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

With Dr. Stefan Pleus, Institut für Diabetes-Technologie, Universität Ulm, and Chair of the IFCC Working Group on CGM.

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Need the 101 before diving in?

CGM Regulation FAQ: Got T1D? It’s THE most important thing you will read this year!

You may also want to build your foundation by understanding why we need an international standard — and why the iCGM framework alone won’t be enough.

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

In this episode, we go deep into the future of continuous glucose monitoring (CGM) standards. Dr. Stefan Pleus explains why the current 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.
Work for screening and early diagnosis of type 1 diabetes.
Provide people with diabetes consistency across devices.

Key insights summarised from the discussion with Stefan Pleus:

If you design your study material and methods to avoid rapid glucose changes, you will get good results — but that’s not real life. Many systems perform worse at high rates of change, and unless you test that, you don’t know the risk.
We introduced comparative data characteristics — requiring minimum data in low, high, and rapid change zones — so that stress test conditions are covered, not just the easy ones.
Every method has bias. Unless you retrospectively correct comparator results against higher-order reference materials/methods, you cannot align CGM readings across manufacturers.
With a more robust study design, today’s systems will look less accurate — not because they’ve changed, but because we’re finally stress-testing them properly.
An international standard typically takes 3–5 years. Without alignment between FDA and Europe, we risk duplication, cost, and stalled innovation. The biggest barrier is regulatory will, not the science.”

Why this matters

Without standardisation, clinical trials, diagnostics, and everyday insulin dosing risk being inconsistent across devices. By 2030, the opportunity is to create a global, reproducible framework that ensures fairness for users, clarity for clinicians, and valid results for researchers.