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 claims. Quotes from the Episode “CE marking is not a quality standard. You have to dig into study design — and that’s not practical for the average person with diabetes or most clinicians.” – John Pemberton “CGM systems often perform worse at high rates of change than at stable glucose levels. That’s why stress-testing is vital.” – Dr. Guido Freckmann “Different CGM systems can give the same time-in-range but very different HbA1c and complication risks. That’s unacceptable.” – John Pemberton “Manufacturers can design studies to get good results by avoiding rapid glucose swings. Without rules, accuracy is only on paper.” – Dr. Guido FreckmannFull Show notes and FAQ, and consider buying me a Coffee to keep pumping Support GNL: https://buy.stripe.com/9B63cx4UO3KEdKC0Sp7Re00The GDisclaimerThis podcast is for education and informational purposes only. It does not constitute medical advice and is not a substitute for individualised care.The Glucose Never Lies® is independent by designWe do not accept sponsorships and advertising. We operate via education grants and donations from listeners who value independence. So, consider:Buying the GNL a Coffee:https://www.buymeacoffee.com/jspfree2EnquiriesCollaboration: John Pemberton — [email protected]: Anjanee Kohli — [email protected] The Glucose Never Lies®Website: https://theglucoseneverlies.com/Instagram: https://www.instagram.com/theglucoseneverliesLinkedIn: https://www.linkedin.com/company/theglucoseneverliesLinkedIn: John Pemberton: https://www.linkedin.com/in/john-pemberton-587104361/X: https://twitter.com/GlucoseNLiesDisclaimer This content is for informational purposes only and does not constitute medical advice.© The Glucose Never Lies Ltd. All rights reserved.