全部 标题 作者
关键词 摘要

OALib Journal期刊
ISSN: 2333-9721
费用:99美元

查看量下载量

相关文章

更多...
Sensors  2010 

Estimating Plasma Glucose from Interstitial Glucose: The Issue of Calibration Algorithms in Commercial Continuous Glucose Monitoring Devices

DOI: 10.3390/s101210936

Keywords: continuous glucose monitoring, calibration algorithms

Full-Text   Cite this paper   Add to My Lib

Abstract:

Evaluation of metabolic control of diabetic people has been classically performed measuring glucose concentrations in blood samples. Due to the potential improvement it offers in diabetes care, continuous glucose monitoring (CGM) in the subcutaneous tissue is gaining popularity among both patients and physicians. However, devices for CGM measure glucose concentration in compartments other than blood, usually the interstitial space. This means that CGM need calibration against blood glucose values, and the accuracy of the estimation of blood glucose will also depend on the calibration algorithm. The complexity of the relationship between glucose dynamics in blood and the interstitial space, contrasts with the simplistic approach of calibration algorithms currently implemented in commercial CGM devices, translating in suboptimal accuracy. The present review will analyze the issue of calibration algorithms for CGM, focusing exclusively on the commercially available glucose sensors.

References

[1]  UK Prospective Diabetes Study (UKPDS) Group (UPDSG). Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet?1998, 352, 837–853, doi:10.1016/S0140-6736(98)07019-6. 9742976
[2]  DCCT, RG. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med?1993, 329, 977–986, doi:10.1056/NEJM199309303291401. 8366922
[3]  Service, FJ; Molnar, GD; Taylor, WF. Urine glucose analyses during continuous. Jama?1972, 222, 294–298, doi:10.1001/jama.1972.03210030020004. 4678682
[4]  Sonksen, PH; Judd, SL; Lowy, C. Home monitoring of blood-glucose. Method for improving diabetic control. Lancet?1978, 1, 729–732. 76745
[5]  Walford, S; Gale, EA; Allison, SP; Tattersall, RB. Self-monitoring of blood-glucose. Improvement of diabetic control. Lancet?1978, 1, 732–735. 76746
[6]  Danowski, TS; Sunder, JH. Jet injection of insulin during self-monitoring of blood glucose. Diabet Care?1978, 1, 27–33, doi:10.2337/diacare.1.1.27.
[7]  Ikeda, Y; Tajima, N; Minami, N; Ide, Y; Yokoyama, J; Abe, M. Pilot study of self-measurement of blood glucose using the Dextrostix-Eyetone system for juvenile-onset diabetes. Diabetologia?1978, 15, 91–93, doi:10.1007/BF00422251. 700277
[8]  Skyler, JS; Lasky, IA; Skyler, DL; Robertson, EG; Mintz, DH. Home blood glucose monitoring as an aid in diabetes management. Diabet Care?1978, 1, 150–157, doi:10.2337/diacare.1.3.150.
[9]  Cass, AE; Davis, G; Francis, GD; Hill, HA; Aston, WJ; Higgins, IJ; Plotkin, EV; Scott, LD; Turner, AP. Ferrocene-mediated enzyme electrode for amperometric determination of glucose. Anal Chem?1984, 56, 667–671, doi:10.1021/ac00268a018. 6721151
[10]  Newman, JD; Turner, AP. Home blood glucose biosensors: A commercial perspective. Biosens Bioelectron?2005, 20, 2435–2453, doi:10.1016/j.bios.2004.11.012. 15854818
[11]  Goldstein, DE; Little, RR; Lorenz, RA; Malone, JI; Nathan, DM; Peterson, CM. Tests of glycemia in diabetes. Diabet Care?2004, 27, 91–93, doi:10.2337/diacare.27.2007.S91.
[12]  Chang, KW; Aisenberg, S; Soeldner, JS; Hiebert, JM. Validation and bioengineering aspects of an implantable glucose sensor. Trans Amer Soc Artif Intern Organ?1973, 19, 352–360, doi:10.1097/00002480-197301900-00060.
