WO2020245765A1

WO2020245765A1 - Telemedicine system and method for diabetology

Info

Publication number: WO2020245765A1
Application number: PCT/IB2020/055277
Authority: WO
Inventors: Francesco CANNONE; Pasquale Pio PAZIENZA; Aurelio CARELLA
Original assignee: Emtesys Srl
Current assignee: Emtesys Srl
Priority date: 2019-06-06
Filing date: 2020-06-04
Publication date: 2020-12-10
Anticipated expiration: 2021-12-06
Also published as: IT201900008208A1

Abstract

Telemedicine system (100) for diabetology comprising: - a digital glucometer (101) comprising a power supply and energy management unit (102), a processing unit (103), a wireless communication module (104), a keyboard (105) and a display (106); - a virtual SIM card integrated in the wireless communication module (104); - at least one remote processing unit (107) provided with an Internet connection and with a management system configured for acquiring and analyzing the data detected by the digital glucometer (101) and transmitted to said at least one remote processing unit (107), and for transmitting the analyzed data to the digital glucometer (101); The wireless communication module (104) is a cellular network modem and the display (106) is configured to display the data detected by the digital glucometer (101) and the data transmitted to the digital glucometer (101) by the at least one remote processing unit (107).

Description

"Telemedicine system and method for diabetology"

The present invention relates to a telemedicine system for diabetology.

The present invention relates also to a telemedicine method for diabetology.

In particular, the present invention relates to a telemedicine system and method for diabetology that, to the standard functions of a glucometer, associates the support of a computing platform to acquire, manage and analyze data .

As is known, there are systems able to detect the blood glucose of diabetic patients including digital glucometers capable of transmitting clinical data to remote servers, on which servers specific software applications acquire and analyze data, thus providing healthcare professionals with the appropriate tools to make accurate diagnoses by correcting, if necessary, the methods of treatment of diabetes. Such systems are part of the area of expertise of telemedicine, and specifically, as anticipated, of telemedicine applied to diabetology. A first known telemedicine system for diabetology is described by the international patent application WO2011119896A1 whose subject is an apparatus for insertion of a medical device in the skin of a subject, as well as methods of inserting medical devices. Said apparatus includes a sheath, a device support movable between a proximal and distal position, a sharp support movable between a proximal and distal position, a handle movable between a proximal and distal position, and a driver.

The international patent application W02015187801A1, in addition, disclose a system, an apparatus and a method for transmitting and receiving medical test data provided with memory that stores computer-executable instructions, a processor, communicatively coupled to the memory that facilitates execution of the computer-executable instructions. In addition, a transmission means operatively associated with a device, a receiver adapted and configured to receive data from the transmission means, a central database adapted and configured to compile the data, are provided. The data are transformed into an output comprised of an aggregate of medical test data from at least one medical test.

Still, the international application published as WO2015103543 describes a system configured to process data coming from different monitoring techniques and capable of providing assistance to diabetic patients at different levels. The system is scalable, i.e. ranging from advice on long-term trends and prognosis, to automated closed-loop control in real time.

A further example of known technical solution is described by the international patent application W02004027676 which discloses a telemedicine system for monitoring chronical conditions, such as asthma or diabetes, that includes an electronic measuring device, for example an electronic peak expiratory flow meter or an electronic blood glucose meter connected to a GPRS cell phone. The mobile phone receives, formats and automatically transmits the data acquired by the medical device to a remote server, that can recognize the data and make them available to a doctor, analyzing the data and providing automatic alerts to the patient and/or to the doctor.

Finally, the patent application CN108324287 describes a non-invasive system which includes a glucometer and a smartphone, in which a blood detection unit transmits the acquired data to a processor. The meter is also equipped with a detecting unit and a Bluetooth unit. The detecting unit transmits the acquired signal to the processor that transmits the glucose data to a display and a control unit for viewing. The Bluetooth unit is in communication with a Bluetooth module of a user's smartphone and transmits the numerical value of the blood glucose to the same mobile phone .

