New clinical opinion calls for greater consistency in CGM evaluation
A new international clinical opinion has called for improved consistency and transparency in the evaluation of continuous glucose monitoring (CGM) systems, with the Co-Director of the DSN Forum UK among the contributing authors.
Amanda Williams contributed to the work, which was developed through a modified Delphi process involving clinicians, scientists and researchers and highlights three key barriers currently limiting the reliable interpretation and comparison of glucose-derived measures across CGM technologies.
The first challenge highlighted is limited transparency. In some regulatory settings, including those using Conformité Européenne (CE) marking, important documentation such as clinical-study reports, analytical data and reference-method information required for market authorisation is not publicly accessible.
The second barrier relates to variation in study procedures. Differences in reference-glucose methods, sampling strategies, glucose-manipulation protocols and participant characteristics mean that accuracy estimates cannot always be consistently interpreted between systems.
The clinical opinion also highlights calibration alignment as a further challenge. Even where evaluation processes are transparent and standardised, differences in calibration algorithms and reference glucose datasets can still result in variations in device performance and glucose reporting. These discrepancies may influence automated insulin delivery behaviour and impact interpretation when individuals transition between CGM systems.
Alongside this work, the International Federation of Clinical Chemistry and Laboratory Medicine has also released a validated framework for CGM performance evaluation, aiming to support a more unified approach to reference-method selection, dynamic in-clinic testing and structured reporting.
The study stated: “This international clinical opinion proposes a pathway towards internationally interpretable CGM evaluation: immediate transparency of clinical evidence, routine declaration of calibration alignment and progressive adoption of validated standardised procedures.”
Amanda Williams, who is also the Lead Nurse for Diabetes and Endocrinology at East Kent Hospitals University NHS Foundation Trust, added: “The international diabetes community now needs to move beyond basic market approval and towards globally comparable standards for CGM evaluation.
“Transparency of clinical evidence and standardised assessment methods are no longer optional extras given the role these technologies play in insulin dosing and automated insulin delivery.”
According to the authors, these recommendations provide an important foundation for more reliable interpretation and globally comparable assessment of CGM technologies.
To access the international clinical opinion, click here.