CN101189512A - Use of multiple data points and filtering in an analyte sensor - Google Patents
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Abstract
The invention relates to use of multiple data points and filtering in an analyte sensor. Embodiments of the present invention improve the accuracy of measurements and/or in vivo calibrations of a biosensor by (1 ) using more than one sensor signal value and/or more than one directly sampled and measured value, such as a capillary blood glucose value, and/or by (2) delaying the acquisition of a sensor output value that is compared with a directly sampled and measured value, such as a capillary blood glucose value, during a calibration. In an embodiment of the present invention, the median of a series of measured values, or a median or mean of the medians, may be utilized to provide more consistent and accurate measurement data and/or to compensate for error or artifact.
Description
Cross reference to related application
The application requires the right of priority of following two applications, and comprise in this application by the mode all quoted full content: U.S. Provisional Patent Application these applications, application number is 60/687,199, the applying date is on June 2nd, 2005, and name is called " using a plurality of data points to carry out the calibration first and the subsequent calibrations of analyte sensor "; The non-temporary patent application of the U.S., application number are 11/421,564, and the applying date is on June 1st, 2006, and name is called " use a plurality of data points and carry out filtering in analyte sensor ".
Technical field
Embodiments of the present invention relate to field of medical devices, more particularly, relate to that data obtain, detection of analytes, and measurement of correlation and calibration steps.
Background technology
Suffer from other of imbalance diabetes beastly aspect in, need frequent test blood sugar concentration.According to current techniques, the diabetic must puncture his finger tip or other body part and get blood.
Many solutions have been devoted to alleviate this discomfort and have been utilized the implantable sensor that maybe can insert of continuous monitoring glucose to increase monitoring and control.Not only from the viewpoint of patient comfort, and from the viewpoint of patient health, easy to use all is to consider emphatically.For patient, the easy more blood sugar level reading that reads him, he just does probably more continually like this.Thereby along with more frequent measurement, patient regulates his glucose level probably better, and avoids thus destroying systemic chronic complicating diseases or the acute complications of patient under the danger that enters the hypoglycemic shock state because of poisonous glucose level.And by measuring his or her glucose level more continually, patient can understand the response that its health is exerted oneself to the health that consumes all kinds food and the various degree of consumption better.It is good more that patient understands ground to the response characteristic of its health, can adjust his food, exercise and the injection of insulin or the therapy of ingesting more goodly.Except frequent measurement, the accuracy of measurement is also very important.
Description of drawings
In conjunction with the accompanying drawings, according to following detailed description, will readily appreciate that embodiments of the present invention.In order to be easy to this explanation, with the identical construction package of same reference numerals sign.Embodiments of the present invention are come illustration by the mode of embodiment, but are not limited to the mode among the figure of accompanying drawing.
Fig. 1 illustration kapillary blood sugar (CBG) value of calibration point and the figure of sensor output value appear when glucose descends fast;
Fig. 2 illustration kapillary blood sugar (CBG) value of calibration point and the figure of sensor output value appear when the glucose fast rise;
Fig. 3 illustration according to the present invention each embodiment during fast changing glucose level, at the design sketch that postpones to carry out data correction and uncorrected calibration;
Fig. 4 illustration indication multiple spot and the sensor output of the relative sensitivity of single-point calibration method and the figure of kapillary blood sugar value according to an embodiment of the present invention;
Fig. 5 illustration according to an embodiment of the present invention at the interval intermediate value of a series of primary current values and the tables of data of interval average;
Fig. 6 illustration according to an embodiment of the present invention interval intermediate value and the figure of interval average; And
Fig. 7 illustration the figure of intermediate value of the intermediate value of intermediate value according to an embodiment of the present invention and average.
Embodiment
In the detailed description below, the use same reference numerals that forms this explanation part is represented that the accompanying drawing of same section describes, and illustrate by can specifically putting into practice illustrated embodiment of the present invention.Should be appreciated that without departing from the scope of the invention, can utilize other embodiment, and can carry out structure or logical changes.Therefore, following detailed description should be considered as restriction, and should limit according to the embodiment of the present invention scope by claims and equivalent thereof.
Can various operations be described as a plurality of lock out operation successively by the mode that helps to understand embodiments of the present invention; Yet the order of description should not be interpreted as hinting that these operations depend on order.
