Noninvasive Monitoring of Diabetes Mellitus
Development and Demonstration of the Technology and Measurement Instrumentation for Noninvasive Diagnostics and Monitoring of Diabetes Mellitus
Tech Area / Field
- MED-DID/Diagnostics & Devices/Medicine
- INF-SIG/Sensors and Signal Processing/Information and Communications
- INF-SOF/Software/Information and Communications
- INS-MEA/Measuring Instruments/Instrumentation
3 Approved without Funding
Belarussian State University of Informatics and Radioelectronics, Belarus, Minsk
- Republican Endocrinological Center, Belarus, Minsk
- Brunel University / Department of Electronic and Computer Engineering, UK, Middlesex, Uxbridge\nHeinrich Heine Universität Düsseldorf / Universitätsklinikum Düsseldorf, Germany, Düsseldorf\nUniversity of Aveiro / Department of Electronics and Telecommunication, Portugal, Aveiro
Project summaryObjective of the research - development and demonstration of technology and measuring devices for non-invasive diagnostics and monitoring of diabetes mellitus (DM). By monitoring we mean permanent observation of blood sugar level what is extremely important to ensure taking medication on time for insulin-dependent patients. DM diagnostics by non-invasive technique has the following advantages: the test is quick and painless, there is no risk of HIV infection and different forms of viral hepatitis, it is safe for both patients and medical staff, and does not require complicated biochemical tests and medical supplies.
Urgency of the proposed project and goal There is a great demand for inexpensive and user friendly diagnostic technology for medical tests in inpidual application [Tamada J.A., Lesho M., Tierney M.Y. (2002) Continuous glucose monitoring. IEEE Spectrum, pp. 52-57].
DM (diabetes mellitus) takes the third place in the world for the number of cases and severity after cardiovascular diseases and cancer. According to different sources of information there are from 120 to 180 million diabetic patients in the world, that is 2-3% of the planet population. Millions of people suffer from unrevealed forms of diabetes or have higher risk to get sick due to they have relatives with DM. Expert estimation forecasts double increase of the number of DM patients every 15 years. 10-20% of DM patients are diagnosed with Type I or insulin-dependent diabetes and required permanent monitoring of the blood sugar level. Average life expectancy of the DM patients suffering from DM from their early childhood is 28 years.
There are about 130,000 registered patients with diabetes in the Republic of Belarus at the moment. About 15% of them have the most severe form of DM - insulin-dependent diabetes, which requires blood sugar test up to 7 times a day. The existing technique of blood test is a traumatic procedure. The development of inexpensive device for non-invasive monitoring of DM to painlessly determine blood sugar level is important for these people. There is no such device in the world.
Urgency and necessity in the development of such device and interest in the results of the project are underlined in the letters from Research Clinical Institute of Radiation Medicine & Endocrinology (Ministry of Health of the Republic of Belarus), from Republican Fund of Fundamental Research, from Research & Production Republican Unitary Enterprise «Diatekh» of the National Academy of the Republic of Belarus, Industrial Republican Unitary Enterprise «MPOVT» of the Ministry of Industry of the Republic of Belarus, Unitary Enterprise «Belagropromtechnaladka» of the Republic of Belarus.
Influence of the project on the progress in the field of medical facilities development. The participants of the project have undertaken the preliminary research to evaluate connection of spectral characteristics of glycated hemoglobin with the level of blood sugar content [Kholodova E.A., Mokhort T.V. and others (1996) Glycated proteins in the clinic of diabetes mellitus. Medical News, 1996, #5, p.3-6]. The project will result in creation of the device for non-invasive monitoring of DM for the first time in the world. This will help numerous diabetic patients to painlessly determine blood sugar level and exclude risk related to traditional blood test procedure with finger pricking.
Project participants The highly skilled professionals from Belarusian State University of Informatics & Radio Electronics (BSUIR) (Headquarters Organization), Republican Endocrinology Centre (REC) (Institute-participant) are invited for project implementation. Of 30 main developers, 3 persons are Doctors of Science and 8 are Candidates of Science. Nineteen specialists have experience in the development of weapon, airborne information-measuring systems, navigation and positioning systems, in the development of control-testing equipment and biochemical weapon. Eight persons have patents on devices and technologies for military industry.
Expected results and their application Category – applied research and developments. The following results are anticipated upon project completion:
1. Determined absorption spectra of pure hemoglobin forms, formulated medical-sanitary requirements to the device, and designed hardware and software architecture.
2. Developed the technique of hemoglobin forms concentration check; defined software structure and database (DB) model for experimental data.
3. Analyzed spectra of 200 blood samples with the known hemoglobin forms content, defined the device structure and packaging.
4. Created algorithms and programs for signal processing, selected optimal wavelengths for the device measuring unit, evaluated measurement accuracy and precision as well as device sensitivity.
5. Completed programming of measuring units, developed signal conversion unit for diabetes sensor. Measuring systems will be tested under laboratory conditions and compared with the results of biochemical (200 blood samples) and spectrometric methods.
6. Designed device housing and display panel. Conducted tests of the device on 300 patients, and compared with biochemical and spectrophotometric methods.
