HK1124502B - A system, tools and devices for diabetes care - Google Patents

Description

Systems, tools, and devices for diabetes care

CROSS-REFERENCE TO RELATED APPLICATIONS

Priority from swiss patent application No.1468/05, filed 9/2005, the disclosure of which is incorporated herein by reference in its entirety.

Background

The present invention relates to a system, diagnostic tool, therapeutic tool and teaching tool for diabetes autonomous management. The invention also relates to a medical device for diabetes care, in particular a blood glucose meter or an insulin pump or a continuous glucose monitoring device. The invention also relates to a program for diabetes management and a data carrier comprising such a program.

Prior Art

Considerable progress has been made in developing diagnostic, therapeutic and instructional tools for the autonomous management of diabetes. However, it is rarely appreciated that all of these tools are characterized by a considerable and ever-changing margin of error in the daily lives of diabetics. Prior knowledge of the effect of such errors on postprandial blood glucose and thus their contribution to increasing the risk of hypoglycemia and hyperglycemia is still insufficient.

Currently known systems, in particular for continuous glucose monitoring, do not show practical results to avoid forming potentially erroneous treatment decisions based on unreliable measurement values (values that may have too large measurement errors). With such a system only a retrospective analysis of the measurement results can be made. [ Mastrototaro J., The MiniMed Continuous Glucose monitoring System. journal of Petric Endocronology & Metabolism, 12, 751-758(1999) ].

Other systems for continuous monitoring of glucose do display actual measurements, but are not approved for therapeutic decision-making. In both cases, a strip test device was used to measure the blood Glucose value for this decision [ FDA approximate order Glucose automatic Glucose Biograph-P990026, http:// www.fda.gov/cdrh/pdf/p990026.html ].

Based on the manufacturer's information, a system for continuous glucose monitoring would be able to allow treatment decisions without the validation of conventional testing systems. [ Feldman B, Brazg R, Schwartz S, Weinstein R.A Continuous Glucose Sensor Based on Wired enzyme Technology, diabetes Technology & Therapeutics, 5, 5, 769-.

Summary of The Invention

The main object of the present invention is to provide a system that allows a diabetic or a practitioner to predict a postprandial blood glucose level. It is another object of the present invention to provide a model for accounting for the effects of testing and evaluation errors in diabetes treatment and diabetes autonomic care. It is also an object of the present invention to provide a device that allows a more accurate prediction of postprandial blood glucose and thus gives effective treatment recommendations.

These and even further objects, which will become more apparent as the description continues, are now achieved by a system for determining postprandial blood glucose which takes into account the following factors:

-a pre-prandial blood glucose measurement by autonomous monitoring of glucose

The influence of the carbohydrate fraction on the maximum glucose uptake (maximum glucose oxidase)

-an estimate of the amount of carbohydrates in a meal

Effect of preprandial insulin on maximum glucose reduction

Insulin dosage

Wherein the margin of error for autonomously monitored preprandial glucose is taken into account and the postprandial glucose value is calculated according to the treatment plan.

The system or tool was developed to assess the impact and clinical relevance of the magnitude of error of parameters affecting glucose. It is based on the diabetes treatment concept of injecting insulin before meal to achieve the purpose of normal blood sugar content after meal. The system or tool includes parameters:

a) pre-meal measurements, b) the effect of the carbohydrate fraction (CARB-P) on the maximum glucose rise value, c) patient assessment of the amount of carbohydrates in food, d) the effect of insulin on the maximum glucose fall value, e) insulin dosage. The present invention analyzes the maximum effect (e.g., in the order of 1 mg/dl) of the above parameters (including at least the margin of error of the pre-prandial measurement parameters) on postprandial glucose. Preferably covering the range of clinical relevance of pre-prandial blood glucose values (30-330mg/dl), the system simulates post-prandial blood glucose values as a result according to the treatment algorithm in adult diabetics. If the postprandial "result" is not euglycemic but becomes hyperglycemic or hypoglycemic, the "Critical Point (CP)" can be estimated. All of the above parameters can cause a critical point in postprandial blood glucose if it reaches a certain margin of error. All forms of the invention relate to glucose measurement or glucose monitoring in any tissue compartment and tissue and body fluids, such as interstitial fluid, where such measurement or monitoring may be performed. The preferred case is to measure blood glucose, which is described as a preferred example in the examples, unless otherwise stated.

