U.S. patent application number 11/970232 was filed with the patent office on 2009-07-09 for insulin pump with insulin therapy coaching.
Invention is credited to Michael Blomquist, Kevin Kopp, Thomas Alan Savard.
Application Number | 20090177147 11/970232 |
Document ID | / |
Family ID | 40845155 |
Filed Date | 2009-07-09 |
United States Patent
Application |
20090177147 |
Kind Code |
A1 |
Blomquist; Michael ; et
al. |
July 9, 2009 |
INSULIN PUMP WITH INSULIN THERAPY COACHING
Abstract
An apparatus comprising a pump configured to deliver insulin, an
input configured to receive information related to managing
diabetes of a user, a user interface, and a controller
communicatively coupled to the pump, the input, and the user
interface. The controller includes an insulin timing module
configured to initiate delivery of insulin in a time relation to
when a meal is to be consumed by the user and to adjust delivery of
the insulin according to the received information. Other devices,
systems, and methods are disclosed.
Inventors: |
Blomquist; Michael; (Blaine,
MN) ; Kopp; Kevin; (St. Paul, MN) ; Savard;
Thomas Alan; (Arden Hills, MN) |
Correspondence
Address: |
SCHWEGMAN, LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS
MN
55402
US
|
Family ID: |
40845155 |
Appl. No.: |
11/970232 |
Filed: |
January 7, 2008 |
Current U.S.
Class: |
604/67 ; 604/131;
604/66; 702/19 |
Current CPC
Class: |
A61B 5/746 20130101;
A61M 5/1723 20130101; A61M 2202/0007 20130101; A61M 2205/3327
20130101; G16H 70/20 20180101; A61M 2230/201 20130101; A61B 5/4836
20130101; A61B 5/14532 20130101; A61M 5/14244 20130101; A61M 5/142
20130101; G06F 19/00 20130101; G16H 20/17 20180101; A61M 2005/14208
20130101 |
Class at
Publication: |
604/67 ; 604/131;
702/19; 604/66 |
International
Class: |
A61M 31/00 20060101
A61M031/00; A61M 37/00 20060101 A61M037/00; G01N 33/48 20060101
G01N033/48 |
Claims
1. An apparatus comprising: a pump configured to deliver insulin;
an input configured to receive information related to managing
diabetes of a user; a user interface; and a controller
communicatively coupled to the pump, the input, and the user
interface, wherein the controller includes an insulin timing module
configured to initiate delivery of insulin in a time relation to
when a meal is to be consumed by the user and to adjust delivery of
the insulin according to the received information.
2. The apparatus of claim 1, wherein the user interface includes a
display, wherein the information related to managing diabetes of a
user includes a blood glucose level of the user, and wherein the
insulin timing module is configured to: delay delivery of a meal
bolus of insulin when the information indicates that the blood
glucose level of the user is lower than a threshold blood glucose
level; and display at least one of a recommendation that the user
not eat, or to initiate delivery of a correction bolus of insulin
when the information indicates that the blood glucose level of the
user is higher than the threshold blood glucose level.
3. The apparatus of claim 1, wherein the information related to
managing diabetes of a user includes an indication whether the user
has abnormal gastric emptying, and wherein the timing module is
configured to delay delivery of a meal bolus of insulin when
abnormal gastric emptying is indicated.
4. The apparatus of claim 1, wherein the insulin timing module is
configured to initiate delivery of a combination meal bolus that
includes a first portion that is delivered immediately and a second
portion that is delivered over an extended period, wherein the
information related to managing diabetes of a user includes an
indication whether the user has abnormal gastric emptying, and
wherein the insulin timing module is configured to generate a delay
between the first portion and the second portion of the combination
meal bolus when abnormal gastric emptying is indicated.
5. The apparatus of claim 1, wherein the information related to
managing diabetes of a user includes an indication whether the user
is taking a drug to assist uptake of insulin, and wherein the
insulin timing module is configured to adjust the meal bolus of
insulin, when taking the drug is indicated, by at least one of
changing an amount of insulin delivered in the meal bolus,
providing the meal bolus over an extended period of time, or
delivering the meal bolus as a combination bolus including a first
portion that is delivered immediately and a second portion that is
delivered over an extended period.
6. The apparatus of claim 1, wherein the information related to
managing diabetes of a user includes an indication of a drug a user
is taking, and wherein the insulin timing module is configured to,
in response to the indication, recommend at least one of a change
in an amount of insulin delivered in a bolus, a change to a user's
total daily dose of insulin, or a change in a frequency of blood
glucose checks of the user.
7. The apparatus of claim 1, wherein the information related to
managing diabetes of a user includes a nutrient content of the
meal, and wherein the controller includes an insulin calculation
module configured to: calculate an amount of insulin to deliver in
a meal bolus of insulin to cover an amount of carbohydrates in the
meal using a carbohydrate ratio; and calculate an additional amount
of insulin to deliver in the meal bolus using at least one of a fat
ratio and an amount of fat indicated in the nutrient content, a
protein ratio and an amount of protein indicated in the nutrient
content, or an amount of fiber indicated in the nutrient
content.
8. The apparatus of claim 1, wherein the insulin timing module is
configured to deliver a first portion of a meal bolus of insulin
near the beginning of a meal time period, wherein the information
related to managing diabetes of a user includes a nutrient content
of the meal consumed, and wherein the controller includes an
insulin calculation module configured to calculate at least one of
a second portion of the meal bolus based on the nutrient content of
the meal, or an amount of additional carbohydrates to be
consumed.
9. The apparatus of claim 1, wherein the information related to
managing diabetes of a user includes a nutrient content of the
meal, and wherein the controller includes an insulin calculation
module configured to: calculate an amount of insulin to deliver
immediately using an amount of fast absorbing carbohydrates in the
meal; and calculate an amount of insulin to deliver over an
extended time period using at least one of an amount of slow
absorbing carbohydrates in the meal, an amount of fat in the meal,
or an amount of protein in the meal.
10. The apparatus of claim 1, wherein the controller includes a
timer, and the controller is configured to generate, after a timed
duration after delivery of the insulin, a reminder to the user to
eat.
11. A method comprising: receiving information into a device having
an insulin pump, wherein the information relates to managing
diabetes of a user of the insulin pump device; and adjusting a
delivery of insulin according to the received information, wherein
the insulin is to be delivered by the device in relation to a time
period when a meal is to be consumed by the user.
12. The method of claim 11, wherein the receiving information into
the insulin pump device includes receiving information related to a
blood glucose level of the user, and wherein the adjusting a
delivery of insulin includes delaying delivery of a meal bolus of
insulin when the information indicates that the blood glucose level
of the user is lower than a threshold blood glucose level.
13. The method of claim 11, wherein the receiving information into
the insulin pump device includes receiving an indication whether
the user has abnormal gastric emptying, and wherein the adjusting a
delivery of insulin includes delaying delivery of a meal bolus of
insulin when abnormal gastric emptying is indicated.
14. The method of claim 11, wherein the receiving information into
the insulin pump device includes receiving an indication whether
the user has abnormal gastric emptying, and wherein the adjusting a
delivery of insulin includes generating a delay between a portion
of a combination meal bolus of insulin that is delivered
immediately and a portion of the combination meal bolus that is
delivered over an extended period.
15. The method of claim 11, wherein the receiving information into
the insulin pump device includes receiving an indication whether
the user is taking a drug to assist uptake of insulin, and wherein
the adjusting a delivery of insulin includes at least one of
changing an amount of insulin delivered in a meal bolus of insulin,
providing the meal bolus over an extended period of time, or
providing the meal bolus as a combination bolus including a portion
that is delivered immediately and a portion that is delivered over
an extended period when taking the drug is indicated.
16. The method of claim 11, wherein the receiving information into
the insulin pump device includes receiving an indication of a drug
a user is taking, and wherein adjusting a delivery of insulin
includes recommending, in response to the indication, at least one
of a change in an amount of insulin delivered in a bolus, a change
to a user's total daily dose of insulin, or a change in a frequency
of blood glucose checks of the user.
17. The method of claim 11, wherein the receiving information into
the insulin pump device includes receiving information including a
nutrient content of the meal, and wherein the adjusting a delivery
of insulin includes: calculating an amount of insulin to deliver in
a meal bolus of insulin to cover an amount of carbohydrates in the
meal using a carbohydrate ratio; and calculating an additional
amount of insulin to deliver in the meal bolus using at least one
of a fat ratio and an amount of fat indicated in the nutrient
content, a protein ratio and an amount of protein indicated in the
nutrient content, or an amount of fiber indicated in the nutrient
content.
18. The method of claim 11, including: delivering a first portion
of a meal bolus of insulin near the beginning of a meal time
period, wherein the receiving information includes receiving
information into the insulin pump device related to nutrient
content of the meal consumed; and calculating at least one of a
second portion of the meal bolus based on the received information
related to nutrient content, or an amount of additional
carbohydrates to be consumed.
19. The method of claim 11, wherein the receiving information into
the insulin pump device includes receiving information including a
nutrient content of the meal, and wherein the adjusting a delivery
of insulin includes: calculating an amount of insulin to deliver
immediately using an amount of fast absorbing carbohydrates in the
meal; and calculating an amount of insulin to deliver over an
extended time period using at least one of an amount of slow
absorbing carbohydrates in the meal, an amount of fat in the meal,
or an amount of protein in the meal.
20. The method of claim 11, wherein the receiving information into
the insulin pump device includes receiving information related to a
blood glucose level of the user, and wherein the adjusting a
delivery of insulin includes displaying at least one of a
recommendation that the user not eat, or that delivery of a
correction bolus be initiated when the information indicates that
the blood glucose level of the user is higher than a threshold
blood glucose level.
21. The method of claim 11, including generating, after a timed
duration after delivery of the insulin, a reminder to the user to
eat.
22. An apparatus comprising an input configured to receive blood
glucose information, wherein the information includes a blood
glucose level of a user; a user interface; and a controller
communicatively coupled to the input and the user interface,
wherein the controller includes: an alert module configured to
provide an alert to the user, via the user interface, to check
blood glucose level; a blood glucose stability module configured to
calculate a measure of a past stability of the blood glucose level
of the user; and a randomization module configured to randomize,
according to the measure of the past stability, at least one of
whether to provide the alert to the user, a type of alert to
provide, and a user input to the user interface to reset a provided
alert.
23. The apparatus of claim 22, wherein the blood glucose stability
module is configured to calculate, from at least a portion of past
blood glucose levels of the user, at least one of a central
tendency of the blood glucose level of the user, a maximum blood
glucose level of the user, a minimum blood glucose level of the
user, and a standard deviation of the blood glucose level of the
user.
24. The apparatus of claim 22, including a pump communicatively
coupled to the controller and configured to deliver insulin,
wherein the alert module includes a timer, and wherein the alert
module is configured to provide the alert a timed duration after
delivery of a bolus of insulin.
25. The apparatus of claim 22, wherein the alert module includes a
timer, and wherein the alert module is configured to provide the
alert a timed duration after the blood glucose information
indicates that the blood glucose level of the user differs from a
target blood glucose level by a threshold value.
