US2009177147A1PendingUtilityA1
Insulin pump with insulin therapy coaching
Est. expiryJan 7, 2028(~1.5 yrs left)· nominal 20-yr term from priority
A61M 2005/14208A61M 5/14244A61M 5/1723A61M 2202/0007A61M 5/142A61B 5/746A61M 2230/201A61M 2205/3327A61B 5/4836G16Z 99/00A61B 5/14532G16H 20/17G16H 70/20
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Claims
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.
Claims
exact text as granted — not AI-modified1 . 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.Cited by (0)
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