Classifications

• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
• • 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
  • G16H20/60—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets

Definitions

• the invention relates to a method for managing or assisting in the control, in particular the regulation, of a physiological parameter of an individual, and of automated calculation of a quantity dependent on this physiological parameter and other parameters.
• the invention will be more particularly described with regard to a chronic pathology such as diabetes, without however being limited thereto. It can be applied to other pathologies such as hypertension or hemophilia, or to other types of assistance or monitoring linked to a physiological parameter requiring regular monitoring.
• Each diabetic has their own insulin dose administration protocol, which has been developed by the specialist practitioner such as the diabetologist.
• a protocol depends in particular on the patient's age, gender, eating habits, and the history of blood glucose levels measured, in particular at least the day before, or even the last few days spent at the same time slot .
• This protocol is presented as a “roadmap” according to:
• time slots over a day, for example breakfast, morning, midday meal, afternoon, dinner, evening and bedtime;
• the protocols can be very different depending on the individual.
• Today, existing software applications for calculating the insulin dose have standard protocols which are already integrated and each associated with a calculation algorithm which is fixed in the application. It is therefore impossible to take into account individualized protocols.
• the object of the invention is therefore to propose a method for managing or helping to control a physiological parameter, in particular linked to a chronic pathology such as diabetes, which can be adapted to any management protocol / control of said parameter, and can take into account different parameters external to the individual to calculate as accurately as possible a quantity influencing said physiological parameter, and even provide a forecast of the results.
• the process for managing or assisting in the control or regulation of a physiological parameter of an individual comprises the steps of:
• the method further comprising a step of recording (in real time by the individual himself) in the database of information relating to his own protocol to the control individual such as the adaptation of the quantity influencing the physiological parameter, and a step of processing said information using electronic processing means and a computer program, to transform it (in real time ) into a mathematical calculation algorithm capable of ensuring the automatic calculation of the quantity influencing the physiological parameter (each time the calculation is implemented, in particular just after the step of recovering a value of the physiological parameter to a given instant and its recording in the database).
• the step of entering protocol information to transform it into a calculation algorithm is done in real time thanks to a dedicated software application, i.e. by the user or an authorized third party via the application software after making the software application available to the user.
• the information is entered in real time (generally only once after loading the software application and before its use in the recovery of the physiological parameter data, and with the possibility of modifying the information later), namely that the linked information in the protocol are in no way pre-recorded in the program (algorithm) for calculating the quantity influencing the physiological parameter.
• the invention therefore allows each individual to enter his own personalized management or control protocol in order to obtain a fully personalized calculation, and not to provide a calculation from a basic protocol already included in the calculation process (already included in the calculation computer program and cannot be modified by the user).
• the user / authorized third party therefore has control over the entry of information relating to the protocol and which can be modified at any time.
• the physiological parameter to be checked is the blood sugar level
• the quantity influencing said the physiological parameter is a dose of insulin
• the control protocol is the protocol for adjusting insulin doses
• the physiological parameter to be checked is the voltage
• the control protocol is the protocol for adapting a quantity influencing the tension in the event of hypertension, or
• the physiological parameter to be checked is the prothrombin level and the control protocol is the protocol for adapting a quantity influencing the prothrombin rate in the event of hemophilia.
• the process for managing or assisting in the control or regulation of a physiological parameter of an individual consists in managing or assisting in the control or regulation of the glycemia level d 'an individual, and the method comprises the following steps:
• a step prior to at least the first implementation of the method which consists in recording (in real time) in a database, information relating to a protocol specific to the individual for adjusting insulin doses, the recording being implemented by at least one dedicated software application and an input and display interface system such as a computer, a tablet or a smartphone;
• the method comprises a step of processing the protocol information, using electronic processing means and a computer program, to transform it (in real time) into a mathematical calculation algorithm which will ensure by thereafter, from other data that will be recorded at least when recovering a blood sugar level and geolocation, the automated calculation of insulin doses at a given time for the individual.
• the automated calculation step via the dedicated software application (from the calculation algorithm designed in real time) to calculate at least one dose of insulin adapted to the present moment and influencing the blood sugar level, is thus carried out at least from the individual's prerecorded adaptation protocol and from the history of the individual's blood glucose values, as well as data related to nutrition if these have just been recorded because necessary to calculate in real time the dose intended to be administered, as well as the data linked to the geolocation which can influence the dose to be administered (in particular according to the atmospheric pressure and / or the temperature of the place where the 'individual).