The invention is also illustrated by a therapeutic, diagnostic and instructional tool having the following features, wherein the tool comprises the following parameters: a) pre-meal measurements, b) the effect of the carbohydrate fraction (CARB-P) on the maximum glucose rise value, c) patient assessment of the amount of carbohydrates in food, d) the effect of insulin on the maximum glucose fall value, e) insulin dosage. The tool analyzes the maximum effect on postprandial glucose of the above parameters including at least the magnitude of error in the preprandial glucose parameter (e.g., in an order of 1 mg/dl). Preferably one or several other parameters are also taken into account together with the error magnitude. Preferably covering a range of clinical relevance of pre-prandial blood glucose values (30-330mg/dl), the tool simulates post-prandial blood glucose values as a result according to a treatment algorithm.

The invention is also illustrated by a device, in particular a blood glucose meter or a continuous glucose monitor or an insulin pump, characterized in that the device determines postprandial glucose by including the following parameters: a) pre-meal measurements, b) the effect of the carbohydrate fraction (CARB-P) on the maximum glucose rise value, c) patient assessment of the amount of carbohydrates in food, d) the effect of insulin on the maximum glucose fall value, e) insulin dosage. The device analyses (e.g. in a step of 1 mg/dl) the maximum effect on postprandial glucose of the above parameters including at least the magnitude of the error in the preprandial glucose parameter. Preferably also one or several other parameters and their error magnitudes are taken into account. Preferably covering a range of clinical relevance of pre-prandial blood glucose values (30-330mg/dl), the device simulates post-prandial blood glucose values as a result according to a treatment algorithm.

The device can then give treatment recommendations based on postprandial glucose. Which can avoid reaching the critical point by giving advice or realize a function of avoiding reaching the critical point.

The invention is also illustrated by a software program or a data carrier containing a program characterized by the following parameters: a) pre-meal measurements, b) the effect of the carbohydrate fraction (CARB-P) on the maximum glucose rise value, c) patient assessment of the amount of carbohydrates in food, d) the effect of insulin on the maximum glucose fall value, e) insulin dosage. The program analyzed the maximum effect on postprandial glucose of the above parameters including at least the magnitude of error in the preprandial glucose parameter (e.g., in an order of 1 mg/dl). Preferably also one or several other parameters and the error magnitudes thereof are taken into account. Preferably covering a range of clinical relevance of pre-prandial blood glucose values (30-330mg/dl), the program simulates post-prandial blood glucose values as a result according to a treatment algorithm.

In a preferred embodiment of the invention, errors in one or several of the following parameters are also taken into account:

the effect of the carbohydrate fraction on the maximum glucose rise, preferably the glycemic rise,

-an estimate of the amount of carbohydrates in the meal,

-effect of insulin intake on maximum glucose drop, preferably blood glucose drop,

-insulin dosage.

In a further preferred embodiment of the invention, postprandial glucose, preferably blood glucose values, are determined for different ranges of preprandial glucose values according to the treatment regime and the results are displayed as postprandial glucose (preferably blood glucose) relative to preprandial glucose. In a further preferred embodiment, it is determined whether the critical point is reached by exceeding a lower limit value for glucose or exceeding an upper limit value for glucose, likewise preferably blood glucose.

Preferably the treatment regimen comprises the autonomic modulation of carbohydrates relative to preprandial Blood Glucose (BG) according to the relationship:

BG(mg/dl)：＜40 40-60 61-120 121-160 161-200 201-240 241-300 301-360

CARB-P(n)：X+2 X+1 X X-1 X-2 X-3 X-4 X-5

wherein X equals the number of carbohydrate moieties (X ═ 1, 2, 3, 4, or 5) for the blood glucose range of 61-120 mg/dl.

It is further preferred that the treatment regimen comprises an autonomic adjustment of the preprandial insulin dosage according to the relationship:

BG(mg/dl)： ＜61 61-80 81-120 121-160 161-200 201-240 241-300 301-360

insulin dose (U): 0-1Y Y +1Y +2Y +3Y +4Y +5Y

Wherein Y is equal to, for example, 1 unit of insulin per 1 CARB-P for the blood glucose range of 81-120 mg/dl.

The invention further comprises a new error grid for measurement error assessment of a blood glucose meter or continuous glucose monitor.

