MXPA99006715A - Apparatus and system for the telematic control of physiological parameters of patients - Google Patents

Abstract

The portable and reduced size apparatus has an analyser for analysing the glucose in the blood, and providing a series of values. Said values can be processed in situ by a microprocessor and displayed on a screen of a personal computer connected to the glucose analyser. The telematic control system for patients provided with the apparatus of the invention would provide, simultaneously, that the data calculated in the portable apparatus would be transmitted to a central unit for the remote interpretation of the data through a mobile telephone which is also interconnected with the microprocessor and the analyser. Said transmission may be a direct bidirectional transmission (central unit-patient et vice versa) or a multidirectional transmission (central unit-peripheral units-patient) with as many connections as desired.

Description

V '. »Apparatus and system of telematic control of physiological parameters of patients FIELD OF THE INVENTION The invention is assigned to the field of the measurement of certain physiological parameters, in particular blood glucose levels, carried out by the patient himself and their processing in a remote unit.

State of the art Initially the analysis of glucose in diabetics was carried out indirectly, by means of the quantification of glucose in urine. This method of analysis represented a great advance in the diagnosis and follow-up of the disease. However, this method did not serve to detect the hypoglycemia nor the instantaneous real values that the patient had at the time of the analysis, so the results were merely indicative. Currently, these procedures are left limited to very specific circumstances, such as, for example, the quantification of ketone bodies. The next step in the control of diabetes was the measurement of capillary blood glucose. The first autoanalysers appeared in the United States, developed by the company Miles ES384417 and ES466707 (the latter in the name of KDK) and replaced the laboratory analyzes. That first generation of autoanalyzers provided the level of blood glucose in just one minute and by a blood sample obtained with a simple prick on a finger using test strips. However, its high price at that time made it out of reach for many patients. With the passage of time, the price of autoanalyzers has become considerably cheaper, which has led to the widespread practice of its use. This generalization of the use of autoanalyzers has meant an immediate advantage, such as the radical decrease in consultations in outpatient clinics and health centers for the performance of glucose tests; and, on the other hand, a decrease in the number of diabetic admissions. On the other hand, the use of autoanalyzers has shown that self-control begins to be a determining factor in the decrease in hospital admissions, which frees the health system from economic burdens that more than compensate for the cost of the test strips needed for the controls. The evolution of the autoanalyzers has not only meant an improvement in its accuracy and cost, but also in the ease of use. The first autoanalysers were large devices, which required a connection to the power grid, complex calibrations and cumbersome operation, while the current devices are no larger than a credit card, enjoy autonomy and use is extremely simple. Also the test strips have evolved substantially: the first ones needed to be washed and subjected to a drying while the current ones are of direct reading, without the patient having to proceed to any manipulation. Likewise, the test strips have increased their reading ranges, reaching in some brands at 0-600 mg / dl, and the physical-chemical fundamentals of the control have improved towards greater accuracy, speed and economy. Diabetes is a chronic disease, which causes serious physical and psychological damage to patients and causes very high economic costs for public and private health systems. Damages and costs that will increase as more cases are diagnosed, increase the life expectancy and increase the health demand of the affected groups. Self-analysis of blood glucose has revolutionized the care of patients with diabetes. Undoubtedly, during the past decade self-analysis of glycemia reached widespread acceptance equally among health professionals and patients. It is estimated that one million diabetics now use blood glucose testing devices at home.

It is believed that intensive long-term therapy will have a clear impact on certain complications of diabetes, as are the micro and macro vascular alterations. Strict control has already made it possible for diabetic women to have healthy, normal-weight babies. The control techniques can be grouped into two main sections: techniques that assess the patient's situation in the medium term and techniques that instantly indicate the blood glucose level. For quite some time now, the techniques of fructosamine and the quantification of hemoglobin Ale have been used in combination for the metabolic control of the patient. The first method allows the quantification of metabolic control for short periods -one month-, while the second is useful to assess the patient's control during the last three months. Until now, the use of these techniques involved carrying out a blood test. At present, the multinational Bayer Pharmaceutical Chemistry has developed a system for the quantification of glycosylated hemoglobin Ale that is carried out, without the need to send the blood sample to the laboratory, in the same specialist's office using a simple tabletop device. The important acceptance of this technique, low cost and high precision, allows an immediate assessment of metabolic control by the specialist and prevents displacement and reiteration of patient consultations. In the same sense, Bayer has developed a similar procedure for the quantification of renal involvement by determining microalbuminuria.

INSTANT TECHNIQUES These techniques provide immediate information about blood glucose levels. Several laboratories offer autonomous analysis equipment whose easy handling allows its use by the patient.

METHOD OF ANALYSIS The test methods for measuring blood glucose are generally divided into three categories: reduction, colorimeters and enzymes. Reduction methods involve the reduction of a metal compound by carbohydrates. Due to its lack of specificity to glucose, this method is subject to false positives and, currently, is rarely used. Colorimetric methods, such as the reaction with o-tolouidine, react with other monosaccharide aldehydes and are not specific to glucose. Therefore, enzymatic methods are preferred for blood glucose tests. Most laboratories use systems with enzyme-based reagents, either hexokinase or glucose oxidase, which are very specific to glucose. All commercially available glucose autoanalysis systems use glucose oxidase technology.

SAMPLE OF ANALYSIS: TOTAL BLOOD, PLASMA OR SERUM The type of blood sample appropriate for blood glucose tests varies depending on the method used.

Glycemic self-analysis systems use only whole blood samples. Some laboratory systems measure glucose in whole blood, plasma or serum, while others can only do so in serum or plasma. Plasma and serum have a glucose concentration slightly different from that of whole blood. Although glucose is evenly distributed in the liquid phase of the blood, the red blood cells have a solid phase that does not contain glucose. In whole blood, the solid phase of red blood cells dilutes the concentration of glucose in the plasma.

ORIGIN OF THE SAMPLE: ARTERIAL, CAPILLARY, VENOUS Arterial blood has higher blood glucose levels, followed by capillary blood and venous blood.

Fasting, blood glucose levels are approximately 5 mg / dl higher than capillary levels. Capillary levels are 2 to 5 mg / dL higher than venous levels. After meals, blood glucose levels in the arterial and capillary blood can be 20 to 70 mg / dL higher than in venous blood. When comparing the result of self-analysis of capillary blood glucose obtained by puncture in the finger with a laboratory result, a possible recent consumption of food should be taken into account. In a recent study involving 33 diabetic subjects (who were studied at different times after food consumption), blood glucose measurements showed that most of the total capillary blood levels were only slightly higher than the levels of Total venous blood. However, some patients had significantly higher capillary blood glucose levels (up to 48 mg / dL than venous levels).

MOMENT OF TAKING SAMPLES The blood glucose levels of diabetic patients can fluctuate significantly over short periods of time. Therefore, the time of taking the samples may affect the results of the blood glucose test when two different blood samples are drawn for comparison (eg a sample by capillary puncture in the finger for a self-test) of blood glucose and a venous sample for a laboratory determination). Thus, the samples must be extracted with a short time margin between them.

ADDITIVES There are several preservatives or anticoagulants that, when added to a blood sample, conserve it and prevent its coagulation. A coagulated sample, even if only partially, does not react properly on a test strip and should not be used. The samples treated with heparin-like anticoagulants or ethylenediaminetetra-acetic acid (EDTA) are suitable for blood glucose autoanalysis tests. However, fluoride inhibits enzyme reactions in strip tests, resulting in low blood glucose readings. It should be taken into account that in some laboratory methods with glucose oxidase samples treated with fluoride can be used.