• the method notably compares one or more blood sugar levels previously recovered and if necessary calculates decreases or increases in insulin dose according to the personalized adaptation protocol recorded.
• the step of recording in the database of information relating to the adaptation protocol specific to the individual relates to information relating to the protocol personalized set up for the individual for the regulation of his blood sugar level, this adaptation protocol having been set up by the practitioner of the individual; this step is necessarily carried out before the first use / implementation of the process by the individual in order to then regularly calculate his insulin doses.
• the custom protocol information is entered by the user or a third party.
• the dedicated software application is precisely designed for entering the personalized protocol, and for modifying the data of the personalized protocol later in time (in the event of modification by the practitioner of the individual adaptation protocol).
• the adaptation protocol consists of giving the individual instructions on how to adapt their insulin doses according to the time of day, taking into account the blood sugar levels of the previous day and the day.
• the method of the invention proves to be completely innovative vis-à-vis the prior art.
• assistance or control processes and their software applications have made it possible, with the capture of information in real time, of data linked to a meal that the individual is preparing to take or to the physical exercise that it will do, to indicate a recommended dose of insulin, this dose calculation being based on a dose calculation algorithm already included in the software application when the software application is made available to an individual.
• this prior art calculation algorithm is generic to apply to a larger number of individuals (at least as a function of sex and weight).
• this generic calculation algorithm cannot be modified in real time.
• the process of the invention is completely personalized; as a preliminary step, it is necessary to enter all the information of the protocol for administration / adaptation of insulin doses which has been prescribed by the practitioner for an individual for the purpose of using the method.
• it has the advantage once the previous step has been carried out and the calculation algorithm which has been generated in real time, of being implemented by taking into account the history of the blood sugar levels of said individual and also of geolocation.
• the practitioner changes the dose administration protocol, to modify via the dedicated software application, the protocol initially or previously recorded, to generate a new algorithm for calculating the doses.
• the method for controlling the blood sugar level comprises different stages associated with different parameters which are not only linked to the measurement as such of the blood sugar level, these parameters being linked in particular to nutrition and / or activity physical condition of the individual and the individualized protocol for adjusting insulin doses, as well as the history of blood sugar levels specific to the individual.
• the method makes it possible, from the history of blood sugar levels and from the insulin administration protocol established by the doctor specifically for the individual, to calculate in an automated manner and in real time the dose of ad hoc insulin that the individual must administer himself.
• the step of entering information for recording the protocol is preferably recorded by the user's doctor (authorized third party).
• the user's doctor authorized third party.
• the control method of the invention also makes it possible to record in a database the history of blood sugar levels combined with nutrition and physical activity in order to deduce therefrom statistical data intended to be further processed by practitioners for for example changing the treatment protocols or carrying out studies on the evolution of the blood sugar level according to the type of individual, the type of physical activity, the type of nutrition.
• the information of the protocol includes data relating to the physical activity of the individual.
• the step of recording in the database information relating to the individual's protocol is carried out only once (by the user or an authorized third party) before the regular implementation of the process by the user, the protocol being able to be updated by recording new associated information (that is to say that the information of the protocol can be modified at any time).
• the recording of the protocol consists of a manual entry of the doctor's handwritten prescription via a software application on an entry and display interface system, the computer program translating the entry into the quantity calculation algorithm. influencing the physiological parameter, for example insulin doses.
• the automated calculation of an insulin dose at a given time is a function of at least one previous value of the blood sugar level, of a low threshold value of the blood sugar level and / or a high threshold value of the rate of blood sugar, a weighting coefficient based on data related to physical activity, and possibly a carbohydrate level based on data related to nutrition.
• the method comprises a step of recording and processing additional data during the recovery of a value of the quantity influencing the physiological parameter (such as the recovery of the blood sugar level), this additional data being the location of the 'individual, weather and / or temperature and / or altitude and / or altitude and / or atmospheric pressure and / or humidity and / or state of mind of the individual.
• the recovery of the value of the quantity influencing the physiological parameter is carried out by measuring the quantity (such as the blood sugar level or the blood pressure or the prothrombin level), and by recording it manually or orally, or even automatically via a connected measurement system, on an interface system between the individual and the database.
• the quantity such as the blood sugar level or the blood pressure or the prothrombin level
• the method further comprises at least one step of alerting alert to G user / individual and / or sending alerts to third parties, automatically and / or voluntarily by the individual.
