US20080228056A1 - Basal rate testing using frequent blood glucose input - Google Patents

Basal rate testing using frequent blood glucose input Download PDF

Info

Publication number
US20080228056A1
US20080228056A1 US11/685,617 US68561707A US2008228056A1 US 20080228056 A1 US20080228056 A1 US 20080228056A1 US 68561707 A US68561707 A US 68561707A US 2008228056 A1 US2008228056 A1 US 2008228056A1
Authority
US
United States
Prior art keywords
insulin
blood glucose
basal
delivered
configured
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/685,617
Inventor
Michael Blomquist
Thomas Alan Savard
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tandem Diabetes Care Inc
Original Assignee
Smiths Medical ASD Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smiths Medical ASD Inc filed Critical Smiths Medical ASD Inc
Priority to US11/685,617 priority Critical patent/US20080228056A1/en
Assigned to SMITHS MEDICAL MD, INC. reassignment SMITHS MEDICAL MD, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BLOMQUIST, MICHAEL, SAVARD, THOMAS ALAN
Publication of US20080228056A1 publication Critical patent/US20080228056A1/en
Assigned to SMITHS MEDICAL ASD, INC. reassignment SMITHS MEDICAL ASD, INC. MERGER (SEE DOCUMENT FOR DETAILS). Assignors: SMITHS MEDICAL MD, INC.
Assigned to TANDEM DIABETES CARE, INC. reassignment TANDEM DIABETES CARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SMITHS MEDICAL ASD, INC.
Assigned to CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P., CAPITAL ROYALTY PARTNERS II L.P. reassignment CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P. SHORT-FORM PATENT SECURITY AGREEMENT Assignors: TANDEM DIABETES CARE, INC.
Assigned to CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P., CAPITAL ROYALTY PARTNERS II (CAYMAN) L.P., CAPITAL ROYALTY PARTNERS II L.P., PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P. reassignment CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P. SHORT-FORM PATENT SECURITY AGREEMENT Assignors: TANDEM DIABETES CARE, INC.
Assigned to TANDEM DIABETES CARE, INC. reassignment TANDEM DIABETES CARE, INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: CAPITAL ROYALTY PARTNERS II L.P., CAPITAL ROYALTY PARTNERS II L.P. - PARALLEL FUND "A" L.P.
Assigned to TANDEM DIABETES CARE, INC. reassignment TANDEM DIABETES CARE, INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: CAPITAL ROYALTY PARTNERS II (CAYMAN) L.P., CAPITAL ROYALTY PARTNERS II L.P., CAPITAL ROYALTY PARTNERS II L.P. - PARALLEL FUND "A" L.P., PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
Application status is Abandoned legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3456Computer-assisted prescription or delivery of medication, e.g. prescription filling or compliance checking
    • G06F19/3468Computer-assisted delivery of medication via infusion or injection
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M2005/14208Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M2005/14288Infusion or injection simulation
    • A61M2005/14292Computer-based infusion planning or simulation of spatio-temporal infusate distribution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/005Parameter used as control input for the apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/201Glucose concentration

Abstract

An apparatus comprising a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration during delivery of insulin according to a specified basal insulin rate pattern, and a controller communicatively coupled to the input and the user interface. The controller includes an insulin calculation module configured for determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline. Other devices and methods are disclosed.

Description

    TECHNICAL FIELD
  • The field generally relates to patient insulin management devices and, in particular, but not by way of limitation, to systems, devices and methods for adjusting insulin therapy.
  • BACKGROUND
  • 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.
  • 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.
  • Blood glucose (BG) management devices help a diabetic person manage their blood glucose. For example, an insulin pump is a BG management device that provides insulin throughout the day. A glucose monitor (GM) or meter is a BG management device that measures blood glucose levels. Some GMs require a finger-stick to acquire a sample of blood that is applied to a test strip to get a blood glucose reading. Some GMs are able to provide continuous monitoring of blood glucose. Other BG management devices include computers running software to help a diabetic person manage insulin therapy. However, most BG management devices are limited in the control over blood glucose that they offer.
  • SUMMARY
  • This document discusses, among other things, devices and methods for managing insulin therapy. A device example includes a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration during delivery of insulin according to a specified basal insulin rate pattern, and a controller communicatively coupled to the input and the user interface. The controller includes an insulin calculation module configured for determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline.
  • A method example includes receiving a user prompt in a blood glucose (BG) management device to start a basal insulin rate test, receiving sampled blood glucose data that is obtained during a specified duration of time when insulin is delivered according to a specified basal insulin rate pattern, and determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered in trying to meet a target blood glucose baseline during the basal insulin rate test using the BG management device.
  • This summary is intended to provide an overview of the subject matter of the present 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
  • FIG. 1 is a block diagram of portions of a BG management device.
  • FIG. 2 shows example illustrations of a blood glucose concentration graph and a basal rate pattern.
  • FIG. 3 is a block diagram of portions of an example of a BG management device that includes a pump mechanism.
  • FIG. 4 is an illustration of a BG management device that includes an insulin pump.
  • FIG. 5 is another block diagram of portions of a BG management device that includes a pump mechanism.
  • FIG. 6 is a block diagram of a BG management device that includes a blood glucose sensor circuit.
  • FIG. 7 is a block diagram of portions of another example of a BG management device.
  • FIG. 8 is a flow diagram of a method of using a BG management device to execute a basal rate test.
  • FIG. 9 is a flow diagram of another method of using a BG management device to execute a basal rate test.
  • DETAILED DESCRIPTION
  • In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and specific embodiments in which the invention may be practiced are shown by way of illustration. It is to be understood that other embodiments may be used and structural or logical changes may be made without departing from the scope of the present invention.
  • 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 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 use and program the pump.
  • 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). Typically, a basal rate for a pump is initially programmed by a clinician based on a total daily dose (TDD) of insulin for a diabetic person. The clinician may determine TDD based on many factors including the type of diabetes of the patient and the patient's weight, age, and level of fitness. The amount of basal insulin is typically determined to be a percentage of TDD, such as 40%, 50%, or 60% for example. The total daily dose is then divided by 24 to obtain an average basal rate. For example, if a patient's TDD is determined to be 40 units of insulin, and 50% of the TDD is used for basal delivery, the average basal rate is 20 units/24 hours or 0.83 u/hr.
  • Many insulin pump users may use three or more different basal rates during the course of a day. Basal rates can be adjusted to change delivery every few minutes (e.g., 20-30 minutes) by increments as small as 0.05 u/hr to better track changes in demand, such as from an increase typically needed before dawn or a decrease needed during long active periods. Insulin pump users may use different basal rates for overnight, for breakfast to mid-afternoon, and for mid-afternoon to bedtime. Appropriate basal rates vary from person to person, may be different for a person at various times of the day, and may change for a person over time. Inappropriate basal rate settings may result in low blood glucose levels overnight or high blood glucose levels in the morning. An insulin pump user may go through several iterations of trial and error before finding appropriate basal rates. Because a patient's basal insulin needs may change over time, such as with weight change or with a change in fitness level, basal rate testing may be performed periodically to ensure that an appropriate basal rate is being delivered by an insulin pump. Blood glucose (BG) management devices are more valuable to a diabetic person if the device conveniently assists them in determining their appropriate basal rate or rates.
  • Apparatus Embodiments
  • FIG. 1 is a block diagram of portions of a BG management device 100. Examples of a BG management device 100 include, among other devices, an insulin pump, a blood glucose monitor (GM) or meter, and a computing device running software to assist a diabetic patient in managing insulin therapy. Examples of a computing device include, among other things, a personal computer or a personal data assistant (PDA).
  • The BG management device 100 includes a user interface 105, an input 110, and a controller 115 communicatively coupled to the input 110 and the user interface 105. The controller 115 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 user interface 105 generates an electrical signal to begin a basal rate test when prompted by a user. The user interface 105 may include a pushbutton, keypad, or a computer mouse. The user interface 105 may include a display operatively coupled to the controller 115 to provide patient or user instructions for the basal rate test. Examples of instructions include, among other things, instructing the patient not to eat during the test, to maintain a normal activity level, and not to administer an insulin correction bolus during the test. The display may include a touch-screen. The user of the device may be a clinician, caregiver, or a diabetic patient. The user prompts the BG management device 100 using the user interface 105 to begin a basal rate test. The basal rate test assists the user in determining one or more appropriate basal rates.
  • As part of a basal rate test, the patient receives insulin according to a specified basal rate pattern or profile. If the BG management device 100 includes an insulin pump, the basal insulin may be delivered using the BG management device 100. If the BG management device 100 does not include an insulin pump, the basal insulin may be delivered using a separate device that includes an insulin pump.
  • If the BG management device 100 includes an insulin pump, the BG management device 100 may further include a memory 116 to store at least one basal rate pattern. The controller 115 may display instructions for the user to enter one or more basal rates to be delivered according to time of day. For example, the BG management device 100 may allow the user to enter basal rate values in 0.05 u/hr increments, and to enter time in increments of one-half hour throughout the day. In some embodiments, the BG management device 100 stores different basal rate patterns according to different segments of the day, such as early in the day, late in the day, and overnight for example. In some embodiments, the input 110 may include a communication port and a basal rate pattern may be loaded from a second device into memory 116.
  • The input 110 is configured to receive sampled blood glucose data of the patient as part of the basal rate test. The blood glucose data provides an indication of the concentration level of the patient's blood sugar and the data may be obtained from blood directly or from insterstitial fluid. The blood glucose data is obtained during a specified time duration. The specified time duration includes a time when insulin is delivered according to a specified basal rate pattern, but may include a time prior or after the delivery of insulin as well. The configuration of the input 110 may depend on the type of BG management device 100. If the BG management device 100 is an insulin pump, the input 110 may be coupled to a GM included in the pump or the input 110 may include a communication port to receive the blood glucose data from a second device. The second device may include a GM or the second device may receive the blood glucose data from a third device. In some embodiments, the input 110 is coupled to the user interface 105, and the user may manually input the data into the pump through a keypad or keyboard included in the user interface.
  • The controller 115 includes an insulin calculation module 120. Modules can be software, hardware, firmware or any combination of software, hardware, and firmware. Multiple functions can be performed in one or more modules. The insulin calculation module 120 determines at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline.
  • FIG. 2 shows example illustrations (not real data) of a blood glucose concentration graph 205 and a basal rate pattern 220 or profile during a basal rate test. Assume, as shown in the blood glucose concentration graph 205, that the patient's target blood glucose baseline 215 is 150 mg/dl (milligrams per deciliter) and that this is the patient's blood glucose concentration level before the basal rate test. Basal insulin is being delivered according to a basal rate pattern 220. At time to, the user elects to begin a basal rate test. User instructions for the basal rate test may be provided. The blood glucose concentration is determined from blood glucose data received into the input 110 during the basal rate test. The basal rate test may run over several hours, e.g., six to eight hours. In some embodiments, the blood glucose data may be stored in memory for processing. In some embodiments, the blood glucose data may be processed by the insulin calculation module 120 as it is received.
  • If the patient's blood glucose level remains at the target blood glucose baseline 215 or within a specified range of the target blood glucose baseline 215, the basal profile is appropriate. If the patient's blood glucose level rises above the target blood glucose baseline 215 or rises above a specified range of the target blood glucose baseline 215, the basal rate is too low and there was an under-delivery of basal insulin. If the patient's blood glucose level falls below the target blood glucose baseline 215 or falls below a specified range of the target blood glucose baseline 215, the basal rate is too high and there was an over-delivery of basal insulin.
  • In the example in FIG. 2, the patient's blood glucose begins to rise at time t3. The change in the blood glucose from the baseline reaches 190 mg/dl, or an increase of 40 mg/dl. At time t4, the basal rate pattern 220 includes an increase in basal rate. The blood glucose level of the patient begins to change direction, here a decrease, at time t5. The time duration from the increase at t3 to the change in direction at t5 is about two hours in this example. The blood glucose level of the patient eventually falls to 110 mg/dl, or a total decrease of 80 mg/dl. At time t7, the blood glucose level of the patient begins to again change direction. This time the change in direction is an increase in blood glucose concentration. The time duration from the decrease at t5 to the change in direction at t7 is about six hours.
  • In some embodiments, the insulin calculation module 120 is configured to determine the over-delivered amount or the under-delivered amount of basal insulin using a correction factor of the patient and a variance of a blood glucose level from the target blood glucose baseline 215. A correction factor refers to the amount of drop in blood glucose concentration of the patient for one unit of insulin. In FIG. 2, the 40 mg/dl increase corresponds to an under-delivery of basal insulin. The under-delivery may be due to the basal rate being too low or due to an increased demand from the patient during that time of day. The 80 mg/dl decrease corresponds to an over-delivery of basal insulin.
  • To calculate the amount under-delivered, the insulin calculation module 120 divides the increase in blood glucose level (+40 mg/dl) by the correction factor of the patient to determine the amount of insulin required to lower the blood glucose level to the target blood glucose baseline 215. This is the amount of insulin that was under-delivered to the patient during the basal rate test. Assume in the example of FIG. 2 that the patient's correction factor is one unit per 40 mg/dl. In this case, a correction bolus of one unit of insulin would decrease the patient's blood glucose level to the blood glucose baseline. To calculate the amount of insulin over-delivered, the insulin calculation module 120 divides the decrease in blood glucose level (−80 mg/dl) by the correction factor of the patient (1 u per 40 mg/dl). This corresponds to a correction bolus of −2 units of insulin, i.e., the amount of insulin delivered needs to be reduced by 2 units of insulin.
  • The under-delivered or over-delivered amount can be used to recommend changes to the basal rate pattern. In the example of FIG. 2, the insulin calculation module 120 may determine that the existing basal rate pattern 220 needs to be increased at some point by one unit of insulin to address the 40 mg/dl increase and decreased at some point by 2 units of insulin to address the 80 mg/dl decrease.
  • The BG management device 100 is more valuable if recommended changes anticipate an under-delivery or over-delivery. However, anticipating when to change the basal rate is complicated by a delay, or a lag time, in insulin uptake before the insulin becomes effective. Another complication is that the lag time may be different for glucose levels measured using blood and glucose levels measured using interstitial fluid. Measuring blood glucose concentration using the interstitial fluid may make the uptake appear to have additional lag time. In some embodiments, the insulin calculation module 120 recommends a change in a basal rate that precedes any actual times of under-delivery or over-delivery by a time duration that compensates for a lag time associated with the subcutaneous insulin delivery and with the glucose measurement method.
  • In some embodiments, in addition to the uptake lag time, the insulin calculation module 120 uses the time from a beginning of a change in the blood glucose level to a change in direction of the blood glucose data values to determine a recommended change to the basal insulin rate pattern 220. In the example of FIG. 2, it is determined that one unit of insulin is needed to correct the under-delivery of insulin resulting in the 40 mg/dl increase in blood glucose level. The increase began at t3 and a change in direction occurred two hours later at t5. The insulin calculation module 120 may recommend a change that includes adding one unit of insulin to the basal rate pattern 220 and spreading the delivery out over two hours corresponding to the change in direction time, i.e., a rate of 0.5 u/hr. This shown by the basal rate increase 225 of 0.5 u/hr for two hours over time t1 to t2. The time t1 is shifted earlier than the time of the increase at t3 by a time duration to compensate for a delay in the insulin uptake so that the insulin may act on the blood glucose.
  • Also in FIG. 2, an over-delivery of 2 units of insulin resulted in an 80 mg/dl increase in blood glucose level. The decrease began at t5 and a change in direction occurred six hours later at t7. The insulin calculation module 120 may recommend a change that includes subtracting two units of insulin from the basal rate pattern 220 over six hours at a rate of 0.33 u/hr. This shown by the basal rate decrease 230 of 0.33 u/hr for six hours over time t2 to t6. The time t2 is early enough to compensate for the delay in insulin uptake.
  • The lag time for insulin uptake may depend on several factors. In some embodiments, the insulin calculation module 120 determines a time duration to compensate for such a time lag using the type of insulin delivered. Some insulin types have a faster uptake than other types, and the insulin calculation module 120 may use a table stored in a memory of the BG management device to correlate a time duration to an insulin type. In some embodiments, the insulin calculation module 120 calculates the compensating time duration using an activity level of the patient and/or the fitness level of the patient. In some embodiments, the compensating time lag is pre-determined from clinical studies and is stored in a memory for use by the insulin calculation module 120.
  • In some embodiments, the insulin calculation module 120 may adjust the correction factor before determining an amount of insulin under or over-delivered. In certain embodiments, the insulin calculation module 120 may use a correction factor multiplier to adjust the correction factor when determining the amount of insulin under or over-delivered, and consequently adjusting the amount of insulin in any recommended changes to the basal rate pattern 220. For example, assume as in FIG. 2 that the patient's correction factor is one unit per 40 mg/dl. If the correction factor multiplier is 1.3, the insulin calculation module uses a correction factor of one unit per 52 mg/dl [(1.3)(40 mg/dl/unit)]. For the 40 mg/dl increase in FIG. 2, the insulin calculation module 120 divides the increase in blood glucose level (40 mg/dl) by the correction factor of the patient (1 u per 52 mg/dl). This corresponds to a correction bolus of 0.77 units [(40)/(52)] of insulin. The insulin calculation module 120 may recommend adding 0.39 u/hr for two hours to the basal rate pattern.
  • Using a correction factor multiplier results in a lower amount of basal insulin allowing adjustments to be made more safely made. This may give a user more confidence in using the recommended changes to the basal rate pattern 220. The 80 mg/dl decrease corresponds to a correction bolus of 1.54 units of insulin. The insulin calculation module 120 may recommend subtracting 0.26 u/hr for six hours to the basal rate pattern. The controller 115 may store the correction factor multiplier in a memory. The correction factor multiplier may be manually set or programmed by a clinician. The clinician may set the correction factor multiplier to a value that accords to a level of confidence or comfort to the clinician in the recommended changes to the basal rate pattern 220.
  • In some embodiments, if the blood glucose data received during the basal rate test indicates that the blood glucose level of the patient is outside of a specified range of blood glucose levels, the controller 115 cancels the basal insulin rate test. If the blood glucose level is above the range, the controller 115 may recommend a correction bolus to be taken by the patient. The insulin calculation module 120 calculates the amount of insulin in the correction bolus by dividing the blood glucose concentration by the specified correction factor for the patient.
  • If the blood glucose level is below the range, the controller 115 may recommend an amount of carbohydrates to be eaten by the patient. The insulin calculation module 120 calculates the amount of carbohydrates using a correction factor specified for the patient and a carbohydrate ratio specified for the patient. A carbohydrate ratio refers to the amount of carbohydrates reduced, or covered, by a unit of insulin.
  • For example, assume that at the beginning of a basal rate test, the blood glucose level of a patient is 40 mg/dl below the specified range and the specified correction factor is 1 unit per 80 mg/dl. The insulin calculation module 120 determines that −0.5 units of insulin (−40/80) are required to bring the blood glucose level back within the specified range. Negative insulin cannot be delivered so this corresponds to a requirement for carbohydrates. Assume that the carbohydrate ratio of the patient is 20 grams of carbohydrates per unit of insulin (20 g/u). The insulin calculation module 120 multiplies the amount of insulin by the carbohydrate ratio to determine that the patient should eat 10 grams of carbohydrates [(0.5)(20)]. The insulin calculation module 120 may take into account additional factors such as the health status of the patient and the activity level of the patient in recommending the carbohydrate amount. In some embodiments, if the blood glucose of the patient is outside the specified range of blood glucose levels, the controller 115 suspends the start of the basal insulin rate test until the blood glucose of the patient is within the specified range of blood glucose levels.
  • As discussed previously, appropriate basal rates may differ for a patient throughout the course of a day. The BG management device 100 may include a timer circuit 117 operatively coupled to the controller 115. The controller 115 displays user instructions to execute a basal rate test at one or more specified times during a day. In some embodiments, controller 115 displays user instructions to run the basal insulin rate test on multiple days. The controller 115 may prompt the user to run the test during substantially the same time on the multiple days. This may result in more appropriate basal delivery rates being used at different times during the day.
  • It is often difficult to maintain a stable blood glucose target value overnight because the correction factor varies as a function of time. In order to stabilize the glucose value at a target blood glucose value, the basal rate may often be adjusted during overnight periods to compensate for changes in the correction factor. An insulin pump user may go through several iterations of trial and error while attempting to find appropriate overnight basal rates. A trial and error method may result in less than optimal control of overnight blood glucose level.
  • According to some embodiments, the BG management device 100 automatically executes a basal rate test during a period when food intake is restricted, such as overnight for example. The basal rate test may start a specified time after a user prompts the BG management device 100 to execute the basal rate test. For example, if the period is overnight, the user prompt may start a timer circuit and the controller 115 may initiate the overnight basal rate test when a time duration expires. The insulin calculation module 120 automatically determines one or more basal rates for a basal rate profile using a basal rate calibration and verification technique. The basal blood glucose value g can be approximated by

