Skip to main content

CGM—How Good Is Good Enough?

  • Chapter
  • First Online:
Book cover Prediction Methods for Blood Glucose Concentration

Part of the book series: Lecture Notes in Bioengineering ((LNBE))

Abstract

Continuous glucose monitoring (CGM) systems are more informative than the traditional self-monitoring of capillary blood glucose (BG). Although advances in CGM technology have significantly improved the clinical utility of CGM devices compared with earlier versions, it is often difficult to assess the accuracy and precision of current devices due to differences in assessment protocols and reporting of results. Because CGM sensor accuracy can impact both the clinical utility and patient acceptance of CGM use, it is important to consider the performance characteristics seen in the current systems when assessing the clinical value of this technology. Moreover, standardization of the metrics used to assess CGM accuracy and precision are needed to help developers, clinicians, and patients make informed decisions regarding the CGM systems they are considering. In this chapter, we discuss the most commonly used methods for the assessment of CGM system performance, the accuracy and reliability of current CGM systems, and the remaining unsolved technological and physiological hurdles.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Anderson, J.M., Rodriguez, A., Chang, D.T.: Foreign body reaction to biomaterials. Semin. Immunol. 20(2), 86–100 (2008)

    Article  Google Scholar 

  2. Bailey, T.S., Zisser, H.C., Garg, S.K.: Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study. Diabetes Technol. Ther. 9(3), 203–210 (2007)

    Article  Google Scholar 

  3. Bailey, T., Zisser, H., Chang, A.: New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. Diabetes Technol. Ther. 11(12), 749–755 (2009)

    Article  Google Scholar 

  4. Bartelme, A., Bridger, P.: The role of reimbursement in the adoption of continuous glucose monitors. J. Diabetes Sci. Technol. 3(4), 992–995 (2009)

    Article  Google Scholar 

  5. Basu, A., Dube, S., Slama, M., Errazuriz, I., Amezcua, J.C., Kudva, Y.C., Peyser, T., Carter, R.E., Cobelli, C., Basu, R.: Time lag of glucose from intravascular to interstitial compartment in humans. Diabetes 62(12), 4083–4087 (2013)

    Article  Google Scholar 

  6. Battelino, T., Phillip, M., Bratina, N., Nimri, R., Oskarsson, P., Bolinder, J.: Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care 34(4), 795–800 (2011)

    Article  Google Scholar 

  7. Beck, R.: T1D exchange overview - 25.000 opportunities, few limitations. American Diabetes Association 72nd Scientific Sessions, Philadelphia (2012)

    Google Scholar 

  8. Blevins, T.C., Bode, B.W., Garg, S.K., Grunberger, G., Hirsch, I.B., Jovanovič, L., Nardacci, E., Orzeck, E.A., Roberts, V.L., Tamborlane, W.V., Rothermel, C.: Statement by the American association of clinical endocrinologists consensus panel on continuous glucose monitoring. endocr pract 16(5), 730–745 (2010)

    Article  Google Scholar 

  9. Buckingham, B., Beck, R.W., Tamborlane, W.V., Xing, D., Kollman, C., Fiallo-Scharer, R., Mauras, N., Ruedy, K.J., Tansey, M., Weinzimer, S.A., Wysocki, T.: Continuous glucose monitoring in children with type 1 diabetes. J. Pediatr. 151(4), 388–393 (2007)

    Article  Google Scholar 

  10. Calhoun, P., Lum, J., Beck, R.W., Kollman, C.: Performance comparison of the medtronic sof-sensor and enlite glucose sensors in inpatient studies of individuals with type 1 diabetes. Diabetes Technol. Ther. 15(9), 758–761 (2013)

    Article  Google Scholar 

  11. Campbell, C.E., von Recum, A.F.: Microtopography and soft tissue response. J. Investig. Surg. 2(1), 51–74 (1989)

    Article  Google Scholar 

  12. Castle, J.R., Ward, W.K.: Amperometric glucose sensors: sources of error and potential benefit of redundancy. J. Diabetes Sci. Technol. 4(1), 221–225 (2010)

    Article  Google Scholar 

  13. Chia, C.W., Saudek, C.D.: Glucose sensors: toward closed loop insulin delivery. Endocrinol. Metab. Clin. North Am. 33(1), 175–195 (2004)

    Article  Google Scholar 

  14. Clinical and Laboratory Standards Institute: POCT05A: performance metrics for continuous glucose monitoring – approved guideline (2008)

    Google Scholar 

  15. Continuous glucose monitoring and intensive treatment of type 1 diabetes (2008). www.nejm.org

  16. Cryer, P.E.: Hypoglycemia: still the limiting factor in the glycemic management of diabetes. Endocr. Pract. 14(6), 750–756 (2008)

