CN102088898A - Analyte measurement and management device and associated methods - Google Patents
Analyte measurement and management device and associated methods Download PDFInfo
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- CN102088898A CN102088898A CN2009801270772A CN200980127077A CN102088898A CN 102088898 A CN102088898 A CN 102088898A CN 2009801270772 A CN2009801270772 A CN 2009801270772A CN 200980127077 A CN200980127077 A CN 200980127077A CN 102088898 A CN102088898 A CN 102088898A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
- A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means 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
- A61M5/172—Means 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
- A61M5/1723—Means 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
Abstract
A method for measuring and managing an analyte (e.g., blood glucose) in a bodily fluid includes storing a therapeutic administration protocol in a memory module of an analyte measurement and management device and measuring the analyte in the bodily fluid sample using an analyte measurement module of the device. The method also includes calculating, with a processor module of the device, a recommended therapeutic agent dosage (for example, an insulin dosage) and a recommended administration time for user-activated delivery of the dosage by employing the therapeutic administration protocol. The method further includes displaying the recommended therapeutic agent dosage and administration time to a user on a visual display of the device, delivering a therapeutic agent dosage to the user via a user-activated therapeutic agent delivery device, and detecting the user-activated administration of the therapeutic agent using a delivery device communication module of the device. In addition, the method includes communicating the aforementioned detection to the processor module and/or memory module using the delivery device communication module. The method employs analyte measurement, memory, processor, and delivery device modules, as well as a visual display, and user interface that are integrated as a single hand-held unit.
Description
Background technology
The introducing of type 2 diabetes mellitus patient insulin treatment and management are to shocking thing of patient Lai Shuoshi, and very complicated owing to used conventional method in the therapeutic process and device, this is a kind of burden to the supplier.May be necessary for the patient a large amount of trainings is provided.The patient may need for example multiple notion of association and behavior, comprises machinery, electronics and software aspect that hypoglycemia handles, injects and correctly use insulin administration device and blood glucose meter to use.In addition, the patient must learn according to doctor's indication (for example every meal, every day, per two weeks or weekly) beginning regularly and regulate insulin dose.
Detailed indication about prescription blood sugar test and insulin titration scheme is write out or is checked on paper by the health care professional usually.The patient often keeps hand-written record, so that defer to.
After carrying out insulinize, the situation of poor blood glucose control appears in the doctor's office of being everlasting during the patient, so healthcare provider's (being the doctor) can guess whether poor blood glucose control whether owing to for example do not defer to indication, perhaps needs to strengthen the intensity of insulinize, and perhaps both have both at the same time.
Description of drawings
The accompanying drawing that is incorporated herein and constitutes this description part schematically shows the preferred embodiments of the present invention, and be used from explanation feature of the present invention (the wherein similar similar key element of numeral) with top given general introduction and following given detailed description one, wherein:
Fig. 1 is the simplified plan view according to embodiment of the invention analysis measurement and management devices;
Fig. 2 is the simplified block diagram that illustrates according to the intraware of the analysis measurement of the embodiment of the invention and management devices;
Fig. 3 is the flow chart that illustrates according to the method for embodiments of the invention operation analysis thing measuring device, in the method, has calculated and has recommended dosage of therapeutic agent and recommend the recommendation administration time of dosage of therapeutic agent;
Fig. 4 is the exemplary process diagram that illustrates according to the method for embodiments of the invention operation analysis thing measuring device, in the method, has imported the therapeutic agent type and has shown the dosage regimen inventory;
Fig. 5 is the exemplary process diagram that illustrates according to the method for embodiments of the invention operation analysis thing measuring device, in the method, has imported user's healthy overview and has shown recommendation therapeutic agent and dosage regimen;
Fig. 6 is the exemplary process diagram that illustrates according to the method for embodiments of the invention operation analysis thing measuring device, in the method, selects reinforced dosage regimen;
Fig. 7 is the exemplary process diagram that illustrates according to the method for embodiments of the invention operation analysis thing measuring device, in the method, has restarted and has recommended regimen;
Fig. 8 illustrates the flow chart of the method for operation analysis thing measuring device according to an embodiment of the invention, in the method, does not confirm if receive test or administration in time window, then reminds user test and takes therapeutic agent;
Fig. 9 is the flow chart that illustrates according to the method for embodiments of the invention operation analysis thing measuring device, in the method, has selected more than one therapeutic agent and has shown more than one the regimen of recommending;
Figure 10 is the exemplary process diagram that illustrates according to the method for embodiments of the invention operation analysis thing measuring device, in the method, has shown the report of prompting and compliance;
Figure 11 shows a series of user interface screen images (display) of the method that can be used for a plurality of embodiment according to the present invention;
Figure 12 shows the user interface screen image, and this image helps the healthcare provider to select to can be used for dosage regimen according to the method for embodiment;
Figure 13 shows user interface image, has shown the summary report that can be used for the method according to this invention in this image;
Figure 14 shows exemplary " goal treatment " therapeutic agent dosage regimen that can be used in the embodiment of the invention;
Figure 15 shows another exemplary " goal treatment " therapeutic agent dosage regimen that can be used in the embodiment of the invention;
Figure 16 shows another exemplary " goal treatment " scheme that can be used for the embodiment of the invention;
Figure 17 is the analysis measurement that uses with user activated therapeutic agent delivery device according to the embodiment of the invention and the simplified block diagram of management devices; And
Figure 18 is the flow chart that illustrates according to each stage of the method for the embodiment of the invention.
The specific embodiment of the embodiment of the invention
Below describe in detail and should read with reference to the accompanying drawings, the similar key element in the wherein different accompanying drawings is used identical numbering.Accompanying drawing may not be drawn in proportion, and accompanying drawing shows embodiment chosen, rather than is intended to limit the scope of the invention.Describe in detail by way of example rather than restrictive one has illustrated principle of the present invention.This description allows those skilled in the art can prepare and use the present invention clearly, and has described some embodiment of the present invention, modification, variations, alternative form and purposes, comprises that it is believed that at present is to implement best mode of the present invention.
