Is it possible to constantly and accurately monitor blood sugar levels, in people with Type 1 diabetes, with a discrete device (non-invasive or invasive)?

P Avari, M Reddy, N Oliver
Author Information
  1. P Avari: Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK. ORCID
  2. M Reddy: Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK.
  3. N Oliver: Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, London, UK. ORCID

Abstract

Real-time continuous glucose monitors using subcutaneous needle-type sensors continue to develop. The limitations of currently available systems, however, include time lag behind changes in blood glucose, the invasive nature of such systems, and in some cases, their accuracy. Non-invasive techniques have been developed, but, to date, no commercial device has been successful. A key research priority for people with Type 1 diabetes identified by the James Lind Alliance was to identify ways of monitoring blood glucose constantly and accurately using a discrete device, invasive or non-invasive. Integration of such a sensor is important in the development of a closed-loop system and the technology must be rapid, selective and acceptable for continuous use by individuals. The present review provides an update on existing continuous glucose-sensing technologies, and an overview of emergent techniques, including their accuracy and limitations.

References

  1. Gadsby R, Snow R, Daly AC, Crowe S, Matyka K, Hall B et al. Setting research priorities for Type 1 diabetes. Diabet Med 2012; 29: 1321-1326.
  2. National Institute for Health and Care Excellence (NICE). Type 1 diabetes in adults: diagnosis and management, Guidance and guidelines (NG17). London: NICE, 2015.
  3. Vashist SK. Non-invasive glucose monitoring technology in diabetes management: a review. Anal Chim Acta 2012; 750: 16-27.
  4. Insights M. Glucose Biosensor Market Size to Reach $31 Billion by 2022 | Million Insights. @PRNewswire; 2018. Contract No.: 18.09.2018. Available at https://www.prnewswire.com/news-releases/glucose-biosensor-market-size-to-reach-31-billion-by-2022--million-insights-681600061.html Last accessed 27 Feb 2019">http: https://www.prnewswire.com/news-releases/glucose-biosensor-market-size-to-reach-31-billion-by-2022--million-insights-681600061.html Last accessed 27 February 2019.
  5. Parkin CG, Graham C, Smolskis J. Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization. J Diabetes Sci Technol 2017; 11: 522-528.
  6. Toschi E, Wolpert H. Utility of Continuous Glucose Monitoring in Type 1 and Type 2 Diabetes. Endocrinol Metab Clin North Am 2016; 45: 895-904.
  7. Polonsky WH, Hessler D, Ruedy KJ, Beck RW. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care 2017; 40: 736-741.
  8. Litchman ML, Allen NA. Real-Time Continuous Glucose Monitoring Facilitates Feelings of Safety in Older Adults With Type 1 Diabetes: A Qualitative Study. J Diabetes Sci Technol 2017; 11: 988-995.
  9. Hovorka R, Nodale M, Haidar A, Wilinska ME. Assessing performance of closed-loop insulin delivery systems by continuous glucose monitoring: drawbacks and way forward. Diabetes Technol Ther 2013; 15: 4-12.
  10. Chaugule S, Oliver N, Klinkenbijl B, Graham C. An Economic Evaluation of Continuous Glucose Monitoring for People with Type 1 Diabetes and Impaired Awareness of Hypoglycaemia within North West London Clinical Commissioning Groups in England. Eur Endocrinol 2017; 13: 81-85.
  11. Kovatchev BP, Patek SD, Ortiz EA, Breton MD. Assessing sensor accuracy for non-adjunct use of continuous glucose monitoring. Diabetes Technol Ther 2015; 17: 177-186.
