19 – iCGM vs eCGM vs Standardisation by the IFCC: CGM Regulation with Dr. Guido Freckmann
Suggest guests or get in contact19 – iCGM vs eCGM vs Standardisation by the IFCC: CGM Regulation with Dr. Guido FreckmannFull show notes and FAQ, and consider buying me a Coffee to keep pumpingContinuous glucose monitoring (CGM) has transformed diabetes care — but how do we know which systems are accurate, safe, and truly comparable? In this episode, John Pemberton is joined by Dr. Guido Freckmann (Institute of Diabetes Technology, Ulm; former chair of the IFCC CGM Working Group). Together they unpack: Why CE marking in Europe is not a quality standardHow the FDA’s iCGM framework (2018) was groundbreaking, but has limitations in study designWhy the proposed eCGM model for Europe risks monopolising the market without fixing accuracy problemsThe IFCC’s roadmap towards a full ISO standard for CGM – robust, reproducible, and aligned with clinical realityFull Show notes and FAQ, and consider buying me a Coffee to keep pumpingKey Themes & Watch-Outs🔹 CE Mark ≠ Quality StandardCE marking is a regulatory pathway, not a guarantee of performance.Manufacturers can submit selective data, and the results are not public.🔹 ICGM (2018): A Step Forward, But OutdatedFDA iCGM rules set minimum standards, but study design criteria were vague.Devices can appear accurate by avoiding stressful glucose swings.🔹 Why Standardisation MattersStandardisation would define not just performance metrics but also how studies are run.It would align CGM systems to the same comparator (capillary or venous) and reduce therapy discrepancies.🔹 Capillary vs Venous DebateCapillary glucose reflects what people actually test and what their bodies are exposed to.Venous alignment risks giving a “false reassurance” of being in range.An agreement is needed: whichever is chosen must be standardised, with bias correction.🔹 Clinical ImpactDifferent CGMs can give the same time-in-range but very different HbA1c and complication risk.That undermines trust, confuses therapy adjustments, and makes clinical trial endpoints unreliable.🔹 Looking AheadCGM standardisation is in motion, but likely won’t be implemented before 2030.Until then, clinicians and people with diabetes need to scrutinise study design and remain critical of performance claiFor collaboration, partnerships, or press enquiries:John Pemberton —
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