20 — Standardization of Testing CGM Performance: The Nuts and Bolts with Stefan Pleus of the IFCC

Suggest guests or get in contactEpisode 20 — Standardization of Testing CGM Performance: The Nuts and BoltsWith Dr. Stefan Pleus (Institut für Diabetes-Technologie, Universität Ulm; Chair of the IFCC Working Group on CGM).Full show notes and FAQ, and consider buying me a Coffee to keep pumping.In this episode, we go deep into the future of continuous glucose monitoring (CGM) standards. Dr. Pleus explains why the FDA iCGM framework (2018) is no longer enough, what a robust international standard would look like, and why ISO standardisation by 2030 is essential if CGM is to:Be a reliable basis for insulin dosingAct as a trusted comparator in clinical trialsEnable screening and early diagnosis of type 1 diabetesProvide consistency across devices for people with diabetesKey insights from Stefan Pleus:Study design matters: if you avoid rapid glucose changes, results look good — but that’s not real life.Stress-testing requires minimum data in low, high, and rapid-change zones.Every comparator has bias: retrospective correction is essential to align results across manufacturers.With better study designs, today’s systems may appear less accurate — but only because we’re finally testing them properly.Global alignment between FDA and Europe is needed; without it, innovation risks stalling.Why this matters: Without standardisation, insulin dosing, clinical trials, and diagnostics will remain inconsistent across devices. The 2030 opportunity is a global, reproducible framework that ensures fairness for users, clarity for clinicians, and valid results for researchers.Full show notes and FAQ, and consider buying me a Coffee to keep pumping.Support GNL: https://buy.stripe.com/9B63cx4UO3KEdKC0Sp7Re00The Glucose Never Lies® is a registered trademark of The GNL Ltd. Company No. 16733595. UK VAT No. GB 516 3272 08.DisclaimerThis 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.