The invention further comprises a method or a device, in particular a blood glucose meter or a continuous blood glucose monitor or an insulin pump, wherein at least one result or recommendation is given on the basis of at least one blood glucose analysis result and wherein the result or recommendation is given in dependence of measurement errors.

Preferably the device is a portable device for measuring the blood glucose level of a patient. The device or method is preferably adapted to display the result or the advice in a first measurement value range or in several first measurement value ranges, despite measurement errors, and to prevent the display of the result or the advice in a second measurement value range or in several measurement value ranges, depending on the measurement errors, or to display the result or the advice in a different mode. The display may be located on the device or separate therefrom and connected to the device, either by wire or wirelessly. The device may comprise at least one motion sensor and the display may be activated or blocked in dependence of a signal from the motion sensor. Said means preferably comprise therein a system or a tool or a program according to the main claim.

Brief description of the drawings

The present invention will be better understood and objects other than those set forth above will become apparent by reference to the following detailed description thereof. The description refers to the accompanying drawings in which:

FIG. 1 shows a screenshot portion of a first embodiment of the present invention;

FIG. 2 shows a parameter list of a system or tool according to this embodiment of the invention;

FIG. 3 shows a table of error magnitudes for the parameters of FIG. 2;

FIG. 4 shows a graph generated by a system or tool or program according to the present invention where all parameters are zero error;

FIG. 5 shows the graph of FIG. 4, but with a pre-prandial self-monitored blood glucose value error of + 20%;

FIG. 6 shows another graph as shown in FIG. 5 in which the autonomously monitored blood glucose value error is 12%;

FIG. 7 shows the graph shown in FIG. 5, but with an error of + 25%;

FIG. 8 shows the graph shown in FIG. 5, but with an error of + 40%;

FIG. 9 is a table of parameter errors that result in a threshold point for postprandial blood glucose levels;

FIG. 10 illustrates a known error grid model (error grid model) for determining the acceptability of measurement errors;

FIG. 11 illustrates a new error grid model in accordance with the present invention;

FIG. 12 illustrates a new error grid model for measuring the quality of blood glucose measurements;

fig. 13 shows a new error grid model compared to the known EGA model.

Detailed description of the invention

Fig. 1 shows a screenshot of a preferred embodiment of the present invention. As explained above, the invention may be embodied as a system, a tool, a device, in particular a blood glucose meter, or a program. All of these embodiments are included when the present invention is explained below and sometimes referred to as the Diabetes Error Test Model (DETM).

The preferred DETM "calculates" the postprandial blood glucose value. Preferably it does not show a profile of Blood Glucose (BG) over time, but is primarily concerned with the greatest effect due to insulin and carbohydrates consumed. However, these are not the only factors that affect the BG results. Several factors can affect postprandial BG. Parameters that can be set as shown in fig. 2 are considered in DETM. Figure 3 shows the error magnitudes for this embodiment of the invention. The parameters may be set in the illustrated embodiment by entering values in fields and by moving the illustrated sliding input means (fig. 1). Of course, in other embodiments of the invention, for example in a device that is a blood glucose meter or continuous glucose monitor, the parameter, such as pre-meal blood glucose, may be measured directly or entered via an input means on the device or pre-stored data. The parameters shown in fig. 1 and 2 are: a) pre-meal Blood Glucose (BG) in the range of 30mg/dl to 330mg/dl, actually measured pre-meal by a device for autonomously monitoring blood glucose, e.g. with a strip glucometer; b) variability or influence of the carbohydrate fraction, giving rise to blood glucose values in terms of how many mg/dl of one carbohydrate fraction, and can be set between 20mg/dl and 80 mg/dl; c) the amount of carbohydrate fraction (C-P) that the patient intends or estimates to eat, which has a value of 1 to 5; d) insulin variability or impact, giving blood glucose drop values in terms of how many mg/dl of insulin per unit, and can be set between 30mg/dl and 50 mg/dl; and e) insulin dosage.

Fig. 3 shows the error magnitudes of the following parameters: a) percent error in measured preprandial glucose concentration, ranging from-50% to + 50% error (0% means no error); b) error or denaturation of the influence of carbohydrate influences, with 45mg/dl as normal value and error of maximum 80mg/dl and minimum 20 mg/dl; c) an estimated error% of the amount of carbohydrate fraction needed, between 40% and 200%, wherein 100% means an estimated error free for diabetic patients; d) insulin-induced error or variability in the drop in glucose concentration, which is error-free at a value of 40mg/dl, with maximum and minimum error values of 50mg/dl and 30 mg/dl; and e) error% in dosing the exact amount of insulin can be set between-25% and + 50%, where 0% means no error in dosing (dosing).

