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Optical in Vivo Glucose Monitor

#3045


Developing 2D (Dual-Parameter) Methods and Means of Polarization Spectroscopy for Estimating Glucose Concentration in Vivo and Creating Artificial Pancreas

Tech Area / Field

  • PHY-OPL/Optics and Lasers/Physics
  • MED-OTH/Other/Medicine
  • BIO-CHM/Biochemistry/Biotechnology

Status
3 Approved without Funding

Registration date
07.04.2004

Leading Institute
Vavilov State Optical Institute (GOI), Russia, St Petersburg

Supporting institutes

  • Vavilov State Optical Institute (GOI) / Small-Scale State Enterprise "Laser Physics", Russia, St Petersburg\nRussian Academy of Sciences / Physical Technical Institute, Russia, St Petersburg

Collaborators

  • Albany Nanotech, USA, NY, Albany\nSamsung Electronics Co., Ltd / Samsung Advanced Institute of Technology, Korea, Yongin City\nConsiglio Nazionale delle Ricerche / Istituto di Fisica Applicata Nello Carrara, Italy, Florence\nUniversity of Pennsylvania, USA, PA, Philadelphia\nGunma University, Japan, Gunma\nTroika Consulting, USA, DC, Washington\nInstitute for Analitical Sciences, Germany, Dortmund

Project summary

Diabetes is one of the World’s leading causes of death. Today, over 150 million people around the world have diabetes. The disease is reaching epidemic proportions. In the United States, over 17 million people have diabetes and rate of growth is 61% in the last decade. Every year 800,000 new cases are reported, in the United States, of which 125,000 are people younger that 19, making diabetes the most common life-threating chronic disorder in the United States. One in every three children now being born in the United States ultimately will be expected to have diabetes.

The proper treatment of diabetes requires strict regulation of glucose. The Diabetes Control and Complications Trial (DCCT) is a clinical study conducted from 1983 to 1993 by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The study showed that strict regulation of blood glucose helped prevent diabetic complications such as blindness, stroke, heart disease and amputation of limps. The DCCT study was the largest, most comprehensive diabetes study ever conducted, the DCCT involved 1,441 volunteers with type 1 diabetes and 29 medical centers in the United States and Canada. {Source: US National Institutes of Health Web site: http://diabetes.niddk.nih.gov/dm/pubs/control/}.

The combined cost of diabetic complications has been estimated in the United States at approximately $ 100 billion in 2000 - $45 billion for direct health care costs and $55 billion for lost of productivity. Many complications caused by diabetes could be prevented by a continuous and accurate glucose monitoring system.

A continuous glucose monitoring system would allow diabetics to efficiently regulate their blood glucose. Unfortunately, there does NOT exist any method to continuously and accurately monitor blood glucose. In other words, strict regulation of blood glucose is difficult. Diabetics must now have to draw blood several times a day.

Currently, enzymatic and optic sensors are proposed for a monitoring system. Development of enzymatic sensors meets problems of consumable means and utilization of disposed chemicals [1]. Spectral optical sensors (SOS) [2, 3, 4] have no such problems in principle and have the needed sensitivity for determining glucose in the required range 2-25 mM/L. There is an interest to SOS in the world rising from year to year. Practically every day, news appear on new patents and papers on this subject [5-16, 24, 25, 29]. Developments with the stage of clinic tests are far less numerous.

Reports were on the “Diasensor 2000” from Biocontrol Technology, further work was reported from "Futrex" Co. [8], ”Animas” [7], and "Glucomedtech" [14-16]. However, the declared goals are still not attained because of the basic optical sensors’ drawback - instability of measurement results. The instability is owing mainly to random for in vivo conditions variations in concentrations of other (except glucose) bio solutes interfering in the measurements.

Polarimetric glucose sensors also have the necessary sensitivity but are affected by a less number of interfering components of human body due to the high specificity of the observed hiral effect. A similar approach is used by the German Company "Glucomedtech" [14-16]. The German workers pay the main attention to polarimetric measuring methods and means for fine filtering blood (dialysis) for optical analysis. Creating such means is a serious technical problem that is not currently solved. Eye and body liquids are natural pure media not requiring the dialysis. But water, proteins and other micro components present in these fluids also interfere with the task of a spectroscopic and polarimetric glucose determination [3, 24].