  • g(t)≅c(t)b(t−τ),   (1)
  • where c(t) is the basal correction factor, b(t) is the basal insulin rate, and τ is the delay or lag time associated with the uptake of a subcutaneous infusion of insulin. Food consumption and exercise are assumed to be negligible during the period of the test.
  • The insulin calculation module 120 may perform a rapid calibration that can be executed during a period as short as two time periods, such as two nights for example. The correction factor c(t) may vary as a function of time. To determine c(t), blood glucose data values g1(t) and basal insulin delivery rates b1(t) are recorded periodically throughout a first observation period. Rewriting Equation (1) to solve for c(t) for the first period yields
  • c 1 ( t ) = g 1 ( t ) b 1 ( t - τ 1 ) . ( 2 )
  • The delay for insulin uptake τ1 can be an assumed value based on current estimates from clinical studies that use that type of insulin, or can be determined on a per patient basis using stochastic or deterministic time series analysis of prior or current basal test data. The time series analysis of the blood glucose data values may be performed under pulse function, step function, or continuous changes in insulin delivery. The time-dependent changes in insulin delivery may be present in the user's current basal profile or the user may be prompted to create a time-dependent change by the insulin calculation module. The stochastic or deterministic time series analysis can be performed on blood glucose data obtained from previous calibration or observation periods, such as previous nights for example. Thus, the delay for insulin uptake may be determined using blood glucose data obtained prior to the basal rate test.
  • A desired target blood glucose value gt(t) may be a constant or a function of time. Equation (1) can be written as

  • g t(t)≅c 1(t)b 1(t−τ 1),   (3)
  • where c1(t) is the correction factor determined from the first period of data values from Equation (2). Solving equation (3) for a controlling basal insulin rate bt(t) that achieves the desired gt(t) yields
  • b t ( t ) = g t ( t + τ 1 ) c 1 ( t + τ 1 ) . ( 4 )
  • It is assumed that the correction factor c(t) is a periodic function that repeats on a twenty four hour cycle, and that c(t) determined from data and basal rates during the first period of reduced food intake will be similar on subsequent periods twenty-four hours later.
  • During the second period of observation, blood glucose data values g2(t) and basal rates b2(t) are again recorded periodically. Ideally g2(t)=gt(t), but in reality g2(t)=gt(t)+ε(t), where ε(t) is the residual deviation from the target blood glucose value. Thus, Equation (1) can be written as

  • g t(t)+ε(t)=c 1(t)b 1(t−τ1).   (5)
  • Assuming that ε(t) is primarily due to the error in the estimate of τ1, Equation (5) can be rewritten as

  • g t(t)+ε(t)=c 1(t)b t1(t−(τ1−τ)),   (6)
  • where τ is the error in the delay estimate. Combining Equations 5 and 6 gives