The preferred treatment algorithm for DETM is a clinical trial according to German Diabetes Research Institute/German Diabetes center of Heinrich-Heine-University of Duesseldorf, as shown in tables 1 and 2:

TABLE 1

Carbohydrate autonomy regulation relative to pre-meal BG(base value: X number of CARB-P in BG range of 61-120mg/dlAmount (X ═ 1, 2, 3, 4, or 5)BG(mg/dl) ＜40 40-60 61-120 121-160 161-200 201-240 241-300 301-360 CARB-P(n)：X+2 X+1 X X-1 X-2 X-3 X-4 X-5

TABLE 2

Autonomic modulation of preprandial insulin analog doses(base value: Y; for the BG range of 81-120mg/dl, e.g. 1U/1 CARB-P)BG(mg/dl)： ＜61 61-80 81-120 121-160 161-200 201-240 241-300 301-360Insulin dose (U): 0-1Y Y +1Y +2Y +3Y +4Y +5Y

Thus, as an example of Table 1, if a carbohydrate fraction value X of 1 to 5 is considered in the blood glucose range of 61 to 120mg/dl, the value of that fraction will be corrected to X-2 when the autonomously monitored blood glucose value is in the range of 161 to 200 mg/dl.

As an example of Table 2, if the pre-prandial blood glucose level is autonomously monitored at 81 to 120mg/dl, one unit of insulin (Y) per carbohydrate fraction is considered, while if the blood glucose level is 161 to 200mg/dl, it is adjusted up by +2 units. Other treatment algorithms may be used, but the preferred algorithm is simple and easy to implement as it increases or decreases the carbohydrate fraction and insulin units based on autonomously monitoring the blood glucose range for the meal as indicated. The range may be varied to vary the algorithm, and fractions of insulin units or carbohydrate moieties may be used.

The purpose of the therapy algorithm is to guide the BG of a patient's whole blood to normal blood glucose (60-160 mg/dl). This range, 60-160mg/dl, is referred to as the target range. Of course, the use of insulin or carbohydrates for BG > 120mg/dl can be selected for adjustment. For example, the calculation based on the preferred treatment algorithm may be as follows: where the error in autonomously monitoring blood glucose is taken into account is 10%, and for example, the error in the effect of carbohydrates and insulin may additionally be taken into account, but is set to 0% in the calculation, so the blood glucose rise for one carbohydrate fraction is 45mg/dl and the insulin-induced fall is 40 mg/dl:

actual BG: 120

Measurement error: 10 percent of

CARP-P Effect: 45

Insulin effect: 40

Error: 0 percent of

Number of carbohydrate moieties: 5Carp-P

Actual BG with error (measured blood glucose value): 120mg/dl × 1.1 ═ 132mg/dl

According to the above treatment algorithm, 132mg/dl results in:

since the current blood glucose was in the range of 121 to 160, 1 less CARP-P (X-1) was consumed than planned, and thus 120mg/dl + (4X 45mg/dl) - (5X 40mg/dl) ═ 100mg/dl, the blood glucose levels were normal;

alternatively, since the current blood glucose is in the range of 121 to 160, if the planned carbohydrate fraction is consumed, 1 unit more insulin (+1Y) is taken, so that 120mg/dl + (5 × 45) - (6 × 40) ═ 105mg/dl, and thus the blood glucose amount is normal.

The system, tool, device and program according to the invention allow to calculate the post-prandial blood glucose value, which is the result of the pre-prandial blood glucose value, if the treatment regime is implemented according to a preferred algorithm (or if it can be according to another algorithm). The postprandial blood glucose concentration value is then preferably displayed relative to the glucose concentration measured before the meal. First, the impact of BG measurement error was evaluated, while all other parameters remained 0% error. FIG. 4 shows the postprandial glucose concentration maintained within the target range (represented by the horizontal lines of postprandial glucose concentrations at 60mg/dl and 160 mg/dl). As an indication of an error in autonomously monitored glucose concentration, a 0% error bar is additionally shown (which would not normally occur), so the preferred display shows the measured pre-meal blood glucose value on the horizontal x-axis only, and the calculated post-meal blood glucose value on the left vertical axis y.