Embodiments of the invention provide analyte (for example blood glucose) measurement and management devices and correlation technique, these methods have been simplified training, and so that simply and easily mode, the minimum device of employing instructed the patient with regard to the time of relevant analysis measurement (i.e. test) and the consumption and the administration time of therapeutic agent (for example insulin).The embodiment of analysis measurement and management devices and system also by collect, tissue and storing analysed in depth the information that the patient defers to prescription analysis property management reason medicament instructions about how to take medicine significant degree and come to provide useful help for healthcare provider (for example doctor).
Fig. 1 shows analysis measurement and the management devices 100 that is used for detecting (measure or measure) and management individual blood concentration of glucose, also abbreviates " instrument ", " analysis measurement device " and " checkout gear " herein as.As this paper was further described, analysis measurement and management devices 100 used with user activated therapeutic agent delivery device.In this regard, term " user's activation " is meant such therapeutic agent delivery device, carry out man-machine interactively effect (for example by the button on user's thrust unit) between its claimed apparatus and the user and begin the single therapy agent and send incident, and under the situation that does not have this type of man-machine interactively effect not delivering therapeutic agents give the user.The limiting examples of this type of user activated therapeutic agent delivery device is described in 024 (temporarily with the attorney LFS-5180 sign) to some extent at the U.S. Provisional Application No.61/040 of common pending trial, and this provisional application is incorporated this paper by reference in full into.
FPDP 113 accepts to be attached to the suitable adapter on the connecting line, thereby allows analysis measurement device 100 to be connected to external device (ED), for example personal computer.FPDP 113 can be any port (serial or parallel) that allows to carry out transfer of data, for example serial port of wired or wireless form or parallel port.The personal computer that moves suitable software allows visit and revises configuration information (for example current time, date and language), and can analyze the data that analysis measurement device 100 is collected.In addition, personal computer can be carried out the advanced analysis function, and/or diagnoses and the treatment ability to improve to other computer transmission data (promptly passing through the Internet).Analysis measurement device 100 is connected with the Local or Remote computer and helps improving healthcare provider's diagnosis and treatment ability.
Referring to Fig. 2, wherein show the exemplary internal placement of analysis measurement device 100.Analysis measurement device 100 can comprise processor 200, its described herein and shown in some embodiment in be 32 RISC microcontroller.Processor can be through I/ O port 214 and 202 two-way connections of memorizer, memorizer described herein and shown in some embodiment in be EEPROM.What be connected with processor 200 through I/O port 214 in addition is FPDP 113, user interface button 106,108 and 110 and display driver 236.FPDP 113 can be connected to processor 200, thereby makes data to transmit between memorizer 202 and external device (ED) (for example personal computer).User interface button 106,108,110 is directly connected to processor 200.Processor 200 is by display driver 236 control display 104.
Described herein and shown in embodiment in, analysis measurement device 100 can comprise special IC (ASIC) 204, to be provided for measuring the electronic circuit of glucose level in the blood that is applied on the test strip 10 of inserting test strip port one 12.Aanalogvoltage can be delivered to ASIC 204 or passes out from ASIC 204 through analog interface 205.Analogue signal from analog interface 205 can be converted to digital signal by A/D converter 216.Processor 200 also comprises core 208, ROM 210 (comprising computer code), RAM 212 and clock 218.In one embodiment, processor 200 is configured to (or being programmed for): for example make all user interface button all invalid in a period of time after analyte is measured, except the single button of display unit display analysis thing value.In an alternative embodiment, processor 200 is configured to (or being programmed for): ignore any input from all user interface button, except the single button of display unit display analysis thing value.
Described herein and shown in embodiment in, analysis measurement device 100 can comprise RF identification (RFID) reader/interrogator 220.In one embodiment, reader/interrogator is communicated by letter with passive RFID tags, with identification therapeutic agent delivery device.In an alternative embodiment, reader/interrogator is communicated by letter with the passive RFID tags in the therapeutic agent delivery device, to detect the administration of therapeutic agent.
Fig. 3 is the exemplary process diagram that illustrates according to the method for described herein and illustrated embodiment operation analysis thing measuring device.Method 300 comprises step 302,304,306 and 308.Step 302 comprises with the analysis measurement device comes the Measurement and analysis thing.In one embodiment of the invention, adopt electrochemical techniques to come the Measurement and analysis thing, analyte is a blood glucose.In other embodiments of the invention, adopt photometry to come the Measurement and analysis thing, analyte is a blood glucose.In other embodiments of the invention, analyte is HbA1 C, adopts immunoassay or electrochemical techniques to come the Measurement and analysis thing.Step 304 comprise based on therapeutic agent type, nearest analysis measurement value, nearest analysis measurement time, former analysis measurement value, former dosage of therapeutic agent and in the past the administration time of dosage of therapeutic agent come the dosage of therapeutic agent of calculated recommendation and recommend the recommendation administration time of dosage of therapeutic agent.In one embodiment of the invention, therapeutic agent is an insulin, and the analyte of measurement is a blood glucose.Step 306 is included in and shows dosage of therapeutic agent of recommending and the recommendation administration time of recommending dosage of therapeutic agent on the display of analysis measurement device.In one embodiment of the invention, the display of analysis measurement device is LCD, and the recommendation administration time showing of the dosage of therapeutic agent of recommendation and recommendation dosage of therapeutic agent is on user interface.Step 308 comprises that dosage of therapeutic agent of will recommend and the recommendation administration time of recommending dosage of therapeutic agent and nearest analysis measurement value are stored in the memorizer of analysis measurement device.In one embodiment of the invention, the memorizer of analysis measurement device comprises removable memorizer, for example single memory modules in upright arrangement (SIMM) card.In one embodiment of the invention, this method also is included in and shows the prompting of using the dosage of therapeutic agent of recommending on the display of analysis measurement device.In one embodiment of the invention, prompting can be sound prompting (for example beeping sound) or sensation prompting (for example vibration).In one embodiment of the invention, this method also is included in the prompting that shows the Measurement and analysis thing on the display of analysis measurement device.In one embodiment of the invention, prompting allows the user remember the blood glucose that will measure them.In one embodiment of the invention, prompting allows the user remember and wants administration of insulin.In one embodiment of the invention, this method comprises also whether definite current time and date are in the time window of analysis measurement; If the analysis measurement time does not appear in the time window, then give the alarm; In the memorizer of analysis measurement device, store alarm record then.In one embodiment of the invention, adopt the internal clocking of analysis measurement device to determine current date and time.In one embodiment of the invention, this method comprises that also dosage of therapeutic agent is recommended in retrieval from the memorizer of analysis measurement device; Determine whether current time and date are in the administration time window of recommending dosage of therapeutic agent; If recommend the administration time of dosage of therapeutic agent not appear in the administration time window of recommending dosage of therapeutic agent, then give the alarm; In the memorizer of analysis measurement device, store alarm record then.In one embodiment of the invention, be stored in alarm record in the memorizer of analysis measurement device and can be used to set up deferring to the measurement recommended and therapeutic agent dosage regimen.