GLUCOLYSIS Blood samples must undergo blood glucose analysis in the first 30 minutes after collection. With the autoanalysis methods of glycemia, this is not usually a problem since the patient performs the test immediately after practicing the puncture in the finger. However, the concentration of glucose in a sample of whole blood to which no antiglucolytic agent has been added will be reduced at a rate of about 7 to 10 mg / dL per hour, at room temperature. This reduction is due to glucosis. Since the reduction of total blood glucose is proportional to hematocrit levels, glycolysis is faster in blood samples that have higher hematocrit levels.

INTERFERING SUBSTANCES The use of glucose oxidase for measurements with test strips ensures a high degree of specificity to glucose. Glucose oxidase (GO) acts on glucose to form gluconic acid and hydrogen peroxide (H2O2) • In autoanalysis methods based on spectrophotometry, the reduced (colorless) chromogen is oxidized by oxygenated water through the action of peroxidase (PO) to form oxidized (colored) chromogen. The amount of oxidized chromogen that is formed is proportional to the amount of glucose present in the sample. Natural oxidizing or reducing substances such as dric acid or glutathione can interfere with the peroxidase reaction. Although there is no evidence that the presence of normal physiological concentrations of these substances cause clinically significant errors, differences can be observed between patients. Drugs can interfere with the peroxidase reaction and, in some cases, can cause significant errors in the results of the test. The presence of high levels of bilirubin can cause a decrease in blood glucose values with some methods that use glucose oxidase. Ascorbic acid levels well above normal values can also cause a reduction in glycemic results by interfering with the chromogen oxidation.

USER TECHNIQUE AND QUALITY CONTROL The analysis procedures vary with the different glycemic autoanalysis systems and the recommended procedures must be followed. The 1986 consensus statement on glycemic self-analysis concluded that all systems were sufficiently accurate; however, the user's technique is the main source of erroneous results. Therefore, quality checks should be carried out regularly. These controls consist of the maintenance, calibration and verification of the system and the checking of the control solution. The application of a suitable blood sample volume to the test strip, starting the analysis at the right moment, controlling the reaction time and the elimination of blood, either by drying or entrainment, are stages of the procedure sensitive to error by part of the user. Quality control and correct technique on the part of the user are also important in clinical laboratory tests. Calibrators, controls, reagents, tubes, sampling devices and other specific parts of the instruments should be checked regularly. The laboratories have well-defined quality control procedures. The accuracy of blood glucose tests in the laboratory is monitored regularly by means of external quality control programs. In a test of 1,754 licensed laboratories, a sample with a mean glucose concentration of 94 mg / dL produced a range ((+/-) 2 SD) of 76 to 122 mg / dl, and a sample with a mean glucose concentration of 145 mg / dl, gave an interval of 123 to 167 mg / dl. Thus, even in a tightly controlled laboratory environment, in which trained technicians perform the tests, a variability between laboratories of up to (+/-) 19% in the results of the blood glucose tests can occur.

THE TECHNOLOGY OF THE ONE TOUCH SYSTEM Until the introduction of the One Touch system, all the commercialized blood glucose analysis equipment could be defined as "first generation" technologies that evolved from the reactive strips of visual reading. This type of system requires that the drop of blood is deposited at the appropriate moment to start the analysis, that the reaction time is controlled until the blood is eliminated from the strip, and this last operation is also carried out manually, by drying or drag. These three steps are potential sources of variability of the test results. The One Touch system was designed to take advantage of all the advantages of a reactive strip read instrumentally and to eliminate the intervention of the user in these three steps, thus eliminating the sources of variability. This advance of design over the previous systems makes One Touch a "second generation" system. Three are the technical elements of the One Touch system that distinguish it from the first generation systems: 1 - The specific porous hydrophilic membrane of the test strip. 2 - The electronic optical system that detects the application of the sample of the test strip. 3 - The system of bichromatic optics that accurately reads the colorimetric reaction, even in the presence of red blood cells. Each of these three key elements serves specific functions that reduce the variability of the results of the analysis. The One Touch test strip incorporates the already established glucose oxidase / peroxidase chemistry in a particular microporous hydrophilic membrane with a structure similar to a microscopic sponge . The membrane has three purposes: 1) it acts as a reservoir to hold a precise amount of sample, 2) it acts as a filter to exclude the formed elements from the sample and 3) it acts as a smooth optical surface to take the reflectance measurements. Inc. This third feature is essential for the meter to read the lower surface of the strip while the blood remains on the upper surface. In addition, the hydrophilic properties of the membrane facilitate the application of blood over the area of analysis. Once the sample is applied to the test strip and penetrates the membrane, the meter detects a sudden change in reflectance and starts the 45 second time sequence. This is how the meter, instead of the user, controls the start of the analysis. The control of time to eliminate or clean the blood from the strip and the actual elimination, either by drying or dragging, are eliminated in the One system Touch through a bichromatic optics system. The best way to describe this technology is by explaining the analysis procedure in detail. To perform a blood glucose measurement with One Touch, a test strip is inserted into the One Touch meter and connected. The meter takes a 0 reading on the unreacted strip and instructs the user to "APPLY THE SAMPLE". When the whole blood sample is placed on the surface of the membrane, the plasma is rapidly absorbed into the membrane while the red cells and excess plasma are excluded and remain on the surface. When the sample penetrates the membrane, the meter detects a change in reflectance and starts a 45-second sequence. Blood glucose reacts with oxygen catalyzed by glucose oxidase (GO) and forms water oxygenated (H Oo), which subsequently reacts with the chromogens of the indicator with the help of horseradish peroxidase (HPO) according to the following equation: GO Glucose + O - - > Gluconic Acid + H 2 OU2 Within 45 seconds the reaction has reached the end point and a reflectance reading is taken. The indamin chromogen formed as a result of the chemical reactions described in the above equation absorbs light from a first light-emitting diode. However, the components of the blood in the reaction mixture and the excess sample also absorb at the same wavelength of this diode. In order to correct this background interference, a second sample is taken with a 2nd light emitting diode, but with a different wavelength peak, which detects the blood but not the chromogen. When these two signals are subtracted, the interference signal is isolated. The chromogen signal thus generated is correlated with the glucose concentration by a calibration process. This is done by measuring the total blood glucose concentration with the glucose analyzer (Yellow Springs Instrument Model 23A) which employs a glucose oxidase chemistry with electrochemical detection of the peroxide. The optical signal for a batch of One Touch test strips is related to the concentration of glucose by means of a calibration curve. Calibration codes are a family of mathematically related curves that match the differences in the response of batches of One Touch reagents. Using this method, the One Touch system measures the total blood glucose concentration.

FUNDAMENTALS OF THE AMPEROMETRIC BIOSENSOR This type of biosensor is based on the method of electrochemical analysis by amperometry. This is a method that uses a very small amount of electricity that does not vary the composition of the sample. The test strip is formed in this case, by three electrodes: work, auxiliary and reference. In this technique, the potential between the working electrode and the auxiliary electrode is set and the intensity of the current generated during the reaction is measured. During this period, the potential between the working electrodes and the auxiliary electrode may vary due to changes in the polarization concentration and overpower (typical phenomena of electrolysis), so a third electrode, the reference electrode, is used to achieve fix the potential. The materials used in the electrodes must be antioxidants (usually used graphite, silver or silver chloride). The intensity of the current is a function of the concentration of the sample, as well as the potential. Under certain conditions, it is possible to deduce, after a previous calibration, the concentration of the electrolyzed substance by measuring its intensity. The measurement of the intensity allows to follow the variations of the concentrations in the course of the chemical or electrochemical reaction, whereby the titration reaction is controlled (the valuation consists of following the intensity of the current throughout a chemical reaction) .