[13]  Bessman, SP; Schultz, RD. Progress toward a glucose sensor for the artificial pancreas. Adv Exp Med Biol?1974, 50, 189–196. 4613153
[14]  Layne, EC; Schultz, RD; Thomas, LJ; Slama, G; Sayler, DF; Bessman, SP. Continuous extracorporeal monitoring of animal blood using the glucose electrode. Diabetes?1976, 25, 81–89, doi:10.2337/diabetes.25.2.81. 1248675
[15]  Gough, DA; Andrade, JD. Enzyme electrodes. Science?1973, 180, 380–384, doi:10.1126/science.180.4084.380. 4573391
[16]  Williams, DL; Doig, AR, Jr; Korosi, A. Electrochemical-enzymatic analysis of blood glucose and lactate. Anal Chem?1970, 42, 118–121, doi:10.1021/ac60283a032. 5409504
[17]  Albisser, AM; Leibel, BS; Ewart, TG; Davidovac, Z; Botz, CK; Zingg, W. An artificial endocrine pancreas. Diabetes?1974, 23, 389–396. 4598089
[18]  Albisser, AM; Leibel, BS; Ewart, TG; Davidovac, Z; Botz, CK; Zingg, W; Schipper, H; Gander, R. Clinical control of diabetes by the artificial pancreas. Diabetes?1974, 23, 397–404. 4598090
[19]  Pfeiffer, EF; Thum, C; Clemens, AH. The artificial beta cell—A continuous control of blood sugar by external regulation of insulin infusion (glucose controlled insulin infusion system). Horm Metab Res?1974, 6, 339–342, doi:10.1055/s-0028-1093841. 4607598
[20]  Fogt, EJ; Dodd, LM; Jenning, EM; Clemens, AH. Development and evaluation of a glucose analyzer for a glucose controlled insulin infusion system ((Biostator). Clin Chem?1978, 24, 1366–1372. 679460
[21]  Mastrototaro, J. The miniMed continuous glucose monitoring system (CGMS). J Pediatr Endocrinol Metab?1999, 12, 751–758. 10626266
[22]  Girardin, CM; Huot, C; Gonthier, M; Delvin, E. Continuous glucose monitoring: A review of biochemical perspectives and clinical use in type 1 diabetes. Clin Biochem?2009, 42, 136–142, doi:10.1016/j.clinbiochem.2008.09.112. 18951887
[23]  Aussedat, B; Dupire-Angel, M; Gifford, R; Klein, JC; Wilson, GS; Reach, G. Interstitial glucose concentration and glycemia: implications for continuous subcutaneous glucose monitoring. Amer J Physiol Endocrinol Metab?2000, 278, E716–E728.
[24]  Jansson, PA; Fowelin, J; Smith, U; Lonnroth, P. Characterization by microdialysis of intracellular glucose level in subcutaneous tissue in humans. Amer J Physiol?1988, 255, E218–E220. 3407771
[25]  Thome-Duret, V; Reach, G; Gangnerau, MN; Lemonnier, F; Klein, JC; Zhang, Y; Hu, Y; Wilson, GS. Use of a subcutaneous glucose sensor to detect decreases in glucose concentration prior to observation in blood. Anal Chem?1996, 68, 3822–3826, doi:10.1021/ac960069i. 8914483
[26]  Monsod, TP; Flanagan, DE; Rife, F; Saenz, R; Caprio, S; Sherwin, RS; Tamborlane, WV. Do sensor glucose levels accurately predict plasma glucose concentrations during hypoglycemia and hyperinsulinemia. Diabet Care?2002, 25, 889–893, doi:10.2337/diacare.25.5.889.
[27]  Boyne, MS; Silver, DM; Kaplan, J; Saudek, CD. Timing of changes in interstitial and venous blood glucose measured with a continuous subcutaneous glucose sensor. Diabetes?2003, 52, 2790–2794, doi:10.2337/diabetes.52.11.2790. 14578298
[28]  Sternberg, F; Meyerhoff, C; Mennel, FJ; Mayer, H; Bischof, F; Pfeiffer, EF. Does fall in tissue glucose precede fall in blood glucose. Diabetologia?1996, 39, 609–612, doi:10.1007/BF00403309. 8739922
[29]  Rebrin, K; Steil, GM; van Antwerp, WP; Mastrototaro, JJ. Subcutaneous glucose predicts plasma glucose independent of insulin: Implications for continuous monitoring. Amer J Physiol?1999, 277, E561–E571. 10484370