  • ε(t)=c 1(t)[b t(t−τ 1)−b t(t−(τ1−τ))].   (7)
  • Curve fitting or other standard minimization techniques can be used to determine the most appropriate estimate of τ to satisfy Equation (7). Once τ is determined, the control estimate for the basal insulin delivery rate or rates bt(t) that achieves the desired blood glucose target gt(t) can be written as
  • b t ( t ) = g t ( t + τ 2 ) c 1 ( t + τ 2 ) , ( 8 )
  • where τ21−τ. The insulin calculation module may then recommend changes to the t basal rate pattern using bt(t).
  • The rapid calibration technique is a method to quickly achieve improved control over blood glucose level. In some embodiments, the insulin calculation module 120 executes a basal rate test that uses a generalized calibration technique to achieve more accurate estimates of bt(t). The generalized calibration method uses least squares estimation techniques with at least two periods of observing blood glucose data and basal insulin delivery rates. Referring back to Equation (1) and with g(t) and b(t) measured over several periods, τ and c(t) can be estimated by curve fitting with a finite order polynomial or an orthogonal series approximation such as a Fourier series approximation for example. The resulting estimate of bt(t) is calculated using Equation 3 with τ and c(t) estimated from the curve fit results.
  • According to some embodiments, the BG management device includes an insulin pump. FIG. 3 is a block diagram of portions of an example of a BG management device 300 that includes a pump mechanism 330 to deliver insulin to the patient. The pump mechanism 330 is operatively coupled to the controller 115. The controller 115 may track the amount of insulin delivered via the pump mechanism 330. The BG management device 300 includes a memory 116 operatively coupled to the controller 115 to store one or more basal rate patterns 325. The BG management device delivers basal insulin according to the basal rate patterns. The BG management device 300 also may deliver insulin through boluses such as a correction bolus or a carbohydrate bolus. In some embodiments, the BG management device 300 has a timer circuit 117 that includes a real time clock coupled to the controller 115. The controller 115 is configured to vary a basal rate of insulin delivery by a time of day according to a basal rate pattern.
  • In some embodiments, the insulin calculation module 120 is able to keep track of the amount of active insulin in the patient. This is sometimes referred to as insulin on board (IOB). To track the amount of active insulin, the controller 115 uses the amount of insulin delivered, the time that elapsed since delivery of insulin and a duration of how long the insulin is active in the blood. The duration may be determined using kinetic action, which is the time it takes for insulin to disappear from the blood, or the duration of insulin action (DIA), which is how long the insulin lowers blood glucose. In some embodiments, the controller 115 cancels a basal rate test if the insulin calculation module 120 determines that the active insulin amount is above a specified threshold insulin amount. This minimizes the risk of IOB confounding the results of the basal rate test.
  • In some embodiments, the controller 115 cancels the basal insulin rate test if the controller 115 determines that an insulin bolus dose, such as a correction insulin bolus or a carbohydrate insulin bolus, is delivered during the basal insulin rate test. In some embodiments, if the user enables an insulin bolus delivery, the controller 115 displays a warning that the basal insulin test will be canceled if the user elects to proceed with delivery of the insulin bolus dose.
  • FIG. 4 is an illustration of a BG management device 400 that includes an insulin pump. The BG management device 400 includes a cassette or cartridge of insulin and tubing 440 connectable to a patient such as by a Luer lock 445. The BG management device 400 includes a user interface that may include a display 402 operatively coupled to a controller 115. The user interface may also include one or more keys 404.
  • Returning to FIG. 3, the blood glucose data obtained during the basal insulin rate test may be produced by a second device separate from the BG management device 300. The controller 115 displays user instructions for the basal rate test. The user interface 105 and the input 110 are configured to receive the sampled blood glucose data entered manually by the user through the user interface 105. The controller 115 may periodically prompt the user to enter a blood glucose value at different times during the test, or to enter the blood glucose data all at once after the test.
  • FIG. 5 is another block diagram of portions of a BG management device 500 that includes a pump mechanism 530 and delivers basal insulin according to one or more basal rate patterns 525 stored in memory 116. A blood glucose monitor, or GM 550, is communicatively coupled to the input 110. The input 110 is configured to receive the sampled blood glucose data from the GM 550. In some examples, the GM 550 is included in the BG management device 500 and is coupled to the input 110. In some examples, the GM 550 is included in a second device. The input 110 may receive the blood glucose data during the basal rate test or after the test is run. The input 110 may include a communication port, such as communication port 447 located on the rear face of the device in FIG. 4, and the GM 550 is communicatively coupled to the input 110 by the communication port 447. In some embodiments, the communication port 447 is a wired port such as a serial interface or bus interface for communicating with the second device. In some embodiments, the communication port 447 is a wireless port such as an infrared (IR) communication port or a radio frequency (RF) communication port. The input 110 wirelessly receives the sampled blood glucose data from the second device.
  • Returning to FIG. 5, in some embodiments, the GM 550 is a continuous GM and automatically collects the sampled blood glucose data. For example, the GM 550 may include a blood glucose sensor. The blood glucose sensor produces a blood glucose signal representative of a blood glucose level of the patient. The GM 550 samples the blood glucose signal to obtain the sampled blood glucose data
  • In some embodiments, the GM 550 may need to prompt the user to begin a blood glucose measurement. For example, the GM 550 may require diabetes test strips to take a blood glucose measurement. The controller 115 prompts the user, via a display, to begin a blood glucose measurement using the GM 550. The user then provides a new test strip to the GM 550 when prompted during the basal rate test. In another example, the GM 550 may include a drum of diabetes test strips and the user advances the drum to a fresh or unused test strip when prompted by the controller 115. The controller 115 may display a recommended basal rate after the basal rate test. The controller 115 may also communicate a recommended change in the basal rate to the second device via a communication port.
  • According to some embodiments, the BG management device is a GM. FIG. 6 is a block diagram of a BG management device 600 that includes a blood glucose sensor circuit 635 operatively coupled to the input 110. The blood glucose sensor circuit 635 produces a blood glucose signal representative of a blood glucose level of the patient and provides the sampled blood glucose data to input 110. In some embodiments, the blood glucose sensor circuit 635 includes an implantable blood glucose sensor. In some embodiments, the blood glucose sensor includes a percutaneous blood glucose sensor. The blood glucose sensor circuit 635 may include signal conditioning circuits, such as for signal filtering and signal amplification for example. If an implantable blood glucose sensor is used, the blood glucose sensor circuit 635 may include a communication circuit configured to receive blood glucose data wirelessly, such as by RF communication.
  • The BG management device 600 includes a second input 630 communicatively coupled to the controller 115. The second input 630 receives information related to basal insulin delivery, such as one or more basal rate patterns used during the basal rate test. The information related to insulin delivery may be received into a memory 116. The insulin calculation module 120 determines at least one of an amount of insulin over-delivered and an amount of insulin under-delivered during the basal rate test using the insulin delivery information and the sampled blood glucose data. The BG management device 600 may include a communication port 647 coupled to the second input 630. The communication port 647 receives the information related to insulin delivery from a second device. In some embodiments, the communication port 647 is a wired port such a serial interface or bus interface. In some embodiments, the communication port 647 is a wireless port such as an infrared (IR) communication port or a radio frequency (RF) communication port. The second input 630 wirelessly receives the insulin delivery data from the second device. As an example, the second device may be an insulin pump. The insulin calculation module 120 may determine changes to the basal rate pattern used to deliver basal insulin during the basal rate test. The controller 115 communicates recommended changes through the communication port 647 or may display the recommended changes on a display.
  • In some embodiments, the user interface 105 and the second input 630 are configured to receive the information related to insulin delivery by a user manually entering the information through the user interface 105. The insulin delivery information may be obtained from a pump for example. The controller 115 may display any recommended changes to the basal rate pattern.
  • FIG. 7 is a block diagram of portions of another example of a BG management device 700. BG management device 700 includes neither a GM nor an insulin pump. The BG management device 700 includes a user interface 105, an input 110, and a controller 115 communicatively coupled to the input 110 and the user interface 105. The input 110 includes at least one communication port 747 configured for receiving sampled blood glucose information. The communication port 747 may provide a wired connection to a second device, or the communication port 747 may provide a wireless connection to a second device. The sampled blood glucose information may include at least one time-stamp in order to align the sampled blood glucose information to information related to insulin delivery.
  • The insulin delivery information may be received through the same communication port 747 or a second communication port. The communication ports may be any combination of wired or wireless communication ports. The insulin delivery information includes information related to basal insulin delivered according to a basal rate pattern, and may include at least one time-stamp to align the insulin delivery information with the blood glucose information. The insulin calculation module 120 determines at least one of an amount of insulin over-delivered and an amount of insulin under-delivered during the basal rate test using the insulin delivery information and the sampled blood glucose data. The insulin calculation module 120 may recommend changes to the basal rate pattern. The controller 115 may communicate recommended changes to the basal rate pattern through the communication port 747 and/or the controller 115 may display the recommended changes.
  • Method Embodiments
  • FIG. 8 is a flow diagram of a method 800 of using a BG management device to execute a basal rate test. At block 805, a user prompt is received in a BG management device to start a basal insulin rate test. The user interface may include a push-button, keypad, or mouse. The user interface may also include a display to display one or more instructions for the user to execute the basal rate test, and to display to display any recommend changes to a basal rate or a basal rate pattern. In some embodiments, the method 800 includes displaying instructions for the basal insulin rate test using the BG management device.
  • At block 810, sampled blood glucose data is received in the BG management device. The blood glucose data is obtained from a patient during a specified time duration, including a time during delivery of insulin according to a basal insulin rate pattern that is part of the basal rate test.
  • At block 815, at least one of an amount of basal insulin over-delivered or an amount of basal insulin under-delivered is determined. The over-delivery and/or under-delivery occur in trying to meet a target blood glucose baseline during the basal insulin rate test. In some embodiments, the method 800 includes the BG management device automatically recommending changes, if any, to the basal insulin rate pattern.
  • In some embodiments, the method 800 includes determining an amount of basal insulin over-delivered or an amount of basal insulin under-delivered using the correction factor and the variance from the blood glucose baseline concentration. In some embodiments, the amount of insulin over or under-delivered is determined using an adjusted correction factor. The correction factor may be adjusted using a correction factor multiplier. In some embodiments, recommending a change may include spreading out the change to the basal delivery rate pattern out over a time duration corresponding to a time to a change in direction of the blood glucose data values.
  • In some embodiments, the method includes recommending changes to the basal insulin rate pattern that precede any actual times of over-delivery or under-delivery by a time duration that compensates for a delay or lag time associated with subcutaneous insulin delivery. In some embodiments, the method 800 includes calculating the lag time using at least one of i) the type of insulin delivered during the basal rate test, ii) the activity level of the patient at the time the basal rate test takes place, iii) the fitness level of the patient, and iv) the method of obtaining the blood glucose data, e.g., whether the blood glucose data was obtained from blood or from interstitial fluid. In some embodiments, the method 800 includes calculating the lag time using blood glucose data obtained prior to the basal insulin rate test.
  • According to some embodiments, the BG management device includes an insulin pump. The method 800 includes determining an amount of active insulin (IOB) at the beginning of the basal rate test. The IOB may be determined before delivering basal insulin according to a basal rate pattern of the basal insulin test. In some embodiments, if an amount of active insulin is above a specified threshold active insulin amount, the BG management device may cancel the basal rate test. In some embodiments, the method 800 includes canceling the basal insulin rate test if an insulin bolus dose, such as a correction bolus or a carbohydrate bolus, is delivered during the basal insulin rate test.
  • According to some embodiments, the BG management device includes an insulin pump and a GM. The method 800 includes automatically receiving the sampled blood glucose data from the blood glucose monitor. In some embodiments, the BG management device includes the insulin pump and the blood glucose data is obtained using a separate device. The method 800 includes receiving the sampled blood glucose data into the BG management device from the separate device through a communication port. The communication port may be a wireless port or a wired port. The separate device may be a continuous GM.
  • In some embodiments, the separate device may be a GM that requires some action by the user to obtain a blood glucose reading. For example, the GM may require the user to place a test strip into the GM in order to obtain a glucose reading. In some embodiments, the method 800 may include prompting the user through a user interface to obtain blood glucose data using the separate device. The prompting may be periodic during the basal rate test.
  • In some embodiments, the blood glucose data obtained from the separate device is entered manually into the BG management device. The method 800 includes the BG management device receiving the blood glucose data through the user interface. The user interface is configured for manual entry of blood glucose data, such as by including a keypad and a display. The user reads the blood glucose data from the separate GM and manually enters the blood glucose data into the BG management device. In some embodiments, the method 800 includes the BG management device periodically prompting the user to manually enter a blood glucose value during the basal rate test.
  • According to some embodiments, the BG management device includes a GM and does not include an insulin pump. The basal insulin is delivered according to a basal rate pattern using a second separate device. The sampled blood glucose data is received automatically using the included GM. The method 800 further includes receiving information related to insulin delivery into the BG management device from the separate device, including an amount of insulin delivered according to the basal rate pattern. The BG management device determines at least one of an amount of insulin over-delivered and an amount of insulin under-delivered during the basal rate test using the insulin delivery information and the sampled blood glucose data.
  • In some embodiments, the method 800 includes receiving the insulin delivery information into the BG management device through a communication port. As part of the basal rate test, the BG management device may communicate a recommended change to the basal rate pattern to the separate device using the communication port. This is useful if the separate device is an insulin pump. In some embodiments, the method 800 includes receiving the insulin delivery information into the BG management device by manually entering the insulin delivery information. The information is manually entered via a user interface on the BG management device. Any recommended changes to the basal rate pattern may be displayed on the BG management device.
  • According to some embodiments, the BG management device does not include a GM or an insulin pump. The basal insulin is delivered according to a basal rate pattern using a second separate device, such as an insulin pump for example. The method 800 includes providing insulin delivery information, such as an amount of insulin delivered according to the basal rate pattern, to the BG management device using the second device.
  • The BG management device receives sampled blood glucose data from the second separate device or a third device. At least one of the insulin delivery information and the sampled blood glucose data includes a time-stamp to allow for alignment of the insulin delivery information and the blood glucose data. For example, the time-stamp for the insulin delivery may be the time at which the basal rate changes. The BG management device determines at least one of an amount of insulin over-delivered and an amount of insulin under-delivered during the basal rate test using the insulin delivery information and the sampled blood glucose data. Any recommended changes to the basal rate pattern may be displayed on the BG management device.
  • In some embodiments, the method 800 includes executing the basal insulin rate test during a substantially same time on multiple days. In some examples, the method 800 includes executing an overnight basal rate test. In some examples, the method includes executing an overnight basal rate test that includes an overnight basal rate calibration and verification technique.
  • FIG. 9 is a flow diagram of another method 900 of using a BG management device to execute a basal rate test. At block 905, sampled blood glucose data is received in a BG management device. The blood glucose data may be obtained from a patient during a specified time duration according to a specified basal insulin rate pattern that is part of the basal rate test. At block 910, a time varying correction factor c(t) is determined using the sampled blood glucose data and the specified basal insulin rate pattern. At block 915, a time varying basal rate pattern b(t) is determined. The time varying basal rate pattern is to achieve the target blood glucose baseline. The target blood glucose baseline may be a constant or a time varying function g(t). In some embodiments, the method 900 includes generating a change to the test-specified basal rate pattern using the determined time varying basal rate pattern b(t). In some embodiments, the method includes recommending a change to the test-specified basal rate pattern, such as by using a display for example.
  • The accompanying drawings that form a part hereof, show by way of illustration, and not of limitation, specific embodiments in which the subject matter may be practiced. The embodiments illustrated are described in sufficient detail to enable those skilled in the art to practice the teachings disclosed herein. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. This Detailed Description, therefore, is not to be taken in a limiting sense, and the scope of various embodiments is defined only by the appended claims, along with the full range of equivalents to which such claims are entitled.
  • Such embodiments of the inventive subject matter may be referred to herein, individually and/or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, it should be appreciated that any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations, or variations, or combinations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
  • The Abstract of the Disclosure is provided to comply with 37 C.F.R. §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.

