U.S. patent application number 15/072408 was filed with the patent office on 2016-07-14 for system and method for integration of insulin pumps and continuous glucose monitoring.
The applicant listed for this patent is Tandem Diabetes Care, Inc.. Invention is credited to Shaun Buchanan, Jason Farnan, Michael Rosinko, Sean Saint.
Application Number | 20160199571 15/072408 |
Document ID | / |
Family ID | 51530706 |
Filed Date | 2016-07-14 |
United States Patent
Application |
20160199571 |
Kind Code |
A1 |
Rosinko; Michael ; et
al. |
July 14, 2016 |
SYSTEM AND METHOD FOR INTEGRATION OF INSULIN PUMPS AND CONTINUOUS
GLUCOSE MONITORING
Abstract
A portable insulin pump can integrate and display data from a
continuous glucose monitor (CGM) to allow a user to more readily
determine whether any interaction with the pump is necessary. Data
from the CGM can automatically be transmitted to the pump and can
be displayed for user analysis or automatically analyzed to present
recommendations to the user based on combined data from the CGM and
the pump.
Inventors: |
Rosinko; Michael; (Anaheim,
CA) ; Saint; Sean; (San Diego, CA) ; Farnan;
Jason; (San Diego, CA) ; Buchanan; Shaun;
(Carlsbad, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Tandem Diabetes Care, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
51530706 |
Appl. No.: |
15/072408 |
Filed: |
March 17, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13800453 |
Mar 13, 2013 |
|
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15072408 |
|
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Current U.S.
Class: |
604/151 |
Current CPC
Class: |
A61M 2230/201 20130101;
A61M 2205/505 20130101; A61M 2205/52 20130101; A61M 2205/8206
20130101; A61M 5/14244 20130101; A61M 2205/502 20130101; G06F
19/3468 20130101; G16H 20/17 20180101; A61M 5/1723 20130101 |
International
Class: |
A61M 5/142 20060101
A61M005/142; A61M 5/172 20060101 A61M005/172 |
Claims
1. A portable insulin pump, comprising: a graphical user interface;
a receiver adapted to receive information from a continuous glucose
monitor; and a processor functionally linked to the receiver to
obtain the information from the continuous glucose monitor and to
the graphical user interface to control display of information on
the graphical user interface, wherein the processor is configured
to automatically display a startup screen on the graphical user
interface when the graphical user interface is activated from an
inactive condition, the startup screen including: a current glucose
level of a user based off of the information received from the
continuous glucose monitor; historical data relating to the glucose
level of the user based off of the information received from the
continuous glucose monitor; and an estimate of the amount of
un-metabolized insulin remaining in the user's body.
2. The portable insulin pump of claim 1, wherein the historical
data is presented in a graphical format illustrating glucose levels
of the user over time.
3. The portable insulin pump of claim 2, wherein the startup screen
further includes a timeframe object that is selectable to set the
timeframe over which the historical data is displayed.
4. The portable insulin pump of claim 1, further comprising a
battery that powers the processor and a reservoir that contains
insulin for delivery to the user, and the startup screen further
includes at least one of a battery life indicator indicating a
remaining life of the battery and a reservoir level indicator
indicating a remaining amount of insulin in the reservoir
5. The portable insulin pump of claim 1, wherein the startup screen
further includes a bolus object, the bolus object selectable to
initiate delivery of an insulin bolus.
6. The portable insulin pump of claim 5, wherein the processor is
further configured to, upon selection of the bolus object, display
an unlock screen requiring a user to unlock the graphical user
interface to initiate delivery of the insulin bolus.
7. The portable insulin pump of claim 1, wherein the graphical user
interface includes a touch sensitive screen on which the startup
screen is displayed.
8. The portable insulin pump of claim 1, wherein activating the
graphical user interface from an inactive condition includes
turning the graphical user interface on and activating the
graphical user interface from a sleep mode.
9. The portable insulin pump of claim 1, wherein the processor is
further configured to display the startup screen when no commands
have been entered into the graphical user interface for a
predetermined period of time.
