 may include an
alarm system 120 that alerts a user 40 when the patient's blood
glucose level BG is outside the target range BG.sub.TR. The alarm
system 120 may produce an audible sound via speaker 122 in the form
of a beep or some like audio sounding mechanism. In some examples,
the alarm system 120 displays a warning message or other type of
indication on the display 116 of the patient device 110 to provide
a warning message. The alarm system 120 may also send the audible
and/or visual notification via the network 20 to the hospital
system 140 (or any other remote station) for display on the display
146 of the hospital system 140 or played through speakers 152 of
the hospital system 140.
[0091] The process 200 prompts a user 40 to input patient
information 208a at block 208. The user 40 may input the patient
information 208a, for example, via the user device 110 or via the
hospital electronic medical record systems 140 located at a
hospital 42 (or a doctor's office). The user 40 may input new
patient information 208a as shown in FIG. 2B or retrieve previously
stored patient information 208a as shown in FIG. 2C. In some
implementations, the process 200 provides the user 40 with a
patient list 209 (FIG. 2C) where the user 40 selects one of the
patient names from the patient list 209, and the process 200
retrieves that patient's information 208a. The process 200 may
allow the user 40 to filer the patient list 209, e.g.,
alphabetically (first name or last name), by location, patient
identification. The process 200 may retrieve the patient
information 208a from the non-transitory memory 144 of the
hospital's electronic medical system 140 or the non-transitory
memory 114 of the patient device 110 (e.g., where the patient
information 208a was previously entered and stored). The patient
information 208a may include, but is not limited to, a patient's
name, a patient's identification number (ID), a patient's height,
weight, date of birth, diabetes history, physician name, emergency
contact, hospital unit, diagnosis, gender, room number, and any
other relevant information. In some examples, the diagnosis may
include, but is not limited to, burn patients, Coronary artery
bypass patients, stoke patients, diabetic ketoacidosis (DKA)
patients, and trauma patients. After the user 40 completes
inputting the patient information 208a, the process 200 at block
202 determines whether the patient 10 is being treated with an
intravenous treatment module by prompting the user 40 (e.g., on the
display 116, 146) to input whether the patient 10 will be treated
with an intravenous treatment module. If the patient 10 will not be
treated with the intravenous treatment module, the process 200
determines at block 210 whether the patient 10 will be treated with
a subcutaneous treatment module, by asking the user 40 (e.g., by
prompting the user 40 on the display 116, 146). If the user 40
indicates that the patient 10 will be treated with the subcutaneous
treatment, the process 200 flows to block 216, where the user 40
enters patient subcutaneous information 216a, such as bolus insulin
type, target range, basal insulin type and frequency of
distribution (e.g., 1 dose per day, 2 doses per day, 3 doses per
day, etc.), patient diabetes status, subcutaneous type ordered for
the patient (e.g., Basal/Bolus and correction that is intended for
patients on a consistent carbohydrate diet, or Basal and correction
that is intended for patients who are NPO or on continuous enteral
feeds), frequency of patient blood glucose measurements, or any
other relevant information. In some implementations, the patient
subcutaneous information 216a is prepopulated with default
parameters, which may be adjusted or modified. When the user 40
enters the patient subcutaneous information 216, the subcutaneous
program begins at block 226. The process may determine whether the
patient 10 is being treated with an intravenous treatment or a
subcutaneous treatment by prompting the user 40 to select between
two options (e.g., a button displayed on the display 116, 146), one
being the intravenous treatment and the other begin the
subcutaneous treatment. In some implementations, the subcutaneous
program (at block 226) includes six sub programs: a subcutaneous
standard program (FIGS. 9A-9B); a subcutaneous for tube-fed
patients program (FIG. 10); a subcutaneous program without meal
boluses (FIG. 11); a meal-by-meal subcutaneous program without
carbohydrate counting (FIG. 12); a meal-by-meal subcutaneous
program with carbohydrate counting (FIGS. 13A-13B); and a
subcutaneous program for non-diabetic patients (FIG. 14).
[0092] In some implementations and referring back to block 202, if
the process 200 determines that the patient 10 will be treated with
the intravenous treatment module, the process 200 prompts the user
40 at block 204 for setup data 204a, such as patient parameters
204a relevant to the intravenous treatment mode. In some examples,
the patient parameter 204a relating to the intravenous treatment
may be prepopulated, for example, with default values that may be
adjusted and modified by the user 40. These patient parameters 204a
may include an insulin concentration (i.e., the strength of insulin
being used for the intravenous dosing, which may be measured in
units/milliliter), the type of insulin and rate being administered
to the patient, the blood glucose target range BG.sub.TR, the
patient's diabetes history, a number of carbohydrates per meal, or
any other relevant information. In some implementations, the type
of insulin and the rate of insulin depend on the BG of the patient
10. For example, the rate and type of insulin administered to a
patient 10 when the blood glucose value BG of the patient 10 is
greater or equal to 250 mgl/dl may be different than the rate and
type of insulin administered to the patient 10 when the blood
glucose value BG of the patient is greater than 250 ml/dl. The
blood glucose target range BG.sub.TR may be a configurable
parameter, customized based on various patient factors. The blood
glucose target range BG.sub.TR may be limited to 40 mg/dl (e.g.,
100-140 mg/dl, 140-180 mg/dl, and 120-160 mg/dl).
[0093] After the user 40 inputs patient parameters 204a for the
intravenous treatment at block 204, the process 200 prompts the
user 40 to input the blood glucose value BG of the patient 10 at
block 206. The blood glucose value BG may be manually inputted by
the user 40, sent via the network 20 from a glucometer 124, sent
electronically from the hospital information or laboratory system
140, or other wireless device. The process 200 determines a
personalized insulin dose rate, referred to as an insulin infusion
rate IIR, using the blood glucose value BG of the patient 10 and a
dose calculation process 300.
[0094] In some implementations, the process 200 executes on the
processor 112, 132, 142 the following instruction set. Other
instructions are possible as well.
TABLE-US-00001 { $this->load->helper(`formula`); $PatientID =
$this->input->post("PatientID"); $CurrentBG =
$this->input->post("iv_bg_input"); $Premeal =
$this->input->post("pre_meal"); $EstCarbs =
$this->input->post("carbs"); $CancelPreMeal =
$this->input->post("CancelPreMeal"); $PatientEat =
$this->input->post("patient_eat"); $ActualCarbs = 0;
$MealBolus = $this->input->post("MealBolus"); $MealBolusCount
= 0; $LastBGData = $this->iv->GetLastIVBG($PatientID);
$PreviousBG = $LastBGData->BGValue; $PreviousBGRate =
$LastBGData->InsulinRate; $iir_results =
$this->CalculateIIR($PatientID, $CurrentBG, $LastBGData,
$EstCarbs); $MealBolusDose = 0; $iir = $iir_results["iir"];
$multiplier = $iir_results["multiplier"]; $ActualCarbs = 0;
$PostPlateCheck = false; $MinutesInTransition = $this->iv-
>GetTransitionMinutesInTransition($PatientID);
$StartingMultiplier = $LastBGData->SensitivityFactor;
if($LastBGData->EstNumberOfCarbs == 12 && $LastBGData-
>ActualNumberOfCarbs == 15) {$LastBGCarbsGiven = true;} else
{$LastBGCarbsGiven = false;} if($PatientEat == 0 &&
$EstCarbs>0 && $Premeal!= 1) { $MealBolusData =
$this->iv- >GetCurrentMealBolusInfo($PatientID);
if($MealBolusData ["NumCount"]<2) { $CancelPreMeal = "yes"; } }
if($Premeal == "1") { $MealBolus = 1; $ActualCarbs = 0;
$MealBolusCount = 0; } else if($MealBolus == 1) { $MealBolus = 1;
$EstCarbs = $LastBGData->EstNumberOfCarbs; $meal_eat =
$this->input->post("meal_eat"); if($meal_eat=="input")
{$ActualCarbs = $this->input->post("meal_eat_input_val");}
else {$ActualCarbs = $meal_eat/100*$EstCarbs;} $TimeInterval =
$LastBGData->TimeInterval ; $MealBolusCount = 1; if($ActualCarbs
==0) {$MealBolus = 0;} } else { $MealBolusData = $this->iv-
>GetCurrentMealBolusInfo($PatientID); if
($MealBolusData["NumCount"] > 0 &&
$MealBolusData["NumCount"]<=2) { $MealBolus = 1; $EstCarbs =
$MealBolusData["EstNumberofCarbs"]; $ActualCarbs =
$MealBolusData["ActualNumberofCarbs"]; $MealBolusCount =
$MealBolusData["NumCount"]; if($MealBolusData["NumCount"] <2) {
$TimeInterval = $this->iv-
>getPostPlateCheckInterval($PatientID); $PostPlateCheck = true;
} else { $TimeInterval = $MealBolusData["TimeInterval"] ; } } }
if($CancelPreMeal=="yes") {$MealBolus =0;} if($MealBolus ==1) {
if($Premeal != "1") { $multiplier =
$LastBGData->SensitivityFactor; } $MB =
$this->CalculateMealBolusIIR($PatientID, $CurrentBG, $EstCarbs,
$ActualCarbs, $LastBGData, $multiplier, $MealBolusCount,
$TimeInterval ); if ($PostPlateCheck) {$ActualCarbs = 0;} $iir =
round($MB[0],1); $MealBolusDose = round($MB[2],2);
if($MealBolusDose == 0.00) {$MealBolusDose = 0.01;} } $iir_display
= $iir; if($this->default->InsulinUnitOfMeasure !=
`units/hr`) { $iir_display =
$iir_display/$LastBGData->InsulinConcentration; $iir =
$iir/$LastBGData->InsulinConcentration; } // settings
$hospital_settings = $this->patient-
>GetHospitalUnitInfoByHospitalUnitID($LastBGData->HospitalUnitID);
//get the value from configurable option $HypoTreatmentValue=
is_numeric($hospital_settings-
>HypoTreatment)?$hospital_settings->HypoTreatment:60;
$StopInsulinBGValue = $this->systemsettings-
>GlobalSetting("StopInsulinBGValue"); if(
(trim(strtolower($StopInsulinBGValue)) == "targetlow") ||
empty($StopInsulinBGValue) || !isset($StopInsulinBGValue) ||
($StopInsulinBGValue > $LastBGData->TargetLow) )
{$StopInsulinBGValue = $LastBGData->TargetLow;} //if IIR gets
this high, stop!!! $StopInsulinRecommendation =
getOneField("StopInsulinRecValue","xStopInsulinRecommendation","Sto
pInsulinRecID", $hospital_settings->StopInsulinRecomm);
$default_iir_limit = $this->options-
>ListData("Warning_IRGreaterThanValue","xWarning_IRGreaterThan","Warnin-
g_IRGr eaterThanID = "` . $hospital_settings->DisplayWarn .
`"",true)- >Warning_IRGreaterThanValue; $ShowHighRateWarning =
($iir >= $default_iir_limit); $HighRateLimit =
$default_iir_limit; $showInsulinResistance = false; $showD50 =
false; $showHTF = false; $stopInsulin = false; $D50 = 0;
if($CurrentBG >= 250) { $showInsulinResistance = $this->iv-
>CheckIfInsulinResistance($PatientID); } if ( ($CurrentBG <=
$HypoTreatmentValue) && ($CurrentBG <
$LastBGData->TargetLow) ) { $D50 = (100-$CurrentBG)*0.4; $D50 =
round($D50, 0); //IIR for D50 is always 0 $iir = 0; $iir_display =
0; if ($CurrentBG <= $HypoTreatmentValue) { $showD50 = true; }
else { if ($CurrentBG > 60) { $showHTF = true; } } }
$stopInsulin = ($showD50 || ( $CurrentBG<=$StopInsulinBGValue
&& $CurrentBG < $LastBGData->TargetLow)); $showIIR =
(!($showD50 || $showHTF )); $showD50Dupe = false; if($showD50
&& $LastBGData->BGID > 0) { if(
($LastBGData->MinutesFromLastBG<20) &&
($LastBGData->BGValue < $CurrentBG) ) { $showD50 = false;
$showD50Dupe = true; $iir = 0; $D50 = 0; } } if($stopInsulin) {$iir
= "0";} $UseGTFluid = $this->UseGTFluid ($PatientID,
$CurrentBG); $BGData = array( "ActualCarbs"=>$ActualCarbs,
"EnableFluidManage" => $hospital_settings-
>EnableFluidManage, `FluidType` => ($UseGTFluid)?$LastBGData-
>Over250Fluid:$LastBGData->Under250Fluid, "FluidRate` =>
($UseGTFluid)?$LastBGData-
>Over250Rate:$LastBGData->Under250Rate, `BGValue` =>
$CurrentBG, `InsulinRate` => $iir, `SensitivityFactor` =>
$multiplier, `D50W` => $D50, `PatientEat`=>$PatientEat,
`MealBolusDose` => $MealBolusDose, "CreateDate" =>
getOneField("dbo.fnGluDateTime( )", "Patients", "PatientID",
$PatientID) ); if($stopInsulin) { $iir = 0;$iir_display = 0; }
$ShowWarningContactPhysician= ($iir >=
$StopInsulinRecommendation && $StopInsulinRecommendation!=
""); if($ShowWarningContactPhysician) { $ShowHighRateWarning
=false; $iir = $StopInsulinRecommendation; $iir_display =
$StopInsulinRecommendation; $BGData["InsulinRate"] =
$StopInsulinRecommendation; $BGData["SensitivityFactor"] =
$StartingMultiplier; } $SameIIR = false; if($PreviousBGRate ==
$iir_display){ $SameIIR = true; } $data= array( "iir" => $iir,
"iir_display"=>$iir_display, "InsulinUnitOfMeasure" =>
$this->default- >InsulinUnitOfMeasure,
"showInsulinResistance" => $showInsulinResistance,
"showD50"=>$showD50, "showD50Dupe"=>$showD50Dupe,
"showHTF"=>$showHTF, "showIIR"=>$showIIR,
"stopInsulin"=>$stopInsulin, "D50"=>$D50,
"HypoTreatmentValue"=>$HypoTreatmentValue, `PrevD50W` =>
$LastBGData->D50W, "LastBGData" => $LastBGData, "default"
=> $this->default, "SecondNurseVerification" =>
$hospital_settings- >EnableSecondNurseVer, "ShowHighRateWarning"
=> $ShowHighRateWarning, "HighRateLimit" => $HighRateLimit,
"ShowWarningContactPhysician" => $ShowWarningContactPhysician,
`BGData`=>$BGData, `SameIIR`=>$SameIIR,
`PatientEat`=>$PatientEat, "IsDistinueIV"
=>$MinutesInTransition>=240?true:false,
`EnableHypoglycemiaMessage`=>$hospital_settings-
>EnableHypoglycemiaMessage, `MinutesFromLastBG` =>
$LastBGData->MinutesFromLastBG,
`HypoglycemiaMessage`=>$hospital_settings-
>HypoglycemiaMessage, `LastBGCarbsGiven` =>$LastBGCarbsGiven,
`IVDiscontinueRecomm` => $this->iv-
>IVDiscontinueRecomm($PatientID, $iir),
`AreLastFourInsulinRatesLow` => $this->iv-
>AreLastFourInsulinRatesLow($PatientID, $iir) ); //Loading
History Data $UserID =
$this->session->userdata[`logged_in`][`UserID`];
if(($data["showIIR"])) { $DosageAmount = $data["iir_display"];
$DosageLabel =
dealWithInsulinMeasurement($data["InsulinUnitOfMeasure"],$data["iir
display"]); } if($data["showD50"]) { if($EnableHypoglycemiaMessage
= 1) { $DosageAmount = "null"; $DosageLabel = "Stop Insulin
Infusion"; } else { $DosageAmount = $D50; $DosageLabel = "D50 or
12-15 Grams of Carbs"; } } //if $DosageAmount is empty and
$DosageLabel is empty if(empty($DosageAmount) &&
empty($DosageLabel)){ $DosageAmount = 0; $DosageLabel = null; }
$this->load->model("patient");
$this->patient->AddDosageRecommendationHistory($PatientID,
1,1, $CurrentBG, $DosageAmount, $DosageLabel, $UserID);
$this->load->view("forms/bg/iv_bg_checkboxes", $data); }
function UseGTFluid($PatientID, $CurrentBG) { //BR5.2 if($CurrentBG
>= 300) {return true;} //BR5.1 $Last3BGs =
$this->iv->Last2BGs($PatientID); if(count($Last3BGs) == 0
&& $CurrentBG >= 250) {return true;} //BR5.3
if($CurrentBG>=250 && $Last3BGs[0]->OverUnder ==
"over") {return true;} //BR5.4 if($CurrentBG>=250 &&
$Last3BGs[0]->BGValue >=250 &&
$Last3BGs[1]->BGValue >=250) {return true;} //default BR5.5
return false; } function CalculateMealBolusIIR($PatientID,
$CurrentBG, $EstimatedCarbs, $ActualCarbs, $LastBGData,
$Multiplier, $MealBolusCount, $TimeInterval) {
$InsulinUnitsOfMeasure = GetOneField("SettingValue",
"GlobalSettings", "SettingName", "InsulinUnitOfMeasure"); $r =
PreMealIIR( $PatientID, $CurrentBG, $Multiplier,
$LastBGData->InsulinConcentration, $EstimatedCarbs,
$ActualCarbs, $TimeInterval, $InsulinUnitsOfMeasure,
$MealBolusCount ); $r[0] = round($r[0], 5); return $r; } function
CalculateIIR($PatientID, $CurrentBG, $LastBGData, $EstCarbs) {
/*Adjust Multiplier*/ $multiplier =
$LastBGData->SensitivityFactor; /*add the condition
$LastBGData->SensitivityFactor == $LastBGData-
>PreBGSensitivityFactor if change the Multiplier by manually ,it
should not be changed. updated by stanley on 10/30/2013 */
if(($LastBGData->BGID!=0 || $EstCarbs > 0) &&
($LastBGData- >SensitivityFactor =
$LastBGData->PreBGSensitivityFactor) ) { if( ($CurrentBG >
$LastBGData->TargetHigh) && (($CurrentBG /
$LastBGData->BGValue) > 0.85) ) { $multiplier = $multiplier*
1.25; } elseif($CurrentBG < $LastBGData->TargetLow) {
$multiplier = $multiplier * 0.8; } } $multiplier =
round($multiplier, 5); //Calc IIR $IIR = round( ($CurrentBG - 60) *
$multiplier, 1); if($IIR < 0) {$IIR = 0;} $return = array(
"iir"=>$IIR, "multiplier" => $multiplier, ); return $return;
}
[0095] FIG. 3 provides a dose calculation process 300 for
calculating the insulin infusion rate IIR of the patient 10 for
intravenous treatment after the process 200 receives the patient
information 208a discussed above (including the patients' blood
glucose value BG). At block 301 the dose calculation process 300
determines if the patient's blood glucose BG is less than a stop
threshold value BG.sub.THstop. If not, then at block 303 the dose
calculation process 300 goes to block 304 without taking any
action. If, however, the patient's blood glucose BG is less than a
stop threshold value BG.sub.THstop, then the calculation dose
process sets the patient's regular insulin dose rate IRR to zero at
block 302, which then goes to block 322. The dose calculation
process 300 determines at decision block 304 if the inputted blood
glucose value BG is the first inputted blood glucose value.
