Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient; User input means
  • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
  • A61B5/743—Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
  • A61B5/7271—Specific aspects of physiological measurement analysis
  • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient; User input means
  • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
  • A61B5/7445—Display arrangements, e.g. multiple display units
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
  • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
  • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
  • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
• • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

Definitions

• the invention relates to a system and a diagnostic tool and a therapeutic tool and an educational tool for diabetes self management.
• the invention further relates to a medical device for diabetes care and in particular a blood glucose meter or an insulin pump or a continuous glucose monitoring device.
• the invention further relates to program for diabetes management and to a data carrier including such a program.
• the system or tool has been developed to evaluate the effects and the clinical relevance of the margins of error of parameters affecting glucose. It is based on a diabetes treatment concept aimed at normoglycemia after meals by preprandial injections of insulin.
• the system or tool includes as parameters: a) preprandial measurement, b) effect of carbohydrate portions (CARB-P) on maximum glucose increase, c) patient estimate of carbohydrate amounts in food, d) effect of insulin on maximum glucose decrease, e) insulin dosage.
• the invention analyzes (for example in lmg/dl steps) the maximum effect of the above parameters (including the margins of error of at least the parameter of preprandial measurement) on postprandial glucose. Covering preferably the clinically relevant range of preprandial blood glucose values (30-330 mg/dl) the system simulates the postprandial blood glucose values as outcome according to a treatment algorithm in adult persons with diabetes. If the postprandial "outcome” is not normoglycemia but turns into hyperglycemia or hypoglycemia, a "critical point (CP)" can be evaluated. All of the above parameters can induce a critical point of postprandial blood glucose if they reach a specific margin of error.
• the invention in all its forms relates to the glucose measurement or glucose monitoring in any tissue compartment and tissues and body fluids, e.g. interstitial fluids where such measurement or monitoring is possible.
• a preferred case is the measurement of blood glucose and in the examples this case is described as the preferred example unless otherwise stated.
• the invention is further manifested by a therapeutic tool and a diagnostic tool and an educational tool with the features that the tool includes as parameters: a) preprandial measurement, b) effect of carbohydrate portions (CARB-P) on maximum glucose increase, c) patient estimate of carbohydrate amounts in food, d) effect of insulin on maximum glucose decrease, e) insulin dosage.
• the tool analyzes (for example in lmg/dl steps) the maximum effect of the above parameters including the margins of error at least of the parameter preprandial glucose on postprandial glucose. Preferably one or several of the other parameters are as well considered with their margins of error.
• the tool simulates the postprandial blood glucose values as outcome according to a treatment algorithm.
• the invention is further manifested by a device, in particular a blood glucose meter or a continuous glucose monitor or an insulin pump, with the features that the device determines postprandial glucose by including as parameters: a) preprandial measurement, b) effect of carbohydrate portions (CARB-P) on maximum blood glucose increase, c) patient estimate of carbohydrate amounts in food, d) effect of insulin on maximum glucose decrease, e) insulin dosage.
• the device analyzes (for example in lmg/dl steps) the maximum effect of the above parameters, including the margins of error at least of the parameter preprandial glucose, on postprandial glucose. Preferably one or several of the other parameters are as well considered with their margins of error. Covering preferably the clinically relevant range of preprandial blood glucose values (30- 330 mg/dl) the device simulates the postprandial blood glucose values as outcome according to a treatment algorithm.
• the device can then give a suggestion of treatment based on the postprandial glucose. It can avoid reaching a critical point by giving advice or perform functions that avoid reaching the critical point.
• the invention is further manifested by a software program or a data carrier including such a program that is provided with the features that it includes as parameters: a) preprandial measurement, b) effect of carbohydrate portions (CARB-P) on maximum glucose increase, c) patient estimate of carbohydrate amounts in food, d) effect of insulin on maximum glucose decrease, e) insulin dosage.
• the program analyzes (for example in lmg/dl steps) the maximum effect of the above parameters including the margins of error at least of the parameter preprandial glucose on postprandial glucose. Preferably one or several of the other parameters are as well considered with their margins of error. Covering preferably the clinically relevant range of preprandial blood glucose values (30-330 mg/dl) the program simulates the postprandial blood glucose values as outcome according to a treatment algorithm.
• postprandial glucose is determined for different ranges of preprandial glucose values, preferably blood glucose values, according to the therapeutic scheme and the result is displayed as postprandial glucose (preferably blood glucose) over preprandial glucose .