10. A graphical user interface for a portable insulin pump, the
graphical user interface adapted to display a startup screen when
the graphical user interface is activated from an inactive
condition, the startup screen including: a current glucose level of
a user based off of information received from a continuous glucose
monitor; historical data relating to the glucose level of the user
based off of the information received from the continuous glucose
monitor; and an estimate of the amount of un-metabolized insulin
remaining in the user's body.
11. The graphical user interface of claim 10, wherein the
historical data is presented in a graphical format illustrating
glucose levels of the user over time.
12. The graphical user interface of claim 10, wherein the startup
screen further includes a timeframe object that is selectable to
set the timeframe over which the historical data is displayed.
13. The graphical user interface of claim 10, wherein the startup
screen further includes at least one of a battery life indicator
indicating a remaining life of a battery and a reservoir level
indicator indicating a remaining amount of insulin in a
reservoir.
14. The graphical user interface of claim 10, wherein the startup
screen further includes a bolus object, the bolus object selectable
to initiate delivery of an insulin bolus.
15. The graphical user interface of claim 14, wherein the startup
screen is configured to, upon selection of the bolus object,
display an unlock screen requiring a user to unlock the graphical
user interface to initiate delivery of the insulin bolus.
16. The graphical user interface of claim 10, comprising a touch
sensitive screen on which the startup screen is displayed.
17. The graphical user interface of claim 10, wherein activating
the graphical user interface from an inactive condition includes
turning the graphical user interface on and activating the
graphical user interface from a sleep mode.
18. A portable insulin pump, comprising: a user interface; a
receiver adapted to receive information related to a glucose level
of a user from a continuous glucose monitor; and a processor
functionally linked to the receiver to obtain the information from
the continuous glucose monitor and to the user interface to control
display of information on the user interface, wherein the processor
is configured to: receive a current blood glucose level of the user
from the continuous glucose monitor; determine whether the current
blood glucose level is above a threshold; and if the current blood
glucose level is above the threshold, automatically calculate a
bolus of insulin to bring the user's blood glucose level below the
threshold and present the bolus to the user on the user interface
as a recommended correction bolus.
19. The portable insulin pump of claim 18, wherein the processor is
further configured to: receive a confirmation from the user; and
deliver the recommended correction bolus in response to the
confirmation.
20. The portable insulin pump of claim 18, wherein the user
interface is a graphical user interface including a touch sensitive
screen on which the recommended correction bolus is displayed.
Description
RELATED APPLICATION
[0001] This application is a continuation of application Ser. No.
13/800,453 filed Mar. 13, 2013, which is hereby fully incorporated
herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to ambulatory infusions pumps
and, more particularly, to integrating features of continuous
glucose monitoring with insulin pumps.
BACKGROUND
[0003] There are many applications in academic, industrial, and
medical fields that benefit from devices and methods that are
capable of accurately and controllably delivering fluids, such as
liquids and gases that have a beneficial effect when administered
in known and controlled quantities. Such devices and methods can be
particularly useful in the medical field where treatments for many
patients include the administration of a known amount of a
substance at predetermined intervals.
[0004] Insulin-injecting pumps have been developed for the
administration of insulin for those suffering from both type I and
type II diabetes. Recently, continuous subcutaneous insulin
injection and/or infusion therapy with portable infusion devices
has been adapted for the treatment of diabetes. Such therapy may
include the regular and/or continuous injection or infusion of
insulin into the skin of a person suffering from diabetes and offer
an alternative to multiple daily injections of insulin by an
insulin syringe or an insulin pen. Such pumps can be
ambulatory/portable infusion pumps that are worn by the user and
may use replaceable cartridges. Examples of such pumps and various
features that can be associated with such pumps include those
disclosed in U.S. patent application Ser. No. 13/557,163, U.S.
patent application Ser. No. 12/714,299, U.S. patent application
Ser. No. 12/538,018, U.S. Provisional Patent Application No.
61/655,883, U.S. Provisional Patent Application No. 61/656,967 and
U.S. Pat. No. 8,287,495, each of which is incorporated herein by
reference.