In one embodiment of the invention, therapeutic agent is a protamine zine insulin, and time window is the early morning or the late into the night.In one embodiment of the invention, therapeutic agent comprises long-acting and Semilente Insulin, and the time window of administering long-lasting insulin is the early morning or the late into the night, and the time window of using Semilente Insulin is for before the meal.In one embodiment of the invention, therapeutic agent is oral antidiabetic, GLP-1 preparation, insulin and insulin mixture or their combination.In one embodiment of the invention, therapeutic agent is the medicine that is used for metabolism management, hormone therapy, oncology, pain control, regeneration class medical science or their combination.In one embodiment of the invention, therapeutic agent is the medicine that is used for diabetes management.
In one embodiment of the invention, after carrying out blood glucose measurement or after opening the analysis measurement device, the analysis measurement device shows the dosage of therapeutic agent of recommendation automatically.In one embodiment of the invention, if the analysis measurement value is greater than or less than predetermined threshold value, recommend dosage of therapeutic agent to can be the function of previous analysis measurement value more than.For example, if blood sugar measured height, then the insulin dose of Tui Jianing can increase, if instead blood sugar measured low, then insulin dose can reduce.In one embodiment of the invention, analysis measurement device inquiry user, and when the user accepts, show the dosage of therapeutic agent of recommending.Inquiry can be adopted the form of explicit user interface prompt on the analysis measurement device.User's acceptance can comprise pushes specific user interface button.In one embodiment of the invention, the dosage of therapeutic agent of recommendation shows with the unit form of insulin.
In one embodiment of the invention, the dosage of therapeutic agent of recommendation is shown to the user to activate the form that promotes user button on the therapeutic agent delivery device the associated user.For example, the displacement that promotes to can be used to activate by the user therapeutic agent delivery device of this type of button starts sending of scheduled volume therapeutic agent.This type of user activates the non-limiting example of therapeutic agent delivery device and describes to some extent in aforementioned U.S. Provisional Patent Application number 61/040,024 (temporarily with attorney LFS-5180 sign).
In one embodiment of the invention, the user can be switched between the recommendation dosage of therapeutic agent that shows insulin units or button promotion form.Switching between insulin units and button promote can realize by analysis measurement device users interface.In one embodiment of the invention, the dosage of therapeutic agent of recommendation shows with graphic form.Graphic form can comprise block diagram, bar diagram, line graph, cake chart, circular diagram and light figure.In one embodiment of the invention, the dosage of therapeutic agent of recommendation is presented to the user by the audio-frequency module of checkout gear with audio form.In one embodiment of the invention, the dosage of therapeutic agent of recommendation is no more than default maximum daily dose.For example, the maximum daily dose of insulin can be imported the analysis measurement device, and limit the dosage of therapeutic agent of recommending every day subsequently.In one embodiment of the invention, the timestamp of analysis measurement is used to determine before the meal early, still measured before the snack before ante prandium, dinner.For example, 7 are carried out analysis measurement and can be considered early before the meal in the morning, and in the afternoon 5 measure can be considered dinner before.In one embodiment of the invention, this method comprises also that the prompting user determine to measure and is before the meal early, before ante prandium, dinner or carries out before the snack.In one embodiment of the invention, this method comprises also that the prompting user determine to measure and is before the meal early, before ante prandium, dinner or carries out before the snack; And the prompting user if to have meal be not before the meal early, before ante prandium or the dinner, then write down nearest dining or snack time started.For example, carry out, then can import the concrete time started of snack if measure outside default breakfast, lunch, dinner window.
In one embodiment of the invention, this method comprises that also dosage of therapeutic agent is recommended in retrieval from the memorizer of analyte measuring device; On the display of analysis measurement device, show dosage of therapeutic agent of recommending and the recommendation administration time of recommending dosage of therapeutic agent; If prompting user's current time and date are approximately equal to the recommendation administration time of recommending dosage of therapeutic agent, then confirm to recommend the administration of therapeutic agent; Push at least one user interface button, confirm the administration of therapeutic agent; And the administration record of store treatment agent in the memorizer of analysis measurement device.In one embodiment of the invention, the analysis measurement device is a blood glucose meter, and therapeutic agent is an insulin, adopts the insulin dispensation apparatus to carry out administration, confirms dosage by the user interface button of pushing on the blood glucose meter.In one embodiment of the invention, dosage is different with the dosage of therapeutic agent of recommendation if this method also comprises prompting user therapeutic agent, then imports the dosage of therapeutic agent.For example, if recommended dose is 4 units and only injected 3 units, then the user just imports 3 units.In one embodiment of the invention, dosage is different with the dosage of therapeutic agent of recommendation if this method also comprises prompting user therapeutic agent, then imports the dosage of therapeutic agent; And the prompting user confirms the dosage of therapeutic agent.Confirm that actual dosage has improved the accuracy that dosage is recommended.In one embodiment of the invention, dosage is different with the dosage of therapeutic agent of recommendation if this method also comprises prompting user therapeutic agent, then imports the dosage of therapeutic agent; The prompting user confirms the dosage of therapeutic agent; And the dosage of store treatment agent in the memorizer of analysis measurement device.As previously mentioned, the memorizer of analysis measurement device can comprise removable part, for example the SIMM card.In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; And show described percentage ratio.Report gathers the concordance that can be used for obtaining with suggested design, is particularly useful for exchanging with the health doctor.In one embodiment of the invention, this method also comprise calculate and show weekly, every month, per season, every year or 6 weeks interior analysis measurement meansigma methodss.In one embodiment of the invention, this method also comprises calculates the percentage ratio that exceeds high analyte thing measured value range in a period of time and exceed harmonic analysis thing measured value range, and shows percentage ratio and the period that exceeds high analyte thing measured value range and exceed harmonic analysis thing measured value range.Can on measuring device, preset or set high low range, and high low range can be used for diagnosis and treatment disease, for example diabetes by user or health doctor.In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value in a period of time to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; And show described percentage ratio and period.In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; Activate download function; Data download and report from the analyte measuring device; Confirm to download and finish; And storage data downloaded and report in the memorizer that externally installs.External device (ED) comprises personal computer, network computer system, outside removable memory reader, PDA and mobile phone.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection insurance incentive mechanism, disease control or motivation program.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection performance emolument program.In one embodiment of the invention, can insure incentive mechanism, motivation program and performance emolument program by internet access.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection clinical data registration office.