The participants in the project have an experience of analogous scientific research in the framework of the city (St-Petersburg) medical-and-social program “Diabetes” [26] employing both spectroscopic [26] and polarimetric [21-23] instruments for assessing glucose. For their reduced interference in the glucose determination the project proposes to develop new, as compared with conventional approaches [3, 4], instrumentation for spectral analysis using a dual-parameter method.

We have developed a revolutionary new method to accurately monitor glucose continuously. Our method combines polarimetric and spectroscopic measurements in one beam. This dual-parameter approach will allow our system to be significantly more accurate than uniparametric systems. Our sensor is implantable. The advantage of implanting the sensor is the removal of the effects of skin optics. Scientists at Texas A&M (College Station, Texas USA) demonstrated that an implantable spectroscopic sensor will remove the effects of skin optics [25].

We expect our implantable polarimetric/spectrometric sensor to be a long-lasting, implantable monitor that uses optical methods to measure blood glucose levels accurately and continuously, and wirelessly transmits the results to an external display unit, as a means of improving the quality of life for diabetics and reducing the costs and complications of this chronic disease. The sensor also could be used with an insulin infusion pump and control algorithms to provide closed-loop control of blood sugar, the equivalent of an artificial pancreas, that would reduce complications of the disease. Recent developments in nanotechnology allow our polarimetric-spectroscopic sensor to be miniaturized – using MEMS (Microelectromechanical Systems). The sensor can now be implantable and have a size about a US Quarter (diameter -1-2 Centimeters). The Ioffe Center for Nanoheterostructure Physics will assist in sensor construction (Director is a Nobel laureate J. Alferov).

The worldwide market for a continuous glucose monitor is estimated to exceed $1 billion annually. The new monitor would reduce monitoring costs and eliminate the need for finger prick tests for 3 million insulin-requiring diabetics in the United States and millions more world wide.

This project fully complies with ISTC’s goals:

1. The project proposes a series of physical and technical studies with subsequent use of them for creating a system for an automatic diabetes therapy – a prototype of artificial pancreas.

2. The project is to be accomplished by a highly qualified creative team of scientists working in different fields and having an experience of co-operation in solving large complex problems. The data obtained in the project’s studies will be laid in the base of technical proposals for creating a prototype of artificial pancreas. This further stage may be developed in the framework of co-operative programs of Russia and other countries for bettering the public health and quality of public life.

3. The project provides a peaceful field of activity to defense scientists. It will help to a closer integration of the scientific community.

References

1. Jacob Jaremko, Otto Rorstad, MD, Advances Toward the Implantable Artificial Pancreas for Treatment of Diabetes. Diabetes Care, 1998, Vol. 21, No. 3, 1998, 444-450.

2. Omar S. Khalil. Spectroscopic and clinical Aspects of Noninvasive Glucose Measurements. Clinical Chemistry 45(2),1999,165-177.

3. Roger J. McNichols, Gerard L. Cote’ Optical glucose sensing in biological fluids: an overview. Journal of Biomedical Optics 5(1), 2000,5-16.

4. Heise H.M., Glucose Measurements by Vibrational Spectroscopy, Handbook of Vibrational Spectroscopy, John M. Chalmers and Peter R. Griffith (Editors), 2002.

5. Heise H.M., et al. Multivariate Determination of Glucose in Whole Blood by Attenuated Total Reflection Infrared Spectroscopy, Anal. Chem., 61, 1989, 2009-2015.

6. P. Bhandare, et al. Multivariate Determination of Glucose in Whole Blood using Partial-least-squares and Artificial Neural Networks Based on Mid-infrared Spectroscopy. Appl. Spectrosc. 47, 1993, 1214-1221.

7. Crothall Katherine D. Implantable sensor and system for in vivo measurement and control of fluid constituent levels. US Patent 6,049,727. 2000.

8. Rosenthal R.D. Method, apparatus for near-infrared quantitative analysis. US Patent 5,703,364. 1997.

9. Masayuki Yokota, Yuji Sato, Ichirou Yamagucki, Takeshi Kenmochi and Toshihiko Yoshino. A compact polarimetric glucose sensor using a high-performance fibre-optic Faradey rotator. Institute of Phusics Publishing / Meas. Sci. Technol. 15(2004) 143-147.