[0005] Portable insulin pumps can be used in conjunction with
continuous glucose monitoring (CGM) devices. A CGM provides a
substantially continuous estimated blood glucose level through a
transcutaneous sensor that measures analytes, such as glucose, in
the patient's interstitial fluid rather than their blood. CGM
systems typically consist of a transcutaneously-placed sensor, a
transmitter and a monitor. A CGM system allows a patient or
caregiver to insert a single sensor probe under the skin for
multiple days. Thus, the patient is only required to perform a
single moderately invasive action with a single entry point in the
subdermal layer on, e.g., a weekly basis.
[0006] Ambulatory insulin infusion pumps typically allow the
patient or caregiver to adjust the amount of insulin delivered, by
a basal rate or a bolus, based on blood glucose data obtained by a
blood glucose meter or CGM. Some ambulatory insulin infusion pumps
may include the capability to interface with a BGM or CGM such as,
e.g., by receiving measured or estimated blood glucose levels and
prompting the user to adjust the level of insulin being
administered or planned for administration or, in cases of
abnormally high blood glucose readings, prompting temporary
cessation of insulin administration. These portable pumps may
incorporate a BGM or CGM within the hardware of the pump or may
communicate with a dedicated BGM or CGM via, wired or wireless data
communication protocols. Such pumps may be particularly important
in facilitating patient compliance and improved or more accurate
treatment of diabetes. The delivery of insulin from a portable
insulin pump making use of CGM data necessitates accurate and
reliable CGM data output.
[0007] Generally, when CGM devices are used in conjunction with
insulin pumps, the CGM device has a separate display from the
insulin pump and the user must manually transfer data from the CGM
to the pump in order for the pump to incorporate the data into its
functioning. Even in instances where the pump can automatically
receive CGM data, such as through a wireless connection, or
incorporates the CGM in the pump, a user often must scroll through
a number of screens of the pump to review the pump and CGM data and
make a determination as to whether and how the data indicates that
the user should activate the pump.
[0008] Therefore, there is a need for a system and a method for
better integrating usage of CGM devices and data with insulin
pumps.
SUMMARY OF THE INVENTION
[0009] A portable insulin pump can integrate and display data from
a continuous glucose monitor (CGM) to allow a user to more readily
determine whether any interaction with the pump is necessary. A
screen of the pump, which can be a startup screen automatically
displayed whenever the pump is turned on or activated from a sleep
mode, can display a current glucose level of the user and
historical glucose data obtained from the CGM as well as an
estimate of the amount of un-metabolized insulin remaining in the
user's body. This information allows the user to immediately assess
whether any action needs to be taken with the pump, such as to
deliver a bolus, without having to scroll through multiple pages
and options to obtain the necessary information.
[0010] In an embodiment, a portable insulin pump includes a
graphical user interface, a receiver adapted to receive information
from a continuous glucose monitor and a processor functionally
linked to the receiver and the graphical user interface. The
processor can be configured to display a startup screen on the
graphical user interface when the graphical user interface is
activated from an inactive condition, such as being turned off or
in sleep mode. The startup screen can display a current glucose
level of a user and historical glucose level data based off of
information received from the CGM at the receiver. The startup
screen can also display an estimate of the amount of un-metabolized
insulin remaining in the user's body.
[0011] In another embodiment, a portable insulin pump can integrate
with a continuous glucose monitor to automatically calculate a
recommended bolus for a user. When the user uses a blood sample to
calibrate the CGM with an actual blood glucose reading, the CGM can
automatically transmit that blood glucose value to the pump. The
pump can then determine whether that value is above a threshold
and, if so, automatically calculate a bolus of insulin to bring the
user's blood glucose level below the threshold.
[0012] Certain embodiments are described further in the following
description, examples, claims, and drawings. These embodiments will
become more apparent from the following detailed description when
taken in conjunction with the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective view of an infusion pump according
to an embodiment of the present invention.
[0014] FIG. 2 is a block diagram representing an embodiment of an
infusion pump.
[0015] FIG. 3 depicts a screen shot of a home screen page of a
graphical user interface of an infusion pump according to an
embodiment of the present invention.
[0016] FIG. 4 is a partial schematic view depicting a continuous
glucose monitor according to an embodiment of the present invention
deployed on a patient.
[0017] FIG. 5 depicts a screen shot of a screen page of a graphical
user interface of an infusion pump according to an embodiment of
the present invention.