This explanation can use based on solid as above all/down, the back/explanation at the preceding and top/end.This explanation only is used for convenient the discussion, rather than the application of restriction embodiments of the present invention.
For purposes of the present invention, phrase " A/B " refers to A or B.For purposes of the present invention, phrase " A and/or B " refers to " (A), (B), or (A and B) ".For purposes of the present invention, phrase " A, B, and among the C at least one " refers to " (A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C) ".For purposes of the present invention, phrase " (A) B " refers to " (B) or (AB) ", that is, A is an optional components.
This explanation can use phrase " in one embodiment, " or " in a plurality of embodiments, " each phrase can refer to the embodiment that one or more is identical or different.And, at the employed term of embodiments of the present invention " comprise ", " comprising ", " having " etc. be synonym.
Embodiments of the present invention are utilized more than one sensor signal value and/or more than one kapillary blood sugar value by (1) and/or are obtained and kapillary blood sugar value sensor output value relatively by (2) delay between the biology sensor alignment epoch, thereby have improved the accuracy of the body internal calibration of this biology sensor.In an embodiment of the present invention, can utilize intermediate value or the intermediate value of intermediate value or the average of average of series of measured values, to provide more consistent and measurement data and/or error or artefact compensated more accurately.Wave filter can be used for calibration steps, and/or be used for the error of compensation during detection of analytes after calibration.
Though above-mentioned concern and this run through use in full as exemplary analyte be glucose, can be in conjunction with embodiments of the present invention are used in the measurement of other analyte (for example, lactate).And, by in biology sensor, utilizing more than one enzyme, can utilize more than one analyte of same measurement device, and/or calibrate more than one analyte according to the embodiment of the present invention.
In embodiments of the present invention, in order to generate calibration, can consider to postpone sensor output.In another embodiment, calibration steps can use single-point or the multipoint iterations that is separated or combines with the output delay at the solution sensor.In one embodiment, the time shift calibration steps that uses height at dextrose equivalent to change speed solves the delay in the sensor output, and this compares with the calibration that does not have time shift, can improve the accuracy of estimation of glucose sensor.
The use of according to the embodiment of the present invention, relative with single-point calibration system multiple spot calibration system provides some benefits to the user.Be in the data of collecting the period in the mammalian body along with biology sensor is current more and more, and these sufficient data can provide the valuable information that can help appropriate calibrating installation.
As an example, suppose that obtaining main body every day the glucose sensor that the kapillary thorn refers to (fingerstick) blood sample and wear indwelling for twice reaches 5 days.After the calibration in morning when beginning in the 3rd day, this main body has had 5 calibration values of total.These calibration values often can be obtained by widely different concentration of glucose, thereby valuable information is provided.
In an embodiment of the present invention, not a value of only using in these blood glucose values (following the sensor signal that obtains after a few minutes), can use all or a plurality of at least paired blood sugar and the multiple spot of sensor signal to calibrate but can carry out.In an embodiment, can utilize plotting to calculate the tropic that relates to all these data in sensor signal on the Y-axis and the kapillary blood sugar value of marking and drawing on X-axis.In one embodiment, then, can draw the tropic, and the slope of this tropic becomes the Sensitirity va1ue that uses in the calibration.In one embodiment, the sensor signal value at zero glucose place can be used as equation (standard linear regression formula: S=mG+b at this line, wherein, S is the sensor signal that calculates, m is slope or sensitivity, G is a dextrose equivalent, and b is y intercept (being also referred to as side-play amount or background current (background current))) the Y intercept.In one embodiment, can be used to provide added value with the value in the zero external sensor signal that obtains in glucose place before implanting, to estimate the value of b rightly.
In an embodiment of the present invention, compare with value early, can bigger weight come the nearer calibration value of weighting (time weight).In this respect, it is valuable using many points, especially because single-point (measuring from sensor signal or from the haemanalysis thing) for example may be accompanied by, from the glucose measurement meter that uses, perhaps from sensor itself, perhaps from some other errors or artifactitious inaccuracy.In one embodiment, can and be weighted (for example time weight) to these sensitivity subsequently by the obtained Sensitirity va1ue of repeatedly calibrating and finish weighting.