[0096] The patient's regular insulin dose rate IIR is calculated at
block 320 in accordance with the following equation:
IIR=(BG-K)*M (3A)
where K is a constant, known as the Offset Target, with the same
unit of measure as blood glucose and M is a unit-less multiplier.
In some examples, the Offset Target K is lower than the blood
glucose target range of the patient 10. The Offset Target K allows
the dose calculation process 300 to calculate a non-zero stable
insulin dose rate even with a blood glucose result is in the blood
glucose target range BG.sub.TR.
[0097] The initial multiplier M.sub.I, determined by the physician
40, approximates the sensitivity of a patient 10 to insulin. For
example, the initial multiplier equals 0.02 for adults ages 18 and
above. In some examples, the initial multiplier M.sub.I equals 0.01
for frail elderly patients 10 who may be at risk for complications
arising when their blood glucose level BG falls faster than 80
mg/dl/hr. Moreover, the physician 40 may order a higher initial
multiplier M.sub.I for patients 10 with special needs, such as CABG
patients (i.e., patients who have undergone coronary artery bypass
grafting) with BMI (Body Mass Index which is a measure for the
human body shape based on the individual's mass and height) less
than 30 might typically receive an initial multiplier of 0.05,
whereas a patient 10 with BMI greater than 30 might receive an
initial multiplier M.sub.I of 0.06. In addition, a patient's weight
may be considered in determining the value of the initial
multiplier M.sub.I, for examples, in pediatric treatments, the
system 100 calculates a patient's initial multiplier M.sub.I using
the following equation:
M.sub.I=0.0002.times.Weight of patient (in kilograms) (3B)
In some implementations, K is equal to 60 mg/dl. The dose
calculation process 300 determines the target blood glucose target
range BG.sub.TR using two limits inputted by the user 40, a lower
limit of the target range BG.sub.TRL and an upper (high) limit of
the target range BG.sub.TRH. These limits are chosen by the user 40
so that they contain the desired blood glucose target as the
midpoint. Additionally, the Offset Target K may be calculated
dynamically in accordance with the following equation:
K=BG.sub.Target-Offset, (4)
where BG.sub.Target is the midpoint of the blood glucose target
range BG.sub.TR and Offset is the preconfigured distance between
the target center BG.sub.Target and the Offset Target, K.
[0098] In some implementations, the insulin dose rate IRR may be
determined by the following process on a processor 112, 132, 142.
Other processes may also be used.
TABLE-US-00002 function IIR($sf, $current_bg, $bg_default = 60,
$insulin_concentration, $ins_units_of_measure = `units/hr`) {
settype($sf,`float`); settype($bg_default,`float`);
settype($current_bg,`float`);
settype($insulin_concentration,`float`); /* @param $sf =
sensitivity factor from db @param $current_bg = the current bg
value being submitted @param $db_default = the default "Stop
Insulin When" value....If it isn`t passed, it defaults to 60 @param
$insulin_concentration = the default insulin concentration from
settings */ if($current_bg > 60) { $iir = array( ); $iir[0] =
round(($current_bg - $bg_default) * $sf, 1); if
($ins_units_of_measure != `units/hr`) { $iir[1] =
round(($current_bg - $bg_default) * $sf/ $insulin_concentration
,1); } return $iir; } else { return 0; } }
[0099] Referring to decision block 304, when the dose calculation
process 300 determines that the inputted blood glucose value BG is
the first inputted blood glucose value, then the dose calculation
process 300 defines the value of the current multiplier M equal to
an initial multiplier (M) at block 306. The dose calculation
process 300 then calculates, at block 320, the Insulin Infusion
Rate in accordance with the IIR equation (EQ. 3A) and returns to
the process 200 (see FIG. 2).
[0100] However, referring back to decision block 304, when the dose
calculation process 300 determines that the inputted blood glucose
value BG is not the first inputted blood glucose value, the dose
calculation process 300 determines if the Meal Bolus Module has
been activated at decision block 308. If the dose calculation
process 300 determines that the Meal Bolus Module has been
activated, then the dose calculation process 300 begins a Meal
Bolus process 500 (see FIG. 5).
[0101] Referring back to decision block 308, if the Meal Bolus
Module has not been activated, the dose calculation process 300
determines, at decision block 310, if the current blood glucose
value BG is greater than the upper limit BG.sub.TRH of the blood
glucose target range BG.sub.TR. If the blood glucose value BG is
greater than the upper limit BG.sub.TRH of the blood glucose target
range BG.sub.TR, the dose calculation process 300 determines, at
block 314, a ratio of the current blood glucose value BG to the
previous blood glucose value BG.sub.P, where BG was measured at an
earlier time than the current BG. The process 200 then determines
if the ratio of the blood glucose to the previous blood glucose,
BG/BG.sub.P, is greater than a threshold value L.sub.A, as shown in
the following equation:
(BG/BG.sub.P)>L.sub.A (5)
where BG is the patient's current blood glucose value; BG.sub.P is
the patient's previous blood glucose value; and L.sub.A is the
threshold ratio of BG/BG.sub.P for blood glucose values above the
upper limit of the blood glucose target range BG.sub.TRH. If the
ratio BG/BG.sub.P exceeds the threshold ratio L.sub.A, then the
Multiplier M is increased. In some examples, the threshold ratio
L.sub.A equals 0.85.
[0102] If the dose calculation process 300 determines that the
ratio (BG BG.sub.P) of the blood glucose value BG to the previous
blood glucose value BG.sub.P is not greater than the threshold
ratio L.sub.A for a blood glucose value BG above the upper limit
BG.sub.TRH of the blood glucose target range BG.sub.TR, then the
dose calculation process 300 sets the value of the current
multiplier M to equal the value of the previous multiplier M.sub.P,
see block 312.
M=M.sub.P (6)
[0103] Referring back to block 314, if the dose calculation process
300 determines that the ratio (BG/BG.sub.P) of the blood glucose
value BG to the previous blood glucose BG.sub.P is greater than the
threshold ratio L.sub.A for a blood glucose value above upper limit
BG.sub.TRH of the blood glucose target range BG.sub.TR, then dose
calculation process 300 multiplies the value of the current
multiplier M by a desired Multiplier Change Factor (M.sub.CF) at
block 318. The dose calculation process 300 then calculates the
insulin infusion rate at block 320 using the IIR equation (EQ. 3A)
and returns to the process 200 (see FIG. 2).
[0104] Referring back to block 310, when the dose calculation
process 300 determines that the current blood glucose value BG is
not greater than the upper limit BG.sub.TRH of the blood glucose
target range BG.sub.TR, the dose calculation process 300 then
determines if the current blood glucose concentration BG is below
the lower limit BG.sub.TRL of the blood glucose target range
BG.sub.TR at decision block 311. If the current blood glucose value
BG is below the lower limit BG.sub.TRL of the blood glucose target
range BG.sub.TR, the dose calculation process 300 at block 316
divides the value of the current multiplier M by the Multiplier
Change Factor (M.sub.CF), in accordance with the following
equation:
M=M.sub.P/M.sub.CF (7)
and calculates the current insulin infusion rate IIR using equation
3 at block 320 and returns to the process 200 (see FIG. 2).
[0105] At block 311, if the dose calculation process 300 determines
that the blood glucose value BG is not below the lower limit of the
blood glucose target range BG.sub.TRL, the dose calculation process
300 sets the value of the current multiplier to be equal to the
value of the previous multiplier M.sub.P at block 312 (see EQ.
6).
[0106] Referring again to FIG. 3, at block 311, if the current
blood glucose value BG is below the lower limit of the target range
BG.sub.TRL, logic passes to decision block 322, where the process
300 determines if the current blood glucose concentration BG is
below a hypoglycemia threshold BG.sub.Hypo. If the current blood
glucose BG is below the hypoglycemia threshold BG.sub.Hypo, logic
then passes to block 324, where the process 300 recommends
hypoglycemia treatment, either by a calculation of an
individualized dose of intravenous glucose or oral hypoglycemia
treatment.
[0107] Referring back to FIG. 2A, after the dose calculation
process 300 calculates the insulin infusion rate IIR, the process
200 proceeds to a time calculation process 400 (FIG. 4A) for
calculating a time interval T.sub.Next until the next blood glucose
measurement.
[0108] FIG. 4A shows the time interval calculation process 400 for
calculating a time interval T.sub.Next between the current blood
glucose measurement BG and the next blood glucose measurement
BG.sub.next. The time-duration of blood glucose measurement
intervals T.sub.Next may vary and the starting time interval can
either be inputted by a user 40 at the beginning of the process
200, 300, 400, or defaulted to a predetermined time interval,
T.sub.Default (e.g., one hour). The time interval T.sub.Next is
shortened if the blood glucose concentration BG of the patient 10
is decreasing excessively, or it may be lengthened if the blood
glucose concentration BG of the patient 10 becomes stable within
the blood glucose target range BG.sub.TR.
[0109] The time-interval calculation process 400 determines a value
for the time interval T.sub.Next based on several conditions. The
time-interval process 400 checks for the applicability of several
conditions, where each condition has a value for T.sub.next that is
triggered by a logic-test (except T.sub.default). The process 400
selects the lowest value of T.sub.next from the values triggered by
logic tests (not counting T.sub.default). If no logic test was
triggered, the process selects T.sub.default. This is accomplished
in FIG. 4A by the logic structure that selects the lowest values of
T.sub.next first. However, other logic structures are possible as
well.
[0110] The time calculation process 400 determines at decision
block 416 if the current blood glucose BG is below the lower limit
BG.sub.TRL (target range low limit) of the blood glucose target
range BG.sub.TR. If the current blood glucose BG is below the lower
limit BG.sub.TRL of the blood glucose target range BG.sub.TR, then
the time calculation process 400 determines, at decision block 418,
if the current blood glucose BG is less than a
hypoglycemia-threshold blood glucose level BG.sub.Hypo.
[0111] If the current blood glucose BG is less than the
hypoglycemia-threshold blood glucose level BG.sub.Hypo the time
calculation process 400 sets the time interval T.sub.Next to a
hypoglycemia time interval T.sub.Hypo, e.g., 15 or 30 minutes, at
block 426. Then the time calculation process 400 is complete and
returns to the process 200 (FIG. 2) at block 428.
[0112] If the current blood glucose BG is not less than (i.e., is
greater than) the hypoglycemia-threshold blood glucose level
BG.sub.Hypo at block 418, the time calculation process 400
determines at block 422 if the most recent glucose percent drop
BG.sub.%Drop, is greater than the threshold glucose percentage drop
% Drop.sub.Low Limit (for a low BG range) using the following
equation:
BG % drop > % Drop Low Limit ( 8 A ) since BG % drop = ( ( BG P
- BG ) BG P ) ( 8 B ) then , ( ( BG P - BG ) BG P ) > % Drop Low
Limit ( 8 C ) ##EQU00001##
where BG.sub.P is a previously measured blood glucose.
[0113] If the current glucose percent drop BG.sub.%Drop, is not
greater than the limit for glucose percent drop (for the low BG
range) % Drop.sub.Low Limit, the time calculation process 400
passes the logic to block 412. In some examples, the low limit %
Drop.sub.Low Limit equals 25%.
[0114] Referring back to block 422, if the current glucose percent
drop BG.sub.%DroP is greater than the limit for glucose percent
drop (for the low BG range) % Drop.sub.Low Limit, the time
calculation process 400 at block 424 sets the time interval to a
shortened time interval T.sub.Short, for example 20 minutes, to
accommodate for the increased drop rate of the blood glucose BG.