[0018] FIG. 6 depicts a screen shot of an unlock screen of a
graphical user interface of an infusion pump according to an
embodiment of the present invention.
[0019] FIG. 7 depicts a screen shot of a bolus recommendation
screen of a graphical user interface of an infusion pump according
to an embodiment of the present invention.
[0020] FIG. 8 is a flowchart of a method of recommending a
correction bolus according to an embodiment of the present
invention.
DETAILED DESCRIPTION
[0021] Provided herein are systems, devices and methods for
integrating usage of ambulatory infusion pumps with continuous
glucose monitoring devices. Some embodiments may include advances
in the internal components, the control circuitry, and improvements
in a user interface of the systems and devices. The advances may
allow for a safer and more accurate delivery of medicament to a
patient than is currently attainable today from other devices,
systems, and methods. Although embodiments described herein may be
discussed in the context of the controlled delivery of insulin,
delivery of other medicaments, including, for example, glucagon,
pramlintide, etc., as well as other applications are also
contemplated. Device and method embodiments discussed herein may be
used for pain medication, chemotherapy, iron chelation,
immunoglobulin treatment, dextrose or saline IV delivery, or any
other suitable indication or application. Non-medical applications
are also contemplated.
[0022] FIG. 1 depicts an embodiment of a pump 12 such as an
infusion pump that can include an internal pumping or delivery
mechanism and reservoir for delivering medicament such as insulin
to a patient and an output/display 44. The type of output/display
44 may vary as may be useful for a particular application. The type
of visual output/display may include LCD displays, LED displays,
plasma displays, OLED displays and the like. The output/display 44
may also be an interactive or touch sensitive screen 46 having an
input device such as, for example, a touch screen comprising a
capacitive screen or a resistive screen. The pump 12 may
additionally include a keyboard or other input device known in the
art for data entry, which may be separate from the display. The
output/display 44 of the pump 12 may also include a capability to
operatively couple to a secondary display device such as a laptop
computer, mobile communication device such as a smartphone or
personal digital assistant (PDA) or the like. Further details
regarding such pump devices can be found in U.S. Patent Application
No. 2011/0144586, which is incorporated herein by reference.
[0023] FIG. 2 illustrates a block diagram of some of the features
that may be incorporated within the housing 26 of the pump 12. The
pump 12 includes a processor 42 that functions to control the
overall functions of the device. The infusion pump 12 may also
include a memory device 30, a transmitter/receiver 32, an alarm 34,
a speaker 36, a clock/timer 38, an input device 40, the processor
42, a user interface suitable for accepting input and commands from
a user such as a caregiver or patient, a drive mechanism 48, and an
estimator device 52. One embodiment of a user interface as shown in
FIG. 2 is a graphical user interface (GUI) 60 having a touch
sensitive screen 46 with input capability. The memory device 30 may
be coupled to the processor 42 to receive and store input data and
to communicate that data to the processor 42. The input data may
include user input data and non-user/sensor input data. The input
data from the memory device 30 may be used to generate therapeutic
parameters for the infusion pump 12. The GUI 60 may be configured
for displaying a request for the user to input data and for
receiving user input data in response to the request, and
communicating that data to the memory.
[0024] The processor 42 may communicate with and/or otherwise
control the drive mechanism, output/display, memory, a
transmitter/receiver and other components. In some embodiments, the
processor 42 may communicate with a processor of another device,
for example, a continuous glucose monitor (CGM), through the
transmitter/receiver. The processor 42 may include programming that
can be run to control the infusion of insulin or other medicament
from the cartridge, the data to be displayed by the display, the
data to be transmitted via the transmitter, etc. The processor 42
may also include programming that may allow the processor to
receive signals and/or other data from an input device, such as a
sensor that may sense pressure, temperature or other parameters.
The processor 42 may determine the capacity of the drug delivery
reservoir and/or the volume of fluid disposed in the drug delivery
reservoir and may set therapeutic parameters based on its
determination.