In one embodiment of the invention, this method also comprises at least a signal of reception from the dispensation apparatus of confirming the therapeutic agent administration; And the administration record of in the memorizer of analysis measurement device, storing therapeutic agent.In addition, the method according to this invention can comprise the steps: that the recommendation administration time of dosage of therapeutic agent and associated recommendation dosage of therapeutic agent is recommended in retrieval from memorizer (being also referred to as memory module herein); And on the visual display unit of analysis measurement device, show recommendation dosage of therapeutic agent and the administration time that so retrieves to the user.In one embodiment of the invention, signal is a wireless signal, for example bluetooth or RF identification (RFID).In one embodiment of the invention, dispensation apparatus is pump or pen.In one embodiment of the invention, the RFID assembly in the dispensation apparatus is passive, and the RFID assembly in the analysis measurement device is active.In one embodiment of the invention, the RFID assembly in the dispensation apparatus provides power by received signal from the analysis measurement device.In one embodiment of the invention, dispensation apparatus comprises passive, active or half passive RF label.In one embodiment of the invention, this method also comprises the therapeutic agent surplus in the dispensation apparatus is stored in the memorizer of analysis measurement device.In one embodiment of the invention, the therapeutic agent surplus that also is included in the dispensation apparatus of this method gives the alarm to the user during daily dose less than preset dose or expection.In one embodiment of the invention, this method also comprises the surplus that shows therapeutic agent in the dispensation apparatus with the form of unit, day or figure.In one embodiment of the invention, signal can comprise and therapeutic agent type, barrel type, information that the barrel volume is relevant with the dispensation apparatus type.For example, insulin pump can send signal to the analysis measurement device, and wherein signal comprises that, pump type long-pending with used insulin type, stock tube type, stock cylindrical shell and each button promote relevant group and annotate the relevant information of increments (for example No. 1 button promotion is equivalent to 3 units).In one embodiment of the invention, this method comprises that also using each button to promote relevant group annotates the input of increment as the scheme algorithm.In one embodiment of the invention, this method also comprises the surplus that shows the agent of dispensation apparatus internal therapy after the received signal.In one embodiment of the invention, this method also comprises and shows that finish the required button of recommended dose promotes residue degree.In one embodiment of the invention, this method also comprises signal sent to dispensation apparatus from the analysis measurement device, so that tighten dispensation apparatus during the default maximum in the therapeutic dose of sending exceeds the Preset Time window.For example, if exceeded a day maximal dose, can transmit a signal to pump from the analyte measuring device, to stop insulin delivery until second day.In one embodiment of the invention, this method also comprises: if the therapeutic dose of sending exceeds the preset maximum value in the Preset Time window, then send a signal to a plurality of dispensation apparatus from the analysis measurement device, to stop delivering therapeutic agents.In one embodiment of the invention, the analysis measurement device can be based on the dosage of therapeutic agent unit that determines to show which kind of form from the signal of dispensation apparatus.In one embodiment of the invention, if receive signal from dispensation apparatus outside the Preset Time window, the analysis measurement device can send warning.In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; And show described percentage ratio.In one embodiment of the invention, this method also comprise calculate and show weekly, every month, per season, every year or 6 weeks interior analysis measurement meansigma methodss.In one embodiment of the invention, this method also comprises the percentage ratio that exceeds high analyte thing measured value range in calculating a period of time and exceed harmonic analysis thing measured value range; And demonstration exceeds high analyte thing measured value range and the percentage ratio and the period that exceed harmonic analysis thing measured value range.In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value in a period of time to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; And show percent and period.In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; Activate download function; From analysis measurement device data download and report; Confirm to download and finish; And with data downloaded and the report be stored in the memorizer of external device (ED).In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection insurance incentive mechanism, disease control or motivation program.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection performance emolument program.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection clinical data registration office.
Fig. 4 is the exemplary process diagram that illustrates according to the method for described herein and illustrated embodiment operation analysis thing measuring device.Method 400 comprises step 402,404,406,408 and 410.Step 402 comprises selects the therapeutic agent type.In one embodiment of the invention, step 402 comprises a kind of insulin of selection.Step 404 comprises that demonstration is fit to the dosage regimen inventory that uses with therapeutic agent.In one embodiment of the invention, step 404 comprises that demonstration comprises the dosage regimen inventory of measuring frequency, medicine frequency and dosage.Step 406 comprises the selection dosage regimen.Step 408 comprises the selection of confirming therapeutic agent type and dosage regimen.Step 410 comprises that therapeutic agent type and the selected dosage regimen that will select are stored in the memorizer of analysis measurement device.In one embodiment of the invention, select dosage regimen by the menu of user interface.In one embodiment of the invention, select dosage regimen to comprise the input password, to prevent unexpected change dosage regimen.In one embodiment of the invention, start selection therapeutic agent type by insert hardware key to the analysis measurement device.In one embodiment of the invention, hardware key is inserted test strip port connector or FPDP, to start the selection of therapeutic agent type.In one embodiment of the invention, because analysis measurement value (as the HbA1c value) is in the preset range or a series of analysis measurement values (as blood glucose) are in the preset range, therefore start the selection of therapeutic agent type and dosage regimen.
