ITRM20130125A1 - DIAGNOSTIC SYSTEM FOR MEASURING THE GLICEMIA USABLE WITH PORTABLE ELECTRONIC DEVICES - Google Patents

Description

TECHNICAL FIELD OF THE INVENTION

The invention presented in this document relates to the field of systems and methods for the management and self-measurement of blood glucose levels and alert systems to indicate health emergency situations for patients with diabetes.

BACKGROUND AND STATE OF THE ART

Diabetes mellitus, a group of metabolic disorders that present unstable blood glucose levels, is a significant global health problem and is on the rise. According to the "World Health Organization" around 246 million adults with diabetes have been estimated in the world, a number expected to grow, according to forecasts, to 380 million in 2025.

In 2006, the United Nations General Assembly unanimously adopted a resolution recognizing diabetes as a global pandemic, which poses a serious threat to world health, also recognizing it as a chronic disease, associated with chronic, debilitating and costly complications. for the health system.

The impact of diabetes on the quality of life and on the costs of the national health system is a consequence of both the chronicity of the disease and the fact that the complications that occur are multi-organ with consequent morbidity and premature mortality. People with diabetes have a noticeable decrease in life expectancy.

The commitment of those who work in this field, in close contact with the many and serious physical, but also psychological problems, and with the management of daily life that the diabetes disease so often involves, is therefore to raise awareness as much as possible the population of diabetic patients on the need to follow, with constancy and regularity, a series of simple but precious measures that make it possible to combat the onset of complications of this disease.

To avoid the onset of complications of the disease, it is of fundamental importance not to reach too high levels of glycemia in the blood and therefore the need arises for frequent monitoring and / or self-monitoring as well as the possibility of having a form of prediction of the physiological behavior of the body in response to certain situations (glycemic diary). It is evident that it is therefore necessary to have tools available to facilitate the execution of these two tasks as much as possible.

Since mobile phones and consumer electronic devices are easy to use, widely used and everyday tools for most people, in recent years the use of glucometers that use this device for the purpose of improving the service is becoming particularly important. / or cost reduction.

Starting from the fact that frequent monitoring of blood glucose is potentially able to provide information of inestimable importance, capable of making a significant improvement in the care of the patient with type 1 diabetes mellitus and of the patient being treated with insulin in general, also recording a positive impact on the quality of life of the diabetic patient, the present invention intends to create a new medical device that allows self-monitoring of blood glucose using one's mobile phone (or other electronic device with the necessary requirements) as a processing unit, data storage and transmission.

Nowadays, this analysis can be performed by the patient very easily, thanks to the use of practical and small devices that allow you to have the test result in a few seconds, but these devices must always be carried with you, so it is it is necessary to make them easily transportable, resistant and practical.

As previously written, for the correct management of diabetes not only frequent checks of blood glucose levels are necessary, but it is important to have information available regarding the direction, importance, duration, frequency and potential causes of fluctuations in the blood. blood glucose levels, warning patients in the event of hypoglycemia or sudden changes in blood glucose concentration, which is why the use of devices that can be equipped with data processing and archiving tools is particularly important.

Portable blood glucose meters allow you to measure the concentration of glucose in whole blood, usually capillary blood obtained from a fingertip.

The drop of blood is placed on a test strip and inserted into the reading instrument.

The principle on which the measurement of the most common glucometers is based consists in the quantification of an enzymatic reaction, the oxidation of glucose operated by glucose-oxidase, which is proportional to its concentration in the blood. The reaction occurs by placing a blood sample on a glucose oxidase test strip.

There are numerous types of glucose meters, which differ both in technological functions, as well as in size and design. The trend of all companies is to produce compact and easy-to-use meters, in such a way as to allow patients to transport and use them with extreme simplicity and therefore to allow an active life for people with diabetes.

In recent years there has been an adaptation of blood glucose meters to new technologies such as those of portable devices such as smartphones, tablets and PCs with related applications and methods of management, data processing as well as storage and transmission of the same.

Some examples of the interaction of blood glucose meters / consumer electronic devices can be found in the patents listed below:

-WQ 2008/061552 - Blood Glucose meter capable of Wireless Communication;

-WQ 02/00112 A2 - Glucose Metering System;

-WO 2008/064053 A3 - System and method for diabetes management using consumer electronic devices;

-WO 03/036409 A2 - mobile System of transferring glycemic data between health professionals and diabetic patients;

-WO 2QQ5 / 079664 Al - Blood glucose monitor for mobile communication device;

-WQ 2012/083840 Al - Mobile phone based glucose sensing and alerting System;

-CN 102565413 A - Blood glucose meter adopting computer and mobile phone for control and management;

-US 2012/0047745 Al - Mobile Apparatus, method and System for processing blood sugar affecting factors;

-US 2011/0082711 Al - Personal digital assistant or organizer for monitoring glucose levels; - US 2011/0119086 Al System for managing treatment of a particular health condition via a mobile phone device;

-US 2012/0029327 Al - Controlling diabetes with a cellular GPRS-linked glucometer -pedometer

-US 2012/0065894 Al - Medicai System and method for providing glycemic response Information;

-US 2012/0271655 Al - method and systems for enabling application on a mobile computing device to access data associated with a peripheral medicai device.