    Article  Google Scholar 

  17. Damiano, E.R., El-Khatib, F.H., Zheng, H., Nathan, D.M., Russell, S.J.: A comparative effectiveness analysis of three continuous glucose monitors. Diabetes Care 36(2), 251–259 (2013)

    Article  Google Scholar 

  18. Damiano, E.R., McKeon, K., El-Khatib, F.H., Zheng, H., Nathan, D.M., Russell, S.J.: A comparative effectiveness analysis of three continuous glucose monitors: the Navigator, G4 Platinum, and Enlite. J. Diabetes Sci. Technol. 8(4), 699–708 (2014)

    Article  Google Scholar 

  19. Davey, R.J., Jones, T.W., Fournier, P.A.: Effect of short-term use of a continuous glucose monitoring system with a real-time glucose display and a low glucose alarm on incidence and duration of hypoglycemia in a home setting in type 1 diabetes mellitus. J. Diabetes Sci. Technol. 4(6), 1457–1464 (2010)

    Article  Google Scholar 

  20. Deiss, D., Bolinder, J., Riveline, J.P., Battelino, T., Bosi, E., Tubiana-Rufi, N., Kerr, D., Phillip, M.: Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care 29(12), 2730–2732 (2006)

    Article  Google Scholar 

  21. Freckmann, G., Pleus, S., Link, M., Zschornack, E., Klotzer, H.M., Haug, C.: Performance evaluation of three continuous glucose monitoring systems: comparison of six sensors per subject in parallel. J. Diabetes Sci. Technol. 7(4), 842–853 (2013)

    Article  Google Scholar 

  22. Garg, S.K., Voelmle, M.K., Gottlieb, P.: Feasibility of 10-day use of a continuous glucose-monitoring system in adults with type 1 diabetes. Diabetes Care 32(3), 436–438 (2009)

    Article  Google Scholar 

  23. Geerligs, M., Peters, G.W., Ackermans, P.A., Oomens, C.W., Baaijens, F.P.: Does subcutaneous adipose tissue behave as an (anti-)thixotropic material? J. Biomech. 43(6), 1153–1159 (2010)

    Article  Google Scholar 

  24. Helton, K.L., Ratner, B.D., Wisniewski, N.A.: Biomechanics of the sensor-tissue interface-effects of motion, pressure, and design on sensor performance and foreign body response-part II: examples and application. J. Diabetes Sci. Technol. 5(3), 647–656 (2011)

    Article  Google Scholar 

  25. Helton, K.L., Ratner, B.D., Wisniewski, N.A.: Biomechanics of the sensor-tissue interface-effects of motion, pressure, and design on sensor performance and the foreign body response-part I: theoretical framework. J. Diabetes Sci. Technol. 5(3), 632–646 (2011)

    Article  Google Scholar 

  26. Hermanides, J., Phillip, M., DeVries, J.H.: Current application of continuous glucose monitoring in the treatment of diabetes: pros and cons. Diabetes Care 34(Suppl 2), 197–201 (2011)

    Article  Google Scholar 

  27. Hirsch, I.B., Abelseth, J., Bode, B.W., Fischer, J.S., Kaufman, F.R., Mastrototaro, J., Parkin, C.G., Wolpert, H.A., Buckingham, B.A.: Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study. Diabetes Technol. Ther. 10(5), 377–383 (2008)

    Article  Google Scholar 

  28. Hovorka, R.: Continuous glucose monitoring and closed-loop systems. Diabet. Med. 23(1), 1–12 (2006)

    Article  Google Scholar 

  29. Keenan, D.B., Mastrototaro, J.J., Zisser, H., Cooper, K.A., Raghavendhar, G., Lee, S.W., Yusi, J., Bailey, T.S., Brazg, R.L., Shah, R.V.: Accuracy of the Enlite 6-day glucose sensor with guardian and Veo calibration algorithms. Diabetes Technol. Ther. 14(3), 225–231 (2012)

    Article  Google Scholar 

  30. Klonoff, D.C., Buckingham, B., Christiansen, J.S., Montori, V.M., Tamborlane, W.V., Vigersky, R.A., Wolpert, H.: Continuous glucose monitoring: an endocrine society clinical practice guideline. J. Clin. Endocrinol. Metab. 96(10), 2968–2979 (2011)

    Article  Google Scholar 

  31. Kvist, P.H., Iburg, T., Aalbaek, B., Gerstenberg, M., Schoier, C., Kaastrup, P., Buch-Rasmussen, T., Hasselager, E., Jensen, H.E.: Biocompatibility of an enzyme-based, electrochemical glucose sensor for short-term implantation in the subcutis. Diabetes Technol. Ther. 8(5), 546–559 (2006)