26. The apparatus of claim 22, wherein the user interface includes
a plurality of keys configured to be pressed by a user, and wherein
the randomization module is configured to randomize a sequence of
key presses to reset a generated alert.
27. The apparatus of claim 22, wherein the user interface includes
a speaker, and wherein the randomization module is configured to
randomize an audible indication of an alert via the user
interface.
28. The apparatus of claim 22, including a blood glucose monitor
communicatively coupled to the input.
29. The apparatus of claim 22, including a communication port
coupled to the input and configured to receive blood glucose
information from a second separate device.
30. The apparatus of claim 22, wherein the user interface includes
a display, and wherein the controller is configured to prompt the
user, via the display, to begin a blood glucose measurement using a
separate device.
31. The apparatus of claim 22, wherein the user interface is
configured to receive manual entry of the blood glucose information
from the user.
32. A method comprising: determining that an alert to check blood
glucose level is to be provided to a user of a blood glucose (BG)
management device; calculating a measure of a past stability of the
blood glucose level of the user; and randomly determining,
according to the measure of the past stability, at least one of
whether to provide the alert to the user, a type of the alert to
provide, or a method of receiving an alert reset into the BG
management device.
33. The method of claim 32, wherein calculating the measure of the
past stability includes calculating, from at least a portion of
past blood glucose levels of the user, at least one of a central
tendency of the blood glucose level of the user, a maximum blood
glucose level of the user, a minimum blood glucose level of the
user, and a standard deviation of the blood glucose level of the
user.
34. The method of claim 32, wherein determining that an alert is to
be provided includes determining the alert is to be provided by
timing an interval after delivery of a bolus of insulin.
35. The method of claim 32, wherein determining that an alert is to
be provided includes determining the alert is to be provided by
timing an interval after a blood glucose measurement indicates that
the blood glucose level of the user differs from a target blood
glucose level by a threshold value.
36. The method of claim 32, wherein randomly determining a type of
an alert includes randomly determining an audible aspect of the
alert.
37. The method of claim 32, wherein randomly determining a method
of receiving an alert reset into the device includes randomly
determining a key press sequence to reset the alert.
38. An apparatus comprising: a pump configured to deliver insulin
from an insulin cartridge; a user interface; a memory to store
guideline parameters related to use of the apparatus; and a
controller communicatively coupled to the pump, the memory, and the
user interface, wherein the controller includes: a comparison
module configured to compare patient use parameters to the stored
guideline parameters; and a scoring module configured to calculate
a score indicative of efficacy of patient pump use based on a
comparison by the comparison module, and wherein the controller is
configured to communicate advice to the user on how to increase the
efficacy of patient pump use.
39. The apparatus of claim 38, including: an input communicatively
coupled to the controller and configured to receive blood glucose
information, including a blood glucose level of a user, and wherein
the comparison module is configured to monitor the blood glucose
level of the patient using the information.
40. The apparatus of claim 39, wherein the comparison module is
configured to determine and monitor at least one of: a measure of
central tendency of the blood glucose level, a standard deviation
of the blood glucose level, or an amount of insulin delivered in
any correction boluses as a percentage of total daily dose of
insulin.
41. The apparatus of claim 39, wherein the comparison module is
configured to compare at least one of: a number of times that blood
glucose is not rechecked to a stored guideline number after
receiving a correction bolus, a number of times that blood glucose
is not rechecked after treating a low blood glucose level, or a
number of times that blood glucose is not rechecked after a bolus
of insulin is delivered by the insulin pump device.
42. The apparatus of claim 39, including a blood glucose monitor
communicatively coupled to the input.
43. The apparatus of claim 39, including a communication port
communicatively coupled to the input and configured to receive
blood glucose information from a second separate device.
44. The apparatus of claim 39, wherein the user interface includes
a display, and wherein the controller is configured to prompt the
user, via the display, to begin a blood glucose measurement using a
separate device.
45. The apparatus of claim 39, wherein the user interface is
configured to receive manual entry of the blood glucose information
from the user.
46. The apparatus of claim 38, wherein the comparison module is
configured to compare at least one of: a frequency of entering
blood glucose readings into the device to a stored frequency, a
frequency of missed meal boluses to a stored missed meal bolus
frequency value, timing of blood glucose readings to a stored
timing guideline, an amount of carbohydrates, eaten by the patient,
entered into the device to a stored guideline amount, a number of
between meal snacks entered into the device to a stored number, or
a difference in timing of patient meal times entered into the
device to a stored threshold meal time difference value.
47. The apparatus of claim 38, wherein the comparison module is
configured to compare at least one of: a frequency of insulin
cartridge changes to a stored insulin cartridge change frequency
value, a frequency of infusion set changes to a stored infusion set
change frequency value, a difference in timing of insulin cartridge
changes to a stored threshold change time difference value, or a
frequency that insulin cartridges are allowed to empty to a stored
empty cartridge frequency value.
48. The apparatus of claim 38, wherein the comparison module is
configured to compare at least one of: a frequency of using test
features of the insulin pump device to a stored test frequency
value, a total time that the insulin pump device is inoperative to
a stored total time value, a frequency that a pump generated report
is viewed to a stored report-view frequency value, or a time from
when an alert is generated by the device to a time when a user
responds to the alert to a stored response time value.
49. The apparatus of claim 38, wherein the user interface includes
a display, wherein the scoring module is configured to trend the
score, and wherein the controller is configured to display the
score and score trend on the device.
50. The apparatus of claim 38, wherein calculating a score based on
the monitored patient use includes assigning different weights to
outcomes of comparisons of use parameters to guideline parameters
when calculating the score.
51. The apparatus of claim 38, including a communication port
communicatively coupled to the controller, and wherein the
controller is configured to communicate the advice on how to
increase pump efficacy to a second separate device.
52. A method comprising: monitoring patient use of a device that
includes a pump configured to deliver insulin, wherein the
monitoring includes comparing patient use parameters to stored
guideline parameters; calculating a score indicative of efficacy of
patient pump use based on the monitoring; and communicating advice
to the user on how to increase pump efficacy.
53. The method of claim 52, including receiving blood glucose
information into the device, and wherein monitoring patient use
includes monitoring the blood glucose level of the patient using
the information.
54. The method of claim 53, wherein monitoring blood glucose level
of the patient includes determining at least one of: a central
tendency of the blood glucose level, a standard deviation of the
blood glucose level, or an amount of insulin delivered in any
correction boluses as a percentage of total daily dose of
insulin.
55. The method of claim 53, wherein comparing patient use
parameters to stored guideline parameters includes at least one of:
comparing a number of times that blood glucose is not rechecked to
a stored guideline number after receiving a correction bolus,
comparing a number of times that blood glucose is not rechecked
after treating a low blood glucose level, or comparing a number of
times that blood glucose is not rechecked after a bolus of insulin
is delivered by the insulin pump device.
56. The method of claim 52, wherein comparing patient use
parameters to stored guideline parameters includes comparing at
least one of: a frequency of entering blood glucose readings into
the device to a stored frequency, timing of blood glucose readings
to a stored timing guideline, a frequency of missed meal boluses to
a stored missed meal bolus frequency value, an amount of
carbohydrates, eaten by the patient, entered into the device to a
stored guideline amount, a number of between meal snacks entered
into the device to a stored number, or a difference in timing of
patient meal times entered into the device to a stored threshold
meal time difference value.
57. The method of claim 52, wherein comparing patient use
parameters to stored guideline parameters includes comparing at
least one of: a frequency of insulin cartridge changes to a stored
change frequency value, a difference in timing of insulin cartridge
changes to a stored threshold insulin cartridge change time
difference value, a difference in timing of infusion set changes to
a stored threshold infusion set change time difference value, or a
frequency that insulin cartridges are allowed to empty to a stored
empty cartridge frequency value.
58. The method of claim 52, wherein comparing patient use
parameters to stored guideline parameters includes comparing at
least one of: a frequency of using test features of the insulin
pump device to a stored test frequency value, a total time that the
insulin pump device is inoperative to a stored total time value, a
frequency that a pump generated report is viewed to a stored
report-view frequency value, or a time from when an alert is
generated by the device to a time when a user responds to the alert
to a stored response time value.
59. The method of claim 52, wherein calculating a score based on
the monitored patient use includes assigning different weights to
outcomes of the comparing when calculating the score.
60. The method of claim 52, including: trending the score; and
displaying the score and a score trend on the device.
61. The method of claim 52, wherein communicating advice includes
communicating advice on how to increase pump efficacy to a second
separate device.
62. An apparatus comprising: a pump configured to deliver insulin;
a memory configured to store a delivery pattern of basal insulin; a
user interface configured to receive time change information; and a
controller communicatively coupled to the pump, the memory, and the
user interface, wherein the controller includes a timing module
configured to shift the delivery pattern of basal insulin in time
according to the received time change information.
63. The apparatus of claim 62, wherein the time change information
includes travel information of the user, and wherein the timing
module is configured to: shift the delivery pattern according to a
destination time zone indicated in the travel information; and to
restore the time of the delivery pattern of basal insulin according
to a return time indicated in the travel information.
64. The apparatus of claim 63, wherein the timing module is
configured to shift the delivery pattern by a specified amount of
time per specified time period until the delivery pattern of basal
insulin matches the destination time zone, and to shift the
delivery pattern of basal insulin back by the same or a different
amount of time until the delivery pattern of basal insulin matches
the return time zone according to the return time.
65. The apparatus of claim 62, wherein the memory includes an
indication of a portion of a twenty-four hour period designated as
a sleep segment, and wherein the timing module is configured to
shift the sleep segment portion of the basal insulin delivery
pattern.
66. The apparatus of claim 62, wherein the time change information
includes an indication of a local time change, and wherein the
timing module is configured to shift the delivery pattern by a
fraction of an hour until the delivery pattern of basal insulin
matches the local time.
67. The apparatus of claim 62, wherein the timing module is
configured to shift, according to the information received into the
device, at least one of a correction factor, or a time of day
schedule for a carbohydrate ratio.
68. A method comprising: receiving time change information into a
device having an insulin pump; and shifting a delivery pattern of
basal insulin in time according to the information received into
the device.
69. The method of claim 68, wherein the received time change
information includes travel information of the user, wherein
shifting the delivery pattern of basal insulin includes shifting
the delivery pattern according to a time zone of a destination of
the user, and wherein the method includes restoring the time of the
delivery pattern of basal insulin according to a return time
indicated in the travel information.
70. The method of claim 69, wherein shifting the delivery pattern
of basal insulin includes shifting the delivery pattern by a
specified amount of time per time period until the delivery pattern
of basal insulin matches the destination time zone, and wherein
restoring the time of the delivery pattern includes shifting the
delivery pattern of basal insulin back by the same or a different
amount of time until the delivery pattern of basal insulin matches
the return time zone.
71. The method of claim 68, including receiving an indication of a
portion of a twenty-four hour period to designate a sleep segment,
and wherein shifting a delivery pattern of basal insulin includes
shifting the sleep segment portion of the basal insulin delivery
pattern.
