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

doi:10.1177/19322968221093355

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 journal › Comment/debate › peer-review

2 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 language	English (US)
Pages (from-to)	1698-1710
Number of pages	13
Journal	Journal of Diabetes Science and Technology
Volume	17
Issue number	6
DOIs	https://doi.org/10.1177/19322968221093355
State	Published - Nov 2023
Externally published	Yes

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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10.1177/19322968221093355

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Battelino, T., Brosius, F., Ceriello, A., Cosentino, F., Green, J., Kellerer, M., Koob, S., Kosiborod, M., Lalic, N., Marx, N., Nedungadi, T. P., Rydén, L., Rodbard, H. W., Ji, L., Sheu, W. H. H., Standl, E., Parkin, C. G., & Schnell, O. (2023). Guideline Development for Medical Device Technology: Issues for Consideration. Journal of Diabetes Science and Technology, 17(6), 1698-1710. https://doi.org/10.1177/19322968221093355

Battelino, T, Brosius, F, Ceriello, A, Cosentino, F, Green, J, Kellerer, M, Koob, S, Kosiborod, M, Lalic, N, Marx, N, Nedungadi, TP, Rydén, L, Rodbard, HW, Ji, L, Sheu, WHH, Standl, E, Parkin, CG & Schnell, O 2023, 'Guideline Development for Medical Device Technology: Issues for Consideration', Journal of Diabetes Science and Technology, vol. 17, no. 6, pp. 1698-1710. https://doi.org/10.1177/19322968221093355

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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.",

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AU - Battelino, Tadej

AU - Brosius, Frank

AU - Ceriello, Antonio

AU - Cosentino, Francesco

AU - Green, Jennifer

AU - Kellerer, Monika

AU - Koob, Susan

AU - Kosiborod, Mikhail

AU - Lalic, Nebojsa

AU - Marx, Nikolaus

AU - Nedungadi, T. Prashant

AU - Rydén, Lars

AU - Rodbard, Helena W.

AU - Ji, Linong

AU - Sheu, Wayne Huey Herng

AU - Standl, Eberhard

AU - Parkin, Christopher G.

AU - Schnell, Oliver

PY - 2023/11

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AB - 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.

KW - CGM

KW - continuous glucose monitoring

KW - diabetes technologies

KW - guidelines

KW - randomized controlled trials

KW - real-world evidence

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Guideline Development for Medical Device Technology: Issues for Consideration

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