First clinical evaluation of a new percutaneous optical fiber glucose sensor for continuous glucose monitoring in diabetes

Journal of Diabetes Science and Technology

Volumn 7, Issue 1, 2013, Pages 13-23

  Müller, Achim Josef ^a   Knuth, Monika ^a   Nikolaus, Katharina Sibylle ^a   Krivánek, Roland ^a   Küster, Frank ^a   Hasslacher, Christoph ^b  

^a EyeSense   (Germany)

^b Diabetesinstitut Heidelberg   (Germany)

Author keywords

Concanavalin A; Continuous glucose monitoring; Diabetes; Fluorescence; Glucose sensor

Indexed keywords

CARBOHYDRATE; GLASS FIBER; GLUCOSE; INSULIN;

ADULT; BLOOD GLUCOSE MONITORING; CARBOHYDRATE INTAKE; CLINICAL ARTICLE; CLINICAL EVALUATION; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DIABETIC PATIENT; FEMALE; FIBER OPTICS; GLUCOSE BLOOD LEVEL; GLUCOSE SENSOR; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; PHOTOMETER; SUBCUTANEOUS TISSUE; ULTRAVIOLET RADIATION; AMBULATORY MONITORING; ARTICLE; BLOOD; CLINICAL TRIAL; EQUIPMENT; FLUORESCENCE RESONANCE ENERGY TRANSFER; GENETIC PROCEDURES; METHODOLOGY; MIDDLE AGED;

BIOSENSING TECHNIQUES; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES MELLITUS; FEMALE; FLUORESCENCE RESONANCE ENERGY TRANSFER; HUMANS; MALE; MIDDLE AGED; MONITORING, AMBULATORY;

EID: 84882933923     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681300700103     Document Type: Conference Paper

References (32)

