The Glucose Never Lies® Podcast
Host John Pemberton — diabetes educator, researcher, and dad living with type 1 since 2008 — explores how to think clearly about type 1 diabetes in the real world.
EACH episode translates current evidence and expert practice into decisions you can use: CGM accuracy and interpretation, getting more from pumps and automated insulin delivery, movement as a glucose tool, nutrition that protects performance and enjoyment, sleep, travel, parties, and sport.
Guests include leading clinicians, researchers, and people with lived experience. Expect respectful challenge, plain language, and practical take-aways.
Note: Educational only. No therapeutic relationship or personal medical advice.
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The Glucose Never Lies® Podcast
19 – iCGM vs eCGM vs Standardisation by the IFCC: CGM Regulation with Dr. Guido Freckmann
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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🔹 ICGM (2018): A Step Forward, But Outdated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
- Different 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 Ahead
- CGM 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 Freckmann
Full Show notes and FAQ, and consider buying me a Coffee to keep pumping