The principle on which amperometry is based is polarography (a term initially used in electrolysis reactions in which a working electrode called a drop of mercury was used). For polarographic determination, electrolysis is carried out with a reference electrode; By varying the tension of the electrolysis, the curve i = f (E) is plotted. To calibrate several curves are made at different concentrations of glucose. Next, the height of the diffusion wave is measured, which is proportional to the concentration of the oxidized glucose at the working electrode: id = d. c where c is the concentration (known during calibration) of glucose. In order for the oxidation reaction to reach the saturation point (at which time the intensity reaches the maximum value) it is necessary to apply a minimum potential according to the reaction: Re - > Ox + e. The value of the constant Kd depends on the dimensions and the geometric arrangement. The basic electrical scheme is based on a voltage source of constant V potential (usually 650 mV).

For the reading of the intensity in the galvanometer G to be valid, it is necessary that the potential difference between two points, A and B, be constant (we know that it must be iL x R-j_, and when the intensity i-j_ is saturates the potential is constant). This scheme is valid once calibrated. The calibration in this case would consist of get a proper value for the resistance R so that the potential between points A and B is sufficient to reach the saturation current when the concentration is the maximum. With this potential difference, the saturation current can be measured for any concentration lower than the maximum obtained. The calibration process would be carried out by measuring the current intensity of various known concentrations, and calculating the parameters of the linear regression line associated with the concentration-intensity pairs. Once calibrated, we can approximate the concentration of the sample to be analyzed by interpolation. The calibration is valid for the test strips that have an identical reactive composition, or with very small variation margins. Otherwise, it will be necessary to recalibrate the instrument. The chemical reaction that takes place in the cell is the following: GO [Glucose] + O? Gluconic acid + HoO? [1] H2 ° 2? ° 2 + 2H ~ 2e [2]] In reaction [1], glucose, together with oxygen, reacts to the presence of the enzyme Glucose Oxidase (GO) to generate gluconic acid and oxygenated water (H O).

The trigger of the reaction [2] is the potential V. The electrons that are released give the measure of the current, which is proportional to the concentration of glucose. It is worth mentioning that the test strip on which both the reagents and the electrodes for measuring the potential are located, is made up of a PCB (Printed Circuit Board or Printed Circuit Board), which although of an important physical consistency, supposes an additional cost -Dido. Like most diseases, diabetes has two vulnerable points: timely diagnosis and appropriate treatment. But, unlike other conditions, the very serious individual and societal consequences of diabetes can be substantially reduced with something as simple in theory as it is complicated in practice: precise and periodic control of blood glucose levels. . The procedure is simple in theory, since pharmaceutical laboratories have reached extraordinary levels of precision in the measurement of blood glucose. But it is complicated in practice because, to be effective, the result of blood glucose measurement has to overcome three obstacles: interpretation, time and distance. A good control of the glucose level reduces the risks of diabetes, but triples the danger of suffering decompensation due to hypoglycaemia. That is, the figures have to be interpreted in their context and by the trained personnel to do it. Second, the interpretation has to be made at the right time; if possible, the closest thing to the instant in which the measurement is made, which is when the decisions take on their greatest importance. And, finally, the geographical distance between the doctor and the patient can not be an impediment to interpretation and decision making. There are patents that try to solve this double problem of self-analysis and transmission of data in real time. Thus, patent O94 / 12950 shows us a glucose analysis equipment, with the possibility of printing the results obtained and storing those coming from several patients. However, it does not present a processing of these data nor the possibility of telematic interaction with a central processing unit of the same. Patents 094/11831 and EP483595 partially solve the problem by allowing an interaction between a microprocessor coupled to the glucose analyzer and a remote computer that receives and supplies data through the respective interfaces. The limitation of this equipment is that it needs a communications software via modem, to transmit the data to the processing unit. This in turn transmits a report regarding the data received to the peripheral units, via fax. We see therefore how different equipment is needed, dispersed, in different locations, to transmit the data, with which the transmission in real time begins to be distorted. In other cases, as shown in patents O94 / 06088 and EP462466, patient monitoring is automatic. The medication program includes a series of parameters adapted to different situations that generate automatic responses. However, this type of systems and devices that implement them, suffer from the added value of the judgment issued by the professional at all times, as well as the poor adaptability to unforeseen emergency situations.

These obstacles, which until recently were economically and technically insurmountable, are now surmountable thanks to the vertiginous advance of new technologies. The integration in a single device of the glucose meter, together with a small computer and a mobile phone allows the creation of a solid management and control system for as many patients as the respective systems wish to incorporate. At the same moment that the patient performs his glucose measurement, the computer stores the resulting figure and sends it to a central computer that stores and controls the measurements of all the patients assigned to it. The current coverage of mobile telephony systems allows almost total guarantee in the transmission "on-line" of the figure.

Summary of the Invention The central unit, integrated into a hospital service or referral center, would be connected to the patients' units, on the one hand, and to the peripheral units of physicians, laboratories, patients, etc., on the other. The central computer has enough information about the clinical history of each patient to decide in what circumstances to alert the medical service when the figures exceed what is allowed for that patient. On the other hand, the patient can also use the mobile phone to establish an immediate relationship with his doctor or with the Diabetological Unit that attends him, and the corresponding medical service can transmit the appropriate instructions at the same moment. This is especially important in rural areas, with diabetic patients scattered in a wide geographical area, who remain under the care of a local family doctor. In case the patient or the central computer considers the situation alarming, the contact between doctor, patient and Diabetological Unit is immediate and direct, so that the most appropriate decision can be adopted without the need of waiting or long trips. This system allows coverage in case of urgencies or holidays of a doctor is perfectly covered, so that the specialist can temporarily assign control of their patients to another doctor or the emergency service of the Central Unit. In principle, the system has been designed for the control of blood glucose levels of diabetic patients, but allows to incorporate, by the same procedures and with the same technical scheme, the control of all the physiological variables susceptible to be transmitted telematically .

Each doctor, be it the specialist of a city or the family doctor of a small town, has established the alarm ranges for each of their patients. If the patient of a remote population is suddenly indisposed, or if his routine analysis indicates abnormal figures, the central computer will instantly communicate this circumstance to the doctor responsible for that patient, who, in telephone contact with him, will indicate what is most appropriate in his situation . The system is especially indicated for patients of recent diagnosis; patients afflicted with other complications; pregnant women; elderly patients; young children; people who live alone or in geographically remote areas; patients with dangerous activities or who move frequently, etc. In summary, the invention developed allows hospitalization to be replaced in a large part of the cases. There is also the possibility of multiple or collective uses. It is evident the profitability that a team of these characteristics can represent for collectivities such as asylums, barracks, schools, work centers, etc., in which a single unit permanently controls any emergency situation of all the members that need it. In the same way, the monitoring of patients with the invention can be temporary, depending on specific situations that justify it. The present invention provides a number of advantages over the known technique that can be listed as follows: • 'By means of the high technology used, reduce the patient's dependence on traditional medical services, thus improving their quality of life. Thanks to the constant and personalized follow-up, avoid critical situations to the patients that could mean a serious risk to their health, and sometimes even death. Avoid expensive hospital admissions and reduce significantly the absenteeism of patients, thus softening the social and personal impact of the disease. Facilitate the control and application of the treatment to the patients, thus increasing the attention capacity of the medical services. When blood glucose measurement is done, the patient not only receives a figure, but the interpretation of that figure for their specific circumstances. In the viewer of your unit, the patient will check that their situation is: "Alarm", "High", "Low", "Acceptable", depending on their evolution and the criteria of the specialist who treats them. Secondly, the patient knows that, wherever he is, on the other side of the line is, in addition to the Diabetology Unit or the Hospital Center, the specialist who treats him, or his own family doctor, as the case may be.