In one embodiment of the invention, dosage regimen can comprise one or many startup, titration and test medicament instructions about how to take medicine.In one embodiment of the invention, this method also is included on the analysis measurement device and selects the time zone.In one embodiment of the invention, this method also comprises the dosage of therapeutic agent that must not surpass the every day of affirmation recommendation.In one embodiment of the invention, this method comprise also that input is had a dinner, snack, the time zone and the proximate time window of getting up and sleeping; And will have a dinner, snack, get up and the time zone and the proximate time window of sleeping are stored in the memorizer of analysis measurement device.In one embodiment of the invention, this method also comprise accept or revise have a dinner, snack, the time zone and the proximate time window of getting up and sleeping; And will have a dinner, snack, get up and the time zone and the proximate time window of sleeping are stored in the memorizer of analysis measurement device.In one embodiment of the invention, this method also comprises the dosage regimen that starts dosage regimen update functions, down loading updating; Dosage regimen that confirm to download the dosage regimen finishing, select to upgrade, display update gathers and the dosage regimen of upgrading is stored in the memorizer of analysis measurement device.Renewal has guaranteed to use up-to-date scheme and medicament instructions about how to take medicine.In one embodiment of the invention, can be wireless, download by USB or other physical connections or by being connected to the removable RAM (random access memory) card of inserting the analysis measurement device.In one embodiment of the invention, the analysis measurement device can be electrically connected to network computer and discern by the distinctive software code of analysis measurement device.In one embodiment of the invention, starting the dosage regimen renewal carries out automatically or carries out when the user activates.For example, renewal can be carried out when the analysis measurement device is connected to network automatically, also can manually activate by user interface.In one embodiment of the invention, the user has confirmed startup dosage regimen update functions.
In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; And show described percentage ratio.In one embodiment of the invention, this method also comprise calculate and show weekly, every month, per season, every year or 6 weeks interior analysis measurement meansigma methodss.In one embodiment of the invention, this method also comprises the percentage ratio that exceeds high analyte thing measured value range in calculating a period of time and exceed harmonic analysis thing measured value range; And demonstration exceeds high analyte thing measured value range and the percentage ratio and the period that exceed harmonic analysis thing measured value range.
In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value in a period of time to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; And show described percentage ratio and period.In one embodiment of the invention, this method comprises that also activating report gathers; Calculate actual analysis thing measured value to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent; Activate download function; Data download and report from the analysis measurement device; Confirm to download and finish; And with data downloaded and the report be stored in the memorizer of external device (ED).In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection insurance incentive mechanism, disease control or motivation program.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection performance emolument program.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection clinical data registration office.
Fig. 5 be illustrate according to described herein and shown in the exemplary process diagram of method of embodiment operation analysis thing measuring device.Method 500 comprises step 502,504,506,508,510 and 512.Step 502 comprises the healthy overview of importing the user.Step 504 comprises to be used healthy overview definite recommendation therapeutic agent and recommends regimen.Step 506 is included in and shows on the display of analysis measurement device and recommend therapeutic agent and recommend regimen.Step 508 comprises selects to recommend therapeutic agent and recommends regimen.Step 510 comprises the selection of confirming to recommend therapeutic agent and recommending regimen.Step 512 comprises that therapeutic agent and the selected dosage regimen that will select are stored in the memorizer of analysis measurement device.In one embodiment of the invention, user's healthy overview comprises life style and dietary habit information.In one embodiment of the invention, user's healthy overview comprises the maximal oxygen appetite that the patient consumes.In one embodiment of the invention, user's healthy overview can comprise former blood sugar effects, HbA1 C result, body weight, fasting blood sugar or user's blood glucose tolerance.In one embodiment of the invention, this method also comprises by setting analysis measurement frequency or adjustment of treatment agent dose and customizes and recommend regimen.In one embodiment of the invention, this method also comprises with analysis measurement measurement device analyte; The dosage of therapeutic agent that begins according to user's body weight and therapeutic agent predose coefficient calculations; On the display of analysis measurement device, show the begin treatment agent dose of recommendation and the therapeutic agent administration time of recommendation; And the dosage of therapeutic agent of recommending, the therapeutic agent administration time and the present analysis thing measured value of recommendation be stored in the memorizer of analysis measurement device.If desired, can be configured to allow the user to confirm, customize according to the method and apparatus of the embodiment of the invention and/or accept scheme and any suggestion.In one embodiment of the invention, this method also comprises startup dosage regimen update functions; The dosage regimen of down loading updating, confirm to download gathering and the dosage regimen of upgrading being stored in the memorizer of analysis measurement device of the dosage regimen finishing, select to upgrade, display update dosage regimen.In one embodiment of the invention, can be wireless, insert the analysis measurement device's memory and stick into row and download by USB or other physical connections or by being connected to.In one embodiment of the invention, the analysis measurement device can be electrically connected to network computer and discern by the distinctive software code of analysis measurement device.In one embodiment of the invention, starting the dosage regimen renewal carries out automatically or carries out when the user activates.In one embodiment of the invention, the user has confirmed that the dosage regimen update functions starts.In one embodiment of the invention, this method comprises that also activating report gathers, calculates actual analysis thing measured value to the percentage ratio of recommending the analyte measured value and the actual therapeutic agent dose percentage ratio to the recommendation dosage of therapeutic agent; And show described percentage ratio.
In one embodiment of the invention, this method also comprise calculate and show weekly, every month, per season, every year or 6 weeks interior analysis measurement meansigma methodss.In one embodiment of the invention, this method also comprises the percentage ratio that exceeds high analyte thing measured value range in calculating a period of time and exceed harmonic analysis thing measured value range; And demonstration exceeds high analyte thing measured value range and the percentage ratio and the period that exceed harmonic analysis thing measured value range.In one embodiment of the invention, this method comprises that also activating report gathers, calculates actual analysis thing measured value in a period of time to the percentage ratio of recommending the analyte measured value and the actual therapeutic agent dose percentage ratio to the recommendation dosage of therapeutic agent; And show described percentage ratio and period.In one embodiment of the invention, this method comprises that also activating report gathers, calculate actual analysis thing measured value to the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose to recommending the percentage ratio of dosage of therapeutic agent, activate download function; From analysis measurement device data download and report, confirm to download and finish and data downloaded and report are stored in the memorizer of external device (ED).In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection insurance incentive mechanism, disease control or motivation program.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection performance emolument program.In one embodiment of the invention, this method also comprises the data base who data downloaded is uploaded to connection clinical data registration office.