However, known systems such as those previously described are not able to implement a telemedicine service, specifically related to diabetology, that is comfortable and effective.

First of all, the existing glucometers make it impractical to implement an essential aspect of remote diabetes applications, i.e. the transmission of data in a simple and automatic way to an IT platform through which the results of the measurements are processed.

The known systems, in order to transmit the data, require the user to perform additional actions in addition to those required to perform the habitual gesture of measuring the blood glucose (i.e. the puncture of the finger by means of disposable hands, the application of the drop of blood in the test strip and the expectation for the test result to appear on the meter display) .

The available technologies for collecting and sending data are various: a USB cable combined with a PC connected to the Internet, a Bluetooth module associated with a smartphone provided with a specific app, an add-on module connected to a smartphone provided with a specific app, in rare cases a 2G/3G modem associated with complex and non- automated glucometer software management systems. In addition, in known systems, the idea of exploiting the glucometer as a vehicle of diabetology services is rarely used, since the existing models are limited to implementing the one-way transmission of the measured clinical parameters to a computerized data storage platform.

The purpose of the present invention is to provide a telemedicine system and method for diabetology that are able to monitor the patient in real time in a reliable, quick and efficient way, optimizing resources, both economical and in terms of healthcare professionals, both in the hospitals and at home, having, therefore, characteristics such as to overcome the limitations that still affect the current telemedicine systems and methods for diabetology, with reference to the known technique.

A further purpose of the present invention is to provide a telemedicine system for diabetology that includes a device, the glucometer, which in addition to carrying out the measurement of blood glucose can also be used both to transmit the data relating to the measurements and to receive the diagnostic data processed in real time by a software platform, cloud or local, which in turn is comprised in the system.

Finally, the purpose of the present invention is to provide a telemedicine system for diabetology that allows a bidirectional communication with the aforementioned IT platform through the Internet in an effective and transparent way for patients and healthcare professionals, regardless of the geographical location of the system and of the telephone providers of the specific countries that provide the data connection service.

According to the present invention, a telemedicine system for diabetology is provided, as defined in claim 1.

According to the present invention, a telemedicine method for diabetology is also provided, as defined in claim 7.

For a better understanding of the present invention, a preferred embodiment is now described, purely by way of non-limiting example, with reference to the attached drawing, in which:

- figure 1 shows a schematic view of a telemedicine system for diabetology, according to the invention.

With reference to figure 1, a telemedicine system 100 for diabetology is shown, according to the invention.

More in detail, the telemedicine system 100 for diabetology comprises:

- a digital glucometer 101 able to detect data related to the blood glucose of a user, comprising a power supply and energy management unit 102, a processing unit 103, a wireless communication module 104 for the transmission of said data, a keyboard 105 and a display 106;

a virtual SIM card integrated in the wireless communication module 104 and able to provide Internet access to the digital glucometer 101;

- at least one remote processing unit 107 provided with an Internet connection and with a management system configured for acquiring and analyzing the data detected by the digital glucometer 101 and transmitted to said at least one remote processing unit 107 by means of the wireless communication module 104.

According to an aspect of the invention, the processing unit 103 is a microprocessor or a microcontroller which runs the management logic of the digital glucometer 101. The digital glucometer 101 is, in addition, provided with a rewritable memory unit connected to the processing unit 103 and able to storing the data generated by the digital glucometer 101.

According to an aspect of the invention, the data detected by the digital glucometer 101 and transmitted to the at least one remote processing unit 107 are measures of the blood glucose of the user, i.e. a diabetic patient.

According to an aspect of the invention, the management system running on the at least one remote processing unit 107 is configured to acquire and to analyze the data received from the glucometer 101 and transmit said analyzed data to the digital glucometer 101.

According to another aspect of the invention, the wireless communication module 104 is a cellular network modem, for example a 2G/3G/4G/5G modem.