7. Estimated control and evaluation of measurement accuracy of the device, competed complex hardware and software unit, system and acceptance tests. Created the sample device, developed design plans and engineering specifications.
8. Completed medical tests of the device (500 persons). The test results will be compared with biochemical and spectrometric data. Prepared User Manual and other documentation.
As a result of the project completion, non-invasive DM monitoring methodology will be developed and the device for DM monitoring will be made.
Scientific significance of the project is based on the fact that the new device and technology for non-invasive DM monitoring will be developed for the first time in the world.
Applied importance of the project is that the software and hardware system created on the basis of the developed procedures will enable a noninvasive (without skin damaging) data analysis of sugar level in blood, ensuring safety for patients and attending medical personnel.
Commercial importance of the project is provided by the fact that our device makes the tests in express mode painlessly and without any additional medical supplies. The latest industry achievements in electronic circuitry design, leading engineering methods and hardware technology will be applied when creating the device. This will enable easy commercial manufacture, low production costs and small amount of human resources involved into production cycle. The device is simple to operate and can be used by inpiduals, medical centers as well as for population screening with the purpose of DM revealing. The success in commercial sales is anticipated in the Republic of Belarus and other countries.
Patents on the new device and technology being invented will be submitted to protect intellectual property.
Meeting ISTC Goals and Objectives The project meets ISTC objectives: reorientation of the project participants who were previously involved in the development of high precise military systems, devices and biological weapon to creation of the medical device; integration of project participants into international scientific society in the form of contacts with colleagues from other countries and participation in international scientific conferences; support of applied research in medical field and development of new methods and devices; cooperation in resolving national and international problem of diabetes mellitus diagnostics; transition to market economy, which corresponds civil needs. Project results will help the “weapon scientists” to start their own business after the device is developed and put into production.
Scope of Activities The whole scope of activities is estimated for 3 years and counted for 8984 working days. It is pided into 8 tasks. Realization of these tasks is performed with constant and complete cooperation between the Head University (BSUIR) and Institute Participant (REC).
The sequence and relationships of all project tasks are as follows: to choose wavelengths and their amount that could facilitate identification of blood hemoglobin forms, to investigate light reflection and transmission by blood samples having the known content of different hemoglobin forms (200 blood samples), to develop technique of noninvasive DM monitoring, to create device model, to conduct laboratory tests on the device’s measuring systems (200 blood samples), to perform noninvasive measurements of sugar level in blood and to compare the results with biochemical and spectrophotometric methods (300 patients), to develop hardware and software for the device prototype based on the measurement results, to make thorough medical tests (500 patients) of the prototype in order to provide recommendations for further enhancements.
Taking into account the fact that the first investigations on noninvasive DM monitoring have been already completed and positive results have been received, it is necessary to perform further extended research at the time of implementation phase with close cooperation and communication of biochemists, medical specialists, professionals in laser technology and spectroscopy, designers, programmers, system engineers, and circuitry engineers. This circumstance urges the above-mentioned specialists to participate in realization of all project tasks because changes of the research results obtained by one group of specialists will affect decisions preliminary made by specialists of the other groups.
BSUIR is responsible for architectural solutions, system development, housing, circuitry design and programming. REC performs biochemical and spectrophotometric research; the obtained experimental data will be stored in a database. Preparation and synchronization of technological and medical-biological requirements and medical supervision of all activities are to be performed by both BSUIR and REC.
As the result of project implementation 3 device prototypes will be made.
Role of foreign collaborators According to the scope of activities within the given project, cooperation with foreign collaborators will comprise the following stages: exchange of information during project implementation; comments on submitted project reports; verification of the obtained results; estimation of new technologies developed in the project framework; support for the project team in their participation in international conferences, workshops, joint seminars, discussion of measurement techniques and the device certification.
We continue cooperation with our collaborator Prof., Dr. Sc. Valery A. Sklyarov (Portugal).
Technical approach and methodology Invasive tests of the stable glucose compounds level with different proteins are used in modern laboratory diagnostics. Glycated hemoglobin is the most popular one. Glycated hemoglobin indicates blood sugar level for the previous long period of time. That is why it is traditionally used for glucose level estimation. Project participants have already discovered relationship between spectra of light absorption and dispersion by biological tissues, level of glycated hemoglobin and blood sugar concentration. Further extended scientific research is required to create a device for noninvasive monitoring of diabetes mellitus.
Precision and reliability of noninvasive measurements are ensured by the development of the new technology based on measurement of glycated hemoglobin level in blood, indicating glucose concentration. This technology will allow creating inexpensive and convenient device, which accuracy and precision will just slightly differ from standard invasive biochemical and spectrophotometric tests.
Medical supervision on all project tasks and development of medical-sanitary requirements for information-measuring systems and devices will be performed by medical specialists (from project participants) according to requirements to medical apparatus specified by European standards on non-invasive devices (EN 1060-1/12:95; EN 1060-3/09:97; DIN 58130/97, EN 60601-1-2) and by state standards of the Republic of Belarus. Technical and sanitary-hygienic tests of the device prototypes will be conducted by “Centre of Expertise and Tests in Public Health”.
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