    Article  Google Scholar 

  32. Leelarathna, L., Nodale, M., Allen, J.M., Elleri, D., Kumareswaran, K., Haidar, A., Caldwell, K., Wilinska, M.E., Acerini, C.L., Evans, M.L., Murphy, H.R., Dunger, D.B., Hovorka, R.: Evaluating the accuracy and large inaccuracy of two continuous glucose monitoring systems. Diabetes Technol. Ther. 15(2), 143–149 (2013)

    Article  Google Scholar 

  33. Luijf, Y., Mader, J., Doll, W., Pieber, T., Farret, A., Place, J., Renard, E., Bruttomesso, D., Filippi, A., Avogaroand, A., Arnolds, S., Benesch, C., Heinemann, L., DeVries, J.: Accuracy and reliability of continuous glucose monitoring systems: a head-to-head comparison. Diabetes Technol. Ther. 15(8), 721–726 (2013)

    Article  Google Scholar 

  34. Mastrototaro, J., Shin, J., Marcus, A., Sulur, G., Abelseth, J., Bode, B.W., Buckingham, B.A., Hirsch, I.B., Kaufman, F.R., Schwartz, S.L., Wolpert, H.A.: The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. Diabetes Technol. Ther. 10(5), 385–390 (2008)

    Article  Google Scholar 

  35. Matlaga, B.F., Yasenchak, L.P., Salthouse, T.N.: Tissue response to implanted polymers: the significance of sample shape. J. Biomed. Mater. Res. 10(3), 391–397 (1976)

    Article  Google Scholar 

  36. Morhenn, V.B., Lemperle, G., Gallo, R.L.: Phagocytosis of different particulate dermal filler substances by human macrophages and skin cells. Dermatol. Surg. 28(6), 484–490 (2002)

    Google Scholar 

  37. Obermaier, K., Schmelzeisen-Redeker, G., Schoemaker, M., Klotzer, H.M., Kirchsteiger, H., Eikmeier, H., del Re, L.: Performance evaluations of contiuous glucose monitoring systems: precision absolute relative deviation is part of the assessment. J. Diabetes Sci. Technol. 7(4), 824–832 (2013)

    Article  Google Scholar 

  38. O’Connell, M.A., Donath, S., O’Neal, D.N., Colman, P.G., Ambler, G.R., Jones, T.W., Davis, E.A., Cameron, F.J.: Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial. Diabetologia 52(7), 1250–1257 (2009)

    Article  Google Scholar 

  39. Phillip, M., Battelino, T., Rodriguez, H., Danne, T., Kaufman, F.: Use of insulin pump therapy in the pediatric age-group: consensus statement from the European Society for Paediatric Endocrinology, the Lawson Wilkins Pediatric Endocrine Society, and the International Society for Pediatric and Adolescent Diabetes, endorsed by the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 30(6), 1653–1662 (2007)

    Article  Google Scholar 

  40. Pleus, S., Haug, C., Link, M., Zschomack, E., Freckmann, G., Obermaier, K., Schoemaker, M.: Rate-of-change dependence of the performance of two CGM systems during induced glucose excursions. Diabetes 63(Suppl1), A216 (2014)

    Google Scholar 

  41. Raccah, D., Sulmont, V., Reznik, Y., Guerci, B., Renard, E., Hanaire, H., Jeandidier, N., Nicolino, M.: Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care 32(12), 2245–2250 (2009)

    Article  Google Scholar 

  42. Ramchandani, N., Arya, S., Ten, S., Bhandari, S.: Real-life utilization of real-time continuous glucose monitoring: the complete picture. J. Diabetes Sci. Technol. 5(4), 860–870 (2011)

    Article  Google Scholar 

  43. Ramchandani, N., Heptulla, R.A.: New technologies for diabetes: a review of the present and the future. Int. J. Pediatr. Endocrinol. 2012(1), 28 (2012)

    Article  Google Scholar 

  44. Standards of medical care in diabetes–2012. Diabetes Care 35(1), 11–63 (2012)

    Google Scholar 

  45. Tack, C., Pohlmeier, H., Behnke, T., Schmid, V., Grenningloh, M., Forst, T., Pfutzner, A.: Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol. Ther. 14(4), 330–337 (2012)