Then the time calculation process 400 is complete and returns to
the process 200 (FIG. 2) at block 428.
[0115] Referring back to decision block 416, if the time
calculation process 400 determines that the current blood glucose
BG is not below the lower limit BG.sub.TRL for the blood glucose
target range BG.sub.TR, the time calculation process 400 determines
at block 420 if the blood glucose BG has decreased by a percent of
the previous blood glucose that exceeds a limit % Drop.sub.Regular
(for the regular range, i.e., blood glucose value
BG>BG.sub.TRL), using the formula:
( ( BG P - BG ) BG P ) > % Drop Regular ( 9 ) ##EQU00002##
[0116] If the blood glucose BG has decreased by a percentage that
exceeds the regular threshold glucose percent drop (for the regular
BG range) % Drop.sub.Regular, the time calculation process 400, at
block 425, sets the time interval to the shortened time interval
T.sub.Short, for example 20 minutes. A reasonable value for %
Drop.sub.Regular for many implementations is 66%. Then the time
calculation process 400 is complete and returns to the process 200
(FIG. 2) at block 428. If, however, the glucose has not decreased
by a percent that exceeds the threshold glucose percent drop %
Drop.sub.Regular, (for the regular BG range), the time calculation
process 400 routes the logic to block 412. The process 400
determines, at block 412, a blood glucose rate of descent
BG.sub.DropRate based on the following equation:
BG.sub.DropRate=(BG.sub.P-BG)/(T.sub.Current-T.sub.Previous)
(10)
where BG.sub.P is the previous blood glucose measurement,
T.sub.Current is the current time and T.sub.Previous is the
previous time. Moreover, the process 400 at block 412 determines if
the blood glucose rate of descent B.sub.GDropRate is greater than a
preconfigured drop rate limit BG.sub.dropRateLimit.
[0117] If the time calculation process 400 at block 412 determines
that the blood glucose rate of descent BG.sub.DropRate, has
exceeded the preconfigured drop rate limit BG.sub.dropRateLimit,
the time interval T.sub.Next until the next blood glucose
measurement is shortened at block 414 to a glucose drop rate time
interval T.sub.BGDR, which is a relatively shorter time interval
than the current time interval T.sub.Current, as consideration for
the fast drop. The preconfigured drop rate limit
BG.sub.dropRateLimit may be about 100 mg/dl/hr. The glucose drop
rate time interval T.sub.BGDR may be 30 minutes, or any other
predetermined time. In some examples, a reasonable value for
T.sub.Default is one hour. Then the time calculation process 400 is
complete and returns to the process 200 (FIG. 2) at block 428.
[0118] If the time calculation process 400 determines at block 412
that the glucose drop rate BG.sub.DropRate does not exceed the
preconfigured rate limit BG.sub.dropRateLimit, the time calculation
process 400 determines, at block 408, if the patient's blood
glucose concentration BG has been within the desired target range
BG.sub.TR (e.g., BG.sub.TRL<BG<BG.sub.TRH) for a period of
time T.sub.Stable. The criterion for stability in the blood glucose
target range BG.sub.TR is a specified time in the target range
BG.sub.TR or a specified number of consecutive blood glucose
measurements in the target range BG.sub.TR. For example, the stable
period of time T.sub.Stable may be one hour, two hours, two and a
half hours, or up to 4 hours. If the stability criterion is met
then the time interval T.sub.Next until the next scheduled blood
glucose measurement BG may be set at block 410 to a lengthened time
interval T.sub.Long (such as 2 hours) that is generally greater
than the default time interval T.sub.Default. Then the time
calculation process 400 is complete and returns to the process 200
(FIG. 2) at block 428. If the time calculation process 400
determines that the patient 10 has not met the criteria for
stability, the time calculation process 400 sets the time interval
T.sub.Next to a default time interval T.sub.Default at block 406.
Then the time calculation process 400 is complete and returns to
the process 200 (FIG. 2) at block 428.
[0119] Referring to FIGS. 4B and 4C, once the time calculation
process 400 calculates the recommended time interval T.sub.Next,
the process 200 provides a countdown timer 430 that alerts the user
40 when the next blood glucose measurement is due. The countdown
timer 430 may be on the display 116 of the patient device 110 or
displayed on the display 146 of the hospital system 140. When the
timer 430 is complete, a "BG Due!" message might be displayed as
shown in FIG. 4B. The countdown timer 430 may include an overdue
time 432 indicating the time late if a blood glucose value is not
entered as scheduled.
[0120] In some implementations, the countdown timer 430 connects to
the alarm system 120 of the user device 110. The alarm system 120
may produce an audible sound via the speaker 122 in the form of a
beep or some like audio sounding mechanism. The audible and/or
visual notification may also be sent via the network to the
hospital system 140 (or any other remote station) and displayed on
the display 146 of the hospital system 140 or played through
speakers 152 of the hospital system 140, or routed to the cell
phone or pager of the user. In some examples, the audible alarm
using the speakers 122 is turned off by a user selection 434 on the
display 116 or it is silenced for a preconfigured time. The display
116, 143 may show information 230 that includes the patient's
intravenous treatment information 230a or to the patient's
subcutaneous treatment information 230b. In some examples, the user
40 selects the countdown timer 430 when the timer 430 indicates
that the patient 10 is due for his or her blood glucose
measurement. When the user 40 selects the timer 430, the display
116, 146 allows the user 40 to enter the current blood glucose
value BG as shown in FIG. 4D. For intravenous patients 10, the
process 200 may ask the user 40 (via the display 116, 146) if the
blood glucose is pre-meal blood glucose measurement (as shown in
FIG. 4D). When the user 40 enters the information 230 (FIG. 4D),
the user 40 selects a continue button to confirm the entered
information 230, which leads to the display 116, 146 displaying
blood glucose information 230c and a timer 430 showing when the
next blood glucose measurement BG is due (FIG. 4E). In addition,
the user 40 may enter the patient's blood glucose measurement BG at
any time before the timer 430 expires, if the user 40 selects the
`enter BG` button 436. Therefore, the user 40 may input blood
glucose values BG at any time, or the user 40 may choose to start
the Meal Bolus module process 500 (see FIG. 5) by selecting the
start meal button 438 (FIG. 4E), transition the patient to SubQ
insulin therapy 600 (see FIG. 6), or discontinue treatment 220.
[0121] Referring to FIGS. 5A-5D, in some implementations, the
process 200 includes a process where the patient's blood glucose
level BG is measured prior to the consumption of caloric intake and
calculates the recommended intravenous mealtime insulin requirement
necessary to control the patient's expected rise in blood glucose
levels during the prandial period. When a user 40 chooses to start
the Meal Bolus process 500 (e.g., when the user 40 positively
answers that this is a pre-meal blood glucose measurement in FIG.
4D, or when the user 40 selects the start meal button 438 in FIG.
4E), the Meal Bolus process 500, at decision block 504, requests
the blood glucose BG of the patient 10. The user 40 enters the
blood glucose value BG at 501 or the system 100 receives the blood
glucose BG from a glucometer 124. This blood glucose measurement is
referred to herein as the Pre-Meal BG or BG1. In some examples,
where the user 40 enters the information, the user 40 selects a
continue button to confirm the entered information 230c. In some
examples, the intravenous meal bolus process 500 is administered to
a patient 10 over a total period of time T.sub.MealBolus. The total
period of time T.sub.MealBolus is divided into multiple time
intervals T.sub.MealBolus1 to T.sub.MealBolusN, where N is any
integer greater than zero. In some examples, a first time interval
T.sub.MealBolus1 runs from a Pre-Meal blood glucose value BG1 at
measured at time T.sub.1, to a second blood glucose value BG2 at
measured at time T.sub.2. A second time interval T.sub.MealBolus2
runs from the second blood glucose value BG2 measured at time
T.sub.2 to the third blood glucose value BG3 measured at time
T.sub.3. A third time interval T.sub.MealBolus3 runs from the third
blood glucose value BG3 measured at time T.sub.3 to a fourth blood
glucose value BG4 measured at time T.sub.4. In some implementations
where the time intervals T.sub.MealBolusN are smaller than
T.sub.Default, the user 40 should closely monitor and control over
changes in the blood glucose of the patient 10. For example, a
total period of time T.sub.MealBolus equals 2 hours, and may be
comprised of: T.sub.MealBolus1=30 minutes, T.sub.MealBolus2=30
minutes, and T.sub.MealBolus3=1 hour. This example ends on the
fourth blood glucose measurement. When the Meal Bolus process 500
has been activated, an indication 440 is displayed on the display
116, 146 informing the user 40 that the process 500 is in progress.
The Meal Bolus process 500 prompts the user 40 if the entered blood
glucose value BG is the first blood glucose value prior to the meal
by displaying a question on the patient display 116. If the Meal
Bolus process 500 determines that the entered blood glucose value
BG is the first blood glucose value (BG1) prior to the meal, then
the Meal Bolus process 500 freezes the current multiplier M from
being adjusted and calculates a regular intravenous insulin rate
IRR at block 512. The regular intravenous insulin rate IRR may be
determined using EQ. 3A. Meanwhile, at block 502, the Meal Bolus
process 500 loads preconfigured meal parameters, such as meal
times, insulin type, default number of carbohydrates per meal, the
total period of time of the meal bolus process T.sub.MealBolus,
interval lengths (e.g., T.sub.MealBolus1, T.sub.MealBolus1 . . .
T.sub.MealBolusN), and the percent, "C", of the estimated meal
bolus to be delivered in the first interval T.sub.MealBolus1. In
some examples, when the system 100 includes a hospital electronic
medical record system 140, nutritional information and number of
grams of carbohydrates are retrieved from the hospital electronic
medical record systems 140 automatically. The Meal Bolus process
500 allows the user 40 to select whether to input a number of
carbohydrates from a selection of standard meals (AcutalCarbs) or
to use a custom input to input an estimated number of carbohydrates
(EstimatedCarbs) that the patient 10 is likely to consume. The Meal
Bolus process 500 then flows to block 506, where the estimated meal
bolus rate for the meal is calculated. The calculation process in
block 506 is explained in two steps. The first step is calculation
of a meal bolus (in units of insulin) in accordance with the
following equation:
Estimated Meal Bolus=EstimatedCarbs/CIR (11A)
where CIR is the Carbohydrate-to-Insulin Ratio, previously
discussed.
[0122] The Meal Bolus process 500 then determines the Estimated
Meal Bolus Rate based on the following equation:
Estimated Meal Bolus Rate=Estimated Meal Bolus*C/T.sub.MealBolus1
(11B)
Where, T.sub.MealBolus1 is the time duration of the first time
interval of the Meal Bolus total period of time T.sub.MealBolus. C
is a constant adjusted to infuse the optimum portion of the
Estimated Meal Bolus during first time interval T.sub.MealBolus1.
For instance: if Estimated Meal Bolus=6 units, T.sub.MealBolus1=0.5
hours, and C=25%, then applying Eq. 11A as an example:
Estimated Meal Bolus Rate=(6 units)*25%/(0.5 hours)=3 units/hour
(11C)
The Meal Bolus process 500 calculates the Total Insulin Rate at
block 508 as follows:
Total Insulin Infusion Rate=Estimated Meal Bolus Rate+Regular
Intravenous Rate (12)
[0123] The Meal Bolus process 500 flows to block 510 where it sets
the time interval for the first interval T.sub.MealBolus1 to its
configured value, (e.g., usually 30 minutes), which will end at the
second meal bolus blood glucose (BG2).
[0124] After the first time interval T.sub.MealBolus1 expires
(e.g., after 30 minutes elapse), the Meal Bolus process 500 prompts
the user 40 to enter the blood glucose value BG once again at block
501. When the Meal Bolus process 500 determines that the entered
blood glucose value BG is not the first blood glucose value BG1
entered at block 504 (i.e., the pre-meal BG, BG1, as previously
discussed), the process 500 flows to block 514. At block 514, the
Meal Bolus process 500 determines if the blood glucose value BG is
the second value BG2 entered by the user 40. If the user 40
confirms that the entered blood glucose value BG is the second
blood glucose value BG2 entered, the Meal Bolus process 500 uses
the just-entered blood glucose BG2 to calculate the intravenous
insulin rate IRR at block 516 and flows to block 524.
Simultaneously, if the blood glucose is the second blood glucose
BG2, the Meal Bolus process 500 prompts the user 40 to enter the
actual amount of carbohydrates that the patient 10 received at
block 518. The Meal Bolus process 500 then determines at decision
block 520 and based on the inputted amount of actual carbohydrates,
if the patient did not eat, i.e., if the amount of carbohydrates is
zero (see FIG. 5C). If the Meal Bolus process 500 determines that
the patient did not eat, the Meal Bolus process 500 then flows to
block 540, where the meal bolus module process 500 is discontinued,
the multiplier is no longer frozen, and the time interval
T.sub.Next is restored to the appropriate time interval T.sub.Next,
as determined by process 400. If however, the Meal Bolus process
500 determines that the patient 10 ate, i.e., the actual
carbohydrates is not zero (see FIG. 5D), then The Meal Bolus
process 500 flows to block 522, where it calculates a Revised meal
bolus rate according to the following equations, where the Revised
Meal Bolus and then an amount of insulin (in units of insulin) are
calculated:
Revised Meal Bolus=ActualCarbs/CIR (13A)
[0125] The process at block 522 then determines the amount (in
units of insulin) of estimated meal bolus that has been delivered
to the patient 10 so far:
Estimated Meal Bolus Delivered=Estimated Meal Bolus
Rate*(T.sub.2-T.sub.1) (13B)
where time T1 is the time of when the first blood glucose value BG1
is measured and time T2 is the time when the second blood glucose
value BG2 is measured.
[0126] The process at block 522 then calculates the portion of the
Revised Meal Bolus remaining to be delivered (i.e., the Meal Bolus
that has not yet been delivered to the patient 10) as follows:
Revised Meal Bolus Remaining=Revised Meal Bolus-Estimated Meal
Bolus Delivered (13C)
[0127] The process at block 522 then calculates the Revised Meal
Bolus Rate as follows:
Revised Meal Bolus Rate=Revised Meal Bolus Remaining/Time Remaining
(14A)
where Time Remaining=T.sub.MealBolus-T.sub.MealBolus1. Since the
total time interval T.sub.MealBolus and the first time interval
T.sub.MealBolus1 are preconfigured values, the Time Remaining may
be determined.
[0128] The Meal Bolus process 500 calculates the total insulin rate
at block 524 by adding the Revised Meal Bolus Rate to the regular
Intravenous Rate (IIR), based on the blood glucose value BG:
Total Insulin Rate=Revised Meal Bolus Rate+IIR (14B)
[0129] The Meal Bolus process 500 flows to block 526 where it sets
the time interval T.sub.Next to the second interval
T.sub.MealBolus2, which will end at the third meal bolus blood
glucose BG3 e.g., usually 30 minutes.