72. The method of claim 68, wherein receiving time change
information includes receiving an indication of a local time change
related to daylight savings time, and wherein shifting a delivery
pattern of basal insulin includes shifting the delivery pattern by
a fraction of an hour until the delivery pattern of basal insulin
matches the local time.
73. The method of claim 68, including shifting, according to the
information received into the device, at least one of a correction
factor, or a time of day schedule for a carbohydrate ratio.
74. An apparatus comprising: an input configured to receive blood
glucose data, wherein the blood glucose data is obtained during a
number of specified blood glucose testing times; a user interface;
and a controller communicatively coupled to the input, and the user
interface, wherein the controller includes: a blood glucose data
module configured to calculate a measure of blood glucose
variability of the user from the blood glucose data, and wherein
the controller is configured to adjust a blood glucose testing time
in response to the measure of blood glucose variability.
75. The apparatus of claim 74, wherein the controller includes: a
comparison module configured to compare the measure of blood
glucose variability to a threshold blood glucose variability value,
and wherein the controller is configured to increase the number of
blood glucose testing times if the measure of blood glucose
variability exceeds a blood glucose variability target value by
more than a first threshold blood glucose variability value, and
decrease the number of blood glucose testing times if the measure
of blood glucose variability is less than the blood glucose
variability target value by more than a second threshold blood
glucose variability value.
76. The apparatus of claim 74, including a memory, communicatively
coupled to the controller, to store an indication of a user
preference for a blood glucose testing time, and wherein the
controller is configured to adjust the blood glucose testing time
according to the indication.
77. The apparatus of claim 76, wherein the controller is configured
to schedule a plurality of blood glucose testing times according to
the indication.
78. The apparatus of claim 74, including a blood glucose monitor
communicatively coupled to the input and configured to test blood
glucose in response to a prompt received from the controller.
79. The apparatus of claim 74, including a communication port
coupled to the input and configured to receive blood glucose data
from a device separate from the blood glucose management device,
and wherein the controller is configured to communicate an adjusted
blood glucose testing time to the separate device.
80. The apparatus of claim 74, wherein the user interface includes
a display, wherein the controller is configured to prompt a user,
via the display, to test blood glucose at an adjusted time using a
separate device.
81. The apparatus of claim 80, wherein the user interface is
configured to receive manual entry of the blood glucose data from
the user.
82. The apparatus of claim 74, including: a pump communicatively
coupled to the controller and configured to deliver insulin, and
wherein the controller is configured to adjust the blood glucose
testing time in response to the measure of blood glucose
variability and according to times of insulin delivery.
83. A method comprising: receiving blood glucose data of a user
into a blood glucose (BG) management device, wherein the blood
glucose data is obtained from the user during a number of specified
blood glucose testing times; calculating a measure of blood glucose
level variability from the blood glucose data; and adjusting a
blood glucose testing time in response to the measure of blood
glucose variability.
84. The method of claim 83, wherein adjusting the blood glucose
testing time includes: increasing the number of blood glucose
testing times if the measure of blood glucose variability exceeds a
blood glucose variability target value by more than a first
threshold blood glucose variability value; and decreasing the
number of blood glucose testing times if the measure of blood
glucose variability is less than the blood glucose variability
target value by more than a second threshold blood glucose
variability value.
85. The method of claim 83, wherein adjusting the blood glucose
testing time includes adjusting the blood glucose testing time
according to a preference indicated by the user.
86. The method of claim 85, wherein adjusting the blood glucose
testing time includes scheduling a plurality of blood glucose
testing times according to the preference indicated by the
user.
87. The method of claim 83, wherein receiving blood glucose data
includes automatically receiving the blood glucose data from a
blood glucose monitor included in the BG management device.
88. The method of claim 83, wherein receiving BG data includes:
obtaining sampled blood glucose data using a device separate from
the BG management device; and receiving the sampled blood glucose
data into the BG management device from the separate device through
a communication port, and wherein adjusting the blood glucose
testing time includes communicating an adjusted blood glucose
testing time to the second device.
89. The method of claim 83, wherein receiving sampled blood glucose
data includes periodically prompting a user through a user
interface of the BG management device to test blood glucose using a
separate device, and wherein adjusting the blood glucose testing
time includes communicating an adjusted blood glucose testing time
to the user.
90. The method of claim 89, wherein receiving blood glucose data
includes receiving the blood glucose data through a user interface
of the BG management device configured for manual entry of blood
glucose data.
91. The method of claim 83, including delivering insulin therapy
using the BG management device, and wherein adjusting the blood
glucose testing time includes adjusting the blood glucose testing
time in response to the measure of blood glucose variability and
according to insulin delivery times.
Description
BACKGROUND
[0001] People who suffer from diabetes require insulin to keep
their blood glucose level as close as possible to normal levels. It
is essential for people with diabetes to manage their blood glucose
level to within a normal range. Complications from diabetes can
include heart disease (cardiovascular disease), blindness
(retinopathy), nerve damage (neuropathy), and kidney damage
(nephropathy). Insulin is a hormone that reduces the level of blood
glucose in the body. Normally, insulin is produced by beta cells in
the pancreas. In non-diabetic people, the beta cells release
insulin to satisfy two types of insulin needs. The first type is a
low-level of background insulin that is released throughout the
day. The second type is a quick release of a higher-level of
insulin in response to eating. Insulin therapy replaces or
supplements insulin produced by the pancreas.
[0002] Conventional insulin therapy typically involves one or two
injections a day. The low number of injections has the disadvantage
of allowing larger variations in a person's insulin levels. Some
people with diabetes manage their blood glucose level with multiple
daily injections (MDI). MDI may involve more than three injections
a day and four or more blood glucose tests a day. MDI offers better
control than conventional therapy. However, insulin injections are
inconvenient and require a diabetic person to track the insulin
doses, the amount of carbohydrates eaten, and their blood glucose
levels among other information critical to control.
[0003] It is important for a diabetic person to be treated with the
proper amount of insulin. As discussed previously, high blood sugar
can lead to serious complications. Conversely, a person with low
blood sugar can develop hypoglycemia. Ideally, insulin therapy
mimics the way the body works. An insulin pump is one way to mimic
the body's insulin production. An insulin pump can provide a
background or basal infusion of insulin throughout the day and
provide a quick release or bolus of insulin when carbohydrates are
eaten. If a person develops high blood sugar, a correction bolus of
insulin can be delivered by the pump to correct it. While insulin
pumps improve convenience and flexibility for a diabetic person,
they can be sophisticated devices. Some insulin pumps can be
difficult to program. Proper use of an insulin pump requires a user
to go through a learning curve to properly treat their diabetes
using the insulin pump.
Overview
[0004] This document discusses, among other things, devices and
methods for managing insulin therapy. A device example includes a
pump configured to deliver insulin, an input configured to receive
information related to managing diabetes of a user, a user
interface, and a controller communicatively coupled to the pump,
the input, and the user interface. The controller includes an
insulin timing module configured to initiate delivery of insulin in
a time relation to when a meal is to be consumed by the user and to
adjust delivery of the insulin according to the received
information. Other devices, systems, and methods are disclosed.
[0005] A method example includes receiving information into a
device having an insulin pump. The information relates to managing
diabetes of a user of the insulin pump device. The method also
includes adjusting a delivery of insulin according to the received
information. The insulin is to be delivered by the device in
relation to a time period when a meal is to be consumed by the
user.
[0006] This overview is intended present some subject matter of the
patent application. It is not intended to provide an exclusive or
exhaustive explanation of the invention. The detailed description
is included to provide further information about the subject matter
of the present patent application.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIGS. 1A and 1B illustrate portions of a device that
includes an insulin pump.
[0008] FIG. 2 is a block diagram of portions of an embodiment of a
device to adjust delivery of meal-related insulin.
[0009] FIG. 3 is a flow diagram of an embodiment of a method to
provide adjustment to a meal bolus for a pump user.
[0010] FIG. 4 shows another embodiment of a device to adjust
meal-related insulin delivered with an insulin pump.
[0011] FIG. 5 illustrates a graph of an example of a combination
meal bolus of insulin.
[0012] FIG. 6 illustrates a graph of another example of a
combination meal bolus of insulin.
[0013] FIG. 7 illustrates a graph of an example of this basal
insulin shifting.
[0014] FIG. 8 illustrates a graph of an example of basal insulin
delivered at a ramped rate.
[0015] FIG. 9 is a block diagram of portions of an embodiment of a
blood glucose (BG) management device to reduce alarm fatigue.
[0016] FIG. 10 is a block diagram of portions of another embodiment
of a BG management device to reduce alarm fatigue.
[0017] FIG. 11 is a flow diagram of a method of reducing alarm
fatigue in a BG management device.
[0018] FIG. 12 is a block diagram of portions of an embodiment of a
device that helps a patient improve their use of an insulin
pump.
[0019] FIG. 13 is a flow diagram of a method of using a medical
device to help a patient improve their use of an insulin pump.
[0020] FIG. 14 is a block diagram of portions of an embodiment of a
device that shifts insulin delivery parameters according to a
change in the schedule of a user.
[0021] FIG. 15 is a flow diagram of an embodiment of a method to
shift insulin delivery parameters according to a change in the
schedule of a user of an insulin pump.
[0022] FIG. 16 is a block diagram of portions of an embodiment of a
device to determine blood glucose testing times for an insulin pump
user.
[0023] FIG. 17 is a graphical representation of an example of a
schedule of blood glucose testing times.
[0024] FIG. 18 is a block diagram of portions of another embodiment
of a device to determine blood glucose testing times for an insulin
pump user.
[0025] FIG. 19 is a flow diagram of portions of method to determine
blood glucose testing times for an insulin pump user.
DETAILED DESCRIPTION
[0026] Insulin Pumps can be sophisticated devices. Insulin pumps
that help coach a person in the use of the device may cause the
device to be more effective in treating a person's diabetes.
[0027] FIGS. 1A and 1B illustrate portions of a device 100 that
includes an insulin pump. The device 100 includes a cassette or
cartridge of insulin. The cartridge is connectable to infusion
tubing 140 connectable to a patient such as by a Luer lock 145 or
infusion set 142. The device 100 includes a display 102 and a user
interface that may include the display 102 and include one or more
keys 104. Because proper use of an insulin pump requires a user to
go through a learning curve to properly treat their diabetes using
the pump, it is desirable for a pump to provide assistance to the
user, whether the user is a diabetic patient, a caregiver, or a
clinician.
Adjusting Insulin According to Meals
[0028] It is important for a diabetic to properly control their
blood glucose level. A meal bolus is an amount of insulin delivered
in anticipation of, or in response to, eating a meal. Typically,
the meal bolus insulin is to counteract or cover the amount the
amount of carbohydrates in the meal. The proper amount of insulin
can be influenced by many factors such as the nutrient content of
the food in the meal. Nutrient content refers to the amount of
carbohydrates, protein, and fat in the meal. Determining an
appropriate amount of insulin in the meal bolus can be difficult
for a pump user and may involve trial and error in finding the
right meal bolus for certain meals.