The list of patents reported above is not exhaustive, but presents the state of the art in the field of connection of devices for measuring biological parameters, in particular of blood glucose levels, with consumer electronic devices, in particular with smartphones and tablets, devices now in common use even among elderly people.

The aforesaid patents, however, differ from the invention presented here both in terms of connection / communication with the device, and in the technological solution adopted, both in the design of the device and in the operating modes of the data acquisition / presentation software; the details are explained below.

BRIEF DESCRIPTION OF THE INVENTION

The present invention relates to a portable blood glucose level measurement system, to be connected with appropriate components and data transfer and processing method, to consumer electronics devices such as, by way of example and not [imitative, a cell phone. The greatest advantage of this invention is the possibility of integrating the apparatus for measuring blood glucose levels with consumer electronic devices. This makes it easier, through a special interface, to read the results and the blood glucose diary, without however worsening the performance of the electronic device to which it is connected, as the glucometer is equipped with its own power supply.

In order to perform the functions listed above, the medical device must be composed of a blood glucose level meter equipped with an input port for the reactive strips for measuring blood glucose, a device for processing the blood sample collected on the test strip, a connector that allows communication between the medical device and the electronic device, an interface system between the two devices and software installed on the electronic device for data detection, management and saving.

â € ¢ BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, reference will be made to the attached drawings in the description of the invention; a brief description of them follows.

- FIG. 1: is a simplified representation of the blood glucose measurement device from two different perspectives;

- FIG. 2: "Flow Chart" of the logical operation diagram of the medical device connected to the electronic device;

- FIG. 3: perspective view of the device for measuring blood glucose levels including smartphone in accordance with one of the industrial constructions;

- FIG. 4: Screenshots of the graphic interface of the management, presentation and data acquisition software for devices equipped with an "Android" operating system in accordance with one of the industrial embodiments of the present invention.

DESCRIPTION OF THE INVENTION

As shown in the explanatory drawings, the invention presented here relates to a system for measuring blood glucose levels to be used in association with consumer electronic devices such as tablets, smartphones, etc.

The connection between the medical device for measuring blood glucose levels is made through an electrical connector, such as mini jack or supermini jack, to the audio output of the electronic device.

Electronic devices are used to show the values obtained after the measurement and make them accessible over time, also showing them in graphical form.

The electronic device can be any electronic device with audio and video output, such as smartphones (of any brand and with different operating systems), personal computers, tablets and MP3 players.

The electronic device works thanks to its own operating system, the only requirement for the operating system of the electronic device is to be able to run the software of the medical device and to have the libraries for the management of audio input / output .

The blood glucose meter is a medical device with a simple design to make it more resistant to shocks, it is compact and very light. The connector, which allows the connection between the medical device and the electronic device, is mobile, so as not to create inconvenience in the use of the electronic device.

The medical device for measuring blood glucose levels is equipped with a sensor inside which exploits the reaction of the enzyme Glucose Oxidase with the glucose in the sample, generating electrons that produce a current directly proportional to the glucose content.

Another important aspect of this invention is to have a portable blood glucose level meter that can be connected to other portable devices such as smartphones, equipped with an autonomous power supply so as not to decrease the energy performance of the electronic device itself.

A further technical feature of the present invention is to provide a device for measuring blood glucose levels portable and connectable to other portable devices via mini jack and super mini jack, universally used in electronic devices as connectors for the audio signal, this to make the medical device suitable for connection to the greatest number of electronic devices.

in accordance with the objectives listed above, for the implementation of the blood glucose measurement system through the connection of the medical device with a consumer electronic device such as a smartphone, a software has been developed that allows the acquisition, management and data processing. This software is also equipped with a graphic interface that allows to show the measured values to the patient. The electronic device must run with its own operating system, the medical device software is compatible with different operating systems.

The electronic device can be any type of electronic device, including but not limited to cell phones, smartphones, tablets, mp3 players, personal computers and more. The communication between electronic device and medical device takes place through connector and connection cables.

The simplified operating modes are as follows: the glucose level sensor / transmitter transmits data to the connector through a specific protocol (FSK) for the medical device used; the connector in turn sends the data to the electronic device through a second communication protocol. More precisely, a frequency-shift keying technique is used, where, using an appropriate numerical frequency modulation scheme, the value read by the glucometer becomes a modulating signal that shifts the frequency of the output carrier from one to the other by two predetermined values . Note that none of the aforementioned patents use this communication system.

REALIZATION OF THE INVENTION

Below is a detailed description of one of the possible constructive solutions for the present invention with reference to the relative figures.

