Endocrine Abstracts

Introduction: NICE Guidance 18 updated in March 2022 will make real-time continuous glucose monitoring (rtCGM) the standard of care and recommends the cheapest rtCGM that meets an individual’s needs. Eight rt-CGM devices have Conformité Européene (CE) mark for paediatrics with type 1 diabetes. There are no published performance standards for CE mark; however, the Food & Drug Administration (FDA) published their interoperable CGM (iCGM) criterion. For iCGM approval for adults, robust standards include the 15/15 accuracy requirement for time below range (TBR, <3.9 mmol/l), time in range (TIR, 3.9-10.0 mmol/l), and time above range (>10.0 mmol/l), and the 20/20 accuracy requirement for the glucose range 2.2-22.2 mmol/l. Paediatric iCGM approval requires comparable data. However, if a CGM device has CE mark, there are no further UK accuracy safeguards.

Design and Methods: Step 1) Obtain paediatric peer-reviewed accuracy studies for the eight rt-CGMs available in the UK. Step 2) Compare each rtCGM device accuracy data against the adult 15/15 iCGM requirement; 85% of paired Yellow Spring Instrument (YSI) readings within 0.8 mmol/l (15 mg/dl) for TBR, 70% of paired YSI readings within 15% for TIR, and 80% of paired YSI readings within 15% for TAR. Compare each rtCGM device accuracy data against the 20/20 iCGM requirement; 87% of YSI readings within 1.1 mmol/l (20 mg/dl) for TBR and within 20% when 3.9-22.2 mmol/l.

Results: Glucomen Day® & Medtrum TouchCare® Nano had no peer-reviewed studies prior to CE Mark. The Medtrum TouchCare® A6 and GlucoRx AidexTM studies were excluded as all participants were adults with >80% having type 2 diabetes. The MiniMed Guardian^TM Connect (7-17yrs) study data did not allow assessment against 15/15 criteria. The Dexcom G6^TM (6-17yrs) only failed the 85% accuracy within 0.8 mmol/l for TBR. The Dexcom G7TM (6-17yrs) and Freestyle Libre® 3 (6-17yrs) met the selected iCGM criteria.

Conclusion: Only the Dexcom G7^TM and Freestyle Libre 3^TM performance meet the15/15 and 20/20 adult iCGM accuracy criteria. The Dexcom G6TM failed one measure but has been iCGM approved by the FDA as comparable. Of concern, the Glucomen Day® & Medtrum TouchCare® Nano are available without published data and the Medtrum TouchCare® A6 and GlucoRx Aidex^TM without any peer-reviewed paediatric-specific data.