  12. Bailey TS. Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors. Diabetes Technol Ther 2017; 19(S2): S51-S54.
  13. Cass AE, Sharma S. Microneedle Enzyme Sensor Arrays for Continuous In Vivo Monitoring. Methods Enzymol 2017; 589: 413-427.
  14. Christiansen MP, Garg SK, Brazg R, Bode BW, Bailey TS, Slover RH et al. Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor. Diabetes Technol Ther 2017; 19: 446-456.
  15. Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther 2015; 17: 787-794.
  16. Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol 2015; 9: 209-214.
  17. Shah VN, Laffel LM, Wadwa RP, Garg SK. Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator. Diabetes Technol Ther 2018; 20: 428-433.
  18. Wadwa RP, Laffel LM, Shah VN, Garg SK. Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes. Diabetes Technol Ther 2018; 20: 395-402.
  19. Christiansen MP, Klaff LJ, Brazg R, Chang AR, Levy CJ, Lam D et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther 2018; 20: 197-206.
  20. Zhou J, Zhang S, Li L, Wang Y, Lu W, Sheng C et al. Performance of a new real-time continuous glucose monitoring system: A multicenter pilot study. J Diabetes Investig 2018; 9: 286-293.
  21. Tanenbaum ML, Hanes SJ, Miller KM, Naranjo D, Bensen R, Hood KK. Diabetes Device Use in Adults With Type 1 Diabetes: Barriers to Uptake and Potential Intervention Targets. Diabetes Care 2017; 40: 181-187.
  22. Wong JC, Foster NC, Maahs DM, Raghinaru D, Bergenstal RM, Ahmann AJ et al. Real-time continuous glucose monitoring among participants in the T1D Exchange clinic registry. Diabetes Care 2014; 37: 2702-2709.
  23. Perera R, Oliver N, Wilmot E, Marriott C. Variations in access to and reimbursement for continuous glucose monitoring systems for people living with Type 1 diabetes across England. Diabet Med 2018; 35: 1617-1618.
  24. Joseph JI, Hipszer B, Mraovic B, Chervoneva I, Joseph M, Grunwald Z. Clinical need for continuous glucose monitoring in the hospital. J Diabetes Sci Technol 2009; 3: 1309-1318.
  25. van Steen SC, Rijkenberg S, Limpens J, van der Voort PH, Hermanides J, DeVries JH. The Clinical Benefits and Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients-A Systematic Scoping Review. Sensors (Basel) 2017;17:pii: E146.
  26. Schierenbeck F, Franco-Cereceda A, Liska J. Accuracy of 2 Different Continuous Glucose Monitoring Systems in Patients Undergoing Cardiac Surgery. J Diabetes Sci Technol 2017; 11: 108-116.
  27. Strasma PJ, Finfer S, Flower O, Hipszer B, Kosiborod M, Macken L et al. Use of an Intravascular Fluorescent Continuous Glucose Sensor in ICU Patients. J Diabetes Sci Technol 2015; 9: 762-770.
  28. Smith JL, Rice MJ. Why Have So Many Intravascular Glucose Monitoring Devices Failed? J Diabetes Sci Technol 2015; 9: 782-791.
  29. Damiano ER, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. A Comparative Effectiveness Analysis of Three Continuous Glucose Monitors. Diabetes Care 2013; 36: 251-259.
  30. Bochicchio GV, Nasraway S, Moore L, Furnary A, Nohra E, Bochicchio K. Results of a multicenter prospective pivotal trial of the first inline continuous glucose monitor in critically ill patients. J Trauma Acute Care Surg 2017; 82: 1049-1054.
  31. Crane BC, Barwell NP, Gopal P, Gopichand M, Higgs T, James TD et al. The Development of a Continuous Intravascular Glucose Monitoring Sensor. J Diabetes Sci Technol 2015; 9: 751-761.
  32. Donnelly R, Douroumis D. Microneedles for drug and vaccine delivery and patient monitoring. Drug Deliv Transl Res 2015; 5(4): 311-312.