[0130] After the second interval, T.sub.MealBolus2 expires (e.g.,
30 minutes), the Meal Bolus process 500 prompts the user 40 to
enter the blood glucose value BG once again at block 501. The Meal
Bolus process 500 determines that the entered blood glucose value
BG is not the first blood glucose value entered at block 504
(previously discussed) and flows to block 514. The Meal Bolus
process 500 determines that the entered blood glucose value BG is
not the second blood glucose value entered at block 514 (previously
discussed) and flows to block 528. At block 528, the Meal Bolus
process 500 determines if the blood glucose value BG is the third
value entered. If the entered blood glucose value BG is the third
blood glucose value BG entered, the Meal Bolus process 500
calculates the intravenous insulin rate IRR at block 530 and flows
to block 532.
[0131] At block 532 the process determines the Total Insulin Rate
by adding the newly-determined Regular Intravenous Insulin Rate
(IIR) to the Revised Meal Bolus Rate, which was determined at BG2
and remains effective throughout the whole meal bolus time,
T.sub.mealbolus.
[0132] The Meal Bolus process 500 flows to block 534 where it sets
the time interval T.sub.Next to the third interval T.sub.MealBolus3
for the fourth meal bolus blood glucose, e.g., usually 60 minutes.
In some implementations, more than 3 intervals (T.sub.MealBolus1,
T.sub.MealBolus2 T.sub.MealBolus3) may be used. Additional
intervals T.sub.MealBolusN may also be used and the process handles
the additional intervals T.sub.MealBolusN similarly to how it
handles the third time interval T.sub.MealBolus3. As discussed in
the current example, the third interval T.sub.MealBolus3 is the
last time interval, which ends with the measurement of the fourth
blood glucose measurement BG4.
[0133] After the third time interval, T.sub.MealBolus3, expires
(e.g., 60 minutes), the Meal Bolus process 500 prompts the user 40
to enter the blood glucose value BG once again at block 501. The
Meal Bolus process 500 determines that the entered blood glucose
value BG is not the first blood glucose value entered at block 504
(previously discussed) and flows to block 514. The Meal Bolus
process 500 determines that the entered blood glucose value BG is
not the second blood glucose value entered at block 514 (previously
discussed), nor the third blood glucose level entered at block 528
and flows to block 536. At block 536, the Meal Bolus process 500
determines that the inputted blood glucose is the fourth blood
glucose value BG4. In this example, the fourth blood glucose value
BG4 is the last one. The process 500 then flows to block 538 where
the multiplier is no longer frozen, and the time interval
T.sub.Next is restored to the appropriate time interval T.sub.Next,
as determined by the Timer Adjustment process 400 (FIG. 4A). At
this time, the Meal Bolus process 500 ends and the user 40 is
prompted with a message indicating that the Meal Bolus process 500
is no longer active.
[0134] As shown in FIG. 4E, the process 200 provides a countdown
timer 430 that alerts the user 40 when the next blood glucose
measurement is due. The countdown timer 430 may be on the display
116 of the patient device 110 or displayed on the display 146 of
the hospital system 140. When the timer 430 is complete, a "BG
Due!" message might be displayed as shown in FIG. 4B. Moreover, the
timer 430 may be a countdown timer or a meal timer indicating a
sequence of mealtime intervals (e.g., breakfast, lunch, dinner,
bedtime, mid-sleep).
[0135] In some implementations, a Meal Bolus process 500 may be
implemented by the following process on a processor 112, 132, 142.
Other processes may also be used.
TABLE-US-00003 function PreMealIIR($PatientID, $CurrentBG,
$Multiplier, $InsulinConcentration, $EstCarbs, $ActualCarbs,
$TimeInterval, $InsulinUnitsOfMeasure, $MealBolusCount) { $iir =
array( ); $CarbInsulinRatio = CIR($PatientID); $NormalInsulin =
($CurrentBG - 60) * $Multiplier; if($MealBolusCount == 0) { //first
run - Premeal Bolus $MealBolus = ($EstCarbs /$CarbInsulinRatio);
if($MealBolus <0) {$MealBolus = 0;} $iir[0] = $NormalInsulin + (
$MealBolus *.5 ); $iir[2] = ( $MealBolus *.5 ); /* print "Premeal:
MX: " .$Multiplier. "<BR>"; print ($CurrentBG - 60) *
$Multiplier; print "+" ; print ( $MealBolus *.5 ); */ } else
if($MealBolusCount == 1){ //second run Post Meal Bolus //third run
time interval coming in is actually the //difference between the
premeal BG and the first Post Meal BG (second run) $MealBolus =
($ActualCarbs / $CarbInsulinRatio); $OldMealBolus = ($EstCarbs /
$CarbInsulinRatio); $CurrentMealBolus = ($MealBolus -
($OldMealBolus *.5 * $TimeInterval))/1.5; if($CurrentMealBolus
<0) {$CurrentMealBolus =0;} $iir[0] = $NormalInsulin +
$CurrentMealBolus ; $iir[2] = $CurrentMealBolus ; /* print
"PlateCheck: <BR>MX: " . $Multiplier . "<BR>"; print
"Est Carbs: " . $EstCarbs . "<BR>"; print "ActualCarbs: " .
$ActualCarbs . "<BR>";; print "CarbInsulinRatio: " .
$CarbInsulinRatio . "<BR>"; print "TimeInterval: " .
$TimeInterval . "<BR>"; print "Multiplier: " . $Multiplier;
*/ } else { $MealBolus = ($ActualCarbs / $CarbInsulinRatio);
$OldMealBolus = ($EstCarbs / $CarbInsulinRatio); /* print "Actual
Carbs: " . $ActualCarbs . "<BR>"; print "Est Carbs: " .
$EstCarbs . "<BR>"; print "CIR: " . $CarbInsulinRatio .
"<BR>"; print "Multiplier: " . $Multiplier . "<BR>";
print "CurrentBG: " . $CurrentBG . "<BR>"; print "IIR: " .
(($CurrentBG - 60) * $Multiplier) . "<BR>"; print "MealBolus:
" . $MealBolus . "<BR>"; print "OldMealBolus: " .
$OldMealBolus . "<BR>"; print "TimeInterval: " .
$TimeInterval . "<BR>"; */ $CurrentMealBolus = ($MealBolus -
($OldMealBolus *.5 * $TimeInterval))/1.5; if($CurrentMealBolus
<0) {$CurrentMealBolus =0;} $iir[0] = $NormalInsulin +
$CurrentMealBolus; $iir[2] = $CurrentMealBolus; /* print "Post
PlateCheck: <BR>MX: " . $Multiplier . "<BR>"; print
"IIR: "; print ($CurrentBG - 60) * $Multiplier . "<BR>";
print "Est Carbs: " . $EstCarbs . "<BR>"; print "Acutal
Carbs: " . $ActualCarbs . "<BR>"; print "Old Meal bolus: " .
$OldMealBolus . "<BR>"; print "TimeInterval: " .
$TimeInterval . "<BR>"; print "Meal bolus: " . $MealBolus .
"<BR>"; print "Final Calc: " . $iir[0]; */ } if
($InsulinUnitsOfMeasure != "units/hr") { $iir[0] =
$iir[0]/$InsulinConcentration; } return $iir; }
[0136] Referring to FIGS. 2A and 6A-6B, if the user elects to
initiate the SubQ Transition process 600, the SubQ Transition
process 600 determines at decision block 604 if the current blood
glucose BG is within a preconfigured stability target range
BG.sub.STR, e.g., 70-180 mg/dl, which is usually wider than the
prescribed Target Range, BG.sub.TR. If the blood glucose BG is not
within the preconfigured stability target range BG.sub.STR (e.g.,
BG.sub.Low<BG<BG.sub.High), the SubQ Transition process 600
at block 606 displays a warning notification on the patient display
116. Then, at lock 610, the SubQ Transition process 600 is
automatically discontinued.
[0137] Referring back to block 604, if the blood glucose BG is
within the preconfigured stability target range BG.sub.STR (e.g.
70-180 mg/dl), the SubQ Transition process 600 at decision block
608 determines if the patient's blood glucose measurement BG has
been in the patient's personalized prescribed target range
BG.sub.TR for the recommended stability period T.sub.Stable, e.g.,
4 hours. If the SubQ Transition process 600 determines that the
blood glucose value BG has not been in the prescribed target range
BG.sub.STR for the recommended stability period T.sub.Stable, the
SubQ Transition process 600 moves to block 614 where the system 100
presents the user 40 with a warning notification on the patient
display 116, explaining that the patient 10 has not been in the
prescribed target range for the recommended stability period (see
FIG. 6C). The SubQ Transition process 600 continues to decision
block 618 where it determines whether the user 40 wants the patient
10 to continue the SubQ Transition process or to discontinue the
SubQ Transition process. The SubQ Transition process 600 displays
on the display 116 of the patient device 110 the question to the
user 40 as shown in FIG. 6D. If the user 40 chooses to discontinue
the SubQ Transition process, the SubQ Transition process 600 flows
to block 624, where the SubQ Transition process is
discontinued.
[0138] Referring back to block 618, if the user 40 chooses to
override the warning and continue the SubQ Transition process, the
process 600 prompts the user 40 to enter SubQ information 617 as
shown in FIG. 6E. The SubQ Transition process 600 flows to block
616, where the patient's SubQ Transition dose is calculated as a
patient's total daily dose TDD. In some implementations, TDD is
calculated in accordance with equation:
TDD=QuickTransitionConstant*M.sub.Trans (15A)
where QuickTransitionConstant is usually 1000, and M.sub.Trans is
the patient's multiplier at the time of initiation of the SubQ
transition process.
[0139] Referring again to block 616, in some implementations TDD is
calculated by a statistical correlation of TDD as a function of
body weight. The following equation is the correlation used:
TDD=0.5*Weight(kg) (15B)
[0140] The SubQ Transition process 600 continues to block 620,
where the recommended SubQ dose is presented to the user 40 (on the
display 116) in the form of a Basal recommendation and a Meal Bolus
recommendation (see FIG. 6F).
[0141] Referring again to decision block 608, if the SubQ
Transition process 600 determines that the patient 10 has been in
the prescribed target range BG.sub.TR for the recommended stability
period, T.sub.Stable, SubQ Transition process 600 continues to
block 612, where the patient's total daily dose TDD is calculated
in accordance with the following equation:
TDD=(BG.sub.Target-K)*(M.sub.Trans)*24 (16)
where M.sub.Trans is the patient's multiplier at the time of
initiation of the SubQ transition process.
[0142] In some implementations, the patient's total daily dose TDD
may be determined by the following process on a processor 112, 132,
142. Other processes may also be used.
TABLE-US-00004 function getIV_TDD($PatientID) { //$weight =
getOneField("weight", "patients", "patientID", $PatientID);
//return $weight/2; $CI = get_instance( );
$CI->load->model(`options`); $d =
$CI->options->GetIVTDDData($PatientID); $TargetHigh =
$d["TargetHigh"]; $TargetLow = $d["TargetLow"]; $Multiplier =
$d["Multiplier"]; $MidPoint = ($TargetHigh + $TargetLow) / 2;
$Formula = ($MidPoint - 60) * $Multiplier * 24; return $Formula;
}
[0143] When the patient's total daily dose TDD is calculated, the
SubQ Transition process 600 continues to block 620 where the
recommended SubQ dose is presented to the user 40 as described
above. The SubQ Transition process 600 continues to block 622,
where the SubQ Transition process 600 provides information to the
user 40 including a recommended dose of Basal insulin. The user 40
confirms that the Basal insulin has been given to the patient 10;
this starts a transitions timer using the
TransitionRunTime.sub.Next, usually 4 hours. At this point, normal
calculation rules governing the IIR are still in effect, including
the intravenous IIR timer (Timer Adjustment process 400), which
continues to prompt for blood glucose tests at time intervals
T.sub.Next as described previously. The SubQ Transition process 600
passes to decision block 626, which determines whether the
recommended time interval TransitionRunTime has elapsed, e.g., 4
hours, after which time SubQ Transition process 600 continues to
block 630, providing the user with subcutaneous insulin discharge
orders and exiting the IV Insulin process in block 634.
[0144] Referring back to FIG. 2A, in some implementations, the
subcutaneous program (at block 226) includes six sub programs: a
subcutaneous standard program (FIGS. 9A-9B); a subcutaneous for
tube-fed patients Program (FIG. 10); a subcutaneous program with no
meal boluses (FIG. 11); a meal-by-meal subcutaneous program without
carbohydrate counting (FIG. 12); a meal-by-meal subcutaneous
program with carbohydrate counting (FIGS. 13A-13B); and a
subcutaneous program for non-diabetic patients (FIG. 14). Some
functions or processes are used within the six subcutaneous
programs such as determining the general and pre-meal correction
(FIG. 7), determining the adjustment factor AF (FIG. 8), and
hypoglycemia treatment.
[0145] Referring to FIG. 7, correction boluses CB are used in the
six subprograms of SubQ program (block 226, FIG. 2); because of
this, correction boluses CB may be incorporated into a function
having variables such as the blood glucose measurement BG of a
patient 10, a patient's personalized target blood glucose
BG.sub.Target, and a correction factor CF. Thus, correction boluses
CB are described as a function of the blood glucose measurement BG,
the target blood glucose BG.sub.Target, and the correction factor
CF (see EQ. 19 below). The process 700 calculates the correction
bolus CB immediately after a blood glucose value BG of a patient 10
is measured. Once a calculation of the correction bolus CB is
completed, a nurse 40 administers the correction bolus CB to the
patient 10, right after the blood glucose value BG is measured and
used to calculate the correction bolus CB.
[0146] In some examples, the process 700 may determine the total
daily dose TDD of insulin once per day, for example, every night at
midnight. Other times may also be available. In addition, the total
daily dose TDD may be calculated more frequently during the day, in
some examples, the total daily dose TDD is calculated more
frequently and considers the total daily dose TDD within the past
24 hours. The process 700 provides a timer 702, such as a countdown
timer 702, where the timer 702 determines the time the process 700
executes. The timer 702 may be a count up timer or any other kind
of timer. When the timer 702 reaches its expiration or reaches a
certain time (e.g., zero for a countdown timer 702), the timer 702
executes the process 700. The counter 702 is used to determine at
what time the process 704 calculates the total daily dose TDD. If
the counter is set to 24 hours for example, then decision block 704
checks if the time has reached 24 hours, and when it does, then the
process 700 calculates the total daily dose TDD of insulin. The
correction bolus process 700 determines a total daily dose of
insulin TDD, based on the following equation:
TDD=Sum over previous day (all basal+all meal boluses+all
correction boluses) (17)
[0147] After the process 700 determines the total daily dose TDD of
insulin at block 706, the process 700 determines a Correction
Factor CF immediately thereafter at block 710, using the calculated
total daily dose TDD from block 706 and Eq. 17. The correction
factor CF is determined using the following equation:
CF=CFR/TDD (18)
where CFR is a configurable constant stored in the non-transitory
memory 24, 114, 144 of the system. At block 708, the process 700
retrieves the configurable constant CFR value from the
non-transitory memory 24, 114, 144 to calculate the correction
factor CF at block 710. The configurable constant CFR is determined
from a published statistical correlation and is configurable by the
hospital, nurses and doctors. The flexibility of modifying the
correction constant CF, gives the system 100 flexibility when a new
published configurable constant CFR is more accurate than the one
being used. In some examples, the configurable constant CFR is a
configurable constant set to 1700, other values may also be
available. In some examples, the total daily dose TDD and CF are
determined once per day (e.g., at or soon after midnight).