[0029] FIG. 2 is a block diagram of portions of an embodiment of a
device 200 to automatically adjust meal-related insulin delivered
with an insulin pump. The device 200 includes a controller 205. The
controller 205 can be implemented using hardware circuits,
firmware, software or any combination of hardware, firmware, and
software. Examples, include a microcontroller, a logical state
machine, and a processor such as a microprocessor, application
specific integrated circuit (ASIC), or other type of processor. The
controller 205 is configured to perform or execute a function or
functions. Such functions correspond to modules, which are
software, hardware, firmware or any combination thereof. Multiple
functions may be performed in one or more modules. In some
examples, software or firmware is provided on a computer readable
medium. The computer readable medium includes instructions therein,
which when processed (such as by the controller 205 for example)
results in a device performing the functions described herein.
Examples of a computer readable medium include a compact disc (CD),
memory stick, or remote storage accessible via a communication
network such as the internet or a cell phone network.
[0030] The device 200 also includes a pump 210 or pump mechanism to
deliver insulin to a subject such as a patient or user. The pump
210 may be a positive displacement pump. Descriptions of an example
of a medication pump to deliver insulin are found in Vilks et al.,
"Cartridge and Rod for Axially Loading a Medication Pump," U.S.
Pat. No. 7,033,338, filed Feb. 28, 2002, which is incorporated
herein by reference in its entirety. The device 200 also includes a
user interface 215 and an input 220 that, together with the pump
210, are communicatively coupled to the controller 205. The
communicative coupling allows the controller 205 to exchange
electrical signals with the user interface 215, input 220, and pump
210 even though intervening circuitry may be present. The input 220
receives information into the device 200 related to managing
diabetes of a user. This information may include physiologic data
of the patient and/or any indications for the patient, such as any
physical indications and indications of a drug therapy the patient
is using. The information also may pertain to the meal the patient
has eaten or plans to eat.
[0031] The controller 205 includes an insulin timing module 225
configured to initiate delivery of insulin in a time relation to
when a meal is to be consumed by the user and to adjust delivery of
the insulin according to the received information. The controller
205 may include a timer 245. After a timed duration after delivery
of the insulin timed by the timer 245 or the insulin timing module
225, the controller generates a reminder to the user to eat. The
reminder may be a visual alert displayed on a display 230 included
in the user interface 215, or the device 200 may include a
transducer or speaker and the generated reminder is an audible
alert. In another example, the device may include a mechanical
vibration mechanism and the generated reminder is a vibratory
alert.
[0032] FIG. 3 is a flow diagram of an embodiment of a method 300 to
automatically provide adjustment to a meal bolus for a pump user.
At block 305, information is received into a device having an
insulin pump. The received information relates to managing diabetes
of a user of the insulin pump device. At block 310, delivery of
insulin is adjusted according to the received information. The
insulin is to be delivered by the device in relation to a time
period when a meal is to be consumed by the user. The insulin may
be delivered as a meal bolus prior to the meal, during the time the
meal is scheduled, or after the meal. The insulin may be delivered
as a change in a basal insulin rate pattern or profile.
[0033] Returning to FIG. 2, in some embodiments, the information
related to managing diabetes of a user includes a blood glucose
level of the user. In some embodiments, the device 200 includes a
communication port 235 communicatively coupled to the input 220.
The controller 205 is configured to receive information about the
blood glucose level of the user via the communication port 235 from
a separate second device. In some embodiments, the second device is
a blood glucose monitor. In some embodiments, the communication
port is a wireless port, such as an infrared (IR) port or a radio
frequency (RF) port for example. In some embodiments, the
communication port is a wired port, such as a serial port for
example. In some embodiments, the controller 205 receives blood
glucose information via the user interface 215, such as when the
information is entered using a keypad included in the user
interface.
[0034] FIG. 4 shows another embodiment of a device 400 to
automatically adjust meal-related insulin delivered with an insulin
pump. The device 400 includes a pump to deliver insulin 410, a user
interface 415, and an input 420, communicatively coupled to a
controller 405 that includes an insulin timing module 425. The
device 400 also includes a blood glucose monitor 437
communicatively coupled to the input 420. The blood glucose monitor
437 may be a continuous blood glucose monitor that includes a blood
glucose sensor circuit to produce an electrical blood glucose
signal representative of a blood glucose level of the patient. The
blood glucose sensor circuit may sense blood glucose concentration
from blood or from interstitial fluid. The blood glucose sensor
circuit may include a sensor interface circuit to sample the blood
glucose signal and may provide additional signal processing, such
as filtering or amplification for example. The sensor interface
circuit may provide sampled blood glucose data to the input 420. A
description of a blood glucose sensor circuit can be found in Steil
et al., "Closed Loop System for Controlling Insulin Infusion," U.S.
Pat. No. 6,558,351, filed Jun. 1, 2000, which is incorporated
herein by reference in its entirety.
[0035] It is desirable for diabetics to manage their blood glucose
level to within a normal range. Returning to FIG. 2, the user may
have a meal time scheduled or programmed into the device 200, and
the controller 205 may initiate delivery of insulin in relation to
a scheduled meal time. If the blood glucose information indicates
that the blood glucose level of the user is low (e.g., the blood
glucose level is lower than a threshold blood glucose level), the
insulin timing module 225 may delay delivery of a meal bolus of
insulin. In some embodiments, the user interface 215 includes a
display 230. If the blood glucose information indicates that the
blood glucose level of the user is high (e.g., the blood glucose
level is higher than a threshold blood glucose level), the insulin
timing module may display a recommendation that the user not eat.
In some embodiments, if the blood glucose information indicates
that the blood glucose level of the user is high, the insulin
timing module may display a recommendation that the user initiate a
correction bolus of insulin.
[0036] According to some embodiments, the information related to
managing diabetes received by the controller 205 includes an
indication whether the user has abnormal gastric emptying. An
example of abnormal gastric emptying is gastroparesis.
Gastroparesis refers to a digestive disorder in which the user has
delayed emptying of food from the stomach into the lower intestine.
The indication of abnormal gastric emptying may be stored in a
memory communicatively coupled to the controller 205. The insulin
timing module 225 may delay delivery of meal bolus when abnormal
gastric emptying is indicated for the user.
[0037] FIG. 5 illustrates a graph 500 of an example of a
combination meal bolus of insulin. The graph 500 shows an amount of
insulin delivered versus time. The combination meal bolus includes
a first portion 505 of insulin that is delivered immediately
beginning at time t.sub.0. The first portion 505 concludes at time
t.sub.1 when a second portion 510 of insulin begins to be
delivered. The second portion 510 is delivered over an extended
period of time until time t.sub.2. The extended portion is
delivered at a lower rate and for a longer period of time than the
first portion 505. The combination bolus may be timed by the
insulin timing module 225 of FIG. 2. If abnormal gastric emptying
is indicated for a user, the insulin timing module 225 may change
the combination meal bolus.
[0038] FIG. 6 illustrates a graph 600 of another example of a
combination meal bolus of insulin. The combination meal bolus
includes a first portion 605 of insulin and a second portion 610 of
insulin. The first portion 605 is delivered immediately beginning
at time t.sub.0 and concludes at time t.sub.1. If abnormal gastric
emptying is indicated for the user, the insulin timing module 225
generates a delay between the first portion 605 and the second
portion 610. The second portion is delivered beginning after the
delay at time t.sub.2 and concludes at time t.sub.3.
[0039] According to some embodiments, the information related to
managing diabetes of the user of the device 200 of FIG. 2 includes
an indication of a drug the user is taking. The insulin timing
module 225, in response to the indication, recommends at least one
of a change in an amount of insulin delivered in a bolus, a change
to a user's total daily dose of insulin, or a change in a frequency
of blood glucose checks of the user.
[0040] For example, the information related to managing diabetes
includes an indication that the user is taking a hormone to assist
uptake of insulin (e.g., Symlin.RTM.). When such a hormone is
indicated, the insulin timing module 225 may reduce the amount of
insulin delivered in the meal bolus and may recommend a reduction
in the user's total daily dose of insulin. In some embodiments, the
insulin timing module 225 may deliver the meal bolus over an
extended period of time (e.g., reduce the rate of the meal bolus
but provide the bolus over a longer time, such as the extended
second portion 510 in FIG. 5). In some embodiments, the insulin
timing module 225 may deliver the meal bolus as a combination bolus
that includes a first portion that is delivered immediately and a
second portion that is delivered over an extended period.
[0041] In another example, the information related to managing
diabetes includes an indication that the user is taking a
beta-adrenergic blocking agent. Beta-adrenergic blocking agents may
increase the chance of developing either high or low blood glucose
levels and may cause a low blood glucose level to last longer than
normal. If a beta-adrenergic blocking agent is indicated, the
insulin timing module 225 may change the delivery of a meal bolus
to counteract a likelihood of a high or low blood glucose level
such as by changing the amount of insulin in the meal bolus or
delivering the meal bolus as a combination bolus. Beta-adrenergic
blocking agents also may cover up symptoms indicative of low blood
sugar. For this reasons, the insulin timing module 225 may
recommend an increase in blood glucose checks of the user.
[0042] In another example, the information related to managing
diabetes includes an indication that the user is using a
corticosteroid. Corticosteroids taken over several weeks such as by
being applied to the skin for a long period of time or injected
into a joint may increase the blood glucose level of the user. If a
corticosteroid is indicated, the insulin timing module 225 may
reduce the amount of insulin in a meal bolus.
[0043] In another example, the information related to managing
diabetes includes an indication that the user has consumed some
amount of alcohol. Such consumption can increase the effect of
insulin to lower blood glucose. If alcohol consumption is
indicated, the insulin timing module 225 may reduce the amount of
insulin in a meal bolus.
[0044] According to some embodiments, the information related to
managing diabetes of a user includes information related to the
nutrient content of the meal eaten or anticipated to be eaten by
the user. The controller 205 includes an insulin calculation module
240. Nutrient content includes an amount of fat, protein, fiber
and/or carbohydrates in a meal. The insulin calculation module 240
calculates an amount of insulin to deliver in a meal bolus of
insulin to cover an amount of carbohydrates in the meal using a
carbohydrate ratio.
[0045] A carbohydrate ratio refers to the amount of carbohydrates
covered by a unit of insulin. It is sometimes referred to as a
carbohydrate factor, or carb factor, and is typically specified as
grams of carbohydrates per unit of insulin. An insulin pump may use
the carbohydrate ratio to automatically determine a carbohydrate
insulin bolus amount required to match a number of carbohydrates
ingested by the patient, or at least to keep post-meal blood
glucose within a range that is healthy for a patient. For example,
the patient may plan to eat 70 grams of carbohydrates. If the
carbohydrate ratio is 10 grams of carbohydrates per unit of insulin
(10 g/u), the insulin pump would determine that 7 units of insulin
are required to cover the carbohydrates. An appropriate
carbohydrate ratio may vary from person to person, yet it is
important for a pump to use an appropriate carbohydrate ratio.