The DETM program can display all relevant variables in the glucose concentration result calculation in a further window not shown in fig. 1. Among these are the final carbohydrate fraction (C-P) that the patient will consume after considering his current condition, the insulin (Y IU) that he needs to apply, and of course the glucose concentration result (BG _ R). The "destination" value may be examined for display in a curve, as shown in FIG. 4.

The curve may show postprandial glucose concentrations associated with a changing variable. The other variables were held constant at the set point. The most common preferred curve is the relationship shown between pre-prandial (reference) glucose concentration (with values between 30 and 330mg/dl) and post-prandial results.

In the graph of FIG. 4, it can be seen that all pre-meal values at 30-330mg/dl will result in post-meal values between the target range of 60 to 160mg/dl while all parameters remain at 0% error. The characteristic zigzag shape of this curve and the lower curve are the result of the stepped nature of the treatment algorithm.

FIG. 5 shows that if the pre-prandial glucose concentration values are in the range of 30-130mg/dl and 260-330mg/dl, a + 20% glucose concentration Error (classified by, for example, Error Grid Analysis associated with region A and thus within the permitted range, as described below) yields a postprandial "result" with normal blood glucose levels. However, if the BG value with pre-prandial error is between 131 and 259mg/dl, the post-prandial glucose concentration unexpectedly causes hypoglycemia. Within this range, the target range to the critical point of hypoglycemia has been reached at 12% BG measurement error, as shown in figure 6. Thus, if the pre-meal value is in the range of 30-130mg/dl, a device such as a blood glucose meter or insulin pump can display a useful value or treatment recommendation and act accordingly, while on the other hand such a device will prevent results displayed in the range of 131-259mgdl or will prevent the display of treatment recommendations or will issue a warning. Figures 7 and 8 show postprandial glucose values for other error percentages for autonomously monitored glucose. FIG. 7 shows that since the pre-meal autonomously monitored glucose measurements have an error of + 25% (all other errors of the system remain 0%), the post-meal blood glucose value drops to hypoglycemia. Fig. 8 shows that due to a pre-meal error of 40%, it falls to hypoglycemia.

In summary, the DETM system, tools, apparatus and program allow characterization of errors in parameters affecting BG and correlation of post-prandial BG results. It details the effect of possible errors in parameters affecting glucose concentration on postprandial glucose values within the clinically relevant glucose range. It evaluates the clinical relevance of these errors and provides a detailed risk assessment, focusing on the post-prandial results. It is therefore preferably used in teaching tools for interpreting this relationship to diabetic patients. It may further be used in a device for diabetes care. When used for blood glucose timing, the system, tool or program will learn the measurement error of the device so that postprandial blood glucose can be calculated and a warning issued if a threshold point is reached. The device can further give a corrected treatment recommendation if it detects that the post-prandial blood glucose level will reach a critical point based on the autonomously monitored blood glucose level, the error and other parameters.

Critical point: the threshold is reached if (pre-meal) glycemia becomes (post-meal) low or high glycemia, or (pre-meal) hyperglycemia becomes (post-meal) hypoglycemia, or (pre-meal) hypoglycemia becomes (post-meal) hyperglycemia. For example, if the glucose measurement error is 11%, this causes the pre-prandial glucose value of 219mg/dl to become a post-prandial value of 59mg/dl (outside the target range). This is called the critical point, since 11% is the minimum value for which the glucose measurement error causes at least one value to be outside the target range. Fig. 9 shows a graph of the critical point reached by the parameter error.

The treatment algorithm can be extended to Continuous Glucose Monitoring (CGM). The following assumptions were made for possible glucose changes:

glucose rise very rapidly > +2mg/dl/min UU

Rapid + (1-2) mg/dl/min U

Slowly changing +/-1 mg/dl/min ═

Rapidly decrease- (1-2) mg/dl/min D

Very rapidly decreasing > -2mg/dl/min DD

Glucose Change within 30 minutes (mg/dl/min)

Average value range

UU +3.0 +(2.1→3.9)→ +45 +(31→59)

U +1.5 +(1.0→2.0)→ +23 +(15→30)

＝ ±0 -0.9→+0.9→ ±0 -14→+14

D -1.5 -(1.0→2.0)→ -23 -(15→30)

DD -3.0 -(2.1→3.9)→ -45 -(31→59)

This results in the following treatment algorithm to apply to insulin units:

glucose (mg/dl) < 6161-8081-120121-160161-200201-240241-300301-360

UU 0 Y +1Y +2Y +3Y +4Y +5Y +6Y

U 0 -1Y Y +1Y +2Y +3Y +4Y +5Y

＝ 0 -1Y Y +1Y +2Y +3Y +4Y +5Y

D 0 -2Y -1Y Y +1Y +2Y +3Y +4Y

DD 0 -3Y -2Y -1Y Y +1Y +2Y +3Y

In a DETM procedure, tool, system or device, the CGM algorithm can be used to make any calculations. In particular, the device is a continuously measuring glucose monitor in the case of such an algorithm.