• the therapeutic scheme includes a preprandial insulin dose self- adjustment according to the relation: BG (mg/dl) : ⁇ 61 61-80 81-120 121-160 161-200 201-240 241-300 301-360 Ins.-Dose (U) : 0 -IY Y +1Y +2Y +3Y +4Y +5Y wherein Y equals e.g. 1 unit insulin per 1 CARB-P for the blood glucose range of 81-120 mg/dl.
• the invention further comprises a new error grid for the evaluation of measurement errors of blood glucose meters or continuous glucose monitors.
• the invention further comprises a method or device, and in particular a blood glucose meter or a continuous blood glucose monitor or an insulin pump wherein on the basis of at least one result of the analysis of blood glucose at least one result or an advice is given and wherein the result or advice is given depending on the measurement error.
• the device is a portable device and provided for measuring the blood glucose value of a patient.
• the device or method is preferably adapted to display results or advice in a first measurement range or several first measurement ranges despite the measurement error and adapted to inhibit the display of results or advice or display results or advice in a different mode in a second measurement range or in several measurement ranges depending on the measurement error.
• the display may be on the device or separate therefrom and being in wire or wireless connection with the device.
• the device may comprise at least one movement sensor and the display may be activated or inhibited dependent on a signal from the movement sensor.
• the device has preferably incorporated therein a system or tool or program according to the main claims .
• Figure 1 shows parts of a screenshot of a first embodiment of the inventions-
• Figure 2 shows a list of the parameters of the system or tool according to this embodiment of the invention;
• Figure 3 shows a table of the margins of error for the parameters of Figure 2;
• Figure 4 shows a diagram generated by the system or tool or program according to the invention with zero error of all parameters
• Figure 5 shows a diagram as in Figure 4 but with a +20% error of preprandial self-monitored blood glucose
• Figure 6 shows another diagram as in Figure 5 with an error of 12% for the self-monitored blood glucose
• Figure 7 shows a diagram as in Figure 5 but with an error of +25%
• Figure 8 shows a diagram as in Figure 5 but with an error of +40%
• Figure 9 shows a table of parameter errors leading to critical point in postprandial blood glucose
• Figure 10 shows a known error grid model for judging acceptance of measurement errors
• Figure 11 shows a new error grid model based on the present invention
• Figure 12 shows the new error grid model used to measure the quality of blood glucose measurements
• Figure 1 shows a screenshot of a preferred embodiment of the invention.
• the invention can be embodied as a system, a tool, a device, in particular a glucose meter, or as a program. All these embodiments are encompassed when the invention is explained in the following and sometimes called as Diabetes Error Test Model (DETM) .
• DETM Diabetes Error Test Model
• the preferred DETM calculates" the • postprandial blood glucose value. Preferably it does not show a blood glucose (BG) curve over time 'but focuses mainly on the maximum effect resulting from insulin and carbohydrates consumed. However, these are not the only factors contributing to the BG result. There are numerous factors that affect the postprandial BG. The following are taken into account in the DETM and are shown in Figure 2 as parameters that can be set. Figure 3 shows the margins of error that are used in the present embodiment of the invention. The parameters can be set in the shown example by entering values in the fields and by moving the shown slide input means ( Figure 1) .
• parameters will be either measured directly, such as preprandial blood glucose or be entered via input means on the device or being stored beforehand.
• the parameters shown in Figures 1 and 2 are: a) The pre- prandial blood glucose (BG) being in the range of 30mg/dl to 330mg/dl which has actually been measured preprandial by a device for self-monitoring of blood glucose, for example with a strip blood glucose meter; b) the variability or effect of a carbohydrate portion, giving the blood glucose increase in mg/dl of one carbohydrate portion and being settable between 20mg/dl and 80mg/dl; c) the amount of carbohydrate portions the patients aims or estimates to eat (C-P) with a value of 1 to 5; d) the variability or effect of the insulin, giving the blood glucose decrease in mg/dl for a unit of insulin and being settable between 30mg/d
• C-P the variability or effect of the insulin
• Figure 3 shows the margin of error for the parameters: a) the error in % with which the pre-prandial glucose concentration has been measured, with a range of -50% to +50% error (0% meaning no error); b) the error or variability of the effect of the carbohydrate effect with 45mg/dl as normal value and an error of up to 80mg/dl and down to 20mg/dl; c) the error in estimating the desired amount of carbohydrate portions in % between 40% and 200% and wherein 100% means no error in estimating by the person with diabetes; d) the error or variability of the glucose concentration decrease by the insulin with a value of 40mg/dl as errorless value and highest and lowest error values of 50mg/dl and 30mg/dl; and e) the error in dosing the correct amount of insulin in % and being settable between -25% and +50% wherein 0% means no error in dosing.