Compare with the sample of direct measurement, the geometry of biology sensor is in the delay that may increase the time aspect the analyte level measurement.Be placed on the analyte (as glucose) in the biology sensor measurement clearance liquid (ISF) in the subcutaneous space.ISF is the liquid that is similar to slurry on composition, it immerses adipocyte cells such as (fat cells or ipolytes).Exemplary biology sensor can have several films or the layer that is applied on the electrode (as noble metal electrode).In one embodiment, outmost film can be a permoselective membrane, its objective is that the such analyte of restriction such as glucose is delivered to the speed in enzyme (detection) layer in a large number, and this enzyme layer can be positioned at below the permoselective membrane, that is, and and near electrode.In one embodiment, can specific membrane (specificitymembrane) below the enzyme layer, its objective is that getting rid of the interference compound infiltrates into electrode, simultaneously, allow hydrogen peroxide to infiltrate into electrode and by anodizing.
In typical case, subcutaneous biology sensor must be calibrated in vivo, so that provide the accurate measurement such as the such analyte of glucose to the user.Because be not easy to obtain ISF, so typically the blood measurement of analyte is used for this calibration.
Yet for example, variation in the blood concentration of glucose and biology sensor were registered between time of this variation may exist delay.This delay comprises several factors.The first, glucose has delay from capillary is delivered to the process of ISF.Estimated this transmission for from less than 1 minute to surpassing 5 minutes, and among the result these inconsistent may be because the difference of method causes.The second, glucose permeates in the process of outmost film (a large amount of transmission of this film restriction glucose and allow the infiltration of oxygen) and has delay.The 3rd, glucose has reached after detection (enzyme) layer that comprises glucose oxidase, has the delay of short time during converting glucose and oxygen to gluconic acid and hydrogen peroxide.The 4th, hydrogen peroxide infiltration be positioned at characteristic film between detections (containing enzyme) layer and the indicator electrode during have delay.The 5th, use software or firmware filters may cause mathematical delay.
In one embodiment, it may be useful intermediate value or mean filter being applied on a series of values that for example obtain during 4-8 minute.In one embodiment, this wave filter successfully filtering go out such as the patient's that sensor is arranged by implantation rapid movement and the tangible artefact that causes.In one embodiment, the delay that this wave filter may be introduced minute on equal (n-1)/2, wherein, n be with minute the expression a filter length.This wave filter can used between the detection period that carries out analyte and/or between alignment epoch.
In an embodiment of the present invention, can postpone to manage to increase the accuracy of calibration to Measuring Time.In one embodiment, during calibration process, kapillary blood sugar (CBG) value and sensor output value can be compared, so that reach such sensitivity, this sensitivity can be followed and is used to explain sensor output value in the future.This interpretation process produces the value that derives from the sensor reading of glucose estimator concentration.
In one embodiment, if solved the delay that the various causes described in detail above cause, then can improve the accuracy of calibration.A kind of mode of carrying out calibration is that CBG value and the sensor output value that will obtain simultaneously compare.Yet, postpone because this method can not solve to measure, so this method is defective.If dextrose equivalent changes fast, then the problems referred to above may especially be difficult to solve.
Fig. 1 shows kapillary blood sugar (CBG) value that adopts black circle and the plot that adopts the sensor output value of solid-line curve.Fig. 1 shows the calibration point (dotted line) that occurs when glucose descends fast.In this case, should suppose that background current is 1nA.Introduced delay, can see, sensor curve postpones in CBG value back.
Fig. 2 show subsequently when the glucose fast rise time the glucose alignment epoch between, how this apparent sensitivity (having comprised the error that causes because of delay now) provides deceptive information.
It should be noted that in Fig. 2, actual CBG is 150mg/dl, is 66mg/dl but sensor calculates wrong value.In fact, the calculating under many situations will show, when not considering sensor delay, so, if calibrate, then will systematically underestimate glucose level between the glucose decrement phase.Uniquely when not having error be, the change speed of supposing glucose just in time with alignment epoch between the change speed that occurs identical the time.
Opposite is, if calibrate during the glucose fast rise, then will systematically over-evaluate glucose level, same, unique when to be the speed that changes when not having error identical with speed between alignment epoch.Better method according to an embodiment of the present invention is that the sensor output value that current C BG current value and in a few minutes in future (this duration is identical with delay) are obtained compares.