[30]  Heller, A; Feldman, B. Electrochemical glucose sensors and their applications in diabetes management. Chem Rev?2008, 108, 2482–2505, doi:10.1021/cr068069y. 18465900
[31]  Oliver, NS; Toumazou, C; Cass, AE; Johnston, DG. Glucose sensors: A review of current and emerging technology. Diabet Med?2009, 26, 197–210, doi:10.1111/j.1464-5491.2008.02642.x. 19317813
[32]  Wang, J. Electrochemical glucose biosensors. Chem Rev?2008, 108, 814–825, doi:10.1021/cr068123a. 18154363
[33]  McGarraugh, G. The chemistry of commercial continuous glucose monitors. Diabet Technol Ther?2009, 11, S17–S24.
[34]  Schuhmann, W. Amperometric enzyme biosensors based on optimised electron-transfer pathways and non-manual immobilisation procedures. J Biotechnol?2002, 82, 425–441. 11996220
[35]  Degani, Y; Heller, A. Direct electrical communication between chemically modified enzymes and metal electrodes. 1. Electron transfer from glucose oxidase to metal electrodes via electron relays, bound covalently to the enzyme. J Phys Chem?1987, 91, 1285–1289, doi:10.1021/j100290a001.
[36]  Crone, C. Capillary permeability to small solutes. In Handbook of Physiology: The Cardiovascular system, Microcirculation; American Physiology Society: Bethesda, MD, USA, 1984; Volume IV, pp. 411–466.
[37]  Renkin, E. Capillary permeability to small solutes. In Handbook of Physiology: The Cardiovascular system, Microcirculation; American Physiology Society: Bethesda, MD, USA, 1984; Volume IV.
[38]  Regittnig, W; Ellmerer, M; Fauler, G; Sendlhofer, G; Trajanoski, Z; Leis, HJ; Schaupp, L; Wach, P; Pieber, TR. Assessment of transcapillary glucose exchange in human skeletal muscle and adipose tissue. Amer J Physiol Endocrinol Metab?2003, 285, E241–E251.
[39]  Jensen, BM; Bjerring, P; Christiansen, JS; Orskov, H. Glucose content in human skin: Relationship with blood glucose levels. Scand J Clin Lab Invest?1995, 55, 427–432, doi:10.3109/00365519509104982. 8545601
[40]  Bailey, T; Zisser, H; Chang, A. New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. Diabet Technol Ther?2009, 11, 749–755, doi:10.1089/dia.2009.0075.
[41]  Garg, SK; Voelmle, M; Gottlieb, PA. Time lag characterization of two continuous glucose monitoring systems. Diabet Res Clin Pract?2009, 1, S11–S16.
[42]  Kamath, A; Mahalingam, A; Brauker, J. Analysis of time lags and other sources of error of the DexCom SEVEN continuous glucose monitor. Diabet Technol Ther?2009, 11, 689–695, doi:10.1089/dia.2009.0060.
[43]  Kovatchev, BP; Shields, D; Breton, M. Graphical and numerical evaluation of continuous glucose sensing time lag. Diabet Technol Ther?2009, 11, 139–143, doi:10.1089/dia.2008.0044.
[44]  Kulcu, E; Tamada, JA; Reach, G; Potts, RO; Lesho, MJ. Physiological differences between interstitial glucose and blood glucose measured in human subjects. Diabet Care?2003, 26, 2405–2409, doi:10.2337/diacare.26.8.2405.
[45]  Stout, PJ; Peled, N; Erickson, BJ; Hilgers, ME; Racchini, JR; Hoegh, TB. Comparison of glucose levels in dermal interstitial fluid and finger capillary blood. Diabet Technol Ther?2001, 3, 81–90, doi:10.1089/152091501750220046.
[46]  Wentholt, IM; Hart, AA; Hoekstra, JB; Devries, JH. Relationship between interstitial and blood glucose in type 1 diabetes patients: Delay and the push-pull phenomenon revisited. Diabet Technol Ther?2007, 9, 169–175, doi:10.1089/dia.2006.0007.