• BG (mg/dI) ⁇ 40 40-60 61-120 121-160 161-200 201-240 241-300 301-360
• one unit of insulin (Y) is considered per carbohydrate portion if the self- monitored pre-prandial blood glucose value is in the range of 81 to 120mg/dl but is made higher by +2 units if the blood glucose value is in the range of 161 to 200mg/dl.
• Other treatment algorithms could be used as well but the preferred algorithm is simple to implement since it is based on addition and subtraction of carbohydrate portions and insulin units for the shown ranges of preprandial self-monitored blood glucose. The ranges can be shifted to vary the algorithm and fractions of insulin units or carbohydrate portion could be used.
• the aim of the treatment algorithm is to lead the patient's BG to normoglycemia (60-160 mg/dl), whole blood. This range from 60-160 mg/dl is called target range.
• target range 60-160 mg/dl
• it can be chosen to either adjust using insulin or carbohydrates for BG>120 mg/dl.
• a calculation based on the preferred treatment algorithm can be shown as follows wherein the error of the self- monitored blood glucose is taken into account by 10% and for example additionally the errors of carbohydrate and insulin effects could be considered but are set to zero % in this calculation, so the blood glucose increase of one portion carbohydrates is 45mg/dl and the decrease caused by the insulin is 40mg/dl: True BG: 120 Measurement error: 10% Effect CARP-P: 45 Effect insulin: 40 Error: 0%
• the system, tool, device and program according to the invention allows to calculate the postprandial blood glucose as the outcome of the pre- prandial blood glucose if the therapeutic action is taken according to the preferred algorithm (or if the case may be according to another algorithm) .
• Preferably the values of postprandial glucose concentration is then displayed over pre-prandial measured glucose concentration.
• Figure 4 shows postprandial glucose concentration kept within the target range (shown by the horizontal lines at 60mg/dl and 160mg/dl posprandial glucose concentration) .
• the 0% error line is additionally shown which is usually not the case, so that the preferred display shows only measured pre-prandial blood glucose values on the horizontal x-axis and calculated postprandial blood glucose values on the lefthand vertical y-axis.
• the DETM-program can display all variables relevant in the calculation of the glucose concentration outcome in an additional window not shown in Figure 1. Among those are the final carbohydrate portions the patients will eat after considering his current situation (C-P) , the insulin he needs to apply (Y IU) and of course the glucose concentration result (BG_R). The "interesting" values can be checked to be displayed in a graph as for example shown in Figure 4.
• This graph can display the postprandial glucose concentration in relation to one changing variable.
• the other variables are kept constant to the set value.
• the preferred graph used most often is the shown relation between the pre-prandial (reference) glucose concentration (with values between 30 and 330 mg/dl) and the postprandial outcome.
• BG values are between 131 and 259 mg/dl.
• the critical point where the target range is left for hypoglycemia is already reached at a BG measurement error of +12% as can be shown in Figure 6.
• a device such as a blood glucose meter or an insulin pump will be able to display useful values or therapeutic advice if the preprandial values are in the range of 30-130mg/dl and will act accordingly while on the other hand such a device will inhibit the display of results in the range of 131-259mg/dl or will inhibit displaying therapeutical advice or will give a warning.
• Figures 7 and 8 show postprandial glucose values for other error percentages of the self-monitored glucose.
• Figure 7 shows the postprandial blood glucose to decrease into hypoglycemia due to a preprandial self-monitored glucose measurement with an error of +25% (with all other errors of the system kept to 0%) .
• Figure 8 shows a decrease into hypoglycemia due to a preprandial error of 40%.
• the DETM system, tool, device and program allow to characterize the relevance of errors of parameters affecting BG on postprandial BG outcome. It describes in detail the effects of potential errors of parameters affecting glucose concentration on postprandial glucose values within the clinically relevant glucose range. It evaluates the clinical relevance of these errors and presents a detailed risk assessment with the focus on postprandial outcome. It is therefore preferably used in educational tools for explaining the relations to people with diabetes. It is further used in devices for the diabetes care. When used in a blood glucose meter, the system, tool or program will know the measurement error of this device and can therefore calculate the postprandial blood glucose and can give a warning if a critical point is reached.
