Continuous Glucose Monitoring (CGM) Systems for Diabetes Management

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Continuous Glucose Monitoring (CGM) Systems for Diabetes Management

A second dossier has been received by the NYS Department of Health to review the current evidence for continuous glucose monitoring systems. A continuous glucose monitor (CGM) is a small wearable glucose monitoring device that continuously measures and tracks a person´s glucose levels for the management of diabetes.

New York State Medicaid currently covers real–time continuous glucose monitoring for members with a diagnosis of type 1 diabetes.

The New York State Department of Health will make a determination whether to modify New York State Medicaid coverage of this technology.

Dossier sources of evidence already submitted:

The following evidence was recently submitted to the Department of Health:

  1. AHRQ. AHRQ Systematic Review Surveillance Program: CER #57: Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness. 2016. https://effectivehealthcare.ahrq.gov/ehc/products/242/2182/insulin–blood–sugar–surveillance–160215.pdf
  2. Alfadhli E, Osman E, Basri T. Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes. Diabetology & Metabolic Syndrome. 2016;8:48.
  3. 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. 2011;34(4):795–800. doi:10.2337/dc10–1989.
  4. Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: A randomized controlled trial. Diabetologia. 2012;55(12):3155–3162.
  5. Benkhadra K, Alahdab F, Tamhane S, et al. Real–time continuous glucose monitoring in type 1 diabetes: a systematic review and individual patient data meta–analysis. Clinical Endocrinology. 2017 Mar;86(3):354–360.
  6. Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor–augmented insulin–pump therapy in type 1 diabetes. N Engl J Med. 2010 Jul22;363(4):311–320.
  7. Bergenstal RM, Klonoff DC, Garg SK, et al. Threshold–based insulin–pump interruption for reduction of hypoglycemia. N Engl J Med. 2013 Jul 18;369:224–232.
  8. Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self–monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858–1862.
  9. Bronstone A, Graham C. The potential cost implications of averting severe hypoglycemic events requiring hospitalization in high–risk adults with type 1 diabetes using real–time continuous glucose monitoring. J Diabetes Sci Technol. 2016 Jun 28;10(4):905–913.
  10. Bukara–Radujkovic G, Zdravkovic D, Lakic, S. Short–term use of continuous glucose monitoring system adds to glycemic control in young type 1 diabetes mellitus patients in the long run: a clinical trial. Vojnosanit Pregl. 2011 Aug;68(8):650–654.
  11. Buckingham BA, Raghinaru,D, Cameron,F, et al. Predictive low–glucose insulin suspension reduces duration of nocturnal hypoglycemia in children without increasing ketosis. Diabetes Care. 2015 Jul;38(7):1197–1204.
  12. Chetty VT, Almulla A, Odueyungbo A, Thabane L. The effect of continuous subcutaneous glucose monitoring (CGMS) versus intermittent whole blood finger–stick glucose monitoring (SBGM) on hemoglobin A1c (HBA1c) levels in type I diabetic patients: A systematic review. Diabetes Res Clin Pract. 2008 Jul;81(1):79–87.
  13. Cordua S, Secher AL, Ringholm L, Damm P, Mathiesen ER. Real–time continuous glucose monitoring during labour and delivery in women with Type 1 diabetes – observations from a randomized controlled trial. Diabet Med. 2013;30(11):1374–1381. doi:10.1111/dme.12246.
  14. 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):977–986.
  15. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353(25):2643–2653.
  16. Dinapoli TP. Diabetes in New York State. New York; 2015. https://www.osc.state.ny.us/reports/health/diabetes_2015.pdf
  17. ECRI Institute. Threshold suspend Insulin Delivery Systems for Managing Hypoglycemia in Patients with Type 1 Diabetes Mellitus. HTA Inf Serv. 2016;(July):1–48.
  18. Floyd B, Chandra P, Hall S, et al. Comparative analysis of the efficacy of continuous glucose monitoring and self–monitoring of blood glucose in type 1 diabetes mellitus. J Diabetes Sci Technol. 2012 Sep 1;6(5):1094–1102.
  19. Fonseca VA, Grunberger G, Anhalt H, et al. Continuous glucose monitoring: a Consensus Conference of the American Association of Clinical Endocrinologists and American College of Endocrinology. Endocr Pract. 2016;22(8):1008–1021. doi:10.4158/EP161392.CS.