According to an aspect of the invention, the digital glucometer 101 and the at least one remote processing unit 107 are connected by means of a mobile network.

Advantageously according to the invention, using a virtual SIM card allows to make a change of the phone provider from afar, without having to send the digital glucometer 101 back to the factory.

Another advantage ensured by the use of a virtual SIM card is that it allows not to have to remove the SIM card from the digital glucometer 101.

According to another aspect of the invention, the chosen connectivity provider has to offer a data connection plan based on national and international roaming aimed at providing an automatic access to the network of the provider which, in the given place/country in which the telemedicine system 100 is used, ensures the best signal coverage. In addition, the connectivity provider has to make the telemedicine system 100 accessible from afar via the Internet. According to an aspect of the invention, the management system running on the at least one remote processing unit 107 is a software platform configured, as already mentioned, to acquire, store and analyze the data received from the digital glucometer 101 by means of the wireless communication module 104.

In detail, the software platform can be decomposed, by exemplifying its complex structure, into the following function blocks:

- login and management of different user profiles;

- reception and storage of data;

- management of security, redundancy, and privacy;

display of data according to the different user profiles ;

- data sharing with third party platforms;

- management functionalities;

- health functionalities.

In particular, the latter point mentioned, concerning health functionalities, is of particular relevance.

The main managed health functionalities directly relate to the bidirectional communication between the digital glucometer 101 and the software platform, that is, between the digital glucometer 101 and the at least one remote processing unit 107. These health functions fall into two categories: compliance management, i.e. matching with the prescribed therapy;

- lifestyle management and insulin therapy.

According to an aspect of the invention, by exploiting the bidirectional communication, the software platform sends the following information to the diabetic patient, together with the blood glucose measurement carried out by means of the digital glucometer 101:

a risk range related to the data measured by the digital glucometer 101 and identified with a color code ;

therapeutic message depending on the risk range within which the measure falls.

Advantageously according to the invention, the information processed by the software platform is not static and valid for all diabetic patients, but can be modified by a specialist in order to take into account the specific characteristics of each diabetic patient and to follow the dynamics of the pathology over time. This approach is in line with what is commonly called personalized medicine.

Furthermore, advantageously according to the invention, the bidirectional communication channel between the digital glucometer 101 and the at least one remote processing unit 107 allows, by means of the software platform, to send the following information to the patient:

an estimated average risk level of a severe hyperglycemia or hypoglycemia event expressed by the ADRR index (Average Daily Risk Range) ;

- HBGI (High Blood Glucose Index) ;

- LBGI (Low Blood Glucose Index) ;

- FNC (Non-Conforming Fraction) ;

- an estimated glycated hemoglobin (HbAlc) level

Time In Range (TIR, time in the glycemic safety range) ;

- a level of carbohydrates to be taken;

- a quantity of insulin units to be taken in order to reach a predefined set-point of the blood glucose.

Such data are updated on each new measurement and define both the current state of the pathology and the future state. In particular, the ADRR (Average Daily Risk Rate) , evaluated by applying algorithms certified and validated by the scientific community, is able to predict a severe event of hyperglycemia or hypoglycemia, in this way implementing the function of predictive medicine.

In particular, for diabetic patients with insulin therapy, always by means of the bidirectional communication channel between the digital glucometer 101 and the at least one remote processing unit 107, for example a local or a cloud server, the software platform sends to the patient, together with each pre-prandial measurement, the following information :

- carbohydrates to be taken as required by the diet assigned by a nutritionist;

- insulin unit to be taken in order to reach the blood glucose set-point defined by a specialist.

This information sent to the diabetic patient depends on the blood glucose measurement made before the meal and on parameters defined by the specialist, for example: correction factor, sensitivity factor, desired blood glucose set-point. These parameters can be modified if the specialist deems it appropriate.

Advantageously according to the invention, the telemedicine system 100 provides the diabetic patient with an exhaustive set of information visualized by means of the display 106, useful to show both the data detected by the digital glucometer 101 and the data generated thanks to the feedback provided by the software platform running on the at least one remote processing unit 107.

