The 2025 ADA guidelines recommend the use of real‑time continuous glucose monitoring without fingerstick calibration (rtCGM) or intermittent scanned CGM (isCGM) for diabetes management in adolescent and adult patients receiving any type of insulin therapy.A systematic review and meta‑analysis of randomized controlled trials has shown that fingerstick‑calibration‑free continuous glucose monitoring (CGM) significantly improves glycemic control in patients with type 1 diabetes (T1DM).In patients with type 2 diabetes (T2DM) on multiple daily insulin injections (MDI), CGM improves glycemic control without increasing the risk of hypoglycemia.Furthermore, among insulin‑treated T2DM patients, CGM reduces HbA1c more significantly than self‑monitoring of blood glucose.
A 2024 proposal further emphasized the role of CGM in T2DM management, recommending intermittent or continuous CGM use for all T2DM patients — from newly diagnosed to long‑standing cases — according to their treatment stage (diet control, pharmacotherapy, insulin therapy), to guide patient education, evaluate efficacy, and adjust treatment regimens.
In terms of regulation, CE certification alone is insufficient to ensure the accuracy and safety of CGM devices.The European Union Diabetes Forum (EUDF) is actively promoting the establishment of CGM quality standards, with reference to ongoing technical documents such as BSI PAS 2600.A European expert consensus proposal recommends introducing minimum performance standards similar to iCGM as an additional safeguard on top of CE certification.The proposal covers several specific requirements, including consistent sensor performance throughout the wear period, evaluation of the impact of potential interfering substances, and built‑in safety mechanisms.
With stringent accuracy criteria, iCGM enables more reliable full‑time glucose monitoring, with outstanding performance especially in the hypoglycemic and hyperglycemic ranges.Clinical evidence demonstrates that CGM‑derived metrics such as TIR are significantly associated with patient outcomes, providing a multidimensional assessment tool for diabetes management.Current guidelines recommend CGM for optimizing insulin therapy and patient self‑management, and its integration with digital technology is driving diabetes management toward precision and individualization.The establishment and application of the iCGM standard further promote the standardization of glucose monitoring and are expected to facilitate the implementation of closed‑loop therapeutic systems.