Another aspect of the invention is that by using the DETM model and algorithm, an error checkered model similar to EGA, hereinafter EAA, can be calculated. Fig. 10 shows a known EGA. [ Joan L.Parkes, Scott Pardo, Stephen l.Slatin, Barry H.Ginsberg, "A new consensus Error Grid to estimate the clinical information of the clinical glucose", Diabetes Care, Vol 23, No.8, 1143 and 1148, p.2000.8 ].

With the DETM system, tools and programs with the preferred algorithm, an error checkerboard model similar to EGA can be calculated:

correcting the target range by the acceptable range (50-200 mg/dl); the target range is equivalent to region a of EGA; the acceptable range is equivalent to region B of EGA; for EAA, it is calculated at which measurement error the pre-meal glucose value caused the post-meal BG value to be outside the target/acceptable range.

The results are the relationship between preprandial reference glucose and preprandial self-monitoring glucose, as shown in fig. 11. The solid line represents the target range and the dashed line the acceptable range. The quality of the glucose measurement can now be measured with EAA by projecting the reference values and the autonomic measurements into the squares shown in fig. 12. The points outside the solid/dashed line mean that if the patient measures this value (with the corresponding reference value), his/her glucose concentration will cause low/high blood glucose after applying his treatment algorithm. In this figure, most points lie between the lines, but some points are outside (above). This means that with this glucose meter the patient is at risk of dying from hypoglycemia.

To assess the exact risk, the system, tools, and program provide the option of calculating both EAA and EGA, as shown in fig. 13; in this calculation, it can be seen that 9% of the points are outside the acceptable range. Interestingly, no point is outside region a of the EGA. This indicates that the measurement device is perfect according to EGA, whereas it cannot be used according to EAA. The EGA can be plotted as shown as EAA to provide visual visibility.

Attention and considerations are given to: the DETM and treatment algorithm are calibrated for whole blood. However, the systems, tools, devices, and procedures may provide the option of switching to plasma. The DETM is focused on BG results (with some side effects) after ingestion of food and administration of insulin.

The EAA is concerned with assessing the quality of the measurement device. This quality depends on the treatment algorithm used (which may be suitable for the DETM procedure). Continuous glucose monitoring is performed with minor changes to the standard therapy algorithm without disturbing the algorithm. All parameters/characteristics may be combined. This means that, for example, all EAA calculations can be performed for higher insulin impact, and then on the routine. The DETM program preferably has an attached database so that the test results of the measuring devices can be stored and easily selected.

Measurement errors of an analysis system such as a blood glucose meter or a continuous glucose monitor affect the usefulness and importance of the analysis results. If the measured glucose value is outside the physiologically preferred concentration, treatment is initiated with the aim of restoring the physiologically preferred state. In the case of diabetes, therapeutic intervention such as the administration of insulin or carbohydrates is taken to return the glucose concentration to a normal blood glucose value. The results of the analysis may be displayed or otherwise presented numerically or with treatment recommendations based on measurements, which may be individual measurements or considerations of prior measurements, such as measurements in continuous glucose monitoring.

The therapeutic intervention depends on the concentration or concentration range of the glucose value and the target range of euglycemia. In the present invention, the displayed or presented treatment recommendation is made dependent on the outcome of the glucose value (e.g. postprandial value), which on the other hand depends on the error of the measurement, as explained above. In particular, if the system or tool or program detects that postprandial glucose is within the target range of the actual measurement range, only recommendations are given.

Thus, since the display of the measured values or recommendations, in particular of the treatment recommendations, takes into account the measurement errors and their correlation with the blood glucose values reached later, it is possible to display always beneficial and correct treatment recommendations or measured values to the user. The apparatus may consider the following: the measurement value is in a range in which a recommendation can be given regardless of a measurement error, or in a range in which a recommendation cannot be given or only an improvement can be given due to occurrence of a critical point.