Fig. 6 be illustrate according to described herein and shown in the exemplary process diagram of method of embodiment operation analysis thing measuring device.Method 600 comprises step 602,604,606,608 and 610.Step 602 comprises selects reinforced dosage regimen.Step 604 comprises definite initial recommendation dosage of therapeutic agent of using with reinforced dosage regimen.Step 606 comprises demonstration initial recommendation dosage of therapeutic agent.Step 608 comprises the selection of confirming reinforced dosage regimen.Step 610 comprises initial recommendation dosage of therapeutic agent and selected reinforced dosage regimen is stored in the memorizer of analysis measurement device.In one embodiment of the invention, after the existing dosage regimen of input user, recommend reinforced dosage regimen again.In one embodiment of the invention, if the analysis measurement value is higher, then the analysis measurement device can be recommended reinforced dosage regimen automatically.In one embodiment of the invention, reinforced dosage regimen comprises use short-acting insulin and protamine zine insulin.
In one embodiment of the invention, reinforced dosage regimen comprises from protamine zine insulin and is transformed into the premixing insulin.In one embodiment of the invention, reinforced dosage regimen comprises from the premixing insulin and is transformed into short-acting insulin and protamine zine insulin.In one embodiment of the invention, reinforced dosage regimen comprises from a kind of therapeutic agent and is transformed into another kind of therapeutic agent.In one embodiment of the invention, reinforced dosage regimen comprises one or more therapeutic agents of use.In one embodiment of the invention, this method also comprises the reinforced dosage regimen of notifying user's executed new; And the time, the time of administering therapeutic agent and the type of administering therapeutic agent that show the measurement of execution analysis thing.In one embodiment of the invention, if also comprising inquiry user's detection of analytes or therapeutic agent administration, this method whether do not answer display alarm or warning according to the carrying out of stipulating in the reinforced dosage regimen.In one embodiment of the invention, this method also comprises demonstration 1,2,3 and 4 hour after the meal analysis measurement is after the meal reminded.In one embodiment of the invention, but prompting or warning automatic or manual forbidding.In one embodiment of the invention, this method comprises that also demonstration gathers the report of the data relevant with at least a previous dosage regimen with reinforced dosage regimen.
In one embodiment of the invention, this method also comprises the reinforced dosage regimen that starts reinforced dosage regimen update functions, down loading updating, confirms to download and finish, select the reinforced dosage regimen of upgrading, the reinforced dosage regimen that gathers and will upgrade of the reinforced dosage regimen of display update to be stored in the memorizer of analysis measurement device.In one embodiment of the invention, can be wireless, insert analysis measurement device's memory card and download by USB or other physical connections or by being connected to.In one embodiment of the invention, the analysis measurement device can be electrically connected to network computer and discern by the distinctive software code of analysis measurement device.In one embodiment of the invention, starting the dosage regimen renewal carries out automatically or carries out when the user activates.In one embodiment of the invention, the user has confirmed startup dosage regimen update functions.In one embodiment of the invention, this method comprises that also the report of active device gathers function, calculates actual analysis thing measured value the percentage ratio of recommending the analyte measured value and actual therapeutic agent dose are calculated before the meal and the meansigma methods of 2 hours analysis measurement values after the meal to the percentage ratio of recommending dosage of therapeutic agent and with meal time (for example breakfast, lunch and dinner).
Fig. 7 be illustrate according to described herein and shown in the exemplary process diagram of method of embodiment operation analysis thing measuring device.Method 700 comprises step 702,704,706,708 and 710.Step 702 comprises analysis measurement and the dosage of therapeutic agent result before the retrieval.In one embodiment of the invention, from the memorizer of analysis measurement device or from removable memory that the analysis measurement device links to each other analysis measurement and dosage of therapeutic agent result before the retrieval.Step 704 comprises whether the user who determines the analysis measurement device has deferred to the analysis measurement value of recommendation and the dosage regimen of recommendation.Defer to be included in and carry out analysis measurement and dosage of therapeutic agent in the fixed time window.If step 706 comprises that the user of prompting analysis measurement device defers to degree and is lower than predetermined minimum, then restart the dosage regimen of recommendation.
In one embodiment of the invention, if the time that the user does not defer to less than preset period of time, the analysis measurement device can continue the dosage regimen of recommending automatically.In one embodiment of the invention, when not deferring to, the analysis measurement device can be forbidden the dosage regimen of recommendation automatically.In one embodiment of the invention, the dosage regimen of recommendation can be restarted.In one embodiment of the invention, this method also comprises to the health doctor and sends the warning that appearance is not deferred to.
Fig. 8 be illustrate according to described herein and shown in the exemplary process diagram of method of embodiment operation analysis thing measuring device.Method 800 comprises step 802,804,806,808,810,812,814,816 and 818.Step 802 comprises with analysis measurement measurement device analyte.Step 804 comprises the calculated recommendation dosage of therapeutic agent.Step 806 comprises demonstration recommended dose and administration time.Step 808 comprises affirmation with respect to dosage of having a dinner and time.Step 810 comprises if do not receive affirmation in time window, then reminds user's application dosage.Step 812 comprises report measurement and administration behavior.Step 814 comprises downloading to be measured and the administration behavior.Step 816 comprises upgrading scheme and reporting software.Step 818 comprises measurement, dosage and report information is stored in the memorizer of analysis measurement device.
Fig. 9 be illustrate according to described herein and shown in the method exemplary process diagram of embodiment operation analysis thing measuring device.Method 900 comprises step 902,904,906,908,910 and 912.Step 902 comprises the therapeutic agent of selecting more than one.Step 904 comprises the initial therapy agent dose of importing every kind of therapeutic agent.Step 906 comprises that demonstration is fit to the dosage regimen inventory that uses with every kind of therapeutic agent.Step 908 comprises the dosage regimen of selecting every kind of therapeutic agent.Step 910 comprises the dosage regimen of confirming every kind of therapeutic agent.Step 912 comprises every kind of selected therapeutic agent and every kind of selected dosage regimen is stored in the memorizer of analysis measurement device.In one embodiment of the invention, medication comprises the recommendation time of analysis measurement.In one embodiment of the invention, therapeutic agent can comprise oral antidiabetic, GLP-1 analog, insulin or metabolism agent.In one embodiment of the invention, appear at outside the specified time window, then activate and measure and the dosage prompting if this method also comprises prompting user's measured value or dosage.