In one embodiment, it is as described below to be used to solve a kind of method of this delay: suppose that 6:00 obtains the CBG value in the afternoon.The electronic surveillance unit (EMU) of sensor is presented at the CBG value on the glucose measurement meter or should obtains the CBG value by the automatic EMU of input of value by the glucose measurement meter by patient input.In this, EMU does not carry out calibration, and just equals to postpone the time period (as 5 minutes) of duration simply.Then, at 6:05, EMU obtains signal (or obtaining filtered reading from a series of signal) from biology sensor, and inhibit signal and the CBG level that obtains are previously compared.In one embodiment, this comparison can utilize simple equation of linear regression (utilizing the suitable background current value at zero glucose place) or can utilize the curve fitting equation that characterizes the nonlinear relationship between CBG and the sensor output.
Solving this delay is even more important when glucose signals changes fast.The data sample of obtaining from 13 patients, tested this conception of species with type 1 diabetes.Then, with these sensor subcutaneous placement 5 days.Each sensor per minute is once obtained (every day 1440 times) reading of electric current output, and this output valve is sent to the electronic surveillance unit.In addition, main body utilizes hand-held glucose measurement meter (ROCHE ACCUCHEK) 17-22 ground every day to measure their kapillary blood sugar (CBG) at the finger tip place.Also utilize high accuracy worktable (benchtop) machine, SUPER GL glucose analyser to measure kapillary blood sugar.
Because have a large amount of CBG values that obtain every day, so can not easily test the effect of calibrating during glucose level changes fast.At this special circumstances, have only when glucose level descends by very high speed (average per minute 2.4mg/dl), check retrospectively that just data and every day, twice ground generated calibration point.Fig. 3 shows to utilize thisly to have at the correction data that postpone and not to revise the result of the calibration steps of data.Fig. 3 confirmed when sensor output delay in the time of 5 minutes, and accuracy is greater than not using when postponing and in the accuracy of using when postponing in 10 minutes.In one embodiment, can use delay in 4-10 minute.Accuracy of measurement is as the right percentage of the data that fall into Clarke error form district (Clarke Error Grid Region) A with as average absolute relative error (Mean Absolute Relative Error, i.e. MARE).Calculating is at each right absolute relative error, as the absolute value of the difference between CBG and the sensor glucose estimation, and it is expressed as the percentage of CBG.At these calculating, use continuous single-point calibration every day twice.
In one embodiment, can also use other many data except recently to carrying out calibration.In this method, except using current data, the historical data before can also using.
Express multiple spot down and calibrate the example that can cause than the situation of the better accuracy of single-point calibration.
The output of table 1-sensor
| The calibration number | Nanoampere (nA) | The CBG that measures | Actual CBG |
| ?1 | ?10.5 | ?100 | ?100 |
| ?2 | ?19.5 | ?200 | ?200 |
| ?3 | ?23 | ?250 | ?250 |
| ?4 | ?30 | ?305 | ?305 |
| ?5 | ?40 | ?411 | ?411 |
| ?6 | ?20 | ?220 | ?220 |
| ?7 | ?21 | ?260 | ?200 |
Table 1 expression is from the data of 7 continuous calibrations.In all the other all situations except last calibration, suppose that the CBG that measures is accurately.In last calibration (#7), in the measurement of CBG, there is 30% error.
In one embodiment, for complete continuously some calibration each time, can utilize institute to a little and calculate the tropic.Specifically, in one embodiment, can double weighting nearest data are to (sensor output and CBG), can double weighted background electric current (not shown here), and it is right singly extraordinarily to weigh all other data.
Very similar at the sensitivity that initial 6 calibration calculations go out, and with whether use multipoint iterations or single spot method (wherein, only current data being calibrated being used to) irrelevant.Utilize the Sensitirity va1ue of arbitrary method very near 0.09nA/ (mg/dl) at 1-6 calibration.Yet, when having wrong CBG value (for example), as in the 7th calibration, causing sizable error because the incorrect use of glucose measurement meter or the error of glucose measurement meter.
In one embodiment, utilizing the multiple spot calibration with above-mentioned weighting, is 0.092nA/ (mg/dl) with Calculation of Sensitivity.In contrast, utilizing to have the single spot method of the background current that is assumed to 1nA, is 0.077nA/ (mg/dl) with the Calculation of Sensitivity of the 7th calibration.In one embodiment, if used wrong sensitivity because of unknown, supposing does not have sensor error, and then this mistake will cause 15% absolute relative error.