[0025] The processor 42 may also include additional programming to
allow the processor 42 to learn user preferences and/or user
characteristics and/or user history data. This information can be
utilized to implement changes in use, suggestions based on detected
trends, such as, weight gain or loss. The processor can also
include programming that allows the device to generate reports,
such as reports based upon user history, compliance, trending,
and/or other such data. Additionally, infusion pump device
embodiments of the disclosure may include a "power off" or
"suspend" function for suspending one or more functions of the
device, such as, suspending a delivery protocol, and/or for
powering off the device or the delivery mechanism thereof. For some
embodiments, two or more processors may be used for controller
functions of the infusion pumps, including a high power controller
and a low power controller used to maintain programming and pumping
functions in low power mode, in order to save battery life.
[0026] The memory device 30 may be any type of memory capable of
storing data and communicating that data to one or more other
components of the device, such as the processor. The memory may be
one or more of a Flash memory, SRAM, ROM, DRAM, RAM, EPROM and
dynamic storage, for example. For instance, the memory may be
coupled to the processor and configured to receive and store input
data and/or store one or more template or generated delivery
patterns. For example, the memory can be configured to store one or
more personalized (e.g., user defined) delivery profiles, such as a
profile based on a user's selection and/or grouping of various
input factors, past generated delivery profiles, recommended
delivery profiles, one or more traditional delivery profiles, e.g.,
square wave, dual square wave, basal and bolus rate profiles,
and/or the like. The memory can also store, for example, user
information, history of use, glucose measurements, compliance and
an accessible calendar of events.
[0027] The housing 26 of the pump 12 may be functionally associated
with an interchangeable and a removable glucose meter 20 and/or
infusion cartridge 16. The infusion cartridge 16 may have an outlet
port 54 that may be connected to an infusion set (not shown) via an
infusion set connector 18. Further details regarding some
embodiments of various infusion pumps can be found in U.S. Patent
Application No. 2011/0144586, which is hereby incorporated by
reference.
[0028] Referring to FIG. 3, a front view of the pump 12 is
depicted. The pump 12 may include a user interface, such as, for
example, a user-friendly GUI 60 on a front surface 58 or other
convenient location of the pump 12. The GUI 60 may include a
touch-sensitive screen 46 that may be configured for displaying
data, facilitating data entry by a patient, providing visual
tutorials, as well as other interface features that may be useful
to the patient operating the pump 12. A bolus object 82 can also be
displayed on the screen 46.
[0029] Pump 12 can interface with a continuous glucose monitor
(CGM) that provides a substantially continuous estimated glucose
level through a transcutaneous sensor that measures analytes, such
as glucose, in the patient's interstitial fluid rather than their
blood. Referring to FIG. 4, a CGM system 100 according to an
embodiment of the present invention is shown. The illustrated CGM
system 100 includes a sensor 102 affixed to a patient 104 and is
associated with the insulin infusion device 12. The sensor 102
includes a sensor probe 106 configured to be inserted to a point
below the dermal layer (skin) of the patient 104. The sensor probe
106 is therefore exposed to the patient's interstitial fluid or
plasma beneath the skin and reacts with that interstitial fluid to
produce a signal that can be calibrated with the patient's blood
glucose (BG) level. The sensor 102 includes a sensor body 108 that
transmits data associated with the interstitial fluid to which the
sensor probe is exposed. The data may be transmitted from the
sensor 102 to the glucose monitoring system 100 via a wireless
transmitter, such as a near field communication (NFC) radio
frequency (RF) transmitter or a transmitter operating according to
a "WiFi" or "Bluetooth" protocol or the like, or the data may be
transmitted via a wire connector from the sensor 102 to the monitor
system 100. Transmission of sensor data to the glucose monitor
system 100 by wireless or wired connection is represented in FIG. 4
by the arrow line 112. Further detail regarding such systems and
definitions of related terms can be found in, e.g., U.S. Pat. Nos.
8,311,749, 7,711,402 and 7,497,827, each of which is hereby
incorporated by reference in its entirety.
[0030] In one embodiment, part of the CGM system 100 is
incorporated into the pump 12 such that the processor 42 is adapted
to receive the data from the sensor 102 and process and display the
data on the display 44. In another embodiment, the CGM 100 is a
separate device that communicates with the pump 12 through a wired
or wireless link to transmit the CGM data to the pump 12.
