ArticleJournal of diabetes science and technology2026
Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report.
Article in Journal of diabetes science and technology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
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Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe use of Continuous Glucose Monitoring (CGM) devices has significantly improved diabetes management. However, several limitations persist, including the great variation in accuracy, inconsistent study designs, and variations in regulatory approval standards. Therefore, the need for regulatory harmonization, robust validation, and transparent data reporting is crucial.
methodsThe current consensus report was developed through a structured, multi-phase process to comprehensively assess these challenges. A literature review of databases such as PubMed, Scopus, and the Saudi Digital Library, focusing on publications from 2016 to 2024, evaluated evidence on CGM devices in terms of performance and clinical outcome, with priority given to regional data, randomized controlled trials (RCTs), and systematic reviews. A multidisciplinary panel reviewed the literature, engaging in structured discussions. Recommendations were formulated using the Delphi method, ensuring consensus and alignment with global standards while addressing regional challenges. RESULTS AND RECOMMENDATIONS: The resulting recommendations advocate for aligning Saudi regulatory standards with international frameworks like Food and Drug Administration iCGM criteria, Medical Device Regulation (MDR)-aligned criteria, establishing and enforcing minimum performance criteria, including dynamic testing for glucose fluctuations, strengthening local post-market surveillance capacity, mandating transparent data reporting by manufacturers, and facilitating comprehensive clinical education and cross-sector collaboration.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.