[0148] Once the correction factor CF is determined in EQ. 18, the
process 700 determines the correction bolus insulin dose at block
714 using the following equation:
CB=(BG-BG.sub.Target)/CF (19)
where BG is the blood glucose measurement of a patient 10 retrieved
at block 712, BG.sub.Target is the patient's personalized Target
blood glucose, and CF is the correction factor. The process 700
returns the correction bolus CB at block 716. Rapid-acting analog
insulin is currently used for Correction Boluses because it
responds quickly to a high blood glucose BG. Also rapid acting
analog insulin is currently used for meal boluses; it is usually
taken just before or with a meal (injected or delivered via a
pump). Rapid-acting analog insulin acts very quickly to minimize
the rise of patient's blood sugar which follows eating.
[0149] A Correction Bolus CB is calculated for a blood glucose
value BG at any time during the process 200. Pre-meal Correction
Boluses CB, are calculated using EQ. 19. In the Pre-meal Correction
Bolus equation (19) there is no need to account for Remaining
Insulin I.sub.Rem because sufficient time has passed for almost all
of the previous meal bolus to be depleted. However, post-prandial
correction boluses (after-meal correction boluses) are employed
much sooner after the recent meal bolus and use different
calculations, that account for remaining insulin I.sub.Rem that
remains in the patient's body after a recent meal bolus.
Rapid-acting analog insulin is generally removed by a body's
natural mechanisms at a rate proportional to the insulin remaining
I.sub.Rem in the patient's body, causing the remaining insulin
I.sub.Rem in the patient's body to exhibit a negative exponential
time-curve. Manufacturers provide data as to the lifetime of their
insulin formulations. The data usually includes a half-life or mean
lifetime of the rapid-acting analog insulin. The half-life of the
rapid-acting analog insulin may be converted to mean lifetime
iLifeRapid for rapid-acting insulin by the conversion formula:
iLifeRapid=Half-life*ln(2) (20)
where ln(2) is the natural logarithm {base e} of two.
[0150] The present invention uses the mean lifetime iLifeRapid in
its formulas (EQ. 20). Since the manufacturers and brands of
insulin are few, the system 100 maintains the Half-life or
iLifeRapid value of each insulin manufacturer up-to-date.
[0151] The insulin remaining in the patient's body Remaining
Insulin I.sub.Rem is determined by multiplying the most recent
insulin bolus {Meal Bolus, Correction Bolus, or combined bolus}
times a time-dependent exponentially-declining factor as
follows:
I Rem = ( Previous Bolus ) * e - ( T Current - T Previous
iLifeRapid ) = ( Previous Bolus ) * EXP ( - ( T Current - T
Previous iLifeRapid ) ) ( 21 ) ##EQU00003##
where T.sub.Current is the current time, and T.sub.PrevBolus is the
time at which the last bolus was given to the patient 10. The Post
Meal Correction bolus CB.sub.post is calculated similar to an
ordinary correction bolus CB (EQ. 19) with a deduction of the
remaining insulin I.sub.Rem in the patient's body:
CB post = ( BG - BG Target ) CF - ( Previous Bolus ) e - ( T
Current - T Previous iLifeRapid ) ( 22 ) ##EQU00004##
[0152] In some examples, Post Meal Correction doses CB.sub.Post
(EQ. 22) are taken into consideration only if they are positive
(units of insulin), which means a negative value post meal
correction bolus CB.sub.Post cannot be used to reduce the meal
bolus portion of a new combined bolus.
[0153] Referring to FIG. 8, the process 800 describes a function
that determines an Adjustment Factor AF based on an input of a
Governing Blood GlucoseBGgov. The Adjustment Factor AF is used by
the six subcutaneous subprograms: a subcutaneous standard program
(FIGS. 9A-9B); a subcutaneous for tube-fed patients Program (FIG.
10); a subcutaneous program without meal boluses (FIG. 11); a
meal-by-meal subcutaneous program without carbohydrate counting
(FIG. 12); a meal-by-meal subcutaneous program with carbohydrate
counting (FIGS. 13A-13B); and a subcutaneous program for
non-diabetic patients (FIG. 14). These six subprograms adjust the
insulin dose administered to a patient 10. An insulin adjustment
process 800, applied to Basal doses and Meal Boluses, determines an
adjusted Recommended Basal dose RecBasal, or a Recommended Meal
Bolus RecMealBol, by applying a unit-less Adjustment Factor AF to
the preceding recommendation of the same dose, RecBasal.sub.prev,
or RecMealBol.sub.prev. All dose adjustments are governed by a
Governing Blood Glucose value BG.sub.gov. The Governing Blood
Glucose values BG.sub.gov in the process are selected based on the
criteria of preceding the previous occurrence of the dose to be
adjusted by a sufficient amount of time for the effect (or lack of
effect) of the insulin to be observable and measurable in the value
of the BG.sub.gov.
[0154] At block 802, the adjustment factor process 800 receives the
Governing Glucose value BG.sub.gov from non-transitory memory 24,
114, 144, since the adjustment factor AF is determined using the
Governing Glucose value BG.sub.gov. To determine the adjustment
factor AF, the adjustment factor process 800 considers the blood
glucose target range BG.sub.TR (within which Basal doses and Meal
Boluses, are not changed), which is defined by a lower limit, i.e.,
a low target BG.sub.TRL and an upper limit, i.e., a high target
BG.sub.TRH. As previously discussed, the target range BG.sub.TR is
determined by a doctor 40 and entered manually (e.g., using the
patient device 110 or the medical record system 140, via, for
example, a drop down menu list displayed on the display 116, 146).
Each target range BG.sub.TR is associated with a set of
configurable constants including a first constant BG.sub.AFL, a
second constant BG.sub.AFH1, and a third constant BG.sub.AFH2 shown
in the below table.
TABLE-US-00005 TABLE 1 Target Range Settings Input Ranges
BG.sub.AFL BG.sub.TRL BG.sub.TRH BG.sub.AFH1 BG.sub.AFH2 70-100 70
70 100 140 180 80-120 80 80 120 160 200 100-140 70 100 140 180 220
120-160 90 120 160 200 240 140-180 110 140 180 220 260
[0155] The adjustment factor process 800 determines, at block 804,
if the Governing Glucose value BG.sub.gov is less than or equal to
the first constant BG.sub.AFL (BG.sub.gov<=BG.sub.AFL), if so
then at block 806, the adjustment factor process 800 assigns the
adjustment factor AF to a first pre-configured adjustment factor AF
1 shown in Table 2.
[0156] If, at block 804, the Governing Glucose value BG.sub.gov is
not less than the first constant BG.sub.AFL, (i.e.,
BG.sub.gov.gtoreq.BG.sub.AFL), then at block 808, the adjustment
factor process 800 determines if the Governing Glucose value
BG.sub.gov is greater than or equal to the first constant
BG.sub.AFL and less than the low target BG.sub.TRL of the target
range BG.sub.TR (BG.sub.AFL.ltoreq.BG.sub.gov<BG.sub.TRL). If
so, then the adjustment factor process 800 assigns the adjustment
factor AF to a second pre-configured adjustment factor AF2, at
block 810. If not, then at block 812, the adjustment factor process
800 determines if the Governing Glucose value BG.sub.gov is greater
than or equal to the low target BG.sub.TRL of the target range
BG.sub.TR and less than the high target level BG.sub.TRH of the
target range BG.sub.TR
(BG.sub.TRL.ltoreq.BG.sub.gov<BG.sub.TRH). If so, then the
adjustment factor process 800 assigns the adjustment factor AF to a
third pre-configured adjustment factor AF3, at block 814. If not,
then at block 816, the adjustment factor process 800 determines if
the Governing Glucose value BG.sub.gov is greater than or equal to
the high target level BG.sub.TRH of the target range BG.sub.TR and
less than the second constant BG.sub.AFH1
(BG.sub.TRH.ltoreq.BG.sub.gov<BG.sub.AFH1). If so, then the
adjustment factor process 800 assigns the adjustment factor AF to a
fourth pre-configured adjustment factor AF4, at block 818. If not,
then at block 820, the adjustment process 800 determines if the
Governing Glucose value BG.sub.gov is greater than or equal to the
second constant BG.sub.AFH1 and less than the third constant
BG.sub.AFH2 (BG.sub.AH1.ltoreq.BG.sub.gov<BG.sub.AFH2). If so,
then the adjustment factor process 800 assigns the adjustment
factor AF to a fifth pre-configured adjustment factor AF5, at block
822. If not, then at block 824, the adjustment process 800
determines that the Governing Glucose value BG.sub.gov is greater
than or equal to the third constant BG.sub.AFH2
(BG.sub.gov.gtoreq.BG.sub.AFH2); and the adjustment factor process
800 assigns the adjustment factor AF to a sixth pre-configured
adjustment factor AF6, at block 826. After assigning a value to AF
the adjustment factor process 800 returns the adjustment factor AF
to the process requesting the adjustment factor AF at block 828
(e.g., the subcutaneous process (FIGS. 9A-9B)).
TABLE-US-00006 TABLE 2 Configurable values for Adjustment Factor AF
AF1 = 0.8 AF2 = 0.9 AF3 = 1 AF4 = 1.1 AF5 = 1.2 AF6 = 1.3
[0157] In some examples, a patient 10 may suffer from hypoglycemia
during the execution of the process 200. Hypoglycemia treatment may
be needed in the Intravenous process 300 (FIGS. 3A and 3B) and 400
(FIG. 4A) or in the Subcutaneous process 900 (FIGS. 9A and 9B). The
process 200 includes a sub-process that monitors the current blood
glucose value BG of a patient 10 and determines if it is less than
a hypoglycemia threshold BG.sub.Hypo (configurable by the hospital
or doctor). If the current blood glucose value BG is less than the
hypoglycemia threshold BG.sub.Hypo, a warning message is displayed
on the display 116, 146 warning the patient 10, the nurse and the
doctor 40 of the patient's condition, the value of the low current
blood glucose value BG, a reminder to turn off the insulin (if the
hypoglycemia event occurs in the IV Process (FIG. 2)), and a
selector that allows the nurse or doctor 40 to select the type of
glucose administered to the patient 10. Some of the selections
include: Intravenous D50 (50% glucose by weight) if the patient 10
has an intravenous connection; and Oral glucose (tablets or gel).
Once the nurse or doctor 40 enters, using the patient device 110 or
the medical record system 140, a type of glucose to be administered
to the patient, the process 200 calculates a dose recommendation
(or prescribed dose) and displays the calculated dose on the
display 116, 146. Moreover, the process 200 prompts the nurse or
doctor 40 to input via the patient device 110 or the hospital
device 160, the dose D.sub.hypo administered to the patient 10 to
treat the hypoglycemia by grams of glucose may be determined based
on the following equation:
D.sub.hypo (in grams)=F.sub.HypoTreatment*(BG.sub.Target-BG)
(23)
where BG.sub.TR is the blood glucose target range and
F.sub.HypoTreatment is a hypoglycemia treatment factor that is a
configurable constant. In some examples, the hypoglycemia treatment
factor F.sub.HypoTreatment equals 0.2 (glucose gm/(mg/dl)).
[0158] If the nurse or doctor 40 selected a solution (e.g., D50 as
opposed to oral glucose), the process 200 uses a different formula
to calculate the recommended dose, where the calculated grams of
glucose are divided by the concentration of glucose
C.sub.HypoFluidConc in the fluid in (grams of glucose/ml) to obtain
the recommended dose in units of solution volume (e.g., ml). The
formula is:
D.sub.hypo (in
ml)=(BG.sub.TR-BG)*F.sub.HypoTreatment/C.sub.HypoFluidConc (24)
For D50, the hypoglycemic fluid concentration is 0.5 grams of
glucose/ml.
[0159] Referring to FIGS. 2A and 9A-9B, if the user 40 initiates a
subcutaneous insulin process 900 at block 210 or block 600, also
referred to as a Standard SubQ Program, the subcutaneous insulin
process 900 requests the user 40 to enter SubQ information 617 for
the patient 10, such as patient diabetes status, subcutaneous type
ordered for the patient 10 (e.g., Basal/bolus and correction that
is intended for patients on a consistent carbohydrate diet, or
Basal and correction that is intended for patients who are NPO or
on continuous eternal feeds), total daily dosage (TDD) (e.g.,
calculated using any of EQs. 15A-15C), bolus insulin type (e.g.,
Novolog), basil insulin type (e.g., Lantus) and frequency of
distribution (e.g., 1 dose per day, 2 doses per day, 3 doses per
day, etc.), basil time, basal percentage of TDD, meal bolus
percentage of TDD, daily meal bolus distribution (e.g., breakfast
bolus, lunch bolus and dinner bolus), or any other relevant
information. In some implementations, the patient SubQ information
617 is prepopulated with default parameters, which may be adjusted
or modified. In some examples, portions of the patient SubQ
information 617 is prepopulated with previously entered patient
subcutaneous information 216a. The subcutaneous insulin process 900
may prompt the request to the user 40 to enter the SubQ information
617 on the display 116 of the patient device 110. In some
implementations, the subcutaneous insulin process 900 prompts the
request to the user 40 to enter the SubQ information 617 on the
display 116 of the patient device 110 for new SubQ patients after
transitioning from being treated with an intravenous treatment as
shown in FIG. 9C. For instance, the user 40 may select whether or
not to continue treating the patient with the subcutaneous insulin
process 900. In other implementations, the subcutaneous insulin
process 900 prompts the request on the display 116 for a custom
start of new SubQ patients being treated with the subcutaneous
insulin process 900 shown in FIG. 9D. In some examples, the
subcutaneous insulin process 900 prompts the request on the display
116 for a weight-based start of SubQ patients being treated with
the subcutaneous insulin process 900 as shown in FIG. 9E. For
instance, the user 40 may input the weight (e.g., 108 kg) of the
patient 10, and in some examples, the TDD may be calculated using
EQ. 15B based on the patient's weight.
[0160] Basal insulin is for the fasting insulin-needs of a
patient's body. Therefore, the best indicator of the effectiveness
of the basal dose is the value of the blood glucose BG after the
patient 10 has fasted for a period of time. Meal Boluses are for
the short-term needs of a patient's body following a
carbohydrate-containing meal. Therefore, the best indicator of the
effectiveness of the Meal Bolus is a blood glucose measurement BG
tested about one mean insulin-lifetime iLifeRapid after the Meal
Bolus, where the lifetime is for the currently-used insulin type.
For rapid-acting analog insulin the lifetime is conveniently
similar to the time between meals. The SubQ process 900 begins with
the manual entry of a blood glucose value BG at block 902. Then the
SubQ process 900 determines the type of the blood glucose value BG,
i.e., the time that the blood glucose BG is measured, e.g.,
midsleep, breakfast, lunch, dinner, or bedtime. In some examples,
the subcutaneous insulin process 900 includes a default setup of
three meals per day, but a bedtime snack or other additional meals
may be configurable.
[0161] At block 904, the subcutaneous insulin process 900
determines if the blood glucose type BG.sub.type is Midsleep
(measured during a patient's midsleep). If so, then the
subcutaneous insulin process 900 calculates a midsleep correction
dose CB.sub.Midsleep of insulin at block 914, using the following
equation (based on EQ. 2):
CB.sub.Midsleep=(BG.sub.Midsleep-BG.sub.Target)/CF; (25)
or by the Correction Bolus Function, process 700, (FIG. 7), and
sends the blood glucose value BG at midsleep BG.sub.Midsleep
(received at block 902) to block 942.