Descriptions of systems, devices, and methods to automatically
determine a carbohydrate ratio for an insulin pump user are found
in Blomquist, "Carbohydrate Ratio Testing Using Frequent Blood
Glucose Input," U.S. patent application Ser. No. 11/679,712, filed
Feb. 27, 2007, which is incorporated herein by reference in its
entirety.
[0046] In some embodiments, the insulin calculation module 240
calculates an amount of insulin to deliver in the meal bolus using
an amount of protein indicated in the nutrient content of the meal
and using a protein ratio. Similar to a carbohydrate ratio, a
protein ratio refers to the amount of protein covered by a unit of
insulin. In some embodiments, the insulin calculation module 240
calculates an amount of insulin to deliver in the meal bolus using
an amount of fat indicated in the nutrient content of the meal and
using a fat ratio. A fat ratio refers to the amount of fat covered
by a unit of insulin. The insulin calculation module 240 adds the
amount of insulin needed to cover the fat and/or protein to the
amount of insulin calculated to cover the carbohydrates in order to
determine the total meal bolus amount. In some embodiments, the
insulin calculation module 240 calculates the amount of insulin to
deliver by using the fiber content of the meal to adjust the bolus
amount. Typically, the carbohydrate grams of the meal that are from
un-metabolized fiber are subtracted from the total grams of
carbohydrates eaten.
[0047] According to some embodiments, the insulin timing module 225
delivers a portion of a meal bolus at or near the beginning of a
meal time period. The meal bolus may be scheduled by being
pre-programmed into the device 200 or the user may enter the meal
time through the user interface 215. The information related to
managing diabetes of a user includes a nutrient content of the meal
actually consumed. This information may be entered by the user at
the end of a meal. If the nutrient content information indicates
the partial meal bolus did not have enough insulin to cover the
meal, the insulin calculation module 240 calculates a second
portion of the meal bolus to cover the meal using the nutrient
content information. For example, assume that carbohydrate ratio
for the user is 20 grams of carbohydrates per unit of insulin (20
g/u). Assume the partial meal bolus contained one unit of insulin,
or enough to cover 20 grams of carbohydrates. If the nutrient
information indicates that the user consumed 50 grams of
carbohydrates in the meal, the insulin calculation module 240
calculates that the second portion of the meal bolus should contain
1.5 units of insulin.
[0048] If the nutrient content information indicates the partial
meal bolus had too much insulin to cover what was actually eaten,
the insulin calculation module 240 calculates an amount of
carbohydrates, to be consumed in addition to the meal, to cover the
extra insulin. For example, again assume that carbohydrate ratio
for the user is 20 grams of carbohydrates per unit of insulin (20
g/u) and the partial meal bolus contained one unit of insulin, or
enough to cover 20 grams of carbohydrates. If the nutrient
information indicates that the user only consumed 10 grams of
carbohydrates in the meal, the insulin calculation module 240
calculates that user should consume 10 more grams of carbohydrates
to cover the extra insulin in the partial meal bolus. The
controller 205 may display a recommendation and/or generate an
alert indication to the user to consume the additional
carbohydrates.
[0049] The partial meal bolus feature is useful in a situation
where the user orders meal but there is a delay between the time a
meal bolus is given and the meal actually arrives. The user takes a
partial meal bolus before the meal arrives. The user can then enter
the amount of carbohydrates that are consumed or will be consumed,
and the device calculates the remaining portion of the meal bolus
to deliver. The feature is also useful in the situation where the
insulin pump user is a child. A parent initiates a partial meal
bolus for the child at meal time. The parent then enters the
nutrient content information of the meal actually eaten by the
child and the insulin calculation module 240 calculates the second
portion of the meal bolus according to the information.
[0050] According to some embodiments, the nutrient content
information includes an indication of an amount of fast absorbing
carbohydrates. The information may also include and an amount of
slow absorbing carbohydrates in the meal. The insulin calculation
module 240 calculates an amount of insulin to deliver immediately
in a first portion of a meal bolus using an amount of fast
absorbing carbohydrates in the meal, and calculates an amount of
insulin to deliver over an extended time period using an amount of
slow absorbing carbohydrates in the meal, and/or an amount of fat
in the meal, and/or an amount of protein in the meal. The meal
bolus is delivered as a combination bolus such as those shown in
FIGS. 5 and 6. The insulin timing module 225 may time the durations
of the first and second bolus portions.
[0051] Automatic determination of an appropriate amount of insulin
in the meal bolus can assist an insulin pump user in achieving
better control of their blood glucose levels. As described above,
the delivery of insulin in a time relation to a meal may be
delivered as a change in a basal rate pattern or profile. According
to some embodiments, the information related to managing diabetes
of a user received by the input 220 includes a delivery pattern of
basal insulin to be stored in a memory associated with the
controller 205. The memory may be integral to the controller 205 or
separate from the controller 205. The insulin timing module 225
shifts at least a portion of basal insulin normally delivered
during a time period after the meal time to a time period prior to
the meal time and decreases an amount of insulin delivered after
the meal time period by the amount delivered prior to the meal.
[0052] FIG. 7 illustrates a graph 700 of an example of this basal
insulin shifting. The graph 700 represents the rate of basal
insulin delivered to the insulin pump user versus time. Prior to a
meal time, basal insulin is delivered at a first rate 705. As the
scheduled meal time approaches, the insulin timing module 225
increases the basal rate at time t.sub.1 to a second rate 710. At a
time t.sub.2 after the meal, the insulin timing module 225
decreases the basal rate to a third rate 715. The device 200
delivers insulin at the third rate 715 until time t.sub.3. After
time t.sub.3, insulin is delivered at the first basal rate 705. In
some embodiments, the amount of increase in insulin delivered
during interval t.sub.1-t.sub.2 is substantially the same as the
amount of decrease in insulin delivered during time
t.sub.2-t.sub.3.
[0053] In some embodiments, the insulin timing module 225 shifts
all of the basal insulin to be delivered during a two to three hour
period after a meal time to the hour immediately preceding the meal
time. After the meal time, the insulin timing module 225 may
suspend delivery of basal insulin until all basal insulin that was
shifted to a time prior to the meal would have been delivered by
the un-shifted basal delivery pattern. In FIG. 7, this would
increase the amount of insulin delivered during interval
t.sub.1-t.sub.2 and reduce the amount of insulin delivered during
time t.sub.2- t.sub.3 to zero.
[0054] In some embodiments, the meal times are programmed or
scheduled into the device 200 of FIG. 2, or the device 200 may
deduce when meal times occur from missed meal bolus alerts
programmed into the device. A missed meal bolus alert may be issued
by the device 200 when no meal bolus was delivered by the device
200 at a specified time. Because the meal bolus is delivered before
a meal time, the device can deduce the meal time. In some
embodiments, the device 200 provides an alert to the user of the
shifted basal rate pattern before delivering insulin according to
the new pattern. The alert may in the form of an alarm or a
display. The user then activates the shifted delivery pattern of
basal insulin according to a user response received via the user
interface 215.
[0055] In some embodiments, the insulin timing module 225 ramps the
rate at which the basal insulin is delivered prior to the meal time
period. An example is shown in the graph 800 of FIG. 8. Prior to a
meal time, basal insulin is delivered at a first rate 805. As the
scheduled meal time approaches, the insulin timing module 225 ramps
the basal rate beginning at time t.sub.1 up to a second rate 810 at
time t.sub.2. After the meal, the insulin timing module 225
decreases the basal rate to a third rate 815. In some embodiments,
the insulin timing module 225 ramps the basal rate down to the
third rate 815 until time t.sub.3. The device 200 delivers insulin
at the third rate 815 until time t.sub.4. After time t.sub.3,
insulin is delivered at the first basal rate 805. In some
embodiments, the amount of increase in insulin delivered during
interval t.sub.1-t.sub.3 is substantially the same as the amount of
decrease in insulin delivered during time t.sub.3-t.sub.4.
Avoiding Alarm Fatigue
[0056] An insulin pump may provide an alarm or other kind of alert
to prompt the user to do certain actions that help ensure the user
is making effective use of their pump. These alerts may include a
reminder to the user to initiate a blood glucose measurement.
Recurrent blood glucose measurements may be necessary to give a
patient a good overall view of their blood glucose management. An
alert to measure blood glucose may be generated a timed interval
after a meal, after a correction bolus has been delivered, or after
the user has had a high or low blood glucose reading. Because it is
optional for the user to test their blood glucose when these alerts
occur, many users get in the habit of routinely canceling the alert
and not checking their blood glucose. This is sometimes referred to
as alarm fatigue. Thus, it is desirable to make it more difficult
or less likely for the user to ignore the alert.
[0057] FIG. 9 is a block diagram of portions of an embodiment of a
blood glucose (BG) management device 900 to reduce alarm fatigue.
The device 900 includes a controller 905 communicatively coupled to
a user interface 915 and an input 920. The input 920 receives blood
glucose information into the device 900. The information includes a
blood glucose level of the user. The controller 905 includes an
alert module 950 to provide an alert to the user via the user
interface 915. The alert notifies the user to check their blood
glucose level.
[0058] The controller 905 also includes a blood glucose stability
module 955 to calculate a measure of a past stability of the blood
glucose level of the user using at least a portion of past blood
glucose levels. In some embodiments, the blood glucose stability
module 955 trends the measure. In some embodiments, the blood
glucose stability module 955 measures a central tendency of the
blood glucose level of the user, such as an average blood glucose
value or a median blood glucose value for example. In some
embodiments, the blood glucose stability module 955 measures a
maximum blood glucose level of the user. In some embodiments, the
blood glucose stability module 955 measures a minimum blood glucose
level of the user. In some embodiments, the blood glucose stability
module 955 measures a standard deviation of the blood glucose level
of the user.
[0059] The controller 905 also includes a randomization module 960.
According to the measure of the past blood glucose stability, the
randomization module 960 randomizes the alert function of the
device 900. For example, the randomization module 960 may set the
likelihood of the device 900 generating an alarm based on the
historical stability of the blood glucose level of the user. Users
that have stable blood glucose levels are rewarded with fewer
alerts to check their blood glucose level.
[0060] The randomization module 960 may randomize a type of alert
to provide or may randomize whether to provide the alert to the
user at all. For example, the device 900 may randomize whether to
generate a Check Blood Glucose alarm after eating or after taking a
correction bolus. The randomization module 960 may randomize a
method needed to deactivate an alert or alarm by randomizing a user
input to the user interface 915 needed to reset a provided
alert.
[0061] In some embodiments, the alert module 950 includes a timer
945, and the alert module 950 provides an alert a timed duration
after the blood glucose information indicates that the blood
glucose level of the user differs from a target blood glucose level
by a threshold value. In some embodiments, the device 900 includes
a communication port 935 coupled to the input 920 and the
communication port configured to receive the blood glucose
information from a second separate device. For example, the second
device may be a blood glucose monitor, or a device that
communicates blood glucose information received from a blood
glucose monitor. In some embodiments, the communication port 935 is
a wireless port such as an IR port or an RF port. In some
embodiments, the communication port 935 is a wired port, such as a
serial port for example.
