The Glucose Never Lies® Podcast

19 – iCGM vs eCGM vs Standardisation by the IFCC: CGM Regulation with Dr. Guido Freckmann

John Pemberton Episode 19

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19 – iCGM vs eCGM vs Standardisation by the IFCC: CGM Regulation with Dr. Guido Freckmann

Full show notes and FAQ, and consider buying me a Coffee to keep pumping

Continuous 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 standard
  • How the FDA’s iCGM framework (2018) was groundbreaking, but has limitations in study design
  • Why the proposed eCGM model for Europe risks monopolising the market without fixing accuracy problems
  • The IFCC’s roadmap towards a full ISO standard for CGM – robust, reproducible, and aligned with clinical reality

Full Show notes and FAQ, and consider buying me a Coffee to keep pumping

Key Themes & Watch-Outs

🔹 CE Mark ≠ Quality Standard

  • CE 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🔹 ICGM (2018): A Step Forward, But Outdated

  • FDA iCGM rules set minimum standards, but study design criteria were vague.
  • Devices can appear accurate by avoiding stressful glucose swings.

🔹 Why Standardisation Matters

  • Standardisation 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 Debate

  • Capillary 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 Impact

Disclaimer

This podcast is for education and informational purposes only. It does not constitute medical advice and is not a substitute for individualised care.

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Enquiries

Collaboration: John Pemberton — john@theglucoseneverlies.com

Creatives: Anjanee Kohli — anj@theglucoseneverlies.com

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Disclaimer
This content is for informational purposes only and does not constitute medical advice.

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