DETAILED DESCRIPTION OF THE INVENTION The system is composed of four basic elements or subsystems communicated with each other in real time. These components are: M UNIT CENTRAL.- Subsystem in which the communications of the Mobile Units of Patients and Units of Physicians are centralized. The Central Unit consists of a Relational Database that collects the samples and information generated by the Units Peripherals, for example Mobile terminals of Patients and those of Physicians and makes them available to them in accordance with the requirements of the System. This subsystem consists of the following components: 1.1.1 Element Computers Servers Tolerant of Faults (Fault Tolerance) Interconnected .1.2 Element Operating System Multi-area .1.3 Element Query Terminals 1.1.4 Element Local Area Network 1.1.5 Element Database 1.1.6 Element Management, Supervision and Control Programs 1.1.7 Element Communications and Links type Router with X.25 gate or similar and configurable at different transmission speeds 1.1. Element Communications and point-to-point links at different transmission speeds, with various communication protocols and virtual switched circuits, connectable to different types of modems (among which are those for accessing digital communications via radio, such as GSM, DCS , PCN, etc.) 1.1.9 Complete Element of Electric Power Supply System, with uninterrupted power supply unit, connections and protections. 1.1.10 Elements of Communications and Links with patient terminals, medical terminals and laboratory terminals and with any other terminals necessary for the exchange of information and data 1.1.11 Auxiliary elements: printers, screens, etc., necessary for the normal and complete operation of the Central Unit M LABORATORY TERMINAL.- Subsystem with a fixed (PC) or mobile (Portable) terminal, which can enter in the System analytical data related to a specific patient through a communication with the Database of the Central Unit. This subsystem consists of the following components: 1.2.1 Element personal computers (PC) 1.2.2 Element Operational Programs for PC Computers 1.2.3 Element Databases for PC Computers 1. 2.4 Moderate elements for connection to fixed or cellular, analogue or digital telephone networks 1. 2.5 Element telephones, fixed or portable, digital or analogue phones 1.2.6 Other elements for interconnection with the Central Unit, patient terminals and medical terminals. M MEDICAL UNIT.- Subsystem with a portable terminal of Physician, Fixed (PC) or Portable, that attends to the Mobile Units of Patient through a communication with the Central Unit, from which it receives the information deposited in said center Units Cell phones of the patients and to which it sends the specific information for the follow-up and control of the patient. This subsystem consists of the following components: 1.3.1 Element computers type personal computer (PC) or portable 1.3.2 Element operating programs for computers 1.3.3 Element databases for computers 1.3.4 Elements modems for connection to Fixed or cellular mobile, analogue or digital cellular networks (GSM, DCS, PCN, etc.) 1.3.5 Element telephones, cellular or fixed, digital or analogue telephones 1.3.6 Elements specific programs for control and monitoring of medical parameters of patients and for follow-up and dialogue with the Central Unit, laboratory terminals and between medical terminals 1.3.7 Program elements and communication equipment, liaison, control and monitoring of the Central Unit, patient terminals, laboratory terminals and other medical terminals. communications between these elements, while the patient's mobile terminal system uses as a transmission channel and l GSM Short Message Service (SMS), the medical terminal and the laboratory terminal will connect via GSM (9,600 Bps). The explanation of this choice is as follows: The mobile unit generates and receives a very low traffic of information, which can be transported efficiently in cost, speed and security through the Short Message Service (SMS), which is based on sending packets of 160 characters of signaling in the GSM network. However, the doctor needs to access a large volume of information from each of the patients it serves, therefore, it requires a higher speed to perform this task in a short and friendly response time. PATIENT TERMINAL.- Subsystem with a Patient terminal, mobile, based on the combination of a computer, a GSM Mobile Terminal and a Blood Glucose Level Analyzer, in which the glucose samples are collected and the data are entered necessary to allow the doctor to control and monitor the patient. In turn, it receives from the Central Unit the specific information that doctors generate to attend each patient. This subsystem consists of the following components: 1.4.1 Small patient personal computer element (of the so-called personal agenda, palm-top, pocket calculator, ADP, etc.), including both hardware and software, commercial and specific . 1.4.2 Telephone terminal element of the mobile digital cellular patient (GSM, DCS, PCN, etc.), with its programs and utilities. 1.4.3 Glucose meter autoanalyzer element 1.4.4 Controller element (CPU) whose function is to control the patient terminal. Its functions range from dialing the telephone number of the other subsystems, to the capture of glucose meter data, for later storage in the patient's personal computer and sending it to the other terminals or to the central unit. It also consists of the following components: 1.4.4.1 Printed circuit 1.4.4.2 Low consumption CMOS microprocessor equipment 1.4.4.3 Non-collateral RAM equipment for data storage 1.4.4.4 Flash memory equipment EPROM for storage of the application program 1.4. 4.5 DES cryptography module equipment to ensure communications 1.4.4.7 SMS digital interface equipment with GSM terminal (or with DCS, PCN, etc.) 1.4.5 Element Battery Power 1.4.6 Mold element or housing where they are integrated the personal computer, the telephone and the glucose analyzer 1.4.7 Element of operational, management and communication programs, of the different elements of the patient terminal with each other, and with the terminals or the central unit From the functional point of view, The proposed set must fulfill a series of functions, all of them aimed at facilitating medical services to apply the correct treatment to their patients in the shortest possible time. or possible, especially when it comes to emergency situations. These functions are detailed below. • Analysis of the amount of glucose in the patient's blood sample, and transmission of this data to the patient's terminal. Communication of blood glucose values received by the patient's terminal (from where it is) to the central unit. Maintenance of a database (resident in the patient's equipment) with all the values of the analyzes performed. Visualization and statistical evaluation of the historical data residing in the patient's computer. Evaluation of possible critical situations, generating the corresponding alarms and / or messages to the personnel in charge of the follow-up of the patients. Visualization of patients' histories, stored in the central unit, making it easier for the doctor to obtain conclusions, and therefore, the application of appropriate treatment. Statistical evaluations by different criteria of patient data stored in the central computer.

EXAMPLE OF A PREFERRED EMBODIMENT OF THE INVENTION Next, a preferred example of implementation of the invention is described, broken down according to each of its different components. Variations that do not alter the functionality, nor the basic operating principles of the invention, should be understood as covered by the scope of protection that may eventually be granted to it.

PATIENT TERMINAL The patient terminal consists of a blood glucose autoanalyzer, a compatible PC type computer and a digital mobile telephony equipment [GSM], integrated in a single device. The technical characteristics of the equipment as a whole are those indicated below. 1.4.1 Small patient personal computer element (of the so-called personal agenda, palm-top, pocket calculator, ADP, etc.), including both hardware and software, commercial and specific. 1.4.2 Telephone terminal element of the mobile digital cellular patient (GSM, DCS, PCN, etc.), with its programs and utilities. 1.4.3 Glucose meter autoanalyzer element 1.4.4. Controller element (CPU) whose function is to control the patient terminal. Its functions range from dialing the telephone number of the other subsystems, to the capture of glucose meter data, for later storage on the patient's personal computer and sending it to the other terminals or to the central unit. It also consists of the following components: 1.4.4.1 Printed circuit 1.4.4.2 Low consumption CMOS microprocessor equipment 1.4.4.3 Non-collateral RAM equipment for data storage 1.4.4.4 Flash memory equipment EPROM for storage of the application program 1.4. 4.5 DES cryptography module equipment to ensure communications 1.4.4.7 SMS digital interface equipment with GSM terminal (or with DCS, PCN, etc.) 1.4.5 Element Battery Power 1.4.6 Mold element or housing where they are integrated the personal computer, the telephone and the glucose analyzer 1.4.7 Element of operational, management and communication programs, of the different elements of the patient terminal among themselves, and with the terminals or the central unit.