Figure 10 be illustrate according to described herein and shown in the exemplary process diagram of method of embodiment operation analysis thing measuring device.Method 1000 comprises step 1002,1004,1006,1008 and 1010.Step 1002 comprises with analysis measurement measurement device analyte.Step 1004 comprises if do not carry out analysis measurement in the specified time frame of dosage regimen, then shows the prompting of Measurement and analysis thing.Step 1006 comprises if not administering therapeutic agent in the specified time frame of dosage regimen then shows and uses the prompting of recommending dosage of therapeutic agent.Step 1008 comprises generating to defer to recommends analysis measurement and recommends the report of dosage of therapeutic agent to gather.Step 1010 comprises report is stored in the memorizer of analysis measurement device.In one embodiment of the invention, the dosage of therapeutic agent of manual confirmation recommendation.In one embodiment of the invention, confirm the dosage of therapeutic agent of recommendation automatically.In one embodiment of the invention, the dosage of therapeutic agent of recommendation utilizes pillbox, user activated novopen, user activated inhaler or user activated pump to use.In one embodiment of the invention, pillbox, novopen, inhaler or pump send the RFID signal to the analysis measurement device, to confirm to send the dosage of therapeutic agent of recommendation.
Figure 11 shows a series of user interface screen that show according to embodiments of the invention during the method for operation analysis thing measuring device.In screen 1102, the prompting user measures the morning of blood glucose before the meal.The morning that screen 1104 demonstrations record is the insulin dose and the administration time thereof of blood sugar effects (or fasting blood sugar), recommendation before the meal.Also point out the user to set prompting.Screen 1106 shows the prompting that shows just before the administration time of recommending.
Figure 12 shows the user interface screen that shows according to embodiments of the invention during the method for operation analysis thing measuring device.In screen 1202, remind health doctor or user to select the insulin administration scheme.
Figure 13 shows the user interface screen that shows according to embodiments of the invention during the method for operation analysis thing measuring device.In screen 1302, show that the compliance of section inner analysis thing measurement sometime and dosage of therapeutic agent gathers.
Figure 14 shows the exemplary goal therapeutic scheme that can be used for the embodiment of the invention.Figure 15 shows the exemplary goal therapeutic scheme that can be used for the embodiment of the invention.Figure 16 shows the exemplary goal that can be used for the embodiment of the invention and treats reinforced scheme.
Figure 17 is with the analysis measurement of user activated therapeutic agent delivery device 1799 uses and the simplified block diagram of management devices 1700 according to embodiments of the invention.Except that user interface 1712, analysis measurement and management devices 1700 also comprise can measuring body fluid samples (for example blood) in analyte measurement module 1702, memory module 1704, processor module 1706, visual display unit 1708 and the delivery apparatus communication module 1710 of analyte (for example blood glucose).Analyte measurement module 1702, memory module 1704, processor module 1706, visual display unit 1708, delivery apparatus communication module 1710 and user interface 1712 are got in touch in operation each other.
In addition, visual display unit module 1708 can show the dosage of therapeutic agent of recommendation and the administration time of recommendation to the user, and user interface 1712 can be accepted the input of user to analysis measurement and management devices 1700 by the interface button (not shown among Figure 17) of for example user's operation.
Delivery apparatus communication module 1710 can detect user activated therapeutic agent administration (promptly sending) by user activated therapeutic agent delivery device 1799, then this detection is sent to processor module 1706 and/or memory module 1702.In addition, the analyte measurement module of analysis measurement and management devices 1700, memory module, processor module, visual display unit, user interface and delivery apparatus communication module are turned to single handheld unit by one, such as but not limited to being the unit of element 100 shown in Fig. 1.
In case learn present disclosure, it will be understood by those skilled in the art that analysis measurement and management devices 1700 can carry out any function with respect to Fig. 1 to Figure 16 and apparatus and method relevant with these figure mentioned above through repacking.In addition, analysis measurement and management devices 1700 can be constructed to have other local described features of this paper at embodiments of the invention, for example comprise the feature with respect to the method for Fig. 2 to Figure 16 operation analysis thing measuring device.
Figure 18 illustrates the flow chart in each stage that is used for measuring and manage the method 1800 of body fluid analyte according to the embodiment of the invention.Method 1800 comprises step 1810, is about at least a therapeutic agent dosage regimen and is stored in the memory module of analysis measurement and management devices.
In addition, in step 1870, method 1800 also comprises uses the delivery apparatus communication module that above-mentioned detection is sent to processor module and/or memory module.Should be noted that, this method has adopted analysis measurement device, memorizer, processor and delivery apparatus module and visual display unit and user interface, these devices are turned to single handheld unit by one, for example are to be the unit of analysis measurement and management devices 1700 shown in element 100 and Figure 17 shown in Fig. 1.
In case learn present disclosure, it will be understood by those skilled in the art that method 1800 can be extended to and comprise with respect to the performance of the above-mentioned any function of Fig. 1 to Figure 17 and/or carry out the step that has other local described characteristics of this paper with respect to a plurality of embodiment of the present invention.
Embodiments of the invention are of value to minimizing and start relevant interference, keep and the survey of management analysis quality testing and therapeutic agent medication, for example blood sugar monitoring and insulin administration.The present invention can start and strengthen like a cork, and by providing the simple effective ways that progressively guide the patient to improve the compliance of prescription medicament instructions about how to take medicine.By the actual instructions about how to take medicine information that recommendation instructions about how to take medicine and patient with this paper aforesaid way record adopt, described herein and shown in checkout gear and method effective single recorded and stored system is provided, help patient and health doctor better to nurse.
Though described the present invention, one of skill in the art will recognize that to the invention is not restricted to described modification or accompanying drawing with regard to specific modification and exemplary drawings.In addition, represent to take place under the situation of some incident with certain order in above-mentioned method and step, those of ordinary skill in the art will recognize that the order of some step can be modified, and such modification belongs to modification of the present invention.In addition, some step also can be carried out in parallel procedure under possible situation except can carrying out in proper order as mentioned above simultaneously.Therefore, the invention is intended to cover modification of the present invention, be equal to as long as these modification are in the claims in the scope of the open spirit of the present invention that occurs or with the present invention.