  20. Fonda SJ, Graham C, Munakata J, Powers JM, Price D, Vigersky RA. The cost–effectiveness of real–time continuous glucose monitoring (RT–CGM) in type 2 diabetes. J Diabetes Sci Technol. 2016 Jun 28;10(4):898–904. doi:10.1177/1932296816628547.
  21. Gandhi GY, Kovalaske M, Kudva Y, et al. Efficacy of continuous glucose monitoring in improving glycemic control and reducing hypoglycemia: a systematic review and meta–analysis of randomized trials. J Diabetes Sci Technol. 2011 Jul 1;5(4):952–965.
  22. Garg S, Brazg RL, Bailey TS, et al. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery: the in–clinic ASPIRE study. Diabetes Technol Ther. 2012 Mar;14(3):205–209.
  23. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in–home use of a hybrid closed–loop insulin delivery system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther. 2017 Mar;19(3):1–9. doi:10.1089/dia.2016.0421.
  24. Golden SH, Brown T, Yeh HC, et al. Methods for insulin delivery and glucose monitoring: comparative effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jul. (Comparative Effectiveness Reviews, No. 57.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK99217/
  25. Golden SH, Sapir T. Methods for insulin delivery and glucose monitoring in diabetes: summary of a comparative effectiveness review. J Manag Care Pharm. 2012 Aug;18(6 Suppl):S1–S17.
  26. Golicki DT, Golicka D, Groele L, Pankowska E. Continuous glucose monitoring system in children with type 1 diabetes mellitus: a systematic review and meta–analysis. Diabetologia. 2008 Feb;51(2):233–240.
  27. Hermanides J, Nørgaard K, Bruttomesso D, et al. Sensor–augmented pump therapy lowers HbA1c in suboptimally controlled Type1 diabetes; a randomized controlled trial. Diabet Med. 2011 Oct;28(10):1158–1167.
  28. Hirsch IB, Abelseth J, Bode BW, et al. Sensor–augmented insulin pump therapy: Results of the first randomized treat–to–target study. Diabetes Technol Ther. 2008 Oct;10(5):377–383.
  29. Hoeks LB, Greven WL, de Valk HW. Real–time continuous glucose monitoring system for treatment of diabetes: a systematic review. Diabet Med. 2011 Ap;28(4):386–394.
  30. IQWiG. Continuous interstitial glucose monitoring (CGM) with real–time measurement devices in insulin–dependent diabetes mellitus [Internet]. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2015 Mar. Executive Summary of Final Report No. D12–01. Available from: https://www.iqwig.de/download/D12–01_Executive–Summary_Continuous–glucose–monitoring–CGM–with–real–time–measurement–devices.pdf.
  31. IQWiG. Continuous interstitial glucose monitoring (CGM) with real–time measurement devices in insulin–dependent diabetes mellitus (FINAL REPORT IN GERMAN). Heal Technol Assess Database. 2015;(3). Available from: https://www.iqwig.de/download/D12–01_Abschlussbericht_Kontinuierliche–Glukosemessung–mit–Real–Time–Messgeraeten.pdf
  32. Kerr D, Fayers K. Continuous real–time glucose monitoring systems: time for a closer look. Pr Diab Int. 2008;25(1):37–41.
  33. Kordonouri, O, Pankowska E, Rami B, et al. Sensor–augmented pump therapy from the diagnosis of childhood type 1 diabetes: Results of the Paediatric Onset Study (ONSET) after 12 months of treatment. Diabetologia, 2010 Dec;53(12):2487–2495.
  34. Langendam M, Luijf YM, Hooft L, DeVries JH, Mudde AH, ScholtenRJ. Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochrane.Database.Syst.Rev. 2012 Jan 18;1:CD008101.
  35. Lo Scalzo A, Lenzi L, Chiarolla E, et al. HTA report: new devices for the management of glycaemia in young diabetics, Rome, September 2012.
  36. Ly TT, Brnabic AJ, Eggleston A, et al. A cost–effectiveness analysis of sensor–augmented insulin pump therapy and automated insulin suspension versus standard pump therapy for hypoglycemic unaware patients with type 1 diabetes. Value Health. 2014 Jul;17(5):561–569. doi:10.1016/j.jval.2014.05.008.
  37. Matsuda E, Brennan P. The effectiveness of continuous glucose monitoring for type 1 diabetic adolescents using continuous subcutaneous insulin infusion pumps: A systematic review. JBI Database of Systematic Reviews and Implementation Reports. 2014:12(5):88–120.