[47]  Kovatchev, B; Anderson, S; Heinemann, L; Clarke, W. Comparison of the numerical and clinical accuracy of four continuous glucose monitors. Diabet Care?2008, 31, 1160–1164, doi:10.2337/dc07-2401.
[48]  Moberg, E; Hagstrom-Toft, E; Arner, P; Bolinder, J. Protracted glucose fall in subcutaneous adipose tissue and skeletal muscle compared with blood during insulin-induced hypoglycaemia. Diabetologia?1997, 40, 1320–1326, doi:10.1007/s001250050827. 9389425
[49]  Koschwanez, HE; Reichert, WM. In vitro, in vivo and post explantation testing of glucose-detecting biosensors: current methods and recommendations. Biomaterials?2007, 28, 3687–3703, doi:10.1016/j.biomaterials.2007.03.034. 17524479
[50]  Onuki, Y; Bhardwaj, U; Papadimitrakopoulos, F; Burgess, DJ. A review of the biocompatibility of implantable devices: current challenges to overcome foreign body response. J Diabet Sci Technol?2008, 2, 1003–1015.
[51]  Yu, B; Wang, C; Ju, YM; West, L; Harmon, J; Moussy, Y; Moussy, F. Use of hydrogel coating to improve the performance of implanted glucose sensors. Biosens Bioelectron?2008, 23, 1278–1284, doi:10.1016/j.bios.2007.11.010. 18182283
[52]  Hoss, U; Jeddi, I; Schulz, M; Budiman, E; Bhogal, C; McGarraugh, G. Continuous glucose monitoring in subcutaneous tissue using factory-calibrated sensors: A pilot study. Diabet Technol Ther?2010, 12, 591–597, doi:10.1089/dia.2010.0051.
[53]  Hirsch, IB; Bode, BW; Childs, BP; Close, KL; Fisher, WA; Gavin, JR; Ginsberg, BH; Raine, CH; Verderese, CA. Self-monitoring of blood glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: Consensus recommendations for improving SMBG accuracy, utilization, and research. Diabet Technol Ther?2008, 10, 419–439, doi:10.1089/dia.2008.0104.
[54]  Skeie, S; Thue, G; Nerhus, K; Sandberg, S. Instruments for self-monitoring of blood glucose: Comparisons of testing quality achieved by patients and a technician. Clin Chem?2002, 48, 994–1003. 12089166
[55]  Kuwa, K; Nakayama, T; Hoshino, T; Tominaga, M. Relationships of glucose concentrations in capillary whole blood, venous whole blood and venous plasma. Clin Chim Acta?2001, 307, 187–192, doi:10.1016/S0009-8981(01)00426-0. 11369356
[56]  Colagiuri, S; Sandbaek, A; Carstensen, B; Christensen, J; Glumer, C; Lauritzen, T; Borch-Johnsen, K. Comparability of venous and capillary glucose measurements in blood. Diabet Med?2003, 20, 953–956, doi:10.1046/j.1464-5491.2003.01048.x. 14632723
[57]  Buckingham, BA; Kollman, C; Beck, R; Kalajian, A; Fiallo-Scharer, R; Tansey, M; Fox, LA; Wilson, DM; Weinzimer, SA; Ruedy, KJ; Tamborlane, WV. Evaluation of factors affecting CGMS calibration. Diabet Technol Ther?2006, 8, 318–325, doi:10.1089/dia.2006.8.318.
[58]  Wolpert, HA. The nuts and bolts of achieving end points with real-time continuous glucose monitoring. Diabet Care?2008, 31, S146–149, doi:10.2337/dc08-s238.
[59]  King, C; Anderson, SM; Breton, M; Clarke, WL; Kovatchev, BP. Modeling of calibration effectiveness and blood-to-interstitial glucose dynamics as potential confounders of the accuracy of continuous glucose sensors during hyperinsulinemic clamp. J Diabet Sci Technol?2007, 1, 317–322.
[60]  Choleau, C; Klein, JC; Reach, G; Aussedat, B; Demaria-Pesce, V; Wilson, GS; Gifford, R; Ward, WK. Calibration of a subcutaneous amperometric glucose sensor implanted for 7 days in diabetic patients. Part 2. Superiority of the one-point calibration method. Biosens Bioelectron?2002, 17, 647–654, doi:10.1016/S0956-5663(01)00304-9. 12052350