[0031] Referring to FIG. 5, there can be seen a pump screen 110
incorporating pump 12 data and CGM data according to an embodiment
of the present invention. Pump screen 110 can be displayed on the
touch screen 46 of the GUI 60 on the front surface 58 of the pump
12. Screen 110 can include a battery life indicator 112 and an
insulin indicator 114. Each indicator 112, 114 can include one or
more of a graphical indication, shown in FIG. 4 as a plurality of
indicator bars 116 and a textual indicator 118 such as a percentage
or amount remaining. The time 120 and date 122 can also be
displayed on screen 110. The screen 110 can also include an
indication of the amount of insulin on board 124, that is, the
amount of un-metabolized insulin already present in the user's
body, as well as a time remaining object 126 counting down the
amount of time the insulin on board is calculated to remain in the
user's body. An options key 128 can allow a user to scroll through
various pump operation options and a bolus object 130 can allow a
user to begin programming a bolus of insulin.
[0032] With further reference to FIG. 5, information regarding the
user's glucose level received from the CGM device can be
incorporated and displayed on the pump screen 110 alongside insulin
pump 12 data. The information can include the user's current
glucose level 132 as well as a graphical representation 134 of
historical glucose data that can be used, for example, to view
glucose level trends and rates of change. A timeframe object 136
can be used to select a timeframe over which to view the historical
data. The right side of the graph 134 can include a plurality of
glucose values 138 forming the vertical axis of the graph 134. The
horizontal axis of the graph 134 tracks the time period over which
the data is displayed and can include hash marks 140 or other
indicators, including numerical indicators, indicating equal
divisions of the selected timeframe. The user's glucose level is
therefore shown on the graph 134 as a function of time and can be
shown as discrete points 142 as shown in FIG. 5. Alternatively, the
glucose level versus time can be shown as a continuous line or
curve. The graph 134 can also include a high glucose level
indicator line 144 and a low glucose level indicator line 146
identifying predetermined patient specific thresholds that make it
easy for a user to see when the user's glucose level has crossed a
threshold. Although shown and described as being displayed in a
graphical format, CGM data can also be displayed in a textual and
numerical format on GUI 60 as well as audibly through, e.g., a
speaker.
[0033] The pump screen 110 includes all data that the user needs to
determine whether interaction with the pump is necessary. For
example, for the user to determine whether or not to administer a
bolus of insulin, the key information of the user's current glucose
level 132, the amount of insulin on board 124 and historical
glucose level data 144 indicating recent trends and rates of change
is all displayed to the user on one convenient screen. In addition,
whether underlying requirements for the pump to deliver a bolus are
met, such as the battery life 112 of the pump and the amount of
insulin 114 in the pump reservoir, can also be determined from the
display of this information on the same screen 110.
[0034] The pump screen 110 shown in FIG. 5 can be a default or
startup screen of the GUI 60. As a startup screen, pump screen 110
can be the first screen displayed on the GUI anytime the user
powers the pump 12 on or activates the pump 12 from a sleep mode.
This allows the user to immediately assess whether any action needs
to be taken with the pump, such as to deliver a bolus, charge a
battery or change a cartridge containing the insulin reservoir. The
user can therefore take any necessary action with little more than
a glance at the device, rather than having to scroll through
multiple pages and options to determine whether action needs to be
taken. In some embodiments, the pump 12 can also revert to the
startup pump screen 110 whenever the GUI 60 has been inactive for a
predetermined period of time and/or whenever a home key or home key
sequence is entered.
[0035] If the user determines from the startup pump screen 110 that
a bolus should be delivered, a deliver bolus command can also be
begun directly from the screen 110 by selecting the deliver bolus
object 130. If some other pump interaction is required, the user
can access the necessary command with the options key 128. In some
embodiments, before the user can deliver a bolus or otherwise
change a pump parameter, the user must unlock the startup pump
screen 110, such as by entering a specific numeric sequence or
swiping along the touchscreen 46 in a specific manner. An unlock
screen such as the unlock screen 111 shown in FIG. 6 can pop up
over or in place of the startup pump screen 110 to provide for
unlocking of the device. As shown in FIG. 6, in one embodiment
unlock screen 111 includes a plurality of numerical indicators 148
with which the user enters a previously saved code to unlock the
pump 12. Such an unlock procedure will prevent the user from
accidentally altering pump operation when it is not intended.
