The neonatal continuous glucose monitoring paradox: why at-risk infants still lack access to a transformative technology-A call for needs-led innovation.

Glucose instability in the newborn is common, often clinically silent, and carries serious consequences for neurodevelopment. With rising rates of prematurity and maternal diabetes, the number of infants at risk is growing. Two decades of research have established continuous glucose monitoring (CGM) as feasible in neonatal populations, with the potential for detecting previously missed dysglycaemic episodes alongside reducing the need for repeated invasive blood sampling. Despite this no CGM system is licensed for use in children below 2 years of age. Research in neonates has relied on off-label use of devices designed for adults, with challenges of insertion and regulatory barriers to use in clinical practice. Even the current off-license workaround is under threat as the commercial CGM design is moving toward integrated devices that combine sensors and transmitters. This development will make CGM more difficult to use in newborns, and unsafe in extremely preterm infants. Not only is this an example of inequity of access to those with significant clinical need it is also an innovation opportunity. This lack of needs-led innovation is not unique to CGM but is a case study of a broader issue affecting high-risk, and rare-disease populations. In these settings commercial incentives alone usually fall short and support for derisking development is essential. The EU and FDA have begun building regulatory infrastructure to address this. However, ensuring equitable access to innovations in care, of which CGM is just one example, will require sustained collaboration between clinical teams, research funders, regulators, and industry.