• the result of the value of the quantity influencing the physiological parameter (as according to the result of the blood sugar level, in particular in the event of hypo or hyperglycemia), and / or of absence of implementation of the method of control, and / or when the quantity (such as the insulin dose) influencing the physiological parameter and recorded during an additional recording step does not correspond to the quantity (such as the insulin dose) calculated.
• the information of the protocol to be recorded is entered on an input and display interface system, according to a display and input step by step in data fields.
• the information in the insulin dose adjustment protocol is:
• the unit of insulin dose used (mmol / L or mg / dL or g / L);
• control periods such as night, breakfast, morning, lunch, afternoon, dinner, evening, assigning each period a start time and an end time; meals when a meal is associated with a control period; information related to insulin for each period, in particular the type of insulin, the name of the insulin, if it is a functional insulin therapy, the range of insulin dose according to a value of rate of blood sugar (several ranges can be entered associated with a blood sugar level value);
• the method includes a step of calculating the blood sugar level over time as a function of the type of physical activity, the expected duration, the history of the blood sugar level, in particular during a previous physical activity. , and of the nutrition envisaged, and possibly, a step of calculating the calorie expenditure forecast and a step of programming a glycemic alarm in the event of exceeding the thresholds of low and high values of the individual.
• the method comprises steps for entering data with a view to recording them, in particular for entering data related to the protocol, and steps for displaying information, the entry and display being carried out via a system of remote input, display and communication interface, such as a computer, a smartphone, a tablet, which comprises a software application dedicated to the implementation of the method, preferably the software application being furthermore able to manage other parameters related to the physical activity of the individual such as the physical state of the individual, the weight, the tracing of the route by geolocation, the cardiac activity during the effort, the blood pressure, body temperature, and / or able to connect a community of individuals, each individual being able to make themselves invisible or visible in relation to other individuals and able to participate in private conversations, and / o u able to provide information that is not specific to the individual while dealing with a chronic pathology (such as diabetes) and / or dietetics and / or physical activity, such as professional articles or specialized websites).
• a chronic pathology such as diabetes
• dietetics and / or physical activity
• the method comprises a step of secure identification of the individual implementing said method, and steps of identification and / or invitation of third parties accessing and / or receiving information relating to the method, in particular a step of inviting the practitioner of the individual to record the data of the control protocol (adaptation protocol).
• control protocol adaptive protocol
• the method is such that it can include rapid access to certain information of the individual by reading a Q.R code.
• the invention also relates to a computer program product downloadable from a communication network, and / or stored on a medium readable by computer, tablet or smartphone, and / or executable by a microprocessor, and characterized in that it comprises program code instructions for implementing the method of the invention.
• FIG. 1 represents a diagram of the device for implementing the method according to the invention for controlling a physiological parameter of an individual.
• FIG 2 [FIG 3] Figures 2 and 3 illustrate screenshots of the software application associated with the method and showing the conditions for decreasing and increasing the insulin assay protocol respectively.
• FIG 4 [FIG 5] Figures 4 and 5 illustrate screenshots of the software application showing the entry of information related to the insulin dosage protocol and relating to physical activity.
• the method for controlling the invention of a physiological parameter of an individual is here exemplified with respect to the chronic pathology of diabetes, the parameter to be controlled being the blood sugar level, so that the individual can regulate this rate by administering appropriate insulin doses.
• the process for managing or assisting in the control or regulation of the individual's blood sugar level comprises the steps of:
• the new blood sugar level retrieves the blood sugar level at a given time (called the new blood sugar level) and recording the value of the blood sugar level in a database, recording in the database of values recovered from the glucose level at different times in time to constitute a history of values of the glucose level, each of the values being associated with a precise instant such as a time range,
• the process makes it possible, from the insulin administration protocol established by the doctor specifically for the individual, from the history of blood sugar levels, nutrition, physical activity and other parameters such as the weather, temperature, (geo) location, atmospheric pressure (altitude), and the individual's state of mind, automatically calculate the ad hoc insulin dose that the individual must administer in real time.
• the method of controlling the blood sugar level is not only linked to the measurement as such of the blood sugar level, but takes into account the carbohydrate level (nutrition), the physical activity of the individual. , his external environment of the moment and his mood.
• the control process also makes it possible to record in a database the history of blood sugar levels combined with nutrition and physical activity in order to deduce therefrom statistical data intended to be further processed by practitioners, for example to develop the individual's protocol or protocols for other individuals, or carry out studies on the evolution of the blood sugar level according to the type of individual, the type of physical activity, the type of nutrition.
