Guideline Development for Medical Device Technology: Issues for Consideration

Tadej Battelino, Frank Brosius, Antonio Ceriello, Francesco Cosentino, Jennifer Green, Monika Kellerer, Susan Koob, Mikhail Kosiborod, Nebojsa Lalic, Nikolaus Marx, T. Prashant Nedungadi, Lars Rydén, Helena W. Rodbard, Linong Ji, Wayne Huey Herng Sheu, Eberhard Standl, Christopher G. Parkin, Oliver Schnell

Research output: Contribution to journalComment/debatepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1698-1710
Number of pages13
JournalJournal of Diabetes Science and Technology
Volume17
Issue number6
DOIs
StatePublished - Nov 2023
Externally publishedYes

Keywords

  • CGM
  • continuous glucose monitoring
  • diabetes technologies
  • guidelines
  • randomized controlled trials
  • real-world evidence

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Bioengineering
  • Biomedical Engineering

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