[0062] FIG. 10 is a block diagram of portions of another embodiment
of a BG management device 1000 to reduce alarm fatigue. The device
1000 includes a controller 1005, a user interface 1015, and an
input 1020. The controller 1005 includes an alert module 1050, a
blood glucose stability module 1055, and a randomization module
1060. In some embodiments, the user interface 1015 includes a
display 1030 and the alert module 1050 provides the alert through
the display 1030. In some embodiments, the user interface 1015
includes a speaker 1034, and the randomization module 1060
randomizes an audible indication of an alert, or an audible aspect
of the alert, via the user interface 1015. In some embodiments, the
randomization module 1060 randomizes whether the alert is visual or
audible. In some embodiments, the user interface 1015 includes a
plurality of keys 1032 to be pressed by a user of the device 1000.
The randomization module 1060 randomizes a sequence of key presses
needed to reset a generated alert.
[0063] According to some embodiments, the BG management device 1000
is an insulin pump and includes a pump 1010 to deliver insulin. The
alert module 1050 includes a timer 1045 and the alert module is
configured to provide an alert (e.g., to check the blood glucose
level) a timed duration after delivery of a bolus of insulin.
[0064] According to some embodiments, the BG management device 1000
includes a blood glucose monitor 1037 communicatively coupled to
the input 1020 and the input 1020 receives the blood glucose
information from the blood glucose monitor. In some embodiments,
the user interface 1015 is configured to receive manual entry of
the blood glucose information from the user. In some embodiments,
the user interface 1015 includes a display 1030. The controller
1005 prompts the user, via the display 1030, to begin a blood
glucose measurement using a second separate device.
[0065] FIG. 11 is a flow diagram of a method 1100 of reducing alarm
fatigue in a BG management device. At block 1105, it is determined
that an alert to check blood glucose level is to be provided to a
user of the BG management device. This may be because the device
determines the blood glucose level of the device user differs from
a target blood glucose level by more than a specified threshold
value. At block 1110, a measure of a past stability of the blood
glucose level of the user is calculated by the BG management
device.
[0066] At block 1115, the device randomly determines, according to
the measure of the past stability, at least one of whether to
provide the alert to the user, a type of the alert to provide, or a
method of receiving an alert reset into the BG management device.
Randomly changing the tone or changing the key input needed to
cancel the alarm or alert makes it less likely the user will cancel
the alarm out of habit and makes it more likely to use the alert
feature.
Scoring Insulin Pump Use
[0067] It would be helpful to an insulin pump user if the insulin
pump were able to communicate how well the person was using the
device, and to communicate advice on how to improve their use. This
may increase efficacy of the pump and thereby increase the benefit
to the patient.
[0068] FIG. 12 is a block diagram of portions of an embodiment of a
device 1200 that helps a patient improve their use of an insulin
pump included in the device 1200. The device 1200 includes a
controller 1205 communicatively coupled to a pump 1210 to deliver
insulin, a user interface 1215, and a memory 1240. The memory 1240
is to store guideline parameters related to use of the device 1200.
The guideline parameters are ideal parameters, or range of values
for a parameter, that an insulin pump user would meet if the user
were making the best use of their insulin pump. The guideline
parameters may include default parameters and/or include parameters
programmed into the device 1200 by a diabetes professional. The
programming may be done using the user interface 1215 or by
communicating with the device 1200 using a second separate device
via a communication port coupled to the input 1220. Examples of
parameters include parameters related to the user checking their
blood glucose, parameters related to insulin cartridge use,
parameters related to the dietary habits of the user, and
parameters related to using the features of the insulin pump.
[0069] The controller 1205 includes a comparison module 1225 and a
scoring module 1230. The comparison module 1225 monitors the
patient's use of the device 1200 and compares parameters related to
the patient's use to the guideline parameters stored in memory
1240. The scoring module 1230 calculates a score based on the
monitored patient use and is indicative of the efficacy of the
patient's insulin pump use. The score reflects how well the patient
is following best practices for insulin pump users. Based on the
score, the controller 1205 communicates advice to the user on how
to increase pump efficacy (e.g., how to bring the values of the
patient's use parameters toward the guideline parameter values). A
higher score indicates that the patient is following guidelines
established by their health care provider (e.g., a diabetes
professional) and indicates the patient is following best practice
in controlling their blood glucose.
[0070] In some embodiments, the user interface 1215 includes a
display 1245. The controller 1205 may prompt the user, via the
display, to begin a blood glucose measurement using a separate
device. The user interface 1215 may include keys for receiving
manual entry of the blood glucose information into the device from
the user.
[0071] According to some embodiments, the stored guideline
parameters are related to a user entering blood glucose readings
into the device 1200. In some embodiments, the stored guideline
parameters include the frequency with which blood glucose readings
are entered into the device. The comparison module 1225 records
(e.g., stores) and compares the frequency with which blood glucose
readings are entered into the device 1200 by a user to the
guideline frequency stored in memory. The scoring module 1230
determines a score based on how closely the user's frequency of
entering readings matches the guideline frequency. In some
embodiments, the stored guideline parameters include the timing of
the blood glucose readings. For example, the guideline parameters
may specify one or more times of day that the user is to enter a
blood glucose reading. The comparison module 1225 compares the
actual times the user enters blood glucose readings to the stored
parameter guideline times, and the scoring module 1230 determines a
score based on how closely the user's times match the guideline
times.
[0072] According to some embodiments, the stored guideline
parameters are related to the dietary habits of the user. In some
embodiments, the stored guideline parameters include an amount of
carbohydrates, such as a guideline amount for the user to eat
during a scheduled meal for example. The comparison module 1225
compares the amount of carbohydrates, entered into the device 1200
as having been eaten by the user, to the stored guideline amount of
carbohydrates. In some embodiments, the stored guideline parameters
include a number of between meal snacks. The comparison module 1225
compares the number of between meal snacks, entered into the device
1200 as having been eaten by the user, to a stored guideline number
of between meal snacks. The scoring module 1230 scores the dietary
habits of the user accordingly.
[0073] In some embodiments, the stored guideline parameters include
a difference value in the timing of patient meal times. The
comparison module 1225 compares actual meal times entered into the
device 1200 by a user to scheduled meal times and determines any
differences in the meal times. The comparison module 1225 then
compares to one or more time difference values in the meal times to
the stored guideline meal time difference value. The scoring module
1230 assigns a higher score for consistency in meal times higher
than for a large variation in meal times. In some embodiments, the
stored guideline parameters include the frequency with which a user
fails to initiate a meal bolus before eating. The comparison module
records whether a user fails to take a meal bolus before eating.
The comparison module 1225 compares the frequency that meal boluses
are missed to a stored guideline value for an allowed frequency of
missed meal boluses. The scoring module 1230 generates a lower
score for more missed meal boluses.
[0074] According to some embodiments, the stored guideline
parameters are related to insulin cartridge use and/or infusion set
use. In some embodiments, the stored guideline parameters include
the frequency with which the user changes insulin cartridges. The
device 1200 may include a circuit to detect when the cartridge is
changed. The comparison module 1225 compares the frequency of
actual cartridge changes by a user to the stored guideline insulin
cartridge change frequency value. The scoring module 1230 generates
higher score for how closely the user's frequency of changes
matches the stored guideline. Not changing the insulin cartridge
often enough risks insulin clotting or losing effectiveness of the
insulin due to exposure to higher temperatures.
[0075] In some embodiments, the stored guideline parameters include
the frequency with which the user changes infusion sets. The
comparison module 1225 compares the frequency of actual infusion
set changes as indicated by a user to the stored guideline infusion
set change frequency value. The scoring module 1230 generates
higher score for how closely the user's frequency of actual
infusion set changes matches the stored guideline. Not changing the
infusion set often enough may result in infections.
[0076] In some embodiments, the stored guideline is the frequency
that insulin cartridges for the device 1200 become empty, thereby
interrupting therapy. The comparison module 1225 compares the
frequency that the user allows insulin cartridges to empty to the
stored guideline frequency value. Allowing insulin cartridges to
empty often may indicate that the user is not paying proper
attention to their device 1200 and the scoring module 1230 provides
a higher score the closer the actual frequency that insulin
cartridges become empty matches the guideline frequency. In some
embodiments, the stored guideline parameters include the difference
in timing between insulin cartridge changes. The comparison module
1225 compares the difference in times between insulin cartridge
changes to a stored guideline difference value. The scoring module
1230 would score consistency in insulin cartridge changes higher
than a large variation in time between insulin cartridge
changes.
[0077] According to some embodiments, the stored guideline
parameters are related to use of the features of the device 1200.
In some embodiments, the stored guideline parameters include the
frequency that a user uses the test features of the device 1200.
For example, the device 1200 may include a carbohydrate ratio test
feature. Descriptions of devices and methods that perform a
carbohydrate ratio test are found in Blomquist, "Carbohydrate Ratio
Testing Using Frequent Blood Glucose Input," U.S. patent
application Ser. No. 11/679,712, filed Feb. 27, 2007, which is
incorporated herein by reference in its entirety. The device 1200
may include a basal rate test feature. Descriptions of devices and
methods that perform a basal rate test are found in Blomquist et
al., "Basal Rate Testing Using Frequent Blood Glucose Input," U.S.
patent application Ser. No. 11/685,617, filed Mar. 13, 2007, which
is incorporated herein by reference in its entirety. The device
1200 may include a correction factor test feature. Descriptions of
devices and methods that perform a correction factor test are found
in Blomquist et al., "Correction Factor Testing Using Frequent
Blood Glucose Input," U.S. patent application Ser. No. 11/626,653,
filed Jan. 24, 2007, which is incorporated herein by reference in
its entirety. The comparison module 1225 compares the frequency
with which a user uses a test feature of the device 1200 and
compares the frequency to a stored guideline device test frequency
value. The scoring module 1230 generates a higher score if the user
uses the test features more often.
[0078] In some embodiments, the device 1200 includes a feature that
generates a device report. The controller 1205 is configured to
store events in the memory 1240. Examples of such events include
historical insulin delivery information and recorded use
parameters. In some embodiments, the controller 1205 displays the
report using a display 1245 included in the device 1200. In some
embodiments, device 1200 includes communication port and the
controller 1205 communicates information to a second separate
device via the communication port for formatting and display or
printing of the report. The stored guideline parameters include the
frequency with which a user views a generated report. The
comparison module 1225 compares the frequency with which a user
views a pump generated report to a stored report-view frequency
value.
[0079] In some embodiments, the device includes one or more alert
features. These alerts may include a reminder to the user to
initiate a blood glucose measurement (e.g., after a meal of after a
correction bolus), or after the user has had a high or low blood
glucose reading. The user interface 1215 may include a display 1245
to provide a visual alert, a speaker or transducer to provide an
audible alert, and/or a mechanism to provide a vibratory alert.
[0080] In some embodiments, the stored guideline parameters include
an alert response time. The comparison module 1225 determines the
time from when an alert is generated by the device 1200 to the time
when the user responds to the alert. The comparison module 1225
compares the user response time to the stored guideline response
time value. The scoring module 1230 generates a higher score if the
user's response times are within the guideline response time. In
some embodiments, the stored guideline parameters include the total
time that the device 1200 may be inoperative. The comparison module
1225 compares the total time that a user renders the device 1200
inoperative to the guideline time. The scoring module 1230
generates a higher score the more often the user uses the device
1200.