1. The Diabetes Control and Complications Trial Research Group. 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(14):977-86.
2. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009;32(8):1378-83.
3. Garg SK, Kelly WC, Voelmle MK, Ritchie PJ, Gottlieb PA, McFann KK, Ellis SL. Continuous home monitoring of glucose: improved glycemic control with real-life use of continuous glucose sensors in adult subjects with type 1 diabetes. Diabetes Care. 2007;30(12):3023-5. (Pubitemid 350255236)
4. Klonof DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005;28(5):1231-9.
5. Mastrototaro JJ. The MiniMed continuous glucose monitoring system. Diabetes Technol Ther. 2000;2 Suppl 1:S13-8. (Pubitemid 32107467)
6. Feldman B, Brazg R, Schwartz S, Weinstein R. A continuous glucose sensor based on wired enzyme technology - results from a 3-day trial in patients with type 1 diabetes. Diabetes Technol Ther. 2003;5(5):769-79. (Pubitemid 37339539)
7. 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. Diabetes Care. 2007;30(5):1125-30. (Pubitemid 46684636)
8. Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006;29(1):44-50. (Pubitemid 44033429)
9. Zisser HC, Bailey TS, Schwartz S, Ratner RE, Wise J. Accuracy of the SEVEN continuous glucose monitoring system: comparison with frequently sampled venous glucose measurements. J Diabetes Sci Technol. 2009;3(5):1146-54.
10. Rossetti P, Bondia J, Vehi J, Fanelli CG. Estimating plasma glucose from interstitial glucose: the issue of calibration algorithms in commercial continuous glucose monitoring devices. Sensors (Basel). 2010;10(12):10936-52.
11. Dassau E, Zisser H, C Palerm C, A Buckingham B, Jovanovic L, J Doyle F 3rd. Modular artificial beta-cell system: A prototype for clinical research. J Diabetes Sci Technol. 2008;2(5):863-72.
12. Schultz JS, Mansouri S, Goldstein IJ. Affinity sensor: a new technique for developing implantable sensors for glucose and other metabolites. Diabetes Care. 1982;5(3):245-53. (Pubitemid 12117174)
13. Mansouri S, Schultz JS. A miniature optical glucose sensor based on affinity binding. Biotechnol. 1984;2:885-90.
14. Meadows D, Schultz JS. Fiber-optic biosensors based on fluorescence energy transfer. Talanta. 1988;35(2):145-50.
15. Meadows DL, Schultz JS. Design, manufacture and characterization of an optical fiber glucose affinity sensor based on an homogenous fluorescence energy transfer assay system. Anal Chim Acta. 1993;280(1):21-30. (Pubitemid 23223897)
16. Ballerstadt R, Schultz JS. Competitive-binding assay method based on fluorescence quenching of ligands held in close proximity by a multivalent receptor. Anal Chim Acta. 1997;345(1):203-12. (Pubitemid 27273977)
17. Schultz JS, Sims G. Affinity sensors for individual metabolites. Biotechnol Bioeng Symp. 1979;(9):65-71. (Pubitemid 10108626)
18. Russell RJ, Pishko MV, Gefrides CC, McShane MJ, Coté GL. A fluorescence-based glucose biosensor using concanavalin A and dextran encapsulated in a poly(ethylene glycol) hydrogel. Anal Chem. 1999;71(15):3126-32. (Pubitemid 29372728)
19. Ballerstadt R, Schultz JS. A fluorescence affinity hollow fiber sensor for continuous transdermal glucose monitoring. Anal Chem. 2000;72(17):4185-92.
20. Ballerstadt R, Polak A, Beuhler A, Frye J. In vitro long-term performance study of a near-infrared fluorescence affinity sensor for glucose monitoring. Biosens Bioelectron. 2004;19(8):905-14. (Pubitemid 38201341)
21. Ballerstadt R, Evans C, Gowda A, McNichols R. In vivo performance evaluation of a transdermal near-infrared fluorescence resonance energy transfer affinity sensor for continuous glucose monitoring. Diabetes Technol Ther. 2006;8(3):296-311. (Pubitemid 46100524)
22. Ballerstadt R, Evans C, Gowda A, McNichols R. Fiber-coupled fluorescence affinity sensor for 3-day in vivo glucose sensing. J Diabetes Sci Technol. 2007;1(3):384-93.
23. Pickup JC, Hussain F, Evans ND, Rolinski OJ, Birch DJ. Fluorescence-based glucose sensors. Biosens Bioelectron. 2005;20(12):2555-65. (Pubitemid 40602188)
24. Dutt-Ballerstadt R, Evans C, Gowda A, McNichols R. Preclinical in vivo study of a fluorescence affinity sensor for short-term continuous glucose monitoring in a small and large animal model. Diabetes Technol Ther. 2008;10(6):453-60.
25. Dutt-Ballerstadt R, Evans C, Pillai AP, Orzeck E, Drabek R, Gowda A, McNichols R. A human pilot study of the fluorescence affinity sensor for continuous glucose monitoring in diabetes. J Diabetes Sci Technol. 2012;6(2):362-70.
26. Müller AJ, Knuth M, Nikolaus KS, Herbrechtsmeier P. First clinical evaluation of a new long-term subconjunctival glucose sensor. J Diabetes Sci Technol. 2012;6(4):875-83.
27. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-8. (Pubitemid 30616803)
28. Kovatchev BP, Clarke WL, Breton M, Brayman K, McCall A. Quantifying temporal glucose variability in diabetes via continuous glucose monitoring: mathematical methods and clinical application. Diabetes Technol Ther. 2005;7(6):849-62. (Pubitemid 43133992)
29. Bremer TM, Edelman SV, Gough DA. Benchmark data from the literature for evaluation of new glucose sensing technologies. Diabetes Technol Ther. 2001;3(3):409-18. (Pubitemid 33032551)
30. Kamath A, Mahalingam A, Brauker J. Analysis of time lags and other sources of error of the Dexcom SEVEN continuous glucose monitor. Diabetes Technol Ther. 2009;11(11):689-95.
31. Hasslacher C, Aufarth G, Platten I, Rabsilber T, Smith B, Kulozik F, Knuth M, Nikolaus K, Müller A. Safety and accuracy of a new long-term subconjunctival glucose sensor. J Diabetes. 2012;4(3):291-6.
32. Müller AJ, Knuth M, Nikolaus KS, Krivánek R, Küster F, Hasslacher C, Aufarth G. Blood glucose self-monitoring with a long-term subconjunctival glucose sensor. J Diabetes Sci Technol. 2013;7(1):24-34.