  33. Chua B, Desai SP, Tierney MJ, Tamada JA, Jina AN. Effect of microneedles shape on skin penetration and minimally invasive continuous glucose monitoring in vivo. Sensors and Actuators A: Physical. 2013; 203: 373-381.
  34. Sharma S, El-Laboudi A, Reddy M, Jugnee N, Sivasubramaniyam S, Sharkawy ME et al. A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring. Anal Methods 2018; 10: 2088-2095.
  35. Tsalikian E, Kollman C, Mauras N, Weinzimer S, Buckingham B, Xing D et al. GlucoWatch G2 Biographer alarm reliability during hypoglycemia in children. Diabetes Technol Ther 2004; 6: 559-566.
  36. Bandodkar AJ, Jia W, Yardimci C, Wang X, Ramirez J, Wang J. Tattoo-based noninvasive glucose monitoring: a proof-of-concept study. Anal Chem 2015; 87: 394-398.
  37. Kim J, Campbell AS, Wang J. Wearable non-invasive epidermal glucose sensors: A review. Talanta. 2018; 177: 163-170.
  38. Sato T, Okada S, Hagino K, Asakura Y, Kikkawa Y, Kojima J et al. Measurement of glucose area under the curve using minimally invasive interstitial fluid extraction technology: evaluation of glucose monitoring concepts without blood sampling. Diabetes Technol Ther 2011; 13: 1194-200.
  39. Sieg A, Guy RH, Delgado-Charro MB. Noninvasive and minimally invasive methods for transdermal glucose monitoring. Diabetes Technol Ther 2005; 7: 174-197.
  40. Wentholt IM, Hoekstra JB, Zwart A, DeVries JH. Pendra goes Dutch: lessons for the CE mark in Europe. Diabetologia 2005; 48: 1055-1058.
  41. Kost J, Mitragotri S, Gabbay RA, Pishko M, Langer R. Transdermal monitoring of glucose and other analytes using ultrasound. Nat Med 2000; 6: 347-350.
  42. Oliver NS, Toumazou C, Cass AE, Johnston DG. Glucose sensors: a review of current and emerging technology. Diabet Med 2009; 26: 197-210.
  43. Yadav J, Rani A, Singh V, Murari BM. Prospects and limitations of non-invasive blood glucose monitoring using near-infrared spectroscopy. Biomed Signal Process Control 2015; 18: 214-227.
  44. Vaddiraju S, Burgess DJ, Tomazos I, Jain FC, Papadimitrakopoulos F. Technologies for continuous glucose monitoring: current problems and future promises. J Diabetes Sci Technol 2010; 4: 1540-1562.
  45. Klonoff DC. Overview of Fluorescence Glucose Sensing: A Technology with a Bright Future. J Diabetes Sci Technol 2012; 6: 1242-1250.
  46. Kropff J, Choudhary P, Neupane S, Barnard K, Bain SC, Kapitza C et al. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter. Pivotal Trial. Diabetes Care 2017; 40: 63-68.
  47. Sahu RK, Mordechai S. Spectroscopic techniques in medicine: The future of diagnostics. Appl Spectrosc Rev 2016; 51: 484-499.
  48. Vashist SK. Continuous Glucose Monitoring Systems: A Review. Diagnostics (Basel). 2013; 3: 385-412.
  49. Rojahn S. The Failure of C8 Medisensors’ Bid to Make a Mobile Blood Sugar Monitor 2014. Available at https://www.technologyreview.com/s/529026/blood-sugar-crash/.
  50. Pirnstill CW, Malik BH, Gresham VC, Cote GL. In vivo glucose monitoring using dual-wavelength polarimetry to overcome corneal birefringence in the presence of motion. Diabetes Technol Ther 2012; 14: 819-827.
  51. Gabbay RA, Sivarajah S. Optical coherence tomography-based continuous noninvasive glucose monitoring in patients with diabetes. Diabetes Technol Ther 2008; 10: 188-193.
  52. Amir O, Weinstein D, Zilberman S, Less M, Perl-Treves D, Primack H et al. Continuous noninvasive glucose monitoring technology based on “occlusion spectroscopy”. J Diabetes Sci Technol 2007; 1: 463-469.
  53. Ghazaryan A, Ovsepian SV, Ntziachristos V. Extended Near-Infrared Optoacoustic Spectrometry for Sensing Physiological Concentrations of Glucose. Front Endocrinol (Lausanne) 2018; 9: 112.