[0081] In some embodiments, the device 1200 includes an input 1220.
Blood glucose information is received into the device 1200 via the
input 1220. The blood glucose information may include one or more
blood glucose levels of the user. In some embodiments, the device
1200 includes a blood glucose monitor communicatively coupled to
the input 1220. The blood glucose monitor may be communicatively
coupled via a wireless port or a wired port. The blood glucose
monitor may be a continuous blood glucose monitor. In some
embodiments, the device 1200 includes a communication port coupled
to the input 1220 and configured to receive blood glucose
information from a second separate device. The communication port
may be a wireless communication port (e.g., IR or RF) or may be a
wired port (e.g., a serial port).
[0082] The comparison module 1225 monitors the blood glucose level
of the patient using the information. In some embodiments, the
comparison module 1225 determines and monitors a central tendency
of the blood glucose level of the user from the information, such
as the average value or median value for example. In some
embodiments, the comparison module 1225 uses the blood glucose
information to determine and monitor a standard deviation of the
user's blood glucose level. In some embodiments, the comparison
module 1225 uses the blood glucose information to determine and
monitor an amount of insulin delivered in any correction boluses as
a percentage of TDD. As described previously, the input 1220 may be
communicatively coupled to the input and the blood glucose
information is received by manual entry of the information into the
device 1200.
[0083] According to some embodiments, the stored guideline
parameters are related to the user's management of their blood
glucose level. In some embodiments, the stored guideline parameters
may include a number of times that the user is allowed to neglect
taking a correction bolus when the blood glucose information
indicates that the blood glucose of the patient exceeds a target
blood glucose level by a threshold value. Of course, the stored
number of times may be zero. The comparison module 1225 compares
the number of times that the patient did not initiate a correction
bolus to the stored guideline number of times. The scoring module
1230 generates a higher score the closer the actual number is to
the stored number.
[0084] In some embodiments, the stored guideline parameters are
related to the user's rechecking their blood glucose some interval
after receiving a correction bolus, or some interval after treating
a low blood glucose level. The comparison module 1225 compares the
number of times that the patient failed to recheck their blood
glucose to the stored guideline number of times. In some
embodiments, the stored guideline parameters include a number of
times that the user is allowed to neglect to recheck blood glucose
after a bolus of insulin is delivered by the device 1200. The
comparison module 1225 compares the number of times that the
patient failed to recheck their blood glucose to the stored
guideline number of times. The scoring module 1230 generates a
higher score the closer the actual number is to the stored
number.
[0085] According to some embodiments, the scoring module 1230
trends the calculated score. The controller 1205 may display the
score and/or the score trend on the display 1245 when prompted to
do so (e.g., through the user interface 1215). Such a trend may be
included in a device-generated report. When calculating the score,
the scoring module 1230 assign different weights to outcomes of the
comparisons described. For example, the scoring module may assign a
higher weight to the user making consistent blood glucose
measurements higher than the user using test features of the
device.
[0086] The controller 1205 communicates advice to the user on how
to increase pump efficacy based on the calculated score. For
example, if the controller 1205 determines that there is a poor
score for taking meal boluses, the controller 1205 may display to
the user that the patient's overall use of the device may be
improved by paying more attention to meal boluses. In some
embodiments, the device 1200 includes a communication port and the
advice on how to increase pump efficacy is communicated to a second
separate device.
[0087] In some embodiments, the scoring can be implemented into a
game. This may be useful to encourage young insulin pump users
(e.g., children) to become interested in learning about their pump.
The score may be communicated to a second separate device (e.g., a
computer). The second device could print certificates when the user
meets or exceeds one or more threshold scores. The device 1200 or
the second device can offer advice on how to increase the pump
user's score. The certificates could be redeemable (e.g., by the
manufacturer).
[0088] FIG. 13 is a flow diagram of a method 1300 of helping a
patient improve their use of the insulin pump using a medical
device. At block 1305, patient use of a device is monitored. The
device includes a pump configured to deliver insulin. The patient
use may be monitored using the insulin pump device, and the
monitoring includes comparing patient use parameters to stored
guideline parameters. Examples of the parameters include parameters
related to a user entering blood glucose readings into the insulin
pump, parameters related to the dietary habits of the user,
parameters related to insulin cartridge use, parameters related to
use of the features of the insulin pump, and parameters related to
the user's management of their blood glucose level.
[0089] At block 1310, the medical device calculates a score based
on the monitored patient use. The medical device may weigh some
parameters higher than others when calculating the score. At block
1315, advice is communicated to the user or patient on how to
increase pump efficacy.
Shifting Insulin Therapy Parameters in Time
[0090] An insulin pump provides insulin therapy to a user using one
or more delivery parameters. An example of such a parameter is a
basal rate pattern. Basal rate refers to a type of twenty-four hour
background infusion of insulin by an insulin pump that mimics the
continuous background release of insulin from a normal pancreas. It
is the rate of insulin delivery the patient normally needs
independent of the consumption of meals. The basal rate is
typically specified in insulin units per hour (u/hr). The variation
in the rate as a function of time can be referred to as a basal
rate pattern or profile. Sometimes it is desirable to vary the
basal rate pattern throughout the day to deliver a different basal
rate according to a patient's needs, such as delivering basal
insulin at a different rate when the insulin pump user is sleeping
than when the user is awake. Other parameters may also have
different optimum values at different times of the day.
[0091] A change in the user's schedule may cause the appropriate
values of the delivery parameters to change. If the pump user
travels and crosses time zones, their circadian clock doesn't
immediately adjust to the new time, because, as with jet lag, it
takes time for the user's body to adjust. Consequently, the
delivery parameters may no longer be programmed appropriately. If
the user adjusts the clock on their insulin pump to match the new
time zone, they will instantly adjust their basal rate pattern to
the new time. This may not be appropriate because the user's body
clock will be expecting basal insulin according to the old time
zone. For example, if the user travels from the Pacific Time Zone
to the Eastern Time Zone and adjusts the clock on their insulin
pump three hours later, extra basal insulin scheduled for delivery
at 2:00 AM will be delivered at 2:00 AM in the Eastern Time Zone
while the user's body clock acts as though it is still 11:00
PM.
[0092] A better approach would be to not instantly shift the basal
rate pattern to the new time when the insulin pump clock is
adjusted. Instead the basal rate pattern should be gradually
shifted (e.g., once per day) until the basal rate pattern was
synchronized to the local time. A similar adjustment would be made
on the return home to the original time zone. On a short trip, the
basal rate pattern may not be fully adjusted to the new time.
Additionally, the basal rate pattern could be gradually adjusted
anytime the clock on the insulin pump was changed, such as during a
change to or from daylight savings time.
[0093] FIG. 14 is a block diagram of portions of an embodiment of a
device 1400 that shifts insulin delivery parameters according to a
change in the schedule of a user of the device 1400. The device
1400 includes a controller 1405 communicatively coupled to a pump
1410 configured to deliver insulin, a user interface 1415, and a
memory 1440. The memory 1440 stores a delivery pattern of basal
insulin. Time change information is received into the device 1400
through the user interface 1415. The user interface 1415 may
include one or more keys or buttons for the user to enter the time
change information. The controller 1405 includes a timing module
1425 configured to shift the delivery pattern of basal insulin in
time according to the received information.
[0094] In some embodiments, the time change information includes
travel information of the user. The travel information may include
a destination of the user, or only the change in time zones the
travel will involve. The travel information may include a travel
departure time and travel return time. The timing module 1425
shifts the delivery pattern of basal insulin in time according to a
destination time zone indicated in the travel information, and may
restore the delivery pattern to its original time based on the
travel return time. For example, in some people there is a "dawn
phenomenon" where extra insulin is needed near 1 AM or 2 AM. Such a
person may have a basal rate pattern that increases at that time.
If the user travels from the Eastern Time Zone to the Pacific Time
Zone, the timing module 1425 shifts the delivery pattern of basal
insulin three hours later. Thus, if the basal rate pattern includes
the increase during the early morning hours, the timing module 1425
would shift the increase later in time by three hours. If the
travel information includes a return time, the timing module 1425
would shift the back to the original time three hours earlier upon
the return time.
[0095] In some embodiments, the timing module 1425 shifts the
delivery pattern of basal insulin by a specified amount of time per
time period (e.g., by a fraction of an hour once per day, or a
number of hours once per day) until the delivery pattern matches
the destination time zone, and shifts the delivery pattern of basal
insulin back by the same or a different amount of time until the
delivery pattern matches the return time zone according to the
return time. For example, if the user travels from the Eastern Time
Zone to the Pacific Time Zone, the timing module 1425 shifts the
delivery pattern of basal insulin by one-half hour per day until
the delivery pattern is shifted three hours later. When the user
returns as indicated by the return time or by an indication
provided by the user via the user interface, the timing module 1425
begins shifting the delivery pattern earlier by a specified amount
of time (e.g., the half hour once per day in the example) until the
delivery pattern return to its original time.
[0096] In some embodiments, the time change information includes a
change in local time, such as a change to or from daylight savings
time. The timing module 1425 shifts the delivery pattern by a
specified amount of time per time period until the delivery pattern
matches the time change.
[0097] In some embodiments, the memory 1440 includes an indication
of a sleep segment of the basal insulin delivery pattern. For
example, the delivery pattern may repeat every twenty-four hours
and a portion of the twenty-four hour period is designated as a
sleep segment. Based on the time change information, the timing
module 1425 shifts the sleep segment of the basal insulin delivery
pattern.
[0098] According to some embodiments, the memory 1440 also stores
other parameters related to the delivery of insulin. The controller
1405 may be configured (e.g., by programming) to change the value
of these parameters according to the time of day. The insulin
therapy for the user may improve by shifting these parameters in
time according to a change in schedule of the user (e.g., due to
travel). In some embodiments, the device 1400 may use a different
correction factor at a different time of the day according to a
time of day schedule. The timing module 1425 may shift the time of
day schedule for the correction factor according to the time change
information received into the device 1400 and stored in the memory
1440. In some embodiments, the device 1400 may use a different
carbohydrate ratio at a different time of the day according to a
time of day schedule. The timing module 1425 may shift the time of
day schedule for the correction factor according to the travel
information received into the device 1400.
[0099] FIG. 15 is a flow diagram of an embodiment of a method 1500
to shift insulin delivery parameters according to a change in the
schedule of a user of an insulin pump. At block 1505, information
is received into a device having an insulin pump. The information
may relate to local time change of a user of the insulin pump. At
block 1510, the insulin pump device automatically shifts a delivery
pattern of basal insulin in time according to the information
received into the device. This insulin pump device may be
configured to automatically make the shift by logic circuitry
implemented in the device. The logic circuitry may include
hardware, firmware, or software or any combination of hardware,
firmware, or software.