Thus, the advantages of the present invention lie in these glucose ranges as follows: within these ranges, the device may give correct treatment recommendations despite large measurement errors. On the other hand, such advice may be prevented or modified or replaced with warnings within those ranges where minor errors are required to give a correct treatment advice.

The display is either directly arranged on the device, or arranged in a wireless manner (infrared, radio frequency), or in wired binding (wired) data connection with the device.

In particular, if the device is a device for continuous glucose monitoring that reacts to movements of the wearer in such a way that movements may cause an increase in measurement error, it is preferred to include a movement sensor in the device, so that the errors caused by movements can be included in the above calculations by adding another error parameter.

While there have been shown and described what are at present the preferred embodiments of the invention, it is to be distinctly understood that the invention is not limited thereto but may be otherwise variously embodied and practiced within the scope of the following claims.

Claims (10)

1. A device, being a blood glucose meter or a continuous blood glucose monitor or an insulin pump, incorporating a system for calculating postprandial glucose concentrations by analyzing the maximum impact of the following parameters on postprandial glucose:

-a pre-prandial glucose concentration measurement by autonomous monitoring of glucose

The influence of the carbohydrate fraction on the maximum glucose rise

-an estimate of the amount of carbohydrates in a meal

The effect of insulin on the maximum glucose drop value at meals

-a dose of insulin,

said parameters being directly measurable by said device or inputtable by input means or pre-stored data on said device, wherein said system is adapted to calculate a postprandial blood glucose value as a result according to a treatment plan protocol in adult diabetics,

and wherein

The system is suitable for analysis including autonomously monitored margin of error for pre-prandial glucose and one or more of the following parameters:

the effect of the carbohydrate fraction on the maximum glucose concentration rise value,

-an estimate of the amount of carbohydrates in the meal,

the effect of insulin on the maximum glucose concentration drop value during a meal,

-a dose of insulin,

and wherein

At least one result or recommendation is given by the device on the basis of at least one result of the system's calculation of postprandial glucose, and wherein the result or recommendation is given in dependence of measurement error.

2. The device of claim 1, which is a portable device.

3. A device according to claim 1 or 2, wherein the device is adapted to display a result or advice in a first measurement value range or in several first measurement value ranges, irrespective of measurement errors, and to prevent the display of a result or advice in a second measurement value range or in several measurement value ranges, depending on measurement errors.

4. The device of claim 1, comprising a display, the display being located on or separate from the device and being wired or wirelessly connected to the device.

5. The apparatus of claim 4, comprising at least one motion sensor, wherein the display is capable of being activated or blocked in response to a signal from the motion sensor.

6. An apparatus according to claim 1, wherein the system is adapted to determine postprandial glucose concentrations for different ranges of preprandial glucose concentration values according to a treatment plan protocol.

7. The device according to claim 1, wherein the system is adapted to determine whether the critical point is reached by exceeding a lower limit value for the glucose concentration or exceeding an upper limit value for the glucose concentration.

8. An apparatus according to claim 1, wherein the treatment planning regime of the system comprises autonomous adjustment of carbohydrates relative to pre-prandial glucose concentration according to the following relationship:

BG(mg/dl)：＜40 40-60 61-120 121-160 161-200 201-240 241-300 301-360

CARB-P(n)：X+2 X+1 X X-1 X-2 X-3 X-4 X-5

wherein X is equal to the number of carbohydrate moieties and is 1, 2, 3, 4 or 5 for the blood glucose range of 61-120 mg/dl.

9. The apparatus of claim 1, wherein the treatment planning protocol of the system includes autonomous adjustment of the pre-meal insulin dosage according to the following relationship:

BG(mg/dl)： ＜61 61-80 81-120 121-160 161-200 201-240 241-300 301-360

insulin dose (U): 0-1Y Y +1Y +2Y +3Y +4Y +5Y

Wherein, for a blood glucose range of 81-120mg/dl, Y is equal to one unit of insulin/one CARB-P.

10. The device according to claim 1, which is a continuous blood glucose monitor and the system is adapted for use in the trend of continuous blood glucose monitoring as follows:

glucose (mg/dl) < 6161-8081-120121-160161-200201-240241-300301-360

And wherein the trend is defined as follows:

and wherein Y equals one unit of insulin/one CARB-P.