CENTRAL UNIT This installation has the characteristics of a centralized computer system consisting of a Data Server, a Sentinel Computer, a communications Router, one or more portable computers for the use of the physicians responsible for patient follow-up. , a Printer, an Uninterrupted Power System and a BackUp System for backup copies of the information. The mission of the computer called sentinel is the constant evaluation of all the results received from patients, as well as the issuance of alarm messages when appropriate. In this way, available human resources can be oriented to decision-making tasks or patient care. The equipment called router (router) is intended to channel communications between patients and the central computer, enabling multiple simultaneous connections. The use of this type of equipment in communication environments allows access to remote users in a completely transparent way to the software. This avoids the use of special protocols that unnecessarily lengthen the software development process. The technical characteristics of each of the components of the centralized system are those indicated below: Data server. Intel Pentium 100 Mhz microprocessor. 16 Mb of RAM Memory. 1 Gb of Hard Disk (SCSI). 3 1/2"Floppy Disk Unit Color Monitor High-performance 32 Bit Network Card ; PCI; . High performance 32 Bit Discs Controller. Novell network operating system for 50 users. Client Module Server type Advantaje Xbase Server for 10 users Computer Sentinel . Intel 80486 66 Mhz microprocessor. 4 Mb of RAM Memory. 540 Mb of Disk. VGA Color Monitor. Network Connection Card of 16 Bits Communications Router (router). Compatible with IPX protocols. Compatible Ethernet 802.3. Management capacity of 4 simultaneous connections (ideally 16). Ability to connect in cascade with other units of the same type. Ability to manage user access through a password Medical Team (Notebook). Intel 80486 microprocessor 50 Mhz or later. 4 Mb of RAM Memory. 540 Mb of Hard Disk. 3 1/2"floppy disk drive, color monitor, network card printer, laser quality (preferably from the Hewlett Packard 4 series), printing speed between 8 and 12 ppm, uninterrupted power supply (UPS). 5,000 Watts, Autonomy time from 20 to 30 minutes, ability to activate the network shutdown mechanism automatically, BackUp System, 4 mm DAT tape system, with SCSI interface, connected to a workstation of the network (this implies that said workstation must have a SCSI controller installed) of high performance. The Central Unit will interact with a whole series of peripheral Units, receiving and sending information from and for each one of them. For this, in its structure it will have a whole series of modules specifically designed to communicate with each of said peripheral units. These modules, their function and components are detailed below: CONFIGURATION OF THE CENTRAL UNIT In the Central Unit there is a Local Area Network with two computers: A dedicated Fault Tolerant server, loaded with a Windows NT multitasking and multi-user operating system, in its SERVER option, and a Query terminal, also loaded with Windows NT, in its workstation option (WORKSTATION). For the Analysis, Collection and Management of samples of the Central Unit, the Relational Access Database of Microsoft will be used, on which the application will be developed from where both the SYSTEMS and the MEDICAL TERMINALS will be accessed. In order for all communications to be made through cellular, digital or analog mobile telephony, the Central Unit will have the following elements. - A Router with an X.25 gate configurable at speeds between 64 Kbps and 2 Mbps. A point-to-point link of 64 Kbps, with possibility of extension to 2 Mbps, between the Central Unit and the telephone communications manager. This link will support the X.25 communications protocol and, in principle, a minimum of 10 (ten) Virtual Switching Circuits (CVC's), which will allow initially operating, simultaneously, up to a maximum of 10 doctors, who will have a modem GSM. This link can be expanded in speed and number of CVCs to allow simultaneous access to a greater number of doctors. Fault Tolerant redundant computers with dual configuration of CPU, Source, Hard Disk, etc. must be used to ensure the functionality of the system in case of any failure, equipment or power. and an Uninterruptible Power Supply Unit (UPS) that guarantees the power supply to the Central Unit in the absence of it. For the issuance of documents, the Central Unit will also be equipped with a laser printer connected to the network. The Central Unit will be in charge of giving High and Low in the System, to the medical terminals and to the laboratory terminals. Without the Alta process, no terminal will be able to access the Central Unit neither to send nor to receive the information of the System. When a patient operates with the System, he / she will be able to verify that the equipment is discharged from Alta, if he / she observes in size his / her personal data. With initial registration, in addition to your personal data and the attending physician, the System receives the basic operating information related to medication, diet, controls, clinical report, etc. This information is generated by the doctor and is an essential requirement that is entered in the Central Unit Data Base so that the patient can operate. The doctors will have access to monitor the information of their patients and the one they generate, if they enter the correct access code, when they link with the Central Unit. The laboratories will have access to enter in the Data Base of the Central Unit the analytical data of a patient, if they enter the correct access code when they link with the Central Unit. The process of Discharge of a medical terminal and a laboratory terminal is carried out by canceling the entry word that the System requires when they connect. This process does not suppose a loss of the data that the doctor, the laboratory or the patient have entered in the system. In any case, all the information generated in the System will be recorded and stored in the Database of the Central Unit for future analysis.

PATIENT MODULE Its primary function is to automate the flow of data between the patient and the doctor. The members that compose it are: - Autoanalyzer-computer communication in the patient's terminal. This component transmits the glucose values from the autoanalyzer to the computer of the patient terminal each time an analytical is performed. The program receives from the autoanalyzer a numeric value that converts into a message on the screen (Alarm, High, Low, Acceptable) based on the pre-established reference values for the patient in each period of the day. The values can be modified by the personnel in charge of the control and monitoring of the patients (mainly by the doctor) as it will be seen in the Patient Master Maintenance program. * Terminal communication of the patient-central unit. This component will transmit all the resulting values of the measurements made by the patient (glucose, weight, blood pressure, height and type of physical exercise performed) to the central unit. In principle, this communication will take place each time the patient's equipment receives a value from the autoanalyzer. However, in the event of any unforeseen event (communication failure, failure of the equipment's power system, etc.) the communication will be re-attempted as many times as necessary. Since this communication is controlled by computer mechanisms, the data sent to the central unit will be more reliable and regular over time. As already mentioned, this aspect is of fundamental importance for the application of adequate treatment to the patient. In addition, the patient can also generate requests for help from your computer. This will be possible provided that this service has been enabled for that patient by the personnel in charge of the centralized system. - Maintenance of the database All the biochemical analyzes (glycosylated hemoglobin, fructosamine, cholesterol, LDL, HDL and Triglycerides) and controls (glucose, weight, blood pressure, size and type of physical exercise) made and transmitted to the central computer They will also be stored in the patient's equipment. This will facilitate the visualization of your history by other medical services according to the same criteria followed in the central computer. * Communication central unit-terminal of the patient The doctor can transmit to the patient changes in the parameters of his system (ex: dose of insulin to inject-se, periodicity of the glucose controls, etc ...) that will be stored in the base of patient equipment data; or indications about their treatment in the form of emails. These messages will remain on the patient's equipment until they have been read and voluntarily canceled. From the technical point of view, the data that must be transmitted to the patient's equipment will be deposited by the Sentinel computer in a space on the disc of the Central Unit corresponding to the patient (called a mailbox) and will be collected by the patient each time they connect. to transmit data of the controls carried out. In the same way, the memory of the patient's equipment could be available to other specialists when necessary. * Visualization of the patient's history The data stored in the patient's equipment can be visualized by this or by any other medical service. In this way, the history of the patient will be available at the time it is necessary. Said history can be visualized according to the following criteria: Evolution of the Glycemic Profile. All the data of the glucose measurements taken in a specific time slot can be seen on the screen, in text mode. The values corresponding to the periods in which the patient has performed physical exercise will be highlighted by a fund of different plot in order to easily appreciate its effect on the glycemic profile. In the same way, out-of-range values will be highlighted in different colors. The detailed study of these data by the doctor will allow to determine the trends that occur in the patient's glycemic profile, and therefore, the reasons for each variation; facilitating in this way the application of the appropriate treatment. The evolution of the Glycemic Profile can be seen in text mode (as a table) or in graphic mode. When this information is represented graphically, it facilitates the doctor to read the trends of the glycemic profile by hours, days, weeks, before and after meals, etc. In addition to the evolution of the glycemic profile, the visualization program will allow see the following data on the screen: Evolution of Weight Evolution of Size (children) Evolution of Blood Pressure Evolution of Glycosylated Hemoglobin Evolution of Fructosamine Evolution of Cholesterol Evolution of LDL Evolution of HDL Evolution of Triglycerides CENTINELA MODULE This module will free those in charge of protecting the centralized system from a routine and constant task such as receiving data and evaluating critical situations that respond to reference patterns. The members that compose it are: * Receipt of data transmitted by the patient This component will be permanently running on the computer described as a sentinel and its mission will be to carry out a constant sweep of the communications server of the data server, in order to incorporate any data received to the corresponding patient's history. As soon as this happens, the data received will be available for the rest of the application's programs. * Evaluation of critical situations Once the data has been incorporated into the patient's history, it will be compared with the pre-established values for the patient, for that period of the day. This comparison will allow the sentinel computer to determine if the patient's glucose values are within normal values or not. * Emitting alarms and messages This component of the system aims to issue alarms and messages to the doctor in charge of monitoring each patient when the sentinel computer has evaluated a situation as critical, or when the patient has issued an immediate request for attention. For each new message the doctor's computer will emit an audible signal, and by means of a message on the screen (in a different color) it will indicate how many messages are pending to be read. If any of these messages advises a verbal communication between the doctor and the patient, it will be carried out over the telephone. The messages will be marked with the time they have been read by the recipient, in this way, the responsible doctor can establish with total accuracy the response time given to the sick. * Daily monitoring of patients As each patient transmits the data of their controls to the central unit, the sentinel team will display on a line of the screen the identification of the patient and the data related to the control performed. Values above or below the reference values will be seen in a different color; and those that correspond to the control hours pre-established by the doctor will be seen on a different plot background. This tool will help the doctor to determine in a simple way if patients perform their controls at the established times, and deviations from the reference values of a patient. At the request of the user, all the patients can be seen grouped according to the health center they belong to, instead of viewing them in chronological order according to the time of transmission.