[61]  Choleau, C; Klein, JC; Reach, G; Aussedat, B; Demaria-Pesce, V; Wilson, GS; Gifford, R; Ward, WK. Calibration of a subcutaneous amperometric glucose sensor. Part 1. Effect of measurement uncertainties on the determination of sensor sensitivity and background current. Biosens Bioelectron?2002, 17, 641–646, doi:10.1016/S0956-5663(01)00306-2. 12052349
[62]  Bequette, BW. Continuous glucose monitoring: Real-time algorithms for calibration, filtering, and alarms. J Diabet Sci Technol?2010, 4, 404–418.
[63]  Mastrototaro, J. Glucose Monitor Calibration MethodsU.S. Patent 6,424,847 B1. 23, July, 2002.
[64]  Minimed, M. Minimed Medtronic CGMS System Solutions Software User Guide, 3rd ed ed.; Medtronic MiniMed: Northridge, CA, USA, 2003.
[65]  Shin, JJ; Holtzclaw, R; Danbgui, ND; Kanderian, S; Mastrototaro, J; Hong, PI. Real Time Self-Adjusting Calibration AlgorithmU.S. Patent 7,029,444 B2. 18, April, 2006.
[66]  Mueller, J; John, C; Keenan, D; Wang, L; Mastrototaro, J. Modified Sensor Calibration AlgorithmU.S. Patent 2009/0112478 A1. 30, April, 2009.
[67]  Goode, P; Brauker, J; Kamath, A. System and Methods for Processing Analyte Sensor DataU.S. Patent 6,931,327 B2. 16, August, 2005.
[68]  Kamath, A; Simpson, P; Brauker, J; Goode, P. Calibration Techniques for Continuous Analyte SensorU.S. Patent 20100063373 A1. 11, March, 2010.
[69]  Feldman, B; McGarraugh, G. Method of Calibrating an Analyte Measurement Device, and Associated Methods, Devices and SystemsU.S. Patent 7,299,082 B2. 20, November, 2007.
[70]  Hayter, G; Doniger, K; Budiman, E; Zhang, S; Mazza, J. Method and System for Providing Calibration of an Analyte Sensor in an Analyte Monitoring SystemU.S. Patent 0039702 A1. 14, February, 2008.
[71]  Hayter, G; Budiman, E; Doniger, K; Zhang, S; Mazza, J. Method and System for Dynamically Updatting Calibration Parameters for an Analyte SensorU.S. Patent 0081977 A1. 3, April, 2008.
[72]  Weinstein, RL; Schwartz, SL; Brazg, RL; Bugler, JR; Peyser, TA; McGarraugh, GV. Accuracy of the 5-day freeStyle navigator continuous glucose monitoring system: Comparison with frequent laboratory reference measurements. Diabet Care?2007, 30, 1125–1130, doi:10.2337/dc06-1602.
[73]  Mazze, RS; Strock, E; Borgman, S; Wesley, D; Stout, P; Racchini, J. Evaluating the accuracy, reliability, and clinical applicability of continuous glucose monitoring (CGM): Is CGM ready for real time? Diabet Technol Ther?2009, 11, 11–18, doi:10.1089/dia.2008.0041.
[74]  Keenan, DB; Cartaya, R; Mastrototaro, JJ. Accuracy of a new real-time continuous glucose monitoring algorithm. J Diabet Sci Technol?2010, 4, 111–118.
[75]  Leal, Y; Garcia-Gabin, W; Bondia, J; Esteve, E; Ricart, W; Fernandez-Real, JM; Vehi, J. Real-time glucose estimation algorithm for continuous glucose monitoring using autoregressive models. J Diabet Sci Technol?2010, 4, 391–403.
[76]  Kuure-Kinsey, M; Palerm, CC; Bequette, BW. A dual-rate Kalman filter for continuous glucose monitoring. IEEE Eng Med Biol Soc?2006, 1, 63–66.
[77]  Knobbe, EJ; Buckingham, B. The extended Kalman filter for continuous glucose monitoring. Diabet Technol Ther?2005, 7, 15–27, doi:10.1089/dia.2005.7.15.
[78]  Facchinetti, A; Sparacino, G; Cobelli, C. Enhanced accuracy of continuous glucose monitoring by online extended kalman filtering. Diabet Technol Ther?2010, 12, 353–363, doi:10.1089/dia.2009.0158.

Full-Text

Contact Us

service@oalib.com

QQ:3279437679

WhatsApp +8615387084133