Claims (54)

1. An apparatus comprising:
a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user;
an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration when insulin is delivered according to a specified basal insulin rate pattern; and
a controller communicatively coupled to the input and the user interface, the controller including an insulin calculation module, wherein the insulin calculation module is configured to determine at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline.
2. The apparatus of claim 1, wherein the insulin calculation module is configured to determine the over-delivered amount and the under-delivered amount using a correction factor of the patient and a variance of a blood glucose level from the target blood glucose baseline.
3. The apparatus of claim 2, wherein the insulin calculation module is configured to determine the over-delivered amount and the under-delivered amount using an adjusted correction factor of the patient.
4. The apparatus of claim 2, wherein the insulin calculation module is configured to determine a recommended change, if any, to the basal insulin rate pattern.
5. The apparatus of claim 4, wherein the recommended change precedes any actual time of over-delivery or under-delivery by a time duration that compensates for a lag time associated with subcutaneous insulin delivery.
6. The apparatus of claim 4, wherein the user interface includes a display operatively coupled to the controller, and wherein the controller is configured to display at least one user instruction for the basal insulin rate test.
7. The apparatus of claim 6, wherein the controller is configured to display a recommended change to a basal insulin rate pattern.
8. The apparatus of claim 4, including:
a pump mechanism configured to deliver insulin according to the specified basal insulin rate pattern; and
a memory to store at least one basal insulin rate pattern, wherein the pump mechanism and the memory are operatively coupled to the controller.
9. The apparatus of claim 8, including a blood glucose monitor communicatively coupled to the input.
10. The apparatus of claim 9, wherein the blood glucose monitor is a continuous blood glucose monitor configured to automatically collect the sampled blood glucose data.
11. The apparatus of claim 10, including:
a display operatively coupled to the controller, and
wherein the controller is configured to prompt the user, via the display, to begin a blood glucose measurement using the blood glucose monitor.
12. The apparatus of claim 8, wherein the user interface and the input are configured to receive the sampled blood glucose data entered manually by the user.
13. The apparatus of claim 12, including:
a display operatively coupled to the controller, wherein the controller is configured to display user instructions for the basal rate test, including periodically prompting the user to enter a blood glucose value.
14. The apparatus of claim 8, wherein the insulin calculation module is configured to determine an amount of active insulin in the patient and to cancel the basal insulin rate test if the active insulin amount is above a specified threshold insulin amount.
15. The apparatus of claim 8, wherein the controller is configured to determine whether an insulin bolus dose is delivered and to cancel the basal insulin rate test if it determines that an insulin bolus dose is delivered during the basal insulin rate test.
16. The apparatus of claim 8, including a real time clock coupled to the controller, wherein the controller is configured to vary a basal rate of insulin delivery by a time of day according to the basal rate pattern.
17. The apparatus of claim 4, wherein the input is a first input and the apparatus further includes:
a blood glucose sensor circuit operatively coupled to the first input, the blood glucose sensor circuit configured to produce a blood glucose signal representative of a blood glucose level of the patient and provide the sampled blood glucose data to the first input;
a second input communicatively coupled to the controller, wherein the second input is configured to receive information related to insulin delivery according to the basal rate pattern, and
wherein the insulin calculation module is configured to determine at least one of the amount of basal insulin over-delivered and the amount of basal insulin under-delivered using the insulin delivery information and the sampled blood glucose data.
18. The apparatus of claim 17, including a communication port communicatively coupled to the second input, the communication port to receive the information related to insulin delivery.
19. The apparatus of claim 18, wherein the controller is configured to communicate a recommended change to the basal rate pattern through the communication port.
20. The apparatus of claim 17, wherein the user interface and the second input are configured to receive the information related to insulin delivery that is entered manually by the user.
21. The apparatus of claim 4, wherein the input includes a communication port configured to receive the sampled blood glucose data together with at least one time-stamp and to receive time-stamped information related to insulin delivered according to the basal rate pattern, and
wherein the insulin calculation module is configured to determine at least one of the amount of basal insulin over-delivered or under-delivered using the time-stamped sampled blood glucose data and the time-stamped information related to delivered insulin.
22. The apparatus of claim 21, wherein the controller is configured to communicate a recommended change to the basal rate pattern through the communication port.
23. The apparatus of claim 1, wherein the insulin calculation module is configured to calculate a lag time associated with subcutaneous insulin delivery using at least one of:
a type of insulin;
an activity level of the patient;
a fitness level of the patient; and
the method used to obtain the blood glucose data.
24. The apparatus of claim 1, wherein the insulin calculation module is configured to calculate a lag time associated with subcutaneous insulin delivery using blood glucose data obtained during at least one of a period prior to the basal rate test and a period during the basal rate test.
25. The apparatus of claim 1, wherein the controller is configured to cancel the basal insulin rate test if a blood glucose level of the patient is outside of a specified range of blood glucose level.
26. The apparatus of claim 1, including:
a timer circuit; and
a display, wherein the timer circuit and the display are operatively coupled to the controller, and wherein the controller is configured to display user instructions for the basal insulin rate test at one or more specified times during a day.
27. The apparatus of claim 26, wherein the controller is configured to display user instructions for executing the basal insulin rate test during a substantially same time on multiple days.
28. The apparatus of claim 26, wherein the insulin calculation module is configured to:
determine a time-varying basal insulin rate function using the blood glucose data; and
determine a recommended change, if any, to the basal insulin rate pattern using the time-varying basal insulin rate function.
29. The apparatus of claim 28, wherein the insulin calculation module is configured to:
determine a time-varying overnight basal insulin rate function using the blood glucose data; and
determine a recommended change to an overnight basal insulin rate pattern using the time-varying overnight basal insulin rate function.
30. A method comprising:
receiving a user prompt in a blood glucose (BG) management device to start a basal insulin rate test;
receiving sampled blood glucose data into the BG management device, wherein the sampled blood glucose data is obtained during a specified time duration, including a time duration when insulin is delivered according to a specified basal insulin rate pattern; and
determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered in trying to meet a target blood glucose baseline during the basal insulin rate test.
31. The method of claim 30, including automatically recommending a change, if any, to the basal insulin rate pattern using the BG management device.
32. The method of claim 31, wherein the recommended change to the basal insulin rate pattern precedes any actual time of over-delivery or under-delivery by a time duration that compensates for a lag time associated with subcutaneous insulin delivery.
33. The method of claim 32, including calculating the lag time using at least one of:
a type of insulin;
an activity level of the patient;
a fitness level of the patient; and
whether the blood glucose data was obtained from blood or from interstitial fluid.
34. The method of claim 32, including calculating the lag time using blood glucose data obtained during at least one of a period prior to the basal rate test and a period during the basal rate test.
35. The method of claim 31, including displaying at least one instruction for the basal insulin rate test using the BG management device.
36. The method of claim 31, wherein determining an amount over-delivered and an under-delivered includes determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered using an adjusted correction factor of the patient and a variance of a blood glucose level from the target blood glucose baseline.
37. The method of claim 31, including delivering insulin according to the specified basal insulin rate pattern using the BG management device.
38. The method of claim 37, including:
determining an amount of active insulin in the patient prior to delivering basal insulin according to the basal rate test; and
canceling the basal insulin rate test if an amount of active insulin is above a specified threshold active insulin amount.
39. The method of claim 37, including canceling the basal insulin rate test if an insulin bolus dose is delivered during the basal insulin rate test.
40. The method of claim 37, wherein receiving sampled blood glucose data includes automatically receiving the sampled blood glucose data from a blood glucose monitor included in the BG management device.
41. The method of claim 37, wherein receiving sampled blood glucose data includes:
obtaining the 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.
42. The method of claim 41, wherein receiving sampled blood glucose data includes wirelessly receiving the sampled blood glucose data into the BG management device from the separate device through a wireless communication port.
43. The method of claim 41, wherein receiving sampled blood glucose data includes periodically prompting a user through a user interface of the BG management device to obtain blood glucose data using the separate device.
44. The method of claim 41, wherein receiving sampled blood glucose data includes receiving the sampled blood glucose data through a user interface of the BG management device configured for manual entry of blood glucose data.
45. The method of claim 41, wherein receiving sampled blood glucose data includes prompting a user to manually enter a blood glucose value during the basal insulin rate test.
46. The method of claim 31, including:
delivering insulin according to the specified basal insulin rate pattern using a second device;
wherein receiving sampled blood glucose data includes automatically receiving the sampled blood glucose data from a blood glucose monitor included in the BG management device; and
wherein the method includes receiving information related to insulin delivery, including an amount of insulin delivered according to the basal rate pattern, into the BG management device.
47. The method of claim 46, wherein receiving the information related to insulin delivery includes receiving the information related to insulin delivery from the second device through a communication port.
48. The method of claim 47, including communicating a recommended change to the basal insulin rate pattern to the second device using the communication port.
49. The method of claim 46, wherein receiving the information related to insulin delivery includes receiving the information related to insulin delivery manually through a user interface on the BG management device.
50. The method of claim 46, including displaying a recommended change to the basal insulin rate pattern using the BG management device.
51. The method of claim 31, including:
delivering insulin according to the specified basal insulin rate pattern using a second device;
receiving information related to insulin delivery, including the amount of insulin delivered according to the basal rate pattern, into the BG management device,
wherein receiving sampled blood glucose data includes receiving time-stamped sampled blood glucose data into the BG management device; and
determining the at least one of the amount of basal insulin over-delivered and the amount of basal insulin under-delivered using the time-stamped sampled blood glucose data and the information related to insulin delivery.
52. The method of claim 31, including:
determining a time varying correction factor function using the sampled blood glucose data and the specified basal rate pattern; and
determining a time varying basal rate pattern to achieve the target blood glucose baseline using the correction factor function.
53. The method of claim 52, including recommending a change to the specified basal rate pattern using the determined time varying basal rate pattern.
54. An apparatus comprising:
means for receiving a user prompt in a blood glucose (BG) management device to start a basal insulin rate test;
means for receiving sampled blood glucose data of a patient into a blood glucose (BG) management device, wherein the sampled blood glucose data is obtained during a specified time duration, including a time duration during delivery of insulin according to a specified basal insulin rate pattern; and
means for determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered in trying to meet a target blood glucose baseline during the basal insulin rate test using the BG management device.
US11/685,617 2007-03-13 2007-03-13 Basal rate testing using frequent blood glucose input Abandoned US20080228056A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11/685,617 US20080228056A1 (en) 2007-03-13 2007-03-13 Basal rate testing using frequent blood glucose input

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US11/685,617 US20080228056A1 (en) 2007-03-13 2007-03-13 Basal rate testing using frequent blood glucose input
JP2009553581A JP2010521222A (en) 2007-03-13 2008-02-26 Basal rate tests using blood sugar input
PCT/US2008/002536 WO2008112078A2 (en) 2007-03-13 2008-02-26 Basal rate testing using blood glucose input
EP08726116A EP2129277A2 (en) 2007-03-13 2008-02-26 Basal rate testing using blood glucose input
US15/266,468 US20170000943A1 (en) 2007-03-13 2016-09-15 Basal rate testing using frequent blood glucose input

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US15/266,468 Continuation US20170000943A1 (en) 2007-03-13 2016-09-15 Basal rate testing using frequent blood glucose input

Publications (1)

Publication Number Publication Date
US20080228056A1 true US20080228056A1 (en) 2008-09-18

Family

ID=39708324

Family Applications (2)

Application Number Title Priority Date Filing Date
US11/685,617 Abandoned US20080228056A1 (en) 2007-03-13 2007-03-13 Basal rate testing using frequent blood glucose input
US15/266,468 Pending US20170000943A1 (en) 2007-03-13 2016-09-15 Basal rate testing using frequent blood glucose input

Family Applications After (1)

Application Number Title Priority Date Filing Date
US15/266,468 Pending US20170000943A1 (en) 2007-03-13 2016-09-15 Basal rate testing using frequent blood glucose input

Country Status (4)

Country Link
US (2) US20080228056A1 (en)
EP (1) EP2129277A2 (en)
JP (1) JP2010521222A (en)
WO (1) WO2008112078A2 (en)