MEDICAL MODULE This is the instrument that will allow the doctor to develop his work of control, monitoring and statistical evaluation of each patient in a personalized way, facilitating in this way the application of the treatment for each case. The module is composed of the following members: * Maintenance of the patient's master Through this component of the system, the personnel in charge of the central unit (or the doctor in charge of the patient) will perform the maintenance (registrations, removals, modifications and consultations) of the patient master file. Each patient will be identified with a unique random number, generated by the system in order to avoid duplication or loss of data.

In addition to the filiation data (name, age, doctor in charge of its follow-up, etc ...), the program will allow updating the levels or ranges of glucose of the patient for each period of the day. * Maintenance of the doctor's master Through this component, the personnel in charge of the central unit will perform the maintenance (additions, deletions, modifications and consultations) of the master file of physicians associated with the system. * Receiving messages Messages sent by the sentinel notifying the doctor of critical situations or requests for help from their patients will be managed by this program. The doctor will see a notice in different color on his screen indicating the number of messages that he has to read, followed by an audible signal if the one that has just arrived corresponds to an emergency situation. * Clinical history The history of each patient will be completed with your Clinical History. For this, the doctor will have the possibility to include the information of each of its sections as it occurs. The possibility that the central unit can communicate directly in case of urgency and absence of the guardian doctor, with the patient himself, will be provided. The different chapters of the clinical history are those mentioned below. - Reason for the Consultation - Current Disease - Personal Background - Family Background - Hematimetry - Diabetological Profile - Lipid Study - Renal Study - Biochemistry - Eye Fund - Cardiovascular Assessment - Electro Cardiogram - Other Tests - Systematic Manifestations - Clinical Trial - Treatment - Evolution As time passes and the disease evolves in one direction or another, new data are produced that must be included in the sections mentioned above. In the same way, part of the old information may suffer alterations due to new events that occurred in the life of the patient. Through the use of this program, the doctor will have at his disposal the tools that allow him to keep the clinical history updated, either by including the information as it is produced.; or, by modifying the old data or changing them from one section to another as appropriate. * Control and monitoring This program is a fundamental instrument to assist the doctor in the control and monitoring of their patients. Its use will allow you to determine: If patients perform their analytics at the established times. Deviations from the established reference values The incidence of physical exercise in the evolution of the patient, etc ... * Statistical evaluation The functions of visualizing the history of this system (as explained in the patient's module) they make up a series of programs that, after a statistical evaluation of the data, show the information on the screen according to different criteria. These functions will allow the doctor to assess in perspective the incidence of multiple factors in the evolution of the patient.

CONFIGURATION OF THE SYSTEMS According to the application of the Systems, three types of functionality are distinguished. PERSONAL: The equipment is owned by a single patient who uses it exclusively and will always be personalized with your data. - HOSPITAL: The equipment belongs to a hospital section and is used by the hospital staff to take measurements of a limited number of patients. Depending on the capacity of the equipment, they will record the information of a certain number of patients and, by means of function keys provided in the equipment, the measurements of one or the other patient can be alternated. FOR HEALTH CENTERS: the team is assigned to a Health Center that gives it over a period of time to a patient to follow up on their illness. Each time the team gives in, the Central Unit must discharge the patient. The application of the system will be ready to adopt any previous modality. In the first and third cases, only one patient will operate with the equipment. In the second case, the maximum number of patients to whom the equipment may be applied will depend on the final memory capacity.

CONFIGURATION OF THE MEDICAL AND LABORATORY TERMINALS The medical terminals and the laboratory terminals do not require any special configuration to operate in the System. Any equipment loaded with WINDOWS NT in its option USER, with the Microsoft ACCESS Database, the Application program, a GSM modem and a mobile terminal with data transmission capacity, will be able to access the System and operate without difficulty.

PARAMETERS TO BE MONITORED Both the patient terminal and the medical terminal have access to monitor the following parameters: - Evolution of the blood glucose level. - Evolution of Weight - Evolution of the Size - Evolution of Blood Pressure - Evolution of the following parameters of blood analysis 1 - Cholesterol 2 - HDL-C 3 - LDL-C 4 - Triglycerides 5 - Fructosamine 6 - Hemoglobin Ale. These parameters must be displayed, but they must never be modified, neither in the patient's mobile terminal nor in the Physician's Terminal, since they are vital to issue a diagnosis about a specific patient. In any case, it is the responsibility of the Patient and the Physician to correctly enter the data in the Mobile Terminal of the System. In order to avoid false information, the Mobile Terminal team will be provided with sufficient control and validation mechanisms before their final introduction into the Central Unit Database. Any erroneous information will be corrected by introducing a subsequent information that will prevail over the previous one. To introduce the mentioned parameters, except the Blood Glucose Level that is performed automatically without the intervention of any operator, there will be several dialog screens (Weight, Size, Voltage, etc).

The data can be entered manually by the Patient, the Physician or the Laboratory that performs the corresponding Analysis. In the case of the patient he will do it on his Mobile Terminal. In the case of the doctor or a laboratory, they will do so through a direct connection to the Central Unit. In any case, all the data entered in the System will be stored in the Database of the Central Unit to guarantee a perfect follow-up after the flow of the information. With regard to the level of blood glucose, a series of programmed daily measures are planned, which the doctor will prescribe to the patient from his terminal: Before breakfast, After breakfast, Before lunch, After eating, etc. In addition to these, the patient can perform as many as he or she wants, although only a maximum of 24 samples per day will be displayed on the device. However, the doctor may have access from your application to know the value of all measures taken.