Fig. 4 shows the comparison that utilizes the Sensitirity va1ue that above-mentioned data computation goes out.In Fig. 4, will be at the right data of the 7th data to being depicted as the band circle points.Multiple spot sensitivity (slope) is depicted as solid line, and single-point sensitivity is depicted as dotted line.
In an embodiment of the present invention, utilizing multiple spot between monitoring/detection and/or alignment epoch can be to obtain the multiple spot DATA REASONING, and then mean filter or median filter are applied to these data with another mechanism that reaches shown data point.
In one embodiment, be in the biology sensor of feature with accidental error (artefact), compare with statistics based on average, it is useful using the statistics based on intermediate value.
Fig. 5 was illustrated in period of 360 seconds, the table that illustrative sensors is measured per 10 seconds.Row 1 shows the second number in elapsed time.Row 2 shows the primary current output (for example, the output of ammeter formula glucose sensor) of biology sensor.It should be noted that, with improper value runicization and the italicization that exists.
In another embodiment according to an embodiment of the present invention, can provide following tables of data (table 2) to utilize the influence of intermediate value interval value (specifically, utilizing the intermediate value of intermediate value or the intermediate value of average) with illustration.
Table 2-interval value and displayed value
| Interval value (supposition sensitivity is 0.62nA/ (mg/dl)) | Displayed value (supposition sensitivity is 0.62nA/ (mg/dl)) | |||||||
| Minute | Intermediate value (nA) | Intermediate value (glucose) | Average (nA) | Average (glucose) | The intermediate value of intermediate value (nA) during 5 minutes | The intermediate value of intermediate value during 5 minutes (glucose mg/dl) | The intermediate value of average (nA) during 5 minutes | The intermediate value of average during 5 minutes (glucose mg/dl) |
| ?1 | ?44.0 | ?71.0 | ?51.0 | ?82.3 | ||||
| ?2 | ?44.5 | ?71.8 | ?45.2 | ?72.8 | ||||
| ?3 | ?41.0 | ?66.1 | ?32.0 | ?51.6 | ||||
| ?4 | ?41.5 | ?66.9 | ?41.8 | ?67.5 | ||||
| ?5 | ?40.5 | ?65.3 | ?41.2 | ?66.4 | ?41.5 | ?66.9 | ?41.8 | ?67.5 |
| ?6 | ?42.0 | ?67.7 | ?55.7 | ?89.8 | ?41.5 | ?66.9 | ?41.8 | ?67.5 |
| ?7 | ?44.0 | ?71.0 | ?51.0 | ?82.3 | ?41.5 | ?66.9 | ?41.8 | ?67.5 |
| ?8 | ?44.5 | ?71.8 | ?45.2 | ?72.8 | ?42.0 | ?67.7 | ?45.2 | ?72.8 |
| ?9 | ?41.0 | ?66.1 | ?32.0 | ?51.6 | ?42.0 | ?67.7 | ?45.2 | ?72.8 |
| ?10 | ?41.5 | ?66.9 | ?41.8 | ?67.5 | ?42.0 | ?67.7 | ?45.2 | ?72.8 |
| ?11 | ?40.5 | ?65.3 | ?41.2 | ?66.4 | ?41.5 | ?66.9 | ?41.8 | ?67.5 |
| ?12 | ?42.0 | ?67.7 | ?55.7 | ?89.8 | ?41.5 | ?66.9 | ?41.8 | ?67.5 |
| ?13 | ?44.0 | ?71.0 | ?51.0 | ?82.3 | ?41.5 | ?66.9 | ?41.8 | ?67.5 |
| ?14 | ?44.5 | ?71.8 | ?45.2 | ?72.8 | ?42.0 | ?67.7 | ?45.2 | ?72.8 |
| ?15 | ?41.0 | ?66.1 | ?32.0 | ?51.6 | ?42.0 | ?67.7 | ?45.2 | ?72.8 |
| ?16 | ?41.5 | ?66.9 | ?41.8 | ?67.5 | ?42.0 | ?67.7 | ?45.2 | ?72.8 |
| ?17 | ?40.5 | ?65.3 | ?41.2 | ?66.4 | ?41.5 | ?66.9 | ?41.8 | ?67.5 |
| ?18 | ?42.0 | ?67.7 | ?55.7 | ?89.8 | ?41.5 | ?66.9 | ?41.8 | ?67.5 |
Embodiment is as shown in table 2 hereto, and shown intermediate value value and average value (interval value) repeated once in per 6 minutes, so that bigger sample set to be provided.Fig. 6 provides the plot of the data of difference intermediate value value and average value calculating method.Although in above-mentioned table 2, used term " displayed value ", in embodiments of the present invention, also can utilize video data or not need video data to show raw data or interval censored data.Utilize term " video data " the most selected, and may be to be preferred for data presented thus in embodiment to identify in three kinds of selections (original, interval, demonstration).