• the purpose of the process is to provide a result regarding the insulin dose, either in real time or according to a time projection.
• implementation 1 that are at least, a data storage and processing system 2 (hereinafter referred to as the processing) and an interface system 3 between the individual and the data processing system 2.
• processing data storage and processing system 2
• interface system 3 between the individual and the data processing system 2.
• the interface system 3 comprises at least one display screen, remote communication means in particular via the Internet and / or mobile communication networks, and an interface software application 4 which is dedicated to the method.
• an interface system 3 is for example a computer, a tablet or a smartphone, in which the dedicated software application 4 has been installed.
• the data processing system 2 comprises at least remote communication means, data recording means, at least one database and data processing means comprising one or more microprocessors and at least one program for computer.
• the data processing system 2 is preferably hosted by a server type hosting system.
• the data processing system 2 is intended to receive the data transmitted by the interface system 3 and to process them in real time to deliver at least one result of evaluation of an insulin dose when the software application d 'dedicated interface 4 is implemented by recording a new blood sugar level. All the data entered / saved in the software application 4 via the interface system 3 is transmitted to the data processing system 2.
• the means of implementing the evaluation method of the invention are designed so that each individual is identified when connecting to the interface software application 4 and by the data processing system 2.
• the measured blood sugar level, the insulin dose assessment result, and / or other information linked to the result are intended to be recorded by the data processing system 2 and communicated to the individual, and possibly to one or more third parties.
• the information transmitted to third parties is selected according to the nature of the third party, for example according to whether the third party is a caregiver (relative, individual's family) or a person supervising the individual / patient (doctor, pharmacist, nurse, etc. .)
• control method further comprises an alert notification to the user / individual and the sending of alerts to third parties, automatically and / or voluntarily by the user. function:
• the alert notification to the individual is made audibly and / or visually via or on the interface system 3.
• the sending of alerts is done automatically from the data processing system 2 or voluntarily by the individual from his software application via the interface system 3.
• the software application has an alert field which appears for example on the screen of the interface system 3 in the form of a single touch button.
• an alert information message is automatically sent to registered third parties to send this type of alert.
• the alert information message transmitted to the third party is adapted to the means of reception of the third party; it can be for example a telephone message, an email, a text message.
• the means for implementing the method further include a portable device for rapid identification of the patient and information related to this patient, in order to that any third party can identify the individual and some of their vital information when the individual is unable to speak.
• the portable device in particular includes a QR Code.
• This portable device is for example in the form of a card or a bracelet. It is not necessary for the third party to have the software application, scanning the QR Code allows access to information.
• the data processing system 2 includes a specific database for reading the QR Code to access only a limited number of individual data.
• the control method of the invention therefore comprises, prior to its daily implementation, a step of recording data linked to the protocol for adjusting the insulin doses that the individual is intended to receive on a daily basis.
• This step of recording the protocol is carried out by the referring practitioner who must have previously downloaded the software application 4 to his interface system.
• the practitioner receives an invitation and an authorization from the user / patient to enter, via the software application, several information in the database linked to the user's account.
• the information fields to be entered are proposed step by step according to a display of data fields as they are entered.
• the information is as follows:
• the unit of insulin dose used (mmol / L or mg / dL or g / L);
• control periods such as night, breakfast, morning, lunch, afternoon, dinner, evening, assigning each period a start time and an end time; meals when a meal is associated with a control period;
• information related to insulin for each period in particular the type of insulin (slow or fast), the name of the insulin, if it is a functional insulin therapy (yes or no), the dose range of insulin based on a blood sugar level value (several ranges can be entered associated with a blood sugar level value); adaptation of the insulin dose (adaptation or not) for a given period; in the event of adaptation, the selection of the adaptation method from “the traditional method”, “the difference method”, “the difference method D”; in the event of adaptation, information related to the decrease and / or increase in the insulin dose, which is a function of conditions dependent on the history of the blood sugar level;
• FIGS. 2 and 3 show the conditions of decrease and respectively of increase:
• the measurement of blood sugar at a given time is done by any appropriate means, via a blood or interstitial fluid sample and means of analysis of blood sugar from blood or interstitial fluid.
• a patch to stick on the skin which realizes by the presence of a sensor, the measurement of the glycemia in the interstitial liquid, and is suitable to transmit the measurement information to a smartphone by scanning the sensor.
• the measured value is entered manually in the interface system 3 or transmitted to it directly when the measurement device is a connected object.