Advantageously, the described procedures allow to follow the trend of insulin therapy in a "closed loop", thanks to the feedback provided by the software platform: the evaluations and corrections made on the therapy are not carried out in the "open loop", based on the statistics and classifications in which the specialist tries, during the visit (usually twice a year) , to put the diabetic patient, but are based on the effects of the therapy displayed through the software platform, day by day (365 days a year) , thus implementing features that fall within the paradigm of precision medicine.

Advantageously according to the invention, the wireless communication module 104 integrated in the digital glucometer 101 allows a real-time bidirectional communication of said digital glucometer 101 with the at least one remote processing unit 107.

Another advantage of the telemedicine system 100 according to the invention is that the data transmitted by the digital glucometer 101 to the at least one remote processing unit 107 are acquired automatically without requiring a patient intervention.

In known systems, in fact, due to the absence of a communication module integrated in the glucometer, the real-time data are sent by a marginal fraction of diabetic patients.

According to another aspect of the invention, the operation of the processing unit 103 of the digital glucometer 101 is managed by a firmware configured to efficiently interface the functionalities provided through the management system, i.e. the software platform, running on the at least one remote processing unit 107.

According to an aspect of the invention, the display 106 has a size between 2,6" and 3,0", and preferably equal to 2,8", and is configured to display the data detected by the digital glucometer 101 and the data transmitted to the digital glucometer 101 by the at least one remote processing unit 107.

Advantageously according to the invention, the size of the display 106 ensures a large viewing area, useful both to visualize the data detected by the digital glucometer 101 and the data analyzed by the at least one remote processing unit 107 and transmitted to the digital glucometer 101.

Advantageously according to the invention, the telemedicine system 100 allows to detect the blood glucose measurements of the diabetic patients while simultaneously delivering innovative tele-diabetology services in a simple way on the display 106 of the digital glucometer 101.

As previously said, the present invention also refers to a telemedicine method for diabetology, comprising the steps of:

- detecting the blood glucose of a diabetic patient through a digital glucometer equipped with a power supply unit and energy management unit, a processing unit, a wireless communication module equipped with a virtual SIM card, a keyboard and a display;

- sending data detected by the digital glucometer and related to the blood glucose of diabetic patients, by means of the wireless communication module through the Internet to at least one remote processing unit provided with an Internet connection and a software platform for acquiring and analyzing data collected and transmitted by the digital glucometer;

- sending the data analyzed from the at least one remote processing unit to the glucometer, said data including a risk range related to the measurement and identified with a color code, a therapeutic message depending on the risk range in which the measure is comprised, an estimated average risk level of a severe hyperglycemia or hypoglycemia event expressed by the ADRR index (Average Daily Risk Range) , HBGI (High Blood Glucose Index) , LBGI (Low Blood Glucose Index) , FNC (Non-Conforming

Fraction) , an estimated glycated hemoglobin (HbAlc) level, Time In Range (TIR) , a level of carbohydrates to be taken as expected from a diet assigned by a nutritionist, a quantity of insulin units to be taken in order to reach a predefined set-point of the blood glucose.

Advantageously according to the invention, the telemedicine method for diabetology ensures a significant improvement in the efficiency of glycemic self-control and more generally of the diabetology service.

Therefore, the telemedicine system 100 allows to provide the software platform, in a simple way, thanks to the digital glucometer 101, with the measurements of assisted diabetic patients while simultaneously conveying innovative tele-diabetology services through the display 106.

Another advantage of the telemedicine system for diabetology is that it uses a single device, the glucometer, both to measure the blood glucose of diabetic patients and to transmit the data related to the measurements .

Another advantage of the telemedicine system for diabetology is that it allows to introduce important functionalities of precision medicine, personalized medicine and predictive medicine in the field of tele- diabetology .