In embodiments of the present invention, before displayed value on the EMU, can move additional calculations: the continuous intermediate value of nearest 5 minutes sections (intermediate value of intermediate value).Can carry out this calculating at all the other a plurality of previous periods (as from 3 to 10 minutes) except 5 minutes.
In alternative embodiment, continuous intermediate value that can computation of mean values, it provides some corrections to the error of being found in the average itself.
It should be noted that in above-mentioned table 2 and Fig. 7, the continuous intermediate value of intermediate value provides level and smooth relatively data set, and the continuous intermediate value of average continues to show original artifactitious vestige.
In one embodiment, for calibration, can use the intermediate value of intermediate value, its debug data better.If the intermediate value of use average (or the average of average-not shown) then may not can get rid of original artifactitious influence fully.For example, use data, if when 11 minutes, 12 minutes or 13 minutes, carry out calibration from table 2, even then use the intermediate value of average, calibration value also is accurately, if but when 8 minutes, 9 minutes or 10 minutes, carry out calibration, then calibration has comprised initial error.As shown in table 2, when using median method (wave filter), then this method correctly is categorized as data hypoglycemia (less than 70mg/dl) in whole table record (tracing), but when using average, then for time of about 50%, it is normoglycemic value that system will be worth mis-classification.
Because calibration error can continue till calibration next time, so they are serious errors.By utilizing all calibrations before perhaps many, and/or utilize the intermediate value of intermediate value value or intermediate value to minimize error in the calibration.In one embodiment, utilize the moving median of average Billy to use the mobile average (moving average) of average better, but may not can the same with the moving median that utilizes intermediate value accurate.In one embodiment, utilizing aspect the multi-site data, weight is hanged down in farther calibration, with further raising accuracy.
In one embodiment, utilize aforesaid all or the most of measurement data points can be better than eliminating one or more data point.For example, even get rid of high or minimum raw data points during each minute, artefact also may exist.If in 1 minute, have more than one wrong low value or in 1 minute, have more than one wrong high value, then eliminate not debug value fully of high data point and/or low data point.
In an embodiment of the present invention, can also be with the physiology filter applies in data stream.The physiology wave filter is programmed for the speed accepted of the tolerance interval that the discriminance analysis thing is measured and/or the change of this analyte.For example, be known that, glucose level in the health can be because of not converting glycogen to glucose and be discharged into the blood flow from liver subsequently liver from the intestinal absorption carbohydrates or during fasting state after the feed, and cause per minute to increase more than about 6-10mg/dl.In addition, the glucose level in the health generally can not descend than the about 6-10mg/dl of per minute quickly, because in order to descend, glucose generally must be absorbed by myocyte, lipocyte or brain cell, and has restriction for cell is taken in speed.Thereby, rise quickly or descend if glucose level presents than physiology restriction, then can use the physiology wave filter, getting rid of these values, and alternatively use the limits value of tolerance interval.
In an embodiment of the present invention, can provide system or the device of carrying out method described herein.In one embodiment, skin upper sensor control module can be connected to biology sensor.This skin upper sensor control module can comprise the processor with programming instruction, and this programming instruction is configured to carry out the method for embodiment of the present invention.
Although purpose for the explanation preferred implementation, in this illustration and specific embodiment has been described, but those of ordinary skills should understand, without departing from the scope of the invention, can with for obtain various widely alternatives and/or the embodiment that is equal to that identical purpose calculates or realize replacing shown in and described embodiment.Those skilled in the art will understand easily, can realize by the unusual mode of broad variety according to the embodiment of the present invention.This application is intended to cover the modification or the modified example of the embodiment of this discussion.Therefore, obvious is only to be limited by claims and equivalent thereof according to the embodiment of the present invention.