Cited By (51)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100218132A1 (en) * 2008-12-23 2010-08-26 Roche Diagnostics Operations, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
US20100317952A1 (en) * 2009-05-22 2010-12-16 Abbott Diabetes Care Inc. Methods for reducing false hypoglycemia alarm occurrence
WO2011033509A1 (en) * 2009-09-18 2011-03-24 Medingo Ltd. Devices, systems and methods for quantifying bolus doses according to user parameters
US20110264071A1 (en) * 2007-10-10 2011-10-27 Optiscan Biomedical Corporation Fluid component analysis systems and methods for glucose monitoring and control
WO2011157395A1 (en) * 2010-06-18 2011-12-22 Roche Diagnostics Gmbh Systems and methods for optimizing insulin dosage
US8208984B2 (en) 2007-01-24 2012-06-26 Smiths Medical Asd, Inc. Correction factor testing using frequent blood glucose input
US8219222B2 (en) 2007-05-24 2012-07-10 Smiths Medical Asd, Inc. Expert system for pump therapy
US20120179135A1 (en) * 2011-01-12 2012-07-12 Rinehart Joseph B System and method for closed-loop patient-adaptive hemodynamic management
US8221345B2 (en) 2007-05-30 2012-07-17 Smiths Medical Asd, Inc. Insulin pump based expert system
US8287495B2 (en) 2009-07-30 2012-10-16 Tandem Diabetes Care, Inc. Infusion pump system with disposable cartridge having pressure venting and pressure feedback
US8346399B2 (en) 2002-02-28 2013-01-01 Tandem Diabetes Care, Inc. Programmable insulin pump
WO2013023014A1 (en) * 2011-08-11 2013-02-14 Scherb Cliff System and method for determining an amount of insulin to administer to a diabetic patient
US8414523B2 (en) 2008-01-09 2013-04-09 Tandem Diabetes Care, Inc. Infusion pump with add-on modules
US8417311B2 (en) 2008-09-12 2013-04-09 Optiscan Biomedical Corporation Fluid component analysis system and method for glucose monitoring and control
WO2013102158A1 (en) 2011-12-30 2013-07-04 Abbott Diabetes Care Inc. Method and apparatus for determining medication dose information
US8532933B2 (en) 2010-06-18 2013-09-10 Roche Diagnostics Operations, Inc. Insulin optimization systems and testing methods with adjusted exit criterion accounting for system noise associated with biomarkers
WO2013184896A1 (en) * 2012-06-07 2013-12-12 Medtronic Minimed, Inc. Diabetes therapy management system for recommending adjustments to an insulin infusion device
US8657807B2 (en) 2002-02-28 2014-02-25 Tandem Diabetes Care, Inc. Insulin pump having a suspension bolus
US20140066892A1 (en) * 2012-08-30 2014-03-06 Medtronic Minimed, Inc. Insulin on board compensation for a closed-loop insulin infusion system
US8718949B2 (en) 2008-01-07 2014-05-06 Tandem Diabetes Care, Inc. Insulin pump with blood glucose modules
US8755938B2 (en) 2011-05-13 2014-06-17 Roche Diagnostics Operations, Inc. Systems and methods for handling unacceptable values in structured collection protocols
US8766803B2 (en) 2011-05-13 2014-07-01 Roche Diagnostics Operations, Inc. Dynamic data collection
US8849458B2 (en) 2008-12-23 2014-09-30 Roche Diagnostics Operations, Inc. Collection device with selective display of test results, method and computer program product thereof
US8882701B2 (en) 2009-12-04 2014-11-11 Smiths Medical Asd, Inc. Advanced step therapy delivery for an ambulatory infusion pump and system
US8954373B2 (en) 2009-09-30 2015-02-10 Dreamed Diabetes Ltd. Monitoring device for management of insulin delivery
WO2015035304A1 (en) * 2013-09-06 2015-03-12 Tandem Diabetes Care, Inc. System and method for mitigating risk in automated medicament dosing
WO2015116401A1 (en) * 2014-01-31 2015-08-06 Aseko, Inc. Insulin management
US9117015B2 (en) 2008-12-23 2015-08-25 Roche Diagnostics Operations, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
CN105046042A (en) * 2012-08-30 2015-11-11 美敦力迷你迈德公司 Safeguarding techniques for closed-loop insulin infusion system
US20160030670A1 (en) * 2014-08-01 2016-02-04 The General Hospital Corporation Blood Glucose and Insulin Control Systems and Methods
AU2015200829B2 (en) * 2012-08-30 2016-06-16 Medtronic Minimed, Inc. Safeguarding techniques for a closed-loop insulin infusion system
US9378333B2 (en) 2008-05-02 2016-06-28 Smiths Medical Asd, Inc. Display for pump
US9486580B2 (en) 2014-01-31 2016-11-08 Aseko, Inc. Insulin management
US9623179B2 (en) 2012-08-30 2017-04-18 Medtronic Minimed, Inc. Safeguarding techniques for a closed-loop insulin infusion system
US9662445B2 (en) 2012-08-30 2017-05-30 Medtronic Minimed, Inc. Regulating entry into a closed-loop operating mode of an insulin infusion system
US9669160B2 (en) 2014-07-30 2017-06-06 Tandem Diabetes Care, Inc. Temporary suspension for closed-loop medicament therapy
US9814835B2 (en) 2012-06-07 2017-11-14 Tandem Diabetes Care, Inc. Device and method for training users of ambulatory medical devices
US9833191B2 (en) 2012-11-07 2017-12-05 Bigfoot Biomedical, Inc. Computer-based diabetes management
US9849239B2 (en) 2012-08-30 2017-12-26 Medtronic Minimed, Inc. Generation and application of an insulin limit for a closed-loop operating mode of an insulin infusion system
US9867953B2 (en) 2013-06-21 2018-01-16 Tandem Diabetes Care, Inc. System and method for infusion set dislodgement detection
US9878096B2 (en) 2012-08-30 2018-01-30 Medtronic Minimed, Inc. Generation of target glucose values for a closed-loop operating mode of an insulin infusion system
US9886556B2 (en) 2015-08-20 2018-02-06 Aseko, Inc. Diabetes management therapy advisor
US9892234B2 (en) 2014-10-27 2018-02-13 Aseko, Inc. Subcutaneous outpatient management
US9962486B2 (en) 2013-03-14 2018-05-08 Tandem Diabetes Care, Inc. System and method for detecting occlusions in an infusion pump
US10016561B2 (en) 2013-03-15 2018-07-10 Tandem Diabetes Care, Inc. Clinical variable determination
US10130767B2 (en) 2012-08-30 2018-11-20 Medtronic Minimed, Inc. Sensor model supervisor for a closed-loop insulin infusion system
WO2018226659A1 (en) * 2017-06-06 2018-12-13 Polymer Technology Systems, Inc. Systems and methods for verification value of user entered values resulting from point of care testing using a meter
US10188793B2 (en) 2014-06-10 2019-01-29 Bigfoot Biomedical, Inc. Insulin on board calculation, schedule and delivery
US10213547B2 (en) 2013-12-26 2019-02-26 Tandem Diabetes Care, Inc. Safety processor for a drug delivery device
US10216767B2 (en) 2008-12-23 2019-02-26 Roche Diabetes Care, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
US10258736B2 (en) 2012-05-17 2019-04-16 Tandem Diabetes Care, Inc. Systems including vial adapter for fluid transfer

Citations (84)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5050612A (en) * 1989-09-12 1991-09-24 Matsumura Kenneth N Device for computer-assisted monitoring of the body
US5311175A (en) * 1990-11-01 1994-05-10 Herbert Waldman Method and apparatus for pre-identification of keys and switches
US5485408A (en) * 1992-09-09 1996-01-16 Sims Deltec, Inc. Pump simulation apparatus
US5713856A (en) * 1995-03-13 1998-02-03 Alaris Medical Systems, Inc. Modular patient care system
US5745378A (en) * 1995-12-04 1998-04-28 Abbott Laboratories Parameter input for drug delivery pump
US5876370A (en) * 1995-10-11 1999-03-02 Sims Deltec, Inc. Intermittent fluid delivery apparatus and method
US5885211A (en) * 1993-11-15 1999-03-23 Spectrix, Inc. Microporation of human skin for monitoring the concentration of an analyte
US6023629A (en) * 1994-06-24 2000-02-08 Cygnus, Inc. Method of sampling substances using alternating polarity of iontophoretic current
US20010001144A1 (en) * 1998-02-27 2001-05-10 Kapp Thomas L. Pharmacy drug management system providing patient specific drug dosing, drug interaction analysis, order generation, and patient data matching
US6233471B1 (en) * 1998-05-13 2001-05-15 Cygnus, Inc. Signal processing for measurement of physiological analysis
US20010041831A1 (en) * 2000-01-21 2001-11-15 Starkweather Timothy J. Ambulatory medical apparatus and method having telemetry modifiable control software
US20020002326A1 (en) * 1998-08-18 2002-01-03 Causey James D. Handheld personal data assistant (PDA) with a medical device and method of using the same
US6368272B1 (en) * 1998-04-10 2002-04-09 Proactive Metabolics Company Equipment and method for contemporaneous decision supporting metabolic control
US6379301B1 (en) * 1997-01-10 2002-04-30 Health Hero Network, Inc. Diabetes management system and method for controlling blood glucose
US6505059B1 (en) * 1998-04-06 2003-01-07 The General Hospital Corporation Non-invasive tissue glucose level monitoring
US6517482B1 (en) * 1996-04-23 2003-02-11 Dermal Therapy (Barbados) Inc. Method and apparatus for non-invasive determination of glucose in body fluids
US20030032867A1 (en) * 2001-06-21 2003-02-13 Animas Corporation. System and method for managing diabetes
US20030036683A1 (en) * 2000-05-01 2003-02-20 Kehr Bruce A. Method, system and computer program product for internet-enabled, patient monitoring system
US20030050621A1 (en) * 2001-09-07 2003-03-13 Lebel Ronald J. Safety limits for closed-loop infusion pump control
US6539250B1 (en) * 1999-12-15 2003-03-25 David S. Bettinger Programmable transdermal therapeutic apparatus
US20030060765A1 (en) * 2000-02-16 2003-03-27 Arthur Campbell Infusion device menu structure and method of using the same
US6546269B1 (en) * 1998-05-13 2003-04-08 Cygnus, Inc. Method and device for predicting physiological values
US6544212B2 (en) * 2001-07-31 2003-04-08 Roche Diagnostics Corporation Diabetes management system
US6551276B1 (en) * 1998-08-18 2003-04-22 Medtronic Minimed, Inc. External infusion device with remote programming bolus estimator and/or vibration alarm capabilities
US6558351B1 (en) * 1999-06-03 2003-05-06 Medtronic Minimed, Inc. Closed loop system for controlling insulin infusion
US20030088238A1 (en) * 2001-09-26 2003-05-08 Poulsen Jens Ulrik Modular drug delivery system
US20040015132A1 (en) * 1998-01-06 2004-01-22 Eric Brown Method for improving patient compliance with a medical program
US20040015102A1 (en) * 2002-06-05 2004-01-22 Cummings Elizabeth A. Analyte testing device
US20040068230A1 (en) * 2002-07-24 2004-04-08 Medtronic Minimed, Inc. System for providing blood glucose measurements to an infusion device
US20050021006A1 (en) * 1998-09-18 2005-01-27 Tonnies Jan G. Infusion pump comprising a computer for calculating the respective maximum permissible dosage
US20050022274A1 (en) * 2003-04-18 2005-01-27 Robert Campbell User interface for infusion pump remote controller and method of using the same
US20050050621A1 (en) * 2003-09-08 2005-03-10 Thomas Kirk M. Toilet ventilation system and method
US20050065760A1 (en) * 2003-09-23 2005-03-24 Robert Murtfeldt Method for advising patients concerning doses of insulin
US6882940B2 (en) * 2000-08-18 2005-04-19 Cygnus, Inc. Methods and devices for prediction of hypoglycemic events
US20060001550A1 (en) * 1998-10-08 2006-01-05 Mann Alfred E Telemetered characteristic monitor system and method of using the same
US20060014670A1 (en) * 2002-12-27 2006-01-19 Green Daniel T Compositions and methods for the prevention and control of insulin-induced hypoglycemia
US6998387B1 (en) * 1998-03-19 2006-02-14 Amylin Pharmaceuticals, Inc. Human appetite control by glucagon-like peptide receptor binding compounds
US20060047192A1 (en) * 2004-08-26 2006-03-02 Robert Hellwig Insulin bolus recommendation system
US20060047538A1 (en) * 2004-08-25 2006-03-02 Joseph Condurso System and method for dynamically adjusting patient therapy
US20060080059A1 (en) * 2004-07-10 2006-04-13 Stupp Steven E Apparatus for collecting information
US20070021733A1 (en) * 2003-10-21 2007-01-25 Novo Nordisk A/S Internal fluid connector
US20070060796A1 (en) * 2003-10-24 2007-03-15 Yoon Nyun Kim Insulin pump for use in conjunction with mobile communication terminal capable of measuring blood glucose levels and network system for transmitting control information for insulin pump
US20070060871A1 (en) * 2005-09-13 2007-03-15 Medtronic Minimed, Inc. Modular external infusion device
US20080004601A1 (en) * 2006-06-28 2008-01-03 Abbott Diabetes Care, Inc. Analyte Monitoring and Therapy Management System and Methods Therefor
US20080033361A1 (en) * 2006-08-03 2008-02-07 Smiths Medical Md, Inc. Interface for medical infusion pump
US20080051714A1 (en) * 2006-08-23 2008-02-28 Medtronic Minimed, Inc. Infusion medium delivery system, device and method with needle inserter and needle inserter device and method
US20080051709A1 (en) * 2006-08-23 2008-02-28 Medtronic Minimed, Inc. Infusion medium delivery device and method with compressible or curved reservoir or conduit
US7341577B2 (en) * 2002-04-30 2008-03-11 Renishaw Plc Implantable drug delivery pump
US20080065016A1 (en) * 1992-09-09 2008-03-13 Deltec, Inc. Drug pump systems and methods
US20080071251A1 (en) * 2006-09-18 2008-03-20 Maas Medical, Llc Method and system for controlled infusion of therapeutic substances
US20080097289A1 (en) * 2006-09-06 2008-04-24 Medtronic Minimed, Inc. Intelligent Therapy Recommendation Algorithm and Method of Using the Same
US20080172030A1 (en) * 2006-10-17 2008-07-17 Blomquist Michael L Insulin pump having aweekly schedule
US20090005726A1 (en) * 2007-06-27 2009-01-01 Steven Paul Jones Insulin Pump Having Expected Bolus Interval and an Early Bolus Interval
US20090036753A1 (en) * 2007-07-31 2009-02-05 King Allen B Continuous glucose monitoring-directed adjustments in basal insulin rate and insulin bolus dosing formulas
US7491187B2 (en) * 2002-03-22 2009-02-17 K.U. Leuven Research & Development Automatic infusion system based on an adaptive patient model
US7515060B2 (en) * 2006-10-17 2009-04-07 Smiths Medical Md, Inc. Insulin pump for the visually impaired
US20090105646A1 (en) * 2007-10-18 2009-04-23 Animas Corporation Multi-Frequency Communication System For A Drug Infusion Device
US7647237B2 (en) * 1998-04-29 2010-01-12 Minimed, Inc. Communication station and software for interfacing with an infusion pump, analyte monitor, analyte meter, or the like
US7651845B2 (en) * 2004-05-13 2010-01-26 The Regents Of The University Of California Method and apparatus for glucose control and insulin dosing for diabetics
US20100030045A1 (en) * 2008-07-31 2010-02-04 Medtronic Minimed, Inc. Analyte sensor apparatuses comprising multiple implantable sensor elements and methods for making and using them
US20100030387A1 (en) * 2006-10-23 2010-02-04 Luyi Sen Intelligent Remote-Controlled Portable Intravenous Injection and Transfusion System
US20100056993A1 (en) * 2006-07-21 2010-03-04 The Regents Of The University Of Colorado Medical Systems and Methods of Use
US20100057043A1 (en) * 2006-11-27 2010-03-04 University Of Virginia Patent Foundation Method, System, and Computer Program Product for the Detection of Physical Activity by Changes in Heart Rate, Assessment of Fast Changing Metabolic States, and Applications of Closed and Open Control Loop in Diabetes
US7674485B2 (en) * 2003-05-14 2010-03-09 Indus Biotech Pvt. Ltd. Synergistic composition for the treatment of diabetes mellitus
US20100095229A1 (en) * 2008-09-18 2010-04-15 Abbott Diabetes Care, Inc. Graphical user interface for glucose monitoring system
US7869851B2 (en) * 2004-12-23 2011-01-11 Roche Diagnostics Operations, Inc. System and method for determining insulin bolus quantities
US20110033833A1 (en) * 2008-01-07 2011-02-10 Michael Blomquist Pump with therapy coaching
US20110040251A1 (en) * 2008-01-09 2011-02-17 Michael Blomquist Infusion pump with add-on modules
US20110054391A1 (en) * 2006-07-28 2011-03-03 Ward W Kenneth Analyte sensing and response system
US20110053121A1 (en) * 2007-06-18 2011-03-03 Roche Diagnostics International Ag Method and glucose monitoring system for monitoring individual metabolic response and for generating nutritional feedback
US7912674B2 (en) * 2006-10-31 2011-03-22 Roche Diagnostics International Ag Method for processing a chronological sequence of measurements of a time dependent parameter
US20110071765A1 (en) * 2008-05-16 2011-03-24 Ofer Yodfat Device and Method for Alleviating Postprandial Hyperglycemia
US7920907B2 (en) * 2006-06-07 2011-04-05 Abbott Diabetes Care Inc. Analyte monitoring system and method
US20110087165A1 (en) * 2009-10-13 2011-04-14 Chad Amborn Two piece medication cassette closure apparatus and method
US20110092788A1 (en) * 2009-10-15 2011-04-21 Roche Diagnostics Operations, Inc. Systems And Methods For Providing Guidance In Administration Of A Medicine
US20110098548A1 (en) * 2009-10-22 2011-04-28 Abbott Diabetes Care Inc. Methods for modeling insulin therapy requirements
US8093212B2 (en) * 2002-02-28 2012-01-10 The Penn State Research Foundation Methods of treating nerve-related vision disorders by an insulinomimetic agent
US8114350B1 (en) * 2000-05-15 2012-02-14 Silver James H Sensors for detecting substances indicative of stroke, ischemia, infection or inflammation
US20120041415A1 (en) * 2001-12-19 2012-02-16 Medtronic Minimed, Inc. Medication delivery system and monitor
US8119593B2 (en) * 2008-08-11 2012-02-21 Mannkind Corporation Method of treating diabetes type 2 by metformin and an ultrarapid acting insulin
US8129429B2 (en) * 2008-01-11 2012-03-06 Reata Pharmaceuticals, Inc. Synthetic triterpenoids and methods of use in the treatment of disease
US8140312B2 (en) * 2007-05-14 2012-03-20 Abbott Diabetes Care Inc. Method and system for determining analyte levels
US8152789B2 (en) * 2001-10-23 2012-04-10 Medtronic Minimed, Inc. System and method for providing closed loop infusion formulation delivery
US8372040B2 (en) * 2005-05-24 2013-02-12 Chrono Therapeutics, Inc. Portable drug delivery device including a detachable and replaceable administration or dosing element