  54. Pleitez MA, Lieblein T, Bauer A, Hertzberg O, von Lilienfeld-Toal H, Mantele W. In vivo noninvasive monitoring of glucose concentration in human epidermis by mid-infrared pulsed photoacoustic spectroscopy. Anal Chem 2013; 85: 1013-1020.
  55. Sim JY, Ahn CG, Jeong EJ, Kim BK. In vivo Microscopic Photoacoustic Spectroscopy for Non-Invasive Glucose Monitoring Invulnerable to Skin Secretion Products. Sci Rep 2018; 8: 1059.
  56. Choi H LS, Beutler J, Porch A. Microwave noninvasive blood glucose monitoring sensor: Human clinical trial results - IEEE Conference Publication. IEEE MTT-S International Microwave Symposium; Honololu, HI, USA: IEEE, 2017.
  57. Sen DK, Sarin GS. Tear glucose levels in normal people and in diabetic patients. Br J Ophthalmol 1980; 64: 693-695.
  58. Ascaso FJ, Huerva V. Noninvasive Continuous Monitoring of Tear Glucose Using Glucose-Sensing Contact Lenses. Optom Vis Sci 2016; 93: 426-434.
  59. Park J, Kim J, Kim SY, Cheong WH, Jang J, Park YG et al. Soft, smart contact lenses with integrations of wireless circuits, glucose sensors, and displays. Sci Adv 2018;4:eaap9841.
  60. Update on our Smart Lens program with Alcon [Internet]. 2018. Available from: https://blog.verily.com/2018/11/update-on-our-smart-lens-program-with.html Last accessed 27 February 2019.
  61. Bruen D, Delaney C, Florea L, Diamond D. Glucose Sensing for Diabetes Monitoring: Recent Developments. Sensors (Basel) 2017;17: pii: E1866.
  62. Wilson AD. Advances in electronic-nose technologies for the detection of volatile biomarker metabolites in the human breath. Metabolites 2015; 5: 140-163.
  63. Leopold JH, Bos LDJ, Colombo C, Sterk PJ, Schultz MJ, Abu-Hanna A. Non-invasive breath monitoring with eNose does not improve glucose diagnostics in critically ill patients in comparison to continuous glucose monitoring in blood. J Breath Res 2017; 11: 026002.
  64. Caduff A, Zanon M, Mueller M, Zakharov P, Feldman Y, De Feo O et al. The Effect of a Global, Subject, and Device-Specific Model on a Noninvasive Glucose Monitoring Multisensor System. J Diabetes Sci Technol 2015; 9: 865-872.
  65. Song K, Ha U, Park S, Yoo H. An impedance and multi-wavelength near-infrared spectroscopy IC for non-invasive blood glucose estimation. 2014 Symposium on VLSI Circuits Digest of Technical Papers: IEEE, 2014. pp. 1-2.
  66. Bahartan K, Horman K, Gal A, Drexler A, Mayzel Y, Lin T. Assessing the Performance of a Noninvasive Glucose Monitor in People with Type 2 Diabetes with Different Demographic Profiles. J Diabetes Res 2017; 2017.
  67. Geng Z, Tang F, Ding Y, Li S, Wang X. Noninvasive Continuous Glucose Monitoring Using a Multisensor-Based Glucometer and Time Series Analysis. Sci Rep 2017; 7: 12650.
  68. Thomas A, Heinemann L, Ramírez A, Zehe A. Options for the Development of Noninvasive Glucose Monitoring: Is Nanotechnology an Option to Break the Boundaries? J Diabetes Sci Technol 2016; 10: 782-789.
  69. Cash KJ, Clark HA. Nanosensors and nanomaterials for monitoring glucose in diabetes. Trends Mol Med 2010; 16: 584-593.
  70. Yum K, McNicholas TP, Mu B, Strano MS. Single-Walled Carbon Nanotube-Based Near-Infrared Optical Glucose Sensors toward In Vivo Continuous Glucose Monitoring. J Diabetes Sci Technol 2013; 7: 72-87.

MeSH Term

Biosensing Techniques
Blood Glucose
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 1
Equipment Design
Equipment and Supplies
Glycemic Control
Humans
Monitoring, Physiologic

Chemicals

Blood Glucose

Word Cloud

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