Auto-Adjustment of Blood Glucose Testing Time
[0100] Proper management of blood glucose by insulin pump users
includes periodic measurement of the user's blood glucose. For
example, this may involve the user taking a blood glucose
measurement to determine whether a correction bolus is needed or
whether a meal bolus was effective. Testing blood glucose at proper
times may give the patient a more accurate picture of their blood
glucose control. This can be done by determining statistically
significant, or historically significant, blood glucose sampling
times and prompting the patient to measure their blood glucose at
these times will give the patient that more accurate picture of
their blood glucose control.
[0101] FIG. 16 is a block diagram of portions of an embodiment of a
device 1600 to automatically determine blood glucose testing times
for an insulin pump user. The device 1600 includes a controller
1605 communicatively coupled to a user interface 1615 and an input
1620. The input 1620 receives blood glucose data of the insulin
pump user into the device 1600. The blood glucose data is obtained
during a number of specified blood glucose testing times. The
controller 1605 includes a blood glucose data module 1625.
[0102] The blood glucose data module 1625 calculates a measure of
the user's blood glucose variability from the blood glucose data.
In some embodiments, the blood glucose data module calculates a
measure of statistical variability of the user's blood glucose such
as one or more of a standard deviation of the blood glucose data,
an average deviation of the blood glucose data, a variance of the
blood glucose data, or a range of the blood glucose data. The
controller 1605 adjusts a blood glucose testing time in response to
the measure of blood glucose variability. For example, the measure
of blood glucose variability may indicate that the user's blood
glucose level is stable at certain times of the day and varies at
other times of the day. The controller 1605 automatically adjusts
one or more testing times to cover the period of greater
variability.
[0103] In some embodiments, the device 1600 includes a display
1630. The controller 1605 prompts the user, via the display 1630,
to initiate a blood glucose test. In some embodiments, the device
includes a speaker or transducer communicatively coupled to the
controller 1605 and provides an audible prompt to the user. The
controller 1605 adjusts the blood glucose testing times by changing
the times that it prompts the user to initiate a test.
[0104] According to some embodiments, the controller 1605 includes
a comparison module 1655. The comparison module 1655 compares the
measure of blood glucose variability to a threshold blood glucose
variability value. The controller 1605 increases the number of
blood glucose testing times if the measure of blood glucose
variability exceeds a blood glucose variability target value by
more than a first threshold blood glucose variability value. The
controller 1605 decreases the number of blood glucose testing times
if the measure of blood glucose variability is less than the blood
glucose variability target value by more than a second threshold
blood glucose variability value. This rewards the user with less
testing times if the user is managing to keep their blood glucose
relatively stable at a normal level.
[0105] In some embodiments, the device 1600 includes a memory 1640
communicatively coupled to the controller 1605. The memory 1640
stores an indication of a user preference for a blood glucose
testing time. The controller 1600 adjusts the blood glucose testing
time according to the indication. The indication may specify that
fewer tests be requested by the device 1600 during certain times of
the day. For example, the patient may specify that the device 1600
may request no more than two tests per week between the hours of
11:30 PM and 6:00 AM. The indication may be programmed into the
device via the user interface 1615. The device 1600 limits the
request for a blood glucose test as indicated even though the blood
glucose data may show significant variation during that time.
[0106] In some embodiments, the controller 1605 creates or updates
a schedule of a plurality of blood glucose testing times according
to the patient indication and/or the measure of blood glucose
variability provided by the blood glucose data module 1625. The
schedule may be stored in memory 1640.
[0107] FIG. 17 is a graphical representation of an example of a
schedule 1700 or plan of blood glucose testing times. A circle 1705
in the schedule indicates a device 1600 prompt for user to initiate
a blood glucose test. The schedule 1700 may be created by the
controller 1605 and stored in memory 1640, or an initial schedule
1700 may be programmed into the memory 1640 (e.g., by a care
provider) and the controller 1605 adjusts the blood glucose testing
times in the schedule 1700 according to the measure of blood
glucose variability and/or indicated patient preferences. The
schedule 1700 shown illustrates six test times per day over a
period of five days, and the prompts are shown in relation to meal
times and sleep times of the patient. Throughout the five days, the
six testing times are staggered on different days to obtain blood
glucose data at various times. The number of days and number of
tests per day may be indicated by patient preference in the memory
1640. For the example shown, the controller 1605 may have created
the schedule 1700 due to a patient indication of no more than five
days of testing per week, no more than six tests per day, and no
more than three overnight tests per week. The controller 1605
schedules the testing times based on the preferences and on the
historical variation in blood glucose of the patient.
[0108] As additional blood glucose data is collected. The
controller 1605 may make further adjustments to the schedule 1700.
Based on the blood glucose variability, the controller 1605 may
change the testing times, add testing times (unless disallowed by
preferences), or subtract testing times (as indicated 1710 on day
5). The blood glucose testing plan helps the patient to have a more
comprehensive picture of their daily blood glucose by changing the
times that the blood glucose tests are requested. According to some
embodiments, the device 1600 is a blood glucose monitor. The device
1600 prompts the user to initiate a blood glucose test, such as via
the display 1630 for example.
[0109] FIG. 18 is a block diagram of portions of another embodiment
of a device 1800 to automatically determine blood glucose testing
times for an insulin pump user. The device 1800 includes a
controller 1805, a user interface 1815, and an input 1820. The
device 1800 also includes a pump 1810 to deliver insulin
communicatively coupled to the controller 1805. The input 1820
receives blood glucose data of the insulin pump user into the
device 1800. The controller 1805 includes a blood glucose data
module 1825 to calculate a measure of the user's blood glucose
variability from the blood glucose data.
[0110] In some embodiments, the controller 1805 adjusts the blood
glucose testing time in response to the measure of blood glucose
variability and according to times of insulin delivery. For
example, the controller 1805 may schedule a blood glucose testing
time to occur a timed duration after the insulin pump user
initiates a meal bolus. This may be useful to monitor whether the
meal bolus properly controls the user's blood glucose after meal
time. In another example, the controller 1805 may schedule a blood
glucose testing time to occur a timed duration after a change to a
basal insulin rate pattern. This may be useful to monitor the
effect of an increase or decrease in basal rate on the user's blood
glucose.
[0111] In some embodiments, the user interface 1815 includes a
display 1830. To obtain blood glucose data the controller 1805
prompts the insulin pump user, via the display 1830, to test blood
glucose using a separate device. The controller 1805 adjusts the
blood glucose testing times by prompting the user to initiate a
blood glucose measurement at a different time. In some embodiments,
the user interface 1815 includes one or more keys or buttons, and
the user interface 1815 and the input 1820 are configured to
receive the blood glucose data by manual entry of the data by the
user.
[0112] In some embodiments, the device 1800 includes a
communication port 1835 communicatively coupled to the input 1820
as shown in FIG. 16. The communication port 1635 may be a wireless
port (e.g., an IR or RF port) or a wired port (e.g., a serial
port). The controller 1805, 1605 receives the blood glucose data
via the communication port 1635 from a separate device (e.g., a
blood glucose monitor). The controller 1805, 1605 adjusts the blood
glucose testing times by communicating a new testing time via the
communication to the separate device, or by providing a prompt for
the user to initiate a blood glucose test using the separate
device.
[0113] In some embodiments, the device 1800 includes a blood
glucose monitor 1837 communicatively coupled to the input 1820. The
device 1800 receives blood glucose data, via the input 1820, from
the blood glucose monitor 1837. In some embodiments, controller
1805 adjusts the blood glucose testing times by generating a prompt
to the user to initiate a blood glucose measurement using the blood
glucose monitor.
[0114] FIG. 19 is a flow diagram of portions of method 1900 to
automatically determine blood glucose testing times for an insulin
pump user. At block 1905, blood glucose data of a user of an
insulin pump is received into a blood glucose (BG) management
device. In some embodiments, the BG management device includes an
insulin pump. In some embodiments, the BG management device
includes a blood glucose monitor. The blood glucose data is
obtained from the user during a number of specified blood glucose
testing times.
[0115] At block 1910, the BG management device calculates a measure
of blood glucose level variability from the blood glucose data.
Examples of the variability measurement include a standard
deviation of the blood glucose data, an average deviation of the
blood glucose data, a variance of the blood glucose data, a range
of the blood glucose data, or combinations of the variability
measurements.
[0116] At block 1915, the BG management device adjusts a blood
glucose testing time in response to the measure of blood glucose
variability. In some embodiments, the BG management device adjusts
a testing time by generating a prompt to initiate testing at an
adjusted time. In some embodiments, the BG management device
adjusts a testing time by communicating a prompt to initiate a test
or measurement to a blood glucose monitor included in the BG
management device or included in separate device.
[0117] If the blood glucose testing times determined by the BG
management device become statistically significant over time, the
BG management device helps a patient obtain a better view of their
overall blood glucose control.
[0118] The above detailed description includes references to the
accompanying drawings, which form a part of the detailed
description. The drawings show, by way of illustration, specific
embodiments in which the invention can be practiced. These
embodiments are also referred to herein as "examples." All
publications, patents, and patent documents referred to in this
document are incorporated by reference herein in their entirety, as
though individually incorporated by reference. In the event of
inconsistent usages between this document and those documents so
incorporated by reference, the usage in the incorporated
reference(s) should be considered supplementary to that of this
document; for irreconcilable inconsistencies, the usage in this
document controls.
[0119] In this document, the terms "a" or "an" are used, as is
common in patent documents, to include one or more than one. In
this document, the term "or" is used to refer to a nonexclusive or,
such that "A or B" includes "A but not B," "B but not A," and "A
and B," unless otherwise indicated.
[0120] It is to be understood that the above description is
intended to be illustrative, and not restrictive. For example, the
above-described embodiments (and/or aspects thereof) may be used in
combination with each other. Many other embodiments will be
apparent to those of skill in the art upon reviewing the above
description. The scope of the invention should, therefore, be
determined with reference to the appended claims, along with the
full scope of equivalents to which such claims are entitled. In the
appended claims, the terms "including" and "in which" are used as
the plain-English equivalents of the respective terms "comprising"
and "wherein." Also, in the following claims, the terms "including"
and "comprising" are open-ended, that is, a system, device,
article, or process that includes elements in addition to those
listed after such a term in a claim are still deemed to fall within
the scope of that claim. Moreover, in the following claims, the
terms "first," "second," and "third," etc. are used merely as
labels, and are not intended to impose numerical requirements on
their objects.
[0121] The Abstract of the Disclosure is provided to comply with 37
C.F.R. .sctn.1.72(b), requiring an abstract that will allow the
reader to quickly ascertain the nature of the technical disclosure.
It is submitted with the understanding that it will not be used to
interpret or limit the scope or meaning of the claims. In addition,
in the foregoing Detailed Description, it can be seen that various
features are grouped together in a single embodiment for the
purpose of streamlining the disclosure. This method of disclosure
is not to be interpreted as reflecting an intention that the
claimed embodiments require more features than are expressly
recited in each claim. Rather, as the following claims reflect,
inventive subject matter lies in less than all features of a single
disclosed embodiment. Thus the following claims are hereby
incorporated into the Detailed Description, with each claim
standing on its own.
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