  38. Medical Advisory Secretariat. Continuous glucose monitoring for patients with diabetes: an evidence based analysis. Ont Health Technol Assess Ser [Internet]. 2011 July; 11(4):1–29.
  39. Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: Updated data from the T1D exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971–978. doi:10.2337/dc15–0078.
  40. Murphy HR, Rayman G, Lewis K, et al. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008;337:907–910.
  41. National Institute of Clinical Excellence. Integrated sensor–augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system). NICE Clin Guid. 2016 Feb. Available from: https://www.nice.org.uk/guidance/dg21
  42. Newman SP, Cooke D, Casbard, A, et al. A randomized controlled trial to compare minimally invasive glucose monitoring devices with conventional monitoring in the management of insulin–treated diabetes mellitus (MITRE). Health Technol Assess. 2009 May;13(28):iii–xi,1–194.
  43. O´Connell MA, Donath S, O'Neal DN, et al. Glycemic impact of patient–led use of sensor–guided pump therapy in type 1 diabetes: a randomised controlled trial. Diabetologia. 2009 Jul;52(7):1250–1257.
  44. Pickup JC, Freeman SC, Sutton AJ. Glycemic control in type 1 diabetes during real time continuous glucose monitoring compared with self–monitoring of blood glucose: meta–analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
  45. Poolsup N, Suksomboon N, Kyaw AM. Systematic review and meta–analysis of the effectiveness of continuous glucose monitoring (CGM) on glucose control in diabetes. Diabetol Metab Syndr. 2013;5:39.
  46. Raccah D, Sulmont V, Reznik Y, et al. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care. 2009 Dec;32(12):2245–2250.
  47. Riemsma R, Ramos IC, Birnie R, et al. Integrated sensor–augmented pump therapy systems [the MiniMed® Paradigm™ Veo system and the Vibe™ and G4® PLATINUM CGM (continuous glucose monitoring) system] for managing blood glucose levels in type 1 diabetes: a systematic review and economic evaluation. Health Technol Assess. 2016 Feb;20(17).
  48. Roze S, Saunders R, Brandt AS, de Portu S, Papo NL, Jendle J. Health– economic analysis of real–time continuous glucose monitoring in people with type 1 diabetes. Diabet Med. 2015 May;32(5):618–626. doi:10.1111/dme.12661.
  49. SBU Alert Report no 2013–04. Continuous subcutaneous glucose monitoring for diabetes. Available from: www.sbu.se/201304e
  50. Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real–time continuous glucose monitoring in pregnant women with diabetes A randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877–1883.
  51. Solans M, Kotzeva A, Almazán A. Sistemas de monitorización continua de glucose en tiempo real. Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad, Política Social e Igualdad. Ministerio de Ciencia e Innovación. Agència d’Informació, Avaluació iQualitat en Salut de Cataluña; 2011. Informes de Evaluación de Tecnologías Sanitarias, AIAQS núm. 2010/06.
  52. Szypowska A, Ramotowska A, Dzygalo K, Golicki D. Beneficial effect of real–time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta–analysis of randomized trials. Eur J Endocrinol. 2012 Apr;166(4):567–574.
  53. Wei Q, Sun Z, Yang Y, Yu H, Ding H, Wang S. Effect of a CGMS and SMBG on maternal and neonatal outcomes in gestational diabetes mellitus: a randomized controlled trial. Sci Rep. 2016;6(87):1–9. doi:10.1038/srep19920.
  54. Wentholt I, Hoekstra J, De Vries J. Continuous glucose monitors: the long–awaited watch dogs? Diabetes Technol Ther. 2007 Oct;9(5):399–409.
  55. Wojciechowski P, Rys P, Lipowska A, Gaweska M, Malecki MT. Efficacy and safety comparison of continuous glucose monitoring and self–monitoring of blood glucose in type 1 diabetes: systematic review and meta–analysis. Pol Arch Med Wewn. 2011;121(10):333–344.
  56. Wong JC, Foster NC, Maahs DM, et al. Real–time continuous glucose monitoring among participants in the T1D exchange clinic registry. Diabetes Care. 2014;37(10):2702–2709. doi:10.2337/dc14–0303.
  57. Yeh HC, Brown TT, Maruthur N, et al. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta–analysis. Ann Intern Med. 2012 Sep 4;157(5):336–347.
  58. Yoo HJ, An HG, Park SY, et al. Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Diabetes Res Clin Pract. 2008 Oct;82(1):73–79.