Claims (20)
- One kind measure and management body fluid in the method for analyte, described method comprises:At least a therapeutic agent dosage regimen is stored in the memory module of analysis measurement and management devices;Use the analyte in the analyte measurement module measuring body fluid samples of described analysis measurement and management devices;Be stored in the described therapeutic agent dosage regimen in the described memory module of processor module of described analysis measurement and management devices by employing, at least the administration time of the dosage of therapeutic agent of calculated recommendation and recommendation is so that the user activates the sending of dosage of therapeutic agent of described recommendation;On the visual display unit of described analysis measurement and management devices, show the dosage of therapeutic agent of described at least recommendation and the administration time of recommendation to the user;By user activated therapeutic agent delivery device to described user's delivery treatments agent dose;Use the delivery apparatus communication module of described analysis measurement and management devices to detect the described therapeutic agent administration of described user activated; AndUse described delivery apparatus communication module that this detection is sent in described processor module and the memory module at least one;Wherein said analysis measurement device, memorizer, processor, visual display unit, user interface and delivery apparatus communication module are turned to single handheld unit by one.
- 2. method according to claim 1 also comprises the step of being imported dining information by the user interface of described analysis measurement and management devices by the user.
- 3. method according to claim 1, wherein said analyte are blood glucose, and described therapeutic agent is an insulin.
- 4. method according to claim 1, wherein said step display show the dosage of therapeutic agent of described recommendation in the mode that promotes user button on described user activated therapeutic agent delivery device.
- 5. method according to claim 1, wherein said delivery step are to finish by the button that the user promotes on the described user activated therapeutic agent delivery device.
- 6. method according to claim 1, wherein said communication steps adopt the RFID technology to finish.
- 7. method according to claim 1, wherein said delivery step comprise the dosage of therapeutic agent of sending the therapeutic agent that is selected from metabolism management medicine, hormone therapy agent, tumor preparation, pain therapy agent, regenerative medicine reagent and their combination.
- 8. method according to claim 1 also comprises the step of being confirmed sending of described therapeutic agent and actual therapeutic agent dose by the user interface of described analysis measurement and management devices by described user.
- 9. method according to claim 1, the described therapeutic agent dosage regimen of wherein said calculation procedure have been used the time, the analysis measurement value before at least one, the dosage of therapeutic agent before at least one of therapeutic agent type, nearest analysis measurement value, described nearest analysis measurement and the time of described dosage of therapeutic agent before at least one in described computational process.
- 10. method according to claim 1 wherein also comprises by described processor module generating the step that report gathers, and described report gathers and comprises that at least detected user activates the percentage ratio of administration to the dosage of therapeutic agent of recommendation.
- 11. method according to claim 10 also is included in the step that the described report of demonstration gathers on the described visual display unit.
- 12. method according to claim 10 also comprises described report gathered from described analysis measurement and management devices outputing to external device (ED).
- 13. method according to claim 1, wherein said detection step adopts wireless technology.
- 14. method according to claim 1, also comprise when not detecting the described therapeutic agent administration of user activated near the scheduled time window of described medical delivery apparatus communication module described recommendation administration time, use the alarm module of described analysis measurement and management devices to generate the step of alarm.
- 15. method according to claim 1 also comprises and upgrades the step that is stored in the described therapeutic agent dosage regimen in the described memory module.
- 16. method according to claim 1 is further comprising the steps of:The report that renewal is stored in the described memory module gathers software.
- 17. method according to claim 1 is further comprising the steps of:The dosage of therapeutic agent that retrieval is recommended from described memory module and the administration time of recommendation; AndOn described visual display unit, show described recommendation dosage of therapeutic agent that retrieves and the described recommendation administration time that retrieves to the user.
- 18. comprising, method according to claim 1, wherein said detection step detect actual therapeutic agent dose and actual therapeutic agent administration time.
- 19. method according to claim 18 is further comprising the steps of:The result of described measuring process, described recommendation dosage of therapeutic agent, described actual therapeutic agent dose and described actual therapeutic agent administration time are stored in the described memory module.
- 20. method according to claim 1 is further comprising the steps of:Select to be used for the treatment dosage regimen of described calculation procedure in a plurality of therapeutic agent dosage regimens from be stored in described memory module.
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| CN104394760A (en) * | 2012-07-02 | 2015-03-04 | 柯尼卡美能达株式会社 | Icterus meter and icterus meter output method |
| CN110404140A (en) * | 2013-01-29 | 2019-11-05 | 赛诺菲-安万特德国有限公司 | Electronic module and medicine delivery device |
| US11324892B2 (en) | 2013-01-29 | 2022-05-10 | Sanofi-Aventis Deutschland Gmbh | Electronic module and drug delivery device |
| CN110404140B (en) * | 2013-01-29 | 2022-09-30 | 赛诺菲-安万特德国有限公司 | Electronic module and drug delivery device |
| US11707573B2 (en) | 2013-01-29 | 2023-07-25 | Sanofi-Aventis Deutschland Gmbh | Electronic module and drug delivery device |
| WO2017096511A1 (en) * | 2015-12-07 | 2017-06-15 | 香港商台北市生活智能科技有限公司 | System for automatically obtaining treatment record |
| WO2017166292A1 (en) * | 2016-04-01 | 2017-10-05 | 创新精密仪器有限公司 | Portable medicine management apparatus |
| CN112739396A (en) * | 2018-07-26 | 2021-04-30 | 赛诺菲 | Method for regulating dosage of medicament |
| US11967407B2 (en) | 2018-07-26 | 2024-04-23 | Sanofi | Method of adjusting medication doses |
Also Published As
| Publication number | Publication date |
|---|---|
| KR20110014176A (en) | 2011-02-10 |
| CA2723352A1 (en) | 2009-11-12 |
| AU2009244268A1 (en) | 2009-11-12 |
| WO2009137661A1 (en) | 2009-11-12 |
| JP2011523478A (en) | 2011-08-11 |
| EP2320787A1 (en) | 2011-05-18 |
| BRPI0912210A2 (en) | 2016-09-06 |
| IL208710A0 (en) | 2010-12-30 |
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