Another advantage of the telemedicine system for diabetology is that it allows to achieve direct results such as an increase in the degree of involvement of the diabetic patient, an increase in the performance of health services, a reduction in hospitalizations and complications of diabetes, as well as indirect results such as the increase in the quality of life of the patient and the reduction of the costs for the national health service.

A further advantage of the telemedicine system for diabetology is that it is inexpensive, thanks even to the use of the virtual SIM card which allows to achieve economies of scale, particularly during the series production of the digital glucometer.

Furthermore, the telemedicine system and method for diabetology are efficient and easy to apply.

Finally, the telemedicine system and method for diabetology allow a real-time monitoring of the blood glucose level of diabetic patients in a reliable and efficient way by implementing personalized, predictive and precise medicine techniques.

It is finally clear that the telemedicine system and method for diabetology described and illustrated herein can be subject to modifications and variations without departing from the protective scope of the present invention, as defined in the appended claims.

Claims

1. Telemedicine system (100) for diabetology comprising :

a digital glucometer (101) able to detect data related to the blood glucose of a user, comprising a power supply and energy management unit (102), a processing unit (103), a wireless communication module (104) for the transmission of said data, a keyboard (105) and a display (106) ;

a virtual SIM card integrated in the wireless communication module (104) and able to provide Internet access to the digital glucometer (101);

- at least one remote processing unit (107) provided with an Internet connection and with a management system configured for acquiring and analyzing the data detected by the digital glucometer (101) and transmitted to said at least one remote processing unit (107) by means of the wireless communication module (104), and for transmitting the analyzed data to the digital glucometer (101);

characterized in that said wireless communication module (104) is a cellular network modem and in that the display (106) is configured to display the data detected by the digital glucometer (101) and the data transmitted to the digital glucometer (101) by the at least one remote processing unit (107) .

2. Telemedicine system (100) according to claim 1, characterized in that said processing unit (103) is a microcontroller .

3. Telemedicine system (100) according to claim 1, characterized in that said digital glucometer (101) and said at least one remote processing unit (107) are connected by means of a mobile network.

4. Telemedicine system (100) according to claim 1, characterized in that said management system running on the at least one remote processing unit (107) is a software platform configured to acquire, store and analyze the data received from the digital glucometer (101) by means of the wireless communication module (104) .

5. Telemedicine system (100) according to claim 1, characterized in that the display (106) has a size of 2,8".

6. Telemedicine system (100) according to claim 1, characterized in that said at least one remote processing unit (107) transmits to the digital glucometer (101) data selected in the group comprising:

- a risk range related to the data measured by the digital glucometer (101) and identified with a color code;

- a therapeutic message depending on the risk range; an estimated average risk level of a severe hyperglycemia or hypoglycemia event expressed by the ADRR index (Average Daily Risk Range) ; - HBGI (High Blood Glucose Index) ;

- LBGI (Low Blood Glucose Index) ;

- FNC (Non-Conforming Fraction) ;

- an estimated glycated hemoglobin (HbAlc) level;

- Time In Range (TIR, time in the glycemic safety range) ;

- a level of carbohydrates to be taken;

7. Telemedicine method for diabetology comprising the steps of:

- detecting the blood glucose of a diabetic patient through a digital glucometer equipped with a power supply unit, a processing unit, a wireless communication module equipped with a virtual SIM card, a keyboard and a display;

- sending data detected by the digital glucometer and related to the blood glucose of diabetic patients, by means of the wireless communication module through the Internet to at least one remote processing unit provided with an Internet connection and a software platform for acquiring and analyzing data collected and transmitted by the digital glucometer; - sending the data analyzed from the at least one remote processing unit to the glucometer, said data including a risk range related to the measurement and identified with a color code, a therapeutic message depending on the risk range in which the measure is comprised, an estimated average risk level of a severe hyperglycemia or hypoglycemia event expressed by the ADRR index (Average Daily Risk Range) , HBGI (High Blood Glucose Index) , LBGI (Low Blood Glucose Index) , FNC (Non-Conforming