[0162] If the entered blood glucose BG is not measured during
midsleep, i.e., BG.sub.type is not equal MidSleep, then the
subcutaneous insulin process 900 determines if the blood glucose
type BG.sub.type is measured during breakfast
(BG.sub.type=Breakfast) at block 906. If so, then the subcutaneous
insulin process 900 calculates a breakfast correction dose
CB.sub.Breakfast of insulin at block 916, using the following
equation (based on EQ. 2):
CB.sub.Breakfast=(BG.sub.Breakfast-BG.sub.Target)/CF; (26)
and the patient 10 is administered the breakfast correction dose
CB.sub.Breakfast as soon as possible. Block 906 sends the blood
glucose value BG at breakfast to block 924 and block 950. At block
924, the nurse 40 administers the patient 10 with the breakfast
bolus RecBreakBol.sub.(current)), and then passes the breakfast
blood glucose BG.sub.Breakfast to block 936 (where the next
Recommendation Breakfast bolus is calculated after the lunch BGtype
is entered). Once the lunch blood glucose is entered at block 902,
and the adjustment factor parameter AF based on the lunch blood
glucose is determined (FIG. 8), the adjustment factor AF is also
sent to block 936. At block 936, the process 900 determines the
next recommended Breakfast Bolus RecBreakBol.sub.(Next) based on
the following equation:
RecBreakBol.sub.(Next)=(RecBreakBol.sub.(current))*AF (27)
At block 950, the subcutaneous insulin process 900 determines if
the breakfast blood glucose BG.sub.Breakfast has been tested, if
not then the subcutaneous insulin process 900 blocks basal
recommendation, and posts a warning, displayed on the display 116,
146, to the patient 10, nurse and doctor 40 at block 954 and is
stored in the non-transitory memory 24, 114, 144 at block 954.
However, if the breakfast blood glucose BG.sub.Breakfast has been
tested, then the subcutaneous insulin process 900 selects, at block
942, the Governing blood glucose BG.sub.gov as the lesser of the
two blood glucose values, i.e., the midsleep blood glucose
BG.sub.MidSleep or the breakfast blood glucose BG.sub.Breakfast, as
shown in the following equation:
BG.sub.gov (for Basal adjustment)=MIN(BG.sub.MidSleep or
BG.sub.Breakfast) (28)
[0163] In some implementations, the governing blood glucose
BG.sub.gov for Basal is the lesser of the MidSleep blood glucose
BG.sub.MidSleep or the breakfast blood glucose BG.sub.Breakfast
unless the system 100 determines that the MidSleep blood glucose
BG.sub.MidSleep caused a Correction bolus dose CB greater than a
maximum value (MSCorrMAX), and the following equation applies:
(Time of BG.sub.Breakfast-Time of BG.sub.MidSleep Correction
dose)<DTmin (29)
where DT.sub.min is a preset time window. In other words:
TABLE-US-00007 { IF {(TbreakfastBG - TMSCorr) > DTmin} AND
{MidSleep Correction > MSCorrMAX} THEN {BGgov for Basal} = MAX{
pre-breakfastBG, MidSleepBG} ELSE {BGgov for Basal} =
MIN{pre-breakfastBG, MidSleepBG} }
[0164] After determining the governing blood glucose BG.sub.gov,
the subcutaneous insulin process 900 determines the adjustment
factor AF at block 944 (see. FIG. 8). The adjustment factor process
800, returns the adjustment factor AF as a function of the
governing blood glucose BG.sub.gov. The subcutaneous insulin
process 900 sends the adjustment factor AF to block 946, where the
subcutaneous insulin process 900 determines the adjustment to the
patient's insulin dose by the following equation:
RecomBasal=(previous RecomBasal.sub.PM)*AF, (30)
and the nurse 40 give the patient 10 the Recommended basal dose
RecomsBasal at block 948.
[0165] In some implementations, where the patient 10 receives
multiple Basal doses per day, the subcutaneous insulin process 900
provides the patient 10 with equal doses each time. Therefore, the
recommended basal doses RecomBasal for a full day are equal to the
first recommended basal dose of Eq. 30. This makes it possible to
administer the morning Basal dose RecomBasal immediately after the
Breakfast BG has been tested.
[0166] For meal Bolus adjustments, the adjustment is applied to the
meal bolus of the same meal of the previous day (known as the
Governing Meal Bolus MB.sub.gov). An equivalent statement is that
the next day's meal bolus is the adjustment applied to the current
meal bolus. The adjustment is based on the Governing Blood Glucose
BG.sub.gov, which is the next scheduled blood glucose BG, following
the Governing Meal Bolus MB.sub.gov. The adjustment value is
determined by the Adjustment Factor process 800 (FIG. 8), whose
input is the Governing Blood Glucose BG.sub.gov and whose output is
the adjustment factor AF. The adjustment factor AF is multiplied by
the Governing Meal Bolus MB.sub.gov to obtain the adjusted
Recommended Meal Bolus RecMealBol.
[0167] If either the governing blood glucose BG.sub.gov or the
governing meal bolus MB.sub.gov is missing, then the previous day's
Recommended Meal Bolus RecMealBol.sub.prev is kept in place.
[0168] The SubQ process 900 is designed with three meals during the
day, Breakfast, Lunch, Dinner. Considering the lunch as the meal,
after the blood glucose BG is manually entered at block 902, the
SubQ process 900, at block 908, determines that the blood glucose
type, BG.sub.type is lunch, i.e., BG.sub.Lunch. the SubQ process
900, at block 918 determines the correction dose based on the
following equation (based on EQ. 2):
CB.sub.Lunch=(BG.sub.Lunch-BG.sub.Target)/CF, (31)
[0169] Once the SubQ process 900 determines the correction dose,
the dose is displayed on the display 114, 146 so that the nurse 40
can administer the dose to the patient 10 as soon as possible.
[0170] The current Recommended Lunch Bolus is available at block
962; it has been available since the previous day's Dinner BG. This
current Recommended Lunch Bolus is displayed on the display, and
the nurse gives the Lunch Bolus RecLunchBol.sub.Current at block
926. The SubQ process 900 does not determine a new recommended dose
until the Dinner blood glucose is tested at block 910. Then the
dinner blood glucose BG serves as the BG.sub.gov for the Lunch
Bolus and the SubQ process sends the BG.sub.gov to block 932, which
is the input/output box of the adjustment factor process 800. The
adjustment factor process 800 returns the adjustment factor
parameter AF, which is in turn sent to block 938. At block 938, the
process determines the Next Recommended Lunch Bolus,
RecLunchBol.sub.Next based on the following equation:
RecLunchBol.sub.Next=RecLunchBol.sub.Current*AF (32)
[0171] The other meals, Breakfast and Dinner follow the same
pattern as the example of Lunch set forth above.
[0172] Considering dinner as the meal, after the blood glucose BG
is manually entered at block 902, the SubQ process 900, at block
910, determines that the blood glucose type, BG.sub.type is dinner.
The SubQ process 900, at block 920 determines the correction dose
based on the following equation (based on EQ. 2):
CB.sub.Dinner=(BG.sub.Dinner-BG.sub.Target)/CF, (33)
[0173] Once the SubQ process 900 determines the correction dose,
the dose is displayed on the display 116, 146 so that the nurse 40
can administer the dose to the patient 10 as soon as possible.
[0174] The current Recommended Dinner Bolus
RecDinnerBolus.sub.Current is available at block 962; it has been
available since the previous day's Bedtime blood
glucose.sub.Bedtime. This current Recommended Dinner Bolus is
displayed on the display, and the nurse gives the patient 10 the
recommended Dinner Bolus RecDinnerBolus.sub.current at block 928.
The SubQ process 900 does not determine a new recommended dose
RecomBolus until the bedtime blood glucose is tested at block 912.
Then the bedtime blood glucose BG serves as the BG.sub.gov for the
dinner Bolus and the SubQ process sends the BG.sub.gov to block
934, which is the input/output box of the adjustment factor process
800. The adjustment factor process 800 returns the adjustment
factor parameter AF, which is in turn sent to block 940. At block
940, the process 900 determines the Next recommended Dinner Bolus
RecDinnerBolus.sub.Next based on the following equation:
RecDinnerBolusNext=RecDinnerBolus.sub.Current*AF (34)
[0175] When the SubQ process 900 determines that the blood glucose
BG type BG.sub.type is bedtime BG.sub.Bedtime (i.e., the blood
glucose BG is taken at bedtime) at block 912, the SubQ process 900
determines at block 922 the correction dose (based on EQ. 2):
CB.sub.Bedtime=(BG.sub.Bedtime-BG.sub.Target)/CF, (35)
[0176] As previously mentioned, the SubQ process 900 is
configurable to add additional blood glucose BG measurements having
blood glucose type BG.sub.type of miscellaneous, as shown in block
956. The SubQ process 900 determines a correction dose at block
958.
RecMiscBolus.sub.Next=(RecMiscBolus.sub.Current)*AF (36)
[0177] FIG. 10 shows the SubQ for Tube-Fed Patients process 1000
for critically ill patients who are ordered nil per os (NPO), which
means that oral food and fluids are withheld from the patient 10.
This process 1000 is designed specifically for patients 10 who are
receiving a nutrition formula via a tube to the stomach or
intravenous TPN (total parenteral nutrition). TPN is when the
patient 10 is only receiving nutritional benefits intravenously.
Neither TPN nor Tube-Fed patients require meal boluses because they
are not eating meals. Instead, they are given equal boluses of
Rapid-Acting insulin at equally-spaced scheduled times around the
clock to meet the continuous insulin needs of their continuous
tube-feeding or TPN nutrition; these boluses are called
Equal-Boluses (EqBolus).
[0178] SubQ for Tube-Fed Patients process 1000 allows the nurse or
doctor 40 to divide the day into equal intervals, via the display
110, 140. In addition, the nurse or doctor 40 can choose the number
of scheduled blood glucose measurements BG per day, which equals
the number of intervals per day. Each interval includes a scheduled
blood glucose measurement BG and an Equal-Bolus EqBolus. The
scheduled blood glucose times are: Tsched1; Tsched2; Tsched3 . . .
etc., with associated blood glucoses BG1; BG2; BG3 . . . etc. The
SubQ for Tube-Fed Patients process 1000 displays the time and BG
number of the next-scheduled blood glucose, via the display 110,
140 at block 1040. Optionally, the SubQ for Tube-Fed Patients
process 1000 may employ a countdown timer 1050 to obtain the blood
glucose measurements BG at the proper times.
[0179] To prevent the BG schedule from "migrating around the
clock-face", the following method is used: The SubQ for Tube-Fed
Patients process 1000 determines if the time at which the blood
glucose BG was measured BG.sub.Time falls within one of the
intervals listed above. If so, then the countdown timer 1050 is set
to time-out on the next scheduled blood glucose time Tsched1,
Tsched2, Tsched3, . . . etc. Each interval is configured with a
start time margin (M.sub.Start) and an end time margin (M.sub.End).
The SubQ for Tube-Fed Patients process 1000 may be summarized as
follows:
IF
[(T.sub.sched1-M.sub.Start)<BG.sub.Time<=(T.sub.sched1+M.sub.End-
)]; THEN Set countdown timer to time-out at T.sub.sched2; IF
[(T.sub.sched2-M.sub.Start)<BG.sub.Time<=(T.sub.sched2+M.sub.End)];
THEN Set countdown timer to time-out at T.sub.sched3 . . . and so
on. In some examples, where there are four intervals configured,
then the last interval's logic is as follows: IF
[(T.sub.sched4-M.sub.Start)<BG.sub.Time<=(T.sub.sched4+M.sub.End)];
THEN Set countdown timer to time-out at T.sub.sched1.
[0180] In some implementations, the SubQ for Tube-Fed Patients
process 1000 provides two blood glucose schedule plans: Six blood
glucose BG tests per day; or four blood glucose BG tests per day.
The nurse or doctor 40 can select which one to use for a specific
patient 10. The first blood glucose plan for six blood glucose
measurements per day includes the following details: each scheduled
blood glucose measurement is four hours apart from the next, e.g.,
00:00, 04:00, 08:00, 12:00, 16:00, and 20:00, with a start margin
M.sub.start of 2 hours and an end margin M.sub.end of 2 hours. If a
blood glucose measurement BG falls within the interval (i) from
{T.sub.sched(i)-2 hrs} to {T.sub.sched(i)+2 hrs} the Countdown
Timer is set to expire on the next scheduled time, T.sub.sched
(i+1).
[0181] The second blood glucose plan for four blood glucose
measurements per day is shown in FIG. 10. FIG. 10 further shows a
miscellaneous blood glucose measurement that is not scheduled. The
blood glucose measurements are each scheduled six hours apart from
the next at 00:00, 06:00, 12:00, and 18:00, with a start margin
M.sub.start of 4 hours and an end margin M.sub.end of 2 hours. If a
the blood glucose measurement falls within the interval (i) from
{T.sub.sched(i)-4 hrs} to {T.sub.shed(i)+2 hrs} the Countdown Timer
is set to expire on the next scheduled BG T.sub.sched(i+1). All
four of the blood glucose BG tests.
TABLE-US-00008 TABLE 3 Blood Glucose Measurement every 6 hours
Start Margin (M.sub.Start) 4 hours End Margin (M.sub.End) 2 hours
T.sub.sched1 00:00 T.sub.sched2 06:00 T.sub.sched3 12:00
T.sub.sched4 18:00
[0182] The SubQ for Tube-Fed Patients process 1000 starts with a
manual blood glucose measurement BG entry accompanied by the blood
glucose measurement time BG.sub.Time at block 1002. At block 1080,
an interactive popup asks the user if the blood glucose is a
"Scheduled BG" or a miscellaneous (`Misc") blood glucose test that
is not scheduled. If the user chooses "Misc", then the SubQ for
Tube-Fed Patients process 1000, at block 1012, assigns a value of
"Misc" to the field BGype and records the date-time stamp
("Recorded time"). At block 1030, the SubQ for Tube-Feeding process
1000 determines a correction dose CB for the manual blood glucose
measurement, using EQ. 2. The SubQ for Tube-Feeding process 1000
displays the correction dose CB on the display 116, 146, to the
patient 10, nurse and doctor 40 at block 1040 and stores the value
in non-transitory memory 24, 114, 144 at block 1042.
[0183] Returning to block 1080, if the user chooses "Scheduled BG",
the SubQ for Tube-Fed Patients process 1000 determines, at block
1004, if the blood glucose time BG.sub.Time is within the interval
from (T.sub.sched1-M.sub.start) to (T.sub.sched1+M.sub.End). If the
blood glucose measurement time BG.sub.Time is within the interval,
i.e., (T.sub.sched1-M.sub.Start)<BG.sub.Time
(T.sub.sched1+M.sub.End), then the SubQ for Tube-Fed Patients
process 1000, at block 1014, assigns the value "BG1" to the field
BGtype, resets the countdown timer to T.sub.sched 2 and displays a
reminder of the next BG time on the display 116, 146 at block 1040.
