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Guideline Development for Medical Device Technology: Issues for Consideration

Journal of Diabetes Science and Technology, vol. 17, pp. 1698–1710

Abstract

Advances in the development of innovative medical devices and telehealth technologies create the potential to improve the quality and efficiency of diabetes care through collecting, aggregating, and interpreting relevant health data in ways that facilitate more informed decisions among all stakeholder groups. Although many medical societies publish guidelines for utilizing these technologies in clinical practice, we believe that the methodologies used for the selection and grading of the evidence should be revised. In this article, we discuss the strengths and limitations of the various types of research commonly used for evidence selection and grading and present recommendations for modifying the process to more effectively address the rapid pace of device and technology innovation and new product development.

Authors 18

  1. University of Ljubljana · Ljubljana University Medical Centre

    Affiliation as printed

    University Medical Center Ljubljana, University of Ljubljana, Ljubljana, Slovenia

  2. University of Arizona

    Affiliation as printed

    University of Arizona College of Medicine–Tucson, AZ, USA

  3. MultiMedica

    Affiliation as printed

    IRCCS MultiMedica, Milan, Italy

  4. Karolinska University Hospital · Karolinska Institutet

    Affiliation as printed

    Cardiology Unit, Department of Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden

  5. Duke Medical Center

    Affiliation as printed

    Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA

  6. Marienhospital Stuttgart

    Affiliation as printed

    Marienhospital Stuttgart, Stuttgart, Germany

  7. Affiliation as printed

    PCNA National Office, Madison, WI, USA

  8. UNSW Sydney · The George Institute for Global Health · Saint Luke's Hospital · University of Missouri–Kansas City

    Affiliation as printed

    Saint Luke’s Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA

    The George Institute for Global Health, University of New South Wales, Sydney, Australia

    Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA

  9. University of Belgrade · Univerzitetski Klinički Centar Srbije

    Affiliation as printed

    Clinic for Endocrinology, Diabetes and Metabolic Diseases, University Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia

  10. Universitätsklinikum Aachen · RWTH Aachen University

    Affiliation as printed

    Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany

  11. American Heart Association

    Affiliation as printed

    American Heart Association, Dallas, TX, USA

  12. Karolinska Institutet

    Affiliation as printed

    Department of Medicine K2, Karolinska Institute, Stockholm, Sweden

  13. Affiliation as printed

    Endocrine and Metabolic Consultants, Rockville, MD, USA

  14. Peking University People's Hospital

    Affiliation as printed

    Peking University People’s Hospital, Beijing, China

    Peking University People's Hospital, Beijing, China

  15. Taichung Veterans General Hospital

    Affiliation as printed

    Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung City

  16. Affiliation as printed

    Forschergruppe Diabetes e.V., Munich, Germany

  17. Affiliation as printed

    CGParkin Communications Inc., Henderson, NV, USA

  18. Oliver Schnell corresponding
    Affiliation as printed

    Forschergruppe Diabetes e.V., Munich, Germany

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References 155