Aspects of these features are further explained in U.S. Provisional
Patent Application Ser. No. 61/656,997 and in U.S. patent
application Ser. No. 13/______ entitled "Preventing Inadvertent
Changes in Ambulatory Medical Devices," filed Mar. ______, 2013 by
M. Rosinko, et al., each of which is hereby incorporated by
reference.
[0036] Because CGM devices estimate blood glucose levels from
analyzing interstitial plasma or fluid rather than blood as with
blood glucose monitors that utilize a sample of blood obtained
from, e.g., a finger stick, CGM devices generally are not as
well-suited for accurate blood glucose monitoring. Accordingly,
CGMs are most often used for identifying trends in blood glucose
levels over time and for providing estimates thereof. However, to
ensure that a CGM device is estimating the user's glucose level as
accurately as possible, such devices require a user to calibrate
with an actual blood sample several times a day that is then used
to compare the user's actual blood glucose level with the glucose
levels measured by the CGM. Typically, after this is done the user
must then manually enter the blood glucose data into the pump to
allow therapy parameters to be calculated based on the data.
Aspects of advanced calibration techniques that may be used in such
systems are found in U.S. patent application Ser. No. 13/______
entitled "Predictive Calibration" to Saint, the entirety of which
is incorporated by reference.
[0037] However, in an embodiment of a pump 12 that communicates
with a CGM and that integrates CGM data and pump data as described
herein, the CGM can automatically transmit the blood glucose data
determined from the calibration sample to the pump. The pump can
then automatically determine therapy parameters based on the data.
For example, if the calibration sample indicates that the user's
blood glucose is over a high blood glucose threshold, the pump can
automatically calculate an insulin bolus to bring the user's blood
glucose below the threshold. In one embodiment, the pump presents
the bolus to the user as a recommended bolus 150 on the GUI 60 that
the user must approve in order for it to be delivered as shown in
FIG. 7. In some embodiments, a visual, audible or tactile alarm, or
some combination of these, can automatically be issued to alert the
user to a suggested action and reason for the action, such as a
high blood glucose reading and corresponding recommended bolus.
[0038] Referring now to FIG. 8, a flowchart of a method of
recommending a correction bolus 152 is depicted. At step 158, a
user submitted blood sample is received at the CGM for calibration
purposes. The blood glucose level of the blood sample is determined
and then automatically transmitted to the pump at step 156. The
pump determines at step 158 whether the blood glucose level is
above a patient specific threshold level. If it is not, at step 160
no action is taken by the pump. If the level is above the
threshold, then at step 162 the pump automatically calculates a
correction bolus and displays the correction bolus as a
recommendation to the user at step 164. If the user confirms the
recommended bolus, the bolus is delivered to the user by the pump
at step 166.
[0039] With regard to the above detailed description, like
reference numerals used therein may refer to like elements that may
have the same or similar dimensions, materials, and configurations.
While particular forms of embodiments have been illustrated and
described, it will be apparent that various modifications can be
made without departing from the spirit and scope of the embodiments
herein. Accordingly, it is not intended that the invention be
limited by the forgoing detailed description.
[0040] The entirety of each patent, patent application,
publication, and document referenced herein is hereby incorporated
by reference. Citation of the above patents, patent applications,
publications and documents is not an admission that any of the
foregoing is pertinent prior art, nor does it constitute any
admission as to the contents or date of these documents.
[0041] Modifications may be made to the foregoing embodiments
without departing from the basic aspects of the technology.
Although the technology may have been described in substantial
detail with reference to one or more specific embodiments, changes
may be made to the embodiments specifically disclosed in this
application, yet these modifications and improvements are within
the scope and spirit of the technology. The technology
illustratively described herein may suitably be practiced in the
absence of any element(s) not specifically disclosed herein. The
terms and expressions which have been employed are used as terms of
description and not of limitation and use of such terms and
expressions do not exclude any equivalents of the features shown
and described or portions thereof and various modifications are
possible within the scope of the technology claimed. Although the
present technology has been specifically disclosed by
representative embodiments and optional features, modification and
variation of the concepts herein disclosed may be made, and such
modifications and variations may be considered within the scope of
this technology.
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