• the device can further give a corrected treatment advice if it detects that based on the self-monitored blood glucose value, the error and the other parameters a critical point would be reached for the postprandial blood glucose value .
• the Critical Point A Critical Point is reached if (preprandial) normoglycemia turns into (postprandial) hypo- or hyperglycemia or (preprandial) hyperglycemia turns into (postprandial) hypoglycemia or (preprandial) hypoglycemia turns into (postprandial) hyperglycemia.
• the glucose measurement error For example if the glucose measurement error is 11% this leads for the preprandial glucose value of 219 mg/dl to a postprandial value of 59 mg/dl (outside the target range) . As 11% is the lowest value for the glucose measurement error to result in at least one value outside the target range this is called the Critical
• Figure 9 shows a table of critical points reached by parameter errors .
• the treatment algorithm can be extended to Continuous Glucose Monitoring (CGM) .
• CGM Continuous Glucose Monitoring
• glucose-Trend (mg/dl/min) glucose-Chang ;e(mg/dl) in 30 minutes mean range mean range
• Glucose (mg/dl) ⁇ 61 61-80 81-120 121-160 161-200 201-240 241-300 301-360
• the CGM- algorithms can be used for any calculation made.
• the device in this case of algorithm is a continuously measuring glucose monitor.
• FIG. 10 shows the EGA as known. [Joan L.Parkes, Scott Pardo, Stephen 1. Slatin, Barry H. Ginsberg, "A new consensus Error Grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose", Diabetes Care, VoI 23, No. 8, pages 1143-1148, August 2000] .
• an error grid model similar to the EGA can be calculated:
• the target range is amended with an acceptance range (50- 200 mg/dl) ;
• the target range is the equivalent to EGA zone A;
• the acceptance range is the equivalent to EGA zone B; for the EAA it is calculated which measurement error at which pre-prandial glucose value leads to a post-prandial BG value outside the target/acceptance range
• the system, tool and program offers the option of calculating both EAA and EGA as shown in Figure 13: In this calculation it can be seen that 9% of the points are outside the acceptance range. Interestingly, no point is outside zone A of the EGA. This means, that according to the EGA, this measurement device is perfect, according to the EAA it is unusable.
• the EGA can be painted into the EAA as shown to provide an optical visualization. Notes and considerations: the DETM and treatment algorithms are calibrated to whole blood.
• the DETM focuses on the BG-outcome after food intake and insulin administration (with several side effects) .
• the EAA focuses on evaluating the quality of a measurement device. This quality depends on the treatment algorithm used (which can be adapted in the DETM-program)
• the DETM-program has preferably a database attached so that results from tests of measurement devices can be stored and selected easily
• the measurement error of an analytical system such as a blood glucose meter or a continuous glucose monitor influences the usefulness and significance of the analytical result. If the measured glucose value is outside of a physiologically preferable concentration a therapeutic action is initiated with the aim- of restoring the physiologically preferred state. In case of diabetes mellitus therapeutical interventions such as administering insulin or carbohydrates are taken to bring the concentration of glucose back to normoglycemia .
• the analytical result can be displayed or otherwise presented as numerical value or as a therapeutic advice based on the measurement which can be a single measurement or a measurement and a consideration of earlier measurements as in continuous glucose monitoring.
• the therapeutic intervention depends on the concentration or concentration range of the glucose value and the target range for normoglycemia.
• the display or presentation of a therapeutic advice is made dependent on the outcome of the glucose value (e.g. the postprandial value) which on the other hand depends on the error of the measurement as explained above.
• an advice is only given if the above explained system or tool or program detects that postprandial glucose is within the target range for the actual measurement range.
• a therapeutic advice or measurement display that is always informative and correct for the user. It can be taken into account by the device that a measurement is within a range that allows an advice despite the measurement error or is within a range that leads to a critical point so that no advice or a modified advice has to be given.
• An advantage of the present invention is therefore that in those ranges of glucose where a correct therapy advice can be given despite a large measurement error such advice will be given. On the other hand in those ranges where it is necessary to have a low error for giving a correct therapy advice such an advice can be inhibited or modified or replaced by a warning.
• the display is arranged either directly on the device or is arranged in wireless (infrared, radiofrequencies) or wirebound data connection with the device .
• the device is a continuously monitoring glucose device that reacts on movements of the wearer in such a way that movements may increase the measurement error it is preferred to have a movement sensor included in the device so that the error by movement can be included in the above explained calculation by adding a further error parameter.

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• 2006
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