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Episode 20 — Standardization of Testing CGM Performance: The Nuts and Bolts

With 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 dosing
• Act as a trusted comparator in clinical trials
• Enable screening and early diagnosis of type 1 diabetes
• Provide consistency across devices for people with diabetes

Key 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.