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU546785B2 (en) * 1980-07-23 1985-09-19 Commonwealth Of Australia, The Open-loop controlled infusion of diabetics
US7267665B2 (en) * 1999-06-03 2007-09-11 Medtronic Minimed, Inc. Closed loop system for controlling insulin infusion
EP1728468A1 (en) * 2005-06-04 2006-12-06 Roche Diagnostics GmbH Evaluation of blood glucose concentration values for adaptation of insulin dosage
US7766829B2 (en) * 2005-11-04 2010-08-03 Abbott Diabetes Care Inc. Method and system for providing basal profile modification in analyte monitoring and management systems
US20080172027A1 (en) * 2006-10-17 2008-07-17 Blomquist Michael L Insulin pump having basal rate testing features

Patent Citations (102)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5050612A (en) * 1989-09-12 1991-09-24 Matsumura Kenneth N Device for computer-assisted monitoring of the body
US5311175A (en) * 1990-11-01 1994-05-10 Herbert Waldman Method and apparatus for pre-identification of keys and switches
US20080065007A1 (en) * 1992-09-09 2008-03-13 Deltec, Inc. Drug pump systems and methods
US5485408A (en) * 1992-09-09 1996-01-16 Sims Deltec, Inc. Pump simulation apparatus
US20080065016A1 (en) * 1992-09-09 2008-03-13 Deltec, Inc. Drug pump systems and methods
US5885211A (en) * 1993-11-15 1999-03-23 Spectrix, Inc. Microporation of human skin for monitoring the concentration of an analyte
US6687522B2 (en) * 1994-06-24 2004-02-03 Cygnus, Inc. Device for sample of substances using alternating polarity
US6023629A (en) * 1994-06-24 2000-02-08 Cygnus, Inc. Method of sampling substances using alternating polarity of iontophoretic current
US5713856A (en) * 1995-03-13 1998-02-03 Alaris Medical Systems, Inc. Modular patient care system
US5876370A (en) * 1995-10-11 1999-03-02 Sims Deltec, Inc. Intermittent fluid delivery apparatus and method
US5745378A (en) * 1995-12-04 1998-04-28 Abbott Laboratories Parameter input for drug delivery pump
US6517482B1 (en) * 1996-04-23 2003-02-11 Dermal Therapy (Barbados) Inc. Method and apparatus for non-invasive determination of glucose in body fluids
US6379301B1 (en) * 1997-01-10 2002-04-30 Health Hero Network, Inc. Diabetes management system and method for controlling blood glucose
US20040015132A1 (en) * 1998-01-06 2004-01-22 Eric Brown Method for improving patient compliance with a medical program
US20010001144A1 (en) * 1998-02-27 2001-05-10 Kapp Thomas L. Pharmacy drug management system providing patient specific drug dosing, drug interaction analysis, order generation, and patient data matching
US6998387B1 (en) * 1998-03-19 2006-02-14 Amylin Pharmaceuticals, Inc. Human appetite control by glucagon-like peptide receptor binding compounds
US6505059B1 (en) * 1998-04-06 2003-01-07 The General Hospital Corporation Non-invasive tissue glucose level monitoring
US6368272B1 (en) * 1998-04-10 2002-04-09 Proactive Metabolics Company Equipment and method for contemporaneous decision supporting metabolic control
US7647237B2 (en) * 1998-04-29 2010-01-12 Minimed, Inc. Communication station and software for interfacing with an infusion pump, analyte monitor, analyte meter, or the like
US6233471B1 (en) * 1998-05-13 2001-05-15 Cygnus, Inc. Signal processing for measurement of physiological analysis
US6546269B1 (en) * 1998-05-13 2003-04-08 Cygnus, Inc. Method and device for predicting physiological values
US6872200B2 (en) * 1998-08-18 2005-03-29 Medtronic Minimed, Inc. External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities
US20080033357A1 (en) * 1998-08-18 2008-02-07 Medtronic Minimed, Inc. External Infusion Device with Remote Programming, Bolus Estimator and/or Vibration Alarm Capabilities
US20020002326A1 (en) * 1998-08-18 2002-01-03 Causey James D. Handheld personal data assistant (PDA) with a medical device and method of using the same
US6551276B1 (en) * 1998-08-18 2003-04-22 Medtronic Minimed, Inc. External infusion device with remote programming bolus estimator and/or vibration alarm capabilities
US6554798B1 (en) * 1998-08-18 2003-04-29 Medtronic Minimed, Inc. External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities
US20040073095A1 (en) * 1998-08-18 2004-04-15 Minimed Inc. Handheld personal data assistant (PDA) with a medical device and method of using the same
US6997920B2 (en) * 1998-08-18 2006-02-14 Medtronic Minimed, Inc. External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities
US7025743B2 (en) * 1998-08-18 2006-04-11 Medtronic Minimed, Inc. External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities
US20050021006A1 (en) * 1998-09-18 2005-01-27 Tonnies Jan G. Infusion pump comprising a computer for calculating the respective maximum permissible dosage
US7324012B2 (en) * 1998-10-08 2008-01-29 Medtronic Minimed, Inc. Telemetered characteristic monitor system and method of using the same
US20080030369A1 (en) * 1998-10-08 2008-02-07 Medtronic Minimed, Inc. Telemetered characteristic monitor system and method of using the same
US20060001550A1 (en) * 1998-10-08 2006-01-05 Mann Alfred E Telemetered characteristic monitor system and method of using the same
US6558351B1 (en) * 1999-06-03 2003-05-06 Medtronic Minimed, Inc. Closed loop system for controlling insulin infusion
US6539250B1 (en) * 1999-12-15 2003-03-25 David S. Bettinger Programmable transdermal therapeutic apparatus
US6558320B1 (en) * 2000-01-20 2003-05-06 Medtronic Minimed, Inc. Handheld personal data assistant (PDA) with a medical device and method of using the same
US20030065308A1 (en) * 2000-01-21 2003-04-03 Lebel Ronald J. Ambulatory medical apparatus with hand held communication device
US20020065454A1 (en) * 2000-01-21 2002-05-30 Lebel Ronald J. Microprocessor controlled ambulatory medical apparatus with hand held communication device
US20010041831A1 (en) * 2000-01-21 2001-11-15 Starkweather Timothy J. Ambulatory medical apparatus and method having telemetry modifiable control software
US20030060765A1 (en) * 2000-02-16 2003-03-27 Arthur Campbell Infusion device menu structure and method of using the same
US20090088731A1 (en) * 2000-02-16 2009-04-02 Medtronic Minimed, Inc. Infusion Device Menu Structure and Method of Using the Same
US20030036683A1 (en) * 2000-05-01 2003-02-20 Kehr Bruce A. Method, system and computer program product for internet-enabled, patient monitoring system
US8114350B1 (en) * 2000-05-15 2012-02-14 Silver James H Sensors for detecting substances indicative of stroke, ischemia, infection or inflammation
US6882940B2 (en) * 2000-08-18 2005-04-19 Cygnus, Inc. Methods and devices for prediction of hypoglycemic events
US20030032867A1 (en) * 2001-06-21 2003-02-13 Animas Corporation. System and method for managing diabetes
US7179226B2 (en) * 2001-06-21 2007-02-20 Animas Corporation System and method for managing diabetes
US6544212B2 (en) * 2001-07-31 2003-04-08 Roche Diagnostics Corporation Diabetes management system
US20030050621A1 (en) * 2001-09-07 2003-03-13 Lebel Ronald J. Safety limits for closed-loop infusion pump control
US20030088238A1 (en) * 2001-09-26 2003-05-08 Poulsen Jens Ulrik Modular drug delivery system
US8152789B2 (en) * 2001-10-23 2012-04-10 Medtronic Minimed, Inc. System and method for providing closed loop infusion formulation delivery
US20120041415A1 (en) * 2001-12-19 2012-02-16 Medtronic Minimed, Inc. Medication delivery system and monitor
US8093212B2 (en) * 2002-02-28 2012-01-10 The Penn State Research Foundation Methods of treating nerve-related vision disorders by an insulinomimetic agent
US7491187B2 (en) * 2002-03-22 2009-02-17 K.U. Leuven Research & Development Automatic infusion system based on an adaptive patient model
US7341577B2 (en) * 2002-04-30 2008-03-11 Renishaw Plc Implantable drug delivery pump
US20040015102A1 (en) * 2002-06-05 2004-01-22 Cummings Elizabeth A. Analyte testing device
US20040068230A1 (en) * 2002-07-24 2004-04-08 Medtronic Minimed, Inc. System for providing blood glucose measurements to an infusion device
US7678762B2 (en) * 2002-12-27 2010-03-16 Diobex, Inc. Methods for reducing the risk of hypoglycemia
US7678763B2 (en) * 2002-12-27 2010-03-16 Diobex, Inc. Compositions and methods for the prevention and control of insulin-induced hypoglycemia
US20060014670A1 (en) * 2002-12-27 2006-01-19 Green Daniel T Compositions and methods for the prevention and control of insulin-induced hypoglycemia
US20050022274A1 (en) * 2003-04-18 2005-01-27 Robert Campbell User interface for infusion pump remote controller and method of using the same
US7674485B2 (en) * 2003-05-14 2010-03-09 Indus Biotech Pvt. Ltd. Synergistic composition for the treatment of diabetes mellitus
US20050050621A1 (en) * 2003-09-08 2005-03-10 Thomas Kirk M. Toilet ventilation system and method
US20050065760A1 (en) * 2003-09-23 2005-03-24 Robert Murtfeldt Method for advising patients concerning doses of insulin
US20070021733A1 (en) * 2003-10-21 2007-01-25 Novo Nordisk A/S Internal fluid connector
US20070060796A1 (en) * 2003-10-24 2007-03-15 Yoon Nyun Kim Insulin pump for use in conjunction with mobile communication terminal capable of measuring blood glucose levels and network system for transmitting control information for insulin pump
US7651845B2 (en) * 2004-05-13 2010-01-26 The Regents Of The University Of California Method and apparatus for glucose control and insulin dosing for diabetics
US20060080059A1 (en) * 2004-07-10 2006-04-13 Stupp Steven E Apparatus for collecting information
US20060047538A1 (en) * 2004-08-25 2006-03-02 Joseph Condurso System and method for dynamically adjusting patient therapy
US20060047192A1 (en) * 2004-08-26 2006-03-02 Robert Hellwig Insulin bolus recommendation system
US7869851B2 (en) * 2004-12-23 2011-01-11 Roche Diagnostics Operations, Inc. System and method for determining insulin bolus quantities
US8372040B2 (en) * 2005-05-24 2013-02-12 Chrono Therapeutics, Inc. Portable drug delivery device including a detachable and replaceable administration or dosing element
US20070060871A1 (en) * 2005-09-13 2007-03-15 Medtronic Minimed, Inc. Modular external infusion device
US7920907B2 (en) * 2006-06-07 2011-04-05 Abbott Diabetes Care Inc. Analyte monitoring system and method
US20080004601A1 (en) * 2006-06-28 2008-01-03 Abbott Diabetes Care, Inc. Analyte Monitoring and Therapy Management System and Methods Therefor
US20100056993A1 (en) * 2006-07-21 2010-03-04 The Regents Of The University Of Colorado Medical Systems and Methods of Use
US20110054391A1 (en) * 2006-07-28 2011-03-03 Ward W Kenneth Analyte sensing and response system
US20080033361A1 (en) * 2006-08-03 2008-02-07 Smiths Medical Md, Inc. Interface for medical infusion pump
US20080051709A1 (en) * 2006-08-23 2008-02-28 Medtronic Minimed, Inc. Infusion medium delivery device and method with compressible or curved reservoir or conduit
US20080051714A1 (en) * 2006-08-23 2008-02-28 Medtronic Minimed, Inc. Infusion medium delivery system, device and method with needle inserter and needle inserter device and method
US20080097289A1 (en) * 2006-09-06 2008-04-24 Medtronic Minimed, Inc. Intelligent Therapy Recommendation Algorithm and Method of Using the Same
US20080071251A1 (en) * 2006-09-18 2008-03-20 Maas Medical, Llc Method and system for controlled infusion of therapeutic substances
US7515060B2 (en) * 2006-10-17 2009-04-07 Smiths Medical Md, Inc. Insulin pump for the visually impaired
US20080172030A1 (en) * 2006-10-17 2008-07-17 Blomquist Michael L Insulin pump having aweekly schedule
US20100030387A1 (en) * 2006-10-23 2010-02-04 Luyi Sen Intelligent Remote-Controlled Portable Intravenous Injection and Transfusion System
US7912674B2 (en) * 2006-10-31 2011-03-22 Roche Diagnostics International Ag Method for processing a chronological sequence of measurements of a time dependent parameter
US20100057043A1 (en) * 2006-11-27 2010-03-04 University Of Virginia Patent Foundation Method, System, and Computer Program Product for the Detection of Physical Activity by Changes in Heart Rate, Assessment of Fast Changing Metabolic States, and Applications of Closed and Open Control Loop in Diabetes
US8140312B2 (en) * 2007-05-14 2012-03-20 Abbott Diabetes Care Inc. Method and system for determining analyte levels
US20110053121A1 (en) * 2007-06-18 2011-03-03 Roche Diagnostics International Ag Method and glucose monitoring system for monitoring individual metabolic response and for generating nutritional feedback
US20090005726A1 (en) * 2007-06-27 2009-01-01 Steven Paul Jones Insulin Pump Having Expected Bolus Interval and an Early Bolus Interval
US20090036753A1 (en) * 2007-07-31 2009-02-05 King Allen B Continuous glucose monitoring-directed adjustments in basal insulin rate and insulin bolus dosing formulas
US20090105646A1 (en) * 2007-10-18 2009-04-23 Animas Corporation Multi-Frequency Communication System For A Drug Infusion Device
US20110033833A1 (en) * 2008-01-07 2011-02-10 Michael Blomquist Pump with therapy coaching
US20110040251A1 (en) * 2008-01-09 2011-02-17 Michael Blomquist Infusion pump with add-on modules
US8129429B2 (en) * 2008-01-11 2012-03-06 Reata Pharmaceuticals, Inc. Synthetic triterpenoids and methods of use in the treatment of disease
US20110071765A1 (en) * 2008-05-16 2011-03-24 Ofer Yodfat Device and Method for Alleviating Postprandial Hyperglycemia
US20100030045A1 (en) * 2008-07-31 2010-02-04 Medtronic Minimed, Inc. Analyte sensor apparatuses comprising multiple implantable sensor elements and methods for making and using them
US8119593B2 (en) * 2008-08-11 2012-02-21 Mannkind Corporation Method of treating diabetes type 2 by metformin and an ultrarapid acting insulin
US20100105999A1 (en) * 2008-09-18 2010-04-29 Abbott Diabetes Care Inc. Graphical User Interface for Glucose Monitoring System
US20100095229A1 (en) * 2008-09-18 2010-04-15 Abbott Diabetes Care, Inc. Graphical user interface for glucose monitoring system
US20110087165A1 (en) * 2009-10-13 2011-04-14 Chad Amborn Two piece medication cassette closure apparatus and method
US20110092788A1 (en) * 2009-10-15 2011-04-21 Roche Diagnostics Operations, Inc. Systems And Methods For Providing Guidance In Administration Of A Medicine
US20110098548A1 (en) * 2009-10-22 2011-04-28 Abbott Diabetes Care Inc. Methods for modeling insulin therapy requirements