• All measurements of the blood sugar level over time and entered in the interface system 3 are transmitted and recorded in the data processing system 2 to establish a database of the history of the blood sugar level.
• the glycemic logbook and the glycemic targets are recorded in the data processing system 2 via the interface system 3 and the software application 4.
• the glycemic diary includes not only the history of the blood sugar level and the doses of insulin administered, but also the data relating to nutrition such as each meal, and therefore the carbohydrate levels as a function of nutrition, as well as the physical activity, and the periods associated with these different parameters.
• the glycemic objective are the thresholds for low and high values of the blood sugar level specific to each individual, configurable in the application and intended to be recorded in the database.
• the low and high values correspond to the values that will trigger the alerts if the measured blood sugar level is below the low value (hypoglycemia) or above the high value (hyperglycemia).
• these include the data which are entered manually by the individual when he knows exactly the level of carbohydrate associated with the food, the pre-recorded data corresponding to a list of foods that the user can select on the software application, the data entered automatically by scan and wireless remote connection such as Bluetooth, NFC, wifi.
• the nutrition-related data stored in the database is at least the name of the food, the carbohydrate level and the associated glycemic index.
• the data relating to physical activity include the data linked to physical activity that the individual is preparing to perform (calculation of the dose planned for the activity done afterwards), or those immediately done (preceding dose calculation).
• the data related to physical activity include at least, the type of physical activity, the expected duration, the recording of the blood sugar level just before the start of the activity, possibly the entry of what is planned in nutrition during the activity, and the recording of the blood sugar level on arrival.
• the data processing system 3 is able to perform a forecast calculation of the blood sugar level over time and advantageously calorie expenditure, as well as the programming of a glycemic alarm in case of exceeding the thresholds of low and high values of the individual.
• the forecast calculation is updated.
• the type of physical activity is for example chosen from a menu listing different types of sport, such as running, walking, cycling, swimming, etc. It is possible to record in the application and therefore in the database, an activity which would not be previously listed.
• the latter data which is not included in the protocol is entered and stored in a data library apart from the data associated with the protocol.
• This data relating to physical activity is entered and stored in a data library apart from the data associated with the protocol.
• the actual duration of physical activity is measured by a stopwatch integrated into the interface system 2.
• Other parameters related to physical activity can be recorded, such as in a non-exhaustive manner, weight, tracing the route by geolocation, cardiac activity during exercise, blood pressure, body temperature , etc. All these parameters are entered manually or supplied to the interface system 2 by connected means of the bracelet or fitness watch, tensiometer, thermometer, scale type.
• the control process advantageously takes into account parameters such as weather (for example temperature, humidity, atmospheric pressure), the temperature of the environment in which finds the individual when measuring the individual's blood sugar level, location, and mood / mood.
• weather for example temperature, humidity, atmospheric pressure
• the weather, the temperature and the location are preferably recorded automatically by the geolocation of the interface system 2 and of the associated software applications which supply the information to said interface system.
• the state of mind is captured by the individual on the interface system by selecting one of the states proposed by the software application 4, for example from a scale of faces and / or a scale numeric of values and / or written expressions such as "happy", "stressed", "physical form", etc.
• the values of the aforementioned parameters are recorded in real time in libraries of data, and associated, as for physical activity and nutrition data recorded in real time, with measured blood sugar levels, to provide a history of data in order to analyze them and study the behavior of blood sugar in relation to these different parameters, so that you can modify and adapt the individual's protocol. For example, an individual who lives by the sea and has a protocol established accordingly in relation to his habits, goes on holiday at altitude in the mountains possibly by practicing an activity different from that usual, will see his blood sugar level switch.
• the method of controlling an individual's blood sugar level from the automated calculation of an insulin dose uses not only the measurement of the blood sugar level, but also data related to nutrition and physical activity. of the individual (in terms of their habits or at the time of taking the measurements), as well as data relating to the individualized insulin dosing protocol, the software application dedicated to the process providing ease of data entry and in particular the individualized protocol. To these parameters, can be added to lead to the most accurate calculation of the dose to be administered, additional parameters such as the mood of the individual, his geolocation, the weather of the place where he is.
• the software application 4 is advantageously designed, not only for entering, transmitting and displaying data concerning the individual, but also for:
• chat - online chat
• chat with a community of individuals using the same software application or privately, the user may be visible or invisible in relation to other users, and if he makes himself visible can be geolocated.

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