Then, the SubQ for Tube-Fed Patients process 1000, at block 1022,
determines the correction dose CB based on the blood glucose value
BG1, using EQ. 2:
CB=(BG-BG.sub.Target)/CF (2)
or using the Correction Dose Function, process 700. The SubQ for
Tube-Feeding process 1000 displays the correction dose CB on the
display 116, 146, to the patient 10, nurse and doctor 40 at block
1040 and stores the value in non-transitory memory 24, 114, 144 at
block 1042. Additionally, the SubQ for Tube-Fed Patients process
1000, at block 1044, uses the blood glucose value BG1 as the
governing BG for adjusting the value of the four Equal-Boluses
(EqBolus). Specifically, at block 1044, the SubQ for Tube-Fed
Patients process 1000 uses the blood glucose value BG1 as the input
value BG.sub.gov for the Adjustment Factor (AF) function for
determining a value for the AF. The SubQ for Tube-Fed Patients
process 1000, at block 1046, retrieves the Previous Day's
Recommended Equal-Bolus from memory 24, 114, 144, and at block
1048, determines a new value for the Recommended Equal-Bolus (e.g.,
all four EqBolus) by multiplying the AF value from block 1044 by
the Previous Day's Recommended Equal-Bolus from block 1046. The
SubQ for Tube-Feeding process 1000 displays the Recommended
Equal-Bolus (EqBolus) on the display 116, 146, to the patient 10,
nurse and doctor 40 at block 1040 and stores the value in
non-transitory memory 24, 114, 144 at block 1042.
[0184] However, if at block 1004 the SubQ for Tube-Fed Patients
process 1000 determines that the blood glucose measurement time
BG.sub.Time is not within the interval from
(T.sub.sched1-M.sub.start) to (T.sub.sched1+M.sub.End), the SubQ
for Tube-Fed Patients process 1000 determines if the blood glucose
measurement time BG.sub.Time is within a second interval
(T.sub.sched2-M.sub.start) to (T.sub.sched2+M.sub.End) at block
1006, and if so, then the SubQ for Tube-Fed Patients process 1000
at block 1016 assigns the value "BG2" to the field BGtype, resets
the countdown timer to T.sub.sched3 and displays a reminder of the
next BG time on the display 116, 146 at block 1040. Then, the SubQ
for Tube-Fed Patients process 1000, at block 1024, determines the
correction dose CB based on the blood glucose value BG2, using EQ.
2 or using the Correction Dose Function, process 700.
[0185] The SubQ for Tube-Feeding process 1000 displays the
correction dose CB on the display 116, 146, to the patient 10,
nurse and doctor 40 at block 1040 and stores the value in
non-transitory memory 24, 114, 144 at block 1042. Additionally, the
SubQ for Tube-Fed Patients process 1000, at block 1036, uses the
blood glucose value BG2 as the governing BG for adjusting the Basal
dose. Specifically, at block 1036, the SubQ for Tube-Fed Patients
process 1000 uses the blood glucose value BG2 as the input value
BGgov for the Adjustment Factor (AF) function for determining a
value for the AF.
[0186] The SubQ for Tube-Fed Patients process 1000, at block 1056,
retrieves the last Basal dose of the previous day RecBasal.sub.Last
from memory 24, 114, 144, and at block 1058, determines a current
day's Recommended Basal Dose RecBasal by multiplying the AF value
by the RecBasal.sub.Last, as follows:
RecBasal=(RecBasal.sub.Last)*AF (37)
The SubQ for Tube-Feeding process 1000 displays the RecBasal on the
display 116, 146, to the patient 10, nurse and doctor 40 at block
1040 and stores the value in non-transitory memory 24, 114, 144 at
block 1042.
[0187] However, if at block 1006 the SubQ for Tube-Fed Patients
process 1000 determines that the blood glucose measurement time
BG.sub.Time is not within the interval from
(T.sub.sched2-M.sub.Start) to (T.sub.sched2+M.sub.End), the SubQ
for Tube-Fed Patients process 1000 determines if the blood glucose
measurement time BG.sub.Time is within a third interval
(T.sub.sched3-M.sub.start) to (T.sub.sched3+M.sub.End) at block
1008, and if so, then the SubQ for Tube-Fed Patients process 1000
at block 1018 assigns the value "BG3" to the field BGtype, resets
the countdown timer to T.sub.sched4 and displays a reminder of the
next BG time on the display 116, 146 at block 1040. Then, the SubQ
for Tube-Fed Patients process 1000, at block 1026, determines the
correction dose CB based on the blood glucose value BG3, using EQ.
2 or using the Correction Dose Function, process 700.
[0188] However, if at block 1008 the SubQ for Tube-Fed Patients
process 1000 determines that the blood glucose measurement time
BG.sub.Time is not within the interval from
(T.sub.sched3-M.sub.Start) to (T.sub.sched3+M.sub.End), the SubQ
for Tube-Fed Patients process 1000 determines if the blood glucose
measurement time BG.sub.Time is within a fourth interval
(T.sub.sched4-M.sub.start) to (T.sub.sched4+M.sub.End) at block
1010, and if so, then the SubQ for Tube-Fed Patients process 1000
at block 1020 assigns the value "BG4" to the field BGtype, resets
the countdown timer to T.sub.sched1 and displays a reminder of the
next BG time on the display 116, 146 at block 1040. Then, the SubQ
for Tube-Fed Patients process 1000, at block 1028, determines the
correction dose CB based on the blood glucose value BG4, using EQ.
2 or using the Correction Dose Function, process 700.
[0189] FIG. 11 describes a SubQ Without Meal Boluses process 1100,
where the blood glucose measurements BG are deferred until after
the meals, resulting in large after-meal correction boluses that
incorporate insulin to cover the meals. The SubQ Without Meal
Boluses process 1100 divides the day into intervals that may be of
equal duration or unequal duration. Each interval includes a
scheduled blood glucose measurement BG. In some examples, the SubQ
Without Meal Boluses process 1100 includes five blood glucose
measurements BG per day. The SubQ Without Meal Boluses process 1100
may be configured to include other numbers of time intervals. In
addition, the SubQ Without Meal Boluses process 1100 includes
configurable blood glucose BG measurement times. In some examples,
the measurement schedule includes blood glucose measurements BG
places about one to three hours after regular mealtimes, which is
an appropriate timing for post-meal correction.
[0190] The scheduled Blood glucose measurement times BG times are
named with a T.sub.sched0, T.sub.sched1, T.sub.sched2 etc. The
Time-intervals are marked by Time Boundaries, named "T.sub.bound"
with numbered subscripts. These time-values are configurable. An
example of default times are shown in the following table:
TABLE-US-00009 TABLE 4 Default Times T.sub.bound0 = 0:00
BG.sub.MidSleep: T.sub.sched1 = 03:00 T.sub.bound1 = 05:00
BG.sub.Before-Breakfast: T.sub.sched2 = 07:00 T.sub.bound2 = 08:00
BG.sub.After-Breakfast: T.sub.sched3 = 10:00 T.sub.bound3 = 11:00
BG.sub.After-Lunch: T.sub.sched4 = 15:00 T.sub.bound4 = 18:00
BG.sub.Bedtime: T.sub.sched5 = 22:00
[0191] Similar to the SubQ for tube-fed patients process 1000 (FIG.
10), the SubQ Without Meal Boluses process 1100 (FIG. 11) includes
a countdown timer 1001 used to obtain the blood glucose BG tests at
the proper times.
[0192] To prevent the BG schedule from "migrating around the
clock-face", the following method is used:
[0193] The SubQ Without Meal Boluses process 1100 determines if the
time at which the blood glucose BG was measured BG.sub.Time falls
within one of the intervals. If so, then the countdown timer is set
to time-out on the next interval's scheduled blood glucose
measurement T.sub.sched1, T.sub.sched2, T.sub.sched3, . . . etc.
This can be thought of as a "snap-to-the-schedule" feature. Each
interval is configured with a start time margin (M.sub.start) and
an end time margin (M.sub.End). The SubQ Without Meal Boluses
process 1100 may be summarized as follows:
IF [T.sub.bound0.ltoreq.Br.sub.Time.ltoreq.T.sub.bound1]; THEN Set
countdown timer to time-out at T.sub.sched2 IF
[T.sub.bound1<BG.sub.Time.ltoreq.T.sub.bound2]; THEN Set
countdown timer to time-out at T.sub.sched3 IF
[T.sub.bound2.ltoreq.Br.sub.Time.ltoreq.T.sub.bound3]; THEN Set
countdown timer to time-out at T.sub.sched4 IF
[T.sub.bound3.ltoreq.BG.sub.Time.ltoreq.T.sub.bound4]; THEN Set
countdown timer to time-out at T.sub.sched5 IF
[T.sub.bound4.ltoreq.BG.sub.Time.ltoreq.T.sub.bound0]; THEN Set
countdown timer to time-out at T.sub.sched1
[0194] The SubQ Without Meal Boluses process 1100 starts with a
manual blood glucose measurement BG entry accompanied by the blood
glucose measurement time BG.sub.Time at block 1102. Then at block
1104, the SubQ Without Meal Boluses process 1100 determines if the
blood glucose measurement time BG.sub.Time is within the interval
from T.sub.bound0 to T.sub.bound1. If the blood glucose measurement
time BG.sub.Time is within the interval, i.e.,
T.sub.bound0<BG.sub.Time.ltoreq.T.sub.bound1, then the SubQ
Without Meal Boluses process 1100, at block 1114, resets the
countdown timer to T.sub.sched2. Then the SubQ Without Meal Boluses
process 1100, determines a correction dose CB at block 1122, using
EQ. 2.
[0195] However, if at block 1104 the SubQ Without Meal Boluses
process 1100 determines that the blood glucose measurement time
BG.sub.Time is not within the interval from T.sub.bound0 to
T.sub.bound1, the SubQ Without Meal Boluses process 1100 determines
if the blood glucose measurement time BG.sub.Time is within a
second interval T.sub.bound1 to T.sub.bound2, and if so then the
SubQ Without Meal Boluses process 1100 at block 1116, resets the
countdown timer to T.sub.sched3 and at block 1124, determines a
correction dose CB, using EQ. 2.
[0196] However, if at block 1106 the SubQ Without Meal Boluses
process 1100 determines that the blood glucose measurement time
BG.sub.Time is not within the interval from T.sub.bound1 to
T.sub.bound2, the SubQ Without Meal Boluses process 1100 determines
if the blood glucose measurement time BG.sub.Time is within a third
interval T.sub.bound2 to T.sub.bound3 at block 1108, and if so then
the SubQ Without Meal Boluses process 1100 at block 1118, resets
the countdown timer to T.sub.sched4 and at block 1126, determines a
correction dose CB, using EQ. 2.
[0197] However, if at block 1108 the SubQ Without Meal Boluses
process 1100 determines that the blood glucose measurement time
BG.sub.Time is not within the third time interval from T.sub.bound2
to T.sub.bound3, the SubQ Without Meal Boluses process 1100
determines if the blood glucose measurement time BG.sub.Time is
within a fourth interval T.sub.bound3 to T.sub.bound4, and if so
then the SubQ Without Meal Boluses process 1100 at block 1120,
resets the countdown timer to T.sub.sched5 and at block 1128,
determines a correction dose CB, using EQ. 2.
[0198] However, if at block 1110 the SubQ Without Meal Boluses
process 1100 determines that the blood glucose measurement time
BG.sub.Time is not within the fourth time interval from
T.sub.bound3 to T.sub.bound4, the SubQ Without Meal Boluses process
1100 determines if the blood glucose measurement time BG.sub.Time
is within a fifth interval T.sub.bound4 to T.sub.bound5, and if so
then the SubQ Without Meal Boluses process 1100 at block 1130,
resets the countdown timer to T.sub.sched1 and at block 1131,
determines a correction Dose CB, using EQ. 2.
[0199] As shown, the SubQ Without Meal Boluses process 1100 repeats
itself five times since there are five scheduled blood glucose
measurement BG; however, the SubQ Without Meal Boluses process 1100
may include more or less time intervals.
[0200] The SubQ Without Meal Boluses process 1100 adjusts the basal
insulin dosage by first determining the Governing blood glucose
BG.sub.gov at block 1134. The SubQ Without Meal Boluses process
1100 determines the Governing blood glucose BG.sub.gov as the blood
glucose BG closest to 06:00 earlier on the same day as the basal
dose whose recommendation is being calculated. To insure that the
closest blood glucose BG is obtained, the basal dose is not allowed
until an elapsed time after 06:00 equal to the elapsed time from
the preceding BG until 0600. This is to insure that all opportunity
for "another BG closer to 0600" has passed.
[0201] The SubQ Without Meal Boluses process 1100 passes the
Governing blood glucose BG.sub.gov from block 1134 to block 1136,
which determines the adjustment factor AF (see FIG. 8) and passes
it to block 1138. At block 1138, the SubQ Without Meal Boluses
process 1100 determines the current day's recommended first basal
dose using the following equation:
RecBasal.sub.First=(RecBasal.sub.Last(prev))*AF, (38)
[0202] The basal dose may be one of several administered to the
patient 10 during the day, but all the doses are kept at the same
value.
[0203] The process 1000 displays the correction dose CB and the
recommended basal dose on the display 116, 146, to the patient 10,
nurse and doctor 40 at block 1140 and stores the values in
non-transitory memory 24, 114, 144 at block 1142.
[0204] Referring to FIG. 12, the Meal-by-Meal SubQ Without
Carbohydrate-counting process 1200 calculates the Recommended Meal
Bolus by employing the preceding Meal Bolus (of any type or
time-of-day) as the Governing Meal Bolus MB.sub.gov and employing
the next blood glucose following the Governing Meal Bolus as the
Governing Blood Glucose BG.sub.gov. This means BG.sub.gov is often
the current BG in real-time.
[0205] The Correction Boluses and Basal Dose adjustment are
conducted similar to the Standard SubQ process 300 (FIGS. 9A and
9B). Therefore, a correction dose is determined at blocks 1214,
1216, 1218, 1220, 1222, 1258 based on the blood glucose type.
[0206] The Meal Bolus Adjustment portion of the Meal-by-Meal SubQ
process 1200 begins with a manual blood glucose measurement BG
entry at block 1202. If the blood glucose measurement BG is
determined by block 1204 to be a blood glucose type BG.sub.type of
a Midsleep BG, then the process 900 sends the blood glucose
measurement to block 1242. If the blood glucose measurement BG is
not a blood glucose type BG.sub.type of a Midsleep BG, then
Meal-by-Meal SubQ process 1200 determines at block 1206 whether the
BG is a Breakfast blood glucose BG.sub.Breakfast. If the BG is
determined at block 1206 to be a Breakfast blood glucose
BG.sub.Breakfast, then at block 1250, the process 1200 determines
if the breakfast blood glucose BG.sub.Breakfast has been tested, if
not then the process 1200 blocks basal recommendation, and posts a
warning, displayed on the display 116, 146, to the patient 10,
nurse and doctor 40 at block 1254 and is stored in the
non-transitory memory 24, 114, 144 at block 1251. However, if the
breakfast blood glucose BG.sub.Breakfast has been tested, then the
process 1200 selects, at block 1242, the Governing blood glucose
BG.sub.gov as the lesser of the two blood glucose values, i.e., the
midsleep blood glucose BG.sub.MidSleep or the breakfast blood
glucose BG.sub.Breakfast, as shown in EQ. 28 (above).
[0207] After determining the governing blood glucose BG.sub.gov,
the process 1200 determines the adjustment factor AF at block 1244
(see. FIG. 8). The adjustment factor process 800, returns the
adjustment factor AF as a function of the governing blood glucose
BG.sub.gov. The process 1200 sends the adjustment factor AF to
block 1246, where the process 1200 determines the adjustment to the
patient's insulin dose by the following EQ. 30, then the nurse 40
give the patient 10 the Recommended basal dose RecomsBasal at block
1248.