Cited By (100)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8346399B2 (en) 2002-02-28 2013-01-01 Tandem Diabetes Care, Inc. Programmable insulin pump
US8657807B2 (en) 2002-02-28 2014-02-25 Tandem Diabetes Care, Inc. Insulin pump having a suspension bolus
US8821433B2 (en) 2006-10-17 2014-09-02 Tandem Diabetes Care, Inc. Insulin pump having basal rate testing features
US8734428B2 (en) 2006-10-17 2014-05-27 Tandem Diabetes Care, Inc. Insulin pump having selectable insulin absorption models
US8998878B2 (en) 2006-10-17 2015-04-07 Tandem Diabetes Care, Inc. Insulin pump having correction factors
US8208984B2 (en) 2007-01-24 2012-06-26 Smiths Medical Asd, Inc. Correction factor testing using frequent blood glucose input
US9008803B2 (en) 2007-05-24 2015-04-14 Tandem Diabetes Care, Inc. Expert system for insulin pump therapy
US8219222B2 (en) 2007-05-24 2012-07-10 Smiths Medical Asd, Inc. Expert system for pump therapy
US9474856B2 (en) 2007-05-24 2016-10-25 Tandem Diabetes Care, Inc. Expert system for infusion pump therapy
US9833177B2 (en) 2007-05-30 2017-12-05 Tandem Diabetes Care, Inc. Insulin pump based expert system
US8221345B2 (en) 2007-05-30 2012-07-17 Smiths Medical Asd, Inc. Insulin pump based expert system
US20110264071A1 (en) * 2007-10-10 2011-10-27 Optiscan Biomedical Corporation Fluid component analysis systems and methods for glucose monitoring and control
US9414782B2 (en) 2007-10-10 2016-08-16 Optiscan Biomedical Corporation Fluid component analysis systems and methods for glucose monitoring and control
US8449524B2 (en) * 2007-10-10 2013-05-28 Optiscan Biomedical Corporation Fluid component analysis systems and methods for glucose monitoring and control
US10052049B2 (en) * 2008-01-07 2018-08-21 Tandem Diabetes Care, Inc. Infusion pump with blood glucose alert delay
US20140350371A1 (en) * 2008-01-07 2014-11-27 Tandem Diabetes Care, Inc. Infusion pump with blood glucose alert delay
US8801657B2 (en) 2008-01-07 2014-08-12 Tandem Diabetes Care, Inc. Pump with therapy coaching
US8718949B2 (en) 2008-01-07 2014-05-06 Tandem Diabetes Care, Inc. Insulin pump with blood glucose modules
US8840582B2 (en) 2008-01-09 2014-09-23 Tandem Diabetes Care, Inc. Infusion pump with activity monitoring
US8414523B2 (en) 2008-01-09 2013-04-09 Tandem Diabetes Care, Inc. Infusion pump with add-on modules
US9889250B2 (en) 2008-01-09 2018-02-13 Tandem Diabetes Care, Inc. Infusion pump with temperature monitoring
US9378333B2 (en) 2008-05-02 2016-06-28 Smiths Medical Asd, Inc. Display for pump
US8417311B2 (en) 2008-09-12 2013-04-09 Optiscan Biomedical Corporation Fluid component analysis system and method for glucose monitoring and control
US9302045B2 (en) 2008-09-12 2016-04-05 Optiscan Biomedical Corporation Fluid component analysis system and method for glucose monitoring and control
US20100218132A1 (en) * 2008-12-23 2010-08-26 Roche Diagnostics Operations, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
US9659037B2 (en) 2008-12-23 2017-05-23 Roche Diabetes Care, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
US9918635B2 (en) 2008-12-23 2018-03-20 Roche Diabetes Care, Inc. Systems and methods for optimizing insulin dosage
US10216767B2 (en) 2008-12-23 2019-02-26 Roche Diabetes Care, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
US9117015B2 (en) 2008-12-23 2015-08-25 Roche Diagnostics Operations, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
US8849458B2 (en) 2008-12-23 2014-09-30 Roche Diagnostics Operations, Inc. Collection device with selective display of test results, method and computer program product thereof
US9579456B2 (en) * 2009-05-22 2017-02-28 Abbott Diabetes Care Inc. Methods for reducing false hypoglycemia alarm occurrence
US20100317952A1 (en) * 2009-05-22 2010-12-16 Abbott Diabetes Care Inc. Methods for reducing false hypoglycemia alarm occurrence
US8758323B2 (en) 2009-07-30 2014-06-24 Tandem Diabetes Care, Inc. Infusion pump system with disposable cartridge having pressure venting and pressure feedback
US9211377B2 (en) 2009-07-30 2015-12-15 Tandem Diabetes Care, Inc. Infusion pump system with disposable cartridge having pressure venting and pressure feedback
US8298184B2 (en) 2009-07-30 2012-10-30 Tandem Diabetes Care, Inc. Infusion pump system with disposable cartridge having pressure venting and pressure feedback
US8926561B2 (en) 2009-07-30 2015-01-06 Tandem Diabetes Care, Inc. Infusion pump system with disposable cartridge having pressure venting and pressure feedback
US8287495B2 (en) 2009-07-30 2012-10-16 Tandem Diabetes Care, Inc. Infusion pump system with disposable cartridge having pressure venting and pressure feedback
US9919105B2 (en) 2009-09-18 2018-03-20 Roche Diagnostics Operations, Inc. Devices, systems and methods for quantifying bolus doses according to user parameters
WO2011033509A1 (en) * 2009-09-18 2011-03-24 Medingo Ltd. Devices, systems and methods for quantifying bolus doses according to user parameters
US9507917B2 (en) 2009-09-30 2016-11-29 Dreamed Diabetes Ltd. Monitoring device for management of insulin delivery
US8954373B2 (en) 2009-09-30 2015-02-10 Dreamed Diabetes Ltd. Monitoring device for management of insulin delivery
US8882701B2 (en) 2009-12-04 2014-11-11 Smiths Medical Asd, Inc. Advanced step therapy delivery for an ambulatory infusion pump and system
US10016559B2 (en) 2009-12-04 2018-07-10 Smiths Medical Asd, Inc. Advanced step therapy delivery for an ambulatory infusion pump and system
US8532933B2 (en) 2010-06-18 2013-09-10 Roche Diagnostics Operations, Inc. Insulin optimization systems and testing methods with adjusted exit criterion accounting for system noise associated with biomarkers
WO2011157395A1 (en) * 2010-06-18 2011-12-22 Roche Diagnostics Gmbh Systems and methods for optimizing insulin dosage
CN102947833A (en) * 2010-06-18 2013-02-27 霍夫曼-拉罗奇有限公司 Systems and methods for optimizing insulin dosage
US8617135B2 (en) * 2011-01-12 2013-12-31 The Regents Of The University Of California System and method for closed-loop patient-adaptive hemodynamic management
US20120179135A1 (en) * 2011-01-12 2012-07-12 Rinehart Joseph B System and method for closed-loop patient-adaptive hemodynamic management
US8766803B2 (en) 2011-05-13 2014-07-01 Roche Diagnostics Operations, Inc. Dynamic data collection
US8755938B2 (en) 2011-05-13 2014-06-17 Roche Diagnostics Operations, Inc. Systems and methods for handling unacceptable values in structured collection protocols
WO2013023014A1 (en) * 2011-08-11 2013-02-14 Scherb Cliff System and method for determining an amount of insulin to administer to a diabetic patient
WO2013102158A1 (en) 2011-12-30 2013-07-04 Abbott Diabetes Care Inc. Method and apparatus for determining medication dose information
EP2797660A4 (en) * 2011-12-30 2015-08-19 Abbott Diabetes Care Inc Method and apparatus for determining medication dose information
US20130184547A1 (en) * 2011-12-30 2013-07-18 Abbott Diabetes Care Inc. Method and Apparatus for Determining Medication Dose Information
US10258736B2 (en) 2012-05-17 2019-04-16 Tandem Diabetes Care, Inc. Systems including vial adapter for fluid transfer
US20130338629A1 (en) * 2012-06-07 2013-12-19 Medtronic Minimed, Inc. Diabetes therapy management system for recommending basal pattern adjustments
US20130345663A1 (en) * 2012-06-07 2013-12-26 Medtronic Minimed, Inc. Diabetes therapy management system for recommending bolus calculator adjustments
WO2013184896A1 (en) * 2012-06-07 2013-12-12 Medtronic Minimed, Inc. Diabetes therapy management system for recommending adjustments to an insulin infusion device
US9814835B2 (en) 2012-06-07 2017-11-14 Tandem Diabetes Care, Inc. Device and method for training users of ambulatory medical devices
US9623179B2 (en) 2012-08-30 2017-04-18 Medtronic Minimed, Inc. Safeguarding techniques for a closed-loop insulin infusion system
US9364609B2 (en) * 2012-08-30 2016-06-14 Medtronic Minimed, Inc. Insulin on board compensation for a closed-loop insulin infusion system
AU2013309425B2 (en) * 2012-08-30 2018-10-18 Medtronic Minimed, Inc. Safeguarding measures for a closed-loop insulin infusion system
CN105046042A (en) * 2012-08-30 2015-11-11 美敦力迷你迈德公司 Safeguarding techniques for closed-loop insulin infusion system
JP2015526242A (en) * 2012-08-30 2015-09-10 メドトロニック ミニメド インコーポレイテッド System and method for controlling insulin infusion device
US10130767B2 (en) 2012-08-30 2018-11-20 Medtronic Minimed, Inc. Sensor model supervisor for a closed-loop insulin infusion system
AU2015200829B2 (en) * 2012-08-30 2016-06-16 Medtronic Minimed, Inc. Safeguarding techniques for a closed-loop insulin infusion system
US20140066892A1 (en) * 2012-08-30 2014-03-06 Medtronic Minimed, Inc. Insulin on board compensation for a closed-loop insulin infusion system
US20140066885A1 (en) * 2012-08-30 2014-03-06 Medtronic Minimed, Inc. Safeguarding measures for a closed-loop insulin infusion system
US9662445B2 (en) 2012-08-30 2017-05-30 Medtronic Minimed, Inc. Regulating entry into a closed-loop operating mode of an insulin infusion system
US9878096B2 (en) 2012-08-30 2018-01-30 Medtronic Minimed, Inc. Generation of target glucose values for a closed-loop operating mode of an insulin infusion system
US9849239B2 (en) 2012-08-30 2017-12-26 Medtronic Minimed, Inc. Generation and application of an insulin limit for a closed-loop operating mode of an insulin infusion system
AU2015200829C1 (en) * 2012-08-30 2016-10-13 Medtronic Minimed, Inc. Safeguarding techniques for a closed-loop insulin infusion system
US9526834B2 (en) * 2012-08-30 2016-12-27 Medtronic Minimed, Inc. Safeguarding measures for a closed-loop insulin infusion system
US9999728B2 (en) 2012-08-30 2018-06-19 Medtronic Minimed, Inc. Regulating entry into a closed-loop operating mode of an insulin infusion system
US9833191B2 (en) 2012-11-07 2017-12-05 Bigfoot Biomedical, Inc. Computer-based diabetes management
US9962486B2 (en) 2013-03-14 2018-05-08 Tandem Diabetes Care, Inc. System and method for detecting occlusions in an infusion pump
US10016561B2 (en) 2013-03-15 2018-07-10 Tandem Diabetes Care, Inc. Clinical variable determination
US9867953B2 (en) 2013-06-21 2018-01-16 Tandem Diabetes Care, Inc. System and method for infusion set dislodgement detection
WO2015035304A1 (en) * 2013-09-06 2015-03-12 Tandem Diabetes Care, Inc. System and method for mitigating risk in automated medicament dosing
EP3041528A4 (en) * 2013-09-06 2017-04-26 Tandem Diabetes Care, Inc. System and method for mitigating risk in automated medicament dosing
EP3041528A1 (en) * 2013-09-06 2016-07-13 Tandem Diabetes Care, Inc. System and method for mitigating risk in automated medicament dosing
US9867937B2 (en) 2013-09-06 2018-01-16 Tandem Diabetes Care, Inc. System and method for mitigating risk in automated medicament dosing
US10213547B2 (en) 2013-12-26 2019-02-26 Tandem Diabetes Care, Inc. Safety processor for a drug delivery device
WO2015116401A1 (en) * 2014-01-31 2015-08-06 Aseko, Inc. Insulin management
US9604002B2 (en) 2014-01-31 2017-03-28 Aseko, Inc. Insulin management
US9965595B2 (en) 2014-01-31 2018-05-08 Aseko, Inc. Insulin management
US9710611B2 (en) 2014-01-31 2017-07-18 Aseko, Inc. Insulin management
US9898585B2 (en) 2014-01-31 2018-02-20 Aseko, Inc. Method and system for insulin management
US9486580B2 (en) 2014-01-31 2016-11-08 Aseko, Inc. Insulin management
US10255992B2 (en) 2014-01-31 2019-04-09 Aseko, Inc. Insulin management
US9892235B2 (en) 2014-01-31 2018-02-13 Aseko, Inc. Insulin management
US9233204B2 (en) 2014-01-31 2016-01-12 Aseko, Inc. Insulin management
US9504789B2 (en) 2014-01-31 2016-11-29 Aseko, Inc. Insulin management
US10188793B2 (en) 2014-06-10 2019-01-29 Bigfoot Biomedical, Inc. Insulin on board calculation, schedule and delivery
US9669160B2 (en) 2014-07-30 2017-06-06 Tandem Diabetes Care, Inc. Temporary suspension for closed-loop medicament therapy
US20160030670A1 (en) * 2014-08-01 2016-02-04 The General Hospital Corporation Blood Glucose and Insulin Control Systems and Methods
US10128002B2 (en) 2014-10-27 2018-11-13 Aseko, Inc. Subcutaneous outpatient management
US9892234B2 (en) 2014-10-27 2018-02-13 Aseko, Inc. Subcutaneous outpatient management
US9886556B2 (en) 2015-08-20 2018-02-06 Aseko, Inc. Diabetes management therapy advisor
WO2018226659A1 (en) * 2017-06-06 2018-12-13 Polymer Technology Systems, Inc. Systems and methods for verification value of user entered values resulting from point of care testing using a meter