STATISTICS The values registered in the Mobile Terminal will serve to generate statistical information of medical interest for the patient. The statistical values will have two representation modes: Tables and Graphs.

When the presentation is chosen in the Tables mode, the patient will have access to all the registered data, presenting these in the template by means of a continuous lines function (scrolling), to avoid the limitation of the screen size. The Graph mode will graphically represent the measurements of that interval of the Table. The evolution of the blood glucose level will be accompanied by the following measures: Average value of scheduled hour samples Average complete value of all daily samples Standard deviation of the mean - Exercise performed Change of dose The rest of the graphs present the evolution of those measures (Weight, Size, Blood pressure, etc). All graphics will be two-dimensional in linear format. This same information, even expanded, will be accessible at the doctor's terminal.

TREATMENT The system will provide the following information to the patient about the treatment prescribed by the doctor: MEDICATION: It tells you the medicines and doses you should take. CONTROLS: It tells you what controls and at what time you should perform. DIET: It tells you what diet you should follow. This information is generated by the doctor from his terminal, it is entered in the database and sent to the patient via GSM.

ALARMS The doctor will generate a table with the Blood Glucose Levels that indicate to the patient the state of the metabolic control associated with each analysis carried out at each moment of the day.

CLINICAL REPORT Like the Medication, the System stores the updated Clinical Report of the patient. This information is generated by the doctor from his terminal, it is entered in the database and sent to the patient via GSM. At the request of the patient or any other doctor who attends, it may be presented on screen, although it can not be modified.

FUNCTIONAL DESCRIPTION OF THE PATIENT TERMINAL The following describes the functionality of the mobile Patient Terminal.

ICONS There are eight function keys in the TERMINAL, which give access to the eight basic general functions of the equipment. By pressing each of them you have access to the use of the different options associated with them. Next, these eight keys and the associated options are structured. 1. - TREATMENT: Shows the treatment that the Doctor prescribes to the patient. This information is read only and can not be altered by the patient. That is, the information is edited by the Physician and entered into the System, then transmitted to the patient via GSM and stored in the device until a new Treatment is received. 2. - ANALYSIS Allows analysis of the Glucose Level and shows the obtained data.

When the patient selects this function, the System activates the internal blood glucose level analyzer. As with conventional test strip analyzers, the team will indicate the steps the patient must follow to complete the analysis successfully. The analyzer measurement is automatically recorded in the equipment memory and sent to the Central Unit Database. The doctor will be able to access this information and monitor the patient's progress when they connect and request their information. The mobile terminal is capable of presenting up to 24 measurements of blood glucose level per day (One per hour). When a measurement is made, it is associated with the time it is done. The Central Unit sends information about the value of the measure and the hour and minute it occurs. In the case that the patient performs more than one measure per hour, the team will warn the patient of this fact but only present in that interval the last measurement made. However, when the Table of 24 daily measurements is presented, it will be indicated that in one hour there is more than one measure. When the doctor detects an anomaly in one of the values of the Table, he will have the option to know each of the measurements made in said period. When there is an incorrect introduction of data, the patient can indicate this fact by means of a message to the Central Unit. Together with the measurement one presents a table of values generated by the doctor that indicates the state of the metabolic control associated with it, according to the time of the day in which it is performed. In the event that the maximum and minimum alarm thresholds are exceeded, this information will be given to the patient to call his doctor. 3. - DATA ENTRY . By means of this function the patient will be able to enter data in the mobile terminal's computer. These data are very varied and are a relevant complement to the measurement of the blood glucose level. When the patient selects this function, the System presents six options on the screen: I EXERCISE: It helps you to introduce the exercise periods that you perform during the day such as sports, gymnastics, etc.

This information is important so that the doctor can correctly interpret the variations in the blood glucose level. II AUTODOSIFICACION: When the patient changes the dosage that prescribes the doctor has this function to record the new dose that is being applied. Like the exercise, this information is of great importance to the doctor. - III BLOOD TENSION: The patient will be able to store in the equipment the Blood Pressure measurements (Maximum and Minimum) that are made. The team will record the values of the measure and the date and time it is performed. - IV SIZE: This information is important in the diagnosis of children of growing age. It is a measure spaced out in time. The team will record the value of the measurement in centimeters and the date and time it is made. - V WEIGHT: The weight measurements of the patient can be registered in the equipment through this function. The team will record the value of the measure in kilos and the date and time it is made. VI BLOOD LYSIS: There are several parameters of the blood that are relevant in the diagnosis of the patient. These are the following data: - Cholesterol - HDL-C. (High density lipoprotein) - LDL-C. (Low density lipoprotein) - Triglycerides. - Fructosamine. - Hemoglobin Ale. When the patient performs a blood test, these data can be entered into the system, an introduction that will be carried out by the patient himself, by the laboratory that performs them or by the attending physician. The input of the previous data is manual, so it is not free of errors. Although the equipment adopts mechanisms to help validate data entries, there will always be a margin of error for the manual character. 4. - STATISTICS TABLES AND GRAPHICS. Shows the historical evolution of patient analytics GLUCOSE LEVEL. Allows the patient to make measurements of the blood glucose level.

BLOOD PRESSURE. It shows the historical evolution of blood pressure.

SIZE Shows the historical evolution of the patient's size. WEIGHT. It shows the historical evolution of the patient's weight.

BLOOD TEST. It shows the historical evolution of blood analytics. CHOLESTEROL. It shows the historical evolution of the cholesterol level. HDL-C. It shows the historical evolution of the HDL level. LDL-C. It shows the historical evolution of the LDL level. TRIGLYCERIDES. It shows the historical evolution of the level of Triglicé-ridos. FRUCTOSAMINE. It shows the historical evolution of the level of Fructosamine HEMOGLOBIN Ale.

It shows the historical evolution of the Hemoglobin level. The information provided by this function is very useful and serves to correctly interpret the evolution that the patient is performing before a given treatment. The analysis can be done in two different ways: By means of tables or by means of graphs. In the table mode, the statistical information of the parameter to be analyzed will reach all the introduced measures, although limited by the available screen space of the equipment, which means that continuous visualization techniques are used to navigate all of them. In the graphic mode, only the measurements can be displayed in a time interval. In the case of Blood Glucose Level measurements, an indication of the exercise and self-dosing data entered by the patient will appear together with them.

. - CLINICAL REPORT Shows the patient's last medical history The mobile terminal's computer allows the clinical report prepared by the doctor to be stored. This report is very useful for the patient, who can show it to any doctor who treats him. The report is entered into the system and loaded into the System through a GSM communication. 6. - SOS Make an emergency call to your Doctor or the Control Center. In case of urgency, the patient can quickly request the attention of his Physician activating this function. The equipment will record the emergency telephone number of your Physician or of the Central Unit, so that when this function is pressed, the call is automatic and does not require pressing any additional data. 7. - INFORMATION Selects and Shows the data of the Patient and the Physician who attends it. DOCTOR. It shows the data of the Doctor that takes care of the Patient.

PATIENT. It shows the data relative to the Patient in Treatment.

SELECTION OF THE PATIENT. Allows you to select one of the Patients given Discharge. FUNCTIONS OF THE SYSTEM. It allows to visualize parameters of interest of the team. PRINT. • It allows to print the Tables of the stored data. As for the equipment, there is a series of data that can be useful, such as available memory, floppy disk version, etc. This information, although not vital for the patient, is very useful for the maintenance of the equipment. 8. - TELEPHONE It allows to make communications TELEPHONE FOR VOICE. Allows the use of the System as a normal calling telephone. RECEIVING THE MESSAGE. It allows to receive messages through the Short Message Service. By means of this function, the patient will be able to use the System in the same way as the basic functions of a conventional GSM telephone terminal.