[0208] If the Meal-by-Meal SubQ process 1200, at block 1206,
determines that the blood glucose measurement BG is not a breakfast
blood glucose measurement BG.sub.Breakfast, then it is passed to
block 1208 where a determination is made whether the blood glucose
measurement BG is a Lunch blood glucose BG.sub.Lunch. If it is a
Lunch blood glucose BG.sub.Lunch, then block 1208 routes the Lunch
BG to block 1230 where it is used as the input (BGgov) for the AF
Function. The AF Function returns a value of the Adjustment Factor
(AF), which is routed to block 1238 where the Recommended Lunch
Bolus is calculated by the following equation:
RecLunchBol=AF*RecBreakfastBol.sub.Prev (39)
[0209] The process 1200 sends the Recommended Lunch Bolus
RecLunchBolus to the remote processor at block 1254, to the display
114, 146, at block 1252, and to block 1240 for Dinner bolus
calculation.
[0210] If the blood glucose BG is determined at block 1208 to not
be a Lunch blood glucose BG.sub.Lunch, then it is routed to block
1210. If the BG is determined by block 1210 to be a Dinner blood
glucose BG.sub.Dinner, then the blood glucose BG is routed to block
1232 where it is used as the input (BG.sub.gov) for the adjustment
factor process 700. The AF Function returns a value of the
Adjustment Factor AF, which is routed to block 1240. The preceding
Recommended Lunch Bolus is available at block 1240, which has all
the necessary data to calculate the Recommended Dinner Bolus by the
following equation:
RecDinnerBol=AF*(RecLunchBolrev) (40)
[0211] The process 1200 sends the Recommended Dinner Bolus,
RecDinnerBol to the remote processor at block 1254, to the display
114, 146, block 1252, and to block 1236 for the next day's
Breakfast bolus calculation.
[0212] If the process 1200 determines the blood glucose BG at block
1210 to not be a Dinner BG, then the process 1200 routes the blood
glucose BG to block 1212. If the process 1200 determines the blood
glucose BG at block 1212 to be a Bedtime BG, then the process 1200
routes the BG to block 1234 where it is used as the input
(BG.sub.gov) for the AF Function. The AF Function returns a value
of the Adjustment Factor (AF), which is routed to block 1236. The
preceding Recommended Dinner Bolus (from the previous day) is
available at block 1236, which has all the necessary data to
calculate the Recommended Breakfast Bolus by the following
equation:
RecBreakfastBol=AF*(RecDinnerBolrev) (41)
[0213] The process 1200 sends the Recommended Breakfast Bolus to
the remote processor at block 1254, to the Subject Data Display,
block 1252, and to block 1238 for Lunch bolus calculation.
[0214] The Meal-by-Meal SubQ With Carbohydrate-counting program
calculates the Recommended Meal Bolus by dividing the carbohydrates
in the upcoming meal by CIR (Carbohydrate-to-Insulin Ratio). The
Carbohydrate-to-Insulin Ratio CIR is in the form of a single
parameter that is re-calculated at each meal and passed to the next
meal. The Governing CIR is defined as the CIR passed to the current
meal from the preceding meal. The process employs the next blood
glucose BG following the Governing CIR as the Governing BG
(BG.sub.gov). This means BG.sub.gov is often the current BG in
real-time.
[0215] The Correction Boluses and Basal Dose adjustment are
conducted similar to the Standard SubQ process 300 (FIGS. 9A and
9B). Therefore, a correction dose CB is determined at blocks 1314,
1316, 1318, 1320, 1322, 1258 based on the blood glucose type.
[0216] Referring to FIGS. 13A and 13B, the Meal Bolus Adjustment
portion of the Meal-by-Meal Process 1300 begins with a manual BG
entry at block 1302. If the process 1300 determines the blood
glucose value BG at block 1304 to not be a Midsleep BG, then the
process 1300 makes a determination at block 1306 whether the BG is
a Breakfast BG. If the process 1300 determines the blood glucose BG
at block 1308 to be a Breakfast blood glucose BG.sub.breakfast,
then at block 1350, the process 1300 determines if the breakfast
blood glucose BG.sub.Breakfast has been tested. If not, then the
process 1300 blocks basal recommendation and posts a warning,
displayed on the display 116, 146, to the patient 10, nurse, and
doctor 40 at block 1354. The process 1300 stores the warning in the
non-transitory memory 24, 114, 144 at block 1351. If, however, the
breakfast blood glucose BG.sub.Breakfast has been tested, then the
process 1300 selects, at block 1342, the Governing blood glucose
BG.sub.gov as the lesser of the two blood glucose values, i.e., the
midsleep blood glucose BG.sub.MidSleep or the breakfast blood
glucose BG.sub.Breakfast, as shown in EQ. 28 (above).
[0217] After determining the governing blood glucose BG.sub.gov,
the process 1300 determines the adjustment factor AF at block 1344
(see. FIG. 8). The adjustment factor process 800 returns the
adjustment factor AF as a function of the governing blood glucose
BG.sub.gov. The process 1300 sends the adjustment factor AF to
block 1246, where the process 1300 determines the adjustment to the
patient's insulin dose by the following EQ. 30, then the nurse 40
gives the patient 10 the Recommended basal dose RecomsBasal at
block 1348.
[0218] If the process 1300 determines the blood glucose BG at block
1306 to not be a Breakfast BG, then the process 1300 passes the
blood glucose BG to block 1308, where the process 1300 determines
whether the blood glucose BG is a lunch blood glucose BG.sub.lunch.
If the blood glucose BG is a Lunch blood glucose BG.sub.lunch, then
the process 1300, at block 1308, routes the lunch blood glucose
BG.sub.lunch to block 1330, where it is used as the input
(BG.sub.gov) for the adjustment factor AF Function. The adjustment
factor AF Function (FIG. 8) returns a value of the Adjustment
Factor AF, which is routed to block 1334 where the
Carbohydrate-to-Insulin Ratio (CIR) is calculated by the following
formula:
CIR=(CIR from Breakfast)/AF (42)
[0219] The Meal-by-Meal with Carb-Counting process 1300 routes the
Carbohydrate-to-Insulin Ratio CIR to block 1338 where the
Recommended Lunch Bolus is calculated as follows:
RecLunchBolus=(Carbohydrate gms in Lunch)/CIR (43)
[0220] The Carbohydrate-to-Insulin Ratio CIR is also sent from
block 1334 to block 1336 for use in the upcoming Dinner
calculations.
[0221] If the process 1300 determines the blood glucose BG at block
1308 to not be a lunch blood glucose BG.sub.lunch, then the process
1300 routes the blood glucose BG to block 1310. If the process 1300
determines the blood glucose BG at block 1310 to be dinner blood
glucose BG.sub.dinner, then the process 1300 routes the blood
glucose BG to block 1332, where it is used as the input
(BG.sub.gov) for the adjustment factor AF Function. The adjustment
factor AF Function returns a value of the Adjustment Factor (AF),
which the process 1300 routes to block 1336, where the
Carbohydrate-to-Insulin Ratio CIR is calculated by the following
formula:
CIR=(CIR from Lunch)/AF (44)
[0222] The Meal-by-Meal with Carb-Counting process 1300 routes the
CIR to block 1340 where the Recommended Dinner Bolus is calculated
as follows:
RecDinnerBol=(Carbohydrate gms in Dinner)/CIR (45)
[0223] The Carbohydrate-to-Insulin Ratio CIR is also sent from
block 1336 to block 1332 for use in the upcoming Breakfast
calculations. The process 1300 sends the Recommended Dinner Bolus,
RecomDinnerBol to the remote processor at block 1354, and to the
display 114, 146, block 1352.
[0224] If the process 1300 determines the blood glucose BG at block
1310 to not be a Dinner BG, then the process 1300 routes the blood
glucose BG to block 1312. If the process 1300 determines the blood
glucose BG at block 1312 to be a Bedtime BG, then the process 1300
routes the blood glucose BG to block 1330, where it is used as the
input (BGgov) for the AF Function. The AF Function returns a value
of the Adjustment Factor (AF), which is routed to block 1332, where
the Carbohydrate-to-Insulin Ratio (CIR) is calculated by the
following formula at block 1334:
CIR=(CIR from Dinner)/AF (46)
[0225] The Meal-by-Meal with Carb-Counting process 1300 routes the
CIR to block 1336 where the Recommended Breakfast Bolus is
calculated as follows:
RecBreakfastBol=(Carbohydrate gms in Breakfast)/CIR (47)
[0226] The CIR is also sent from block 1330 to block 1334 for use
in the upcoming Lunch calculations. The process 1300 sends the
Recommended Breakfast Bolus to the remote processor at block 1354,
and to the Subject Data Display at block 1352.
[0227] FIG. 14 shows a subcutaneous process 1400 for non-diabetic
patients 10 who have a temporary condition of diabetes-like
symptoms. A typical example is stress-hyperglycemia, a condition
that is encountered when the patient's body is under stress due to
surgery, certain medications, or another disease other than
diabetes. The stress causes the patient's body to react by raising
the blood glucose. As the patient recovers, this hyperglycemic
condition typically disappears, sometimes rapidly, leaving the
patient without need of insulin. The principle of the process is to
rapidly reduce the entire insulin dosing regimen of the patient by
a factor NonDMfactor, whenever a blood glucose measurement BG falls
below a threshold.
[0228] The Non-DM process 1400 begins at block 1402 with a blood
glucose measurement BG. The process 1400 determines at block 1460
if the blood glucose BG is below a threshold for insulin reduction
NonDMfloor. If the blood glucose BG is less than the values of the
last recommended NonDMfloor, the process 1400 reduces, at block
1462, the value of all the last-recommended insulin doses in a
table at block 1463, by multiplying each value by a dimensionless
configurable constant whose value is between 0 and 1, threshold for
insulin reduction NonDMfactor. The group at block 1463 includes the
last-recommended-doses such as Breakfast Bolus BG.sub.Breakfast,
Lunch Bolus BG.sub.Lunch, Dinner Bolus BG.sub.Dinner, and Basal
Dose, irrespective of whether the dose has been given or not. In
other words, the latest recommendation (or prescribed dose) is
changed whether a dose was given or not. In many implementations,
the threshold for insulin reduction NonDMfactor is configured to a
value of 0.5.
[0229] Corrective insulin may also be reduced. This is accomplished
by raising the Correction Factor CF as follows: Returning to block
1462, the logic is passed to block 1464, where a value of Total
Daily Dose of Insulin TDD is recalculated each time the dose is
reduced. This is accomplished by summing all the newly-reduced
values of the last recommended values of meal boluses and basal
doses. The process 1400 passes the TDD to block 1466, where a live
Correction Factor is calculated as follows:
CF=CFR/TDD (46)
[0230] Returning to block 1402, the process 1400 routes the blood
glucose BG to block 1404 where the process 1400 determines if the
blood glucose type BG.sub.type is MidSleep BG.sub.Midsleep. If so,
then the process 1400 routes the MidSleep blood glucose
BG.sub.Midsleep to block 1442. If it is determined at block 1405
that the blood glucose type BG.sub.type is not MidSleep, the logic
is passed to block 1406, where it is determined if the blood
glucose type BG.sub.type is Breakfast BG.sub.Breakfast. If the
blood glucose type BG.sub.type is Breakfast BG.sub.Breakfast, the
process 1400 calculates a Correction dose CB at block 1416 and is
administered as soon as possible. Also, if blood glucose type
BG.sub.type is Breakfast BG.sub.Breakfast, the logic is passed to
box 1424, where the previously-recommended Breakfast meal bolus is
administered. The value of this previously-recommended Breakfast
meal bolus is passed to block 1436, where it is one of the two
required parameters for calculation of the Next Recommended
Breakfast Bolus. Returning to block 1406, the process 1400 routes
the Breakfast BG to box 1450.
[0231] The condition at block 1450 is that the administration of
basal is blocked by not-posting the recommended Basal dose until
the arrival of the breakfast blood glucose BG.sub.Breakfast from
block 1406, where the breakfast blood glucose BG.sub.Breakfast is
sent to block 1442. At block 1442, the process 1400 determines the
governing blood glucose BG.sub.gov for Basal adjustment as the
lesser of the two blood glucose values, midsleep blood glucose
BG.sub.Midsleep and breakfast blood glucose BG.sub.Breakfast. At
block 1444, the process 1400 inputs the governing blood glucose
BG.sub.gov for Basal into the Adjustment Factor AF Function (FIG.
7), which returns an Adjustment Factor AF for basal adjustment. The
process 1400 sends the adjustment factor AF to block 1446, where it
is used to calculate the Recommended First Basal Dose of the day by
the formula:
Recommended first Basal Dose=AF*(Previous day's last Basal Dose)
(48)
[0232] Basal dosing is adjusted only once per day, because a
fasting blood glucose BG is needed as the governing blood glucose
BG.sub.gov, and the midsleep blood glucose BG.sub.Midsleep and
breakfast blood glucose BG.sub.Breakfast BG are the only reliable
fasting blood glucose measurements BG during the day. If more than
one basal dose is used, then the values are set to be equal to the
first basal dose of the day. The last basal dose of the day is used
as the Governing Basal Dose because it is the most recent dose at
the time of the midsleep blood glucose BG.sub.Midsleep and B
breakfast blood glucose BG.sub.Breakfast.
[0233] If the process 1400 determines at block 1406 that the Blood
Glucose type BG.sub.type is not Breakfast, the logic passes to
block 1408, where the process 1400 determines if the BG.sub.type is
Lunch. If the BG.sub.type is Lunch, the process 1400 calculates a
Correction dose CB at block 1418, which is administered as soon as
possible. Also, the logic passes to box 1426, where the
previously-recommended Lunch meal bolus is administered. The
process 1400 passes the value of this previously-recommended Lunch
meal bolus to block 1438, where it is one of the two required
parameters for calculation of the Next Recommended Lunch Bolus.
Returning to block 1408, the process 1400 also routes the lunch
blood glucose BG.sub.lunch to block 1430, providing the second of
the two required parameters for calculation of the Next Recommended
Breakfast Bolus as follows:
Next Recom. Breakfast Bolus=AF*(Current Recom Breakfast Bolus)
(49)
[0234] If it is determined at block 1408 that BG.sub.type is not
Lunch, the logic passes to block 1410, where the process 1400
determines if the BG.sub.type is Dinner. If the BG.sub.type is
Dinner, the process 1400 calculates a Correction dose at block
1420, which is administered as soon as possible. Also, the logic is
passes to box 1428, where the previously-recommended Dinner meal
bolus is administered. The value of this previously-recommended
Dinner meal bolus is passed to box 1440, where is one of the two
required parameters for calculation of the Next Recommended Dinner
Bolus. Returning to block 1410, the process 1400 also routes the
Dinner blood glucose BG.sub.Dinner to block 1432, providing the
second of the two required parameters for calculation of the Next
Recommended Lunch Bolus as follows:
Next Recom. Lunch Bolus=AF*(Current Recom Lunch Bolus) (50)
[0235] If it is determined at block 1410 that BGtype is not Dinner,
the logic passes to block 1412, where the process 1400 determines
if the BG.sub.type is Bedtime. If the