Also Published As

Publication number Publication date
WO2008112078A2 (en) 2008-09-18
JP2010521222A (en) 2010-06-24
US20170000943A1 (en) 2017-01-05
EP2129277A2 (en) 2009-12-09
WO2008112078A3 (en) 2008-10-30

Similar Documents

Publication Publication Date Title
JP6017758B2 (en) Patient information input interface for the treatment system
JP6006330B2 (en) Graphical user interface associated with the bolus calculator present in the portable diabetes management device
DK2207473T3 (en) modified sensorkalibreringsalgoritme
US9572934B2 (en) Robust closed loop control and methods
CA2683504C (en) Closed loop/semi-closed loop therapy modification system
US10154804B2 (en) Model predictive method and system for controlling and supervising insulin infusion
US8246540B2 (en) System for determining insulin dose using carbohydrate to insulin ratio and insulin sensitivity factor
US6368272B1 (en) Equipment and method for contemporaneous decision supporting metabolic control
US9320471B2 (en) Algorithm sensor augmented bolus estimator for semi-closed loop infusion system
US5822715A (en) Diabetes management system and method for controlling blood glucose
US7556613B2 (en) Array and method for dosing a hormone regulating blood sugar in a patient
US20100280441A1 (en) Overnight closed-loop insulin delivery with model predictive control and glucose measurement error model
US9392969B2 (en) Closed loop control and signal attenuation detection
US9199031B2 (en) Maintaining glycemic control during exercise
US7785313B2 (en) Closed loop/semi-closed loop therapy modification system
CA2671721C (en) Method and system for providing sensor redundancy
US10173007B2 (en) Closed loop control system with safety parameters and methods
US8732188B2 (en) Method and system for providing contextual based medication dosage determination
US9833177B2 (en) Insulin pump based expert system
US7402153B2 (en) Closed-loop method for controlling insulin infusion
US9943644B2 (en) Closed loop control with reference measurement and methods thereof
US8204729B2 (en) Device for predicting and managing blood glucose by analyzing the effect of, and controlling, pharmacodynamic insulin equivalents
US7354420B2 (en) Closed loop system for controlling insulin infusion
CA2753210C (en) Cgm-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction insulin delivery
US9697332B2 (en) Method and system for providing data management in integrated analyte monitoring and infusion system

Legal Events

Date Code Title Description
AS Assignment

Owner name: SMITHS MEDICAL MD, INC., MINNESOTA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BLOMQUIST, MICHAEL;SAVARD, THOMAS ALAN;REEL/FRAME:019411/0232

Effective date: 20070312

AS Assignment

Owner name: SMITHS MEDICAL ASD, INC., MASSACHUSETTS

Free format text: MERGER;ASSIGNOR:SMITHS MEDICAL MD, INC.;REEL/FRAME:023389/0085

Effective date: 20090731

Owner name: SMITHS MEDICAL ASD, INC.,MASSACHUSETTS

Free format text: MERGER;ASSIGNOR:SMITHS MEDICAL MD, INC.;REEL/FRAME:023389/0085

Effective date: 20090731

AS Assignment

Owner name: TANDEM DIABETES CARE, INC., CALIFORNIA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SMITHS MEDICAL ASD, INC.;REEL/FRAME:029121/0430

Effective date: 20120716

AS Assignment

Owner name: CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.

Free format text: SHORT-FORM PATENT SECURITY AGREEMENT;ASSIGNOR:TANDEM DIABETES CARE, INC.;REEL/FRAME:029529/0886

Effective date: 20121224

Owner name: CAPITAL ROYALTY PARTNERS II L.P., TEXAS

Free format text: SHORT-FORM PATENT SECURITY AGREEMENT;ASSIGNOR:TANDEM DIABETES CARE, INC.;REEL/FRAME:029529/0886

Effective date: 20121224

AS Assignment

Owner name: PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.

Free format text: SHORT-FORM PATENT SECURITY AGREEMENT;ASSIGNOR:TANDEM DIABETES CARE, INC.;REEL/FRAME:032608/0780

Effective date: 20140404

Owner name: CAPITAL ROYALTY PARTNERS II (CAYMAN) L.P., TEXAS

Free format text: SHORT-FORM PATENT SECURITY AGREEMENT;ASSIGNOR:TANDEM DIABETES CARE, INC.;REEL/FRAME:032608/0780

Effective date: 20140404

Owner name: CAPITAL ROYALTY PARTNERS II L.P., TEXAS

Free format text: SHORT-FORM PATENT SECURITY AGREEMENT;ASSIGNOR:TANDEM DIABETES CARE, INC.;REEL/FRAME:032608/0780

Effective date: 20140404

Owner name: CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.

Free format text: SHORT-FORM PATENT SECURITY AGREEMENT;ASSIGNOR:TANDEM DIABETES CARE, INC.;REEL/FRAME:032608/0780

Effective date: 20140404

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION

AS Assignment

Owner name: TANDEM DIABETES CARE, INC., CALIFORNIA

Free format text: RELEASE BY SECURED PARTY;ASSIGNORS:CAPITAL ROYALTY PARTNERS II L.P.;CAPITAL ROYALTY PARTNERS II L.P. - PARALLEL FUND "A" L.P.;PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.;AND OTHERS;REEL/FRAME:046761/0843

Effective date: 20180808

Owner name: TANDEM DIABETES CARE, INC., CALIFORNIA

Free format text: RELEASE BY SECURED PARTY;ASSIGNORS:CAPITAL ROYALTY PARTNERS II L.P.;CAPITAL ROYALTY PARTNERS II L.P. - PARALLEL FUND "A" L.P.;REEL/FRAME:046763/0268

Effective date: 20180808