    Article  Google Scholar 

  46. Tamborlane, W.V., Beck, R.W., Bode, B.W., Buckingham, B., Chase, H.P., Clemons, R., Fiallo-Scharer, R., Fox, L.A., Gilliam, L.K., Hirsch, I.B., Huang, E.S., Kollman, C., Kowalski, A.J., Laffel, L., Lawrence, J.M., Lee, J., Mauras, N., O’Grady, M., Ruedy, K.J., Tansey, M., Tsalikian, E., Weinzimer, S., Wilson, D.M., Wolpert, H., Wysocki, T., Xing, D., Chase, H.P., Fiallo-Scharer, R., Messer, L., Gage, V., Burdick, P., Laffel, L., Milaszewski, K., Pratt, K., Bismuth, E., Keady, J., Lawlor, M., Buckingham, B., Wilson, D.M., Block, J., Benassi, K., Tsalikian, E., Tansey, M., Kucera, D., Coffey, J., Cabbage, J., Wolpert, H., Shetty, G., Atakov-Castillo, A., Giusti, J., O’Donnell, S., Ghiloni, S., Hirsch, I.B., Gilliam, L.K., Fitzpatrick, K., Khakpour, D., Wysocki, T., Fox, L.A., Mauras, N., Englert, K., Permuy, J., Bode, B.W., O’Neil, K., Tolbert, L., Lawrence, J.M., Clemons, R., Maeva, M., Sattler, B., Weinzimer, S., Tamborlane, W.V., Ives, B., Bosson-Heenan, J., Beck, R.W., Ruedy, K.J., Kollman, C., Xing, D., Jackson, J., Steffes, M., Bucksa, J.M., Nowicki, M.L., Van Hale, C., Makky, V., O’Grady, M., Huang, E., Basu, A., Meltzer, D.O., Zhao, L., Lee, J., Kowalski, A.J., Laffel, L., Tamborlane, W.V., Beck, R.W., Kowalski, A.J., Ruedy, K.J., Weinstock, R.S., Anderson, B.J., Kruger, D., LaVange, L., Rodriguez, H.: Continuous glucose monitoring and intensive treatment of type 1 diabetes. N. Engl. J. Med. 359(14), 1464–1476 (2008)

    Article  Google Scholar 

  47. Weinzimer, S., Xing, D., Tansey, M., Fiallo-Scharer, R., Mauras, N., Wysocki, T., Beck, R., Tamborlane, W., Ruedy, K., Chase, H.P., Fiallo-Scharer, R., Messer, L., Tallant, B., Gage, V., Tsalikian, E., Tansey, M.J., Larson, L.F., Coffey, J., Cabbage, J., Wysocki, T., Mauras, N., Fox, L.A., Bird, K., Englert, K., Buckingham, B.A., Wilson, D.M., Clinton, P., Caswell, K., Weinzimer, S.A., Tamborlane, W.V., Doyle, E.A., Mokotoff, H., Steffen, A., Ives, B., Beck, R.W., Ruedy, K.J., Kollman, C., Xing, D., Stockdale, C.R., Jackson, J., Steffes, M.W., Bucksa, J.M., Nowicki, M.L., Van Hale, C.A., Makky, V., Grave, G.D., Horlick, M., Teff, K., Winer, K.K., Becker, D.M., Cleary, P., Ryan, C.M., White, N.H., White, P.C.: Prolonged use of continuous glucose monitors in children with type 1 diabetes on continuous subcutaneous insulin infusion or intensive multiple-daily injection therapy. Pediatr. Diabetes 10(2), 91–96 (2009)

    Article  Google Scholar 

  48. Weinzimer, S., Miller, K., Beck, R., Xing, D., Fiallo-Scharer, R., Gilliam, L.K., Kollman, C., Laffel, L., Mauras, N., Ruedy, K., Tamborlane, W., Tsalikian, E.: Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial. Diabetes Care 33(1), 17–22 (2010)

    Article  Google Scholar 

  49. Wilson, D.M., Beck, R.W., Tamborlane, W.V., Dontchev, M.J., Kollman, C., Chase, P., Fox, L.A., Ruedy, K.J., Tsalikian, E., Weinzimer, S.A.: The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. Diabetes Care 30(1), 59–64 (2007)

    Article  Google Scholar 

  50. Zisser, H.C., Bailey, T.S., Schwartz, S., Ratner, R.E., Wise, J.: Accuracy of the SEVEN continuous glucose monitoring system: comparison with frequently sampled venous glucose measurements. J. Diabetes Sci. Technol. 3(5), 1146–1154 (2009)

    Article  Google Scholar 

  51. Zschornack, E., Schmid, C., Pleus, S., Link, M., Klotzer, H.M., Obermaier, K., Schoemaker, M., Strasser, M., Frisch, G., Schmelzeisen-Redeker, G., Haug, C., Freckmann, G.: Evaluation of the performance of a novel system for continuous glucose monitoring. J. Diabetes Sci. Technol. 7(4), 815–823 (2013)

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Michael Schoemaker .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Schoemaker, M., Parkin, C.G. (2016). CGM—How Good Is Good Enough?. In: Kirchsteiger, H., Jørgensen, J., Renard, E., del Re, L. (eds) Prediction Methods for Blood Glucose Concentration. Lecture Notes in Bioengineering. Springer, Cham. https://doi.org/10.1007/978-3-319-25913-0_3

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-25913-0_3

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-25911-6

  • Online ISBN: 978-3-319-25913-0

  • eBook Packages: EngineeringEngineering (R0)

Publish with us

Policies and ethics