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A novel flash glucose monitoring system in patients with diabetes mellitus type 1 and 2: which are the pieces of evidence for payer decision-makers?

Internal and Emergency Medicine volume 13, pages 947–949 (2018)Cite this article

Abstract

A rigorous health technology assessment is necessary to evaluate a new technology. However, healthcare regulatory agencies have less restrictive rules about medical devices, despite some recent warnings about this relevant matter. The evaluation should have at least two key issues, which require attention. The first one is its effectiveness, and the second one is its economic sustainability. In this paper, we deal with a novel glucose-sensing technology as a case study to examine the matter in depth. An evidence-based point of view is used to highlight this important issue.

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References

  1. Nobre MR, Costa FM (2012) Surrogate outcomes are associated with low methodological necrosis factor agents: a systematic review. Evid Based Med 17(1):3–7

    Article  PubMed  Google Scholar 

  2. Callea G, Armeni P, Marsilio M et al (2016) The impact of HTA and procurement practices on the selection and prices of medical devices. Soc Sci Med 174:89–95

    Article  PubMed  Google Scholar 

  3. Porzsolt F, Rocha NG, Toledo-Arruda AC et al (2015) Efficacy and effectiveness trials have different goals, use different tools, and generate different messages. Pragmat Obs Res 6:47–54

    Article  PubMed  PubMed Central  Google Scholar 

  4. Bolinder J, Antuna R, Geelhoed-Duijvestijn P et al (2016) Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet 388(10057):2254–2263

    Article  PubMed  Google Scholar 

  5. Haak T, Hanaire H, Ajjan R et al (2016) Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Ther. https://doi.org/10.1007/s13300-016-0223-6

    PubMed  PubMed Central  Article  Google Scholar 

  6. Kyeremanteng K, Wan C, D’Egidio G et al (2016) Approach to economic analysis in critical care. J Crit Care 36:92–96

    Article  PubMed  Google Scholar 

  7. Porzsolt F, Ghosh AK, Kaplan RM (2009) Qualitative assessment of innovations in healthcare provision. BMC Health Serv Res 19(9):50

    Article  Google Scholar 

  8. Meltzer M, Pizzi LT, Jutkowitz E (2012) Payer decision-making with limited comparative and cost effectiveness data: the case of new pharmacological treatments for gout. Evid Based Med. 17(4):105–108

    Article  PubMed  Google Scholar 

  9. Medical Device:510(k) FDA Submission Process. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm. Accessed 30 Oct 2017

  10. Shapiro AR (2017) FDA approval of nonadjunctive use of continuous glucose monitors for insulin dosing: a potentially risky decision. JAMA 318(16):1541–1542

    Article  PubMed  Google Scholar 

  11. Ibrahim AM, Dimick JB (2017) Monitoring medical devices: missed warning signs within existing data. JAMA 318(4):327–328

    Article  PubMed  PubMed Central  Google Scholar 

  12. European Medicine Agency. Mandate, Objectives and Rules of Procedure for the EMA/CAT and Medical Devices’ Notified Body (EMA/CATNB) Collaboration Group (CG). http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/12/WC500099532.pdf. Accessed 30 Oct 2017

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Acknowledgements

We thank Dr. Marta Alioto for the revision of the language.

Funding

No financial, nor any other material support was received in support of this work.

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Affiliations

  1. Department of Internal Medicine, National Relevance and High Specialization Hospital Trust, ARNAS Civico, Di Cristina, Benfratelli, Piazza Nicola Leotta 2, 90127, Palermo, Italy

    Salvatore Corrao

  2. Centre of Research for Effectiveness and Appropriateness in Medicine (C.R.E.A.M.), Di.Bi.M.I.S, University of Palermo, Palermo, Italy

    Salvatore Corrao

  3. Department of Endocrinology, Gravina Hospital, Caltagirone, Italy

    Biagio Nativo

  4. Department of Organizational, Clinical, and Translational Research, I.E.ME.S.T, Palermo, Italy

    Giuseppe Natoli & Marika Lo Monaco

  5. Department of Medical and Surgical Sciences, “Magna-Græcia” University of Catanzaro, Catanzaro, Italy

    Francesco Perticone

Authors
  1. Salvatore Corrao
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  2. Biagio Nativo
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  3. Giuseppe Natoli
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  4. Marika Lo Monaco
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  5. Francesco Perticone
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Correspondence to Salvatore Corrao.

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Corrao, S., Nativo, B., Natoli, G. et al. A novel flash glucose monitoring system in patients with diabetes mellitus type 1 and 2: which are the pieces of evidence for payer decision-makers?. Intern Emerg Med 13, 947–949 (2018). https://doi.org/10.1007/s11739-018-1855-5

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  • DOI: https://doi.org/10.1007/s11739-018-1855-5

Keywords

  • Biomedical technology
  • Technology assessment
  • Biomedical
  • Decision making
  • Organizational
  • Economic
  • Ethics