10. Chuan Pu, Yu Hwa Lo, Optical polarization sensing apparatus and method. US Patent 6,188,477 B1, D. 2001-13-02.

11. Heise H.M., et al. Noninvasive blood glucose sensors based on near-infrared spectroscopy. Artificial Organs, vol. 18, 439, 1994.

12. Cote; Gerard l., Fox; Martin D., Northrop; Robert B., Optical glucose sensor apparatus and method, US patent 5,209,231. 1993.

13. Hutchinson, Donald P., Personal glucose monitor, US patent 5,009,230.1991.

14. Barnicol W. K. R., Weiler N., Experiments Aimed at Enabling the Development of an Implantable Glucose Sensor Based on Polarimetry. Biomedizinische Technik, V.40, N.5, 1995.

15. Zirk K., Potzschke H., Barnicol W.K.R., A Minitiaturisable High Sensitive Polarimeter as Detector of an Implantable Glucose Probe: 1. Optical Amplification of the Measuring Quantity, Biomedizinische Technik, Vol. 46, No. 6, 2001; 2. Opto-electronic Amplification and Processing of Measuring Signals, Biomedizinische Technik, Vol. 46, No. 10, 2001.

16. Zirk K., Barnikol W., Device for combined and simultaneous use of several measuring methods for analyzing components of a liquid mixture of several substances, Pat. WO 02/01202 A1 of 3 Jan. 2002.

17. Popov Yu.V.Sorokina O.G., Kukuy L.M. Methods and equipment for the extracorporal optical influence on blood. J. Opt. Technol. N 12, 1994.

18. Petrovsky G. T., Slavin M. D., Slavina L. A., Izvarina N. L., Pankevich M. O., Apparatus and method for noninvasive glucose measurements. US patent 6,097,975 Date 2001.

19. On the seventieth anniversary of the birth of G.T. Petrovsky. Journal of Optical technology, Vol.68, No. 8, August 2001.

20. A. Popov, V.V. Sherstnev, A.N. Baranov, C. Aliber and Yu.P.Yakovlev "Continuous-wave operation of single mode GaInAsSb lasers emitting near 2.2 m at peltier temperatures" Elect. Lett. 1998, vol. 34.

21. Chuvashov V. D. New methods and facilities for polarization refractometry. J. Opt. Technol., Vol. 64, No.3, 1997, 179-181.

22. Chuvashov V.D. RF Patent N 2,088,896 A method for measuring polarization plane rotation angle of optical emission and a photoelectric polarimeter for its implementation. 1997 (1992).

23. Chuvashov V.D. RF Patent N 2,112,937 Polarimeter. 1998 (1992).

24. B. D. Cameron, H. Corde, and G. L. Cote Development of an Optical Polarimeter for in vivo Glucose Monitoring Part of the SPIE Conference on Optical Diagnostics of Biological Fluids San.Jose, California, January 1999.

25. Gerald G. Bosquet, Gerald L. Cote, Ashok Gowda, Roger McNichols, Sohi Rastegar METHOD AND APPARATUS FOR ANALYTE DETECTION USING INTRADERMALLY IMPLANTED SKIN PORT Patent No.: US 6,438,397 B1 Date of Patent: Aug. 20, 2002.

26. Slavina L. A., Chuvashov V. D., et al Report for Medical Komitet (St. – Petersburg) «Development Noninvasive Method and Means for blood glucose in human body sensing», 1999.

27. Yu. D. Akulshin, E.N. Pyatyshev, D. N. Es'kov, V. A. Parfenov Microelectromechanical systems: New possibilities of space-based optoelectronic apparatus J. Opt. Technol. 89(11), November 2002.

28. Lyubimov V.V., Kalintsev A.G., Konovallov A.B., Lyamtsev O.V., Kravtsenyuk O.V., Murzin A.G., Golubkina O.V., Mordvinov G.B., OPMs L.N., Yavorskaya L.M., Application of the photon average trajectories method to real-time reconstruction of tissue in homogeneities in diffuse optical tomography of strongly scattering media, Phys.Med.Biol. 2002 Jun 21; 47(12):2109-28.


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