Claims (32)
1. the calibration steps of the biology sensor of a Measurement and analysis thing, this method comprises:
Obtain the haemanalysis substrate concentration;
Obtain a plurality of biology sensor output signal values;
Median filter is applied to described a plurality of biology sensor output signal value, to obtain the intermediate value sensor output value;
Described haemanalysis substrate concentration and described intermediate value sensor output value are compared, to obtain the transducer sensitivity value; And
Utilize the signal output of the described biology sensor of described transducer sensitivity value calibration.
2. method according to claim 1 wherein, obtains at least one in described a plurality of biology sensor output signal value between 4 minutes and 10 minutes after obtaining described haemanalysis substrate concentration.
3. method according to claim 1 wherein, obtained at least one in described a plurality of biology sensor output signal value in about 5 minutes after obtaining described haemanalysis substrate concentration.
4. method according to claim 1, wherein, the described haemanalysis substrate concentration of obtaining comprises by thorn and refers to taking blood sample and utilize external analysis thing meter to measure the haemanalysis substrate concentration of this blood sample.
5. method according to claim 1, wherein, described a plurality of biology sensor output signal values are to obtain in 1 minute interval.
6. method according to claim 1, wherein, described a plurality of biology sensor output signal values are obtained in a plurality of intervals.
7. method according to claim 6, wherein, described median filter is at first obtained the interval sensor output value of intermediate value at each interval in described a plurality of intervals, and then, described median filter is obtained the intermediate value sensor output value by the interval sensor output value of described intermediate value.
8. method according to claim 6, described method also comprises: mean filter is at first obtained the mean value interval sensor output value at each interval in described a plurality of intervals, then, described median filter is obtained the intermediate value sensor output value by described mean value interval sensor output value.
9. method according to claim 1, wherein, the described step that obtains the haemanalysis substrate concentration comprises and obtains a plurality of haemanalysis substrate concentrations.
10. method according to claim 9, this method also comprise at each obtained haemanalysis substrate concentration and obtain the transducer sensitivity value, and described transducer sensitivity value is by time weight.
11. method according to claim 1 wherein, shows described signal output as value on the electronic surveillance unit.
12. method according to claim 1, this method also is included in and obtains before the described transducer sensitivity value, obtain the background current value of described biology sensor, and from described a plurality of biology sensor output signal values or described intermediate value sensor output value, deduct described background current value.
13. method according to claim 1, described method also comprise the physiology filter applies in described a plurality of biology sensor output signal values.
14. method according to claim 1, wherein, described biology sensor comprises the glucose sensor through skin.
15. method according to claim 1, wherein, described analyte is a glucose.
16. method according to claim 1, wherein, described transducer sensitivity value is by straight line or curve extrapolation to the fixed background electric current at zero glucose place are obtained.
17. method according to claim 16, wherein, described background current is calculated as the mark or the multiple of the biology sensor output signal value at zero glucose place.
18. one kind is used for system that the biology sensor of Measurement and analysis thing is calibrated, this system comprises:
Skin upper sensor control module; With
Biology sensor, this biology sensor are connected to described skin upper sensor control module, and wherein, described skin upper sensor control module comprises programming instruction, and described programming instruction is configured to: receive the haemanalysis substrate concentration; Receive a plurality of biology sensor output signal values; Median filter is applied to described a plurality of biology sensor output signal value, to obtain the intermediate value sensor output value; Described haemanalysis substrate concentration and described intermediate value sensor output value are compared, to obtain the transducer sensitivity value; And the signal output that utilizes the described biology sensor of described transducer sensitivity value calibration.
19. system according to claim 18, wherein, described a plurality of biology sensor output signal value is obtained in a plurality of intervals, and, described programming instruction also is configured to use median filter, described median filter is at first obtained the interval sensor output value of intermediate value at each interval in described a plurality of intervals, and described then median filter is obtained the intermediate value sensor output value by the interval sensor output value of described intermediate value.
20. system according to claim 18, wherein, described a plurality of biology sensor output signal value is obtained in a plurality of intervals, and, described programming instruction also is configured to use mean filter, this mean filter is at first obtained the mean value interval sensor output value at each interval in described a plurality of intervals, and described then median filter is obtained the intermediate value sensor output value by described mean value interval sensor output value.