Claims (15)

At all times the received calls can be attended following the instructions that appear on the screen. Only in the case of carrying out an analysis of the Blood Glucose Level will the incoming call function be deactivated, in which case it will be diverted to the GSM mailbox until the patient finishes the analysis. These 8 functions have been conceived in an open environment, which allows in the future to add more options to the computer of the mobile terminal with only a change of equipment programming, such as communications with a telephone modem, downloading data on a computer, etc. This is possible, thanks to the graphical representation interface of the equipment. The only exception of the new functions with respect to the eight shortcut keys described is that they must be selected by navigating the screen with the cursor keys and executing the one chosen with the ENTER key. CLAIMS

1. - Telematic patient monitoring system that consists of: • Automatically autoanalyzing a certain physiological parameter indicating a specific disease, in a peripheral unit (patient's terminal), preferably portable. B Record said analyzed data, together with other data annexed at the time of the measurement made, in a historical database, in the memory of a computer, existing in the peripheral unit of the patient, ß Send the data set recorded in the computer memory of the peripheral unit of the patient, including the numerical value obtained from the parameter analyzed, to a central unit for processing, ß Monitor each patient individually or in a group, in said central unit and / or in conjunction with other peripheral units (Terminals of Laboratories and / or Medical Terminals). M Send an order from the central unit to the peripheral units of the patient and / or to the laboratory terminals and / or to the medical terminals, based on the result of the analysis of the data set received from the peripheral unit of the patient and their comparison , at least, with the general database of said central unit.

2.- Patient telematics monitoring system according to claim 1, characterized in that the communication between the central unit and the peripherals, and vice versa, is by mobile cellular telephony.

3. Telematics monitoring system for patients according to claims 1 and 2, characterized in that the recorded data in the patient's peripheral unit constitute a historical resident base that can be consulted by the patient himself, by the central unit and / or by other units peripheral.

4. System for telematic monitoring of patients according to any of the preceding claims in which the historical database resident in the peripheral unit of the patient can intervene in the statistical processing of the data set received at a given time, from the patient himself, and which takes place in the central unit.

5. The patient telematics monitoring system according to any of the preceding claims, characterized in that the computer of the peripheral unit of the patient consists of a program that compares the data received from the autoanalyzer, together with the annexed data recorded at the time of analysis, with a set of reference values recorded for each patient, and emits a certain order or signal, both in the patient's own peri-unit, and in the other units, including the central unit.

6. System telematic monitoring of patients according to claim 5 characterized in that the set of reference values recorded in the computer of the peripheral unit of the patient, can be modified over time.

7. - Patient telematics monitoring system according to any of the preceding claims characterized in that the order or signal sent from the central unit to the. peripheralOnce the previously received data set has been processed, it may consist of one or more of the following indications: • medication • diet • treatment • change in the sequence of controls the patient must perform • alarm levels linked to his illness.

8.- Patient telematic monitoring system according to claim 7, characterized in that the commands or signals of the central unit are received in the peripheral units of the patient via telephone by messages in the computer through a modem or direct voice.

9. System telematic monitoring of patients according to any of the preceding claims characterized in that the physiological value analyzed is the concentration in blood or urine of a biochemical parameter.

10. System of telematic monitoring of patients according to any of the preceding claims characterized because the biochemical parameter analyzed is glucose and the patients monitored are diabetic. 11.- Telematics monitoring system for patients according to any of the preceding claims, characterized in that the central unit consists of: Element computers Fault Tolerance Servers Interconnected Element Operating System Multi-area Element Query Terminals Element Local Area Network Base Element Data Element Management, Supervision and Control Programs Element Communications and Router-type links with X.25 gate or similar and configurable at different transmission speeds Element Communications and point-to-point links at different transmission speeds, with different transmission protocols communications and virtual switched circuits, connectable to different types of modems, among which are those of access to communications via radio (GSM, DCS, PCN and similar).

Complete Element of Electric Power Supply System, with uninterrupted power supply unit, connections and protections.

Elements of Communications and Links with the patient terminals, the terminals of doctors and the terminals of laboratory and with any other terminals necessary for the exchange of information and data Auxiliary Elements: printers, screens, and the like. 12.- Patient telematics monitoring system according to any of the preceding claims, characterized in that the laboratory terminals consist of: Element computers personal type (PC) Element Operational Programs for PC Computers Element Databases for PC Computers Elements modems for connection to fixed or cellular, analog or digital telephone networks Element portable, digital and analog phones, landlines and cell phones Other elements for interconnection with the Central Unit, patient terminals and medical terminals 13.- Telematics monitoring system for patients according to any of the previous claims, characterized in that the medical terminals consist of: Element personal computers (PCs) portable or fixed Element operating programs for computers Element databases for computers Elements modems for connection to fixed or cellular telephone networks, analog or digital.

Element digital or analog cellular mobile phones Elements specific programs for control and monitoring of medical parameters of patients and for monitoring and dialogue with the central unit, laboratory terminals and between medical terminals Elements programs and equipment for communication, liaison, control and monitoring the central unit, patient terminals, laboratory terminals and other medical terminals.

14. - Telematics monitoring system for patients according to any of the preceding claims, characterized in that the mobile terminal of the patient consists of: * a portable personal computer element of reduced size (of the so-called personal agenda, palm-top, pocket calculator, ADP, etc. .) that includes both hardware and software. * a glucose level autoanalyzer element. * an element of telephone terminal of the digital or analog cellular patient (GSM, DCS, PCN, etc.) with its programs and utilities. * a controller (CPU) whose functions range from the dialing of the telephone number of the other units, to the capture of glucose meter data, its storage in the personal computer and its sending to the other units (Central Unit, terminals of laboratories or medical terminals), which contains: • Printed circuit • Low-power CMOS microprocessor equipment • Non-collateral RAM memory equipment for data storage • EPROM flash memory equipment for storage of the application program • DES cryptography module equipment to ensure communications • SMS digital interconnection equipment with the telephone terminal * Element Battery Power. * Housing element where the elements of the personal computer, the telephone terminal and the autoanalyzer are integrated. * Element operational, management and communication programs, of the different elements of the patient terminal among themselves, and with the subsystems of the Central Unit, Terminals of Laboratories and Medical Terminals.

15. Apparatus, preferably portable and of reduced dimensions, of self-measurement of physiological parameters that can be used as the patient's terminal, in the telematic monitoring system of claims 1 to 14, which consists of: * a portable personal computer element of reduced size (of the so-called personal agenda, palm-top, pocket calculator, ADP, etc.), which includes both hardware and software. * a glucose level autoanalyzer element. * an element of telephone terminal of the digital or analog cellular patient (GSM, DCS, PCN, etc.) with its programs and utilities. * a controller (CPU) whose functions range from the dialing of the telephone number of the other units, to the capture of glucose meter data, its storage in the personal computer and its sending to the other units (Central Unit, terminals of laboratories or medical terminals), which contains: • Printed circuit • Low-power CMOS microprocessor equipment • Non-collateral RAM memory equipment for data storage • EPROM flash memory equipment for storage of the application program • DES cryptography module equipment to ensure communications • SMS digital interconnection equipment with the telephone terminal * Element Battery Power. * Housing element where the elements of the personal computer, the telephone terminal and the autoanalyzer are integrated. * Element operational, management and communication programs, of the different elements of the patient terminal among themselves, and with the subsystems of the Central Unit, Terminals of Laboratories and Medical Terminals,