With reference to FIGS. 1A and FIG. 1B, which are the view in two different perspectives of a constructive solution, the invention has the shape of a parallelepiped measuring 43x29x14 mm the external body of the device (marked by the number 110 in fig. 1A, and 220 in fig. 1 B) , including the upper surface (202 fig. 1B) and the lower surface (102 in fig. 1 A) are made of plastic material.

In the device (FIG. 1A - 110 and FIG. 1B - 210) there is the input port for the test strips (FIG. 1A - 101 and FIG. 1B - 201); the dimensions of the opening correspond to the standard adopted for the test strips on the market (the test strips for blood glucose control are marked with the number FIG. 1A - 100 and FIG. 1B - 200).

In FIG. 3 The device (310) is presented, together with the smartphone (300), which for this particular industrial realization is a smartphone with an Android operating system. Also in figure 3 the electrical connector (305) is highlighted, that is a mini audio jack (tip diameter 3.5 mm).

The HTC smartphone model (300} presented in FIG. 3 could be replaced by any other smartphone but also by other electronic devices equipped with audio output and capable of supporting management software, such as a tablet.

Inside the device for measuring blood glucose levels (FIG. 1A - 110 and FIG. 1B - 210 and FIG. 3 - 310) there is a sensor for detecting glucose levels of the type already in use by the proposer for traditional blood glucose meters; this sensor analyzes fresh capillary blood samples, deposited on test strips for measuring blood glucose levels, with a measurement range of 20-600 mg / dl (1.1-33.3 mmol / l), with a response time of 5 seconds, 0.5pL blood volume required and accuracy according to IS015197.

Data transmission starts from the glucose sensor; the output signals from the glucose sensor are conveyed to an internal chip-modem, hereinafter referred to as "BSICare"; the BSICare output consists of sine waves (analog signal) which in turn, through the FSK protocol described above, are sent to the smartphone. These waves are then captured by the device's audio libraries through the microphone and interpreted by sampling their amplitude. /

In FIG. 2 The logic diagram of the glucometer measurement device connection is shown, with relative timing and possible messages that can be displayed on the electronic device.

In the constructive solution described here in detail, a 3V CR1620 battery has been inserted in both the in order not to draw power from the battery of the mobile phone and reduce its duration, both in order to guarantee the functioning of the meter even in the absence of the mobile phone battery.

The management of the medical device for measuring blood glucose levels takes place completely through the graphic interface (FIG. 4 A, B, C and D) of the management software, to be installed on the electronic device to which it is connected.

To safeguard privacy, the user authentication screen has been introduced (FIG. 4A - 410), to ensure that only the user or those authorized by him can access the data. The authentication process, as in almost all computer / software systems, consists of entering a user name (FIG.4A - 411), a password (FIG.4A - 412) and sending data (FIG.4A - 413), obviously after registration.

Once you have "logged in" to the program, you will access the screen for choosing the operation to be carried out (FIG. 4B - 420).

There are two choices (excluding the possibility of exiting the software FIG. 4B -423):

- glycemic diary (FIG. 4B - 421);

- start the measurement (FIG. 4B - 422).

If you choose the "Glycemic Diary" option, you will access the relative screen (FIG. 4D -440); with this function it is possible to view the value of the blood sugar levels [mg / dl], the period of the day and the date of the stored measurements (FIG. 4D - 441).

These measurements can also be displayed in graphical form (FIG. 4D - 442).

If you choose "Start Measurement" the relevant screen is displayed (FIG. 4C -430).

In this screen, in addition to displaying the blood glucose levels, you must also fill in the field relating to the period in which the measurement was carried out (FIG.4C - 431) and if you want this data to be entered in the glycemic diary you must press the button for saving the measurement (FIG. 4C - 432).

Claims (1)

It claims: 1. A system for the management and self-measurement of blood glucose levels and for the emission of warning signals to indicate emergency situations to be connected to any electronic device equipped with an audio input such as a smartphone; this system is composed of: - removable electrical connector with the shape and size of an audio jack or minijack connector, for the transmission of the collected signal to the electronic device; sensor for measuring the concentration of glucose from blood drops capillary which exploits the reaction of the enzyme Glucose Oxidase with the glucose contained in the blood sample deposited on the lancet, generating electrons that produce a current directly proportional to the concentration of glucose in the blood; battery power system to avoid reducing the autonomy of the electronic device to which the glucose meter is connected; this system is characterized by the use of the frequency-shift keying technique, that is a technique which, using an appropriate numerical frequency modulation scheme, transforms the value read by the sensor for measuring glucose into a modulating signal; this signal shifts the frequency of the carrier output from the audio jack from one to the other by two predetermined values; the transmission of the signal produced by the glucose sensor is thus transmitted to the electronic device via the audio output; the results obtained are shown on the electronic device by means of a dedicated interface capable of storing the data to have a diary available and also graphically show the glycemic curve