21. a method of utilizing biology sensor check and analysis thing, this method may further comprise the steps:
Obtain a plurality of primeval life sensor output signal values;
Median filter is applied to described a plurality of primeval life sensor output signal value, to obtain selected intermediate value sensor output value; And
Be connected to the described selected intermediate value sensor output value of demonstration on the electronic surveillance unit of described biology sensor.
22. method according to claim 21, wherein, described a plurality of primeval life sensor output signal values are to obtain in 1 minute interval.
23. method according to claim 21, wherein, described a plurality of primeval life sensor output signal values obtain in a plurality of intervals.
24. method according to claim 23, wherein, described median filter is at first obtained the interval sensor output value of intermediate value at each interval in described a plurality of intervals, and then, described median filter is obtained selected intermediate value sensor output value by the interval sensor output value of described intermediate value.
25. method according to claim 23, this method also comprises: mean filter is at first obtained the mean value interval sensor output value at each interval in described a plurality of intervals, then, described median filter is obtained selected intermediate value sensor output value by described mean value interval sensor output value.
26. method according to claim 21, this method also is included in and shows before the described selected intermediate value sensor output value, obtain the background current value of described biology sensor, and from described a plurality of primeval life sensor output signal values or described selected intermediate value sensor output value, deduct described background current value.
27. method according to claim 21, this method also comprise the physiology filter applies in described a plurality of primeval life sensor output signal values.
28. method according to claim 21, wherein, described biology sensor comprises the glucose sensor through skin.
29. method according to claim 21, wherein, described analyte is a glucose.
30. a system that utilizes biology sensor check and analysis thing, this system comprises:
Skin upper sensor control module; With
Biology sensor, this biology sensor are connected to described skin upper sensor control module, and wherein, described skin upper sensor control module comprises programming instruction, and described programming instruction is configured to: receive a plurality of primeval life sensor output signal values; Median filter is applied to described a plurality of primeval life sensor output signal value, to obtain selected intermediate value sensor output value; And be connected to the described selected intermediate value sensor output value of demonstration on the electronic surveillance unit of described biology sensor.
31. system according to claim 30, wherein, described a plurality of primeval life sensor output signal value obtains in a plurality of intervals, and, described programming instruction also is configured to use median filter, this median filter is at first obtained the interval sensor output value of intermediate value at each interval in described a plurality of intervals, and described then median filter is obtained selected intermediate value sensor output value by the interval sensor output value of described intermediate value.
32. system according to claim 30, wherein, described a plurality of primeval life sensor output signal value obtains in a plurality of intervals, and, described programming instruction also is configured to use mean filter, this mean filter is at first obtained the mean value interval sensor output value at each interval in described a plurality of intervals, and described then median filter is obtained selected intermediate value sensor output value by described mean value interval sensor output value.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US68719905P | 2005-06-02 | 2005-06-02 | |
| US60/687,199 | 2005-06-02 | ||
| US11/421,564 | 2006-06-01 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102959401A (en) * | 2009-08-27 | 2013-03-06 | 霍夫曼-拉罗奇有限公司 | Calibration method for the prospective calibration of a measuring device |
| CN104138250A (en) * | 2008-12-29 | 2014-11-12 | 美敦力迷你迈德公司 | System and/or method for glucose sensor calibration |
| CN114145738A (en) * | 2022-02-10 | 2022-03-08 | 苏州百孝医疗科技有限公司 | Analyte concentration data generation method and device, and system for monitoring analyte level |
-
2006
- 2006-06-01 CN CNA2006800196063A patent/CN101189512A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104138250A (en) * | 2008-12-29 | 2014-11-12 | 美敦力迷你迈德公司 | System and/or method for glucose sensor calibration |
| CN104138250B (en) * | 2008-12-29 | 2016-12-07 | 美敦力迷你迈德公司 | Glucose sensor calibration system and/or method |
| CN102959401A (en) * | 2009-08-27 | 2013-03-06 | 霍夫曼-拉罗奇有限公司 | Calibration method for the prospective calibration of a measuring device |
| CN102959401B (en) * | 2009-08-27 | 2014-11-26 | 霍夫曼-拉罗奇有限公司 | Calibration method for the prospective calibration of a measuring device |
| CN114145738A (en) * | 2022-02-10 | 2022-03-08 | 苏州百孝医疗科技有限公司 | Analyte concentration data generation method and device, and system for monitoring analyte level |
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